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Index to Consolidated Financial Statements of OvaScience, Inc.

Table of Contents

 

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



FORM 10-K

(Mark One)    

ý

 

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2013

OR

o

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                        to                       

Commission File Number: 001-35890

OVASCIENCE, INC.
(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction of
incorporation or organization)
  45-1472564
(I.R.S. Employer
Identification Number)

215 First Street, Suite 240
Cambridge, Massachusetts

(Address of Principal Executive Offices)

 

02142
(Zip Code)

         Registrant's telephone number, including area code: (617) 500-2802

         Securities registered pursuant to Section 12(b) of the Act:

Title of each class   Name of Each Exchange on Which Registered
Common Stock, par value $0.001 per share   The NASDAQ Stock Market LLC

         Securities registered pursuant to Section 12(g) of the Act: None

         Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes  o     No  ý

         Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. Yes  o     No  ý

         Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days. Yes  ý     No  o

         Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes  ý     No  o

         Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  ý

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

Large accelerated filer o   Accelerated filer ý   Non-accelerated filer o
(Do not check if a
smaller reporting company)
  Smaller reporting company o

         Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes  o     No  ý

         Aggregate market value of voting stock held by non-affiliates of the registrant as of June 28, 2013 (the last day of the registrant's second fiscal quarter of 2013) was: $97.0 million

         As of January 31, 2014, there were 18,563,215 shares of the registrant's Common Stock, par value $0.001 per share, outstanding.

          DOCUMENTS INCORPORATED BY REFERENCE

         Portions of the information required by Part III of Form 10-K will appear in the registrant's definitive proxy statement on Schedule 14A for the 2014 Annual Meeting of Stockholders and are hereby incorporated by reference into this report.

   


Table of Contents


TABLE OF CONTENTS

 
   
  Page  

 

PART I

     

Item 1.

 

Business

    1  

Item 1A.

 

Risk Factors

    27  

Item 1B.

 

Unresolved Staff Comments

    66  

Item 2.

 

Properties

    66  

Item 3.

 

Legal Proceedings

    66  

Item 4.

 

Mine Safety Disclosures

    66  

 

PART II

       

Item 5.

 

Market For Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

    67  

Item 6.

 

Selected Consolidated Financial Data

    68  

Item 7.

 

Management's Discussion and Analysis of Financial Condition and Results of Operations

    69  

Item 7A.

 

Quantitative and Qualitative Disclosures About Market Risk

    81  

Item 8.

 

Consolidated Financial Statements and Supplementary Data

    82  

Item 9.

 

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

    82  

Item 9A.

 

Controls and Procedures

    82  

Item 9B.

 

Other Information

    83  

 

PART III

       

Item 10.

 

Directors, Executive Officers and Corporate Governance

    84  

Item 11.

 

Executive Compensation

    84  

Item 12.

 

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

    84  

Item 13.

 

Certain Relationships and Related Transactions, and Director Independence

    84  

Item 14.

 

Principal Accountant Fees and Services

    84  

 

PART IV

       

Item 15.

 

Exhibits and Financial Statement Schedules

    85  

SIGNATURES

     

Table of Contents


CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

        This Annual Report on Form 10-K and the information incorporated by reference in this Annual Report contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or Securities Act, and Section 21E of the Securities Exchange Act of 1934, or Exchange Act, regarding our strategy, future, operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management. You can identify these forward-looking statements by their use of words such as "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. You also can identify them by the fact that they do not relate strictly to historical or current facts. There are a number of important risks and uncertainties that could cause our actual results to differ materially from those indicated by forward-looking statements. For a description of these risks and uncertainties, please refer to the section entitled "Risk Factors" in this Annual Report and any other risk factors set forth in any information incorporated by reference in this Annual Report. While we may elect to update forward-looking statements wherever they appear in this Annual Report or in the documents incorporated by reference in this Annual Report, we do not assume, and specifically disclaim, any obligation to do so, whether as a result of new information, future events or otherwise.



PART I

Item 1.     Business.

Overview

        OvaScience is a global life science company focused on the discovery, development, and commercialization of new fertility treatments. Our patented technology is based on egg precursor cells ("EggPC SM "), which are found in the outer layer of a woman's own ovaries. The recent discovery of EggPCs countered a long-held medical belief that women are born with a set number of eggs, thereby enabling new possibilities in the treatment of female infertility.

        Our portfolio of fertility treatment options takes advantage of proprietary methods to identify, isolate and concentrate EggPCs from the patient's ovarian tissue. By applying our EggPC technology platform in unique ways, we are developing new fertility treatment options that are designed to improve egg quality and in vitro fertilization ("IVF"). These treatment options under development include the following:

    AUGMENT SM aims to improve egg quality and potentially increase the success of IVF by transferring mitochondria from a woman's EggPCs to her mature egg during IVF. We plan to introduce AUGMENT in 2014 in at least four international regions.

    OvaPrime SM is designed to boost a woman's egg reserve by transferring the EggPCs from the outer layer of her ovary (outer cortex) back into the ovary prior to IVF. We expect to introduce OvaPrime outside of the United States in 2015.

    OvaTure SM seeks to mature a woman's own EggPCs into fertilizable eggs without the need for hormone hyperstimulation.

    OvaXon SM is a joint venture with Intrexon Corporation, which is focused on developing new applications to prevent inherited diseases by gene editing EggPCs for applications in human and animal health.

        We believe our EggPC technology has the potential to make significant advances in the field of fertility because it may enable us to address poor egg and embryo quality due to age and other causes. We believe our EggPC technology could improve IVF by:

        Increasing live birth rates and reducing the number of IVF cycles.     By improving egg quality, we believe we may be able to increase the percentage of IVF treatments which result in live births and, in so doing, reduce the number of IVF cycles required.

        Reducing the incidence of multiple births.     By generating higher quality eggs, we believe our EggPC technology may allow for the transfer of fewer embryos per IVF cycle and, as a result, lower the incidence of multiple births and the associated complications for the mother and baby.

        Lowering the overall cost of IVF.     If we reduce the number of IVF cycles required for a live birth and the incidence of multiple births, we believe our fertility treatment options may also lower the overall costs associated with IVF.

        Reducing the need for hormonal hyperstimulation.     We are designing our OvaTure technology to mature EggPCs into fertilizable eggs in vitro . If successful, OvaTure could reduce, or possibly eliminate, the need for hormonal hyperstimulation for the maturation of multiple oocytes prior to egg retrieval in the IVF process.

        Preventing inherited diseases.     By applying gene editing techniques to EggPCs, we believe we may be able to prevent the transmission of inherited diseases, such as Huntington's Disease, in future generations.

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AUGMENT

        The Company's first fertility treatment is AUGMENT SM , which we plan to introduce to international IVF clinics in 2014 through our AUGMENT Centers of Excellence ("ACE") access program. The goal is for physicians to gain experience using AUGMENT and to generate data. In 2014, we expect to establish ACE clinics in at least four international regions, which we anticipate will result in 40 to 60 AUGMENT cycles this year. By year end 2014, we expect to transition these ACE clinics to commercial centers. We are targeting international regions that combine elements of the following key criteria:

    Key opinion leaders / high volume IVF clinics

    High quality IVF labs

    Out-of-pocket pay and high average cost per cycle

    Donor egg restrictions

        As part of AUGMENT, a woman's eggs may be rejuvenated by injecting mitochondria prepared from her own EggPCs into her egg during IVF. This has the potential to improve egg quality and thereby increase the success of IVF. With higher quality eggs, there is also the potential to reduce the need for multiple embryo transfers, which can result in a lower incidence of conceiving multiples (twins or triplets) and resulting complications.

        AUGMENT complements the existing standard of practice for an IVF cycle. Prior to hormone hyperstimulation, a small tissue biopsy is taken from the outer layer of the ovary, where the EggPCs reside. Our proprietary process identifies and isolates the patient's own EggPCs followed next by the removal of her own mitochondria within the EggPCs. The women's own mitochondria are then injected into her egg at the time of intracytoplasmic sperm injection ("ICSI").

        The development of assisted reproductive technologies has a long history of innovation based on techniques and tools developed in IVF clinics around the world. In fact, all of the major innovations in fertility treatment have been developed in countries outside of the United States, including IVF and ICSI, and more recently, time-lapse imaging, oocyte vitrification and in vitro maturation of oocytes. This is a main reason why the IVF market is predominantly located outside of the United States where 90% of the 1.6 million annual IVF cycles are performed. Given the market size, as well as the innovative history and acceptance of new fertility methods and technologies internationally, we have always had a strategy to make our fertility treatments available to patients worldwide. We plan to introduce our first fertility treatment, AUGMENT, through a limited commercial launch in international IVF clinics in 2014, and we are preparing to launch a second fertility treatment using this approach in 2015. We believe that we will be able to introduce AUGMENT into these regions without pre-market review and approval, but if applicable regulatory bodies disagree, we may abandon AUGMENT in that region or suffer significant delay or expense in seeking necessary approvals. To gain clinical experience with AUGMENT in the United States ahead of a commercial launch, in December 2012, we initiated a study of AUGMENT in the United States. In September 2013, we received an "untitled" letter from the FDA advising us to file an Investigational New Drug (IND) application for AUGMENT. Following the receipt of the FDA letter, we chose to suspend enrollment in the U.S. study. We anticipate having further discussions in 2014 with the FDA to present details on AUGMENT and to determine the appropriate path forward.

Scientific Rationale and Supporting Studies

        Fertility decreases with age, and the energy levels in the egg are believed to play a major role in this decrease. After fertilization, the early stage embryo requires energy for cell division. Inadequate energy results in a failure of the newly formed embryo to develop. We believe that the energy level in a

2


woman's eggs may be enhanced, and the success of embryo development improved, by the insertion of mitochondria prepared from the woman's own EggPCs into her egg at the time of fertilization.

        Studies published in peer reviewed medical journals, including Human Cell (2004), Electronic Journal of Biology (2005), Reproduction Research (2006) and Reproductive Biomedicine (2011), provided the first evidence of the effects of mitochondria on egg quality. In these studies, which involved a number of species, including bovine, porcine, rabbit and murine, third party scientists demonstrated that the addition of mitochondria to eggs with mitochondrial deficiencies increased cellular energy levels, egg quality and the likelihood of fertilization and healthy live births.

        In human studies published in the peer reviewed medical journals Molecular Human Reproduction (1998) and Human Reproduction (2001), researchers transfused cytoplasm from the eggs of younger women donors into the eggs of older women who failed multiple IVF cycles. The cytoplasm is the liquid portion of a human cell that surrounds the nucleus and contains the egg's mitochondria. Each of these studies increased the rates of fertilization, embryo development, implantation and pregnancy for the older women whose eggs were transfused. Of the approximately 30 women included in the study who had previously failed two to five IVF cycles, 13 achieved pregnancies and delivered 16 healthy offspring. Additional published studies showed similar success rates and rates ranging from 25%-44% were reported for women who had previously failed multiple cycles and had not achieved a pregnancy.

        These studies served as the basis for the scientific hypothesis that the addition of healthy donor mitochondria might be used to improve the quality of eggs with mitochondrial deficiencies. However, following publication of these initial human studies, many scientists and clinicians questioned the long term safety of the use of third party donor mitochondria in humans because mitochondria contain DNA. Mitochondria produce energy in all cells of the body. Unlike nuclear DNA, contained in the nucleus, which is inherited from two different people, half from the biological mother and half from the biological father, mitochondrial DNA is inherited solely from the mother. As a result, while the process appeared to be safe with respect to the fertilized egg and the patient, scientists and clinicians questioned whether the presence of mitochondria, and therefore mitochondrial DNA, from two different women might result in health problems later in the child's life. In response to these concerns, the FDA informed sponsors and other researchers that the use of cells in therapy involving the transfer of third party genetic materials, including mitochondrial DNA, requires submission of an investigational new drug application, or IND.

        The approach we are using with AUGMENT builds on these studies but uses a woman's own mitochondria from her own EggPCs to improve her fertility instead of third-party donor mitochondria. While all cells contain mitochondria, we believe the mitochondria from cells involved in reproduction, known as germline cells, as opposed to other cells in the body, known as somatic cells, are the ideal source of mitochondria for transfer to improve egg quality. This is because somatic cells are exposed to environmental toxins and cell waste products that may cause mutations or deletions in mitochondrial DNA that will be passed along to subsequent cells. These mutations and deletions can decrease the quality of the mitochondria and the ability to produce energy. In contrast, the mitochondrial DNA from germline cells contain minimal mutations and deletions. Because the mitochondria within an egg are the template for all subsequent cell reproduction in the offspring, we believe that it is necessary to use high-quality mitochondria to improve egg quality.

        Based on the above studies, the approach we are using with AUGMENT is to use germline mitochondria from the patient's own EggPCs to improve the quality of the patient's eggs. By using mitochondria from the woman's own EggPCs, instead of from a third party donor, AUGMENT does not involve the transfer of third party genetic material.

AUGMENT Steps

        We are designing AUGMENT to use mitochondria from a woman's own EggPCs in IVF procedures to improve the energy and quality of the woman's eggs. The following is a summary of the

3


process that we are using for our ACE program to prepare the patient's own mitochondria for insertion into one of her own mature eggs during IVF:

    Obtain Ovarian Tissue:   Ovarian surface tissue will be obtained by the IVF clinic prior to the AUGMENT procedure.

    Identify and Isolate EggPCs:   Ovarian tissue will be washed, digested with enzymes, and mechanically dissociated to form a solution containing single cells. EggPCs will be separated from the other cells in the single cell solution by a process known as fluorescence activated cell sorting, or FACS. EggPCs can then be processed for isolation of mitochondria (described below) or frozen and stored in vials until the day of egg fertilization in the IVF process.

    Prepare Mitochondria from EggPCs:   EggPCs will be disrupted mechanically and mitochondria isolated by differential centrifugation. Using a standard quantification method, we will assess the number of mitochondria for use in the IVF process.

        Each of the steps described above follows routine clinical laboratory processes and procedures, and none of these steps requires new methods, equipment or technologies to execute. Specifically, the process of isolating the EggPCs will be performed using commercially available separation techniques. We continue to optimize the efficiency of the steps that comprise the AUGMENT process and reduce the anticipated cost of the procedure.

        As we stated in August of 2013, we have contracted with a global third party supplier that is compliant with good tissue practices, or cGTPs, to perform the AUGMENT process from the step of isolating the EggPCs to the step of concentrating the mitochondria in ICSI fertilization buffer. In the future, we may establish our own cGTP-compliant facility and perform these steps in the process ourselves, with the goals of maintaining greater control of the process and reducing the cost of manufacturing.

Development Pipeline

        We have a pipeline of fertility treatments under development, all based on the same EggPC technology. Collectively, it is our goal to offer multiple options so physicians can help patients select the optimal treatment, which could include new solutions for age-related infertility, diminished ovarian reserve, premature ovarian failure, polycystic ovary syndrome, or other conditions affecting fertility.

        OvaPrime SM , the latest addition to our pipeline, is designed to boost a woman's egg reserve using her own EggPCs. Similar to AUGMENT, OvaPrime may be integrated into the IVF cycle starting with a small tissue biopsy of the outer layer of the ovary, where the EggPCs reside. Our proprietary process isolates a woman's own EggPCs, which are next delivered back into the patient's ovaries, where we believe they can mature into fertilizable eggs prior to a standard IVF procedure. We will conduct further studies and continue treatment optimization in 2014 in anticipation of a commercial launch of OvaPrime in 2015 outside of the United States.

        OvaTure SM seeks to create mature fertilizable eggs ex vivo from a woman's own EggPCs without the need for hormone hyperstimulation. Importantly, OvaTure may provide a new treatment option for women with compromised eggs, who are unable to make eggs, or who may be unwilling or unable to undergo hormone hyperstimulation, such as women diagnosed with cancer who seek to preserve their future fertility. To accelerate development, we entered into a collaboration with Intrexon to access their industrialized synthetic biology platform with the goal of completing preclinical studies within two years. We expect we may need to obtain regulatory approval of OvaTure in both the United States and other international markets prior to commercialization. OvaScience owns exclusive human commercial rights for OvaTure in humans.

        OvaScience and Intrexon formed a joint venture in December 2013 called OvaXon to develop an innovative approach to the prevention of genetic disease and animal health. The collaboration

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combines Intrexon's synthetic biology capabilities with OvaTure to prevent the propagation of inherited diseases such as mitochondrial and other genetic disorders in future generations. Each party contributed $1.5 million to OvaXon and has a 50% equity interest. Research and development costs and profits will be split equally. The joint venture anticipates initially targeting the animal health market, which is estimated to grow to $19 billion by 2018 according to consensus estimates for animal divisions of Elanco, Merck, Sanofi, and Zoetis.

        Marketdata Enterprises, Inc., Tampa, Florida, a publisher of independent market research studies, estimates that the U.S. infertility services market reached approximately $4 billion in 2008. According to the 2005 Fertility, Family Planning and Reproductive Health of U.S. Women Report prepared by the U.S. Centers for Disease Control and Prevention, or CDC, approximately 1.2 million women sought infertility treatment in the United States in 2002. Additionally, 1.5 million women aged 15-44 are infertile, according to the 2011 Fertility Clinic Success Report, prepared by the CDC. We believe that our planned sales and marketing team would enable us to call on the clinics responsible for the majority of the IVF procedures performed in the United States annually. Due to demographics, earlier market adoption of IVF in the EU and other factors, we believe that the number of women seeking infertility treatment in the EU is substantially larger than in the United States, according to the European Society of Human Reproduction and Embryology public database as compared to U.S. CDC data.

Egg Precursor Cells

        In 2004, one of our scientific founders, Jonathan Tilly, Ph.D., from the Vincent Center for Reproductive Biology at the Massachusetts General Hospital, or MGH, discovered the existence of EggPCs within the ovaries of adult mice. Subsequent research by Dr. Tilly demonstrated that these EggPCs also exist in human ovaries and have the potential to mature into eggs and, therefore, to replenish a woman's egg supply. This research demonstrated that these EggPCs might provide a source of fresh cellular components, such as mitochondria, that could potentially be used to enhance the quality of existing eggs.

        Dr. Tilly discovered the existence of mouse EggPCs by staining the outer cell layer of the ovary using an antibody that binds specifically to a protein found on EggPCs called mouse VASA homologue. Following publication of this discovery in Nature in 2004, Dr. Tilly performed additional research, beginning in 2005, which demonstrated the existence of human EggPCs in adult human ovaries. In this research, Dr. Tilly replicated the results obtained with mouse tissue using human ovarian tissue. Dr. Tilly was able to isolate precursor cells in the ovaries of reproductive age women using an antibody that binds to the human VASA analogue protein, which is found on human EggPCs. Dr. Tilly also conducted an experiment in which human EggPCs were isolated in vitro and then grafted into female mouse hosts and matured in vivo into eggs that exhibited a genetic signature indicating the eggs could be fertilized. Dr. Tilly's research findings with respect to human EggPCs were published in the March 2012 issue of Nature Medicine .

        Although this research has demonstrated the existence of EggPCs in human ovaries, and suggests that it may be possible to develop human EggPCs into mature, fertilizable eggs, research with respect to human EggPCs is a new and emerging field. As a result, there is ongoing debate regarding the role of EggPCs in human reproduction and whether EggPCs, when isolated from ovarian tissue, can be matured in the laboratory into fertilizable human eggs. We anticipate preclinical proof of concept that human EggPCs can be matured into fertilizable eggs in 2014.

        We hold an exclusive license from MGH to issued patents and various patent applications directed to methods of identifying and isolating EggPCs, compositions comprising EggPCs and methods of using EggPCs to treat infertility and related disorders.

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Background

        Infertility is a widespread problem around the world. Infertility is the inability to achieve pregnancy after 12 consecutive months, or for those who are over 35 years of age, six consecutive months, of trying to conceive through regular unprotected intercourse. In 2011, the European Society for Human Reproduction, or ESHRE, the mission of which is to promote the understanding of reproductive biology and medicine, reported that the worldwide prevalence of infertility among women aged 20 to 44 was approximately 9%. According to the 2011 Assisted Reproductive Technology: Fertility Clinic Success Rates Report, prepared by the CDC, approximately 7.4 million or 12% of women in the United States aged 15 to 44 had used infertility services at some point in their lives.

        There are many steps in the process of natural conception. If any of them fails, a woman will not be able to conceive naturally. The steps are as follows:

    The process begins when the brain signals the pituitary gland to send a hormone, known as follicle stimulating hormone, or FSH, to the ovaries, prompting the ovaries to prepare for egg ovulation. FSH stimulates a group of follicles, which are fluid filled sacs containing one egg each, to grow in the cortex of the ovary.

    Over the next two weeks, the eggs mature and levels of estrogen, a hormone produced by the ovaries, increase.

    As the estrogen levels increase, the pituitary gland produces less FSH. The production of luteinizing hormone, or LH, another hormone produced by the pituitary gland, is then triggered at mid-cycle.

    The mid-cycle peak of LH signals the ovary to release a mature egg from its follicle in a process known as ovulation. The egg enters the fallopian tube and begins to travel through the tube into the uterus. The egg remains viable for about 24 hours.

    For fertilization to occur, a sperm must locate and penetrate the egg while in the fallopian tube. If fertilization occurs, the fertilized egg, or embryo, continues to travel down the fallopian tube into the woman's uterus.

    On approximately the seventh day following fertilization, the embryo develops specialized cells on its surface that enable it to attach, or implant, in the lining of the uterus.

    Once attached, the embryo continues to grow and receives its blood supply from the mother through blood vessels that grow within the umbilical cord.

        There are multiple reasons why the process described above might fail. The reasons attributable to female infertility include:

    poor egg quality resulting from a woman's age or other causes;

    ovulation disorders, including the inability, or reduced ability, to ovulate;

    damage to the ovary caused by cancer or cancer treatments, such as chemotherapy;

    problems with the uterus, for example, due to surgery or infection; and

    a blocked or damaged fallopian tube.

        According to a study published in the peer reviewed medical journal Human Reproduction (1996), the quality of a woman's eggs declines with age. In many instances, the decreased egg quality is the result of inadequate amounts of energy. Energy is required for all functions of the egg, especially during times of rapid cell division and early embryo growth. Cellular energy, known as adenosine triphosphate or ATP, is produced by mitochondria.

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Table of Contents

        Around the world, women are choosing to have children later in life. As reported in a study published in Human Reproduction (2004), a peer reviewed medical journal published on behalf of ESHRE, a woman's chance of conceiving naturally within one year decreases from approximately 75% at age 30 to 44% at age 40. According to the CDC, the average age for a woman having her first child was 25 in 2006, as compared to an average age of approximately 21 in 1970. While an increasing number of women are delaying childbearing and pregnancy until their late 30s and early 40s, current treatments often do not meet the needs of infertile women.

Current Infertility Treatments

        Infertility treatments fall into two broad categories. The first category includes treatments that do not involve the retrieval or handling of an egg from a woman. The two most common types of treatments in this first category are fertility drugs and intrauterine insemination, or IUI. Fertility drugs, such as clomiphene, are administered to a woman to induce ovulation. IUI, also known as artificial insemination, is a procedure that involves placing sperm directly into the uterus. If these treatments are not successful, a couple often will turn to more advanced techniques in the category known as assisted reproductive technology, or ART. ART refers to any fertility treatment involving the handling of both eggs and sperm, including IVF.

        IVF procedures typically involve surgically removing eggs from a woman's ovaries, combining them with sperm in the laboratory, or in vitro , and returning them to the woman's body or donating them to another woman. Because an IVF procedure includes several steps, it is typically referred to as a cycle of treatment.

        IVF is the most common type of ART. Approximately 99% of the ART procedures performed in the United States in 2012 involved IVF and similar dynamics are found in international markets. An IVF procedure typically begins with stimulation of the woman's ovaries by a combination of fertility medications in the hormonal hyperstimulation process. Then one or more eggs are taken from the woman's ovarian follicles and fertilized in vitro . In the final step, one or more embryos are transferred into the woman's uterus. These steps typically occur over a two week period. The IVF procedure also may be performed using eggs donated from another woman.

        During an IVF procedure, fertilization of the egg can occur either by placing a drop of specially washed sperm on the egg and allowing the sperm to penetrate naturally or through a process called intracytoplasmic sperm injection, or ICSI. In an ICSI procedure, a single sperm is injected directly into a mature egg using a small needle to achieve fertilization. ICSI was originally developed for use in couples with severe male factor infertility. Today the procedure is widely used in IVF, even among couples without a diagnosis of male factor infertility. According to the Society of Assisted Reproductive Technologies, or SART, an organization of professionals dedicated to the practice of ART in the United States, ICSI was utilized in 67% of all IVF procedures performed in the United States in 2012. However, according to SART, only 17% of all patients using IVF in the same year had a diagnosis of male factor infertility.

        ART and IVF are often categorized according to (1) whether the procedure uses a woman's own eggs or eggs from a donor and (2) whether the embryos used are newly fertilized, referred to as fresh, or previously fertilized, frozen and then thawed. According to data gathered by SART, the percentages of ART cycles performed in the United States in 2012 in these categories were as follows:

Type of ART Cycle
  % of Total
ART Cycles
 

Fresh Nondonor

    56 %

Frozen Nondonor

    20  

Fresh Donor

    6  

Frozen Donor

    5  

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Table of Contents

        Although ART success rates have increased modestly over the last decade, these rates remain relatively low. According to the CDC, of the 163,039 ART cycles performed in the United States in 2011, only 47,818, or 29%, resulted in live births. Couples seeking to preserve a genetic match must use their own (nondonor) egg and sperm for treatments. However, these patients generally have lower success rates than patients using a third person's younger donor eggs, which typically come from women in their 20s or early 30s. According to the CDC, in 2011, 101,213 fresh nondonor ART cycles were started in the United States, of which 36,266, or 36%, led to a pregnancy and 29,598, or 29%, resulted in a live birth. In contrast, the CDC found that in 2011, 55% of the ART cycles in the United States using fresh donor eggs resulted in a live birth. As shown in the table below, according to a CDC report of 2010 data, IVF pregnancy success rates for women over age 35 remain relatively flat, regardless of the woman's age, when using donor eggs.

GRAPHIC

Shortcomings of ART

        Current ART procedures have significant shortcomings. These include:

        Low live birth rates and high number of IVF cycles.     In a historical cohort study published in Fertility and Sterility (2010), an international peer reviewed journal for professionals who treat and investigate problems of infertility and human reproductive disorders, of the ART patients residing or treated in Massachusetts between 2004 and 2006, approximately 50% received two or more ART cycles, with approximately 25% receiving two cycles and approximately 13% receiving three cycles. In addition, according to this same study, the percentage of women who ultimately achieved a live birth using ART plateaued at approximately 54% after four or more cycles. The need for multiple ART cycles often takes an emotional and physical toll on the woman and significantly increases the costs of ART.

        High incidence of multiple births.     Another problem of IVF is that it entails increased risks of multiple pregnancies and births. In an IVF procedure, it is common practice to transfer several embryos into a woman's uterus in an effort to increase the success rate. However, multiple transfers are also responsible for a high multiple birth rate. According to the CDC, in 2010, there was a 30% rate of multiple births for ART pregnancies using fresh nondonor eggs in the United States. This rate is significantly higher than the 3% rate the CDC reports for multiple births from natural pregnancies in the general United States population. Multiple gestations and births result in increased risks and costs to mother and babies, including preterm birth and low birth weight.

        High cost of treatment.     The average cost to a patient in the United States for a single IVF/ICSI cycle is approximately $16,000, according to studies detailed in Human Reproduction Update (2010) and

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Fertility and Sterility (2009), as adjusted for inflation. However, a study published by Nachtigall et al. in Fertility and Sterility (2012) found that, depending on the IVF clinic, the cost of one treatment cycle can exceed $25,000. Since patients frequently require more than one cycle, the IVF cost per live birth can exceed $50,000. We estimate, based on data compiled from the last decade and reported by ESHRE in Human Reproduction Update (2010), that the cost of one IVF treatment cycle in the EU ranges from approximately $3,000 to $6,250.

        Need for hormonal hyperstimulation.     The hormonal hyperstimulation used in connection with IVF involves daily injections of fertility drugs for time periods ranging from one week to ten days, which often is inconvenient and uncomfortable. Other problems with hormonal hyperstimulation include the frequent production of eggs of inferior quality, the need to carefully oversee the patient and side effects, including hot flashes, blurred vision, mood swings, stomach pain, weight gain, nausea, dizziness, low blood pressure and headaches. In addition, hormonal hyperstimulation cannot be used by some women, such as those with hormone dependent cancers.

The IVF Market

        It is estimated that the international markets account for 90% of global IVF. According to ESHRE, approximately 1.6 million ART cycles are performed each year worldwide. ESHRE estimates that, in 2010, over 565,000 ART cycles were performed in Europe. According to SART, approximately 165,000 IVF cycles were performed in the United States in 2012. Examples of other countries in which a large number of IVF cycles are performed include Japan and Australia; Brazil, Latin America, Russia, Turkey and UAE are estimated to be growing at a rate of 30-40%.

GRAPHIC

        Despite relatively low success rates, risks and other shortcomings, the use of IVF treatments has become increasingly common, especially for women faced with declining fertility due to their age.

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        In many markets globally, IVF is paid for out of pocket, particularly in high growth areas outside the EU and the U.S. Many third party payors, including national health services or government funded insurance programs, as well as private payors, place significant restrictions on coverage and reimbursement for IVF and other ART procedures. These restrictions include limits on the types of procedures covered, limits on the number of procedures covered and overall annual or lifetime dollar limits on reimbursement for IVF and other ART procedures. Our preliminary market research indicates that this is primarily due to the fact that many women seeking IVF treatments are of advanced maternal age and are concerned that fertility and IVF success rates will continue to decline over time. As a result, women and couples will frequently pay out of pocket for fertility treatments, such as IVF, rather than avail themselves of other step-based approaches to fertility treatment, such as oral fertility drugs to stimulate ovulation or IUI procedures, that may be required by insurance programs.

Research and Development Spending

        During the years ended December 31, 2013, and 2012 and the period from April 5, 2011 (inception) to December 31, 2011, we spent approximately $15.8 million, $6.3 million and $1.2 million, respectively, on our research and development activities.

Manufacturing

        We do not own a manufacturing facility. We have contracted with a global third-party supplier to perform the identification and isolation of EggPCs and the preparation of mitochondria steps in the AUGMENT process for our ACE program and early commercial activities. Our supplier has significant experience in tissue and cell therapy manufacturing. In our anticipated launch of AUGMENT and OvaPrime outside the United States, we may use our existing global cGTP-compliant manufacturer, contract with in-country manufacturers or manufacture on-site in clinics using our own equipment and our own employees. We have no experience with manufacturing fertility treatments for commercial purposes and we cannot assure you that our efforts will be successful. In the future, we plan to contract with an additional global supplier and may build our own cGTP-compliant facility to carry out these steps in the AUGMENT process and to manufacture OvaPrime, OvaTure and other potential fertility treatments. In some regions outside of the United States, we may contract with third parties, through partnerships, out-licenses or other arrangements, to process and manufacture our potential fertility treatments.

        The FDA has adopted a comprehensive regulatory program for human cellular and tissue-based products, or HCT/Ps. Certain lower risk HCT/Ps that are regulated as 361 HCT/Ps are subject to the FDA's cGTP requirements. By contrast, HCT/Ps that are regulated as drugs or biologics are subject not only to the FDA's cGTP requirements, but also to its current good manufacturing practices, or cGMPs. We believe that AUGMENT meets the legal criteria for regulation as a 361 HCT/P.

Marketing and Sales

        We are in the process of expanding our global sales and marketing team, initially focused on supporting the limited commercial launch of AUGMENT in four international regions. Our Executive Vice President, Global Commercial Operations, has significant experience in the international female fertility market. In addition, the global IVF market where we intend to introduce AUGMENT is concentrated and we believe would not require a large sales and marketing team to readily target these regions. We anticipate recruiting a few additional employees to support our commercial efforts in select regions as we prepare for the international commercial launch of AUGMENT by the end of 2014 and the introduction of OvaPrime in 2015.

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Anticipated Foreign Subsidiary

        We are in the process of establishing an international subsidiary to which we plan to license the commercial rights to AUGMENT, OvaPrime, OvaTure and any future products. This arrangement would allow any potential value enhancement and future profits for the assets to be shared between us and the subsidiary.

Intellectual Property

        We believe we have a strong and growing intellectual property portfolio. We aggressively strive to protect the proprietary technology that we believe is important to our business, including seeking and maintaining patents intended to cover our products and compositions, their methods of use and processes for their manufacture, as well as any other inventions that are commercially important to the development of our business. We seek to obtain domestic and international patent protection, and endeavor to promptly file patent applications for new commercially valuable inventions. We also 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 on our ability to obtain and maintain patent and other proprietary protection for commercially important technology, inventions and know-how related to our business, defend and enforce our patents, preserve the confidentiality of our trade secrets and operate without infringing the valid and enforceable patents and proprietary rights of third parties. We will also rely on continuing technological innovation and in-licensing opportunities to develop and maintain our proprietary position.

    Patents and Patent Applications

        We have exclusively licensed a portfolio of patent applications owned or co-owned by The General Hospital Corporation, the corporate entity of MGH, pursuant to an agreement that is summarized below. As of February 21, 2014, we held an exclusive license under this agreement to four issued U.S. patents owned by MGH, four pending U.S. non-provisional patent applications owned by MGH, fifty-eight applications pending with patent and trademark offices outside of the U.S. which are owned by MGH, one pending U.S. non-provisional application co-owned by MGH and The President and Fellows of Harvard College, or Harvard, and fifteen applications pending in patent and trademark offices outside of the U.S. which are co-owned by MGH and Harvard.

        One family of patents and applications that we have licensed from MGH is directed to compositions comprising, and methods of isolating, female germline stem cells, and various uses for such female germline stem cells, including methods for IVF, methods for egg production, methods to treat infertility and methods to restore ovarian function. This family includes one issued patent and one allowed patent awaiting issuance, both of which will expire in May 2025, and which include claims directed to the composition and processing methods for obtaining isolated non-embryonic stem cells that express the protein markers characteristic of female germline stem cells. We believe that these patents provide protection for therapeutic compositions comprising EggPCs, which are referred to in the patents as female germline stem cells, as well as elements of the manufacturing process for obtaining such therapeutic compositions. A pending U.S. continuation application and pending European and Canadian counterpart applications, if issued as patents, would also expire in May 2025.

        A second family of patent applications that we have licensed from MGH is directed to methods and compositions for producing female germline cells from stem cells derived from either bone marrow or peripheral blood). This family includes two pending U.S. non-provisional applications and one Canadian application, which, if issued as patent(s), also would expire in May 2025. We believe that patents issuing from this family may provide protection for an alternative method of obtaining EggPCs.

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        A third family of patent applications that we have licensed from MGH is directed to methods and compositions for autologous germline mitochondrial energy transfer. This family includes two allowed U.S. patents awaiting issuance, one pending U.S. non-provisional patent application, and fifty-five counterpart applications that are pending with patent and trademark offices internationally. The allowed patents, and any patents claiming priority to the underlying provisional application, will expire in April 2032. We believe that these allowed patents, and any patents issuing from this family, provide protection for the AUGMENT procedure and several important aspects thereof.

        A fourth family of patent applications that we have licensed from MGH and Harvard is directed to methods and compositions for enhancing the bioenergetic status in female germline cells. This family includes one pending U.S. non-provisional patent application, and fifteen counterpart applications that are pending with patent and trademark offices internationally. Any patents claiming priority to the underlying provisional application would expire in April 2032. We believe that patents issuing from this family may provide protection for aspects of the AUGMENT procedure, as well as culture media that we may develop in the future.

        In addition to the patent portfolio that we have exclusively licensed from MGH, we have one issued U.S. patent and one pending U.S. non-provisional patent application, with all issued patents expiring in June 2026. We believe that patents issuing from this family may provide protection for an alternative method of producing healthy eggs.

    Trade Secrets

        In addition to patents, we expect to rely on trade secrets and know-how to develop and maintain our competitive positions. For example, significant aspects of the procedure by which we plan to process AUGMENT are based on unpatented trade secrets and know-how. Trade secrets and know-how can be difficult to protect. We seek to protect our proprietary technology and processes, in part, by confidentiality agreements with our employees, consultants, scientific advisors and contractors. We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems. While we have confidence in these individuals, organizations and systems, agreements or security measures may be breached and we may not have adequate remedies for any breach. In addition, our trade secrets and know-how may otherwise become known or may be independently discovered by competitors. To the extent that our consultants, contractors or collaborators use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.

    Exclusive License Agreement with Massachusetts General Hospital

        In June 2011, we entered into an exclusive license agreement with MGH under which we acquired an exclusive, worldwide license to specified patent rights owned by MGH and a non-exclusive license under specified know-how disclosed to us under the agreement by MGH which relates to the licensed patent rights. In September 2011, we amended this agreement to include additional patent rights owned by Harvard for which MGH has the right to grant us a license and we have subsequently amended it to broaden our license field. Under the agreement, as amended, we acquired an exclusive, royalty-bearing, worldwide license under the licensed patent rights to make, use and sell products covered by the licensed patent rights or which employ or are based on the licensed know-how and to develop and perform services covered by the licensed patent rights or which employ or are based on the licensed know-how. The license under MGH-owned patent rights and know-how is for human female fertility, the treatment or prevention of inherited (including mitochondrial) diseases or defects in all animals, including humans, assisted and/or artificial reproductive technology in all non-human animals, and the artificial creation of food, research animals and/or animal products; and the license under the MGH and Harvard co-owned patent right is for ex-vivo human female fertility treatments.

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        Under the agreement, as amended, we agreed to pay MGH upfront license fees and reimbursed patent related fees and costs incurred by MGH and Harvard totaling approximately $0.4 million in the aggregate. We also agreed to pay MGH annual license fees, annual maintenance fees, milestone payments, royalties as a percentage of net sales and a percentage of sublicense income that we receive. Annual license fees are creditable against royalties. Annual maintenance fees are due beginning in the third year of the agreement and are not creditable against royalties. Milestone payments of up to an aggregate of approximately $10.7 million are triggered upon the achievement of specified developmental and commercialization milestones and are not creditable against royalties. Additionally, we are required to pay MGH $1.0 million in connection with the first to occur of our next equity financing, a change of control or a certain date, which payment may be in installments depending upon the proceeds from the triggering event. The royalty rate is in the low single digits as a percentage of net sales. Net sales do not include amounts billed to patients by clinics and medical practices that use licensed products or perform licensed services for such patients, but do include the amounts paid to us by such clinics and medical practices.

        If we are required to pay royalties to a third party in consideration of a license or similar right in order to avoid potential infringement of third party patent rights, and the royalty payable to such third party is greater than one percent of net sales, then we may deduct up to 50% of the amounts paid to such third party that are in excess of one percent of net sales, subject to specified limitations, from the payments that we owe to MGH for such licensed product or licensed service; provided, however that the stacking provision does not apply to assisted and/or artificial reproductive technology in all non-human animals.

        We are required to use commercially reasonable efforts to develop and commercialize licensed products and licensed services under the agreement. In particular, we are required to achieve specified development and commercialization milestones by specified dates.

        MGH and Harvard retain the right to, and may grant licenses to other academic, government and non-profit institutions for the right to practice the licensed patent rights within the licensed fields for research and educational purposes only.

        We have the right to terminate the agreement for any reason upon at least 90 days' prior written notice. MGH has the right to terminate the agreement if we fail, subject to a specified cure period, to pay any amounts due and payable under the agreement to MGH, we otherwise materially breach the agreement and fail to cure such breach within a specified cure period, we fail to maintain insurance coverage as required under the agreement, we enter bankruptcy proceedings or make an assignment for the benefit of our creditors, or we or a sublicensee challenges the licensed patent rights in a legal or administrative proceeding. The agreement otherwise terminates upon the expiration or abandonment of all licensed patents and patent applications.

    Collaboration with Intrexon to Accelerate Development of OvaTure

        In December 2013, we entered into a collaboration agreement (the "OvaTure Collaboration") with Intrexon governing the use of Intrexon's synthetic biology technology platform for the accelerated development of our OvaTure platform. The OvaTure Collaboration provides that Intrexon will deliver laboratory and animal data to support the successful filing of a potential IND for OvaTure. Upon the delivery of laboratory and animal data necessary to support the successful filing of a potential IND application, we will incur an obligation to pay Intrexon a mid-single digit royalty on net sales of any OvaTure fertility treatments in the future, and the exact royalty will depend upon whether Intrexon completes the milestone by the targeted deadline of two years after technology transfer.

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        We issued to Intrexon 273,224 shares of common stock upon the execution of the OvaTure Collaboration, owe an additional one-time technology access fee of $2.5 million in cash in December 2014, and a commercial milestone payment three months after the first commercial sale of OvaTure. The shares issued to Intrexon are subject to "piggy-back" registration rights that entitle Intrexon to have the shares included in any new registration statement filed in connection with an underwritten public offering, subject to underwriter cutback. The piggy-back registration rights will not be triggered by any offering subject to a previously filed registration statement, including our current universal shelf registration statement.

        We may terminate the OvaTure Collaboration after ninety (90) days prior written notice, and either party may terminate after a material breach by the other party that is not cured within sixty (60) days. We may assign the OvaTure Collaboration in the event of a change of control transaction. In the event that we pursue the OvaTure program on its own after terminating the OvaTure Collaboration, the royalty will apply if Intrexon intellectual property is utilized.

    OvaXon Joint Venture with Intrexon

        In December 2013, we also entered into a joint venture with Intrexon to leverage Intrexon's synthetic biology technology platform and our technology relating to EggPCs to pursue the development of potential fertility treatments within fields-of-use defined under the joint venture, which include prevention of genetic disease and animal health.

        We and Intrexon formed OvaXon, LLC ("OvaXon") to conduct the joint venture. Each party contributed $1.5 million to OvaXon and each has a 50% equity interest, with research and development costs and profits to be split accordingly. OvaXon will be governed by a board of managers, which initially will have equal representation by OvaScience and Intrexon. Pursuant to an Intellectual Property License between OvaScience and OvaXon, we licensed our technology in the field of the joint venture to OvaXon, and OvaXon entered into a collaboration agreement with Intrexon to develop our technology in the field utilizing Intrexon's synthetic biology platform.

Competition

        The biotechnology and pharmaceutical industries are highly competitive and subject to rapid technological change. There are a number of pharmaceutical companies, biotechnology companies, universities and research organizations actively engaged in research and development of potential fertility treatments. Some of these treatments, similar to AUGMENT, OvaPrime and OvaTure, are designed to address the shortcomings of IVF.

        In particular, we are aware of a number of companies and laboratories that are currently developing potential fertility treatments intended to identify high quality embryos for use in IVF, a university study of the transfer of granulosa cell mitochondria into eggs and a university study of induced pluripotent stem cells, or iPS, showing that iPS cells can be generated from somatic cells and programmed to become differentiated cells, which can include germ line cells such as oocytes. Novocellus Ltd. is developing an embryo viability test, using culture media, to aid in the selection of embryos used in IVF. FertiliTech and Auxogyn, Inc. are developing hardware and software that analyzes embryo development against cell division timing parameters to help identify the highest quality embryo within a group of embryos. If successfully developed, these products could improve outcomes and alleviate some of the other shortcomings of traditional IVF, thereby decreasing the need for our potential fertility treatments. Fertility Focus, along with strategic partner Norgenix, are developing a fertiloscope for the early diagnosis of, and immediate corrective surgery for, the physical causes of infertility. Molecular diagnostic companies like Reprogenetics are developing novel preimplantation genetic diagnosis and screening methods to detect chromosomal and genetic disorders of embryos prior

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to transfer back to the women. Testing embryos in this manner may increase the likelihood of pregnancy, reduce the chances of pregnancy loss, and improve the odds of delivery.

        At this time, we cannot evaluate how our potential fertility treatments, if successfully developed and commercialized, would compare technologically, clinically or commercially to any other potential products being developed or to be marketed by competitors. There can be no assurance that we will be able to compete effectively. Our competitors may develop and commercialize new technologies before we do, allowing them to offer products, services or solutions that are superior to those that we may offer or that establish market positions before the time, if any, at which we are able to bring potential fertility treatments to the market. Many of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources than we do and significantly greater experience in the discovery and development of product candidates, obtaining FDA and other regulatory approvals of products and the commercialization of those products. Accordingly, our competitors may be more successful than we may be in developing, commercializing and achieving widespread market acceptance. Our competitors' products may be more effective, or more effectively marketed and sold, than any treatment we may commercialize and may render our potential fertility treatments obsolete or non-competitive before we can recover the expenses of developing and commercializing any of our potential fertility treatments. We anticipate that we will face intense and increasing competition as new treatments enter the market and advanced technologies become available.

        If we successfully develop AUGMENT and OvaPrime, our ability to gain market acceptance will depend on, among other things, our ability to demonstrate increased IVF success rates, thereby reducing the number of cycles required to produce a live birth, and our ability to reduce multiple births. Our ability to gain market acceptance for OvaTure, if it is approved, will depend on our ability to demonstrate increased pregnancy and live birth rates as compared to traditional IVF and other infertility treatments, reduced multiple births and a reduction in the need for hormonal hyperstimulation for egg retrieval. We anticipate that price also will be an important competitive factor as to both of these potential fertility treatments. At this time, we cannot evaluate how our potential fertility treatments, if successfully developed and commercialized, would compare technologically, clinically or commercially to any other potential products being developed or to be marketed by competitors.

Government Regulation

        Government authorities around the world regulate, among other things, the development, testing, manufacture, quality, approval, distribution, labeling, packaging, storage, record keeping, marketing, import, export and promotion of drugs, biologics and medical devices, as well as other types of medical products. Authorities also heavily regulate many of these activities for HCT/Ps. The level and nature of regulation applied to a treatment depends on, among other things, how regulators classify that treatment. We believe that some of our fertility treatments may be regulated as drugs or biologics, while others, such as AUGMENT and OvaPrime, could be introduced into the market in certain jurisdictions without the need for pre-market review and approval.

    Foreign Regulatory Requirements

        Regulatory authorities around the world impose requirements related to the development, testing, approval, distribution, marketing and promotion of drugs, biologics, medical devices and HCT/Ps. These requirements can sometimes be more or less burdensome than those imposed in the United States. Also, most countries have both a tissue/organ transplant requirement, as well as a form of Assisted Human Reproduction Act, which regulates how IVF is performed in the country.

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        We believe that in certain jurisdictions outside of the United States, we will be able to introduce AUGMENT and OvaPrime into the market in the same way IVF and other assisted reproductive technologies are introduced without the need for pre-market review and approval by the relevant regulatory bodies. Our plans to introduce our ACE access program into international IVF clinics for physicians to gain experience using AUGMENT in 2014 and to generate data, and to transition ACE clinics to commercial centers, depend upon our being able to bring AUGMENT to the market without such pre-review and approval. Also, our plans for a commercial launch of OvaPrime outside of the United States in 2015 depend upon our being able to bring OvaPrime to the market without such pre-review and approval. There can be no assurance that foreign regulatory authorities will agree that AUGMENT or OvaPrime meet the requirements of a class of products exempt from premarket review and approval under applicable regulations. Additionally, foreign regulatory authorities may change their standards for products that are exempt from premarket review and approval. If a particular foreign regulatory authority does not agree that AUGMENT or OvaPrime meets the requirements for such an exemption, we may abandon the use of AUGMENT or OvaPrime in such jurisdictions, or suffer significant delays and expense seeking to obtain any necessary approval.

        Regulatory requirements applicable to our potential fertility treatments in foreign markets vary. Solely by way of example, in the EU, medicinal products, including tissue engineered products, require marketing authorization from the competent regulatory authorities, whereas human cells and tissues that are intended for human applications but that do not fall within the scope of rules governing medicinal products or medical devices are not subject to premarket review and approval, nor do they require extensive preclinical and clinical testing. There are, however, EU rules governing the donation, procurement, testing, processing, preservation, storage and distribution of cells and tissues that are not medicinal products. Establishments that conduct such activities must be licensed and are subject to inspection by regulatory authorities. Such establishments must implement appropriate quality systems and maintain appropriate records to ensure that cells and tissues can be traced from the donor to the recipient and vice versa. There are also requirements to report serious adverse events and reactions linked to the quality and safety of cells and tissues. We believe that AUGMENT will not be regulated in the EU as a medicinal product. Instead, we believe AUGMENT will be subject to the general rules governing the use of cells and tissues for human applications. Thus, in the EU, we believe that we will be able to commercialize AUGMENT without first applying for or receiving marketing authorization. However, regulators in the EU could disagree with us and we might need to seek market authorization. By contrast, it is more likely that we will be required to submit an application to seek marketing authorization from the EU regulatory authorities for OvaTure and possibly other potential fertility treatments.

        While we believe EU marketing authorization is not required for AUGMENT, medical treatments and processes, such as IVF, are regulated at the national level in the EU. Such national regulations may restrict the extent to which the eggs used in IVF treatments may be manipulated and so may prevent us from commercializing AUGMENT, OvaPrime, OvaTure or any other potential fertility treatments in that country.

        In addition, certain other countries outside the EU and United States may have regulations that require us to obtain permission prior to commercializing AUGMENT, OvaPrime, OvaTure and any other potential fertility treatments.

    U.S. Requirements Applicable to Biologics

        Although we have not discussed OvaTure with the FDA, the FDA may regulate OvaTure as a biological product. Our other potential fertility treatments may also be regulated as biological products. In the United States, the FDA regulates biologics under the Public Health Service Act, or PHSA, the Federal Food, Drug, and Cosmetic Act, or FDCA, and implementing regulations. Section 351 of the PHSA prohibits the introduction of a biological product into interstate commerce without an

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FDA-approved application for marketing authorization under that section. For pioneer products, the typical application under section 351 of the PHSA is the biologics license application, or BLA.

        The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state and local statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the development process, approval process or after approval may subject a company to significant sanctions, including refusal to approve pending applications, withdrawal of an approval, clinical holds, warning letters, product recalls, product seizures, injunctions, fines, refusals of government contracts, restitution, disgorgement or other civil or criminal penalties.

        Preapproval Regulation.     The process required by the FDA before a biologic may be marketed in the United States requires numerous steps, including the following:

    completion of preclinical laboratory tests, animal studies and other studies in accordance with current good laboratory practices or other applicable regulations;

    submission to the FDA of an IND, which must become effective before the product can be tested in humans and which must contain preclinical data, together with manufacturing information, analytical data and any available clinical data or literature;

    performance of adequate and well controlled clinical trials in humans according to the FDA's cGCPs, to establish the safety and efficacy, or safety, purity and potency in the case of a biologic, of the product for its intended use(s);

    submission to the FDA of a BLA;

    satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the product is produced to assess compliance with the FDA's cGMPs and to assure that the facilities, methods and controls are adequate to preserve the drug's identity, strength, quality and purity; and

    FDA review and approval of the BLA.

        Before testing new drugs or biologics in humans, a potential product must go through the preclinical testing phase. Preclinical tests include laboratory evaluations of the potential product biological characteristics, as well as animal studies. The sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data and any available clinical data or literature, to the FDA as part of the IND. The sponsor must also include an initial protocol detailing the first phase of the proposed clinical investigation and must update the IND with subsequent protocols if the clinical program advances beyond early testing. The IND automatically becomes effective 30 days after receipt by the FDA unless the FDA imposes a clinical hold within that 30 day time period. If the FDA institutes a clinical hold, the sponsor must resolve any and all concerns to the FDA's satisfaction before clinical trials under the IND can begin. The FDA may also impose clinical holds on a potential product due to safety concerns or non-compliance with cGCPs or other regulations at any time before or during clinical trials.

        Each clinical protocol must be submitted to the FDA for review and to an Institutional Review Board ("IRB") for approval. Protocols detail, among other things, the objectives of the clinical trial, dosing procedures, subject inclusion and exclusion criteria and the parameters to be used to monitor subject safety. An IRB is charged with protecting the welfare and rights of study participants, giving consideration to whether the risks to individual study participants are minimized and reasonable in relation to anticipated benefits. The IRB also approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed.

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        Clinical testing of a biologic generally proceeds in three phases, though in some cases these phases may overlap or be combined. In Phase 1 trials, the investigational product typically is administered to 20 to 80 healthy volunteers to evaluate the safety, dosage tolerance, and other characteristics of the investigational product. Phase 2 trials are typically conducted in a small patient population to evaluate the effectiveness of the investigational product for a particular indication in patients with the targeted condition. Phase 3 clinical trials are conducted in an expanded patient population, usually at geographically dispersed sites, and are intended to further evaluate the dosage, clinical effectiveness, and safety, as well as to establish the product's overall risk/benefit ratio. Phase 3 trials typically form the primary basis for FDA approval of the product.

        Sponsors must submit progress reports at least annually to the FDA, detailing the results of the clinical trials. The sponsor must also submit written IND safety reports to the FDA and to the investigators describing serious and unexpected adverse events or any finding from tests in laboratory animals that suggests a significant risk for human subjects. The FDA, the sponsor or the sponsor's 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 unacceptable health risks. 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 or biologic has been associated with unexpected serious harm to patients. Additionally, sponsors of clinical trials, except Phase 1 trials, are required to submit certain registry and results information for inclusion in a publicly available registry data bank.

        U.S. Review and Approval Process.     The results of preclinical studies and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the product, proposed labeling and other relevant information, are submitted to the FDA as part of a BLA, requesting approval to market the product. The submission of a BLA is typically subject to the payment of substantial user fees.

        The FDA reviews all BLAs submitted to ensure that they are sufficiently complete for substantive review before accepting them for filing. The FDA may request additional information rather than accept an application for filing. Once an application is accepted for filing, the FDA begins an in depth substantive review to determine, among other things, whether the biological product is safe, pure and potent, for its intended use(s) and whether the manufacturing controls are adequate to assure and preserve the product's identity, strength, quality and purity. Before approving an application, the FDA typically inspects the facility where the product is manufactured in order to ensure compliance with cGMPs. The FDA will also determine whether a risk evaluation and mitigation strategy, or REMS, is necessary to assure the safe use of the treatment. If the FDA concludes that a REMS is necessary, the applicant must submit a proposed REMS. The FDA will not approve a marketing application without a REMS, if required.

        The development and approval process is lengthy and resource intensive. Ultimately, the FDA may refuse to allow a clinical program to begin, terminate a clinical development program, require submission of additional preclinical or clinical data or refuse to approve an application for numerous reasons. Even if an applicant submits all of the data requested by the FDA, the agency may ultimately decide that the application does not satisfy the criteria for approval. In addition, even if a product is approved, the scope of the approval may be significantly limited in terms of patient populations, indications, other conditions of use or restrictions on distribution and use, for example, through a REMS. The FDA could also require significant contraindications, warnings or precautions be included in the product labeling.

        Patent Term Restoration and Exclusivity.     If the FDA regulates OvaTure or our other treatments as biologics, certain provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 and the Biologics Price Competition and Innovation Act of 2009 likely would apply.

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        Under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act, certain U.S. patents are eligible for a limited patent term extension of up to five years in order to compensate the sponsor of a new drug or biologic for patent term lost during product testing and FDA review. Only one patent per drug or biologic is eligible for the extension.

        The Biologics Price Competition and Innovation Act of 2009 created a 12 year exclusivity period for innovator biologics. The FDA therefore cannot approve a biosimilar application relying on a specific reference product until 12 years after the reference product is first licensed. BLA supplements are not eligible for any additional exclusivity. In addition, a BLA is not entitled to the 12 year exclusivity if it is a subsequent application filed by the same manufacturer or sponsor as an earlier application, or a licensor, predecessor in interest or other related entity, if the subsequent application relates to: (1) a change, not including a modification to the structure of the biological product, that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or strength or (2) a modification to the structure of the biological product that does not result in a change in safety, purity or potency. The FDA has yet to define the key terms in this exclusivity provision, so the robustness of exclusivity for biologics is somewhat uncertain.

        Post-Approval Requirements.     Any drug or biologic approved for marketing in the United States remains subject to continuing regulation by the FDA. Post-approval requirements include, among other things, record keeping and reporting requirements, packaging requirements, requirements for reporting of adverse drug experiences, import and export controls, restrictions on advertising and promotion and adherence to cGMP requirements. For example, the FDA strictly regulates labeling, advertising and promotion of drugs and biologics. Such products may be promoted only for the FDA-approved indications and in accordance with the provisions of the FDA-approved label. The FDA periodically inspects manufacturing facilities to ensure that the product is being manufactured in accordance with cGMPs and the specifications outlined in the NDA or BLA. Manufacturing facilities must be registered with the FDA and companies must list all of the drugs and biologics they manufacture with the FDA. As a condition of approval, the FDA could also impose one or more post-marketing studies or clinical trials to further assess the benefit to risk profile of the product, which could require the expenditure of significant time and resources. Post-market data may cause the agency to seek significant changes in the labeling for the product including new warnings or a REMS. Even if it does not impose a Phase 4 study or trial on a sponsor, the FDA may withdraw approval for the product if it determines that the benefits of the product no longer outweigh the risks.

        As further described below, many states also regulate the manufacture and distribution of drugs and biologics and require companies to register in order to manufacture or distribute products in the state. Failure to comply with these federal and state requirements could subject a company to significant sanctions, including withdrawal of an approval, warning letters, product recalls, product seizures, injunctions, fines, refusals of government contracts, or civil or criminal penalties.

    Requirements Applicable to Medical Devices in the United States

        In conjunction with our plan to expand our offerings for the treatment of infertility, we may develop new products that the FDA may regulate as medical devices. For example, we believe the FDA likely will regulate as a medical device the innovative culture media solution we are planning to develop. The FDA regulates, among other things, the development, testing, manufacturing, labeling, marketing and distribution of medical devices. The level of regulation applied by the FDA generally depends on the class into which the medical device falls: Class I, II or III. Class I medical devices present the lowest risk and Class III medical devices present the highest risk.

        Most Class I devices are exempt from the FDA premarket review or approval. With some exceptions, Class II devices may be marketed only if the FDA "clears" the medical device through the 510(k) process, which requires a company to show that the device is "substantially equivalent" to

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certain devices already legally on the market. Also with some exceptions, Class III devices are approved through a premarket approval application, which generally requires an applicant to submit data from one or more clinical trials that provide reasonable assurance of the safety and effectiveness of the device. Clinical data is sometimes required for a 510(k) notification as well. Manufacturers conducting clinical trials with medical devices are subject to similar requirements as those conducting clinical trials with drugs or biologics. For example, a manufacturer must obtain IRB approval and informed consent from all subjects, and a manufacturer of a significant risk device must also obtain approval of an investigational device exemption.

        The FDA has broad post-market regulatory and enforcement powers with respect to medical devices, similar to those for drugs and biologics. For example, medical devices are subject to detailed manufacturing standards under the FDA's Quality System Regulations and specific rules regarding labeling and promotion. Medical device manufacturers must also register their establishments and list their products with the FDA.

        As further described below, states also impose regulatory requirements on medical device manufacturers and distributors, including registration and record keeping requirements. Failure to comply with the applicable federal and state medical device requirements could result in, among other things, refusal to approve or clear pending applications or notifications, withdrawal of an approval or clearance, warning letters, product recalls, product seizures, total or partial suspension of production, fines, refusals of government contracts, restitution, disgorgement, or other civil or criminal penalties.

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    Requirements Applicable to HCT/Ps

        We believe AUGMENT belongs to a class of products kown as human cell, tissue, or cellular or tissue-based products ("HCT/Ps"). The United States Food and Drug Administration ("FDA") regulates HCT/Ps either as drugs, biologics or medical devices on the one hand, or a special type of product known as a 361 HCT/P, on the other. We believe that AUGMENT meets the legal criteria for regulation as a 361 HCT/P. A 361 HCT/P is an HCT/P that meets certain criteria, and are therefore regulated by the FDA solely under section 361 of the Public Health Service Act, and FDA's implementing regulations in 21 CFR Part 1271. We anticipate having further discussions in 2014 with the FDA to present details on AUGMENT and its qualifications as a 361 HCT/P, and to determine the appropriate path forward. Through a risk based system initially introduced in 1997, the FDA regulates HCT/Ps under a two-tiered framework. Certain HCT/Ps, which the FDA believes pose greater risks, are regulated as drugs, biologics or medical devices. Such products are subject to the IND requirements and the premarket review and approval or clearance requirements described above. Other HCT/Ps, however, are exempt from these requirements because the agency believes that they present a lower risk. Such products frequently are referred to as "361 HCT/Ps," because the FDA regulates them under the authority given to it under section 361 of the PHSA to create regulations to control the spread of communicable diseases.

        The FDA will regulate an HCT/P as a 361 HCT/P if it meets all of the following criteria:

    (1)
    the HCT/P is minimally manipulated,

    (2)
    the HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent,

    (3)
    the manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, with a few exceptions, and

    (4)
    either:

    the HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function, or

    the HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function and

    (a)
    is for autologous use,

    (b)
    is for allogeneic use in a first or second degree blood relative, or

    (c)
    is for reproductive use.

The FDA defines the term "homologous use" to mean the repair, reconstruction, replacement or supplementation of a recipient's cells or tissues with an HCT/P that performs the same basic function in the recipient as in the donor. The FDA defines the term "autologous use" to mean the implantation, transplantation, infusion or transfer of human cells or tissue back into the individual from whom the cells or tissue were recovered. The term "allogeneic use" refers to the use of cells or tissues taken from one individual within a species and used in another individual of the same species.

        HCT/Ps that meet all of these requirements are deemed 361 HCT/Ps and are regulated exclusively under section 361 of the PHSA and the FDA's regulations at 21 C.F.R. Part 1271. They therefore are not subject to the IND requirements or the premarket review and approval requirements described above.

        We believe that AUGMENT meets the legal criteria for regulation as a 361 HCT/P. In our view, for AUGMENT, both the mitochondria taken from EggPCs and the eggs into which those mitochondria are injected during IVF (1) are minimally manipulated, (2) are intended for homologous use only,

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(3) do not involve the combination of cells or tissue with another article and (4) are dependent upon the metabolic activity of living cells for their primary function and are for reproductive use.

        All HCT/Ps, whether they meet the criteria to be considered a 361 HCT/P or not, are subject to various requirements under the FDA's regulations at 21 C.F.R. Part 1271. While these are the only regulations applicable to HCTP/s that are regulated as 361 HCT/Ps, other FDA regulations apply to HCT/Ps that are regulated as drugs, biologics or medical devices. The FDA's 21 C.F.R. Part 1271 regulations impose requirements relating to registration and listing, donor eligibility testing, cGTPs, adverse event reporting, labeling, and inspections. Failure to comply with these regulations can result in substantial sanctions, including warning letters, product seizure, orders to stop manufacturing and other civil and criminal penalties.

        The Tissue Reference Group, or TRG, is a body within the FDA that is designed to provide advisory opinions regarding whether a particular treatment will be regulated as a 361 HCT/P. Manufacturers are not required to consult with the TRG and instead can market their treatments based on their own conclusion that the treatment meets the 361 HCT/P criteria. If, however, the FDA disagrees with the manufacturer's determination and concludes that the treatment should be regulated as a drug, biologic or medical device, the manufacturer could be subject to numerous sanctions, including warning letters, injunctions, fines, product seizures and civil or criminal penalties. In addition, the manufacturer would then need to complete the testing and premarket approval or clearance process discussed above.

        We have not consulted the TRG with respect to any of our potential fertility treatments. On September 6, 2013, we received an "untitled" letter from the FDA questioning the status of AUGMENT as a 361 HCT/P and advising us to file an IND for the potential fertility treatment. We continue to believe that AUGMENT qualifies as a 361 HCT/P and plan to engage the agency in further discussions during 2014 to present details on AUGMENT and its qualifications as a 361 HCT/P and to determine the appropriate path forward. The FDA could ultimately disagree with our conclusion, however, in which case AUGMENT likely would be regulated as a biological product.

        HCT/P registration and listing.     Every establishment that manufactures an HCT/P must register with the FDA and provide a list of every HCT/P that the establishment manufactures. The definition of manufacture is broad and includes any and all steps in the recovery, processing, storage, labeling, packaging or distribution of any human cell or tissue and the screening or testing of the cell or tissue donor.

        Donor eligibility.     HCT/P manufacturers must maintain procedures for testing, screening and determining the eligibility of donors of cells and tissues used in HCT/Ps. An HCT/P may not be transferred or implanted into an individual until the donor has been determined to be eligible under these procedures. These procedures must involve, among other things, testing donors for certain communicable diseases and the use of quarantines for HCT/Ps that have not yet been shown to meet the eligibility requirements. Cells or tissues that are donated for reproductive use by a sexually intimate partner of the recipient of the HCT/P are exempt from the donor eligibility determination requirements, but must be labeled so as to distinguish the HCT/P from those that have completed donor eligibility testing. Manufacturers must keep detailed records regarding donor eligibility determinations.

        Current Good Tissue Practices.     HCT/Ps must be recovered, processed, stored, labeled, packaged and distributed in a manner that is consistent with the FDA's cGTPs regulations. Cells and tissues must also be screened and tested according to these regulations. The goal of cGTPs is to prevent the introduction, transmission or spread of communicable diseases. The FDA's cGTPs regulations require companies to establish a comprehensive quality program and to comply with rules related to personnel, facilities and equipment used to manufacture HCT/Ps, as well as rules on how these HCT/Ps are

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processed, labeled and stored. Companies must also keep detailed manufacturing records and product complaint files.

        Adverse Reaction Reports.     Manufacturers of nonreproductive HCT/Ps must investigate and report to the FDA certain adverse reactions.

        Inspections.     Establishments that manufacture HCT/Ps must allow the FDA to inspect the establishment and company records.

    Other Regulation of Cellular and Tissue Products

        Regulation of promotion.     The Federal Trade Commission, or FTC, and state governments require claims made in promoting a treatment to be supported by adequate substantiation. Similarly, the FTC and state governments generally require that promotion not be false or misleading. In addition, FDA rules limit the claims that may be made in the promotion of a 361 HCT/P. The FDA determines whether an HCT/P is intended for homologous use based on the labeling, advertising and other indications of the manufacturer's intent. Accordingly, the ways in which an HCT/P is promoted may affect whether the FDA regulates it as a 361 HCT/P or a drug, biologic or medical device.

        State regulation.     Certain states, including New York, California, Florida, Illinois, Maryland, Texas, Massachusetts and others, as well as local governments, extensively regulate facilities and laboratories that recover, test, process, manufacture, store or dispose of certain cells and tissues. These state requirements include, among other things, registration, record keeping, quality and personnel standards. For example, New York requires reproductive tissue banks, which are facilities that possess, store or distribute reproductive tissue for insemination or implantation, to be licensed if the tissues will be distributed into New York. The state also imposes informed consent, storage, record keeping and testing requirements. Some of these state requirements may be more extensive than those imposed by federal law.

        Regulation of clinical laboratories.     The Clinical Laboratory Improvement Act Amendments of 1988, or CLIA, regulates laboratory testing performed on specimens derived from humans. It is designed to impose quality standards for all such testing to ensure the accuracy, reliability and timeliness of results regardless of where the test is performed. CLIA requires that laboratories become certified and imposes rules for quality control, quality assurance, patient test management, personnel and proficiency testing. Laboratories that perform relatively simple tests are subject to lower levels of regulation, while laboratories that conduct more complicated testing must meet more stringent standards. Certain states also impose similar requirements on clinical laboratories. In New York, for example, clinical laboratories that accept specimens from New York state must have a permit and must meet certain quality standards.

        Health Insurance Portability and Accountability Act.     The Health Insurance Portability and Accountability Act, or HIPAA, imposes rules on certain "covered entities." "Covered entities" include healthcare providers that conduct certain transactions in electronic format, healthcare clearinghouses and health plans. Covered entities must, among other things, comply with limitations on the use and disclosure of individually identifiable health information, referred to as protected health information, or PHI, apply certain security standards to electronic PHI and enter into written agreements with business associates before disclosing any PHI to them. In addition, many states have their own laws relating to the privacy of medical information. To the extent that they provide greater protection for the privacy of medical information, such state laws are not pre-empted by HIPAA.

    Other U.S. Healthcare Laws and Compliance Regulations

        In the United States, our activities may be subject to regulation by various federal, state and local authorities in addition to the FDA, likely including the Centers for Medicare and Medicaid Services, or

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CMS, other divisions of the U.S. Department of Health and Human Services, such as the Office of Inspector General, and the U.S. Department of Justice and individual U.S. Attorney offices within the Department of Justice, as well as state and local governments. To the extent AUGMENT, OvaPrime, OvaTure or other potential fertility treatments are reimbursed by federal or state healthcare programs, we would be subject to strict regulation by federal and state laws pertaining to healthcare fraud and abuse, including anti-kickback laws, physician self-referral laws, false claims laws and others. The federal Anti-Kickback Statute, for example, prohibits persons from soliciting, offering, receiving or providing remuneration to induce the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as Medicare or Medicaid. Similar laws exist at the state level, some of which apply to products reimbursed under private insurance programs. The federal False Claims Act, and similar state laws, prohibit presenting false or fraudulent claims for payment by federal payors such as Medicare or Medicaid. We anticipate there will be minimal reimbursement for our products or services by any third party insurers and that federal healthcare programs will be even less likely than commercial insurers to reimburse for our potential fertility treatments. However, to the extent that our potential fertility treatments are reimbursed under federal programs, we nonetheless will likely be required to operate in compliance with applicable federal laws, and to the extent that there is commercial third party reimbursement, we will likely also be required to operate in compliance with applicable state laws. Failure to comply with these laws can result in significant civil and criminal penalties, including exclusion from participation in federal healthcare programs.

        If AUGMENT, OvaPrime, OvaTure or other potential fertility treatments are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements may apply. For example, under the Veterans Health Care Act, or VHCA, drug companies are required to offer certain drug and biological products at a reduced price to a number of federal agencies, including the U.S. Department of Veterans Affairs and the U.S. Department of Defense, the Public Health Service and certain private Public Health Service-designated entities, in order to participate in other federal funding programs including Medicare and Medicaid. Participation under the VHCA requires submission of pricing data and calculation of discounts and rebates pursuant to complex statutory formulas, as well as the entry into government procurement contracts governed by the Federal Acquisition Regulations. In addition, recent legislative changes purport to require that VHCA discounted prices be offered for treatments distributed at retail pharmacies to certain U.S. Department of Defense purchasers for its TRICARE beneficiaries program via a rebate system. We may be subject to these restrictions even though we anticipate that we will receive minimal, if any, revenues from these federal programs.

        Similarly, it is unlikely that state Medicaid programs will elect to cover AUGMENT, OvaPrime, OvaTure or our other future fertility treatments. Nonetheless, to the extent that any of our treatments are approved as drugs or biological products, and we wish to retain the possibility of Medicaid coverage for those fertility treatments, we would be required to enter into a rebate agreement with CMS, which requires the payment of substantial rebates to state Medicaid programs and the reporting of certain pricing information to CMS on a monthly and quarterly basis. For drugs that are covered under Medicare Part B, the manufacturer must report such drugs' average sales price to CMS on a quarterly basis. Failure to report this information in a timely and accurate manner can lead to substantial civil and criminal penalties and to liability under the False Claims Act, even if Medicare Part B reimburses for only a small number of doses of the product.

        The Affordable Care Act includes new reporting and disclosure requirements for pharmaceutical and device manufacturers with regard to payments or other transfers of value made to healthcare providers. Reports submitted under these new requirements will be placed on a public database. If we fail to provide these reports, or if the reports we provide are not accurate, we could be subject to significant penalties.

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        In order to distribute treatments commercially, we must comply with state laws that require the registration of manufacturers and wholesale distributors of pharmaceutical and biological products and medical devices in a state. In certain states, this includes manufacturers and distributors who ship treatments into the state even if such manufacturers or distributors have no place of business within the state. Several states have enacted legislation requiring pharmaceutical companies to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities or register their sales representatives. Many of these laws also prohibit certain sales and marketing practices. In addition, all of our activities are potentially subject to federal and state consumer protection and unfair competition laws.

        Failure to comply with the applicable federal and state regulatory requirements could result in, among other things, refusal to approve or clear pending applications, withdrawal of an approval or clearance, warning letters, product recalls, product seizures, total or partial suspension of production, fines, sanctions, injunctions, refusals of government contracts, restitution, disgorgement or other civil or criminal penalties.

        In addition to those laws and regulations described above, other federal and state laws that could affect our operations include:

    federal laws requiring reporting to the CDC regarding pregnancy success rates and other data compiled by ART programs;

    the Fertility Clinic Success and Certification Act, which requires the CDC to adopt a model certification program for embryo laboratories, and accompanying quality standards, which can then be adopted by states or independent accrediting organizations certified by the states;

    the U.S. Foreign Corrupt Practices Act, which prohibits companies from making certain improper payments to foreign officials and which requires companies to maintain certain record keeping procedures;

    state and federal laws governing human subject research and animal testing;

    occupational safety and health requirements;

    state and local laws and regulations on the handling and disposal of medical waste; and

    the "sunshine" provisions enacted in the Affordable Care Act, which require manufacturers to report certain transfers of value, such as payment for consulting services, to prescribers or other healthcare providers.

Pharmaceutical Coverage, Pricing and Reimbursement

        We believe that very few third party payors, either in the EU, the United States or other countries, including national health services and government funded insurance programs as well as private payors, will agree to cover and reimburse for AUGMENT, OvaPrime, OvaTure or other potential fertility treatments we may attempt to commercialize. Thus, it is likely that IVF clinics and physicians will be able to use AUGMENT, OvaPrime, OvaTure and our other potential fertility treatments only if the patient can afford and is willing to pay for our treatment out of pocket. The cost of AUGMENT, OvaPrime, OvaTure, and our other potential fertility treatments may be beyond the means of many patients.

        Third party payors include government health administrative authorities, managed care providers, private health insurers and other organizations. The process for determining whether a payor will provide coverage for a treatment or procedure may be separate from the process for setting the price or reimbursement rate that the payor will pay for the treatment or procedure. Even if third party payors were to provide some minimal level of coverage and reimbursement for AUGMENT, OvaPrime,

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OvaTure or our other potential fertility treatments, such third party payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness, in addition to the safety and efficacy, of medical products and procedures. In order to obtain reimbursement for AUGMENT, OvaPrime, OvaTure or our other future treatments, we may need to conduct expensive pharmacoeconomic studies in order to demonstrate their medical necessity and cost-effectiveness. The expense of these studies would be in addition to the expense required to obtain any necessary FDA approvals or clearances. Our treatments or procedures may not be considered medically necessary or cost-effective. We believe, however, that even after conducting such studies, very few third party payors will agree to cover and reimburse AUGMENT, OvaPrime, OvaTure or our other potential fertility treatments we may attempt to commercialize.

        A third party payor's decision to provide coverage for a treatment or procedure does not imply that an adequate reimbursement rate will be approved. Adequate third party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in development of AUGMENT, OvaPrime, OvaTure or our other potential fertility treatments. The enactment of sweeping healthcare reform legislation, known as the Affordable Care Act, in 2010 could substantially change the way healthcare is financed by both governmental and private insurers. We anticipate that this legislation will result in additional downward pressure on coverage and reimbursement rates. Such downward pressure could have the effect of reducing the price that we are able to demand for AUGMENT, OvaPrime, OvaTure or our other future treatments. Federal, state and local governments in the United States continue to consider legislation to limit the growth of healthcare costs. Future legislation could limit payments for AUGMENT, OvaPrime, OvaTure, or our other potential fertility treatments.

        Different pricing and reimbursement practices exist in other countries. In the EU, governments influence the price of medical products and procedures through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of consumers' medical costs. Some jurisdictions operate positive and negative list systems under which treatments or procedures may be marketed only after a reimbursement price has been agreed upon. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost-effectiveness of our particular treatments or procedures to currently available therapies. Other member states allow medical companies to fix their own prices, but monitor and control company profits. The downward pressure on healthcare costs has become very intense. As a result, increasingly high barriers are being erected to the entry of new treatments and procedures. Moreover, we believe that very few third party payors, either in the EU, the United States or other countries, including national health services or government funded insurance programs as well as private payors, will agree to cover and reimburse for AUGMENT, OvaPrime, OvaTure or our other potential fertility treatments we may attempt to commercialize.

Employees

        As of December 31, 2013, we had 28 full-time employees, including a total of 17 employees with advanced degrees. None of our employees are represented by a labor union or covered by a collective bargaining agreement. We consider our relationship with our employees to be good.

Our Corporate Information

        We were incorporated under the laws of the State of Delaware in April 2011 under the name Ovastem, Inc. and changed our name to OvaScience, Inc. in May 2011. Our principal executive offices are located at 215 First Street, Suite 240, Cambridge, Massachusetts 02142 and our telephone number is (617) 500-2802. Our website address is www.ovascience.com. The information contained on, or that can be accessed through, our website is not a part of this Annual Report on Form 10-K. We have included our website address in this Annual Report solely as an inactive textual reference.

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Available Information

        You may obtain free copies of our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and amendments to those reports, as soon as reasonably practicable after they are electronically filed or furnished to the United States Securities and Exchange Commission, or the SEC, on the Investors section of our website at www.ovascience.com or by contacting our Corporate Communications department at (617) 500-2802. The contents of our website are not incorporated by reference into this report and you should not consider information provided on our website to be part of this report.

Item 1A.    Risk Factors

RISK FACTORS

         Our business is subject to numerous risks. We caution you that the following important factors, among others, could cause our actual results to differ materially from those expressed in forward looking statements made by us or on our behalf in filings with the SEC, press releases, communications with investors and oral statements. Any or all of our forward looking statements in this Annual Report on Form 10-K and in any other public statements we make may turn out to be wrong. They can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. Many factors mentioned in the discussion below will be important in determining future results. Consequently, no forward looking statement can be guaranteed. Actual future results may differ materially from those anticipated in forward looking statements. We undertake no obligation to update any forward looking statements, whether as a result of new information, future events or otherwise. You are advised, however, to consult any further disclosure we make in our reports filed with the SEC.

Risks Related to Our Financial Position and Need for Additional Capital

Our short operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

        We commenced active operations in April 2011. Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, acquiring and developing our technology, identifying potential fertility treatments, planning for and enrolling patients for our AUGMENT study in humans, planning for the anticipated introduction of our ACE access program into international IVF clinics, planning for studies of OvaPrime, and determining the regulatory path for our potential fertility treatments. We have not yet commenced commercial sale of any fertility treatment and have not yet demonstrated our ability to initiate or successfully complete any clinical trials, obtain marketing approvals or conduct sales, marketing and other activities necessary for successful commercialization of a fertility treatment. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history.

        In addition, as a new business, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown challenges. We will need to transition from a company focused on in-licensing and research to a company capable of developing multiple potential fertility treatments and supporting commercial activities. We may not be successful in such a transition.

We have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.

        Since our inception, we have incurred significant operating losses. Our net loss was $29.0 million for the year ended December 31, 2013 and $45.2 million for the period from April 5, 2011 (inception) to December 31, 2013. To date, we have not generated any revenues and have financed our operations

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through private placements of our Series A preferred stock, Series B preferred stock and common stock. We have devoted significant efforts to acquiring our technology and developing AUGMENT.

        We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. The net losses we incur may fluctuate significantly from quarter to quarter. We anticipate that our expenses will increase if and as we:

    introduce our ACE access program into international IVF clinics for physicians to gain experience using AUGMENT and to generate data;

    educate physicians and embryologists regarding the use of AUGMENT;

    conduct any AUGMENT studies;

    incur costs associated with foreign expansion;

    conduct further studies of, continue optimization of and ultimately commercially launch OvaPrime;

    continue our research and preclinical development of OvaTure, both internally and in collaboration with Intrexon, and other potential fertility treatments;

    initiate any clinical trials of OvaTure and other potential fertility treatments;

    collaborate with Intrexon through the OvaXon joint venture to create new applications to prevent inherited diseases for human and animal health;

    seek approval from the FDA and similar regulatory agencies outside of the United States for our potential fertility treatments that require such approval;

    establish a domestic and international sales, marketing, manufacturing and distribution infrastructure to commercialize AUGMENT, OvaPrime and any other potential fertility treatments we successfully develop;

    maintain, expand and protect our intellectual property portfolio;

    hire additional scientific, clinical, quality control and management personnel to support our potential fertility treatment development and commercialization efforts in the United States and abroad;

    add operational and financial personnel to handle the public company reporting and other requirements to which we are subject;

    seek to identify additional potential fertility treatments; and

    develop, acquire or in-license other potential fertility treatments and technologies.

        To become and remain profitable, we must continue to develop and commercialize AUGMENT and develop and eventually commercialize other potential fertility treatments with significant market potential. This will require us to be successful in a range of challenging activities, including successfully introducing the ACE access program into international IVF clinics, marketing and selling AUGMENT, developing and launching OvaPrime, completing research, preclinical testing and clinical trials of other potential fertility treatments, obtaining marketing approval, if required, manufacturing, marketing and selling those potential fertility treatments that we successfully develop, and addressing the challenges of foreign operations. We may never succeed in these activities and, even if we do, may never generate revenues that are significant or large enough to achieve profitability. We are currently conducting preclinical research and working to optimize the design of the development program for OvaTure, both internally and in collaboration with Intrexon, and collaborating with Intrexon on the OvaXon joint venture. If we do achieve profitability, we may not be able to sustain or increase profitability on a

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quarterly or annual basis. Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research and development efforts, expand our business or continue our operations.

We will need substantial additional funding. If we are unable to raise capital when needed, we would be forced to delay, reduce or eliminate our fertility treatment development programs or commercialization efforts.

        We plan to introduce our ACE access program into international IVF clinics for physicians to gain experience using AUGMENT and to generate data in 2014. We also plan to conduct further preclinical studies and continue optimization of OvaPrime in 2014 in anticipation of a potential commercial launch outside of the United States in 2015. In addition, we expect to incur significant expenses with respect to our research and development of OvaTure and other potential fertility treatments. Any clinical trials that we are required to conduct for these potential fertility treatments will be costly. Furthermore, we expect to incur additional costs associated with operating as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate some or all of our research and development programs or commercialization efforts.

        Assuming we have no revenue from sales of fertility treatments, we expect that our existing cash, cash equivalents and marketable securities will enable us to fund our current operating plan into 2015. Our future capital requirements will depend on many factors, including:

    introducing our ACE access program into international IVF clinics for physicians to gain experience using AUGMENT and to generate data;

    educating physicians and embryologists the use of AUGMENT;

    conducting any AUGMENT studies;

    incurring the costs associated with expansion of foreign operations;

    establishing a domestic and international sales, marketing, manufacturing and distribution infrastructure to commercialize AUGMENT and any other potential fertility treatment, we successfully develop;

    conducting further studies of, continuing optimization of and ultimately commercially launching OvaPrime;

    receiving revenue, if any, from commercial activities of AUGMENT, OvaPrime or any other potential fertility treatments;

    continuing research and preclinical development of OvaTure, both internally and in collaboration with Intrexon, and other potential fertility treatments;

    initiating any clinical trials of OvaTure and other potential fertility treatments;

    collaborating with Intrexon through the OvaXon joint venture to create new applications to prevent inherited diseases for human and animal health;

    following the regulatory process in the United States and abroad, including the premarketing and marketing approval requirements, to which some of our potential fertility treatments may be subject;

    following the regulatory or institutional review board review of our potential fertility treatments that are subject to such review;

    preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;

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    establishing collaborations and partnerships on favorable terms, if at all; and

    developing, acquiring or in-licensing other potential fertility treatments and technologies.

        Identifying and developing potential fertility treatments is a time consuming, expensive and uncertain process that takes years to complete. We may never generate the necessary data or results required to obtain necessary marketing approvals or achieve sales for our potential fertility treatments. We will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all.

Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or potential fertility treatments.

        Until the time, if ever, that we can generate material revenue from our potential fertility treatments, we plan to finance our cash needs through some combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. We do not have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our existing stockholders will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

        If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or potential fertility treatments or grant licenses on terms that may not be favorable to us.

Risks Related to Research, Development and Commercialization of Our Potential Fertility Treatments

The science underlying our three potential fertility treatments, AUGMENT, OvaPrime and OvaTure, is based on recent discoveries, and OvaPrime and OvaTure have not been tested in humans. We may not be able to successfully develop AUGMENT, OvaPrime, OvaTure or other potential fertility treatments.

        AUGMENT, OvaPrime and OvaTure are based on recent scientific discoveries relating to egg precursor cells, and OvaPrime and OvaTure have not been tested in humans, and human testing of AUGMENT has been limited. As a result, our AUGMENT, OvaPrime and OvaTure programs are subject to a higher level of risk than programs based on longer established science that have been the subject of human clinical trials.

        In December 2012, we commenced our AUGMENT study in humans to test the safety and efficacy of AUGMENT. In September 2013, we chose to suspend enrollment in the AUGMENT study in the U.S. This decision followed an "untitled" letter we received from the FDA on September 6, 2013 questioning the status of AUGMENT as a 361 HCT/P and advising us to file an IND application. We anticipate having further discussions with the FDA to present details on AUGMENT and its qualifications as a 361 HCT/P, and to determine the appropriate path forward. We plan to introduce our ACE access program into international IVF clinics for physicians to gain experience using AUGMENT and to generate data. In 2014, we expect to establish ACE clinics in at least four international regions, which we anticipate will result in 40 to 60 AUGMENT cycles in 2014. By the end of 2014, we expect to transition these ACE clinics to commercial centers. The data collected from these clinics, including whether, and by how much, the use of AUGMENT improves egg and embryo quality, increases the pregnancy and live birth rates of IVF and the safety of this potential fertility treatment will impact our ability to commercialize and generate revenues from sales of AUGMENT. If the results at these clinics are unfavorable, AUGMENT may not be viable or significant additional time and

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expense could be required before we are able to commercialize this potential fertility treatment. If we experience delays or difficulties in introducing our ACE program into international IVF clinics, our ability to commercialize AUGMENT could be delayed or prevented.

        We plan to conduct further preclinical studies and continue optimization of OvaPrime in 2014, in anticipation of a commercial launch of OvaPrime outside of the United States in 2015. The data collected in our studies, including whether and by how much OvaPrime boosts egg reserves, will impact our ability to launch and generate revenues from sales of OvaPrime. If the results of our studies are unfavorable, OvaPrime may not be viable or significant additional time and expense could be required before we are able to commercialize this potential fertility treatment.

        One of our scientific founders has successfully conducted laboratory experiments in animals and experiments with human EggPCs, which forms the basis for some aspects of OvaTure. There are, however, significant aspects of OvaTure that will require additional innovation for us to continue its preclinical and clinical development. In addition, successful development of OvaTure depends on our ability to mature human EggPCs into fertilizable eggs outside of the ovaries. Although our scientific founder's research has demonstrated the existence of EggPCs in human ovaries, research with respect to EggPCs is a new and emerging field. As a result, there is ongoing debate regarding the role of EggPCs in human reproduction as well as the ability of EggPCs to mature into fertilizable eggs when isolated from ovaries. The recent nature of the scientific discoveries underlying OvaTure, the ongoing debate regarding the ability to mature human EggPCs into fertilizable eggs, the need for additional innovation and the absence of information from human clinical trials all increase the risks associated with this potential fertility treatment. In any event, we believe that it will be costly and time consuming to develop OvaTure.

        Clinical studies are expensive, difficult to design and implement and uncertain as to outcome. The FDA and IRBs regulate clinical trials and can suspend or terminate them for many reasons. Success in animal and preclinical studies does not ensure that studies in humans will be successful, and interim or preliminary findings do not necessarily predict final results. In addition, the timing of results from and completion of the studies will depend, in part, on our ability to enroll the studies on the timeline expected. Enrollment in the studies could be delayed for a number of reasons, including the unwillingness of patients to undergo, or physicians to prescribe, an additional surgical procedure in connection with IVF.

        We may not be able to initiate or continue any future clinical trials for OvaTure or other potential fertility treatments for several reasons. For example, if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or similar regulatory authorities outside the United States, we will not be able to commence clinical studies. Patients who are eligible for future clinical trials may decide to use already established fertility treatments or to enroll in other clinical trials.

        Patient enrollment is affected by other factors including:

    timing and capacity of GTP processing facilities / third party manufacturers;

    novelty of the potential fertility treatments being tested;

    form of infertility or severity of the condition being treated;

    eligibility criteria for the study in question;

    perceived risks and benefits of the potential fertility treatments under study;

    known side effects of the potential fertility treatments under study, if any;

    efforts of IVF clinics to facilitate enrollment in clinical trials;

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    patient referral practices of physicians;

    ability to monitor patients adequately during and after treatment; and

    proximity and availability of clinical trial sites for prospective patients.

        Our inability to enroll a sufficient number of patients for any clinical trials for OvaTure and other potential fertility treatments would result in significant delays or may require us to abandon one or more clinical trials altogether. Enrollment delays in our clinical trials may result in increased development costs for our potential fertility treatments, which would cause the value of our company to decline and limit our ability to obtain additional financing.

OvaXon, our joint venture with Intrexon, is seeking to create new applications to prevent inherited disease for human and animal health that are based on a novel gene editing based technology, which makes it difficult to predict the time and cost of development and subsequently obtaining regulatory approval.

        OvaXon, our joint venture with Intrexon, is developing new gene editing based applications to prevent inherited disease for human and animal health by leveraging Intrexon's synthetic biology technology platform and our technology relating to EggPCs. OvaXon may experience difficulties in the future related to its gene editing platform, which could cause significant delays or unanticipated costs, and which OvaXon may not be able to solve. OvaXon may also experience delays in developing a sustainable, reproducible and scalable manufacturing process or transferring those processes to commercial partners, which may prevent OvaXon from completing studies or commercializing potential fertility treatments on a timely or profitable basis, if at all.

        The clinical study requirements of the FDA, the EMA and other regulatory agencies and the criteria these regulators use to determine the safety and efficacy of a product candidate vary substantially according to the type, complexity, novelty and intended use and market of the potential product candidate. The regulatory approval process for novel gene based fertility treatments such as those that OvaXon will pursue likely will be more expensive and take longer than for other, better known or extensively studied product candidates.

        The FDA has never approved any gene therapy or gene editing technology for use in humans or other animals. Only one gene therapy product, UniQure's Glybera, which received an EU marketing authorization in 2012, has been approved in the Western world, which makes it difficult to determine how long it will take or how much it will cost to obtain regulatory approvals for OvaXon's potential treatments.

        OvaXon's technologies involve the use of synthetic biologically engineered products or synthetic biological technologies. Public perception about the safety and environmental hazards of, and ethical concerns over, genetically engineered products and processes could influence public acceptance of OvaXon's technologies, potential products and processes. If OvaXon is not able to overcome the ethical, legal and social concerns relating to synthetic biological engineering, any potential treatments it develops may not be accepted. These concerns could result in increased expenses or abandonment of any potential fertility treatments OvaXon develops.

        Regulatory requirements governing gene and cell therapy products have evolved and may continue to change in the future. Further, most of the laws and regulations concerning synthetic biology relate to the end products produced using synthetic biology, but that may change. For example, the Presidential Commission for the Study of Bioethical Issues in December 2010 recommended that the federal government oversee, but not regulate, synthetic biology research. The Presidential Commission also recommended that the government lead an ongoing review of developments in the synthetic biology field and that the government conduct a reasonable risk assessment before the field release of synthetic organisms. Synthetic biology may become subject to additional government regulations as a result of

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the recommendations, which could require OvaXon to incur significant additional expenses in complying with these laws and regulations.

        Regulatory review agencies, committees and advisory groups and any new requirements and guidelines they promulgate may lengthen the regulatory review process, require OvaXon to perform additional studies, increase OvaXon's development costs, which we share with Intrexon, lead to changes in regulatory positions and interpretations, delay or prevent approval and commercialization of these treatment candidates or lead to significant post-approval limitations or restrictions. As OvaXon advances its potential new treatments in human and animal health, it will be required to consult with these regulatory and advisory groups and comply with applicable requirements and guidelines. If OvaXon fails to do so, we may be required to delay or discontinue development of its potential fertility treatments. Delay or failure to obtain, or unexpected costs in obtaining, the regulatory approval necessary to bring a potential fertility treatment to market could decrease our ability to generate sufficient revenue to maintain our business.

Preclinical testing and potential clinical trials of OvaTure and any of our other potential fertility treatments that require such testing and trials may not be successful. If we are unable to commercialize our potential fertility treatments or experience significant delays in doing so, our business will be materially harmed.

        We intend to invest a significant portion of our efforts and financial resources in the identification, preclinical development and clinical trials of potential fertility treatments. Our ability to generate revenues will depend heavily on the successful development and eventual commercialization of our potential fertility treatments. Although we have not discussed OvaTure with the FDA, we believe that the FDA is likely to regulate OvaTure and other potential fertility treatments, as drugs, biologics or medical devices under the PHSA or FDCA. This means, among other things, that we will not be able to market such potential fertility treatments in the United States unless and until we have successfully completed required testing (including clinical testing) and received marketing authorization from the FDA in the form of a NDA or BLA or, for medical devices, a 510(k) clearance or premarket approval application. We have not received approval to market any potential fertility treatments from regulatory authorities in any jurisdiction. We have only limited experience in conducting preclinical testing and clinical trials and filing and supporting the applications necessary to gain marketing approvals and expect to rely on third parties, including contract research organizations, to assist us in this process.

        Prior to initiating any clinical trials of OvaTure or other potential fertility treatments, we may need to submit an IND to the FDA, or a similar application to other regulatory authorities outside of the United States, based on preclinical, animal and other tests. Upon submitting such an IND or similar application, the FDA or other regulatory authorities might determine that the risks involved in OvaTure or our other potential fertility treatments are too great to justify proceeding with a clinical study and impose a partial or full clinical hold. They may require us to do significant and costly additional preclinical work before commencing our clinical trials or may not allow us to proceed with clinical trials at all. In addition, an IRB must review and approve any clinical trial before we can commence that trial. The IRB responsible for reviewing any of our clinical trials may decline to grant approval for a variety of reasons, including that they do not believe that patient rights would adequately be protected. OvaTure and our other potential fertility treatments rely on new and complex technology that impacts human reproductive systems. Therefore, the FDA, equivalent foreign regulatory authorities and IRBs may all be especially cautious in reviewing and approving our clinical protocols for such potential fertility treatments.

        If INDs for OvaTure or other potential fertility treatments do become effective, we will be required to conduct extensive clinical trials to demonstrate the safety, efficacy, purity and potency of our potential fertility treatments in humans. We will need to follow this same process for any future potential fertility treatments that are regulated by the FDA as a biologic or new drug. We will need to

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follow a similar process for any future product candidates that are regulated by the FDA as a medical device.

        Clinical testing is expensive, difficult to design and implement, can take many years to complete, and is uncertain as to outcome. A failure of one or more clinical trials can occur at any stage of testing. The outcome of preclinical testing and early clinical trials may not predict the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their products. The FDA, equivalent foreign regulatory authorities or an IRB can suspend or terminate our clinical development programs at any time, for a number of reasons, including that further study presents unreasonable risk to human subjects or that the rights of those subjects are not protected.

        We may experience numerous unforeseen events during, or as a result of, clinical trials, which could delay or prevent our ability to receive marketing approval or commercialize our potential fertility treatments, including:

    regulators or IRBs may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

    we may have delays in reaching, or fail to reach agreement on, acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;

    clinical trials of our potential fertility treatments may produce negative or inconclusive results, or results subject to varying interpretations, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon potential fertility treatment development programs;

    the number of patients required for clinical trials, and/or the necessary duration of clinical trials of our potential fertility treatments may be larger than we anticipate, enrollment in our clinical trials may be slower than we anticipate or participants may drop out of our clinical trials at a higher rate than we anticipate;

    we or our third party contractors may fail to comply with regulatory requirements, such as conducting trials in accordance with current good clinical practices, and our contractors may fail to meet their contractual obligations to us in a timely manner or at all;

    we may have to suspend or terminate clinical trials of our potential fertility treatments for various reasons, including discovery that the participants are being exposed to unacceptable health risks;

    the cost of clinical trials of our potential fertility treatments may be greater than we anticipate; and

    the supply or quality of our potential fertility treatments or other materials necessary to conduct clinical trials of our potential fertility treatments may be insufficient or inadequate.

        If we are required to conduct additional clinical trials or other testing of our potential fertility treatments beyond those that we contemplate, if we are unable to successfully complete clinical trials or other testing of our potential fertility treatments, if the results of these trials or tests are not positive or are only modestly positive or if there are any safety concerns regarding our potential fertility treatments, we may:

    be delayed in obtaining marketing approval for our potential fertility treatments;

    not obtain marketing approval at all;

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    obtain approval for indications or patient populations that are not as broad as we intend or desire;

    obtain approval with labeling that includes significant restrictions on distribution or safety warnings, including boxed warnings;

    be subject to additional post-marketing testing requirements; or

    have the treatment removed from the market after obtaining marketing approval.

        Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations and changes in regulatory review for each submitted product application may cause delays in the approval or rejection of an application. In addition, securing FDA approval requires the submission of information about the product manufacturing process to, and successful inspection of manufacturing facilities by, the FDA. Our potential fertility treatment development costs will also increase if we experience delays in testing or obtaining marketing approvals. Significant clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our potential fertility treatments or allow our competitors to bring potential fertility treatments to market before we do. Such events could impair our ability to successfully commercialize our potential fertility treatments and may harm our business and results of operations. Even if clinical trials for our potential fertility treatments are completed as planned, the FDA may still conclude that the risks inherent in our potential fertility treatments outweigh the demonstrated benefits, and may refuse to grant us marketing authorization. Any marketing approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the approved potential fertility treatments not commercially viable. If we experience delays in obtaining, or if we fail to obtain any required approvals of OvaTure or other potential fertility treatments, our ability to generate revenues will be materially impaired and our business will be materially harmed.

If serious adverse or inappropriate side effects are identified during the development of our potential fertility treatments or with any procedures with which our potential fertility treatments are used, we may need to abandon or limit our development of those potential fertility treatments.

        None of our potential fertility treatments has been proven effective and safe in humans through clinical trials. It is impossible to predict when or if any of our potential fertility treatments will prove effective or safe in humans or, to the extent required, will receive marketing approval. If our potential fertility treatments are associated with undesirable side effects or have characteristics that are unexpected with respect to the patient or the child conceived using our potential fertility treatments, we may need to abandon their development or limit development to certain uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. In addition, if any of the procedures with which our potential fertility treatments are used is determined to be unsafe, we may be required to delay or abandon our fertility treatment development or commercialization. For example, we expect AUGMENT will be administered as part of the ICSI process and OvaPrime will be administered as part of the IVF process. To the extent physicians limit or abandon the use of ICSI, IVF or other procedures with which AUGMENT or OvaPrime is used, we may need to delay or abandon our development or commercialization of AUGMENT or OvaPrime.

Even if we are able to commercialize any of our potential fertility treatments, they may fail to achieve the degree of market acceptance by physicians, patients and others in the medical community necessary for commercial success.

        If we are able to commercialize AUGMENT or OvaPrime or if any of our other potential fertility treatments receive marketing approval, they may nonetheless fail to gain sufficient market acceptance by physicians, patients and others in the medical community. For example, doctors may continue to rely

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on current treatments, including fertility drugs and traditional IVF, which are well established in the medical community. In addition, the novel nature of AUGMENT, OvaPrime and OvaTure may affect market acceptance by physicians and patients. If our potential fertility treatments do not achieve an adequate level of acceptance, we may not generate significant treatment revenues and we may not become profitable. The degree of market acceptance of AUGMENT, OvaPrime and our other potential fertility treatments, after receipt of any necessary approvals for commercial sale, will depend on a number of factors, including:

    efficacy and potential advantages as compared to traditional IVF or other alternative treatments;

    ability to reduce the number of IVF cycles required to achieve a live birth;

    ability to reduce the cost of traditional IVF;

    ability to reduce the incidence of multiple births;

    the willingness of the target population to undergo, and of physicians to prescribe, an additional surgical procedure in connection with IVF;

    convenience compared to alternative treatments;

    adverse effects on patients or children conceived using our potential fertility treatments;

    ability to improve the side effect profile of infertility treatment;

    the willingness of the target population and of physicians to try new therapies based on recent scientific discoveries;

    limitations on the existing infrastructure to support AUGMENT, OvaPrime or other potential fertility treatments, including adequately trained embryologists and the willingness of IVF clinics to incorporate the process into their current treatment regimen;

    the willingness of patients to pay out of pocket for our potential fertility treatments, which, in the case of AUGMENT and OvaPrime, will be in addition to the price of a standard IVF procedure;

    any negative publicity or political action related to our or similar potential fertility treatments or IVF; and

    the strength of marketing and distribution support.

        In addition, our ability to successfully commercialize our potential fertility treatments will depend on the continued use and acceptance of IVF, ICSI and fertility treatments generally. To the extent that the medical community or patient population determines that these procedures are unsafe or are otherwise not generally accepted, the market for our potential fertility treatments and, therefore, our business would be negatively affected.

If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market our potential fertility treatments we may not be successful in commercializing them.

        We are in the process of expanding on global sales and marketing team, initially focused on supporting the limited commercial launch of AUGMENT in four international regions. To achieve commercial success for any potential fertility treatment, we must either develop a sales and marketing team or outsource these functions to third parties. Our Executive Vice President, Global Commercial Operations, has significant experience in the international female fertility market. We also plan to recruit appropriate sales and marketing resources for countries in which we determine to provide or launch AUGMENT or OvaPrime on our own. In the future, we may choose to expand the sales force for AUGMENT, OvaPrime or other potential fertility treatments.

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        There are risks involved both with establishing our own sales and marketing capabilities and entering into arrangements with third parties to perform these services. For example, recruiting and training a sales force is expensive and time consuming and could delay any fertility treatment launch. If the commercial launch of AUGMENT, OvaPrime or another potential fertility treatment for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

        If we enter into arrangements with third parties to perform sales, marketing and distribution services, our treatment revenues or the profitability of these treatment revenues to us are likely to be lower than if we were to market and sell any potential fertility treatment ourselves. In addition, we may not be successful in entering into arrangements with third parties to sell and market our potential fertility treatments or may be unable to do so on terms that are favorable to us. We likely will have limited control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our potential fertility treatments effectively and in compliance with applicable laws.

We may not be successful in our efforts to identify or discover additional potential fertility treatments. If we do identify additional potential fertility treatments, we may expend our limited resources to pursue a particular potential fertility treatment and fail to capitalize on potential fertility treatments that may be more profitable or for which there is a greater likelihood of success.

        An important element of our strategy is to identify and develop additional potential fertility treatments based on our EggPCs technology. We may be unable to identify any such potential fertility treatments. If we do identify additional candidates, we may not advance such candidates into clinical development for a number of reasons, including:

    there may be evidence that such candidates may have harmful side effects;

    preclinical studies may put into question the efficacy of such candidates;

    we may determine that such candidates are unlikely to achieve marketing approval or market acceptance; or

    such candidates may be too costly to manufacture or market.

        Because we have limited financial and managerial resources, we focus on research programs and potential fertility treatments based on which candidates we believe have the highest likelihood of success and commercial value. As a result, we may forego or delay pursuit of opportunities with other potential fertility treatments that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial treatments or profitable market opportunities. Our spending on current and future research and development programs and potential fertility treatments may not yield any commercially viable treatments. For example, the programs we are considering relating to culture media and EggPCs banking may not reach commercialization or, if commercialized, may not be successful. If we do not accurately evaluate the commercial potential or target market for a particular potential fertility treatment, we may relinquish valuable rights to potential fertility treatments through collaboration, licensing or other royalty arrangements when it would have been more advantageous for us to retain sole development and commercialization rights to such potential fertility treatment.

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We may not be successful in obtaining necessary rights to additional technologies or potential fertility treatments, including from our scientific founders, for our development pipeline through acquisitions and in-licenses.

        We may be unable to acquire or in-license additional technologies or potential fertility treatments from third parties, including our scientific founders, in order to grow our business. A number of more established companies may also pursue strategies to license or acquire potential fertility treatments that we may consider attractive. These established companies may have a competitive advantage over us due to their size, cash resources and greater clinical development and commercialization capabilities.

        For example, we continue to work collaboratively with our scientific founders. These scientists continue to be active in the field of infertility and may develop new potential fertility treatments or intellectual property based on their continued research relating to infertility. The rights to new inventions by our scientific founders generally belong to the hospitals and academic institutions at which they are employed and are not subject to license or other rights in our favor. In the event that our scientific founders, or other third party scientists or entities, develop potential fertility treatments or intellectual property that we wish to acquire or in-license, we may be unable to negotiate such acquisition or in-license. Our failure to reach an agreement for any applicable potential fertility treatment or intellectual property could result in a third party acquiring the related rights and thereby harm our business.

        In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire relevant potential fertility treatments on terms that would allow us to make an appropriate return on our investment.

        We expect competition for acquiring and in-licensing potential fertility treatments that are attractive to us may increase in the future, which may mean fewer suitable opportunities for us as well as higher acquisition or licensing costs. If we are unable to successfully obtain rights to suitable potential fertility treatments on reasonable terms, or at all, our business, financial condition and prospects for growth could suffer.

We face substantial competition, including from more established infertility treatments, such as traditional IVF, as well as advances in new artificial reproductive technologies, which may result in others discovering, developing or commercializing potential fertility treatments before or more successfully than we do.

        There are a number of fertility treatments that are generally accepted in the medical and patient communities, including fertility drugs, IUI and IVF. Competition in the infertility market is largely based on pregnancy and live birth rates and side effects of treatment on patients. Accordingly, our success is highly dependent on our ability to develop potential fertility treatments that improve pregnancy and live birth rates and reduce risks and side effects, as compared to existing treatments. The ability of any potential fertility treatment that we successfully develop to reduce the overall costs associated with IVF also will be an important competitive factor.

        Competitors may develop new infertility drugs, ART therapies, devices and techniques that could render obsolete our potential fertility treatments. There are a number of pharmaceutical companies, biotechnology companies, universities and research organizations actively engaged in research and development of potential fertility treatments. Like AUGMENT, OvaPrime and OvaTure, some of these potential fertility treatments are designed to address the shortcomings of IVF. In particular, we are aware of a number of companies and laboratories that are currently developing potential fertility treatments intended to identify high quality embryos for use in IVF, a university study of the transfer of granulosa cell mitochondria into eggs and a university study of induced pluriopotent stem cells, or iPS, shows that iPS cells can be generated from somatic cells and programmed to become differentiated cells, which can include germ line cells such as oocytes. Novocellus Ltd. is developing an embryo viability test, using culture media, to aid in the selection of embryos used in IVF. FertiliTech and

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Auxogyn, Inc. are developing hardware and software that analyzes embryo development against cell division timing parameters to help identify the highest quality embryo within a group of embryos. If successfully developed, these potential fertility treatments could improve outcomes and alleviate some of the other shortcomings of traditional IVF, thereby decreasing the need for our potential fertility treatments. Fertility Focus, along with its strategic partner Norgenix, are developing a fertiloscope for the early diagnosis of, and immediate corrective surgery for, the physical causes of infertility. Molecular diagnostic companies like Reprogenetics are developing novel preimplantation genetic diagnosis and screening methods to detect chromosomal and genetic disorders of embryos prior to transfer back to the women. Testing embryos in this manner may increase the likelihood of pregnancy, reduce the chances of pregnancy loss, and improve the odds of delivery. At this time, we cannot evaluate how our potential fertility treatments, if successfully developed and commercialized, would compare technologically, clinically or commercially to any other potential fertility treatments being developed or to be marketed by competitors. There can be no assurance that we will be able to compete effectively. OvaXon, our joint venture with Intrexon, is engaged in gene editing, which is a rapidly evolving field. OvaXon could potentially have competitors in both in the United States and internationally, including major multinational pharmaceutical companies, biotechnology companies and universities and other research institutions. Some of the pharmaceutical and biotechnology companies we expect OvaXon to compete with include GlaxoSmithKline plc, Sangamo BioSciences Inc., HemaQuest Pharmaceuticals, Inc., Merck & Co., Inc., and Novartis AG.

        Our competitors may develop and commercialize new technologies before we do, allowing them to offer potential fertility treatments, services or solutions that are superior to those that we may offer or which establish market positions before the time, if any, at which we are able to bring potential fertility treatments to the market. Many of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources than we do and significantly greater experience in the discovery and development of potential fertility treatments, obtaining FDA and other regulatory approvals of potential fertility treatments and the commercialization of those treatments. Accordingly, our competitors may be more successful than we may be in developing, commercializing and achieving widespread market acceptance. Our competitors' potential fertility treatments may be safer, more effective or more effectively marketed and sold than any treatment we may commercialize and may render our potential fertility treatments obsolete or non-competitive before we can recover the expenses of developing and commercializing any of our potential fertility treatments. We anticipate that we will face intense and increasing competition as new treatments enter the market and advanced technologies become available.

We could be subject to negative publicity, political action and additional regulation because of the nature of our potential fertility treatments. These factors could increase our development and commercialization costs.

        Our potential fertility treatments are based on innovative science regarding eggs, embryos and fertilization, and in the case of our OvaXon joint venture, gene editing. These can be controversial subjects and, as a result, we could be subject to adverse publicity, political reaction and regulation, as well as changes to the laws and regulations affecting our potential fertility treatments. This may result in our incurring costs beyond what we anticipate in order to develop and commercialize our potential fertility treatments or may make it impossible to develop our potential fertility treatments at all. In addition, some states are considering adopting legislation defining when personhood begins. To the extent adopted, this legislation could limit, restrict or prohibit the use of IVF, which would have a negative effect on our ability to develop and sell our potential fertility treatments and, as a result, on our business.

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Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any potential fertility treatments that we may develop.

        We face an inherent risk of product liability exposure related to the testing of our potential fertility treatments in human studies and clinical trials and will face an even greater risk if we commercialize AUGMENT, OvaPrime or any other potential fertility treatment that we may develop, including potential fertility treatments developed by OvaXon. Product liability claims involving our activities may be made for significant amounts because our potential fertility treatments involve mothers and children. For example, it is possible that we will be subject to product liability claims that assert that our potential fertility treatments have caused birth defects in children or that such defects are inheritable. In light of the nature of our planned activities, these claims could be made many years into the future based on effects that were not observed or observable at the time of birth. If we cannot successfully defend ourselves against claims that our potential fertility treatments caused injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

    decreased demand for any potential fertility treatment that we may develop;

    injury to our reputation and significant negative media attention;

    withdrawal of clinical trial participants;

    significant costs to defend the related litigation;

    substantial monetary awards or payments to trial participants or patients;

    loss of revenue;

    the diversion of management's resources; and

    the inability to commercialize any potential fertility treatments that we may develop.

        We obtained product liability insurance coverage when we initiated our AUGMENT study in the United States. We will need to maintain product liability insurance coverage for introducing our ACE access program into international IVF clinics for physicians to gain experience using AUGMENT and to generate data, conducting any clinical studies for AUGMENT, launching OvaPrime, or conducting clinical trials for our other potential fertility treatments. Such insurance is increasingly expensive and difficult to procure. In the future, such insurance may not be available to us at all, may only be available at a very high cost and, if available, may not be adequate to cover all liabilities that we may incur. In addition, we may need to increase our insurance coverage in connection with the commercialization of AUGMENT, OvaPrime or other potential fertility treatments. If we are not able to obtain and maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise, our business could be harmed, possibly materially.

Procedures such as IVF, as well as companies that manufacture and store cells and tissues, are the subject of standards and recommendations by national non-governmental bodies. Failure to comply with these standards could harm our commercial prospects or subject us to negative media attention or government sanctions.

        Some national organizations set voluntary guidelines for procedures like IVF and for the manufacture and storage of human cells and tissues. The American Society for Reproductive Medicine, or ASRM, for example, has issued recommendations on the minimum standards that ART practices should employ, including minimum qualifications of personnel and record keeping and informed consent practices. ASRM also has issued guidelines on the number of embryos that should be transferred at a single time through IVF. Similarly, the American Congress of Obstetricians and Gynecologists sets forth guidelines on numerous topics such as the circumstances in which embryos can be used for research purposes and the use of innovative medical procedures in clinical practice. Although voluntary, subject to exceptions discussed below, if we, or third parties that we work with,

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including IVF clinics, fail to comply with these standards, our commercial prospects could be harmed because patients may prefer to use the services and potential fertility treatments of companies that meet these voluntary standards. Similarly, physicians or IVF clinics may be less likely to endorse or use procedures or potential fertility treatments that fail to comply with such standards. In addition, failure to meet the standards could subject us to negative media attention. Moreover, noncompliance with these professional organization standards could subject us to compliance risks in states that have incorporated the standards into state law. For example, the State of Maryland has incorporated certain portions of the American Association of Tissue Banks' Standards for Tissue Banking into its regulations. Failure to comply with certain standards could, therefore, amount to a violation of state law to the extent we operate in a state that adopts a voluntary guideline into its regulations.

Risks Related to Regulatory Approval of Our Potential Fertility Treatments and Other Regulatory Matters

Our plans to introduce AUGMENT and OvaPrime in selected regions outside of the United States depend upon AUGMENT and OvaPrime meeting the requirements of a class of products exempt from premarket review and approval in such regions. Failure to obtain required marketing approval in international regions would prevent our potential fertility treatments from being marketed in such regions.

        We believe that in certain regions outside of the United States, we will be able to introduce AUGMENT and OvaPrime into the market in the same way IVF and other assisted reproductive technologies are introduced without the need for pre-market review and approval by the relevant regulatory bodies. Our plans to introduce our ACE access program into international IVF clinics for physicians to gain experience using AUGMENT and to generate data, and to transition ACE clinics to commercial centers, depend upon our being able to bring AUGMENT to the market without such pre-review and approval. Also, our plans for a commercial launch of OvaPrime outside of the United States in 2015 depend upon our being able to bring OvaPrime to the market without such pre-review and approval. There can be no assurance that foreign regulatory authorities will agree that AUGMENT or OvaPrime meet the requirements of a class of products exempt from premarket review and approval under applicable regulations. Additionally, foreign regulatory authorities may change their standards for products that are exempt from premarket review and approval. If a particular foreign regulatory authority does not agree that AUGMENT or OvaPrime does not meet the requirements for such an exemption, we may abandon the use of AUGMENT or OvaPrime in such regions, or suffer significant delays and expense seeking to obtain any necessary approval.

        Further, in order to market and sell our potential fertility treatments in the EU and many other regions, we or our third party collaborators may need to obtain separate marketing approvals and will need to comply with numerous and varying regulatory requirements. The approval process varies among countries and can involve additional testing. The time required to obtain approval in foreign regions may differ substantially from that required to obtain FDA approval. The regulatory approval process outside the United States generally is subject to risks like those associated with obtaining FDA approval. In addition, in many countries outside the United States, a treatment must be approved for reimbursement before the treatment can be approved for sale in that country. Furthermore, some countries have restrictions particular to IVF, which may impose additional regulatory barriers for market entry for our potential fertility treatments. We may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all. Approval by the FDA for marketing in the United States does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA.

        In the EU, solely by way of example, our potential fertility treatments could be regulated as advanced therapy medicinal products, as medical devices or as human tissues and cells intended for human applications. Products regulated as advanced therapy medicinal products may only be placed on

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the market in the EU once they have been granted a marketing authorization by the European Commission. Securing a marketing authorization from the European Commission requires the submission of extensive preclinical and clinical data and supporting information, including information about the manufacturing process, to the EMA to establish the potential fertility treatment's safety, efficacy and quality. Following review of the marketing authorization application the EMA will issue an opinion, which the European Commission will take into account when deciding whether or not to grant a marketing authorization. Treatments regulated as medical devices in the EU are not subject to premarket review and approval by regulatory authorities. However, before placing the treatment on the market in the EU the manufacturer must demonstrate that the treatment meets certain essential requirements set out in applicable laws. For lower risk devices, the manufacturer may self-declare conformity to the essential requirements and apply the CE mark to the device. All other devices must undergo a conformity assessment procedure by a notified body, which is a third party licensed by regulatory authorities to perform such assessments. If the notified body agrees that the essential requirements have been met, it will issue a CE certificate, which allows the manufacturer to draw up a declaration of conformity and apply the CE mark to the device. Once a medical device has been CE marked it may be marketed throughout the EU.

        Products regulated as human tissues and cells for human applications that do not fall within the definition of an advanced therapy medicinal product or a medical device are not generally subject to premarket review and approval by regulatory authorities. However, the establishments that process and use such human tissues and cells must be licensed and are subject to various quality system and adverse event reporting requirements. We believe that AUGMENT should be subject to this general regimen for human cells and tissues, but regulatory authorities in the EU could disagree with our conclusion and determine that the procedure involves sufficient manipulation of the cells to bring the potential fertility treatment within the scope of the rules governing advanced therapy medicinal products. The relevant criteria for determining which products qualify as advanced therapy medicinal products could also change. If, for example, the European Commission determines that AUGMENT is an advanced therapy medicinal product and, therefore, requires premarket review, we may be required to halt any on-going studies or other uses in humans and conduct a more time consuming and expensive clinical trial program for this potential fertility treatment and may be unable to file for or obtain the necessary approvals to commercialize AUGMENT.

        While we believe EU marketing authorization is not required, medical treatments and processes, such as IVF, are regulated at the national level in the EU. Such national regulations may restrict the extent to which the eggs used in IVF treatments may be manipulated and so may prevent us from commercializing AUGMENT or OvaPrime in that country. In addition, certain other countries outside the EU and United States may have regulations that require us to obtain permission prior to commercializing AUGMENT or OvaPrime.

It is unclear what regulatory pathway FDA will ultimately require AUGMENT or other of our potential fertility treatments to follow.

        We believe that AUGMENT meets the regulatory definition of a 361 HCT/P. AUGMENT involves mere isolation of mitochondria from egg precursor cells, and injection of those mitochondria into the same woman's egg, which we believe constitutes minimal manipulation of both the mitochondria and the egg. AUGMENT involves only homologous use, is not combined with any other article, and has a systemic effect, but is for reproductive use. If FDA ultimately agrees with our conclusions, AUGMENT will not be required to conduct clinical trials pursuant to an IND, nor will it be required to seek FDA pre-market review and approval through an NDA or BLA. However, both AUGMENT and our other potential fertility treatments constitute new technologies, the proper regulatory characterization of which will constitute matters of first impression for FDA. Particularly because AUGMENT and our other potential fertility treatments are potential fertility treatments that are intended to result in the

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creation of human life, there can be no assurance that FDA will agree with our views as to the proper regulatory characterization of AUGMENT or any of our other potential fertility treatments. FDA may conclude that AUGMENT and/or other potential fertility treatments constitute drugs, biologics, or medical devices. If FDA makes such a determination for any of our potential fertility treatments, we would be required to conduct clinical trials under an IND (or IDE for a medical device) and seek FDA pre-market review and approval pursuant to an NDA or BLA (or PMA for a medical device). In that event, we may abandon pursuing that potential fertility treatment in the United States, or suffer significant delays and expense seeking to approve any necessary approval.

On September 6, 2013, we received an "untitled" letter from the FDA questioning the status of AUGMENT as a 361 HCT/P and advising us to file an IND application. We anticipate having further discussions with the FDA to present details on AUGMENT and its qualifications as a 361 HCT/P, and to determine the appropriate path forward. We continue to believe that AUGMENT qualifies as a 361 HCT/P. If the FDA disagrees with our interpretation of the relevant laws and regulations as they apply to AUGMENT, and requires an IND for the AUGMENT study, we may need to delay or abandon development of AUGMENT or other potential fertility treatments in the United States. The submission of an IND and a BLA or NDA would require us to compile significant amounts of data related to the AUGMENT process, as well as data from preclinical and clinical testing. We cannot guarantee that we would ever be able to secure such approval.

        The FDA regulates 361 HCT/Ps, such as AUGMENT, under a two-tiered framework. Certain higher risk HCT/Ps are regulated as new drugs, biologics or medical devices. Manufacturers of new drugs, biologics and some medical devices must complete extensive clinical trials, which must be conducted pursuant to an effective IND or investigational device exemption. The FDA must review and approve a BLA or NDA before a new drug or biologic may be marketed, and in some cases must approve a premarket approval application for medical devices.

        By contrast, the FDA exempts certain lower risk HCT/Ps from these requirements if they meet certain specified criteria. Such products frequently are referred to as "361 HCT/Ps," because the FDA regulates them under the authority given to it under section 361 of the PHSA to create regulations to control the spread of communicable diseases. We believe that AUGMENT meets the criteria for regulation as a 361 HCT/P rather than as a new drug or biologic and, therefore, that AUGMENT will not be subject to the requirement for an IND or FDA premarket review and approval. Thus, our current financial and business plans assume that we will not need to seek or obtain FDA approval for AUGMENT. Rather, we believe that we will have to comply with the requirements for 361 HCT/Ps set forth in FDA regulations and develop adequate substantiation to support marketing claims we make for the AUGMENT procedure.

        The TRG is a body within the FDA designed to provide formal opinions regarding whether a particular product will be regulated as a 361 HCT/P. Product manufacturers are not required to consult with the TRG and instead can market their products based on their own conclusion that the product meets the 361 HCT/P criteria. We have not consulted the TRG.

        The regulatory pathway for cell and tissue-based products is subject to significant uncertainty. The FDA's criteria for regulation as a 361 HCT/P are complex, and the FDA has provided little guidance on the meaning of terms used in the criteria, such as "minimal manipulation," "homologous," or "combination of the cells and tissues with another article." In addition, AUGMENT uses new technology that would present a matter of first impression for the FDA in determining whether to require premarket authorization. Further, AUGMENT may receive a high degree of scrutiny from the FDA due to its use as an aid to reproduction. The FDA or Congress could change the relevant criteria for determining which products qualify as 361 HCT/Ps or the regulatory requirements for HCT/Ps.

        The courts may also interpret those criteria and requirements in unexpected ways. For example, in United States v. Regenerative Sciences LLC , the United States District Court for the District of Columbia

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recently rejected a company's argument that the Regenexx Procedure, which involves the use of stem cells for the treatment of various orthopedic conditions, was exempt from regulation by the FDA because the procedure constitutes the practice of medicine. The court also held that the procedure does not qualify for regulation as a 361 HCT/P because it involves more than "minimal manipulation" of the cells. The court's finding turned on the fact that the Regenexx Procedure involves cell culture and expansion, which changes the biological characteristics of the cells. In February 2014, the United States Court of Appeals for the D.C. Circuit affirmed the lower court's opinion. We think the AUGMENT procedure is distinguishable from the Regenexx Procedure because AUGMENT does not involve cell cultures or cell expansion. Nonetheless, this case suggests that courts may take a narrow view of what constitutes minimal manipulation.

        Importantly, the court also noted the longstanding principle that the FDA's decisions on scientific matters, including the agency's conclusion that the procedure involves more than minimal manipulation, are entitled to substantial deference. This means that if the FDA disagrees with our conclusion that AUGMENT should be regulated as a 361 HCT/P, and not as a new biologic or drug, it may be very difficult to challenge the agency's position in court. If the FDA disagrees with our interpretation of the relevant laws and regulations as they apply to AUGMENT, and requires an IND for the AUGMENT study, we may need to delay or abandon development of AUGMENT or other potential fertility treatments in the United States.

Even if the FDA regulates AUGMENT as a 361 HCT/P, we must still generate adequate substantiation for any claims made in our marketing of AUGMENT. Failure to establish such adequate substantiation in the opinion of federal or state authorities or equivalent authorities outside of the United States could substantially impair our ability to generate revenue.

        Even if we ultimately do not need to submit AUGMENT to the FDA for preapproval, we still must generate adequate substantiation for claims we make in our marketing materials. Both the FTC and the states retain jurisdiction over the marketing of products in commerce and require a reasonable basis for claims made in marketing materials. Many countries outside of the U.S. have similar regulatory authorities that regulate the marketing of products. We intend to generate such adequate substantiation for any claims we make about the AUGMENT procedure. If, however, after we commence marketing of AUGMENT, the FTC or one or more states or foreign authorities conclude that we lack adequate substantiation for our claims, we may be subject to significant penalties or may be forced to alter or cease our marketing of AUGMENT in one or more jurisdictions. Any of this could materially harm our business. In addition, if our promotion of AUGMENT suggests that AUGMENT is not a 361 HCT/P, the FDA or equivalent foreign regulatory authorities might consider the potential fertility treatment to be a new drug or biologic. We will therefore be limited in the promotional claims that we could make about AUGMENT.

Numerous states place restrictions on the operation of facilities and laboratories that recover, test, process, manufacture, store or dispose of certain cells and tissues. If we do not comply with such state regulations, as well as potential local regulations, we could be subject to significant sanctions.

        Various states, including New York, California, Florida, Illinois, Maryland, Texas, Massachusetts and others, impose requirements on facilities and laboratories that recover, test, process, manufacture, store or dispose of certain cells and tissues. These requirements can have significant geographic reach. In Maryland, for example, the permit requirements applicable to tissue banks, including reproductive tissue banks, apply not only to tissue banks located in Maryland, but also those tissue banks located outside of the state that are represented or serviced in Maryland. In some cases, the requirements imposed by states, such as record keeping and testing requirements, may be more stringent than those imposed by the FDA. Failure to comply with these state requirements could subject us to significant sanctions.

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We will not be able to sell any potential fertility treatment that is regulated as a medical device without obtaining and maintaining necessary regulatory clearances or approvals.

        To market any potential fertility treatments that are regulated as medical devices, or that require the use of a new medical device, such as the innovative culture media solution that we are planning to develop, we will need to seek approval or clearance from the FDA, either through the premarket approval process or the 510(k) clearance process. We currently expect to be able to rely on the 510(k) clearance process, as opposed to the premarket approval process, for some of our medical device potential fertility treatments. However, it is difficult to predict whether the FDA will allow us to use the 510(k) pathway or require us to use the premarket approval process. We cannot guarantee that we will be able to obtain clearance or approval of these medical devices through either pathway. In addition, even if the FDA permits us to use the 510(k) pathway, the requirements to bring a product to market through this process may be significantly more resource intensive than we currently expect. The FDA has announced that it intends to make changes to the 510(k) process, and these changes, or any other changes related to FDA's regulation of medical devices, could have an adverse effect on our ability to gain regulatory clearance for, and to commercialize, our potential fertility treatments. In addition, any modifications to medical devices that we successfully bring to market, if any, may require new regulatory clearances or premarket approvals. Marketing a medical device without the necessary clearance or approval could result in a warning letter, fines, injunctions, product seizures or other civil or criminal penalties. Delays in our receipt of regulatory clearance or approval will cause delays in our ability to sell our potential fertility treatments, which will have a negative effect on our ability to generate and grow revenues.

In addition to the challenges associated with obtaining any necessary marketing approvals in international jurisdictions, economic, political and other risks associated with foreign operations could adversely affect our international sales.

        If we succeed with our international commercialization strategy, then our business will be subject to risks associated with doing business internationally. For example, our future results of operations could be harmed by a variety of factors, including:

    changes in foreign currency exchange rates;

    changes in a country's or region's political or economic conditions, particularly in developing or emerging markets;

    trade protection measures and import or export licensing requirements;

    differing business practices associated with foreign operations;

    difficulty in staffing and managing widespread operations, including compliance with labor laws and changes in those laws;

    differing protection of intellectual property and changes in that protection; and

    differing regulatory requirements and changes in those requirements.

        We do not currently have an international infrastructure including, without limitation, sales, manufacturing and distribution capabilities and have no experience in conducting foreign operations. Establishing commercial activities and complying with laws in foreign jurisdictions may be costly and could disrupt our operations.

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Even if we successfully launch AUGMENT, it will be subject to ongoing regulation. We could be subject to significant civil or criminal penalties if we fail to comply with these requirements, and we may be unable to commercialize our potential fertility treatments.

        Even if the FDA allows AUGMENT or any other potential fertility treatment of ours to be marketed as a 361 HCT/P and, therefore, without an NDA or BLA, we will still be subject to numerous post-market requirements, including those related to registration and listing, record keeping, labeling, current good tissue practices, or cGTPs, donor eligibility and other activities. HCT/Ps that do not meet the definition of a 361 HCT/P and, therefore, are approved via an NDA or BLA, are also subject to these and additional ongoing obligations. If we fail to comply with these requirements, we could be subject to warning letters, product seizures, injunctions or civil and criminal penalties. We are currently relying on a third party cGTP-compliant facility to conduct the various steps involved in the AUGMENT process, including the purification of the woman's mitochondria from the ovarian tissue biopsy. In the future, we may establish our own processing facility, which would need to be cGTP compliant. Any failure by us or the third party facility on which we rely to maintain cGTP compliance could require remedial action, such as product recalls and delays in distribution and sales of AUGMENT and any other potential fertility treatments that we develop, as well as enforcement actions.

        Moreover, even if the FDA or equivalent foreign regulatory authorities allow AUGMENT or any other potential fertility treatment to be marketed without premarket approval, the regulatory authorities could still seek to withdraw the potential fertility treatment from the market for a variety of reasons, including if the agency develops concerns regarding the safety or efficacy of the potential fertility treatment or its manufacturing process.

OvaTure and any other potential fertility treatment for which we obtain marketing approval are subject to continuing regulation after approval. We may be subject to significant penalties if we fail to comply with these requirements.

        Any potential fertility treatment, including any potential fertility treatment developed by our OvaXon joint venture, for which we obtain marketing approval or clearance will be subject to continuing regulation by the FDA or equivalent foreign regulatory authorities. For example, such potential fertility treatments will be subject to requirements relating to submission of safety and other post-marketing information and reports, registration and listing, manufacturing, packaging, quality control, storage, distribution, quality assurance and corresponding maintenance of records and documents, labeling, advertising and promotional activities, distribution of samples to physicians and recordkeeping. Even if marketing approval or clearance of a potential fertility treatment is granted, the approval or clearance may be subject to limitations on the uses for which the potential fertility treatment may be marketed, be subject to restrictions on distribution or use through a risk evaluation and mitigation strategy, or contain requirements for costly post-marketing testing to further evaluate the safety or efficacy of the potential fertility treatment. The FDA and equivalent foreign regulation authority closely regulate the post-approval marketing and promotion of drugs, biologics and medical devices to ensure such products are marketed only for the approved indications or cleared uses and in accordance with the provisions of the approved labeling. The FDA and equivalent foreign regulation authority impose stringent restrictions on manufacturers' communications regarding off-label use and if we market our potential fertility treatments other than for their approved indications, we may be subject to enforcement action for off-label marketing.

        In addition, later discovery of previously unknown problems with our potential fertility treatments, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may yield various results, including:

    restrictions on the labeling or marketing of potential fertility treatments;

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    restrictions on distribution or use of potential fertility treatments;

    requirements to conduct post-marketing clinical trials;

    warning or untitled letters from the FDA or equivalent foreign regulatory authorities;

    withdrawal of potential fertility treatments from the market;

    refusal to approve pending applications or supplements to approved applications;

    recall of potential fertility treatments;

    fines, restitution or disgorgement of profits or revenue;

    suspension or withdrawal of marketing approvals;

    refusal to permit the import or export of our potential fertility treatments;

    product seizure;

    injunctions; or

    the imposition of civil or criminal penalties.

It is unlikely that third party payors will cover or reimburse for AUGMENT, OvaPrime or other, future potential fertility treatments and services, and many patients may be unable to afford them.

        Many third party payors, both in the United States and other foreign countries, including national health services or government funded insurance programs as well as private payors, place significant restrictions on coverage and reimbursement for IVF and other ART procedures. Those restrictions may include limits on the types of procedures covered, limits on the number of procedures covered and overall annual or lifetime dollar limits on reimbursement for IVF and other ART procedures. As a result, we believe very few third party payors, either in the United States or outside the United States, will reimburse for AUGMENT, OvaPrime or our other potential fertility treatments and services. Thus, it is likely that IVF clinics and physicians will be able to use AUGMENT, OvaPrime and our other potential fertility treatments and services only if the patient can afford and is willing to pay out-of-pocket. The cost of AUGMENT, OvaPrime and our other potential fertility treatments and services may be beyond the means of many patients. This may limit the size of the market and prices charged for AUGMENT, OvaPrime or our potential fertility treatments and services and, thereby, limit our future revenues.

        Even in those limited situations in which government or private payors may cover AUGMENT, OvaPrime or other potential fertility treatments and services, cost containment pressures may later cause these third party payors to adopt strategies designed to limit the amount of reimbursement paid to IVF clinics and physicians, including but not limited to the following:

    reducing reimbursement rates;

    challenging the prices charged for medical potential fertility treatments or services;

    further limiting potential fertility treatments and services covered;

    challenging whether potential fertility treatments or services are medically necessary;

    taking measures to limit utilization of potential fertility treatments and services;

    negotiating prospective or discounted contract pricing;

    adopting capitation strategies; and

    seeking competitive bids.

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        Additionally, in those limited situations where ART procedures such as IVF are available to disabled patients of childbearing age enrolled in federal healthcare programs, such as Medicare, the covered services and potential fertility treatments may be subject to changes in coverage and reimbursement rules and procedures, including retroactive rate adjustments. These contingencies could even further decrease the range of potential fertility treatments and services covered by such programs or the reimbursement rates paid directly or indirectly for such potential fertility treatments and services. Such changes could further limit our ability to sell our potential fertility treatments, which may have a material adverse effect on our revenues.

        In March 2010, Congress enacted sweeping healthcare reform legislation known as the Affordable Care Act. The Affordable Care Act will substantially change the way that healthcare is financed by both governmental and private insurers and significantly affect the delivery and financing of healthcare in the United States. The Affordable Care Act contains provisions that, among other things, govern enrollment in federal healthcare programs, effect reimbursement changes, encourage use of comparative effectiveness research in healthcare decision making and enhance fraud and abuse requirements and enforcement. The Affordable Care Act imposes a significant annual fee on companies that manufacture or import branded prescription drug products, which could include potential fertility treatments such as OvaTure, if the FDA regulates it as a biologic. The fee, which is not deductible for federal income tax purposes, is based on the manufacturer's market share of sales of branded drugs and biologics, excluding orphan drugs, to, or pursuant to coverage under, specified U.S. government programs. In addition, the law subjects most medical devices to a 2.3% excise tax, beginning on January 1, 2013. The implementation of the Affordable Care Act may have a material adverse effect on our results of operations and financial condition.

        The reimbursement process for products and procedures outside the United States generally is subject to risks, like those associated with reimbursement in the United States, including the risk that it is unlikely that third party payors will cover or reimburse AUGMENT, OvaPrime or other, future potential fertility treatments and services. Many national health services and third party payors in the EU already place coverage and reimbursement limits on ART procedures, including IVF, and may impose even greater limits in the future. In many EU member states medicinal products and medical devices are subject to formal pricing and reimbursement approvals before they can be reimbursed by national health services or government-funded insurance schemes. Reimbursement may be conditional on the agreement by the seller not to sell the product above a fixed price in that country, or the national authority may unilaterally establish a reimbursement price in connection with the inclusion of the product on a list of reimbursable products.

        The likelihood that many third party payors will refuse to cover and reimburse for AUGMENT, OvaPrime and our future potential fertility treatments and services and that many patients will be unable to afford to pay for them out of pocket may reduce the demand for, or the price of, AUGMENT, OvaPrime and other future potential fertility treatments and services, which would have a material adverse effect on our revenues. Additional legislation or regulation relating to the healthcare industry or third party coverage and reimbursement may be enacted in the future, and could adversely affect the revenues generated from the sale of our potential fertility treatments.

Several states and certain foreign countries have enacted legislation that may hamper the ability of IVF clinics and physicians to pass through the cost of our potential fertility treatments to patients or third party payors.

        Several states, including California and New York, and certain foreign countries require direct billing of laboratory or pathology services, prohibit physicians from marking up the cost of laboratory or pathology services when they pass these costs on to patients or other payors or require that physicians disclose to patients what they actually paid to obtain laboratory or pathology services. Additionally, the federal government has enacted regulations limiting the Medicare reimbursement

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available to physicians who contract out the technical component of certain laboratory and pathology procedures.

        To the extent that AUGMENT, OvaPrime or possibly other, future potential fertility treatments or services are treated as laboratory or pathology services for purposes of reimbursement, these laws may make it difficult for us to market those potential fertility treatments and services to IVF clinics and physicians in some states and may also require us to restructure our business model before we can expand into certain markets. To the extent that our IVF clinic and physician customer base anticipates seeking Medicare reimbursement, these laws may require a comprehensive restructuring of our business model, and therefore adversely impact our ability to market our potential fertility treatments. Any additional legislation or regulation in this area could also adversely affect our ability to market our potential fertility treatments.

Even though we anticipate very limited third party coverage and reimbursement for AUGMENT, OvaPrime and our future potential fertility treatments and services, our future arrangements with third party payors and IVF clinics and physicians may be subject to foreign, federal and state fraud and abuse laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

        Even though we anticipate very limited third party coverage and reimbursement, including from federal healthcare programs, for AUGMENT, OvaPrime and possibly other, future potential fertility treatments and services, our future arrangements with third party payors and IVF clinics and physicians may expose us to broadly applicable fraud and abuse laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute AUGMENT, OvaPrime and possibly other, future potential fertility treatments and services for which we obtain marketing approval. Restrictions under federal and state fraud and abuse laws and regulations that may be applicable to our business include the following:

    the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid;

    the federal Stark law prohibits physicians from referring patients to hospitals, laboratories, and other types of entities in which they or their immediate family members have a financial interest, if the referral is for a select list of Medicare or Medicaid-covered services, including most clinical laboratory services, and also prohibits entities that furnish the covered services subsequent to a prohibited referral from billing Medicare or Medicaid for the services provided and from receiving payment from a federal healthcare program for those services;

    the federal False Claims Act imposes civil penalties, often through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

    HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, imposes criminal and civil liability for failure to safeguard the privacy, security and transmission of individually identifiable health information and for executing a scheme to defraud any federal healthcare program;

    the federal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in any matter within the jurisdiction of the executive, legislative, or judicial branch of the U.S. government, including in

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      connection with the delivery of or payment for federally reimbursed healthcare benefits, items or services;

    the federal transparency requirements under the "sunshine" provisions of the Affordable Care Act require manufacturers of drugs, devices, biologics and medical supplies to report to the Department of Health and Human Services information related to physician payments and other transfers of value and physician ownership and investment interests;

    analogous state laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third party payors, including private insurers, and some state laws require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments to physicians and other healthcare providers or marketing expenditures; and

    analogous foreign laws and regulations, such as anti-bribery laws and laws governing the promotion of medicinal potential fertility treatments or medical devices, as well as the Foreign Corrupt Practices Act, may apply to sales or marketing arrangements and interactions with physicians in countries outside the United States.

        Efforts to ensure that our business arrangements with third parties will comply with applicable fraud and abuse laws and regulations will involve substantial costs. It is possible that governmental authorities may conclude that our business practices do not comply with current or future statutes, regulations or case law involving applicable fraud and abuse laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, exclusion from government funded healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations. If any of the IVF clinics or physicians or other providers or entities with whom we expect to do business are found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

        Even the assertion of a violation under any of these provisions could have a material adverse effect on our financial condition and results of operations. Any such assertion would likely trigger an investigation of our business or executives that could cause us to incur substantial costs and result in significant liabilities or penalties, as well as damage to our reputation.

Laws and regulations governing international operations, including the Foreign Corrupt Practices Act, may preclude us from developing, manufacturing and selling certain potential fertility treatments outside of the United States and require us to develop and implement costly compliance programs.

        We have begun to expand our operations outside of the United States, and we must comply with numerous laws and regulations relating to our business operations in each jurisdiction in which we plan to operate. The creation and implementation of international business practices compliance programs is costly and such programs are difficult to enforce, particularly where reliance on third parties is required.

        The Foreign Corrupt Practices Act, or FCPA, prohibits any U.S. individual or business from paying, offering, or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with certain accounting provisions requiring the company to maintain books and records that accurately and fairly

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reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations. The anti-bribery provisions of the FCPA are enforced primarily by the U.S. Department of Justice. The SEC is involved with enforcement of the books and records provisions of the FCPA.

        Compliance with the FCPA is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, the FCPA presents particular challenges in the biotechnology industry, because, in many countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials. Certain payments to hospitals in connection with clinical studies and other work have been deemed to be improper payments to government officials and have led to FCPA enforcement actions.

        The failure to comply with laws governing international business practices may result in substantial penalties. Violation of the FCPA can result in significant civil and criminal penalties. The SEC also may suspend or bar issuers from trading securities on United States exchanges for violations of the FCPA's accounting provisions.

We may have obligations under our contracts with IVF clinics and physicians or other healthcare providers to protect the privacy of patient health information.

        In the course of performing our business, we will obtain, from time to time, confidential patient health information. For example, we may learn patient names and be exposed to confidential patient health information when we provide training on AUGMENT, OvaPrime and possibly other, future potential fertility treatments and services to the staff at IVF clinics and physicians' offices. United States federal and state laws protect the confidentiality of certain patient health information, in particular individually identifiable information, and restrict the use and disclosure of that information. At the federal level, the Department of Health and Human Services promulgated health information and privacy and security rules under HIPAA. At this time, we are not a HIPAA covered entity. However, our current and future business associate or other confidentiality agreements with covered entities contain commitments to protect the privacy and security of patients' health information and, in some instances, may require us to indemnify the covered entity for any claim, liability, damage, cost or expense arising out of or in connection with a breach of the agreement by us. If we were to violate one of these agreements, we could lose customers and be exposed to liability or our reputation and business could be harmed. In addition, the Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted in February 2009, expands the HIPAA privacy and security rules, including imposing many of the requirements of those rules directly on business associates and making business associates directly subject to HIPAA civil and criminal enforcement provisions and associated penalties. We may be required to make costly system modifications to comply with the HIPAA privacy and security requirements. Our failure to comply may result in criminal and civil liability.

        Other federal and state laws apply to the use and disclosure of health information, as well as certain financial information, which could affect the manner in which we conduct our business. Such laws are not necessarily preempted by HIPAA, in particular those laws that afford greater protection to the individual than does HIPAA or cover different subject matter. Such state laws typically have their own penalty provisions, which could be applied in the event of an unlawful action affecting health information.

        In the member states of the EU and many other countries, we will be subject to similar or more stringent data privacy laws, such as those implementing the European Data Protection Directive 95/46/EC, that require us to protect all individually identifiable information and restrict the use, disclosure and onward transfer of that information. Such national laws typically have their own civil or criminal enforcement provisions and associated penalties. We may incur costs in complying with the applicable privacy and security requirements, which may include registration with the national data protection authorities.

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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 the success of our business.

        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. Our operations involve the use of hazardous and flammable materials, including chemicals and biological materials. Our operations also produce hazardous waste products. We generally contract with third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties.

        Although we maintain workers' compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous or radioactive materials.

        In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or production efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Risks Related to the Manufacturing of Our Potential Fertility Treatments

We have entered into an agreement with a third party for the manufacture of AUGMENT and expect to rely on third parties for the manufacture of our other potential fertility treatments for preclinical testing, clinical trials and commercialization. This reliance on third parties increases the risk that we will not have sufficient quantities of our potential fertility treatments or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts because we have limited control of third parties' activities, including manufacturing capacity and costs and regulatory compliance.

        We do not own a manufacturing facility. In July 2013, we entered into a master services agreement with a global third party manufacturer to provide services for the manufacture of AUGMENT to perform the identification and isolation of EggPCs and the preparation of mitochondria steps in the AUGMENT process for our ACE program and early commercial activities. In our anticipated launch of AUGMENT and OvaPrime outside the United States, we may use our existing global cGTP-compliant manufacturer, contract with in-country manufacturers or manufacture on-site in clinics using our own equipment and employees. While we believe that our third party manufacturer has the capability to undertake the manufacture of AUGMENT in accordance with all applicable rules and regulations, there can be no assurance that it will be able to do so successfully. There can be no assurance that our global contract manufacturer, or any in-country manufacturer that we contract with, will maintain consistent quality standards with respect to any in-house manufacturing we do at individual IVF clinics. While we will seek to maintain high standards by working with high quality clinics, providing our own manufacturing equipment and personnel, and conducting regular training and quality audits, there can be no assurance that such clinics will maintain consistent quality standards. We do not have internal capabilities to manufacture AUGMENT, or internal or external capabilities to manufacture OvaPrime, OvaTure or any other potential fertility treatment.

        Reliance on third party manufacturers and laboratories entails additional risks, including:

    reliance on the third party for regulatory compliance and quality assurance;

    the possible breach of the manufacturing or service agreement by the third party; and

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    the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

        We expect to rely on third party manufacturers or third party collaborators for the manufacture of our other potential fertility treatments for preclinical testing, clinical trials and for commercial supply. We may be unable to establish any agreements with third party manufacturers or to do so on acceptable terms.

        Third party manufacturers and laboratories may not be able to comply with cGTP or current good manufacturing practice, or cGMP, regulations or similar regulatory requirements outside the United States. Any performance failure on the part of our existing or future manufacturers and service providers could delay clinical development or marketing approval or adversely affect or impede commercial sales. Our failure, or the failure of our third party manufacturers and service providers, to comply with applicable regulations could also result in sanctions being imposed on us, including fines, injunctions, civil penalties, suspension or withdrawal of approvals, license revocation, seizures or recalls of products, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our potential fertility treatments and harm our business and results of operations.

        We may compete with other companies for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGTP and cGMP regulations and that might be capable of manufacturing for us. It is possible that some of these manufacturers have agreements with our competitors that limit or restrict their ability to contract with us, further narrowing the number of manufacturers that are available to us.

        We do not currently have arrangements in place for redundant supply or a second manufacturing source for AUGMENT. Although we believe that there are other potential alternative manufacturers who could manufacture our potential fertility treatments, we may incur added costs and delays in identifying and qualifying any such replacement. We are pursuing a second manufacturing source for AUGMENT.

        Our current and anticipated future dependence upon others for the manufacture of our potential fertility treatments may adversely affect our future profit margins and our ability to commercialize AUGMENT or any future potential fertility treatments that we seek to market on a timely and competitive basis.

        We do not currently manufacture AUGMENT outside of the United States. If our current third party manufacturer is unable to supply AUGMENT for certain countries outside the United States, we will need to contract with third party manufacturers that comply with cGTP regulations to supply AUGMENT in other jurisdictions in which we decide to commercialize AUGMENT, if any. Although we believe there are other manufacturers who could manufacture our potential fertility treatments outside the United States, we may incur added costs and delays in identifying and qualifying a non-United States manufacturer.

        Providing AUGMENT to patients in regions outside the United States requires coordination internally among our employees and externally with physicians, IVF clinics, regulatory authorities and third party manufacturers, suppliers and carriers. For example, a patient's physician or clinical site will need to coordinate with us to ship a patient's ovarian tissue biopsy to the cGTP-compliant facility responsible for the next steps in the AUGMENT process, and we will need to coordinate with them to ship isolated cellular components from the patient's processed tissue back to them. Such coordination involves a number of risks that may lead to failures or delays in processing our AUGMENT potential fertility treatment. If we are unable to coordinate appropriately, we may encounter delays, incur additional costs or adversely affect our ability to commercialize AUGMENT.

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We intend to improve the efficiency and reduce the cost of our current AUGMENT process prior to commercialization. If we fail to do so, we may not continue commercial activities or generate significant revenues, and the profitability of our planned operations could be adversely affected.

        We continue to enhance the process for AUGMENT. As a result, while we are not able to project the likely AUGMENT costs, we believe that we will need to significantly reduce AUGMENT costs in order to achieve commercial success. We are actively working on initiatives that we have identified which we believe will enable us to achieve these cost savings. However, there can be no assurance that these initiatives will be successful. If we are not successful in reducing AUGMENT costs, we may not be able to continue commercial activities on schedule, if at all, and AUGMENT revenues may be lower than we expect and the profitability of AUGMENT sales could be adversely affected, possibly materially.

In the future, we may build and equip a cGTP-compliant facility for the processing of AUGMENT. Constructing and equipping such a facility in compliance with regulatory requirements will be time consuming and expensive.

        In the future, we may lease, build and equip a cGTP-compliant facility for the processing of AUGMENT. We believe that such a facility may be important to our ability to meet demand for AUGMENT and to process AUGMENT on a cost-effective basis. The leasing, build-out and equipping of this facility will require substantial capital expenditures. In addition, it will be costly and time consuming to recruit necessary additional personnel for the operation of the facility. Furthermore, we do not have experience running a manufacturing facility. Nor do we currently have funding available for any of these purposes. If we are unable to successfully construct and equip a commercial manufacturing facility in compliance with regulatory requirements, or hire additional necessary personnel appropriately, our revenues from AUGMENT, and the profitability of such revenues, may be adversely affected.

Lack of coordination internally among our employees and externally with physicians, IVF clinics and third party suppliers and carriers could result in processing and manufacturing difficulties, regulatory enforcement actions, disruptions or delays and cause us to have insufficient resources to meet any AUGMENT site's requirements or potential commercial requirements.

        Providing AUGMENT to patients requires coordination internally among our employees and externally with physicians, IVF clinics and third party suppliers and carriers. For example, a patient's physician or clinical site will need to coordinate with us to ship a patient's ovarian tissue biopsy to the cGTP-compliant facility responsible for the next steps in the AUGMENT process, and we will need to coordinate with them to ship the patient's egg precursor cells, or the patient's mitochondria from the egg precursor cells, to them. Such coordination involves a number of risks that may lead to failures or delays in processing our AUGMENT potential fertility treatment, including:

    difficulties in the timely shipping of patient-specific materials to us or in the shipping of our potential fertility treatments to the treating physicians due to errors by third party carriers, transportation restrictions or delays or other reasons;

    destruction of, or damage to, patient-specific materials or our potential fertility treatments during the shipping process due to improper handling by third party carriers, hospitals, physicians or us;

    destruction of, or damage to, patient-specific materials during any of the tissue or cell processing steps required for egg precursor cell isolation and selection of the patient-specific mitochondria;

    destruction of, or damage to, patient-specific materials or our potential fertility treatments during storage at our facilities;

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    failure to maintain precise patient records sufficient to ensure the chain of custody procedures are followed;

    destruction of, or damage to, patient-specific materials or our potential fertility treatments stored at clinical and future commercial sites due to improper handling or holding by clinicians, hospitals or physicians;

    failure to ensure adequate quality control and assurances in the AUGMENT process as we increase production quantities; and

    failure to establish or maintain sufficient manufacturing capacity, whether through third party manufacturers or internally.

        If we are unable to coordinate appropriately, we may encounter delays or additional costs in achieving our clinical and commercialization objectives. We, or third parties, could face regulatory action as a result of the failure to comply with cGTPs or other applicable rules. Some or all of these risks may also be applicable to OvaTure and any other future potential fertility treatments.

Risks Related to Our Dependence on Third Parties

We will rely on selected international IVF clinics to gain experience and generate data on AUGMENT through our ACE access program and to introduce, as well as to launch OvaPrime if our preclinical studies and potential fertility treatment optimization efforts are successful. We will also rely on third parties to conduct any clinical trials for other potential fertility treatments. Such third parties may not perform satisfactorily, including failing to meet volume expectations, quality standards or deadlines for the completion of such studies or trials.

        Our reliance on these third parties for providing our potential fertility treatments and for clinical development activities will reduce our control over these activities.

        We will remain responsible for ensuring that AUGMENT and OvaPrime, when and if introduced to international IVF clinics, are introduced with consistent and high quality standards. Moreover, the FDA and equivalent foreign regulatory authorities will require us to comply with GCPs with respect to any clinical trials for any of our potential fertility conducted in connection with a submission to the FDA or foreign regulatory authorities, including an IND or equivalent application, and will require that we record and report clinical trial results to assure that data and reported results are credible and accurate and that the rights and safety are protected. We will also be required to register ongoing FDA-regulated clinical trials and post the results of completed clinical trials on a government-sponsored database, ClinicalTrials.gov, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.

        Our reliance on these third parties for providing AUGMENT to IVF clinics and conducting clinical development activities will reduce our control over these activities. If these third parties do not successfully carry out their contractual duties, meet expected deadlines, provide our potential fertility treatments, conduct our clinical trials in accordance with regulatory requirements or our stated protocols or maintain consistent quality standards, in the case of contract manufacturing and clinics manufacturing our treatments on site, we will not be able to obtain, or may be delayed in obtaining, regulatory approvals for our potential fertility treatments and will not be able to, or may be delayed in our efforts to, successfully commercialize our potential fertility treatments. Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors, and could devote more of their resources to such other entities at the expense of expending sufficient resources on our clinical development activities.

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We expect to depend on collaborations with third parties, particularly Intrexon, for the development and commercialization of our potential fertility treatments. If those collaborations are not successful, we may not be able to capitalize on the market potential of these potential fertility treatments.

        In December 2013, we established a collaboration with Intrexon to accelerate development of OvaTure, and entered into the OvaXon joint venture with Intrexon to create new applications to prevent inherited diseases for human and animal health. Further, we currently intend to commercialize AUGMENT and OvaPrime ourselves in some markets and to collaborate with third parties to commercialize AUGMENT, OvaPrime and any future potential fertility treatments in other markets. In addition, we may seek partners for further development and commercialization of our other potential fertility treatments. These collaborations could take the form of license, distribution, sales representative, joint venture, sponsored research, co-promotion or other arrangements with pharmaceutical and biotechnology companies, other commercial entities and academic and other institutions.

        In any such arrangements with third parties, we will likely have limited control over the amount and timing of resources that such collaborators dedicate to the development or commercialization of our potential fertility treatments. Collaboration agreements may not lead to development or commercialization of potential fertility treatments in the most efficient manner, or at all. Our ability to generate revenues from these arrangements will depend on, among other things, our collaborators' successful performance of the functions assigned to them in these arrangements.

        Collaborations involving our potential fertility treatments would pose the following risks to us:

    collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations and could devote fewer resources to our potential fertility treatments than we expect them to;

    a collaborator with marketing and distribution rights to one or more other potential fertility treatments may not commit sufficient resources to the marketing and distribution of our potential fertility treatments;

    collaborators may not pursue development and commercialization of our potential fertility treatments or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborator's strategic focus or available funding, or external factors such as an acquisition that diverts resources or creates competing priorities;

    collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial, abandon a potential fertility treatment or repeat or conduct new clinical trials;

    collaborators could independently develop, or develop with third parties, potential fertility treatments that compete directly or indirectly with our potential fertility treatments;

    collaborators may create intellectual property that we need to in-license, may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information;

    disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our potential fertility treatments or that result in costly litigation or arbitration that diverts management's attention and resources; and

    collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable potential fertility treatments.

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If we are not able to establish collaborations, we may have to alter our development and commercialization plans.

        Our potential fertility treatment development programs and the potential commercialization of such treatments will require substantial additional cash to fund expenses. We may collaborate with pharmaceutical and biotechnology companies for the development and potential commercialization of some of our potential fertility treatments. For example, we currently intend to seek to collaborate with third parties to commercialize AUGMENT, OvaPrime and other potential fertility treatments we successfully develop in certain EU member states and other parts of the world.

        We face significant competition in seeking appropriate collaborators. Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator's resources and expertise, the terms and conditions of the proposed collaboration, and the proposed collaborator's evaluation of a number of factors. Those factors may include the design or results of our clinical trials, the likelihood of approval by the FDA or similar regulatory authorities outside the United States of our potential fertility treatment, the potential market for such potential fertility treatment, the costs and complexities of manufacturing and delivering the potential fertility treatment to patients, the potential and relative cost of competing fertility treatments, uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of the challenge, and industry and market conditions generally. The collaborator may also consider alternative potential fertility treatments or technologies for similar indications or conditions that may be available to collaborate on and whether such a collaboration could be more attractive than the one with us for our potential fertility treatment. We may also be restricted under existing license agreements from entering into agreements on certain terms with potential collaborators. In addition, there have been a significant number of recent business combinations among pharmaceutical and biotechnology companies that have resulted in a reduced number of potential future collaborators. Collaborations are complex and time consuming to negotiate, document and manage. We may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all.

        If we are not able to obtain a collaborator for a particular program, we may have to curtail the development of such program or of one or more of our other development programs, delay the potential commercialization of such program, reduce the scope of any sales or marketing activities for the program or increase our expenditures and undertake development or commercialization activities for the program at our own expense. If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all. If we do not have sufficient funds, we may not be able to further develop our potential fertility treatments or bring these potential fertility treatments to market and generate revenue.

Risks Related to Our Intellectual Property

If we fail to comply with our obligations under our intellectual property licenses, we could lose license rights that are important to our business.

        We have an exclusive license from MGH with respect to the intellectual property that forms the basis of our business. The license under MGH-owned patent rights and know-how is for human female fertility, the treatment or prevention of inherited (including mitochondrial) diseases or defects in all animals, including humans, assisted and/or artificial reproductive technology in all non-human animals, and the artificial creation of food, research animals and/or animal products; and the license under the MGH and Harvard co-owned patent right is for ex-vivo human female fertility treatments. Our existing MGH license agreement and another agreement granting rights impose, and we expect that future license agreements will impose, various obligations on us, including diligence, milestone payments,

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royalty payments, insurance and other obligations. For example, under our license agreement with MGH, we are required to use commercially reasonable efforts to develop and make available to the public licensed fertility treatments and to satisfy specified diligence milestones within specified timeframes. If we fail to comply with our obligations under this or other of our license agreements, our licensors may have the right to terminate our licenses, in which event we might not be able to market potential fertility treatments that are covered by these agreements, or to convert our licenses to non-exclusive licenses, which could materially adversely affect the value of the potential fertility treatments we developed under the license agreements. Termination of these license agreements or reduction or elimination of our licensed rights may result in our having to negotiate new or reinstated licenses with less favorable terms, or to cease commercialization of licensed technology and potential fertility treatments. This could materially adversely affect our business, particularly in the case of our license from MGH.

If we are unable to obtain and maintain patent protection for our technology and potential fertility treatments, or if our licensors are unable to obtain and maintain patent protection for the technology or potential fertility treatments that we license from them, our competitors could develop and commercialize technology and potential fertility treatments similar or identical to ours, and our ability to successfully commercialize our technology and potential fertility treatments may be adversely affected.

        Our success depends in large part on our and our licensors' ability to obtain and maintain patent protection in the United States and other countries with respect to our proprietary technology and potential fertility treatments. We and our licensors have sought to protect our proprietary position by filing patent applications within the United States and abroad related to our novel technologies and potential fertility treatments that are important to our business. The process of obtaining patent protection is uncertain, and we and our licensors may not succeed in obtaining the patent protection for our novel technologies and potential fertility treatments that we seek. If we and our licensors are unable to obtain and maintain patent protection of sufficient scope for our technology and potential fertility treatments, our competitors could develop and commercialize technology and potential fertility treatments similar or identical to ours, and in that case our ability to successfully commercialize our technology and potential fertility treatments may be adversely affected. This risk is greater outside the United States where some aspects of our in-licensed intellectual property are not protected by patents. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States.

        Moreover, under our license agreement with MGH, we do not have the right to control the preparation, filing and prosecution of the licensed patent applications, to defend the validity and enforceability of the licensed patents against challenges by third parties, or to maintain the licensed patents covering our technology or potential fertility treatments. This could also be the case under any other license agreements we enter into in the future. Therefore, we rely on MGH, and may rely on other licensors in the future, to file, defend and maintain patents that are important to our business. The failure of MGH or other licensors to successfully prosecute, defend and maintain these patents and patent applications in a manner consistent with the best interests of our business could adversely affect our ability to successfully commercialize our technology and potential fertility treatments.

        The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. As a result, the issuance, scope, validity, enforceability and commercial value of our and our licensors' patent rights are highly uncertain. Our and our licensors' pending and future patent applications may not result in patents being issued which protect our technology or potential fertility treatments or that effectively prevent others from commercializing competitive technologies and potential fertility treatments. Changes in either the patent laws or interpretation of the patent laws in the United States

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and other countries may diminish the value of our patents or narrow the scope of our patent protection.

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

        Under the America Invents Act enacted in September 2011, the United States moved to a first inventor to file system in March 2013. Outside the United States, the first to file a patent application is generally entitled to the patent. We may become involved in patent litigation or reexamination, post-grant review, opposition, derivation or interference proceedings challenging our patent rights or the patent rights of others. An adverse determination in any such litigation or proceeding could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or potential fertility treatments and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize potential fertility treatments without infringing third party patent rights.

If the scope of the patent protection we or our licensors obtain is not sufficiently broad, we may not be able to prevent others from developing and commercializing technology and potential fertility treatments similar or identical to ours.

        Our owned and licensed patents and any owned or licensed patent applications that issue as patents may not provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our owned or licensed patents by developing similar or alternative technologies or potential fertility treatments in a non-infringing manner. The issuance of a patent is not conclusive as to its scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in patent claims being narrowed, invalidated or held unenforceable, which could limit our ability to use and commercialize, or to stop or prevent others from using or commercializing, similar or identical technology and potential fertility treatments, or limit the duration of the patent protection of our technology and potential fertility treatments. Given the amount of time required for the development, testing and regulatory review of new potential fertility treatments, patents protecting such candidates might expire before or shortly after such candidates are commercialized. For example, certain of the U.S. patents and patent applications that we exclusively license from MGH will expire in May 2025. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing potential fertility treatments similar or identical to ours.

We may initiate lawsuits to protect or enforce our patents, which could be expensive, time consuming and unsuccessful.

        Competitors may infringe our patents. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during litigation.

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Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.

        Our commercial success depends upon our ability and the ability of our current and future collaborators to develop, manufacture, market and sell our potential fertility treatments and use our proprietary technologies without infringing the proprietary rights of third parties. We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our potential fertility treatments and technology, including interference proceedings before the U.S. Patent and Trademark Office. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future. If we are found to infringe a third party's intellectual property rights, we could be required to obtain a license from such third party to continue developing and marketing our potential fertility treatments and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing technology or treatment. In addition, we could be found liable for monetary damages. A finding of infringement could prevent us from commercializing our potential fertility treatments or force us to cease some of our business operations, which could materially harm our business. Claims that we have wrongfully appropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business.

We may be subject to claims that our employees have wrongfully appropriated, used or disclosed intellectual property of their former employers.

        Many of our employees were previously employed at universities or other biotechnology or pharmaceutical companies. Although we try to ensure that our employees do not appropriate or use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or these employees have appropriated, used or disclosed intellectual property, including information forming the basis of patents and patent applications, trade secrets or other proprietary information, of any such employee's former employer. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel and our reputation may be harmed.

Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.

        Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses, and could distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, such developments could have a substantial adverse effect on the price of our common stock. Such litigation or proceedings could substantially increase our operating losses, reduce the resources available for development activities and adversely affect our ability to raise additional funds. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.

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

        In addition to seeking patents for some of our technology and potential fertility treatments, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position. The protection available for trade secrets is particularly important with respect to our process for manufacturing AUGMENT, to OvaPrime and to our other potential fertility treatments, which will involve significant unpatented know-how. Any appropriation of our know-how, by competing contract manufacturers, collaborators or otherwise, could harm our business and we could suffer financial loss. We seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to such trade secrets, such as our employees, corporate collaborators, outside scientific collaborators, sponsored researchers, contract manufacturers, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent such competitor from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position would be harmed.

Risks Related to Employee Matters and Managing Growth

Our future success depends on our ability to retain our chief executive officer and other key executives and to attract, retain and motivate qualified personnel.

        We are highly dependent on Dr. Dipp, our chief executive officer, Arthur Tzianabos, our chief scientific officer, Mr. Stern, our executive vice president, global commercial operations and Mr. Bleck, our principal financial officer, as well as the other principal members of our management and scientific teams and our scientific co-founders, Drs. Tilly and Sinclair. Although we have entered into employment agreements with Dr. Dipp, Dr. Tzianabos, Mr. Stern and Mr. Bleck providing for certain benefits, including severance in the event of a termination without cause, these agreements do not prevent them from terminating their employment with us at any time. We do not maintain "key person" insurance for any of our executives or other employees. The loss of the services of any of these persons could impede the achievement of our research, development and commercialization objectives.

        In addition to her role as chief executive officer of our company, Dr. Dipp also serves as a general partner of Longwood Fund, LP, a venture capital investment fund and one of our principal stockholders. It is possible that Dr. Dipp may transition to an executive chairman role at our company at some point in the future, once we have meaningfully advanced our development efforts, grown our company overall and identified and hired a suitable successor. In such event, we will need to recruit and hire a new principal executive officer. Our inability to hire a suitable executive to assume this position in a timely fashion could delay the execution of our business plans or disrupt our operations.

        Recruiting and retaining qualified scientific, clinical, manufacturing and sales and marketing personnel will also be critical to our success. We may not be able to attract and retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and

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commercialization strategy. Our consultants and advisors, including our scientific co-founders, may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us.

We expect to expand our research and development and future sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.

        We expect to experience growth in the number of our employees and the scope of our operations, particularly in the areas of research and development and sales and marketing. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the limited experience of our management team in managing a company with such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel.

        The physical expansion of our operations may also lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

A breakdown or breach of our information technology systems could subject us to liability or interrupt the operation of our business.

        Many of our key business processes are facilitated by information technology systems. Information technology systems are potentially vulnerable to breakdown, malicious intrusion and random attack. Likewise, individuals authorized to access our information technology systems may pose a risk by exposing private or confidential data to unauthorized persons or to the public. While we believe that we have taken appropriate security measures to minimize these risks to our data and information technology systems, there can be no assurance that our efforts will prevent breakdowns or breaches in our systems that could adversely affect our business.

Risks Associated with Our Capital Stock

The market price of our common stock may be volatile and may fluctuate in a way that is disproportionate to our operating performance.

        Even if an active trading market develops for our common stock, our stock price may experience substantial volatility as a result of a number of factors, including:

    sales or potential sales of substantial amounts of our common stock;

    the delay or failure to execute our plans for AUGMENT or OvaPrime;

    results of preclinical testing or clinical trials of our potential fertility treatments, including OvaTure, or those of our competitors;

    the cost of our development programs;

    the success of competitive potential fertility treatments or technologies;

    the success of our OvaXon joint venture with Intrexon;

    announcements about us or about our competitors, including clinical trial results, regulatory approvals, new potential fertility treatment introductions and commercial results;

    the recruitment or departure of key personnel;

    developments concerning our licensors or manufacturers;

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    the results of our efforts to discover, acquire or in-license additional potential fertility treatments;

    litigation and other developments relating to our issued patents or patent applications or other proprietary rights or those of our competitors or other material litigation;

    disagreement by the FDA or equivalent foreign regulatory authorities regarding the regulatory pathway applicable to AUGMENT or OvaPrime;

    regulatory or legal developments in the United States or other countries, particularly with respect to IVF procedures;

    conditions in the pharmaceutical or biotechnology industries;

    changes in the structure of healthcare payment systems;

    actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;

    variations in our financial results or those of companies that are perceived to be similar to us; and

    general economic, industry and market conditions.

        Many of these factors are beyond our control. The stock markets in general, and the market for pharmaceutical and biotechnological companies in particular, have historically experienced extreme price and volume fluctuations. These fluctuations often have been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors could reduce the market price of our common stock, regardless of our actual operating performance.

We expect a substantial number of shares will become available for resale in the near future, which may adversely impact any trading market that may develop for our common stock.

        As of December 31, 2013, we had 18,528,215 shares of common stock outstanding, including the unvested Founders' Stock. Of these, 7,630,683 shares may be immediately sold pursuant to one registration statement on Form S-3 (some of which may also be sold pursuant to Rule 144), 3,888,880 shares may be immediately sold pursuant to another registration statement on Form S-3 and 37,434 shares may be sold exclusively pursuant to Rule 144.

        We have also filed Form S-8 registration statements under the Securities Act to register all shares of common stock that we may issue under our equity compensation plans. These shares can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates and lock-up agreements.

        The availability of a substantial number of shares for resale under registration statements or pursuant to Rule 144 promulgated under the Securities Act may adversely impact any trading market that may develop for our common stock or reduce the price at which such shares may be sold.

We have never paid and do not intend to pay cash dividends.

        We have never paid cash dividends on any of our capital stock and we currently intend to retain future earnings, if any, to fund the development and growth of our business. As a result, capital appreciation, if any, of our common stock will be our common stockholders' sole source of gain for the foreseeable future.

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Our executive officers, directors and principal stockholders have the ability to control all matters submitted to stockholders for approval.

        Our executive officers, directors and stockholders who own more than 5% of our outstanding common stock beneficially own shares, in the aggregate, representing approximately 57% of our outstanding capital stock as of December 31, 2013. As a result, if these stockholders were to choose to act together, they would be able to control all matters submitted to our stockholders for approval, as well as our management and affairs. For example, these persons, if they choose to act collectively, would control the election of directors and approval of any merger, consolidation or sale of all or substantially all of our assets. This concentration of voting power could delay or prevent an acquisition of our company on terms that other stockholders may desire.

Provisions in our certificate of incorporation and by-laws and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.

        Provisions in our certificate of incorporation and by-laws may discourage, delay or prevent a merger, acquisition or other change in control of us that stockholders may consider favorable, including transactions in which our common stockholders might otherwise receive a premium price for their shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of our common stock, thereby depressing the market price of our common stock. In addition, because our board of directors is responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors. Among other things, these provisions:

    establish a classified board of directors such that not all members of the board are elected at one time;

    allow the authorized number of our directors to be changed only by resolution of our board of directors;

    limit the manner in which stockholders can remove directors from the board;

    establish advance notice requirements for stockholder proposals that can be acted on at stockholder meetings and for nominations to our board of directors;

    limit who may call stockholder meetings;

    prohibit actions by our stockholders by written consent;

    require that stockholder actions be effected at a duly called stockholders meeting;

    authorize our board of directors to issue preferred stock without stockholder approval, which could be used to institute a "poison pill" that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors; and

    require the approval of the holders of at least 75% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our certificate of incorporation or by-laws.

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

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We are an "emerging growth company" and have elected to comply with certain reduced public company reporting requirements applicable to emerging growth companies, which could make our common stock less attractive to investors.

        We are an "emerging growth company," as defined in the JOBS Act enacted in April 2012. We have chosen and may continue to choose to take advantage of exemptions from various public company reporting requirements for as long as we continue to be an emerging growth company.

        These exemptions include, but are not limited to, (1) not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, (2) reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements, and (3) 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 after the first sale of our common equity securities pursuant to an effective registration statement under the Securities Act. However, if certain events occur prior to the end of such five year period, including if we become a "large accelerated filer," our annual gross revenues exceed $1 billion or we issue more than $1 billion of non-convertible debt in any three year period, we would cease to be an emerging growth company prior to the end of such five year period. We have taken advantage of certain of the reduced disclosure obligations regarding executive compensation in the filings we have made with the SEC and may elect to take advantage of other reduced burdens in future filings. As a result, the information that we provide to our stockholders may be different than you might receive from other public reporting companies in which you hold equity interests. We cannot predict if investors will find our common stock less attractive as a result of our reliance on these exemptions. If some investors find our common stock less attractive as a result of any choice we make to reduce disclosure, there may be a less active trading market for our common stock and our stock price may be more volatile.

        Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards until such time as those standards apply to private companies. However, we have irrevocably elected not to avail ourselves of this extended transition period for complying with new or revised accounting standards and, therefore, we will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.

We will incur increased costs as a result of operating as a public company, particularly once we cease to be an emerging growth company, and our management will be required to devote substantial time to new compliance initiatives.

        As a public reporting company, we have incurred significant legal, accounting and other expenses that we did not incur as a private company. In addition, the Sarbanes-Oxley Act of 2002 and rules subsequently implemented by the SEC and NASDAQ have imposed various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management and other personnel have devoted a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time consuming and costly. For example, we expect that these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced policy limits and coverage or incur substantial costs to maintain the same or similar coverage.

        Pursuant to Section 404 of the Sarbanes-Oxley Act, or Section 404, we are required to furnish a report by our management on our internal control over financial reporting, and, once we cease to be an emerging growth company, will be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To achieve compliance with Section 404 within the prescribed time period we have documented and evaluated our internal

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control over financial reporting, which may be costly. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting.

Item 1B.     Unresolved Staff Comments

        None.

Item 2.     Properties

        We currently occupy approximately 7,900 square feet of office and laboratory space in Cambridge, Massachusetts. 6,000 square feet are under a lease that expires in August 2017 and the remaining 1,900 square feet are under a sublease that expires in August 2015. We believe our facility is sufficient to meet our current needs and that suitable additional space will be available if and when needed.

Item 3.     Legal Proceedings

        On September 16, 2013, a purported shareholder class action, styled Meriam Ratner v. OvaScience, Inc., et al., was filed in the United States District Court for the District of Massachusetts, naming us and certain of our officers as defendants. The lawsuit alleges that we made material misrepresentations and/or omissions of material fact relating to the qualification of AUGMENT as a 361 HCT/P in our public disclosures during the period from February 25, 2013 through September 10, 2013, in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder. On February 2, 2014, we and certain of our officers, as defendants, filed a motion to dismiss with the District Court. On February 3, 2014, plaintiff Meriam Ratner voluntarily dismissed the suit without prejudice.

        We are not party to any other litigation in any court and management is not aware of any contemplated proceeding by any governmental authority against the Company.

Item 4.     Mine Safety Disclosures

        Not Applicable.

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PART II

Item 5.     Market For Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Market Information

        Our common stock began trading on the NASDAQ Global Market ("NASDAQ") on April 30, 2013 under the symbol "OVAS". Our common stock was first traded on the OTC Bulletin Board on November 9, 2012 under the symbol "OVSC." Prior to that date, there was no public market for our common stock.

        The following table sets forth, for the periods indicated, the high and low sales prices and the high and low bid information of our common stock as reported by NASDAQ and the OTC Bulletin Board, as applicable, for the periods indicated:

Year Ended December 31, 2013
  High   Low  

Fourth Quarter 2013

  $ 10.30   $ 8.14  

Third Quarter 2013

  $ 15.75   $ 9.06  

Second Quarter 2013 (beginning April 30, 2013)

  $ 16.00   $ 10.50  

 

 
  High
Closing
Price
  Low
Closing
Price
  High
Bid
Price
  Low
Bid
Price
 

Second Quarter 2013(through April 29, 2013)

  $ 12.50   $ 9.00   $ 13.50   $ 9.00  

First Quarter 2013

  $ 14.00   $ 8.15   $ 15.00   $ 8.15  

Year Ended December 31, 2012

   
 
   
 
   
 
   
 
 

Fourth Quarter 2012 (beginning November 14, 2012)

  $ 9.30   $ 7.50   $ 10.00   $ 7.50  

        The over-the-counter market quotations from November 14, 2012 to April 29, 2013 reflect inter-dealer prices, without retail mark-up, mark-down or commission. The high and low bid prices do not necessarily represent actual transactions.

        On February 25, 2014, the closing price of a share of our common stock on NASDAQ was $10.18.

Holders

        As of January 31, 2014, there were 18,563,215 shares of common stock outstanding, which were held by approximately 250 record holders.

Dividends

        We have never paid cash dividends on any of our capital stock and we currently intend to retain our future earnings, if any, to fund the development and growth of our business. We do not intend to pay cash dividends to holders of our common stock in the foreseeable future.

Recent Sales of Unregistered Securities

        Set forth below is information regarding shares of common stock issued by us between January 1, 2013 and December 31, 2013 that were not registered under the Securities Act. Also included is the consideration, if any, received by us, for such shares and information relating to the section of the Securities Act, or rule of the SEC, under which exemption from registration was claimed.

    (1)
    In March 2013, we issued and sold an aggregate of 3,888,880 shares of our common stock to investors for an aggregate purchase price of approximately $35.0 million. Leerink Swann LLC

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      acted as lead placement agent and Ladenburg Thalmann & Co. Inc., Oppenheimer & Co. Inc., Roth Capital Partners, LLC and Wedbush Securities Inc. acted as co-agents in connection with such private placement of common stock.

    (2)
    In December 2013, we issued 273,224 shares of our common stock to Intrexon Corporation upon the execution of a collaboration agreement as partial consideration for the use of Intrexon's synthetic biology technology platform for the accelerated development of our OvaTure platform.

        No underwriters were involved in the foregoing issuances of securities.

        The offers, sales and issuances of the securities described in paragraph (1) and (2) were deemed to be exempt from registration under the Securities Act in reliance on the exemption from the registration requirements of the Securities Act pursuant to Regulation D promulgated under Section 4(2) of the Securities Act relative to transactions by an issuer not involving a public offering. The recipients in each of these transactions represented to us in connection with their purchase that they were accredited investors and were acquiring the securities for investment only and not with a view to or for sale in connection with any distribution thereof and appropriate legends were affixed to the securities issued in these transactions. Each of the recipients of securities in these transactions was an accredited investor under Rule 501 of Regulation D.

Item 6.     Selected Financial Data

        The selected financial data set forth below is derived from our audited consolidated financial statements and may not be indicative of future operating results. The following selected consolidated financial data should be read in conjunction with Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the consolidated financial statements and the notes thereto included elsewhere in this report. The selected financial data in this section are not intended to replace our consolidated financial statements and the related notes. Our historical results are not necessarily indicative of our future results.

 
   
   
  Period from
April 5,
2011
(inception) to
December 31,
2011
  Period from
April 5,
2011
(inception) to
December 31,
2013
 
 
  Year Ended,
December 31,
 
 
  2013   2012  
 
  (in thousands, except per share amounts)
 

Consolidated Statements of Operations Data:

                         

Total operating expenses(1)

  $ 29,134   $ 13,529   $ 2,624   $ 45,287  

Loss from operations

    (29,134 )   (13,529 )   (2,624 )   (45,287 )

Net loss

    (29,044 )   (13,510 )   (2,624 )   (45,178 )
                   

Accretion of convertible preferred stock to redemption value

            (101 )   (101 )

Net loss applicable to common stockholders

  $ (29,044 ) $ (13,510 ) $ (2,725 ) $ (45,279 )
                   
                   

Net loss per share applicable to common stockholders—basic and diluted

  $ (1.80 ) $ (2.33 ) $ (3.00 ) $ (5.42 )
                   
                   

Weighted average number of common shares used in net loss per share applicable to common stockholders—basic and diluted

    16,160     5,810     909     8,350  
                   
                   

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  As of December 31,  
 
  2013   2012   2011  
 
  (in thousands)
 

Consolidated Balance Sheet Data:

                   

Cash, cash equivalents and short-term investments

  $ 44,427   $ 31,391   $ 4,541  

Total assets

    47,545     32,814     4,585  

Total current liabilities

    5,774     2,086     675  

Total long-term liabilities

    70     7     87  

(1)
In 2013 the loss from operations includes $4.7 million related to the technology access fee to Intrexon related to the OvaTure Collaboration.

Item 7.     Management's Discussion and Analysis of Financial Condition and Results of Operations

        The following discussion should be read in conjunction with our financial statements and related notes appearing elsewhere in this Annual Report on Form 10-K. The following discussion contains forward-looking statements. Actual results may differ significantly from those projected in the forward-looking statements. Factors that might cause future results to differ materially from those projected in the forward-looking statements include, but are not limited to, those discussed in "Risk Factors" and elsewhere in this Annual Report on Form 10-K. See also "Cautionary Note Regarding Forward-Looking Statements."

Overview

        OvaScience is a global life science company focused on the discovery, development, and commercialization of new fertility treatments. Our patented technology is based on egg precursor cells ("EggPC SM "), which are found in the outer layer of a woman's own ovaries. The recent discovery of EggPCs countered a long-held medical belief that women are born with a set number of eggs, thereby enabling new possibilities in the treatment of female infertility.

        Our portfolio of fertility treatment options takes advantage of proprietary methods to identify, isolate and concentrate EggPCs from the patient's ovarian tissue. By applying our EggPC technology platform in unique ways, we are developing new fertility treatment options that are designed to improve egg quality and in vitro fertilization ("IVF"). These treatment options under development include the following:

    AUGMENT SM aims to improve egg quality and potentially increase the success of IVF by transferring mitochondria from a woman's EggPCs to her mature egg during IVF. We plan to introduce AUGMENT in 2014 in at least four international regions.

    OvaPrime SM is designed to boost a woman's egg reserve by transferring the EggPCs from the outer layer of her ovary (outer cortex) back into the ovary prior to IVF. We expect to introduce OvaPrime outside of the United States in 2015.

    OvaTure SM seeks to mature a woman's own EggPCs into fertilizable eggs without the need for hormone hyperstimulation.

    OvaXon SM is a joint venture with Intrexon Corporation, which is focused on developing new applications to prevent inherited diseases by gene editing EggPCs for applications in human and animal health.

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        We believe our EggPC technology has the potential to make significant advances in the field of fertility because it may enable us to address poor egg and embryo quality due to age and other causes. We believe our EggPC technology could improve IVF by:

        Increasing live birth rates and reducing the number of IVF cycles.     By improving egg quality, we believe we may be able to increase the percentage of IVF treatments which result in live births and, in so doing, reduce the number of IVF cycles required.

        Reducing the incidence of multiple births.     By generating higher quality eggs, we believe our EggPC technology may allow for the transfer of fewer embryos per IVF cycle and, as a result, lower the incidence of multiple births and the associated complications for the mother and baby.

        Lowering the overall cost of IVF.     If we reduce the number of IVF cycles required for a live birth and the incidence of multiple births, we believe our fertility treatment options may also lower the overall costs associated with IVF.

        Reducing the need for hormonal hyperstimulation.     We are designing our OvaTure technology to mature EggPCs into fertilizable eggs in vitro . If successful, OvaTure could reduce, or possibly eliminate, the need for hormonal hyperstimulation for the maturation of multiple oocytes prior to egg retrieval in the IVF process.

        Prevent inherited diseases.     By applying gene editing techniques to EggPCs, we believe we may be able to prevent the transmission of inherited diseases, such as Huntington's Disease, in future generations.

AUGMENT

        The Company's first fertility treatment is AUGMENT SM , which we plan to introduce to international IVF clinics in 2014 through our AUGMENT Centers of Excellence ("ACE") access program. The goal is for physicians to gain experience using AUGMENT and to generate data. In 2014, we expect to establish ACE clinics in at least four international regions, which we anticipate will result in 40 to 60 AUGMENT cycles this year. By year end 2014, we expect to transition these ACE clinics to commercial centers. We are targeting international regions that combine elements of the following key criteria:

    Key opinion leaders / high volume IVF clinics

    High quality IVF labs

    Out-of-pocket pay and high average cost per cycle

    Donor egg restrictions

        As part of AUGMENT, a woman's eggs may be rejuvenated by injecting mitochondria prepared from her own EggPCs into her egg during IVF. This has the potential to improve egg quality and thereby increase the success of IVF. With higher quality eggs, there is also the potential to reduce the need for multiple embryo transfers, which can result in a lower incidence of conceiving multiples (twins or triplets) and resulting complications.

        AUGMENT complements the existing standard of practice for an IVF cycle. Prior to hormone hyperstimulation, a small tissue biopsy is taken from the outer layer of the ovary, where the EggPCs reside. Our proprietary process identifies and isolates the patient's own EggPCs followed next by the removal of her own mitochondria within the EggPCs. The women's own mitochondria are then injected into her egg at the time of intracytoplasmic sperm injection ("ICSI").

        The development of assisted reproductive technologies has a long history of innovation based on techniques and tools developed in IVF clinics around the world. In fact, all of the major innovations in

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fertility treatment have been developed in countries outside of the United States, including IVF and ICSI, and more recently, time-lapse imaging, oocyte vitrification and in vitro maturation of oocytes. This is a main reason why the IVF market is predominantly located outside of the United States where 90% of the 1.6 million IVF cycles are performed. Given the market size, as well as the innovative history and acceptance of new fertility methods and technologies internationally, we have always had a strategy to make our fertility treatments available to patients worldwide. We plan to introduce our first fertility treatment, AUGMENT, through a limited commercial launch in international IVF clinics in 2014, and we are preparing to launch a second fertility treatment using this approach in 2015. We believe that we will be able to introduce AUGMENT into these regions without pre-market review and approval, but if applicable regulatory bodies disagree, we may abandon AUGMENT in that region or suffer significant delay or expense in seeking necessary approvals to gain clinical experience with AUGMENT in the United States ahead of a commercial launch. In December 2012, we initiated a study of AUGMENT in the United States. In September 2013, we received an "untitled" letter from the FDA advising us to file an Investigational New Drug (IND) application for AUGMENT. Following the receipt of the FDA letter, we chose to suspend enrollment in the U.S. study. We anticipate having further discussions in 2014 with the FDA to present details on AUGMENT and to determine the appropriate path forward.

Strategic Alliances

        Strategic alliances are integral to our growth. These alliances provide access to breakthrough science, potential funding and innovative drug development programs, all intended to help us realize the full potential of our potential fertility treatment pipeline while at the same time allowing us to retain significant downstream value in our programs through commercialization rights.

    Collaboration with Intrexon to Accelerate Development of OvaTure

    Scope

        In December 2013, we entered into a collaboration agreement (the "OvaTure Collaboration") with Intrexon governing the use of Intrexon's synthetic biology technology platform for the accelerated development of our OvaTure platform. The OvaTure Collaboration provides that Intrexon will deliver laboratory and animal data to support the successful filing of an IND for OvaTure.

        Although we have not discussed OvaTure with the FDA, we expect we will need to obtain regulatory approval of OvaTure in both the United States prior to commercialization. OvaScience owns exclusive human commercial rights for OvaTure.

        We will participate as an equal member on the Joint Steering Committee ("JSC") and Intellectual Property Committee ("IPC"). The JSC shall agree upon the services and the activities to be included in the work plan, and IPC has authority over intellectual property matters. We have the tie-breaking vote if there are any disputes with the JSC.

    Technology Access Fee Payable to Intrexon

        The technology access fee payable to Intrexon is comprised of (1) the issuance of 273,224 shares or $2.5 million of our newly issued common stock, to Intrexon, upon the execution of the OvaTure Collaboration in December 2013, and (2) a $2.5 million cash payment due December 2014, which is payable solely upon the passage of time.

        The technology access fee does not give us the right to any research and development services, and the technology access has no alternative future use to us. We therefore recorded $4.7 million in research and development expense in the year ended December 31, 2013 with $2.5 million recorded to

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additional paid-in capital and common stock and $2.2 million recorded in accrued liabilities, which represents the present value of the $2.5 million technology access fee due in December 2014.

        The shares issued to Intrexon are subject to "piggy-back" registration rights that entitle Intrexon to have the shares included in any new registration statement filed in connection with an underwritten public offering, subject to underwriter cutback. The piggy-back registration rights will not be triggered by any offering subject to a previously filed registration statement, including our current universal shelf registration statement.

    Research and Development Funding and Potential Commercial Milestone

        The JSC will also approve a budget under the work plan. We will reimburse Intrexon for research and development services performed, subject to budget caps. If applicable, OvaScience will also make a commercial milestone payment three months after the first commercial sale of OvaTure.

    Termination Rights

        The collaboration has an indefinite term, with OvaScience having the right to terminate the collaboration after 90 days' prior written notice, and either OvaScience or Intrexon may terminate after a material breach by the other party that is not cured within 60 days. We may assign the collaboration in the event of a change of control transaction.

    Royalties

        Upon the delivery of laboratory and animal data necessary to support the successful filing of an IND application, we will incur an obligation to pay Intrexon a mid-single digit royalty on net sales of any OvaTure fertility treatments, and the exact royalty will depend upon whether Intrexon completes the milestone by the targeted deadline of two years after technology transfer.

    Joint Venture

        In December 2013, we also entered into a joint venture with Intrexon to leverage Intrexon's synthetic biology technology platform and OvaScience's technology relating to egg precursor cells to pursue the prevention of genetic disease and animal health. We and Intrexon formed OvaXon, LLC ("OvaXon") to conduct the joint venture. Each party contributed $1.5 million to OvaXon and each has a 50% equity interest, and research and development costs and profits will be split accordingly. Each party will also have 50% control over OvaXon with disputes resolved through arbitration, if necessary.

        We recorded $1.5 million as an equity method investment in OvaXon LLC in December 2013.

Financial Operations Overview

    Revenue

        To date, we have not generated any revenue. Our ability to generate revenue, if ever, will depend heavily on the successful development and eventual commercialization of AUGMENT, OvaPrime, OvaTure and our other future treatments.

    Research and Development Expenses

        Research and development expenses consist of costs associated with our research activities, discovery efforts and the development of our treatments. Our research and development expenses consist of:

    employee-related expenses, including salaries, benefits, travel and stock-based compensation expense;

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    Fees for acquired technologies which have not yet reached technological feasibility and have no alternative use;

    external research and development expenses incurred under arrangements with third parties, such as contract research organizations, manufacturing organizations and consultants, including our scientific advisory board;

    license fees; and

    facilities, laboratory supplies and other allocated expenses.

        We expense research and development cost to operations as incurred. We account for nonrefundable advance payments for goods and services that will be used in future research and development activities as expenses when the service has been performed or when the goods have been received, rather than when the payment is made.

        We use our employee and infrastructure resources across multiple research and development projects. We do not maintain or evaluate, and therefore do not allocate, internal research and development costs on a project-by-project basis. We do not have actual external or total expenses by project for the inception to date period or for the years ended December 31, 2013, December 31, 2012 and the period from April 5, 2011 through December 31, 2011. Research and development expenses to date have primarily related to the development of AUGMENT.

        We expect our expenses to increase over time for our OvaPrime and OvaTure programs.

        The successful development of our treatments is highly uncertain. As this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete development of our treatments or the period, if any, in which material net cash inflows from our treatments may commence. This is due to the numerous risks and uncertainties associated with developing treatments, including the uncertainty of:

    the scope, rate of progress and expense of our discovery efforts and other research and development activities;

    the safety, efficacy and potential advantages of our treatments as compared to traditional IVF or other therapies;

    our ability to market, commercialize and achieve market acceptance for AUGMENT, OvaPrime, OvaTure and other potential fertility treatments that we are developing or may develop in the future;

    the results of introducing our ACE access program into international IVF clinics to gain clinical experience using AUGMENT and to generate data outside the United States;

    the results of our efforts to study, optimize and ultimately launch OvaPrime outside of the United States;

    the terms and timing of potential regulatory approvals, if any; and

    the expense of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights.

        A change in the outcome of any of these variables with respect to the development of a treatment could mean a significant change in the costs and timing associated with the development of that potential fertility treatment.

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    General and Administrative Expenses

        General and administrative expenses consist primarily of salaries and related costs for personnel, including stock-based compensation expense, in our executive, finance, accounting, legal, corporate communications, corporate development, human resources and commercial functions. Other costs include facilities costs not otherwise included in research and development expense, and professional fees for legal and accounting services. General and administrative costs also consist of the costs of maintaining our intellectual property portfolio.

    Interest Income

        Interest income typically consists of interest earned on cash, cash equivalents and short-term investments.

Critical Accounting Policies and Significant Judgments and Estimates

        Our management's discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation described in greater detail below. We base our estimates on our limited historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

        Our significant accounting policies are described in more detail in the notes to our consolidated financial statements included elsewhere in this Annual Report. However, we believe that the following accounting policies are the most critical to aid you in fully understanding and evaluating our financial condition and results of operations.

    Accrued Research and Development Expenses

        As part of the process of preparing our financial statements, we are required to estimate our accrued expenses. This process involves reviewing quotations and contracts, identifying services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. The majority of our service providers invoice us monthly in arrears for services performed or when contractual milestones are met. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. We periodically confirm the accuracy of our estimates with the service providers and make adjustments if necessary. The significant estimates in our accrued research and development expenses include fees paid to contract research organizations in connection with research and development activities for which we have not yet been invoiced.

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        We base our expenses related to contract research organizations on our estimates of the services received and efforts expended pursuant to quotes and contracts with the contract research organizations that conduct research and development on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the research and development expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or prepayment accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in us reporting amounts that are too high or too low in any particular period.

    Stock-Based Compensation

        As we continue to grow, we expect to make additional stock option and restricted stock grants, which will result in additional stock-based compensation expense. Accordingly, we describe below the methodology we have employed to date in measuring such expenses.

        Since our inception in April 2011, we have applied the fair value recognition provisions of Financial Accounting Standards Board Accounting Standards Codification Topic 718, Compensation—Stock Compensation , which we refer to as ASC 718. Determining the amount of stock-based compensation to be recorded requires us to develop estimates of the fair value of stock options as of their grant date. Stock-based compensation expense is recognized ratably over the requisite service period, which in most cases is the vesting period of the award. For awards with performance conditions, we estimate the likelihood of satisfaction of the performance criteria, which affects the awards expected to vest and the period over which the expense is recognized, and recognize the expense using the accelerated attribution model to the extent the condition is deemed probable. Calculating the fair value of stock-based awards requires that we make highly subjective assumptions. We used the Black-Scholes option pricing model to value our stock option awards.

        The valuation assumptions were determined as follows:

    Risk-free interest rate:   The yield on zero-coupon U.S. Treasury securities for a period that is commensurate with the expected term of the awards.

    Expected annual dividend yield:   The estimate for annual dividends is zero, because we have not historically paid a dividend and do not intend to do so in the foreseeable future.

    Expected stock price volatility:   We determine the expected volatility by using a weighted average of selected peer companies.

    Expected term of options:   We have used the simplified method to calculate the expected term in fiscal 2013 as we have not had significant historical exercise and post-vest termination data to provide a reasonable basis upon which to estimate the expected term for the options granted to employees. The contractual term will be used for option awards granted to non-employees. Historical data will be incorporated into our assumption as it becomes available.

        Under ASC 718, we are required to estimate the level of forfeitures expected to occur and record compensation expense only for those awards that we ultimately expect will vest. We evaluate our estimated forfeiture rate at the end of each reporting period. We estimate forfeitures based upon historical data, adjusted for known trends and anticipated future actual results, and we will adjust the estimate of forfeitures if actual forfeitures differ or are expected to differ from such estimates. Subsequent changes in estimated forfeitures are recognized through a cumulative adjustment in the period of change and will also impact the amount of stock-based compensation expense in future periods.

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        We began trading on the NASDAQ Global Market on April 30, 2013.

        Prior to April 30, 2013, we have historically granted stock options at exercise prices not less than the fair market value of our common stock as determined by our board of directors, with input from management. Our board of directors has historically determined the estimated fair value of our common stock on the date of grant based on a number of objective and subjective factors, including external market conditions affecting the biotechnology industry sector and the prices at which we sold shares of our preferred stock, the superior rights and preferences of securities senior to our common stock at the time of each grant and the likelihood of achieving a liquidity event such as an IPO, the listing of our common stock on a securities exchange, which we refer to as public trading, or sale of our company.

        At the time of each of these stock option grants made prior to November 14, 2012, the exercise price was determined by our board of directors, with input from management, based on the various objective and subjective factors noted below. As of November 14, 2012, the date our common stock first became publicly traded, the fair value at the grant date was determined using the closing price of a share of our common stock, as listed on the OTC Bulletin Board on the grant date. As there was no public market for our common stock prior to November 14, 2012, our board of directors determined the estimated fair value of our common stock on the grant dates, taking into consideration various objective and subjective factors, including:

    external market conditions affecting the biopharmaceutical industry;

    prices at which we sold shares of preferred stock to third party investors;

    the superior rights and preferences of securities senior to our common stock at the time of each grant;

    our historical operating and financial performance;

    the timing of hiring key members of our management team including the nature and timing of regulatory requirements for our potential fertility treatments;

    the status of our research and development efforts;

    the likelihood of achieving a liquidity event, such as an IPO, public trading or sale of our company; and

    estimates, contemporaneous valuations and analysis provided by management.

        There were significant judgments and estimates inherent in the determination of these valuations.

Results of Operations

        We were incorporated on April 5, 2011. As a result, the following table summarizes our results of operations for the years ended December 31, 2013 and 2012 and the period from April 5, 2011 (inception) to December 31, 2011. There is no comparable period for 2011 (in thousands).

 
   
   
   
  2013 / 2012
Comparison
  2012 / 2011
Comparison
 
 
   
   
  Period
from April 5,
2011
(inception) to
December 31,
2011
 
 
  Year Ended,
December 31,
 
 
  Increase /
(Decrease)
  Increase /
(Decrease)
 
 
  2013   2012  
 
  $   %   $   %  

Research and development

  $ 15,802   $ 6,323   $ 1,170   $ 9,479     150 % $ 5,153     440 %

General and administrative

    13,332     7,206     1,454     6,126     85 %   5,752     396 %

Interest income

    90     19         71     374 %   19     100 %
                               

Net loss

  $ (29,044 ) $ (13,510 ) $ (2,624 ) $ (15,534 )   115 % $ (10,886 )   415 %
                               
                               

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    Revenue

        To date, we have not generated any revenues. Our ability to generate revenues, which we do not expect will occur prior to the second half of 2014, if ever, will depend heavily on the successful development and eventual commercialization of AUGMENT, OvaPrime, OvaTure, and our other potential fertility treatments.

    Research and Development Expenses

        The increase in research and development expense for the year ended December 31, 2013 compared to the year ended December 31, 2012 was primarily attributable to:

    an expense of $4.7 million for a technology access fee in connection with a collaboration agreement with Intrexon, Inc. for our OvaTure program;

    an increase of $1.9 million in stock-based compensation for employees and non-employees (including a modification of options that resulted in incremental stock-based compensation expense of $0.4 million) and salaries, bonus, payroll taxes and benefits, which were driven primarily by the hiring of new research and development personnel;

    an increase of $1.6 million in contract research organization expenses and consulting fees primarily related to AUGMENT; and

    an increase of $0.4 million resulting from the impairment of laboratory equipment;

        The increase in research and development expense for the year ended December 31, 2012 compared to the period from April 5, 2011 to December 31, 2011 was primarily attributable to:

    an increase in contract research organization expenses of $2.3 million comprised of expenses for outsourced biology, chemistry, clinical and development services; and

    an increase in compensation and benefits, including stock-based compensation, of $2.0 million primarily due to the hiring of research and development employees.

        Research and development expenses from April 1, 2011 to December 31, 2013 primarily related to the development of AUGMENT. During the year ended December 31, 2013, we recorded a research and development expense of $4.7 million for a technology access fee associated with a collaboration agreement with Intrexon for the OvaTure program.

        We expect research and development expense to increase if our programs successfully advance. We do not believe that the historical costs are indicative of the future costs associated with these programs nor represent what any other future treatment program we initiate may cost. Due to the variability in the length of time and scope of activities necessary to develop a treatment and uncertainties related to cost estimates and our ability to commercialize and/or obtain marketing approval for our treatments, accurate and meaningful estimates of the total costs required to bring our treatments to market are not available.

        Because of the risks inherent in drug discovery and development, we cannot reasonably estimate or know:

    the nature, timing and estimated costs of the efforts necessary to complete the development of our programs;

    the anticipated completion dates of these programs; or

    the period in which material net cash inflows are expected to commence, if at all, from the programs described above and any potential future treatments.

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        There is significant uncertainty regarding our ability to successfully develop any treatments. These risks include the uncertainty of:

    introducing our ACE access program into international IVF clinics for physicians using AUGMENT and to generate data;

    the scope and rate of progress of our preclinical studies and other research and development activities from OvaPrime, OvaTure and our other potential fertility treatments;

    the scope, rate of progress and cost of any clinical trials that we may commence in the future;

    the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights relating to our programs under development;

    the terms and timing of any strategic alliance, licensing and other arrangements that we have or may establish in the future relating to our programs under development;

    the cost and timing of regulatory approvals;

    the cost of establishing clinical supplies of any treatments; and

    the effect of competing technological and market developments.

    General and Administrative Expenses

        The increase in general and administrative expense for the year ended December 31, 2013 compared to the year ended December 31, 2012 was primarily attributable to:

    an increase of $4.2 million in both stock-based compensation and salaries, bonus, payroll taxes and benefits. Stock-based compensation for the year ended December 31, 2013 included expense related to December 2012 restricted stock units and stock options granted to the Chief Executive Officer. Increases in salaries, bonus, payroll taxes and benefits were primarily driven by the hiring of new general and administrative personnel; and

    an increase of $1.2 million in consulting and commercial preparation expenses.

        The increase in general and administrative expense for the year ended December 31, 2012 compared to the period from April 5, 2011 to December 31, 2011 was primarily attributable to:

    an increase of $2.6 million in professional fees, comprised of fees for audit, tax and legal services, corporate filing fees and investor relation fees primarily related to activities associated with becoming a publicly traded company;

    an increase of $1.0 million for higher salaries, bonus, payroll taxes and benefits primarily due to the hiring of general and administrative employees;

    an increase of $0.5 million in consulting expenses primarily for business planning and strategy; and

    an increase of $0.5 million in market research analysis and public relations expense.

    Interest Income

        Interest income for the years ended December 31, 2013 and 2012 increased as compared to the period from April 5, 2011 through December 31, 2011 primarily as a result of higher average balances on our cash equivalents and short-term investments.

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Liquidity and Capital Resources

        We have not generated any commercial sales to date. We have instead relied on the proceeds from sales of equity securities to fund our operations. Our short-term investments primarily trade in liquid markets, and the average days to maturity of our portfolio as of December 31, 2013 are less than six months. Because our treatments are in various stages of development and the outcome of these efforts in uncertain, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of our treatments or whether or when we may achieve profitability.

        Our significant capital resources are as follows (in thousands):

 
  December 31,  
 
  2013   2012  

Cash, cash equivalents and short-term investments

  $ 44,427   $ 31,391  

Working capital

    39,303     29,879  

 

 
   
   
  Period
from April 5,
2011
(inception) to
December 31,
2011
 
 
  Year Ended
December 31,
 
 
  2013   2012  

Cash (used in) provided by:

                   

Operating activities

  $ (18,094 ) $ (11,156 ) $ (1,560 )

Investing activities

    (11,018 )   (17,640 )    

Capital expenditures (included in investing activities above)

    (719 )   (849 )    

Financing activities

    32,414     39,031     6,101  

    Cash Flows

        Cash used in operating activities in all of the periods presented was primarily attributed to the funding of our net loss. Cash flows from operations can vary significantly due to various factors, including changes in the net loss and the timing of disbursements made for accounts payable and accruals.

        Cash used in investing activities for the years ended December 31, 2013 and 2012 included the purchase of and proceeds from maturities of short-term investments. Our investing activities for the years ended December 31, 2013 and 2012 included the purchases of property and equipment. Capital expenditures for the year ended December 31, 2013 consisted primarily of laboratory equipment. There were no investing activities for the period from April 5, 2011 (inception) to December 31, 2011.

        Cash provided by financing activities for the year ended December 31, 2013 was primarily the result of the private placement of an aggregate of 3,888,880 shares of common stock at a price per share of $9.00 resulting in net proceeds of $32.7 million. Cash provided by financing activities for the year ended December 31, 2012 was primarily the result of the sale and issuance of 6,770,563 shares of our Series B preferred stock for net proceeds of approximately $35.0 million and private placement sale of an aggregate of 897,554 shares of common stock at a price per share of $5.50 resulting in net proceeds of $4.0 million.

        We will need substantial additional funds to support our planned operations. In the absence of additional funding, business development activities, and treatment sales, we expect our existing cash, cash equivalents and marketable securities of $44.4 million at December 31, 2013 will enable us to fund our current operating plan into 2015. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our

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treatments, and the extent to which we may enter into collaborations with third parties for development and commercialization of our treatments, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the development of our current treatments. Our future capital requirements will depend on many factors, including:

    introducing our ACE access program into international IVF clinics for physicians to gain experience using AUGMENT and to generate data;

    educating physicians and embryologists the use of AUGMENT;

    conducting any AUGMENT studies;

    incurring the costs associated with expansion of foreign operations;

    establishing a domestic and international sales, marketing, manufacturing and distribution infrastructure to commercialize AUGMENT and any other potential fertility treatment, we successfully develop;

    conducting further studies of, continuing optimization of and ultimately commercially launching OvaPrime;

    receiving revenue, if any, from commercial activities of AUGMENT, OvaPrime or any other potential fertility treatments;

    continuing research and preclinical development of OvaTure, both internally and in collaboration with Intrexon, and other potential fertility treatments;

    initiating any clinical trials of OvaTure and other potential fertility treatments;

    collaborating with Intrexon through the OvaXon joint venture to create new applications to prevent inherited diseases for human and animal health;

    following the regulatory process in the United States and abroad, including the premarketing and marketing approval requirements, to which some of our potential fertility treatments may be subject;

    following the regulatory or institutional review board review of our potential fertility treatments that are subject to such review;

    preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;

    establishing collaborations and partnerships on favorable terms, if at all; and

    developing, acquiring or in-licensing other potential fertility treatments and technologies.

        Until such time, if ever, as we can generate substantial treatment revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. We do not have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or treatments or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our fertility treatment development or future

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commercialization efforts or grant rights to develop and market treatments that we would otherwise prefer to develop and market ourselves.

Off-Balance Sheet Arrangements

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

Contractual Obligations

 
  Payments Due by Period  
Contractual Obligations
  Total   Less than 1 Year   1 - 3 Years   3 - 5 Years   More than 5 Years  

License obligations(1)

  $ 3,060   $ 2,612   $ 224   $ 224     *  

Long-term liabilities(2)

    130     10     30     30     60  

Operating leases

    1,103     323     607     173      

Purchase obligations(3)

    727     727              
                       

  $ 5,020   $ 3,672   $ 861   $ 427   $ 60  
                       
                       

(1)
Amount includes $2.5 million payment due to Intrexon in December 2014 for the second installment of the technology access fee. We have agreed to pay license fees and maintenance fees totaling $0.1 million annually (*). The agreement is cancellable by us. As we are unable to reasonably predict the likelihood, timing or amount of any such milestone, royalty or sublicense income payments, we have excluded them from the table above. This excludes a milestone that may reach $1.0 million in 2014 based on certain criteria.

(2)
Long-term liabilities include current maturities.

(3)
At December 31, 2013 we have non-cancellable payments that become due in January 2014 for research services and a research grant of approximately $0.1 million. Additionally, we have certain minimum purchase requirements with our contract manufacturer of $0.6 million.

Recently Adopted Accounting Standards

        We have not recently adopted any new accounting standards. There are no recently issued accounting standards that have a material impact on us.

Item 7A.     Quantitative and Qualitative Disclosures about Market Risk

        We are exposed to market risk related to changes in interest rates. We had cash, cash equivalents and marketable securities of $44.4 million as of December 31, 2013 and $31.4 million as of December 31, 2012. The cash and cash equivalents as of December 31, 2013 consist of cash in bank deposits, money market funds and corporate debt securities. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates, particularly because our investment strategy is primarily in short term securities. Our available for sale securities are subject to interest rate risk and will fall in value if market interest rates increase.

        A hypothetical 100 basis point increase in interest rates would result in an approximate $0.1 million decrease in the fair value of our investments as of December 31, 2013, as compared to an approximate $0.2 million decrease as of December 31, 2012. We have the ability to hold our fixed income investments until maturity and, therefore, we do not expect our operating results to be affected to any significant degree by the effect of a change in market interest rates on our investments.

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        We contract with third party research and development organizations and contract manufacturers globally. We may be subject to fluctuations in foreign currency rates in connection with any such agreements. Transactions denominated in currencies other than the functional currency are recorded based on exchange rates at the time such transactions arise. As of December 31, 2013, all of our liabilities were denominated in our functional currency.

Item 8.     Consolidated Financial Statements and Supplementary Data

        Our consolidated financial statements, together with the independent registered public accounting firm report thereon, appear at pages F-1 through F-30 of this Annual Report on Form 10-K.

Item 9.     Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

        None.

Item 9A.     Controls and Procedures

Evaluation of Disclosure Controls and Procedures.

        Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2013. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company's management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of December 31, 2013, our principal executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

        The management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934, as amended. The Company's internal control system was designed to provide reasonable assurance to the Company's management and board of directors regarding the preparation and fair presentation of published financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

        The Company's management assessed the effectiveness of the Company's internal control over financial reporting as of December 31, 2013. In making this assessment, it used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission ("COSO") in Internal Control—Integrated Framework. Based on our assessment we believe that, as of December 31, 2013, the Company's internal control over financial reporting is effective based on those criteria.

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        This annual report does not include an attestation report of the company's registered public accounting firm regarding internal control over financial reporting. Management's report was not subject to attestation by the company's registered public accounting firm pursuant to rules of the Securities and Exchange Commission that permit emerging growth companies, which we are, to provide only management's report in this annual report.

Changes in Internal Controls.

        No change in our internal control over financial reporting, identified in connection with the evaluation of such internal control, that occurred during the fiscal quarter ended December 31, 2013 has materially affected, or is reasonably likely to materially affect, the our internal control over financial reporting.

Item 9B.     Other Information

        On January 10, 2014, we announced the appointment of Marc Kozin, former President of L.E.K. Consulting's North American practice, to our Board of Directors. Mr. Marc Kozin will replace Jonathan Tilly, Ph.D., a scientific co-founder of OvaScience who was recently appointed as Chair of the Department of Biology at Northeastern University. Dr. Tilly will continue to serve as a member of OvaScience's Scientific Advisory Board.

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PART III

Item 10.     Directors, Executive Officers and Corporate Governance

        The information required by Item 10 of Form 10-K may be found under the captions "Employees," "Directors," "Corporate Governance" and "Section 16(a) Beneficial Ownership Reporting Compliance" in the definitive proxy statement to be delivered to stockholders in connection with our 2014 Annual Meeting of Stockholders. Such information is incorporated herein by reference.

        We have adopted a written code of business conduct and ethics that applies to our directors, officers and employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. We make available our code of business conduct and ethics free of charge through our website which is located at www.ovascience.com. We intend to disclose any amendment to, or waiver from, our code of business conduct and ethics that is required to be publicly disclosed pursuant to SEC rules.

Item 11.     Executive Compensation

        The information required by Item 11 of Form 10-K may be found in the definitive proxy statement to be delivered to stockholders in connection with our 2014 Annual Meeting of Stockholders. Such information is incorporated herein by reference.

Item 12.     Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

        The information required by Item 12 of Form 10-K may be found under the captions "Security Ownership of Certain Beneficial Owners and Management" and "Securities Authorized for Issuance Under our Equity Compensation Plans" in the definitive proxy statement to be delivered to stockholders in connection with our 2014 Annual Meeting of Stockholders. Such information is incorporated herein by reference.

Item 13.     Certain Relationships and Related Transactions, and Director Independence

        The information required by Item 13 of Form 10-K may be found under the captions "Certain Relationships and Related Transactions" and "Corporate Governance" in the definitive proxy statement to be delivered to stockholders in connection with our 2014 Annual Meeting of Stockholders. Such information is incorporated herein by reference.

Item 14.     Principal Accounting Fees and Services

        The information required by Item 14 of Form 10-K may be found in the definitive proxy statement to be delivered to stockholders in connection with our 2014 Annual Meeting of Stockholders. Such information is incorporated herein by reference.

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PART IV

Item 15.     Exhibits and Financial Statement Schedules

    (a)
    List of documents filed as part of this report:

    (1)
    Consolidated Financial Statements listed under Part II, Item 8 and included herein by reference.

    (2)
    Consolidated Financial Statement Schedules:

        No schedules are submitted because they are not applicable, not required or because the information is included in the Consolidated Financial Statements or Notes to Consolidated Financial Statements.

    (3)
    Exhibits.

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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, on February 27, 2014.

    OVASCIENCE, INC.

 

 

By:

 

/s/ MICHELLE DIPP

        Michelle Dipp, M.D., Ph.D.
        President and Chief Executive Officer


SIGNATURES

        Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons in the capacities and on the dates indicated.

Signature
 
Title
 
Date

 

 

 

 

 
/s/ MICHELLE DIPP

Michelle Dipp, M.D., Ph.D.
  President and Chief Executive Officer and Director (Principal executive officer)   February 27, 2014

/s/ CHRISTOPHER BLECK

Christopher Bleck

 

Principal financial and accounting officer

 

February 27, 2014

/s/ RICHARD ALDRICH

Richard Aldrich

 

Director

 

February 27, 2014

/s/ JEFFREY D. CAPELLO

Jeffrey D. Capello

 

Director

 

February 27, 2014

/s/ MARY FISHER

Mary Fisher

 

Director

 

February 27, 2014

/s/ MARC KOZIN

Marc Kozin

 

Director

 

February 27, 2014

/s/ STEPHEN KRAUS

Stephen Kraus

 

Director

 

February 27, 2014

/s/ THOMAS MALLEY

Thomas Malley

 

Director

 

February 27, 2014

Table of Contents

Signature
 
Title
 
Date

 

 

 

 

 
/s/ HARALD STOCK

Harald Stock, Ph.D.
  Director   February 27, 2014

/s/ CHRISTOPH WESTPHAL

Christoph Westphal, M.D., Ph.D.

 

Director

 

February 27, 2014

Table of Contents


Index to Consolidated Financial Statements of
OvaScience, Inc.

 
  Page

Report of Independent Registered Public Accounting Firm

  F-2

Consolidated Balance Sheets

  F-3

Consolidated Statements of Operations and Comprehensive Loss

  F-4

Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit)

  F-5

Consolidated Statements of Cash Flows

  F-6

Notes to Consolidated Financial Statements

  F-7

F-1


Table of Contents


REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

The Board of Directors and Stockholders of
OvaScience, Inc.

        We have audited the accompanying consolidated balance sheets of OvaScience, Inc. (a development stage company) (the Company) as of December 31, 2013 and 2012, and the related consolidated statements of operations and comprehensive loss, convertible preferred stock and stockholders' equity (deficit), and cash flows for the years ended December 31, 2013 and 2012, the period from April 5, 2011 (inception) to December 31, 2011 and the period from April 5, 2011 (inception) to December 31, 2013. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits.

        We conducted our audit 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. We were not engaged to perform an audit of the Company's internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and 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 consolidated financial position of OvaScience, Inc. as of December 31, 2013 and 2012 and the consolidated results of its operations and its cash flows for the years ended December 31, 2013 and 2012, the period from April 5, 2011 (inception) to December 31, 2011 and the period from April 5, 2011 (inception) to December 31, 2013, in conformity with U.S. generally accounting principles.

/s/ Ernst & Young LLP

Boston, Massachusetts
February 27, 2014

F-2


Table of Contents


OvaScience, Inc.
(A development stage company)

Consolidated Balance Sheets

(In thousands, except share and per share data)

 
  As of  
 
  December 31,
2013
  December 31,
2012
 

Assets

             

Current assets:

             

Cash and cash equivalents

  $ 18,078   $ 14,776  

Short-term investments

    26,349     16,615  

Prepaid expenses and other current assets

    650     574  
           

Total current assets

    45,077     31,965  

Property and equipment, net

    880     756  

Investment in OvaXon

    1,500      

Restricted cash

    88     93  
           

Total assets

  $ 47,545   $ 32,814  
           
           

Liabilities and stockholders' equity

             

Current liabilities:

             

Accounts payable

  $ 1,654   $ 875  

Accrued expenses

    4,120     1,211  
           

Total current liabilities

    5,774     2,086  

Other non-current liabilities

    70     7  
           

Total liabilities

    5,844     2,093  
           

Commitments and contingencies (Note 11)

             

Stockholder's equity:

             

Preferred stock, $0.001 par value; 5,000,000 shares authorized, no shares issued and outstanding

         

Common stock, $0.001 par value per share; 100,000,000 shares authorized; 18,528,215 and 14,268,068 shares issued at December 31, 2013 and December 31, 2012, respectively; 17,541,126 and 12,622,919 shares outstanding at December 31, 2013 and December 31, 2012, respectively

    18     13  

Additional paid-in capital

    86,851     46,848  

Accumulated other comprehensive income/(loss)

    10     (6 )

Deficit accumulated during the development stage

    (45,178 )   (16,134 )
           

Total stockholders' equity

    41,701     30,721  
           

Total liabilities and stockholders' equity

  $ 47,545   $ 32,814  
           
           

   

See accompanying notes.

F-3


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OvaScience, Inc.
(A development stage company)

Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except per share data)

 
  Year Ended,
December 31,
  Period from
April 5, 2011
(inception) to
December 31,
2011
  Period from
April 5, 2011
(inception) to
December 31,
2013
 
 
  2013   2012  

Operating expenses:

                         

Research and development

  $ 15,802   $ 6,323   $ 1,170   $ 23,295  

General and administrative

    13,332     7,206     1,454     21,992  
                   

Total operating expenses

    29,134     13,529     2,624     45,287  
                   

Loss from operations

    (29,134 )   (13,529 )   (2,624 )   (45,287 )
                   

Interest income

    90     19         109  
                   

Net loss

  $ (29,044 ) $ (13,510 ) $ (2,624 ) $ (45,178 )
                   
                   

Accretion of convertible preferred stock to redemption value

            (101 )   (101 )
                   

Net loss applicable to common stockholders

  $ (29,044 ) $ (13,510 ) $ (2,725 ) $ (45,279 )
                   
                   

Net loss per share applicable to common stockholders—basic and diluted

  $ (1.80 ) $ (2.33 ) $ (3.00 ) $ (5.42 )
                   
                   

Weighted average number of common shares used in net loss per share applicable to common stockholders—basic and diluted

    16,160     5,810     909     8,350  
                   
                   

Net loss

    (29,044 ) $ (13,510 )   (2,624 ) $ (45,178 )

Other comprehensive loss:

                         

Unrealized gains / (losses) on available-for-sale securities

    16     (6 )       10  
                   

Comprehensive loss

  $ (29,028 ) $ (13,516 ) $ (2,624 ) $ (45,168 )

Non-cash stock-based compensation expenses included in operating expenses are as follows:

   
 
   
 
   
 
   
 
 

Research and development

  $ 2,361   $ 1,143   $ 269   $ 3,773  

General and administrative

    2,733     239     77     3,049  

   

See accompanying notes.

F-4


Table of Contents


OvaScience, Inc.
(A development stage company)

Consolidated Statements of Stockholders' Equity / (Deficit)

(In thousands, except share data)

 
   
   
   
   
   
   
   
   
   
   
   
 
 
  Series A
convertible
preferred stock
  Series B
convertible
preferred stock
   
   
   
   
   
  Deficit
accumulated
during the
development
stage
   
 
 
   
  Common stock    
  Accumulated
other
comprehensive
income (loss)
  Total
stockholders'
equity
(deficit)
 
 
   
  Additional
paid-in
capital
 
 
  Shares   Amount   Shares   Amount    
  Shares   Amount  
 
   
 

Balance at April 5, 2011 (inception)

      $       $           $   $   $   $   $  

Sale of common stock to founders

                        526,443                      

Vesting of restricted stock

                        683,309     1                 1  

Issuance of Series A convertible preferred stock, net of issuance costs of $101

    6,200,000     6,200                         (101 )           (101 )

Stock-based compensation expense

                                347             347  

Net loss

                                        (2,624 )   (2,624 )
                                               

Balance at December 31, 2011

    6,200,000     6,200                 1,209,752     1     246         (2,624 )   (2,377 )
                                               

Vesting of Founders Stock

                        674,505     1                 1  

Issuance of Series B convertible preferred stock, net of issuance costs of $2,246

            6,770,563     34,992                              

Conversion of Series A convertible preferred stock to common stock on a one-for-2.023 basis

    (6,200,000 )   (6,200 )               3,064,753     3     6,197             6,200  

Conversion of Series B convertible preferred stock to common stock on a one-for-one basis

            (6,770,563 )   (34,992 )       6,770,563     7     34,985             34,992  

Common stock issued as part of the private placement, net of issuance costs of $898

                        897,554     1     4,038             4,039  

Exercise of stock options

                        5,792                      

Stock-based compensation expense

                                1,382             1,382  

Unrealized loss on investments

                                    (6 )       (6 )

Net loss

                                        (13,510 )   (13,510 )
                                               

Balance at December 31, 2012

                        12,622,919     13     46,848     (6 )   (16,134 )   30,721  
                                               

Common stock issued as part of the private placement, net of issuance costs of $2,348

                        3,888,880     4     32,652             32,656  

Issuance of shares to Intrexon

                        273,224         2,500             2,500  

Vesting of Founders Stock

                        658,060     1                 1  

Exercise of stock options

                        42,799         42             42  

Stock-based compensation expense

                                5,094             5,094  

Vesting of restricted stock, net of shares withheld for taxes

                        55,244         (285 )           (285 )

Unrealized gain on investments

                                    16         16  

Net loss

                                        (29,044 )   (29,044 )
                                               

Balance at December 31, 2013

                        17,541,126   $ 18   $ 86,851   $ 10   $ (45,178 ) $ 41,701  
                                               

   

See accompanying notes.

F-5


Table of Contents


OvaScience, Inc.
(A development stage company)

Consolidated Statements of Cash Flows

(In thousands)

 
  Year Ended
December 31,
  Period from
April 5, 2011
(inception) to
December 31,
2011
  Period from
April 5, 2011
(inception) to
December 31,
2013
 
 
  2013   2012  

Cash flows from operating activities:

                         

Net loss

  $ (29,044 ) $ (13,510 ) $ (2,624 ) $ (45,178 )

Adjustments to reconcile net loss to net cash used in operating activities:

                         

Depreciation and amortization

    231     93         324  

Impairment of property and equipment

    364             364  

Amortization of premium

    586     77         663  

Stock-based compensation expense

    5,094     1,382     346     6,822  

Issuance of common stock for technology access fee

    2,500             2,500  

Changes in operating assets and liabilities:

                         

Prepaid expenses and other assets

    (76 )   (530 )   (44 )   (650 )

Accounts payable

    (721 )   599     276     154  

Accrued expenses and other non-current liabilities

    2,972     733     486     4,191  
                   

Net cash used in operating activities

    (18,094 )   (11,156 )   (1,560 )   (30,810 )
                   

Cash flows from investing activities:

                         

Purchases of property, plant and equipment

    (719 )   (849 )       (1,568 )

Maturities of short-term investments

    5,670             5,670  

Purchases of short-term investments

    (15,974 )   (16,698 )       (32,672 )

Decrease / (increase) in restricted cash

    5     (93 )       (88 )
                   

Net cash used in investing activities

    (11,018 )   (17,640 )       (28,658 )
                   

Cash flows from financing activities:

                         

Proceeds from issuance of preferred stock, net of issuance costs

        34,992     6,099     41,091  

Net proceeds from the issuance of common stock

    32,414     4,039     2     36,455  
                   

Net cash provided by financing activities

    32,414     39,031     6,101     77,546  
                   

Net increase in cash and cash equivalents

    3,302     10,235     4,541     18,078  

Cash and cash equivalents at beginning of period

    14,776     4,541          
                   

Cash and cash equivalents at end of period

  $ 18,078   $ 14,776   $ 4,541   $ 18,078  
                   
                   

Supplemental disclosure of non-cash investing and financing activity

                         
                   

Investment in OvaXon

  $ 1,500   $   $   $ 1,500  
                   
                   

Accretion of convertible preferred stock to redemption value

  $   $   $ (101 ) $ (101 )
                   
                   

Conversion of convertible preferred stock to common stock

  $   $ 41,192   $   $ 41,192  
                   
                   

   

See accompanying notes.

F-6


Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements

1. Organization

        OvaScience, Inc., incorporated on April 5, 2011 as a Delaware corporation, is a life science company developing proprietary potential treatments for female infertility based on recent scientific discoveries about the existence of egg precursor cells. As used through these consolidated financial statements, the terms "OvaScience," "we," "us," and "our" refer to the business of OvaScience, Inc. and its wholly owned subsidiary. Our operations to date have been limited to organizing and staffing , business planning, raising capital, acquiring and developing our technology, identifying potential treatments, planning and conducting a study in humans for our most advanced treatment and undertaking preclinical studies of certain potential fertility treatments. We have commenced our planned principal operations but have not generated any significant revenues to date. Accordingly, we are considered to be in the development stage.

        We are subject to a number of risks similar to other life science companies in the development stage, including, but not limited to, the need to obtain adequate additional funding, possible failure to provide our treatments to IVF clinics to gain clinical experience in select countries outside of the United States, the need to obtain marketing approval for certain of our treatments, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company's treatments and protection of proprietary technology. If we do not successfully commercialize any of treatments, we will be unable to generate treatment revenue or achieve profitability. As of December 31, 2013 we had a deficit accumulated during the development stage of approximately $45.2 million.

        Unless otherwise indicated, all information in these financial statements gives retrospective effect to the one-for-2.023 reverse stock split of our common stock (the "Reverse Stock Split") that was effected on March 28, 2012 (see Note 7).

Liquidity

        We have incurred annual net operating losses in each year since our inception. We have not generated any treatment revenues related to our primary business purpose and have financed our operations primarily through private placements of our preferred stock and common stock. We have not completed development of any treatment and have devoted substantially all of our financial resources and efforts to raising capital and research and development. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years.

        We believe that our cash and investments of approximately $44.4 million at December 31, 2013 will be sufficient to fund our current operating plan and continue as a going concern into 2015. We will be required to obtain additional funding in order to continue to fund our operations for 2015 and beyond. There can be no assurances, however, that the current operating plan will be achieved or that additional funding will be available on terms acceptable to us, or at all.

2. Summary of Significant Accounting Policies

Basis of Presentation

        Our consolidated financial statements include the accounts of OvaScience and our wholly-owned subsidiary, OvaScience Securities Corporation. We have eliminated all significant intercompany accounts and transactions in consolidation.

F-7


Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

2. Summary of Significant Accounting Policies (Continued)

        The preparation of consolidated financial statements in accordance with generally accepted accounting principles requires our management to make estimates and judgments that may affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate our estimates and judgments. We based on our estimates of historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ from these estimates under different assumptions or conditions.

Cash Equivalents and Short-Term Investments

        Cash equivalents and short-term investments primarily consist of money market funds and corporate debt securities. Corporate debt securities include obligations issued by corporations in countries other than the United States, including some issues that have not been guaranteed by governments and government agencies. We consider all highly liquid investments with maturities of three months or less at the time of purchase to be cash equivalents. Cash equivalents, which consist of money market funds, are stated at fair value. They are also readily convertible to known amounts of cash and have such short-term maturities that each presents insignificant risk of change in value due to changes in interest rates.

        The appropriate classification of marketable securities is determined at the time of purchase and reevaluated at each balance sheet date. We have classified all of our short-term investments at December 31, 2013 and December 31, 2012 as available-for-sale. We carry available-for-sale securities at fair value, with the unrealized gains and losses reported in accumulated other comprehensive income / (loss), which is a separate component of stockholders' equity.

        The cost of available-for-sale debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion is included in interest income. The cost of securities sold or the amount reclassified out of accumulated other comprehensive income into earnings is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in interest income.

        We conduct periodic reviews to identify and evaluate each investment that is in an unrealized loss position in order to determine whether an other-than-temporary impairment exists. An unrealized loss exists when the current fair value of an individual security is less than its amortized cost basis. Unrealized losses on available-for-sale debt securities that are determined to be temporary, and not related to credit loss, are recorded, net of tax, in accumulated other comprehensive income / (loss). For available-for-sale debt securities in an unrealized loss position, we perform an analysis to assess whether we intend to sell or whether we would more likely than not be required to sell the security before the expected recovery of the amortized cost basis. Where we intend to sell a security, or may be required to do so, the security's decline in fair value is deemed to be other-than-temporary and the full amount of the unrealized loss is recorded within the statement of operations as an impairment loss.

        Regardless of our intent to sell a security, we perform an additional analysis on all securities in an unrealized loss position to evaluate losses associated with the creditworthiness of the security. Credit losses are identified where we do not expect to receive cash flows sufficient to recover the amortized cost basis of a security and are recorded within earnings as an impairment loss.

F-8


Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

2. Summary of Significant Accounting Policies (Continued)

Fair Value Measurements

        We define fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. We determine fair value based on the assumptions market participants use when pricing the asset or liability. We also use the fair value hierarchy that prioritizes the information used to develop these assumptions.

        We value our short-term investments utilizing third party pricing services. The pricing services use observable market inputs to determine value, including benchmark yields, reportable trades, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids, offers, reference data, new issue data, and monthly payment information. We validate the prices provided by our third party pricing services by understanding the models used, obtaining market values from other pricing sources, and confirming that those securities trade in active markets. We valued the balance of the technology access fee payable to Intrexon Inc. for $2.5 million in cash in December 2014 based on a discounted cash flow model. We used a 15% discount rate, which we believe approximates our one year unsecured borrowing rate.

Restricted Cash

        Restricted cash consists of balances held in deposit with major financial institutions to collateralize letters of credit in the names of our landlords pursuant to certain operating lease agreements. We disclose these amounts separately on our consolidated balance sheet as Restricted cash.

Concentrations of Risk

        We have no significant off-balance sheet risk.

        Cash, cash equivalents and marketable securities are the only financial instruments we have that are subject to concentration of credit risk. Cash and cash equivalents are primarily maintained with two major financial institutions in the United States. Deposits at banks may exceed the insurance provided on such deposits. Generally, these deposits may be redeemed upon demand and, therefore, bear minimal risk. Short-term investments consistent of investment grade corporate debt securities. Our investment policy, which has been approved by our board of directors, limits the amount we may invest in any one issuer of investments, thereby reducing credit risk concentrations.

Segment Information

        We make operating decisions based upon the performance of the enterprise as a whole and utilize our consolidated financial statements for decision making. We operate in one segment, which focuses on developing treatments dedicated to the treatment of female infertility.

Research and Development Costs

        We expense research and development costs to operations as incurred. Research and development expenses consist of costs associated with research activities, including license payments paid to third parties for rights to intellectual property, the costs of development of treatments and advances in the field of infertility. We account for nonrefundable advance payments for goods and services that will be used in future research and development activities as expenses when the goods have been received or

F-9


Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

2. Summary of Significant Accounting Policies (Continued)

when the service has been performed rather than when the payment is made. We also include as research and development expense access fees for technologies which have not yet reached technological feasibility and have no alternative use. Research and development expenses consist of:

        We are a party to a collaboration agreement with Intrexon Corporation in which we will reimburse the collaborator for work it has performed. If the arrangement provides for us to reimburse the collaborator for research and development expenses or achieving a development milestone for which a payment is due, as is the case with Intrexon Corporation in future periods, we record the reimbursement or the achievement of the development milestone as research and development expense.

Stock-based Compensation

        For stock options granted to employees and directors with only service-based vesting conditions, we measure stock-based compensation cost at the grant date based on the estimated fair value of the award, and recognize it as expense over the requisite service period on a straight-line basis. We record the expense of services rendered by non-employees based on the estimated fair value of the stock option as of the respective vesting date. Further, we expense the fair value of non-employee stock options that contain only service-based vesting conditions over the requisite service period of the underlying stock options. For awards with performance conditions, we estimate the likelihood of satisfaction of the performance criteria, which affects the awards expected to vest and the period over which the expense is recognized, and recognize the expense using the accelerated attribution model, to the extent achievement of the performance condition is deemed probable. We use the Black-Scholes valuation model in determining the fair value of equity awards

        Stock-based compensation expense is determined based on the fair value of the award at the grant date, including estimated forfeitures, and is adjusted each period to reflect actual forfeitures and the outcomes of certain performance conditions.

Income Taxes

        We account for income taxes under the asset and liability method. Deferred tax assets and liabilities are determined based on differences between financial reporting and income tax basis of assets and liabilities, as well as net operating loss and tax credit carryforwards, and are measured using the enacted tax rates and laws that will be in effect when the differences reverse. Deferred tax assets are reduced by a valuation allowance to reflect the uncertainty associated with their ultimate realization. The effect of a change in tax rate on deferred taxes is recognized in income or loss in the period that includes the enactment date.

F-10


Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

2. Summary of Significant Accounting Policies (Continued)

        We apply judgment in the determination of the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. We recognize any material interest and penalties related to unrecognized tax benefits in income tax expense.

        Due to the uncertainty surrounding the realization of the net deferred tax assets in future periods, we have recorded a full valuation allowance against our otherwise recognizable net deferred tax assets as of December 31, 2013 and 2012.

Property and Equipment

        Property and equipment is stated at cost. Depreciation is recorded using the straight-line method over the estimated useful lives of the applicable assets. Upon sale or retirement, the cost and related accumulated depreciation are eliminated from the respective account and resulting gain or loss, if any, is included in current operations. Amortization of leasehold improvements is included in depreciation expense. Repairs and maintenance charges that do not increase the useful life of the assets are charged to operations as incurred. Property and equipment are depreciated over the following periods:

Laboratory equipment

  3 - 5 years

Furniture

  5 years

Computer equipment

  3 years

Leasehold improvements

  Shorter of asset life or lease term

Impairment of Long-Lived Assets

        We evaluate our long-lived assets for potential impairment. Potential impairment is assessed when there is evidence that events or changes in circumstances have occurred that indicate that the carrying amount of a long-lived asset may not be recovered. Recoverability of these assets is assessed based on undiscounted expected future cash flows from the assets, considering a number of factors, including past operating results, budgets and economic projections, market trends, and potential fertility treatment development cycles. An impairment in the carrying value of each asset is assessed when the undiscounted expected future cash flows, including its eventual residual value, derived from the asset are less than its carrying value. Impairments, if any, are recognized in earnings. An impairment loss would be recognized in an amount equal to the excess of the carrying amount over the undiscounted expected future cash flows. See Note 6 for discussion on impairment charges recognized during the periods presented.

Net Loss per Share

        Basic and diluted net loss per common share is calculated by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period, without consideration for common stock equivalents. Our potentially dilutive shares, which include preferred stock, outstanding stock options, restricted stock units and unvested Founders' shares, are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive.

F-11


Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

2. Summary of Significant Accounting Policies (Continued)

Consolidation of Variable Interest Entities

        We use a qualitative approach in assessing the consolidation requirement for variable interest entities. The approach focuses on identifying which enterprise has the power to direct the activities that most significantly impact the variable interest entity's economic performance and which enterprise has the obligation to absorb losses or the right to receive benefits from the variable interest entity. In the event that we are the primary beneficiary of a variable interest entity, the assets, liabilities, and results of operations of the variable interest entity are included in our consolidated financial statements.

3. Collaboration with Intrexon and OvaXon Joint Venture

Scope

        On December 18, 2013, we entered into a collaboration agreement (the "OvaTure Collaboration") with Intrexon governing the use of Intrexon's synthetic biology technology platform for the accelerated development of our OvaTure platform. The OvaTure Collaboration provides that Intrexon will deliver laboratory and animal data to support the successful filing of an investigational new drug application ("IND") for OvaTure.

        Although we have not discussed OvaTure with the FDA, we expect we will need to obtain regulatory approval of OvaTure in the United States prior to commercialization. OvaScience owns exclusive human commercial rights for OvaTure.

        We will participate as an equal member on the Joint Steering Committee ("JSC") and Intellectual Property Committee ("IPC"). The JSC shall agree upon the services and the activities to be included in the work plan, and IPC has authority over intellectual property matters. We have the tie-breaking vote if there are any disputes with the JSC.

Technology Access Fee Payable to Intrexon

        The technology access fee payable to Intrexon is comprised of (1) the issuance of 273,224 shares, or $2.5 million of our newly issued common stock, to Intrexon, upon the execution of the OvaTure Collaboration in December 2013, and (2) a $2.5 million cash payment due December 2014, which is payable solely upon the passage of time.

        The technology access fee does not give OvaScience the right to any research and development services, and the technology access has no alternative future use to OvaScience. We therefore recorded $4.7 million in research and development expense in the year ended December 31, 2013 with $2.5 million recorded to additional paid-in capital and common stock and $2.2 million recorded in accrued liabilities, which represents the present value of the remaining $2.5 million technology access fee due in December 2014.

        The shares issued to Intrexon are subject to "piggy-back" registration rights that entitle Intrexon to have the shares included in any new registration statement filed in connection with an underwritten public offering, subject to underwriter cutback. The piggy-back registration rights will not be triggered by any offering subject to a previously filed registration statement, including our current universal shelf registration statement.

F-12


Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

3. Collaboration with Intrexon and OvaXon Joint Venture (Continued)

Research and Development Funding and Potential Commercial Milestone

        The JSC will also approve a budget for services to be performed under the work plan. We will reimburse Intrexon for research and development services performed, as dictated by the approved budget. If applicable, OvaScience will also make a commercial milestone payment three months after the first commercial sale of OvaTure.

Termination Rights

        The collaboration has an indefinite term, with OvaScience having the right to terminate the collaboration after 90 days' prior written notice, and either OvaScience or Intrexon may terminate after a material breach by the other party that is not cured within 60 days. We may assign the collaboration in the event of a change of control transaction.

Royalties

        Upon the delivery of laboratory and animal data necessary to support the successful filing of an IND application, we will pay Intrexon a mid-single digit royalty on net sales of OvaTure potential fertility treatments, and the exact royalty will depend upon whether Intrexon completes the Milestone by the targeted deadline of two years after technology transfer.

Joint Venture

        On December 18, 2013, we also entered into a joint venture with Intrexon to leverage Intrexon's synthetic biology technology platform and OvaScience's technology relating to egg precursor cells to pursue the prevention of genetic disease and animal health. We and Intrexon formed OvaXon, LLC ("OvaXon") to conduct the joint venture. Each party contributed $1.5 million to OvaXon and each has a 50% equity interest, and research and development costs and profits will be split accordingly. Each party will also have 50% control over OvaXon with disputes resolved through arbitration, if necessary.

        As of December 31, 2013, we recorded a $1.5 million investment in OvaXon, an equity method investment, with the offset recorded to Accounts Payable. This was paid in January 2014.

        We consider OvaXon a variable interest entity. OvaXon does not have a primary beneficiary as both OvaScience and Intrexon have equal ability to direct the activities of OvaXon through JSC and IPC membership and 50% voting rights. OvaXon has been accounted for under the equity method and is not consolidated. This analysis and conclusion will be updated annually to reflect any changes in ownership or power over OvaXon.

4. Fair Value Measurements

        The fair value of our financial assets and liabilities reflects our estimate of amounts that we would have received in connection with the sale of the assets or paid in connection with the transfer of the liabilities in an orderly transaction between market participants at the measurement date. In connection with measuring the fair value of our assets and liabilities, we seek to maximize the use of observable inputs (market data obtained from independent sources) and to minimize the use of unobservable inputs (our assumptions about how market participants would price assets and liabilities). The following

F-13


Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

4. Fair Value Measurements (Continued)

fair value hierarchy is used to classify assets and liabilities based on the observable inputs and unobservable inputs used in order to value our assets and liabilities:

        For fixed income securities, we reference pricing data supplied by our custodial agent and nationally known pricing vendors, using a variety of daily data sources, largely readily-available market data and broker quotes. The prices provided by third party pricing services are validated by reviewing their pricing methods and obtaining market values from other pricing sources. After completing these validation procedures, we did not adjust or override any fair value measurements provided by the pricing services as of December 31, 2013 or December 31, 2012.

        We review investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment's carrying amount is not recoverable within a reasonable period of time. To determine whether an impairment is other-than-temporary, we consider the intent to sell, or whether it is more likely than not that we will be required to sell, the investment before recovery of the investment's amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, compliance with our investment policy, the severity and the duration of the impairment and changes in value subsequent to year end. As of December 31, 2013 and December 31, 2012, there were no investments with a fair value that was significantly lower than the amortized cost basis or any investments that had been in an unrealized loss position for a significant period.

        The following tables provide the Company's assets and liabilities that are measured at fair value on a recurring basis as of December 31, 2013 and December 31, 2012 (in thousands).

Description
  Balance as of
December 31,
2013
  Level 1   Level 2   Level 3  

Assets:

                         

Cash and money market funds

  $ 18,078   $ 18,078   $   $  

Corporate debt securities (including commercial paper)

    26,349         26,349      
                   

Total assets

  $ 44,427   $ 18,078   $ 26,349   $  
                   
                   

Liabilities:

                         

Technology access fee due to Intrexon

  $ 2,186   $   $   $ 2,186  
                   

Total liabilities

  $ 2,186   $   $   $ 2,186  
                   
                   

F-14


Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

4. Fair Value Measurements (Continued)

 

Description
  Balance as of
December 31,
2012
  Level 1   Level 2  

Assets:

                   

Cash and money market funds

  $ 14,776   $ 14,776      

Corporate debt securities (including commercial paper)

    16,615         16,615  
               

Total assets

  $ 31,391   $ 14,776   $ 16,615  
               
               

        Changes in the fair value of the Level 3 technology access fee due to Intrexon for the year ended December 31, 2013 were as follows:

 
  Technology access fee  
 
  (in thousands)
 

Balance at December 31, 2012

  $  

Collaboration with Intrexon

    2,174  

Fair value adjustment(1)

    12  
       

Balance at December 31, 2013

  $ 2,186  
       
       

(1)
Fair value adjustments consist of interest recorded.

        There have been no changes to the valuation methods during the years ended December 31, 2013 and 2012. There were no transfers of assets or liabilities between Level 1 and Level 2 during the years ended December 31, 2013 and 2012. We had no short-term investments that were classified as Level 3 during the years ended December 31, 2013 or 2012.

        Cash and cash equivalents, prepaid expenses, accounts payable and accrued expenses are carried at amount that approximate fair value due to their short-term maturities.

5. Cash, Cash Equivalents and Marketable Securities

        The following tables summarize the Company's cash, cash equivalents and marketable securities as of December 31, 2013 and December 31, 2012 (in thousands):

December 31, 2013
  Amortized
Cost
  Gross
Unrealized
Gains
  Gross
Unrealized
Losses
  Fair Value  

Cash and money market funds

  $ 18,078   $   $   $ 18,078  

Corporate debt securities

                         

Due in one year or less

    22,631     11     (2 )   22,640  

Due in two years or less

    3,708     2     (1 )   3,709  
                   

Total

  $ 44,417   $ 13   $ (3 ) $ 44,427  
                   
                   

Reported as:

                         

Cash and cash equivalents

  $ 18,078   $   $   $ 18,078  

Short-term investments

    26,339     13     (3 )   26,349  
                   

Total

  $ 44,417   $ 13   $ (3 ) $ 44,427  
                   
                   

F-15


Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

5. Cash, Cash Equivalents and Marketable Securities (Continued)

 

December 31, 2012
  Amortized
Cost
  Gross
Unrealized
Gains
  Gross
Unrealized
Losses
  Fair Value  

Cash and money market funds

  $ 14,776   $   $   $ 14,776  

Corporate debt securities

                         

Due in one year or less

    5,754     2     (1 )   5,755  

Due in two years or less

    10,867     3     (10 )   10,860  
                   

Total

  $ 31,397   $ 5   $ (11 ) $ 31,391  
                   
                   

Reported as:

                         

Cash and cash equivalents

  $ 14,776   $   $   $ 14,776  

Short-term investments

    16,621     5     (11 )   16,615  
                   

Total

  $ 31,397   $ 5   $ (11 ) $ 31,391  
                   
                   

        At December 31, 2013 and 2012 we held eight and fifteen debt securities that had been in an unrealized loss position for less than 12 months, respectively. We held no investments that have been in a continuous unrealized loss position for 12 months or longer. The aggregate fair value of these securities was $9.5 million and $11.6 million at December 31, 2013 and 2012, respectively. We evaluated our securities for other-than-temporary impairments based on quantitative and qualitative factors. We considered the decline in market value for the eight securities as of December 31, 2013 to be primarily attributable to current economic and market conditions. It is not more likely than not that we will be required to sell these securities. Three of these securities were sold in January 2014 for an immaterial realized gain, the remaining five securities we do not intend to sell before the recovery of their amortized cost bases, which recovery is expected within the next 12 months. Based on our analysis, we do not consider these investments to be other-than-temporarily impaired as of December 31, 2013 or 2012.

        As of December 31, 2013, we held $11.7 million in financial institution debt securities and other corporate debt securities located in Canada, the United Kingdom, the Netherlands, Australia, and Norway. As of December 31, 2012, we held $7.6 million in financial institution debt securities and other corporate debt securities located in Canada, the United Kingdom, the Netherlands, and Australia. Based on our analysis, we do not consider these investments to be other-than-temporarily impaired as of December 31, 2013 or 2012.

        We had no realized gains or losses or other-than-temporary impairments on our short-term investments for the years ended December 31, 2013 and 2012, the period from April 5, 2011 (inception) through December 31, 2011 and the period from April 5, 2011 (inception) through December 31, 2013.

F-16


Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

6. Property and Equipment

        Property and equipment and related accumulated depreciation are as follows (in thousands):

 
  December 31,
2013
  December 31,
2012
 

Laboratory equipment

  $ 1,377   $ 663  

Furniture

    106     101  

Computer equipment

    7     7  

Leasehold improvements

    78     78  

Less: accumulated depreciation

    (688 )   (93 )
           

  $ 880   $ 756  
           
           

        We recorded depreciation and amortization expense of $0.2 million, $0.1 million, zero, and $0.3 million for the years ended December 31, 2013 and 2012, the period from April 5, 2011 (inception) through December 31, 2011, and the period from April 5, 2011 (inception) through December 31, 2013, respectively. In July 2013, we entered into a master services agreement with a new global third party manufacturer to provide services for the manufacture of AUGMENT to replace our existing contract manufacturer. As a consequence of the contract manufacturer transition, we determined that we would no longer use certain laboratory equipment, and as such, recorded an impairment loss of $0.4 million. The loss is included within research and development expense.

7. Convertible Preferred Stock

        In July 2011, we sold 6,200,000 shares of Series A Preferred Stock at a price of $1.00 per share for gross proceeds of $6.2 million. We incurred approximately $0.1 million of issuance costs in connection with the sale of the Series A Preferred Stock, which were recorded to additional paid-in capital.

        On March 29, 2012, we sold 6,770,563 shares of Series B Preferred Stock at a price of $5.50 per share for gross proceeds of approximately $37.2 million. We incurred approximately $2.2 million of issuance costs in connection with the sale of the Series B Preferred Stock, which were recorded as a reduction of the proceeds received.

        On August 13, 2012, as a result of the completion of the private placement of our common stock (see Note 8), our Series A and Series B Preferred Stock automatically converted into shares of common stock. Each share of Series A Preferred Stock converted into common stock on a one-for-2.023 basis, into a total of 3,064,753 shares of common stock, and each share of Series B Preferred Stock converted into common stock on a one-for-one basis, into a total of 6,770,563 shares of common stock.

        We assessed the Series A Preferred Stock and the Series B Preferred Stock for any beneficial conversion features or embedded derivatives, including the conversion option, that would require bifurcation from the Series A Preferred Stock and/or the Series B Preferred Stock and receive separate accounting treatment. On the date of the issuance, the fair value of the common stock into which the Series A Preferred Stock and the Series B Preferred Stock, respectively, was convertible was less than the effective conversion price of the Series A Preferred Stock and the Series B Preferred Stock, respectively, and, as such, there was no intrinsic value of the conversion option on the commitment date. In addition, no embedded derivatives were identified that would require bifurcation.

F-17


Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

7. Convertible Preferred Stock (Continued)

        The rights, preferences and privileges of the Series A Preferred Stock and the Series B Preferred Stock were as set forth below until the Series A Preferred Stock and the Series B Preferred Stock converted into common stock on August 13, 2012 (see Note 8).

Conversion

        Shares of Series A Preferred Stock were convertible into common stock based on a defined conversion ratio, which was originally set at one-for-one and following the Reverse Stock Split was one-for-2.023, adjustable for certain dilutive events. Shares of Series B Preferred Stock were convertible into common stock based on a defined conversion ratio, which was one-for-one, adjustable for certain dilutive events. The conversion ratios for the Series A Preferred Stock and the Series B Preferred Stock were subject to change in accordance with anti-dilution provisions contained in our restated certificate of incorporation. More specifically, the applicable conversion ratio was subject to adjustment to prevent dilution on a weighted-average basis in the event that we issued additional shares of common stock or securities convertible or exercisable for common stock at a purchase price less than the then effective applicable conversion ratio. We evaluated this feature and concluded it did not require bifurcation as a derivative because the Series A Preferred Stock and the Series B Preferred Stock were each concluded to have the characteristics of an equity-host and the feature was clearly and closely related to the Series A Preferred Stock and the Series B Preferred Stock, respectively.

        The Series A Preferred Stock and the Series B Preferred Stock were convertible at the option of the holder at any time without any additional consideration. In addition, the Series A Preferred Stock and the Series B Preferred Stock would automatically convert into shares of common stock at the then effective applicable conversion rate, upon the earliest to occur of (a) the closing of the sale of shares of common stock to the public at a price of at least $16.50 per share in an underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933, as amended (the "Securities Act"), provided that such offering results in at least $35.0 million of gross proceeds to us and the our common stock is listed for trading on a national securities exchange, (b) the closing of certain private placement or registered offerings of our equity securities or (c) the effectiveness of a registration statement under the Securities Act covering the re-sale of privately placed securities. In addition, all outstanding shares of Series A Preferred Stock and Series B Preferred Stock would convert into common stock upon the vote or written consent of the holders of 70% of the outstanding Series A Preferred Stock and Series B Preferred Stock, voting as a single class (subject to certain limitations).

Dividends

        Prior to the payment of any dividend, except a common stock dividend, to the common stockholders, the holders of Series A Preferred Stock and Series B Preferred Stock were entitled to receive an amount at least equal to the amount that would have been received by the holders of Series A Preferred Stock and Series B Preferred Stock had all shares of Series A Preferred Stock and Series B Preferred Stock been converted to common stock immediately prior to issuance of the dividend. There were no guaranteed dividends that accrue.

Liquidation preference

        In the event of any liquidation, dissolution or winding up of the Company, including a deemed liquidation event, such as certain mergers or a disposition of substantially all the assets of the

F-18


Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

7. Convertible Preferred Stock (Continued)

Company, unless holders of at least 70% of the outstanding shares of Series A Preferred Stock and Series B Preferred Stock, including certain of our major investors, elected otherwise, the holders of Series A Preferred Stock and Series B Preferred Stock were entitled to receive, in preference to common stockholders, an amount equal to $1.00 per share, in the case of the Series A Preferred Stock, and $5.50 per share, in the case of the Series B Preferred Stock, in each case adjustable for certain dilutive events, plus all declared but unpaid dividends. If we had insufficient assets to pay the holders of Series A Preferred Stock and Series B Preferred Stock the full amount to which they were entitled, the holders of the Series A Preferred Stock and Series B Preferred Stock would share ratably in any distribution in proportion to the respective amounts which would otherwise be payable.

        After payment of such preferential amounts, the remaining assets of the Company, if any, would be distributed ratably to the holders of common stock, Series A Preferred Stock and Series B Preferred Stock on an as-converted to common stock basis. However, the holders of Series A Preferred Stock and Series B Preferred Stock were limited to the receipt of an aggregate amount (including through payment of the preferential amounts described above) equal to the greater of:

    (1)
    $2.00 per share, in the case of the Series A Preferred Stock, and $11.00 per share, in the case of the Series B Preferred Stock, in each case adjustable for certain dilutive events, and

    (2)
    the amount such holders would have received if all Series A Preferred Stock or Series B Preferred Stock, as the case may be, had been converted to common stock immediately prior to the liquidation event.

Voting rights

        Holders of Series A Preferred Stock and Series B Preferred Stock were entitled to vote as a single class with the holders of common stock, and had one vote for each equivalent common share into which the Series A Preferred Stock and the Series B Preferred Stock was convertible. In addition, the affirmative vote of the holders of at least 70% of the outstanding Series A Preferred Stock and Series B Preferred Stock, including certain of our major investors, voting together on an as-converted to common stock basis, was required to amend our organizational documents, declare or pay dividends, subject to limited exceptions, create certain new series or classes of stock or reclassify existing series or classes, exclusively license our material intellectual property, effect a significant change in our business, create indebtedness in excess of $0.25 million, increase the number of shares of common stock reserved for equity compensation, or undertake change of control transactions. Furthermore, the affirmative vote of the holders of at least 60% of the outstanding Series B Preferred Stock was required to amend or repeal our organizational documents, increase the number of shares of Series B Preferred Stock, undertake change of control transactions or exclusively license any of our material intellectual property. The holders of Series A Preferred Stock were entitled to elect two directors and the holders of Series B Preferred Stock were entitled to elect one director. The holders of our common stock, Series A Preferred Stock and Series B Preferred Stock, voting together on an as converted to common stock basis, had the right to elect the remaining directors.

8. Common Stock

        On March 28, 2012, our board of directors and stockholders approved, and we filed, a restated certificate of incorporation effecting a Reverse Stock Split of the outstanding shares of our common

F-19


Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

8. Common Stock (Continued)

stock at a ratio of one share for every 2.023 shares outstanding, so that every 2.023 outstanding shares of common stock before the Reverse Stock Split represented one share of common stock after the Reverse Stock Split. Each stockholder's percentage ownership interest in the Company and proportional voting power remains unchanged after the Reverse Stock Split, except for minor changes and adjustments resulting from rounding of fractional interests. The rights and privileges of the holders of capital stock were unaffected by the Reverse Stock Split. All information in these financial statements has, unless otherwise indicated, been retroactively adjusted for all periods presented to give effect to the Reverse Stock Split.

        On August 13, 2012, we issued and sold in a private placement an aggregate of 897,554 shares of common stock at a price per share of $5.50 resulting in net proceeds of $4.0 million. As a result of the completion of the private placement, on August 13, 2012, our Series A Preferred Stock and Series B Preferred Stock automatically converted into shares of common stock. Each share of Series A Preferred Stock converted into common stock on a one-for-2.023 basis, into a total of 3,064,753 shares of common stock, and each share of Series B Preferred Stock converted into common stock on a one-for-one basis, into a total of 6,770,563 shares of common stock.

        In connection with the private placement, we agreed to file a registration statement (the "Resale S-1") covering the resale of the 6,770,563 shares of common stock issued upon conversion of Series B Preferred Stock and the 897,554 shares of common stock issued and sold in the private placement. We filed the resale S-1 covering the resale of the 7,630,683 shares of common stock on August 29, 2012 and it was declared effective on September 13, 2012.

        On August 13, 2012, we amended our certificate of incorporation and by-laws to divide our board of directors into three classes with staggered three year terms. In addition, our restated certificate of incorporation and amended and restated by-laws provide that directors may be removed only for cause and only by the affirmative vote of the holders of 75% of the shares of capital stock present in person or by proxy and entitled to vote. Under our restated certificate of incorporation and amended and restated by-laws, any vacancy on the board of directors, including a vacancy resulting from an enlargement of the board of directors, may be filled only by vote of a majority of directors then in office. Furthermore, the restated certificate of incorporation provides that the authorized number of directors may be changed only by the board of directors.

        In March 2013, we issued and sold in a private placement an aggregate of 3,888,880 shares of our common stock to investors at $9.00 per share. The private placement resulted in $32.7 million of net proceeds. We filed a registration statement covering the resale of all such shares.

        In December 2013, we issued 273,224 shares of our common stock to Intrexon Corporation at $9.15 per share. The shares were issued in conjunction with a research and development agreement as the first installment of technology access fee (see Note 3).

        We have reserved the following shares of common stock for the potential exercise of stock options and issuance of shares upon vesting of restricted stock units:

 
  December 31,
2013
  December 31,
2012
 

Outstanding stock options

    2,413,237     1,218,153  

Outstanding restricted stock units

    96,155     192,308  

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Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

9. Stock-Based Compensation

        In March 2012, our board of directors and stockholders approved the 2012 Stock Incentive Plan (the "2012 Plan"). The 2012 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock units and other stock-based or cash awards to purchase shares of common stock to eligible employees, officers, directors and consultants. The number of shares of our common stock that are reserved for issuance under the 2012 Plan is equal to the sum of (1) 1,453,253 shares of common stock issuable under the 2012 Plan plus the number of shares of our common stock subject to outstanding awards under the 2011 Plan, described below, that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by us at their original issuance price pursuant to a contractual repurchase right (up to 679,622 shares) plus (2) an annual increase, to be added on the first day of each year beginning in 2013 and each subsequent anniversary until the expiration of the 2012 Plan, equal to the lowest of 975,000 shares of its common stock, 4.0% of the number of shares of our common stock outstanding on the first day of the year and an amount determined by our board of directors. We began making grants under the 2012 Plan following June 11, 2012, the effective date of our registration of securities on Form 10. Shares issued under the 2012 Plan are funded through the issuance of new shares. We ceased granting options under the 2011 Plan following the effective date of our registration of securities on Form 10.

Founders' stock

        In April 2011, we issued 3,509,634 shares of its common stock to founders at a purchase price of $0.002 per share, which was determined by the board of directors to be the fair value of the common stock on the date of issuance. The shares were issued under restricted stock purchase agreements and not pursuant to the 2011 Plan. These restricted stock purchase agreements allow us, at our discretion, to repurchase unvested shares if the founder's relationship with us is terminated. The shares issued to three of the co-founders vested with respect to 25% of the shares on the grant date and with respect to the remaining shares in approximately equal quarterly installments through the fourth anniversary of the grant date. The shares issued to the remaining two co-founders vest in approximately equal quarterly installments from and after the grant date. Additionally, 25% of the then-unvested shares issued to the remaining two co-founders vested in July 2011 in connection with the Series A Preferred Stock financing.

        A summary of our Founders' stock activity and related information is as follows:

 
  Shares  

Unvested at December 31, 2011

    2,319,646  

Granted

     

Vested

    (674,505 )
       

Unvested at December 31, 2012

    1,645,141  

Granted

     

Vested

    (658,060 )
       

Unvested at December 31, 2013

    987,081  

        We record stock-based compensation expense for the common stock subject to repurchase based on the grant date intrinsic value for employees and the vesting date intrinsic value for non-employees. All of the restricted shares were issued at fair value.

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Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

9. Stock-Based Compensation (Continued)

Stock options and restricted stock

        A summary of the Company's stock option activity and related information is as follows (in thousands, except share and per share data):

 
  Shares   Weighted
average
exercise
price per
share
  Weighted
average
remaining
contractual
term
(years)
  Aggregate
intrinsic
value
 

Outstanding at December 31, 2012

    1,218,153     3.83     9.34     5,535  

Granted

    1,537,172     12.87              

Exercised

    (42,799 )   0.99              

Forfeited

    (278,158 )   7.07              

Cancelled

    (21,131 )   4.01              
                         

Outstanding at December 31, 2013

    2,413,237     9.26     9.05     6,087  

Exercisable at December 31, 2013

    468,710     3.46     8.28     3,112  

Vested and expected to vest at December 31, 2013

    1,445,760     8.14     8.90     4,192  

        The total intrinsic value (the amount by which the fair market value exceeded the exercise price) of stock options exercised was $0.4 million, $48 thousand, zero and $0.4 million for the years ended December 31, 2013 and 2012, the period from April 5, 2011 (inception) to December 31, 2011 and the period from April 5, 2011 (inception) to December 31, 2013, respectively.

Stock options

        The fair value of each employee stock-based award is estimated on the grant date using the Black-Scholes option pricing model.

        We have used the simplified method to calculate the expected term in fiscal 2013 as we have not had significant historical exercise and post-vest termination data to provide a reasonable basis upon which to estimate the expected term for the options granted to employees. The contractual term will be used for option awards granted to non-employees. Historical data will be incorporated into our assumption as it becomes available.

        The computation of expected volatility is based on the historical volatility of a representative group of companies with similar characteristics to ours, including stage of potential fertility treatment development and life science industry focus. The representative group of companies consisted of ANI Pharmaceuticals, Inc., Corcept Therapeutics Inc., Neogenomics Inc., Sangamo Biosciences, Inc., and Stem Cells Inc. As a result of being a development stage company in a very early stage of potential fertility treatment development with no revenues, the representative group of companies has certain similar, but not all similar, characteristics to ours. We believe the group selected has sufficient similar economic and industry characteristics and includes companies that are most representative of ours.

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Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

9. Stock-Based Compensation (Continued)

        The fair value of each stock-based award is estimated on the grant date using the Black-Scholes option pricing model using the following assumptions:

 
  December 31,
 
  2013   2012   2011

Risk-free interest rate

  0.91% - 2.11%   0.8% - 1.78%   1.2% - 1.84%

Dividend yield

     

Volatility

  83% - 91%   79% - 89%   79% - 82%

Expected term (years)

  5.1 - 9.93   5.1 - 9.93   6.0 - 9.75

        During the year ended December 31, 2013, we granted 1,537,172 options to purchase common stock to employees with a weighted average exercise price of $12.87 per share at a weighted average grant date fair value of $9.34. During the year ended December 31, 2012, we granted 679,251 options to purchase common stock with a weighted average exercise price of $6.59 per share to employees at a weighted average grant date fair value of $4.82 per share.

        We recognized total stock-based compensation expense for employee stock option grants of $2.3 million, $0.3 million and $26 thousand for the years ended December 31, 2013 and 2012 and for the period from April 5, 2011 (inception) to December 31, 2011, respectively.

        During 2012, we granted 39,685 options to purchase common stock with a weighted average exercise price of $4.81 per share to non-employees. During 2011, we granted 165,339 options to purchase common stock with a weighted average exercise price of $0.04 per share to non-employees.

        Stock-based awards issued to non-employees are accounted for using the fair value method. These stock-based option awards are revalued at each reporting date until vesting. We recognized total stock-based compensation of $2.2 million for the year ended December 31, 2013, $1.0 million for the year ended December 31, 2012 and $0.3 million for the period from April 5, 2011 (inception) to December 31, 2011 for these non-employee awards.

        At December 31, 2013 there was $8.8 million of total unrecognized compensation cost related to non-vested stock options and restricted stock. We expect to recognize these costs over a remaining weighted average period of 2.7 years.

Restricted Stock Units

        On December 5, 2012, we issued a total of 192,308 restricted stock units ("RSUs") to our Chief Executive Officer. This included a grant of 128,205 RSUs with service-based vesting as follows: 16,025 shares on March 31, 2013 and 16,025 shares each quarter thereafter until December 31, 2014. The fair value of the service-based RSUs is based on the closing price of our common stock on the award date, or $7.80 per share. The stock-based compensation expense for this grant will be recognized on a straight-line basis over the vesting period. We also granted 64,103 RSUs that will vest only upon the achievement of performance conditions as determined by the Company's board of directors. On March 20, 2013 the board of directors established the 2013 performance criteria for the first tranche of the award and communicated the performance criteria to the Chief Executive Officer. The grant date stock price of these performance-based RSUs was $10.00 per share. In December 2013, 19,230 performance-based RSUs vested out of a total of 32,051 performance-based RSUs granted. The total fair value of RSUs vested during 2013 (measured on the date of vesting) was $0.8 million. We

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Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

9. Stock-Based Compensation (Continued)

recognized total stock-based compensation for the service-based awards and performance-based awards of $0.7 million and $36 thousand for the years ended December 31, 2013 and 2012, respectively.

        The performance conditions for the 2014 tranche of the performance-based RSUs had not been established as of December 31, 2013. As a result, the measurement date and grant date have not occurred for accounting purposes and no expense has been taken related to these awards as of December 31, 2013. On February 7, 2014 the board of directors established the 2014 performance criteria for the second tranche of the performance-based RSUs and communicated the performance criteria to the Chief Executive Officer. The grant date stock price of these performance-based RSUs was $8.75 per share. Expense for these awards will only be recognized if and when it is deemed probable that the performance conditions will be met.

        As of December 31, 2013, there was $0.5 million of total unrecognized compensation cost related to non-vested service-based RSUs granted under the 2012 Plan. The expense is expected to be recognized over a weighted average period of 1.0 years.

10. Income Taxes

        We had no income tax expense or benefit for the years ended December 31, 2013, 2012 and 2011.

        Subject to the limitations described below at December 31, 2013 and 2012, we had net operating loss carryforwards of approximately $33.0 million and approximately $14.1 million, respectively, to offset future federal taxable income, which expire beginning in 2031 continuing through 2033. The federal net operating loss carryforwards exclude approximately $0.4 million of deductions related to the exercise of stock options. This amount represents an excess tax benefit and has not been included in the gross deferred tax asset reflected for net operating losses. This amount will be recorded as an increase in additional paid in capital on the consolidated balance sheet once the excess benefits are "realized" in accordance with ASC 718. As of December 31, 2013 and 2012, we had net operating loss carryforwards of approximately $32.6 million and approximately $13.9 million, respectively, to offset future state taxable income, which expire beginning in 2031 continuing through 2033. We also had tax credit carryforwards of approximately $0.9 million and approximately $0.2 million as of December 31, 2013 and 2012, respectively, to offset future federal and state income taxes, which expire beginning in 2027 continuing through 2033.

        The NOL and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities and may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code, as well as similar state provisions. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on our value immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years.

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Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

10. Income Taxes (Continued)

        A reconciliation of income taxes computed using the U.S. federal statutory rate to that reflected in operations follows:

 
  Year
Ended
December 31,
2013
  Year
Ended
December 31,
2012
  Period from
April 5, 2011
(inception) to
December 31,
2011
 

Income tax benefit using U.S. federal statutory rate

    34.00 %   34.00 %   34.00 %

State income taxes, net of federal benefit

    5.28 %   5.42 %   5.47 %

Research and development tax credits

    2.31 %   0.00 %   1.70 %

Permanent items

    (1.09 )%   (2.78 )%   (3.93 )%

Change in the valuation allowance

    (40.50 )%   (36.64 )%   (37.24 )%
               

    %   %   %
               
               

        The principal components of our deferred tax assets are as follows (in thousands):

 
  December 31,
2013
  December 31,
2012
 

Deferred tax assets:

             

Net operating loss carryforwards

  $ 12,939   $ 5,527  

Research and development credits

    823     153  

Stock-based compensation

    1,602     142  

Patent and technology access fee

    1,954     129  

Other

    350     (23 )
           

Gross deferred tax assets

    17,668     5,928  

Valuation allowance

    (17,668 )   (5,928 )
           

Net deferred tax asset

  $   $  
           
           

        We have evaluated the positive and negative evidence bearing upon the realizability of our deferred tax assets. We have considered our history of operating losses and concluded, in accordance with the applicable accounting standards, that it is more likely than not that we may not realize the benefit of our deferred tax assets. Accordingly, our deferred tax assets have been fully reserved at December 31, 2013 and 2012. We reevaluate the positive and negative evidence on a quarterly basis.

        The valuation allowance increased approximately $11.7 million during the year ended December 31, 2013, due primarily to the increase in the net operating loss carryforwards and tax credits. The valuation allowance increased approximately $5.0 million during the year ended December 31, 2012, due primarily to the increase in the net operating loss carryforwards and tax credits.

        We apply ASC 740, Income Taxes . ASC 740 provides guidance on the accounting for uncertainty in income taxes recognized in financial statements. At December 31, 2013 and 2012, we had no unrecognized tax benefits.

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Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

10. Income Taxes (Continued)

        We will recognize interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2013, 2012 and 2011, we had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in our consolidated statements of operations.

        We file income tax returns in the U.S. Federal and Massachusetts jurisdictions. The statute of limitations for assessment by the Internal Revenue Service ("IRS") and state tax authorities is open for tax years ended December 31, 2012 and 2011. There are currently no federal or state income tax audits in progress.

        We have not, as yet, conducted a study of research and development ("R&D") credit carryforwards. Such a study, once undertaken by us, may result in an adjustment to our R&D credit carryforwards; however, until a study is completed and any adjustment is known, no amounts are being presented as an uncertain tax position. A full valuation allowance has been provided against our R&D credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no impact to the balance sheet or statement of operations if an adjustment is required.

11. Commitments and Contingencies

        On May 1, 2012, we entered into a commercial building lease agreement. The sixty month lease, which commenced on August 10, 2012, provides for the lease of approximately 6,000 square feet of space in Cambridge, Massachusetts. Base annual rent is initially set at approximately $22,000 per month with an annual increase of 3%. From April 2011 through April 2012, we leased office space from a significant stockholder. There was no formal lease arrangement with the stockholder. In May 2012 we entered into a commercial building sublease agreement. The 24 month sublease, which commenced on August 26, 2013, provides for the lease of 1,900 square feet of space also in Cambridge, Massachusetts. Base rent is approximately $4 thousand per month with an annual increase of 3%.

        Future minimum lease payments as of December 31, 2013 are as follows (in thousands):

Year
   
 

2014

  $ 323  

2015

    315  

2016

    292  

2017

    173  

2018

     
       

  $ 1,103  
       
       

        Rent expense is recorded straight-line over the operating lease term, with deferred rent included on the balance sheet as an other liability. Rent expense for the years ended December 31, 2013 and 2012, for the period from April 5, 2011 (inception) through December 31, 2011 and for the period from April 5, 2011 (inception) through December 31, 2013 amounted to $0.4 million, $0.2 million, $41 thousand and $0.6 million, respectively.

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Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

12. Accrued Expenses

        Accrued expenses consist of the following (in thousands):

 
  December 31,
2013
  December 31,
2012
 

Technology access fee payable to Intrexon (present value)

  $ 2,186   $  

Compensation and related benefits

    719     471  

Legal, audit and tax services

    605     330  

Preclinical, clinical and contract manufacturing

    258     93  

Consulting

    174     139  

Other expenses

    178     178  
           

  $ 4,120   $ 1,211  
           
           

13. Net Loss Per Share

        The following table sets forth the computation of basic and diluted loss per share applicable to common stockholders (in thousands, except per share data):

 
  Year Ended,
December 31,
  Period from
April 5, 2011
(inception) to
December 31,
2011
  Period from
April 5, 2011
(inception) to
December 31,
2013
 
 
  2013   2012  

Net loss applicable to common stockholders

  $ (29,044 ) $ (13,510 ) $ (2,725 ) $ (45,279 )
                   
                   

Weighted average number of common shares used in net loss per share applicable to common stockholders—basic and diluted

    16,160     5,810     909     8,350  
                   
                   

Net loss per share applicable to common stockholders—basic and diluted

  $ (1.80 ) $ (2.33 ) $ (3.00 ) $ (5.42 )
                   
                   

        The amounts in the table below were excluded from the calculation of diluted net loss per share, prior to the use of the treasury stock method, due to their anti-dilutive effect (in thousands):

 
  Year Ended,
December 31,
  Period from
April 5, 2011
(inception) to
December 31,
2011
  Period from
April 5, 2011
(inception) to
December 31,
2013
 
 
  2013   2012  
 
  (in thousands)
 

Series A Preferred Stock

            3,065      

Series B Preferred Stock

                 

Outstanding stock options and restricted stock units

    2,509     1,410     618     2,509  

Founders' stock

    987     1,645     2,319     987  
                   

Total

    3,496     3,055     6,002     3,496  
                   
                   

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Table of Contents


OvaScience, Inc.
(A development stage company)

Notes to Consolidated Financial Statements (Continued)

14. Related Party Transactions

        The Company's chief executive officer, Michelle Dipp, M.D., Ph.D., has not historically received any cash compensation for her service as chief executive officer because of her service as a general partner of one of the Company's principal stockholders. Pursuant to the terms of an employment agreement that the Company entered into with Dr. Dipp, in December 2012 the Company granted Dr. Dipp an option to purchase 339,313 shares of its common stock and restricted stock units in the aggregate amount of 192,308 shares of its common stock (see Note 9). In addition, the Company may in the future determine to compensate Dr. Dipp with cash or other compensation.

        As discussed in Note 11, during 2011 and a portion of 2012, the Company leased office space from one of its principal stockholders.

15. Employee Benefit Plan

        In January 2012, the Company adopted a 401(k) retirement and savings plan (the "401(k) Plan") covering all employees. The 401(k) Plan allows employees to make pre-tax contributions up to the maximum allowable amount set by the Internal Revenue Service. Under the 401(k) Plan, the Company may make discretionary contributions as approved by the board of directors. During the years ended December 31, 2013 and 2012, and for the period from April 5, 2011 (Inception) through December 31, 2013, the Company made contributions to the 401(k) Plan of $0.1 million, $0.1 million, and $0.2 million, respectively. No contributions were made during 2011.

F-28


Table of Contents


SUPPLEMENTARY INFORMATION
(Unaudited)

        The following sets forth certain unaudited consolidated quarterly statements of operations data for each of our last eight quarters. In our opinion, this quarterly information reflects all adjustments consistency only of normal recurring adjustments, necessary for a fair statement for the periods presented. Such quarterly results are not necessarily indicative of future results of operations and should be read in conjunction with audited consolidated financial statements and the notes thereto included elsewhere herein.

 
  Three Months Ended  
 
  March 31,
2013
  June 30,
2013
  September 30,
2013
  December 31,
2013
 
 
  (in thousands, except per share amounts)
 

Total operating expenses(1)(2)

  $ 5,175   $ 6,021   $ 6,925   $ 11,013  

Loss from operations

    (5,175 )   (6,021 )   (6,925 )   (11,013 )

Net loss

    (5,157 )   (5,996 )   (6,891 )   (11,000 )
                   

Accretion of convertible preferred stock to redemption value

                 

Net loss applicable to common stockholders

  $ (5,157 ) $ (5,996 ) $ (6,891 ) $ (11,000 )
                   
                   

Net loss per share applicable to common stockholders—basic and diluted

  $ (0.39 ) $ (0.36 ) $ (0.40 ) $ (0.64 )
                   
                   

Weighted average number of common shares used in net loss per share applicable to common stockholders—basic and diluted

    13,345     16,869     17,048     17,270  
                   
                   

(1)
During the third quarter of 2013, we recorded an impairment of certain laboratory equipment of approximately $0.4 million (see Note 6).

(2)
During the fourth quarter of 2013, we recorded research and development expense of approximately $4.7 million related to a technology access fee to Intrexon (see Note 3).

 
  Three Months Ended  
 
  March 31,
2012
  June 30,
2012
  September 30,
2012
  December 31,
2012
 
 
  (in thousands, except per share amounts)
 

Total operating expenses

  $ 2,966   $ 3,234   $ 3,120   $ 4,209  

Loss from operations

    (2,966 )   (3,234 )   (3,120 )   (4,209 )

Net loss

    (2,966 )   (3,234 )   (3,118 )   (4,192 )
                   

Accretion of convertible preferred stock to redemption value

                 

Net loss applicable to common stockholders

  $ (2,966 ) $ (3,234 ) $ (3,118 ) $ (4,192 )
                   
                   

Net loss per share applicable to common stockholders—basic and diluted

  $ (2.14 ) $ (2.09 ) $ (0.42 ) $ (0.33 )
                   
                   

Weighted average number of common shares used in net loss per share applicable to common stockholders—basic and diluted

    1,383     1,548     7,438     12,612  
                   
                   

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Table of Contents


Exhibit Index

Exhibit No.   Exhibit
  3.1   Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K (File No. 001-35890) filed by the Registrant on April 30, 2013)
        
  3.2   Second Amended and Restated By-laws of the Registrant (incorporated by reference to Exhibit 3.2 to the Current Report on Form 8-K (File No. 001-35890) filed by the Registrant on April 30, 2013)
        
  4.1   Specimen Stock Certificate evidencing the shares of Common Stock (incorporated by reference to Exhibit 4.1 to the Registration Statement on Form S-1 (File No. 333-183602) filed by the Registrant on August 29, 2012)
        
  4.2   Amended and Restated Investors' Rights Agreement, dated March 29, 2012, by and among the Registrant and the other parties thereto (incorporated by reference to Exhibit 4.4 to the Registration Statement on Form 10 (File No. 000-54647) filed by the Registrant on April 11, 2012)
        
  4.3   Registration Rights Agreement, dated August 13, 2012, by and among the Company and the persons party thereto (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K (File No. 000-54647) filed by the Registrant on August 14, 2012)
        
  10.1 # 2011 Stock Incentive Plan (incorporated by reference to Exhibit 10.1 to the Registration Statement on Form 10 (File No. 000-54647) filed by the Registrant on April 11, 2012)
        
  10.2 # Forms of Incentive Stock Option Agreement under the 2011 Stock Incentive Plan (incorporated by reference to Exhibit 10.2 to Amendment No. 1 to the Registration Statement on Form 10 (File No. 000-54647) filed by the Registrant on May 17, 2012)
        
  10.3 # Forms of Nonstatutory Stock Option Agreement under the 2011 Stock Incentive Plan (incorporated by reference to Exhibit 10.3 to Amendment No. 1 to the Registration Statement on Form 10 (File No. 000-54647) filed by the Registrant on May 17, 2012)
        
  10.4 # Form of Restricted Stock Agreement under the 2011 Stock Incentive Plan (incorporated by reference to Exhibit 10.4 to the Registration Statement on Form 10 (File No. 000-54647) filed by the Registrant on April 11, 2012)
        
  10.5 # 2012 Stock Incentive Plan (incorporated by reference to Exhibit 10.5 to the Registration Statement on Form 10 (File No. 000-54647) filed by the registrant on April 11, 2012)
        
  10.6 # Form of Incentive Stock Option Agreement under the 2012 Stock Incentive Plan (incorporated by reference to Exhibit 10.6 to Amendment No. 1 to the Registration Statement on Form 10 (File No. 000-54647) filed by the Registrant on May 17, 2012)
        
  10.7 # Form of Nonstatutory Stock Option Agreement under the 2012 Stock Incentive Plan (incorporated by reference to Exhibit 10.7 to Amendment No. 1 to the Registration Statement on Form 10 (File No. 000-54647) filed by the Registrant on May 17, 2012)
        
  10.8 # Form of Amended and Restated Restricted Stock Agreement between the Registrant and each of Michelle Dipp and Christoph Westphal (incorporated by reference to Exhibit 10.8 to the Registration Statement on Form 10 (File No. 000-54647) filed by the Registrant on April 11, 2012)
        
  10.9 # Amended and Restated Restricted Stock Agreement between the Registrant, Richard Aldrich and the Richard H. Aldrich Irrevocable Trust of 2011, dated March 29, 2012 (incorporated by reference to Exhibit 10.10 to the Registration Statement on Form 10 (File No. 000-54647) filed by the Registrant on April 11, 2012)
 
   

Table of Contents

Exhibit No.   Exhibit
  10.10 Exclusive License Agreement, dated June 27, 2011, between the Registrant and The General Hospital Corporation (incorporated by reference to Exhibit 10.11 to the Registration Statement on Form 10 (File No. 000-54647) filed by the Registrant on April 11, 2012)
        
  10.11 Amendment No. 1 to the Exclusive License Agreement, dated September 7, 2011, between the Registrant and The General Hospital Corporation (incorporated by reference to Exhibit 10.12 to the Registration Statement on Form 10 (File No. 000-54647) filed by the registrant on April 11, 2012)
        
  10.12 †* Amendment No. 2 to the Exclusive License Agreement, dated July 30, 2013, between the Registrant and The General Hospital Corporation
        
  10.13 * Amendment No. 3 to the Exclusive License Agreement, dated September 9, 2013, between the Registrant and The General Hospital Corporation
        
  10.14 †* Amendment No. 4 to the Exclusive License Agreement, dated November 14, 2013, between the Registrant and The General Hospital Corporation
        
  10.15 †* Amendment No. 5 to the Exclusive License Agreement, dated December 18, 2013, between the Registrant and The General Hospital Corporation
        
  10.16   Amended and Restated Voting Agreement, dated March 29, 2012, between the Registrant and the other parties thereto (incorporated by reference to Exhibit 10.15 to the Registration Statement on Form 10 (File No. 000-54647) filed by the Registrant on April 11, 2012)
        
  10.17 # Letter Agreement, dated November 14, 2011, between the Registrant and Christopher Bleck (incorporated by reference to Exhibit 10.17 to the Registration Statement on Form 10 (File No. 000-54647) filed by the Registrant on April 11, 2012)
        
  10.18 # Letter Agreement, dated July 2011, between the Registrant and Scott Chappel (incorporated by reference to Exhibit 10.18 to the Registration Statement on Form 10 (File No. 000-54647) filed by the Registrant on April 11, 2012)
        
  10.19   Form of Indemnification Agreement between the Registrant and each of Richard Aldrich, Michelle Dipp, Stephen Kraus and Christoph Westphal (incorporated by reference to Exhibit 10.21 to the Registration Statement on Form 10 (File No. 000-54647) filed by the Registrant on April 11, 2012)
        
  10.20   Form of Indemnification Agreement between the Registrant and each of Jeffrey Capello, Mary Fisher, Marc Kozin, Thomas Malley, Jonathan Tilly and Harald Stock (incorporated by reference to Exhibit 10.22 to the Registration Statement on Form 10 (File No. 000-54647) filed by the Registrant on April 11, 2012)
        
  10.21   Lease Agreement, dated May 1, 2012, between the Registrant and ARE-MA Region No. 38, LLC, as amended (incorporated by reference to Exhibit 10.23 to Amendment No. 1 to the Registration Statement on Form 10 (File No. 000-54647) filed by the Registrant on May 17, 2012)
        
  10.22   Form of Subscription Agreement (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K (File No. 000-54647) filed by the Registrant on August 14, 2012)
        
  10.23 # Letter Agreement, dated December 5, 2012, between the Registrant and Michelle Dipp (incorporated by reference to Exhibit 10.24 to the Annual Report on Form 10-K (File No. 000-54647) filed by the Registrant on February 25, 2013)
        
  10.24 *# Letter Agreement, dated December 19, 2012, between the Registrant and Alison Lawton
 
   

Table of Contents

Exhibit No.   Exhibit
  10.25 # Restricted Stock Unit Agreement, dated December 5, 2012, between the Registrant and Michelle Dipp (incorporated by reference to Exhibit 10.26 to the Annual Report on Form 10-K (File No. 000-54647) filed by the Registrant on February 25, 2013)
        
  10.26 # Restricted Stock Unit Agreement, dated December 5, 2012, between the Registrant and Michelle Dipp (incorporated by reference to Exhibit 10.27 to the Annual Report on Form 10-K (File No. 000-54647) filed by the Registrant on February 25, 2013)
        
  10.27   Securities Purchase Agreement, dated March 12, 2013, among the Registrant and the persons party thereto (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K (File No. 000-54647) filed by the Registrant on March 14, 2013)
        
  10.28   Registration Rights Agreement, dated March 12, 2013, among the Registrant and the persons party thereto (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K (File No. 000-54647) filed by the Registrant on March 14, 2013)
        
  10.29 # Letter Agreement, dated July 15, 2013, between the Registrant and Arthur Tzianabos (incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q (File No. 001-35890) filed by the Registrant on November 13, 2013)
        
  10.30 # Stock Option Agreement, dated September 10, 2013, between the Registrant and Arthur Tzianabos (incorporated by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q (File No. 001-35890) filed by the Registrant on November 13, 2013)
        
  10.31 # Separation Agreement, dated July 2, 2013, between the Registrant and Scott Chappel (incorporated by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q (File No. 001-35890) filed by the Registrant on November 13, 2013)
        
  10.32 # Non-Employee Director Compensation Policy of the Registrant (effective January 1, 2014) (incorporated by reference to Exhibit 10.4 to the Quarterly Report on Form 10-Q (File No. 001-35890) filed by the Registrant on November 13, 2013)
        
  10.33 # Form of Amendment to Employment Letter Agreements for Alison Lawton and Christopher Bleck relating to the definition of "good reason" termination (incorporated by reference to Exhibit 10.5 to the Quarterly Report on Form 10-Q (File No. 001-35890) filed by the Registrant on November 13, 2013)
        
  10.34 †* Intellectual Property License Agreement, dated December 18, 2013, between the Registrant and OvaXon, LLC
        
  10.35 †* Exclusive Channel Collaboration Agreement, dated December 18, 2013, between the Registrant and Intrexon Corporation and OvaXon, LLC
        
  10.36 †* Exclusive Channel Collaboration Agreement, dated December 18, 2013, between Intrexon Corporation and OvaXon, LLC
        
  21.1 * List of Subsidiaries of the Registrant
        
  23.1 * Consent of Ernst & Young
        
  31.1 * Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
        
  31.2 * Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
        
  32.1 * Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, by Chief Executive Officer
        
  32.2 * Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, by Principal Financial Officer
        
  101.INS ** XBRL Instance Document
 
   

Table of Contents

Exhibit No.   Exhibit
  101.SCH ** XBRL Taxonomy Extension Schema Document
        
  101.CAL ** XBRL Taxonomy Extension Calculation Linkbase Document
        
  101.DEF ** XBRL Taxonomy Extension Definition
        
  101.LAB ** XBRL Taxonomy Extension Label Linkbase Document

Confidential treatment requested as to portions of the exhibit. Confidential materials omitted and filed separately with the SEC.

#
Indicates a management contract or compensatory plan.

*
Filed herewith.

**
Submitted electronically herewith. In accordance with Rule 406T of Regulation S-T, the XBRL related information in Exhibit 101 to this Annual Report on Form 10-K is deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act, is deemed not filed for purposes of Section 18 of the Exchange Act, and otherwise is not subject to liability under these sections.



Exhibit 10.12

 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 2 TO THE EXCLUSIVE LICENSE AGREEMENT

 

This Amendment No. 2 (this “Amendment”) to the Exclusive License Agreement between OvaScience, Inc. (“Company”) and The General Hospital Corporation (“Hospital”), dated June 27, 2011 (the “Agreement”), is effective upon signing by both parties hereto.  Capitalized terms used but not defined within this Amendment have the meanings specified within the Agreement.

 

RECITALS.

 

Whereas, pursuant to Section 12.3 of the Agreement, the Agreement may be amended with the written consent of Company and Hospital;

 

Whereas, Company and Hospital have already entered into Amendment No. 1 to the Agreement, such amendment’s effective date being September 7, 2011; and

 

Whereas, Company and Hospital desire to expand the scope of the license originally granted to Company within the Agreement.

 

Now, therefore, Company and Hospital hereby agree to amend the Agreement as follows:

 

1.                                      The following new section 1.19 is hereby inserted immediately after Section 1.18 of the Agreement, as amended:

 

1.19                        “Expanded Field” shall mean assisted and/or artificial reproductive technology in all non-human mammals, and shall specifically exclude (a) treatments of menopause associated symptoms or diseases other than treatments of infertility; (b) treatments to delay menopause or menopause associated symptoms or diseases other than treatments of infertility; (c) diagnostics; (d) research tools, or any other field not specifically set forth herein.

 

Notwithstanding the foregoing, until such time as Company is required under Section 3.1(b)(i) of this Agreement to present to Hospital a development plan, Hospital hereby grants to Company the exclusive right to negotiate a worldwide, royalty-bearing license under Hospital’s rights in Patent Rights with respect to assisted and/or artificial reproductive technology in all non-human mammals within the fields of (a) treatments of menopause associated symptoms or diseases other than treatments of infertility; (b) treatments to delay menopause or menopause associated symptoms or diseases other than treatments of infertility; and (c) diagnostics.

 

2.                                      The introductory clause of Section 2.1(a) of the Agreement is hereby deleted in its entirety and replaced by the following:

 

(a)                                 Subject to the terms of this Agreement and Hospital’s and Harvard’s respective rights in Patent Rights, Hospital hereby grants to Company both in the License Field and in the Expanded Field with respect to Hospital

 

 

Initialed by Hospital:

KB

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

1



 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 2 TO THE EXCLUSIVE LICENSE AGREEMENT

 

Patent Rights, and the Limited Field with respect to Media Patent Rights, in the License Territory:

 

3.                                      Section 2.1(b)(i) of the Agreement is hereby deleted in its entirety and replaced by the following:

 

(i)                                     the right to grant to Clinical End Users and to final purchasers, users or consumers of Products or Processes the right to use such purchased Products or Processes within the scope of Hospital Patent Rights within either the License Field or the Expanded Field, and within the scope of Media Patent Rights within the Limited Field, in all cases in the License Territory; and

 

4.                                      Section 2.4 of the Agreement is hereby deleted in its entirety and replaced by the following:

 

2.4                               No Additional Rights .  It is understood that nothing in this Agreement shall be construed to grant Company or any of its Affiliates a license, express or implied, under any patent owned solely or jointly by Hospital or Harvard other than the Patent Rights expressly licensed hereunder.  Hospital shall have the right to license any Hospital Patent Rights to any other party for any purpose outside of the License Field, or the Expanded Field, or the License Territory.  Hospital and/or Harvard shall have the right to license any Media Patent Rights to any other party for any purpose outside of the Limited Field or the License Territory.

 

5.                                      Section 3.1 of the Agreement is hereby deleted in its entirety and replaced by the following:

 

3.1                               Diligence Requirements .  Company shall use, and shall cause its Affiliates and Sublicensees, as applicable, to use, commercially reasonable efforts to develop and make available to the public Products and Processes throughout the License Territory in the License Field, Limited Field, and Expanded Field.  Such efforts shall include achieving the following objectives within the time periods designated below following the Effective Date:

 

(a)                                 Pre-Sales Requirements for Product and/or Processes using Hospital Patent Rights and/or Technological Information within License Field :

 

(i)                                     Company shall use commercially reasonable efforts to carry out development of Products and/or Processes within License Field in accordance with development plans mutually agreed by the Parties through their Steering Committee representatives.

 

 

Initialed by Hospital:

KB

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

2



 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 2 TO THE EXCLUSIVE LICENSE AGREEMENT

 

(ii)                                  Company shall secure venture capital or other equity financing of at least $[***] within [***] months following the Effective Date.

(iii)                               Company shall identify one or more study site(s) for a Clinical Proof of Concept study within [***] months following the Effective Date.

(iv)                              Provide written report to Hospital detailing regulatory strategy for developing a Product or Process within License Field within [***] months following the Effective Date.

(v)                                 Enroll the first patient in a Clinical Proof of Concept study within [***] months following the Effective Date.

(vi)                              Complete a Clinical Proof of Concept study within [***] months following the Effective Date; provided that this milestone shall be deemed achieved by the completion of a study prospectively intended to demonstrate Clinical Proof of Concept whether or not Clinical Proof of Concept is achieved with such study.

(vii)                           Achieve a First Commercial Sale as it relates to Hospital Patent Rights or Technological Information within the License Field within [***] months following the Effective Date.

 

(b)                                 Pre-Sales Requirements for Product and/or Processes using Hospital Patent Rights and/or Technological Information within Expanded Field:

 

(i)                                     Company shall develop and present to Hospital development plan for the development of Products and/or Processes within the Expanded Field within [***] months following the Effective Date.

(ii)                                  Achieve a First Commercial Sales as it relates to Hospital Patent Rights or Technological Information within the Expanded Field within [***] months following the Effective Date.

 

(c)                                  Pre-Sales Requirements for Product and/or Processes using Media Patent Rights within the Limited Field:

 

(i)                                     Initiate ex vivo animal studies of a Product or Process using the Media Patent Rights within [***] months following the Effective Date.

(ii)                                  Initiate ex vivo human studies of a Product or Process using the Media Patent Rights within [***] months following the Effective Date.

(iii)                               Achieve First Commercial Sale of a Product or Process using the Media Patent Rights within [***] months following the Effective Date.

 

(d)                                 Post-Sales Requirements for each of the Licensed Field, Limited Field, and Expanded Field.

 

(i)                                     Following the First Commercial Sale of a Product or Process in any country in the License Territory, Company shall directly or

 

 

Initialed by Hospital:

KB

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

3



 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 2 TO THE EXCLUSIVE LICENSE AGREEMENT

 

through its Affiliates and/or Sublicensees make continuing Sales of such Product or Process in such country without any elapsed time period of [***] or more in which such Sales do not occur.

(ii)                                  Company shall directly or through an Affiliate or Sublicensee make such First Commercial Sale within the following countries and regions in the License Territory within [***] years after the Effective Date of this Agreement: (a) Canada, Mexico, Argentina, Brazil, Australia, New Zealand and Japan and (b) at least [***] of the following countries: the U.K., France, Germany, Italy and Spain; provided, however, that Company may satisfy the obligations of this Section 3.1(d)(ii), solely with respect to the Expanded Field, by making any such First Commercial Sale within [***] months following the Effective Date of this Agreement.

 

Achievement of the foregoing objectives shall be deemed to satisfy Company’s obligations to use commercially reasonable efforts under this Section 3.1.  Sections 3.1(a) and 3.1(c) above may be updated or modified from time to time by the Steering Committee, and any such update or modification shall be documented in the minutes of the applicable Steering Committee meeting and may be updated hereto through a written amendment.

 

6.                                      Section 3.2 of the Agreement is hereby deleted in its entirety and replaced by the following:

 

3.2                               Diligence Failures .  If Company fails to fulfill any of its obligations under Section 3.1(d) with respect to any of the countries listed in Section 3.1(d)(ii)(a) or with respect to at least [***] of the countries listed in Section 3.1(d)(ii)(b) in any material respect, then, subject to the notice and cure provisions of Section 10.4, Hospital may treat such failure as a default and, at Hospital’s option, may, solely with respect to the country(-ies) to which such failure relates, either convert the License under 2(a)(i) to non-exclusive or terminate this Agreement and/or any license granted hereunder in accordance with Section 10.4.  For the avoidance of doubt, Hospital shall not, based on Company’s failure to fulfill its obligations under Section 3.1(d), have the right to terminate this Agreement or Company’s licenses hereunder, or convert Company’s licenses hereunder to non-exclusive, with respect to countries in which Company satisfies its obligations under Section 3.1(d).  In addition, if Company, together with its Affiliates, Sublicensees and Clinical End Users, ceases all development and commercialization activities with respect to all Products and Processes for more than [***], Hospital may treat such failure as a default and, at Hospital’s option, may either convert the License under 2(a)(i) to non-exclusive or terminate this Agreement and/or any license granted hereunder in accordance with Section 10.4.  If Company fails to fulfill any of its obligations under Section 3.1(a), 3.1(b) or 3.1(c), then, subject to the notice and cure provisions of Section

 

 

Initialed by Hospital:

KB

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

4



 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 2 TO THE EXCLUSIVE LICENSE AGREEMENT

 

10.4, Hospital may treat such failure as a default and, at Hospital’s option, may, in the case of such failure with respect to Section 3.1(a), solely with respect to the Hospital Patent Rights in the License Field, in the case of such failure with respect to Section 3.1(b), solely with respect to the Hospital Patent Rights in the Expanded Field or in the case of such failure with respect to Section 3.1(c), solely with respect to the Media Patent Rights in the Limited Field, either convert the License under 2(a)(i) to non¬exclusive with respect to the Hospital Patent Rights or the Media Patent Rights, as applicable, or terminate any license granted hereunder with respect to the Hospital Patent Rights or the Media Patent Rights, as applicable, in accordance with Section 10.4.  For the avoidance of doubt, Hospital shall not, based on Company’s failure to fulfill its obligations under Sections 3.1(a), 3.1(b) or 3.1(c), have the right to terminate this Agreement or Company’s licenses hereunder, or convert Company’s licenses hereunder to non-exclusive, other than with respect to the Hospital Patent Rights within the License Field or Expanded Field, or the Media Patent Rights in the Limited Field, as applicable.

 

7.                                      The following new section 4.1(b) is hereby inserted immediately after Section 4.1(a) of the Agreement, as amended.

 

(b)                                 Hospital Patent Rights within Expanded Field License Issue Fee .  Company shall pay Hospital an additional non-refundable license issue fee in the amount of [***] dollars ($[***]) within [***] business days following the signing of this Amendment by both Company and Hospital for the grant of rights under the Hospital Patent Rights within the Expanded Field.

 

8.                                      The following new section 4.3(d) is hereby inserted immediately after Section 4.3(c) of the Agreement, as amended.

 

(d)                                 Hospital Patent Rights within Expanded Field Annual License Fee .  Company shall pay to Hospital the non-refundable amount of [***] dollars ($[***]) as an annual license fee for the grant of rights under the Hospital Patent Rights within the Expanded Field within [***] days after each anniversary of the Effective Date.

 

Each Hospital Patent Rights within Expanded Field Annual License Fee shall be creditable against royalties subsequently due on Net Sales amounts from Products or Processes relying on the Hospital Patent Rights within the Expanded Field made in the same year as such fee is due, and against milestones subsequently due in the same year as such fee is due, but shall not be credited against royalties due on Net Sales made or milestones payable in any other subsequent year.

 

 

Initialed by Hospital:

KB

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

5



 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 2 TO THE EXCLUSIVE LICENSE AGREEMENT

 

9                                         The following new section 4.4(1) is hereby inserted immediately after Section 4.4(k) of the Agreement, as amended.

 

(1)                                 [***] Dollars ($[***]) within [***] days of First Commercial Sale of a Product and/or Process using Hospital Patent Rights and/or Technological Information within the Expanded Field in the first country in which First Commercial Sale of a Product and/or Process using Hospital Patent Rights and/or Technological Information within the Expanded Field is achieved.

 

10.                               Sections 4.5(a) and 4,5(b) are hereby deleted in their entirety and replaced with the following:

 

(a)                                 Beginning with the First Commercial Sale in any country in the License Territory, Company shall pay Hospital during the term of any license granted under Section 2.1(a)(i), a royalty of [***] percent ([***]%) of the Net Sales amounts of all Products or Processes in the License Field and Limited Field, and a royalty of [***] percent ([***]%) of the Net Sales amounts of all Products or Processes in the Expanded Field.  Solely with respect to the Licensed Field and Limited Field; in the event that Company reasonably determines that royalty payments to one or more third parties are required in order to avoid potential infringement of third party patent rights, Company shall notify Hospital via Hospital’s Executive Director, Research Ventures and Licensing promptly following Company’s decision to pursue a license from the applicable third party and, if such payments are in excess of [***] percent ([***]%) of Net Sales, Company may offset a total of [***] percent ([***]%) of such third-party payments that are in excess of [***] percent ([***]%) of Net Sales against any royalty payments that are due under this Section 4.5(a) to Hospital in the same Reporting Period, provided that in no event shall the royalty payments under this Section 4.5(a), when aggregated with any other offsets and credits allowed under this Agreement, be reduced by more than [***] percent ([***]%) in any Reporting Period.  Without limiting the foregoing, in connection with providing notification to Hospital of Company’s intent to pursue a third party license, Company shall provide an explanation of its rationale for pursuing the license.  In the event that Hospital notifies Company that Hospital has concerns regarding Company’s determination to seek such license, the Steering Committee shall be convened to review the determination.  Failing satisfactory resolution from the Steering Committee, the matter shall be discussed between Company’s CEO or Chairman and the Hospital’s Executive Director, Research Ventures and Licensing; provided that, Company’s CEO shall have final decision-

 

 

Initialed by Hospital:

KB

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

6



 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 2 TO THE EXCLUSIVE LICENSE AGREEMENT

 

making authority with respect to such matter and Company shall not be required to delay obtaining the proposed third party license for more than [***] ([***]) days in total as a result of the foregoing Steering Committee and executive consultation process.

 

(b)                                 With respect to any sublicense granted in the License Field or Limited Field, Company shall pay Hospital [***] percent ([***]%) of any and all Sublicense Income received prior to the third (3 rd ) anniversary of the Effective Date, and [***] percent ([***]%) of any and all Sublicense Income received on or after the third (3 rd ) anniversary of the Effective Date.  With respect to any sublicense granted within the Expanded Field, in full satisfaction of Company’s obligations under Sections 4.5(a)-(b) of this Agreement, Company shall pay Hospital [***] percent ([***]%) of (i) any and all Sublicense Income and (ii) any amounts paid to Company by any such Sublicensee as a royalty owed to Company on Net Sales.

 

11.                               Section 7.1 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

7.1                               Hospital Right to Prosecute .  Hospital will protect the Patent Rights from infringement and prosecute infringers when, in its sole judgment, such action may be reasonably necessary, proper and justified.  If Company shall have supplied Hospital with prima facie infringement of a claim of a Hospital Patent Right in the License Field or Expanded Field, or of a Media Patent Right in the Limited Field, in the License Territory by a third party which poses a material threat to Company’s rights under this Agreement, Company may by notice request Hospital to take steps to protect such Patent Right.  Hospital shall notify Company within [***] ([***]) days of the receipt of such notice whether Hospital intends to prosecute the alleged infringement.  If Hospital notifies Company that it intends to so prosecute, Hospital shall, within [***] ([***]) months of its notice to Company either (a) cause such infringement to terminate, or (b) initiate legal proceedings against the infringer.

 

12.                               Section 7.2 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

7.2                               Company Right to Prosecute .  In the event Hospital notifies Company that Hospital does not intend to prosecute infringement identified under Section 7.1, Company may, upon notice to Hospital, initiate legal proceedings against the infringer at Company’s expense with respect to a claim of a Hospital Patent Right in the License Field or Expanded Field, or of a Media Patent Right in the Limited Field, in the License Territory.  Before commencing such action, Company and, as applicable, any Affiliate,

 

 

Initialed by Hospital:

KB

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

7



 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 2 TO THE EXCLUSIVE LICENSE AGREEMENT

 

shall consult with Hospital, concerning, among other things, Company’s standing to bring suit, the selection of counsel and the jurisdiction for such action and shall consider the views of Hospital regarding the proposed action, including, without limitation with respect to potential effects on the public interest.  Company shall be responsible for all costs, expenses and liabilities in connection with any such action and shall indemnify and hold Hospital and Harvard harmless therefrom, regardless of whether Hospital or Harvard is a party-plaintiff, except for the expense of any independent counsel retained by Hospital in accordance with Section 7.5 below.

 

13.                               Section 10.6 of the Agreement is hereby deleted in its entirety and replaced by the following:

 

10.6                        Termination by Company .  Company shall have the right to terminate this Agreement it its entirety by giving ninety (90) days advance written notice to Hospital and upon such termination shall immediately cease all use and Sales of Products and Processes, subject to Section 10.9  Company shall also have the right to terminate its license hereunder with respect to the Hospital Patent Rights in either the License Field or the Expanded Field, or they Media Patent Rights, but in no event all three, by giving ninety (90) days advance written notice to Hospital and upon such termination shall immediately cease all use and Sales of Products and Processes using the Hospital Patent Rights in the License Field or Expanded Field, or the Media Patent Rights, as applicable, subject to Section 10.9.  Following such a termination: (a) with respect to the Hospital Patent Rights in the License Field only, Section 3.1(a), and to the extent not already achieved or paid, Sections 4.3(a), 4.3(b), 4.4(a) and 4.4(b) shall no longer have any force or effect; (b) with respect to the Hospital Patent Rights in the Expanded Field only, Section 3.1(b), and to the extent not already achieved or paid, Sections 4.3(d), and 4.4(1) shall no longer have any force or effect; (c) with respect to the Media Patent Rights only, Section 3.1(c), and to the extent not already achieved or paid, Sections 4.3(c), 4.4(c) and 4.4(d) shall no longer have any force or effect; and (d) except as expressly provided in this Section 10.6, this Agreement shall remain in full force and effect.

 

14.                               Except as expressly modified by this Amendment, all terms and conditions of the Agreement remain in full force and effect.

 

15.                               This Amendment can be executed by the parties hereto by facsimile and in counterparts, each of which is deemed an original and both of which taken together constitutes one agreement binding upon the parties hereto.

 

16.                               The validity, interpretation and performance of this Amendment is controlled by and construed under the laws of the Commonwealth of Massachusetts, without giving effect to the principles of conflicts of law thereof.

 

 

Initialed by Hospital:

KB

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

8



 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 2 TO THE EXCLUSIVE LICENSE AGREEMENT

 

In witness whereof, the parties hereto enter into this Amendment as of the date of the last signature, written below.

 

OvaScience, Inc.

 

The General Hospital Corporation

 

 

d/b/a Massachusetts General Hospital

 

 

 

 

 

 

/s/ Michelle Dipp

 

/s/ K. Betres

By:

Michelle Dipp

 

By

Kris Betres

 

Chief Executive Officer

 

 

Director, Research & Licensing

 

 

 

Research Ventures & Licensing

 

 

 

July 30, 2013

 

June 27, 2013

Date

 

Date

 

 

Initialed by Hospital:

KB

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

9




Exhibit 10.13

 

AMENDMENT NO. 3 TO THE EXCLUSIVE LICENSE AGREEMENT

 

This Amendment No. 3 (this “Amendment”) to the Exclusive License Agreement between OvaScience, Inc. (“Company”) and The General Hospital Corporation (“Hospital”), dated June 27, 2011 (the “Agreement”), is effective upon signing by both parties hereto.  Capitalized terms used but not defined within this Amendment have the meanings specified within the Agreement.

 

RECITALS.

 

Whereas, pursuant to Section 12.3 of the Agreement, the Agreement may be amended with the written consent of Company and Hospital;

 

Whereas, Company and Hospital have already entered into Amendments No. 1 and 2 to the Agreement, such amendments’ effective dates being September 7, 2011 and July 30, 2013, respectively;

 

Whereas, in the course of Company’s business development efforts, Company has become aware of an opportunity to accelerate development of the Expanded Field (as amended herein); and

 

Whereas, Company and Hospital desire to amend the Expanded Field to permit such an opportunity, such Expanded Field subject to the terms outlined in Amendment No. 2 to the Agreement.

 

Now, therefore, Company and Hospital hereby agree to amend the Agreement as follows:

 

1.                                       Section 1.19 of the Agreement is hereby deleted in its entirety and replaced by the following:

 

1.19 “Expanded Field” shall mean assisted and/or artificial reproductive technology in all non-human animals, and shall specifically exclude (a) treatments of menopause associated symptoms or diseases other than treatments of infertility; (b) treatments to delay menopause or menopause associated symptoms or diseases other than treatments of infertility; (c) diagnostics; (d) research tools, or any other field not specifically set forth herein.  Notwithstanding the foregoing, until such time as Company is required under Section 3.1(b)(i) of this Agreement to present to Hospital a development plan, Hospital hereby grants to Company the exclusive right to negotiate a worldwide, royalty-bearing license under Hospital’s rights in Patent Rights with respect to assisted and/or artificial reproductive technology in all non-human animals within the fields of

 

(a)  treatments of menopause associated symptoms or diseases other than treatments of infertility;

(b)  treatments to delay menopause or menopause associated symptoms or diseases other than treatments of infertility; and (c) diagnostics.

 

2.                                       Except as expressly modified by this Amendment, all terms and conditions of the Agreement remain in fill force and effect.

 



 

AMENDMENT NO. 3 TO THE EXCLUSIVE LICENSE AGREEMENT

 

3.                                       This Amendment can be executed by the parties hereto by facsimile and in counterparts, each of which is deemed an original and both of which taken together constitutes one agreement binding upon the parties hereto.

 

4.                                       The validity, interpretation and performance of this Amendment is controlled by and construed under the laws of the Commonwealth of Massachusetts, without giving effect to the principles of conflicts of law thereof.

 

In witness whereof, the parties hereto enter into this Amendment as of the date of the last signature, written below.

 

OvaScience, Inc.

 

The General Hospital Corporation

 

 

d/b/a Massachusetts General Hospital

 

 

 

 

 

 

/s/ Alison Lawton

 

/s/ K. Betres

By:

Alison Lawton

 

By

Kris Betres

 

Chief Operating Officer

 

 

Assoc. Dir., Research & Licensing

 

 

 

Research Ventures & Licensing

 

 

 

September 9, 2013

 

September 9, 2013

Date

 

Date

 

 

Initialed by Hospital:

KB

 

2




Exhibit 10.14

 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 4 TO THE EXCLUSIVE LICENSE AGREEMENT

 

This Amendment No. 4 (this “Amendment”) to the Exclusive License Agreement between OvaScience, Inc. (“Company”) and The General Hospital Corporation (“Hospital”), dated June 27, 2011 (the “Agreement”), is effective upon signing by both parties hereto.  Capitalized terms used but not defined within this Amendment have the meanings specified within the Agreement.

 

RECITALS

 

Whereas, pursuant to Section 12.3 of the Agreement, the Agreement may be amended with the written consent of Company and Hospital;

 

Whereas, Company and Hospital have already entered into Amendments No. 1, 2 and 3 to the Agreement, such amendments’ effective dates being September 7, 2011, July 30, 2013, and September 9, 2013, respectively;

 

Whereas, Company is a biotechnology company engaged in the development of novel treatments for infertility, including its proprietary autologous gennline mitochondrial energy transfer (AUGMENT sm ) in vitro fertilization protocol (“AUGMENT”), which is based on technology licensed from Hospital under the Agreement; and

 

Whereas, Hospital and Company wish to amend Company’s obligations under Section the Agreement as set forth below.

 

Now, therefore, Company and Hospital hereby agree to amend the Agreement as follows:

 

1.                                       Section 3.1(a)(vi) of the Agreement is hereby deleted in its entirety and replaced by the following:

 

(vi)                               Complete a Clinical Proof of Concept Study within [***] ([***]) months following the Effective Date; provided that this milestone shall be deemed achieved by the completion of a study prospectively intended to demonstrate Clinical Proof of Concept whether or not Clinical Proof of Concept is achieved with such study.

 

2.                                       Except as expressly modified by this Amendment, all terms and conditions of the Agreement remain in full force and effect.

 

 

Initialed by Hospital:

KB

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

1



 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 4 TO THE EXCLUSIVE LICENSE AGREEMENT

 

3.                                       This Amendment can be executed by the parties hereto by facsimile and in counterparts, each of which is deemed an original and both of which taken together constitutes one agreement binding upon the parties hereto.

 

4.                                       The validity, interpretation and performance of this Amendment is controlled by and construed under the laws of the Commonwealth of Massachusetts, without giving effect to the principles of conflicts of law thereof.

 

In witness whereof, the parties hereto enter into this Amendment as of the date of the last signature, written below.

 

OvaScience, Inc.

 

The General Hospital Corporation

 

 

d/b/a Massachusetts General Hospital

 

 

 

 

 

 

/s/ Michelle Dipp, CEO

 

/s/ K. Betres

On behalf of:

Alison Lawton

 

By:

Kris Betres

 

Chief Operating Officer

 

 

Assoc. Dir., Research & Licensing

 

 

 

Research Ventures & Licensing

 

 

 

November 14, 2013

 

November 8, 2013

Date

 

Date

 

 

Initialed by Hospital:

KB

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

2




Exhibit 10.15

 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 5 TO THE EXCLUSIVE LICENSE AGREEMENT

 

This Amendment No. 5 (this “Amendment”) to the Exclusive License Agreement between OvaScience, Inc. (“Company”) and The General Hospital Corporation (“Hospital”), dated June 27, 2011 (the “Agreement”), is effective upon signing by both parties hereto. Capitalized terms used but not defined within this Amendment have the meanings specified within the Agreement.

 

RECITALS

 

Whereas, pursuant to Section 12.3 of the Agreement, the Agreement may be amended with the written consent of Company and Hospital;

 

Whereas, Company and Hospital have already entered into Amendments No. 1, 2, 3 and 4 to the Agreement, such amendments’ effective dates being September 7 th  2011, July 30 th  2013, September 9 th  2013, and November 14 th  2013, respectively;

 

Whereas, Company is a biotechnology company engaged in the development of novel treatments for infertility, including its proprietary autologous germline mitochondrial energy transfer (AUGMENT SM ) in vitro fertilization protocol (“AUGMENT”), which is based on technology licensed from Hospital under the Agreement; and

 

Whereas, Hospital and Company wish to amend Company’s obligations under the Agreement as set forth below.

 

Now, therefore, Company and Hospital hereby agree to amend the Agreement as follows:

 

1.                                       Section 1.3 of the Agreement is hereby deleted in its entirety and replaced by the following:

 

1.3                                Clinical End User ” shall mean those laboratories, clinics and medical practices that purchase and/or use Products and/or Processes pursuant to agreements with Company or any of its Affiliates or Sublicensees.

 

2.                                       Section 1.9(a)(i) of the Agreement is hereby deleted in its entirety and replaced by the following:

 

(i)                                      the gross amount billed or invoiced, or if no bill or invoice is issued the amount received, whichever is greatest, by Company and its Affiliates and Sublicensees for or on account of Sales of Product and/or Processes; provided that , with respect to the sale and/or use of Products and/or Processes by Clinical End Users (in

 

 

Initialed by Hospital:

 

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

1



 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 5 TO THE EXCLUSIVE LICENSE AGREEMENT

 

their capacities as Clinical End Users), the amounts paid by Clinical End Users to Company, its Affiliates and Sublicensees shall be considered gross amounts billed or invoiced for purposes of calculating Net Sales and the amounts billed or invoiced by Clinical End Users for Sales to their consumer shall be excluded from the calculation of Net Sales;

 

3.                                       The following new section 1.9(g) is hereby inserted immediately after Section 1.9(f) of the Agreement:

 

(g)                                   For purposes of determining the royalties payable on a Combination Product or Process, Net Sales of Product or Process shall be calculated by multiplying the Net Sales of the Combination Product or Process by the fraction A/A+B, where A is the average selling price, during the Reporting Period in question, of the Product or Process sold separately in the country in which the sale of the Combination Product or Process is made, and B is the average selling price, during the Reporting Period in question, of the Other Components sold separately.  If the Other Components in the Combination Product or Process are not sold separately, then for the purposes of determining royalties payable hereunder, the Parties shall negotiate in good faith to determine an appropriate commercial value for all the components or ingredients in the Combination Product or Process and calculate Net Sales of such Combination Product or Process accordingly.  Notwithstanding anything to the contrary in this Agreement, in no event shall the royalty due to Hospital when aggregated with any other offsets or credits allowed under this Agreement be less than [***] percent ([***]%) of the royalty otherwise due to Hospital under this Agreement in any Reporting Period

 

4.                                       The following new sections 1.20 and 1.21 are hereby inserted immediately after Section 1.19 of the Agreement, as amended:

 

1.20                         JV Field ” shall mean the use of egg precursor cells (“EPCs”), EPC progeny, or any component, factor or organelle derived from any such cell, component, factor or organelle (or any combination thereof), to (a) treat or prevent inherited diseases or defects in either humans or non-human animals; (b) treat or prevent mitochondrial diseases or defects in either humans or non-human animals; or (c) artificially create food, research animals and/or animal products.  For the avoidance of doubt, the JV Field does not include (d) treatments of menopause associated symptoms or diseases other than treatments of infertility; (e) treatments

 

 

Initialed by Hospital:

 

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

2



 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 5 TO THE EXCLUSIVE LICENSE AGREEMENT

 

to delay menopause or menopause associated symptoms or diseases other than treatments of infertility; (f) diagnostics; or (g) research tools or any other field not specifically set forth herein.

 

1.21                         Combination Product or Process ” shall mean a product or process that uses a functionally active component (for clarity, functionally active components exclude routine components, including without limitation common buffers and standard cell culture media) or service offering or process not licensed by Hospital to Company hereunder (“Other Components”) to form a product or process that is a combination of a Product and/or Process and Other Component(s).  For example, and without limiting the generality of this definition, a product or process in which (i) egg precursor cells are matured into an oocyte by a process that would qualify as a Process, and (ii) the resulting oocytes are subjected to a treatment or a product which would not qualify as a Process or Product, respectively, would be a Combination Product or Process.

 

5.                                       The introductory clause of Section 2.1(a) of the Agreement is hereby deleted in its entirety and replaced by the following:

 

(a)                                  Subject to the terms of this Agreement and Hospital’s and Harvard’s respective rights in Patent Rights, Hospital hereby grants to Company in the License Field, the JV Field and the Expanded Field with respect to Hospital Patent Rights, and in the Limited Field with respect to Media Patent Rights, in the License Territory:

 

6.                                       Section 2.1(b)(i) of the Agreement, as amended, is hereby deleted in its entirety and replaced by the following:

 

(i)                                      the right to grant to Clinical End Users and to final purchasers, users or consumers of Products or Processes the right to use such purchased Products or Processes within the scope of Hospital Patent Rights within the License Field, the JV Field, or the Expanded Field, and within the scope of Media Patent Rights within the Limited Field, in all cases in the License Territory; and

 

7.                                       Section 2.4 of the Agreement, as amended, is hereby deleted in its entirety and replaced by the following:

 

2.4                                No Additional Rights .  It is understood that nothing in this Agreement shall be construed to grant Company or any of its Affiliates a license, express or implied,

 

 

Initialed by Hospital:

 

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

3



 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 5 TO THE EXCLUSIVE LICENSE AGREEMENT

 

under any patent owned solely or jointly by Hospital or Harvard other than the Patent Rights expressly licensed hereunder.  Hospital shall have the right to license any Hospital Patent Rights to any other party for any purpose outside of the License Field, the JV Field, or the Expanded Field, or the License Territory. Hospital and/or Harvard shall have the right to license any Media Patent Rights to any other party for any purpose outside of the Limited Field or the License Territory.

 

8.                                       The following new section 3.1(e) is hereby inserted immediately following Section 3.1(d)(ii) of the Agreement, as amended:

 

(e)                                   Pre-Sales Requirements for Product and/or Processes within JV Field :

 

(i)                                      Company shall develop and present to Hospital a development plan for the development of Products and/or Processes within the JV Field no later than [***]20[***].

(ii)                                   Company shall commit at least One Million Dollars ($[***]) towards the research and development of Product and/or Processes directly related to the JV Field, annually, in each calendar year in the range from 20[***]-20[***].

(iii)                                Company shall initiate pre-clinical studies for an IND of a Product or Process in the JV Field no later than [***], 20[***].

(iv)                               Company shall commence clinical trial activity with respect to a Product or Process in the JV Field no later than [***] 20[***].

(v)                                  Achieve a First Commercial Sale of a Product or Process in the JV Field no later than [***] 20[***].

 

9.                                       The following new section 4.4(m) is hereby inserted immediately after Section 4.4(l) of the Agreement, as amended:

 

(m)                              [***] Dollars ($[***]) within [***] ([***]) days of First Commercial Sale of a Product and/or Process in the JV Field in the first country in which a First Commercial Sale is achieved in the JV Field.

 

10.                                Sections 4.5(a)-(b) of the Agreement, as amended, are hereby deleted in their entirety and replaced with the following:

 

(a)                                  Beginning with the First Commercial Sale in any country in the License Territory, Company shall pay Hospital during the term of any license granted under Section 2.1(a)(i), a royalty of [***] percent ([***]%) of the Net Sales amounts of all Products or Processes in the License Field, the JV

 

 

Initialed by Hospital:

 

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

4



 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 5 TO THE EXCLUSIVE LICENSE AGREEMENT

 

Field, and the Limited Field, and a royalty of [***] percent ([***]%) of the Net Sales amounts of all Products or Processes in the Expanded Field.  Solely with respect to the License Field, the JV Field and the Expanded Field; in the event that Company reasonably determines that royalty payments to one or more third parties are required in order to avoid potential infringement of third party patent rights, Company shall notify Hospital via Hospital’s Executive Director, Research Ventures and Licensing promptly following Company’s decision to pursue a license from the applicable third party and, if such payments are in excess of [***] percent ([***]%) of Net Sales, Company may offset a total of [***] percent ([***]%) of such third-party payments that are in excess of [***] percent ([***]%) of Net Sales against any royalty payments that are due under this Section 4.5(a) to Hospital in the same Reporting Period, provided that in no event shall the royalty payments under this Section 4.5(a), when aggregated with any other offsets and credits allowed under this Agreement, be reduced by more than [***] percent ([***]%) in any Reporting Period.  Without limiting the foregoing, in connection with providing notification to Hospital of Company’s intent to pursue a third party license, Company shall provide an explanation of its rationale for pursuing the license.  In the event that Hospital notifies Company that Hospital has concerns regarding Company’s determination to seek such license, the Steering Committee shall be convened to review the determination. Failing satisfactory resolution from the Steering Committee, the matter shall be discussed between Company’s CEO or Chairman and the Hospital’s Executive Director, Research Ventures and Licensing; provided that, Company’s CEO shall have final decision-making authority with respect to such matter and Company shall not be required to delay obtaining the proposed third party license for more than [***] ([***]) days in total as a result of the foregoing Steering Committee and executive consultation process.

 

(b)                                  With respect to any sublicense granted in the License Field or Limited Field, Company shall pay Hospital [***] percent ([***]%) of any and all Sublicense Income received prior to the third (3 rd ) anniversary of the Effective Date, and [***] percent ([***]%) of any and all Sublicense Income received on or after the third (3 rd ) anniversary of the Effective Date. With respect to any sublicense granted in the Expanded Field, Company shall pay Hospital [***] percent ([***]%) of any and all Sublicense Income. With respect to any sublicense granted solely in the JV Field, Company shall pay Hospital [***] percent ([***]%) of any and

 

 

Initialed by Hospital:

 

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

5



 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 5 TO THE EXCLUSIVE LICENSE AGREEMENT

 

all Sublicense Income; provided, however, that Hospital shall credit any amounts paid by Company to Hospital in accordance with Section 4.6 of this Agreement against any Sublicense Income generated within the JV Field.

 

11.                                Section 4.6 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

4.6                                Liquidity Event Milestone Fee .  Company shall pay Hospital [***] Dollars ($[***]) (the “Liquidity Event Fee”), within [***] ([***]) days following the first to occur of the following:

 

(a)                                  The closing of the first (1 st ) sale by the Company of originally issued securities of the Company on or after [***] 20[***] (an “IPO”); provided that , if the proceeds to the Company from such IPO are less than [***] Dollars ($[***]), Company shall pay [***] percent ([***]%) of such proceeds to Hospital within [***] ([***]) days following such closing, and thereafter on each anniversary of such closing, shall pay to Hospital the lesser of [***] percent ([***]%) of such proceeds or the payment amount that, when combined with prior payments pursuant to this Section 4.6(a), would equal [***] Dollars ($[***]); or

 

(b)                                  [***] 20[***]; or

 

(c)                                   The closing of the first to occur of any of the following transactions (each, a “Change of Control”):

 

(i)                                      a sale, conveyance or other disposition of all or substantially all of the assets of the Company (other than to an Affiliate of Company as part of a reorganization or restructuring); or

 

(ii)                                   a merger or consolidation of Company with or into any other entity, unless the stockholders of Company immediately before the transaction own fifty percent (50%) or more of the voting or capital stock of the acquiring or surviving corporation following the transaction;

 

provided that if the proceeds to the Company of such Change of Control are less than [***] Dollars ($[***]), Company shall pay to Hospital [***] Dollars ($[***]) within [***] ([***]) days following such Change of Control and thereafter shall pay to

 

 

Initialed by Hospital:

 

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

6



 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 5 TO THE EXCLUSIVE LICENSE AGREEMENT

 

Hospital [***] Dollars and [***] Cents ($[***]) on each of the first three (3) anniversaries of such Change of Control.

 

Provided, however , that this Section 4.6 shall terminate upon the full payment of the Liquidity Event Fee.

 

12.                                Section 7 of the Agreement, as amended, is hereby deleted in its entirety and replaced with the following:

 

7.                                       THIRD PARTY INFRINGEMENT AND LEGAL ACTIONS

 

7.1                                Hospital Right to Prosecute .  Hospital will protect the Patent Rights from infringement and prosecute infringers when, in its sole judgment, such action may be reasonably necessary, proper and justified.  If Company shall have supplied Hospital with prima facie infringement of a claim of a Hospital Patent Right in the License Field, the JV Field or the Expanded Field, or of a Media Patent Right in the Limited Field, in the License Territory by a third party which poses a material threat to Company’s rights under this Agreement, Company may by notice request Hospital to take steps to protect such Patent Right.  Hospital shall notify Company within [***] ([***]) days of the receipt of such notice whether Hospital intends to prosecute the alleged infringement.  If Hospital notifies Company that it intends to so prosecute, Hospital shall, within [***] ([***]) months of its notice to Company either (a) cause such infringement to terminate, or (b) initiate legal proceedings against the infringer.

 

7.2                                Company Right to Prosecute .  In the event Hospital notifies Company that Hospital does not intend to prosecute infringement identified under Section 7.1, Company may, upon notice to Hospital, initiate legal proceedings against the infringer at Company’s expense with respect to a claim of a Hospital Patent Right in the License Field, the JV Field or the Expanded Field, or of a Media Patent Right in the Limited Field, in the License Territory.  Before commencing such action, Company and, as applicable, any Affiliate, shall consult with Hospital, concerning, among other things, Company’s standing to bring suit, the selection of counsel and the jurisdiction for such action and shall consider the views of Hospital regarding the proposed action, including, without limitation with respect to potential effects on the public interest.  Company shall be responsible for all costs, expenses and liabilities in connection with any such action and shall indemnify and hold Hospital and Harvard harmless therefrom, regardless of whether Hospital or Harvard is a party-plaintiff, except for the expense of any independent counsel retained by Hospital in accordance with Section 7.5 below.

 

 

Initialed by Hospital:

 

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

7



 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 5 TO THE EXCLUSIVE LICENSE AGREEMENT

 

7.3                                Hospital and/or Harvard Joined as Party-Plaintiff .  If Company elects to commence an action as described in Section 7.2 above, Hospital and/or Harvard shall have, in its sole discretion, the option to join such action as a party-plaintiff. If joinder of Hospital and/or Harvard as a party-plaintiff is necessary or desirable in order for Company to bring or maintain such action or to prove damages in such action, and Company requests that Hospital and/or Harvard be joined, Hospital and/or Harvard may either, in its sole discretion, permit itself to be joined as a party-plaintiff at the sole expense of Company, or assign to Company all of Hospital’s and/or Harvard’s right, title and interest in and to the Patent Right which is the subject of such action (subject to all of Hospital’s and/or Harvard’s obligations to the government under law and any other rights that others may have in such Patent Right).  If Hospital and/or Harvard makes such an assignment, such action by Company shall thereafter be brought or continued without Hospital and/or Harvard as a party; provided, however, that Hospital and/or Harvard shall continue to have all rights of prosecution and maintenance with respect to Patent Rights and Company shall continue to meet all of its obligations under this Agreement as if the assigned Patent Right were still licensed to Company hereunder.

 

7.4                                Notice of Actions; Settlement .  Company shall promptly inform Hospital of any action or suit relating to Patent Rights and shall not enter into any settlement, consent judgment or other voluntary final disposition of any action relating to Patent Rights, including but not limited to appeals, without the prior written consent of Hospital and/or Harvard, as applicable.

 

7.5                                Cooperation .  Each Party agrees to cooperate reasonably in any action under Section 7 which is controlled by the other Party, provided that the controlling Party reimburses the cooperating Party for any costs and expenses incurred by the cooperating Party in connection with providing such assistance, except for the expense of any independent counsel retained by the cooperating Party in accordance with this Section 7.5.  Such controlling Party shall keep the cooperating Party informed of the progress of such proceedings and shall make its counsel available to the cooperating Party.  The cooperating Party shall also be entitled to independent counsel in such proceedings but at its own expense, said expense to be offset against any damages received by the Party bringing suit in accordance with Section 7.6.

 

7.6                                Recovery .  Any award paid by third parties as the result of such proceedings (whether by way of settlement or otherwise) shall first be applied to

 

 

Initialed by Hospital:

 

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

8



 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 5 TO THE EXCLUSIVE LICENSE AGREEMENT

 

reimbursement of any legal fees and expenses incurred by either Party and then the remainder shall be divided between the Parties as follows:

 

(i)                                      Company shall receive an amount equal to its lost profits or a reasonable royalty on the infringing sales, or whichever measure of damages the court shall have applied; and

 

(ii)                                   Hospital shall receive an amount equal to the royalties and other amounts that Company would have paid to Hospital if Company had Sold the infringing Products and Services rather than the infringer; and

 

(iii)                                the balance, if any, remaining after Company and Hospital have been compensated under Section 7.6(a) shall be shall be shared [***] percent ([***]%) to the controlling party and [***] percent ([***]%) to the cooperating party.

 

13.                                Section 10.6 of the Agreement, as amended, is hereby deleted in its entirety and replaced by the following:

 

10.6                         Termination by Company .  Company shall have the right to terminate this Agreement in its entirety by giving ninety (90) days advance written notice to Hospital and upon such termination shall immediately cease all use and Sales of Products and Processes, subject to Section 10.9.  Company shall also have the right to terminate its license hereunder with respect to the Hospital Patent Rights in the License Field, the JV Field or the Expanded Field, or the Media Patent Rights, but in no event all four, by giving ninety (90) days advance written notice to Hospital and upon such termination shall immediately cease all use and Sales of Products and Processes using the Hospital Patent Rights in the License Field, the JV Field or the Expanded Field, or the Media Patent Rights, as applicable, subject to Section 10.9.  Following such a termination: (a) with respect to the Hospital Patent Rights in the License Field only, Section 3.1(a), and to the extent not already achieved or paid, Sections 4.3(a), 4.3(b), 4.4(a) and 4.4(b) shall no longer have any force or effect; (b) with respect to the Hospital Patent Rights in the Expanded Field only, Section 3.1(b), and to the extent not already achieved or paid, Sections 4.3(d), and 4.4(l) shall no longer have any force or effect; (c) with respect to the Hospital Patent Rights in the JV Field only, Section 3.1(e), and to the extent not already achieved or paid, Section 4.4(m); (d) with respect to the Media Patent Rights only, Section 3.1(c), and to the extent not already achieved or paid, Sections 4.3(c), 4.4(c) and 4.4(d) shall no longer have any force or effect;

 

 

Initialed by Hospital:

 

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

9



 

CONFIDENTIAL TREATMENT REQUESTED

AMENDMENT NO. 5 TO THE EXCLUSIVE LICENSE AGREEMENT

 

and (e) except as expressly provided in this Section 10.6, this Agreement shall remain in full force and effect.

 

14.                                Except as expressly modified by this Amendment, all terms and conditions of the Agreement remain in full force and effect.

 

15.                                This Amendment can be executed by the parties hereto by facsimile and in counterparts, each of which is deemed an original and both of which taken together constitutes one agreement binding upon the parties hereto.

 

16.                                The validity, interpretation and performance of this Amendment is controlled by and construed under the laws of the Commonwealth of Massachusetts, without giving effect to the principles of conflicts of law thereof.

 

In witness whereof, the parties hereto enter into this Amendment as of the date of the last signature below.

 

OvaScience, Inc.

 

The General Hospital Corporation,

 

 

d/b/a Massachusetts General Hospital

 

 

 

 

 

 

/s/ Michelle Dipp

 

/s/ Irene Abrams

By:

Michelle Dipp, M.D., Ph.D.

 

By:

Irene Abrams

 

Chief Executive Officer

 

 

Executive Director

 

 

 

Research Ventures & Licensing

 

 

 

December 18, 2013

 

December 18, 2013

Date

 

Date

 

 

Initialed by Hospital:

 

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

10




Exhibit 10.24

GRAPHIC

 

January 9, 2014

 

PERSONAL AND CONFIDENTIAL

 

Alison Lawton

39 Robinson Road

Lexington, MA 02420

 

RE:                           Separation Agreement

 

Dear Alison:

 

The purpose of this letter agreement (the “Agreement”) is to set forth the terms regarding your separation of employment from OvaScience, Inc. (the “Company”).  As more fully set forth below, the Company desires to provide you with separation benefits in exchange for certain agreements by you.  This Agreement shall become effective on the eighth (8 th ) day following your acceptance of it (the “Effective Date”) as described below.

 

1.                                       Separation Date.   You acknowledge that your employment with the Company shall terminate effective on January 9, 2014 (the “Separation Date”).  You acknowledge that from and after the Separation Date, you shall not have any authority and shall not represent yourself as an employee or agent of the Company.  The Company will provide you with all wages owed through the Separation Date, including accrued but unused vacation time.  The Company further agrees to pay all normal and reasonable business expenses that you have incurred in the ordinary course of business through the Separation Date.  Receipts for any outstanding business expenses shall be submitted within ten (10) days of the date hereof.

 

2.                                       Consideration.   In exchange for the mutual covenants set forth in this Agreement, the Company agrees to provide you with the following:

 

(a)                                  Continued payment, for a period of nine (9) months, of your gross bi-weekly base salary of $13,461.54, less all applicable federal, state, local and other legally required or authorized deductions (the “Separation Pay”); provided that , you acknowledge and agree that the total amount of Separation Pay that you shall be eligible to receive under this Agreement shall be $262,500.03.  The Separation Pay shall be paid in accordance with the Company’s normal payroll practices, with the first such payment being made on the Company’s first payroll date following the Effective Date.  Provided that you are otherwise in compliance with the terms of this Agreement, if you die before the entire Separation Pay is paid, the balance will be paid to your spouse, if he is not alive at the time to your estate.

 

(b)                                  By law, and regardless of whether you sign this Agreement, you will have the right to continue your medical and dental insurance pursuant to the provisions of the Consolidated Omnibus Budget Reconciliation Act of 1985 (“COBRA”).  The COBRA qualifying event shall be deemed to have occurred on the Separation Date. Upon completion of the appropriate COBRA forms and your execution of this Agreement, and subject to all the requirements of COBRA, you will be allowed to continue participation in the Company’s health

 



 

and dental insurance plans at the Company’s expense (except for your co-pay or your portion of premium payments, if any, which shall be deducted from your Separation Pay to the same extent that such deductions are made for persons currently employed by the Company), until October 9, 2014 (the “Separation Benefits”).  All other benefits shall cease as of the Separation Date.  Notwithstanding any other provision of this Agreement, this obligation shall cease on the date you become eligible to receive health insurance benefits through any other employer, and you agree to provide the Company with written notice immediately upon securing such employment and upon becoming eligible for such benefits.

 

(c)                                   In addition to the provision of Separation Pay and Separation Benefits, the Company agrees to instruct its current executive officers, as such term is defined in Rule 16a-1(f) promulgated under the Securities and Exchange Act of 1934, not to make any statements, written or oral, that disparage you.

 

3.                                       Equity .

 

(a)                                  Pursuant to the terms of your Incentive Stock Option Agreement Granted Under 2012 Stock Incentive Plan, the form of which is attached hereto, the terms of such Agreement, including without limitation Section 4 — Company Right of First Refusal (the “ROFR”), Section 5 — Agreement in Connection with Initial Public Offering (the “IPO Lockup”) and Section 7 — Transfer Restrictions, shall continue to apply to the First Option (defined below) as hereinafter amended (the “First Option Agreement”) and the terms of the Company’s 2012 Stock Incentive Plan (the “Plan”), provided however, that the Company agrees to make a limited waiver of the ROFR and IPO Lockup, upon your written request, to permit your sale of up to 15,000 shares per month from shares issued upon exercise of the Accelerated Vested Option (defined below), but only during the six month period ending on the date twelve months after the Separation Date. On March 7, 2013 you were granted an option (the “First Option”) to purchase 368,892 shares of the Company’s Common Stock (the “Shares”).  As of the Separation Date, no Shares subject to the First Option have vested (the “Vested Shares”) and all of the 368,892 Shares subject to the First Option are unvested (the “Unvested Shares”).  You acknowledge and agree that, upon the Separation Date, 276,669 of the Unvested Shares subject to the Option shall be terminated and you shall have no right(s) to exercise the Option with respect to any portion of such Unvested Shares and the remaining 92,223 shares shall be deemed to vest accordance with the terms set forth in Section 3(b) of this Agreement.

 

(b)                                  As additional consideration for your covenants and obligations hereunder, the Company will accelerate the vesting on 92,223 of the Unvested Shares subject to the First Option Agreement (which otherwise would have vested on January 21, 2014), such that 92,223 Unvested Shares subject to the First Option Agreement will be vested and exercisable by you as of the Effective Date (the “Accelerated Vested Option”), and such acceleration has been approved by the Compensation Committee, acting for the Board of Directors.  You and the Company further agree that the accelerated vesting of the Accelerated Vested Option shall result in a conversion of the option from an incentive stock option taxable in accordance with Section 422 of the Internal Revenue Code of 1986 (as amended) (the “Code”) to a non-qualified stock option taxable in accordance with Section 83(a) of the Code if exercised more than three months after your termination of employment or at earlier if you exercise the Accelerated Vested Option

 

2



 

through the use of the net exercise provision discussed below and upon such exercise you will be required to provide the Company with all minimum applicable federal, state, local and other legally required tax withholdings prior to the Company’s issuance to you of any Shares upon exercise of the Accelerated Vested Option.  You further acknowledge and agree that (i) the Company does not guarantee or make any representations regarding the tax consequences or tax treatment of the Accelerated Vested Option upon exercise or sale of the underlying shares and (ii) the Accelerated Vested Option shall terminate in accordance with the Plan and Section 3 of the First Option Agreement, subject to clause (c) below.

 

(c)                                   As further consideration for your covenants and obligations hereunder, (i) Section 3(c) of the First Option Agreement shall be amended such that the right to exercise the Accelerated Vested Option shall terminate twelve months after the Separation Date instead of three months after the Separation Date and (ii) the Compensation Committee, acting for the Board of Directors, has approved your ability to pay for the exercise of the Accelerated Vested Option by “net exercise” as set forth in Section 5(f)(4) of the Plan.

 

(d)                                  Pursuant to the terms of your Incentive Stock Option Agreement dated June 7, 2013, as hereinafter amended (the “Second Option Agreement”) and the terms of Plan, you were granted an option (the “Second Option”) to purchase 100,300 Shares.  As of the Separation Date, no Shares subject to the Second Option have vested and all of the Shares subject to the Second Option are unvested.  You acknowledge and agree that, upon the Separation Date, all 100,300 of the Shares subject to the Second Option shall be terminated and you shall have no right(s) to exercise the Second Option.

 

(e)                                   You acknowledge and agree that if you breach any term of this Agreement or the terms of the “Non-Competition Agreement” (as defined below) or the Non-Disclosure Agreement (as defined below), then the Accelerated Vested Option (to the extent unexercised) shall be immediately terminated and forfeited to the Company in accordance with the terms of Section 3(c) of the First Option Agreement and the Plan.

 

(f)                                    Except for the First Option Agreement and the Second Option Agreement, you represent and agree that (i) you do not own any other common stock, stock options, or other equity interest in the Company, (ii) you have no right to acquire any stock options, common stock, equity or other interest in the Company other than the Accelerated Vested Option, and (iii) you shall not have any right to vest in any equity interests of the Company or any stock options under any Company equity, stock and/or stock option plan or program (of whatever name or kind) that you may have participated in or were eligible to participate in during your employment with the Company other than the Accelerated Vested Option.

 

(g)                              All references in this Agreement to Shares are subject to appropriate adjustments for stock splits, stock dividends, reverse stock splits, and similar recapitalizations following the Effective Date.

 

4.                                       No Amounts Owing.   You acknowledge and agree that the Separation Pay and Separation Benefits provided for in this Agreement are not otherwise due or owing to you under any Company employment agreement (oral or written) or Company policy or practice, and that

 

3



 

the Separation Pay and Separation Benefits to be provided to you are not intended to, and shall not constitute, a severance plan, and shall confer no benefit on anyone other than the parties hereto.  You further acknowledge and agree that, except for the specific financial consideration set forth in this Agreement and wages due and owing through the Separation Date, you have been paid and provided all wages, commissions, bonuses, vacation pay, holiday pay and any other form of compensation that may be due to you now or which would have become due in the future in connection with your employment with or separation of employment from Company.  For the avoidance of doubt, you specifically acknowledge and agree that you are not eligible or otherwise entitled to receive, and shall not receive, a bonus for the year ended December 31, 2013 and you specifically waive any right or rights to any such bonus under any Company bonus or incentive compensation plan, policy, or agreement, including, without limitation, claims under the Employment Agreement (defined below).

 

5.                                       Cooperation.   You agree that both during and at any time after your employment, you shall cooperate fully with the Company in connection with any matter or event relating to your employment or events that occurred during your employment, including, without limitation, in the defense or prosecution of any claims or actions now in existence or which may be brought or threatened in the future against or on behalf of the Company, including any claims or actions against its affiliates and its and their officers and employees.  Your cooperation in connection with such matters, actions and claims shall include, without limitation, being available, upon reasonable notice to meet with the Company regarding matters in which you have been involved, and any contract matters or audits; to prepare for, attend and participate in any proceeding (including, without limitation, depositions, consultation, discovery or trial); to provide affidavits; to assist with any audit, inspection, proceeding or other inquiry; and to act as a witness in connection with any litigation or other legal proceeding affecting the Company.  In addition, you agree to make yourself reasonably available to speak to Company representatives in connection with any questions or issues that arise related to the transition of your duties or responsibilities.  You further agree that should you be contacted (directly or indirectly) by any person or entity (for example, by any party representing an individual or entity) adverse to the Company, you shall promptly notify Chris Lindblom at the Company.  Chris can be reached at (617) 299-7342.  The Company agrees to make its requests reasonable and to reimburse you for any reasonable expenses incurred by you in connection with your cooperation under this Section 5.

 

6.                                       Confidentiality; Non-Disparagement; Related Covenants.   You hereby acknowledge and agree:

 

(a)                                  that, by no later than the Separation Date, you shall return to the Company all Company documents and property (and any copies, duplicates, or replicas thereof), and that you will abide by any and all common law and/or statutory obligations relating to protection and non-disclosure of the Company’s trade secrets and/or confidential and proprietary documents and information;

 

(b)                                  that, in the event that you receive an order, subpoena, request, or demand for disclosure of the Company’s trade secrets and/or confidential and proprietary documents and information from any court or governmental agency, or from a party to any litigation or

 

4



 

administrative proceeding, you shall as soon as reasonably possible and prior to disclosure notify the Company of same, in order to provide the Company with the opportunity to assert its respective interests in addressing or opposing such order, subpoena, request, or demand;

 

(c)                                   that all information relating in any way to the negotiation of this Agreement, including the terms and amount of financial consideration provided for in this Agreement, shall be held confidential by you and shall not be publicized or disclosed to any person (other than an immediate family member, legal counsel or financial advisor, provided that any such individual to whom disclosure is made agrees to be bound by these confidentiality obligations), business entity, taxing authorities or government agency (except as mandated by state or federal law);

 

(d)                                  that, in exchange for the payments and benefits to be provided to you pursuant to Section 2 of this Agreement, you agree to (i) execute the Non-Competition and Non-Solicitation Agreement attached hereto as Exhibit A (the “Non-Compete Agreement”) and the Invention and Non-Disclosure Agreement attached hereto as Exhibit B (the “Non-Disclosure Agreement”); (ii) you shall honor and abide by the terms of the Non-Competition Agreement and the Non-Disclosure Agreement, which shall survive the termination of your employment with the Company; and (iii) you will abide by any and all common law and/or statutory obligations relating to protection and non-disclosure of the Company’s trade secrets and/or confidential and proprietary documents and information;

 

(e)                                   that you will not make any statements that are disparaging about, or adverse to, the interests or business of the Company (including its officers, directors, employees, direct or indirect shareholders, agents and representatives) including, without limitation, any statements that disparage any person, product, service, finances, financial condition, capability or any other aspect of the business of the Company (including its officers, directors, employees, direct or indirect shareholders, agents and representatives); and

 

(f)                                    that if the Company in good faith determines that you have materially breached any of the foregoing covenants, it shall be relieved of any further obligations hereunder and, in addition to any other legal or equitable remedy available to the Company, shall entitle the Company to recover the Separation Pay, Separation Benefits and the Accelerated Vested Option (to the extent then unexercised) previously provided to you.

 

7.                                       Release of Claims.   You hereby agree that by signing this Agreement and accepting the Separation Pay, Separation Benefits, Accelerated Vested Option and other good and valuable consideration provided for in this Agreement, you are waiving and releasing your right to assert any form of legal claim against the Company(1) whatsoever for any alleged action, inaction or circumstance existing or arising from the beginning of time through the Effective Date.  Your waiver and release herein is intended to bar any form of legal claim, charge, complaint or any other form of action (jointly referred to as “Claims”) against the Company seeking any form of relief including, without limitation, equitable relief (whether declaratory, injunctive or otherwise), the recovery of any damages or any other form of monetary recovery whatsoever

 


(1)                                  For the purposes of this Section 7, the parties agree that the term “Company” shall include OvaScience, Inc., its divisions, affiliates, parents and subsidiaries, and any of its and their respective officers, directors, shareholders, employees, consultants, contractors, attorneys, agents and assigns.

 

5



 

(including, without limitation, back pay, front pay, compensatory damages, emotional distress damages, punitive damages, attorneys’ fees and any other costs) against the Company, for any alleged action, inaction or circumstance existing or arising through the Effective Date.

 

Without limiting the foregoing general waiver and release, you specifically waive and release the Company from any Claim arising from or related to your employment relationship with the Company or the termination thereof, including, without limitation:

 

·                   Claims under any state or federal statute, regulation or executive order  (as amended through the Effective Date) relating to employment,  discrimination, fair employment practices, or other terms and conditions of employment, including but not limited to the Age Discrimination in Employment Act and Older Workers Benefit Protection Act ( 29 U.S.C. § 621 et seq. ), the Civil Rights Acts of 1866 and 1871 and Title VII of the Civil Rights Act of 1964 and the Civil Rights Act of 1991 ( 42 U.S.C. § 2000e et seq. ), the Equal Pay Act ( 29 U.S.C. § 201 et seq. ), the Americans With Disabilities Act ( 42 U.S.C. § 12101 et seq. ), the Massachusetts Fair Employment Practices Statute ( M.G.L. c. 151B § 1 et seq. ), the Massachusetts Equal Rights Act ( M.G.L. c. 93 §102 ), the Massachusetts Civil Rights Act ( M.G.L. c. 12 §§ 11H & 11I ), the Massachusetts Privacy Statute ( M.G.L. c. 214 § 1B ), the Massachusetts Sexual Harassment Statute ( M.G.L. c. 214 § 1C ), and any similar Massachusetts or other state or federal statute.

 

·                   Claims under any Massachusetts (or any other state) or federal statute, regulation or executive order (as amended through the Effective Date) relating to leaves of absence, layoffs or reductions-in-force, wages, hours, or other terms and conditions of employment, including but not limited to the National Labor Relations Act ( 29 U.S.C. § 151 et seq. ), the Family and Medical Leave Act ( 29 U.S.C. §2601 et seq. ), the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. § 1000 et seq. ), COBRA ( 29 U.S.C. § 1161 et seq. ), the Worker Adjustment and Retraining Notification Act ( 29 U.S.C. § 2101 et seq. ) the Massachusetts Wage Act ( M.G.L. c. 149 § 148 et. seq.) , the Massachusetts Minimum Fair Wages Act ( M.G.L. c. 151 § 1 et. seq. ), the Massachusetts Equal Pay Act ( M.G.L. c. 149 § 105A ), and any similar Massachusetts or other state or federal statute.  Please note that this section specifically includes a waiver and release of Claims that you have or may have regarding payments or amounts covered by the Massachusetts Wage Act or the Massachusetts Minimum Fair Wages Act (including, for instance, hourly wages, salary, overtime, minimum wages, commissions, vacation pay, holiday pay, sick leave pay, dismissal pay, bonus pay or severance pay), as well as Claims for retaliation under the Massachusetts Wage Act or the Massachusetts Minimum Fair Wages Act.

 

·                   Claims under any state or federal common law theory, including, without limitation, wrongful discharge, breach of express or implied contract, promissory estoppel, unjust enrichment, breach of a covenant of good faith and fair dealing, violation of public policy, defamation, interference with contractual relations, intentional or negligent infliction of emotional distress, invasion of privacy, misrepresentation, deceit, fraud or negligence or any claim to attorneys’ fees under any applicable statute or common law theory of recovery.

 

6



 

·                   Claims under any state or federal statute, regulation or executive order (as amended through the Effective Date) relating to whistleblower protections, violation of public policy, or any other form of retaliation or wrongful termination, including but not limited to the Sarbanes-Oxley Act of 2002 and any similar Massachusetts or other state or federal statute.

 

·                   Claims under any Company compensation, benefit, stock option, incentive compensation, bonus, restricted stock, and/or equity plan, program, policy, practice or agreement, including, without limitation the Second Option Agreement, the Unvested Shares under the First Option Agreement, the Plan, and the employment letter agreement between you and the Company dated December 19, 2012 (the “Employment Agreement”) but not including the Accelerated Vested Option.

 

·                   Any other Claim arising under any other state or federal law.

 

You explicitly acknowledge that because you are over forty (40) years of age, you have specific rights under the ADEA, which prohibits discrimination on the basis of age, and that the releases set forth in this Section 7 are intended to release any right that you may have to file a claim against the Company alleging discrimination on the basis of age.

 

Notwithstanding the foregoing, this Section 7 does not:

 

·                                         release the Company from any obligation expressly set forth in this Agreement or from any obligation, including without limitation obligations under the Workers Compensation laws, which as a matter of law cannot be released;

 

·                                         prohibit you from filing a charge with the Equal Employment Opportunity Commission (“EEOC”);

 

·                                         prohibit you from participating in an investigation or proceeding by the EEOC or any comparable state or local agency;

 

·                                         release or waive any claims that may arise after the Separation Date ;

 

·                                         prohibit you from challenging or seeking a determination in good faith of the validity of this release or waiver under the ADEA and does not impose any condition precedent, penalty, or costs for doing so unless specifically authorized by federal law.

 

·                                         release or waive claims to vested benefits;

 

·                                         release or waive your rights to indemnification and defense that exist at the time you execute this Agreement; and/or

 

·                                         release your claim to unemployment compensation which the Company will not contest; provided that, the Company shall not be required to falsify any

 

7



 

information that it provides to the Massachusetts Department of Unemployment Assistance related to your application for unemployment benefits.

 

Your waiver and release, however, are intended to be a complete bar to any recovery or personal benefit by or to you with respect to any claim whatsoever, including those raised through a charge with the EEOC, except those which, as a matter of law, cannot be released.

 

You acknowledge and agree that, but for providing this waiver and release, you would not be receiving the Separation Pay, Separation Benefits and the Accelerated Vested Option being provided to you under the terms of this Agreement.  You further agree that should you breach this Section 7, the Company, in addition to any other legal or equitable remedy available to the Company, shall be entitled to recover the Separation Pay, the Accelerated Vested Option and cost of Separation Benefits provided to you pursuant to Section 2 of this Agreement.

 

8.                                       ADEA Review and Revocation Period.   It is the Company’s desire and intent to make certain that you fully understand the provisions and effects of this Agreement.  To that end, you have been encouraged and given the opportunity to consult with legal counsel for the purpose of reviewing the terms of this Agreement.  The Company also is providing you with twenty-one (21) days in which to consider and accept the terms of this Agreement (the “Review Period”) by signing below and returning it to Ileen Winick, Human Resources, OvaScience, Inc., 215 First Street, Cambridge, MA  02142.  You agree that any modifications, material or otherwise, made to this Agreement do not and will not restart or affect in any manner whatsoever, the original twenty-one day Review Period.  In addition, you may rescind your assent to this Agreement within seven (7) days after you sign it (the “Revocation Period”).  To do so, you must deliver a notice of rescission to Ileen.  To be effective, such rescission must be hand delivered or postmarked within the Revocation Period and sent by certified mail, return receipt requested, to Ileen at the address above.

 

9.                                       Taxation Both you and the Company intend this Agreement to be in compliance with Section 409A of the Internal Revenue Code of 1986 (as amended).  You acknowledge and agree, however, that the Company does not guarantee the tax treatment or tax consequences associated with any payment or benefit arising under this Agreement, including, without limitation, to consequences related to Code Section 409A.  In the event any payments or benefits are deemed by the IRS to be non-compliant, this Agreement, at your option, shall be modified to the extent practicable, so as to make it compliant by altering the payments or benefits, or the timing of their receipt, provided that no such modification shall increase the Company’s obligations hereunder.

 

10.                                Voluntary Agreement.   By executing this Agreement, you are acknowledging that you have been afforded sufficient time to understand the terms and effects of this Agreement, that your agreements and obligations hereunder are made voluntarily, knowingly and without duress, and that neither the Company nor its agents or representatives have made any representations inconsistent with the provisions of this Agreement.

 

11.                                Entire Agreement; Modifications; Choice of Law and Venue; Jury Waiver.   You acknowledge and agree that with the exception of the Non-Competition Agreement, Non-Disclosure Agreement, the First Option Agreement, which all shall remain in full force, except as modified herein and effect according to their terms, this Agreement supersedes any and all

 

8



 

prior oral and/or written agreements and sets forth the entire agreement between you and Company.  For the avoidance of doubt, you specifically acknowledge and agree that this Agreement supersedes the Employment Agreement, which is hereby terminated and no longer of any force or effect.  No variations or modifications hereof shall be deemed valid unless reduced to writing and signed by the parties hereto.  This Agreement shall take effect as an instrument under seal and shall be governed by and construed in accordance with the laws of Massachusetts, without giving effect to conflict of law principles.  You agree that any action, demand, claim or counterclaim relating to the terms and provisions of this Agreement, or to its formation or breach, shall be commenced in the Commonwealth of Massachusetts in a court of competent jurisdiction, and you further acknowledge that venue for such actions shall lie exclusively in Massachusetts and that material witnesses and documents would be located in Massachusetts.  Both parties hereby waive and renounce in advance any right to a trial by jury in connection with such legal action.

 

12.                                Severability.   The provisions of this Agreement are severable, and if for any reason any part hereof shall be found to be unenforceable, the remaining provisions shall be enforced in full; provided that, if any provision of Section 7 of this Agreement is or are held unenforceable by any court of law, and you proceed with any Claim (within the scope of Section 7 above) against the Company (including the Company’s divisions, affiliates, parents and subsidiaries, and its and their respective officers, directors, employees, attorneys, agents and assigns) then you agree to return all money paid to you under Section 2 hereof, and the Company shall be relieved from any further obligation to provide you with any further Separation Pay, Separation Benefits, the Accelerated Option or any other form of consideration or compensation described in this Agreement.

 

This Agreement may be signed on one or more copies, each of which when signed will be deemed to be an original, and all of which together will constitute one and the same Agreement.

 

[Signature Page Follows]

 

9



 

If the foregoing correctly sets forth our understanding, please sign, date and return the enclosed copy of this Agreement to me within twenty-one (21) days of the date of this letter.

 

 

Very truly yours,

 

 

 

OvaScience, Inc.

 

 

 

 

 

By:

 

Its:

 

 

Confirmed and Agreed:

 

 

 

 

 

Alison Lawton

 

 

 

Dated:

 

 

 




Exhibit 10.34

 

CONFIDENTIAL TREATMENT REQUESTED

 

EXECUTION COPY

 

INTELLECTUAL PROPERTY LICENSE AGREEMENT

 

This INTELLECTUAL PROPERTY LICENSE AGREEMENT (this “ Agreement ”) is entered into as of December 18, 2013 (the “ Effective Date ”), by and between OvaXon, LLC , a limited liability company organized under the laws of the State of Delaware and having offices at 215 First Street, Suite 240, Cambridge, MA 02142 (hereinafter, “ OvaXon ” or “ Licensee ”) and OvaScience, Inc. , a Delaware corporation having offices at 215 First Street, Suite 240, Cambridge, MA 02142 (“ OvaScience ”).

 

Capitalized terms used in this Agreement and not otherwise defined shall have the meanings given such terms in Article 1 below.

 

RECITALS

 

A.                                     OvaScience Controls certain technology and intellectual property relating to egg precursor cells (“ EPCs ”) and their use.

 

B.                                     By separate agreements, OvaScience and Intrexon Corporation, a Virginia corporation (“ Intrexon ”) have established Licensee as a jointly-owned limited liability company which will develop and commercialize Licensed Processes and Licensed Products in the Field using in part certain intellectual property and technology licensed from Intrexon.

 

D.                                     OvaScience desires to grant Licensee a license or sublicense, as the case may be, subject to the terms and conditions contained herein, under the Licensed Patent Rights and the Licensed Know-How to develop and commercialize Licensed Processes and Licensed Products in the Field.

 

E.                                      OvaXon desires to obtain such a license subject to the terms and conditions hereinafter set forth.

 

NOW, THEREFORE , in consideration of the foregoing and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties agree as follows:

 

ARTICLE 1.  DEFINITIONS

 

When used in this Agreement, the following capitalized terms shall have the meanings set forth below.  The singular shall be interpreted as including the plural and vice versa, unless the context clearly indicates otherwise.

 

“Affiliate” shall mean, with respect to a particular party, any other person or entity that directly or indirectly controls, is controlled by, or is in common control with such party.  As used in this definition, the term “controls” (with correlative meanings for the terms “controlled by” and “under common control with”) means the ownership, directly or indirectly, of fifty percent (50%) or more of the voting securities or other ownership interest of an entity, or the possession, directly or indirectly, of the power to direct the management or policies of an entity, whether

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 



 

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through the ownership of voting securities, by contract, or otherwise.  For purposes of this Agreement, (a) a corporation or other entity shall no longer be an Affiliate of a party when through loss, divestment, dilution or other reduction of ownership, the requisite control no longer exists and (b) neither OvaXon nor OvaScience shall be deemed to be an Affiliate of the other.

 

Control ” or “ Controlled ” shall mean, with respect to any intellectual property right or other intangible property, the possession by Ovascience or an Affiliate of the ability to grant access to, or a license or sublicense of, such rights or property, or to otherwise disclose proprietary or trade secret information, without breaching the terms of any agreement with a third party, infringing upon the intellectual property rights of a third party, misappropriating the proprietary or trade secret information of a third party and without violating any applicable laws or regulations.

 

“Field of Use” or “Field” shall mean (i) genetic modification of the nuclear genome of human EPC cells for the prevention of inheritable disease in humans or animals; (ii) mitochondrial transfer for the treatment of human or companion animal genetic defects or mutations of mitochondrial or nuclear DNA, in which the mitochondria may be genetically modified or non-genetically modified, and autologous or allogeneic; or (iii) artificial reproduction of food and/or research animals using EPCs, in which the EPCs may be genetically modified or non-genetically modified.  Notwithstanding the foregoing, parts (i)-(iii) shall not include any human fertility product, and specifically excludes: (a) AUGMENT in humans or animals; (b) non-GM OvaTure for use in humans; and (c)  in vivo use of non-GM EPCs in humans.  For the purposes of this definition, “GM” shall mean genetically modified, “mtDNA” shall mean mitochondrial DNA, “OvaTure” shall mean the ex vivo differentiation of EPCs into mature, fertilizable oocytes, and “AUGMENT” shall mean the autologous germline mitochondrial energy transfer in vitro fertilization protocol developed by OvaScience and which is the subject of, and at least partially described by, U.S. Patent Application [***].

 

“Intrexon Collaboration Agreement” shall mean the “Exclusive Channel Collaboration Agreement” executed by and between OvaScience and Intrexon on even date herewith, under which OvaScience obtained certain exclusive license rights under and to intellectual property Controlled by Intrexon relevant to the Field.

 

“Intrexon Know-How” shall mean any Know-How licensed to OvaScience under the Intrexon Collaboration Agreement for use in the Field.

 

“Intrexon Patent Rights” shall mean any United States, foreign, international, or regional patents and patent applications licensed to OvaScience under the Intrexon Collaboration Agreement for use in the Field.

 

Know-How ” shall mean inventions, discoveries, trade secrets, improvements, and technical information, whether or not patented or patentable, together with all data, formulas, procedures and results.

 

Licensed Know-How ” shall mean the OvaScience Know-How, the MGH Know-How, and the Intrexon Know-How.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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“Licensed Patent Rights” shall mean the OvaScience Patent Rights, the MGH Patent Rights, and the Intrexon Patent Rights.

 

“Licensed Process” shall mean any process or method (a) the performance, development, or use of which would constitute, but for the licenses granted to Licensee pursuant to this Agreement, an infringement of a Valid Claim within the Licensed Patent Rights and/or (b) the performance, development, or use of which relies upon or utilizes any of the Licensed Know-How.

 

“Licensed Products” shall mean any material, composition, or other product (a) the performance, making, manufacture, use or sale of which would constitute, but for the licenses granted to Licensee pursuant to this Agreement, an infringement of a Valid Claim within the Licensed Patent Rights and/or (b) the performance, development, making, manufacture, or use of which relies upon or utilizes any of the Licensed Know-How.

 

“Licensed Technology” shall mean all Licensed Patent Rights and Licensed Know-How that relate to the Field.

 

“MGH Know-How” shall mean any Know-How licensed to OvaScience under the MGH License.

 

“MGH License” shall mean the “Exclusive License Agreement” executed by and between OvaScience and The General Hospital Corporation on June 27, 2011, as amended on September 7, 2011, July 30, 2013, September 9, 2013 and November 14, 2013, and as may subsequently be amended.

 

“MGH Patent Rights” shall mean any United States, foreign, international, or regional patents and patent applications licensed to OvaScience under the MGH License.

 

“OvaScience Know-How” shall mean any Know-How Controlled by OvaScience on the Effective Date and/or during the Term which (a) pertains to the subject matter of the OvaScience Patent Rights and (b) is reasonably necessary and useful in the development, manufacture or use of, a Licensed Product or Licensed Process for use in the Field, but specifically excluding the Intrexon Know-How and the MGH Know-How.

 

“OvaScience Patent Rights” shall mean any Patents that are Controlled by OvaScience during the Term that (a) contain one or more Valid Claims that cover the development, manufacture or use of a Licensed Product or Licensed Process for use in the Field and (b) are reasonably necessary and useful in the development, manufacture or use of a Licensed Product or Licensed Process for use in the Field, but specifically excluding the Intrexon Patent Rights and the MGH Patent Rights.  For purposes of clarity, OvaScience Patent Rights as of the Effective Date are listed on Appendix A attached hereto and incorporated herein by reference..

 

Patents ” means (a) all patents and patent applications (including provisional applications), (b) any substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations, requests for continued examination, confirmations, re-examinations,

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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extensions, supplementary protection certificates and the like of the foregoing, and (c) any foreign or international equivalents of any of the foregoing.

 

“Term” shall mean the term of this Agreement, which shall commence on the Effective Date and shall continue in each country, unless terminated in accordance with the provisions of Article 10 .

 

“Territory” shall mean worldwide.

 

“Valid Claim” shall mean a claim of (a) an issued patent which has not expired and which has not been held invalid or unenforceable by decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed with the time allowed for appeal having expired, and which has not been admitted to be invalid through reissue, reexamination, or disclaimer or otherwise or (b) a pending patent application, which claim has not been abandoned or finally disallowed without the possibility of appeal.

 

ARTICLE 2.  GRANT; REPORTS; EXCLUSIVITY; REPRESENTATIONS AND WARRANTIES

 

2.1                                In consideration for the payment of the sum of One Hundred Dollars ($100.00), OvaScience hereby grants, subject to Section 2.5 of this Agreement, to Licensee, for the Term of this Agreement, a fully paid-up, exclusive right and license or sublicense (with respect to any Licensed Technology licensed by Intrexon to OvaScience under the Intrexon Collaboration Agreement) during the Term, including the right to grant sublicenses solely as provided in Section 2.4, under the Licensed Technology to make, have made, use, research, develop, have developed, import, offer for sale and sell the Licensed Products and/or the Licensed Processes in the Territory for use in the Field.  Licensee shall not utilize the Licensed Technology for any purpose other than that encompassed by the license granted in this Agreement.

 

2.2                                To provide Licensee with exclusivity with regard to the license granted in Section 2.1 , OvaScience hereby agrees, subject to the reservations and conditions contained in this Agreement, that OvaScience shall not grant any other license during the Term of this Agreement to utilize the Licensed Technology in the Field in the Territory.

 

2.3                                Licensee hereby agrees during the Term that it shall not conduct any activity that applies, either on its own, through an Affiliate or with, for the benefit of, or sponsored by, any third party, or grants any license or other rights to any third party to utilize, any of the Licensed Know-How or Licensed Patents in the research, development or commercialization of any product or service outside the Field or for use in human fertility.

 

2.4                                Subject to the remaining provisions of this Agreement, Licensee shall have the right to enter into sublicense agreements to the extent of the license granted hereunder with respect to the use of Licensed Technology within the Territory and in the Field of Use provided that Licensee is not in default of its obligations hereunder.  All sublicenses granted by Licensee hereunder shall be subject to this Agreement in all respects.  Each such sublicense agreement shall:

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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a.                                       include or have attached copies of Articles 2 (Grant), 4 (Infringement), 5 (Indemnification; Insurance; and Limitation of Liability), 6 (Export Controls), 7 (Confidentiality and Non-Use of Names), 8 (Assignment), and 9 (Dispute Resolution) of this Agreement, and shall provide that the obligations of Licensee to OvaScience contained in such Articles shall be binding upon the sublicensee as if it were a party to this Agreement;

 

b.                                       prohibit further sublicensing by the approved sublicensee unless such further sublicensing is approved in writing by Licensee; and

 

c.                                        contain a provision stating that OvaScience shall be an intended third-party beneficiary of such sublicense agreement;

 

further, a copy of each sublicense will be provided to OvaScience within thirty (30) days of the effective date of each such sublicense.  Upon any termination of this Agreement, each sublicensee’s rights under any sublicense agreement shall also terminate, subject to Section 10.4 hereof.  No sublicense shall relieve Licensee of any of its obligations under this Agreement.  Licensee shall forward to OvaScience a complete copy of all amendments and addenda to each sublicense agreement granted hereunder within thirty (30) days after execution of such amendment, or addenda by the parties thereto.

 

2.5                                                                                Licensee acknowledges and agrees that this Agreement is at all times subject to the terms and conditions of the MGH License in connection with Licensee’s practice of the license to the MGH Know-How and MGH Patent Rights granted to Licensee pursuant to Section 2.1; provided, however, that OvaScience shall be solely responsible for the payment of any and all consideration (including all milestone, royalty and other payments) that may become due and payable on and after the Effective Date under the MGH License in connection therewith (each, an “MGH License Payment”).  Within [***] days after the end of each calendar quarter in which an event occurs that would obligate OvaScience to make an MGH License Payment, including a sale of any Licensed Product or Licensed Process by the Licensee, Licensee shall provide to OvaScience a report showing: (a) the Net Sales (as defined in the MGH License) of each Licensed Product or Licensed Process by country; (b) the total amount of deductions from gross sales to determine Net Sales; (c) the applicable royalty rates for such Licensed Product or Licensed Process in each country after applying any deductions set forth above; (d) a calculation of the amount of payment due under the MGH License; and (e) any other information and/or reports required to be provided by OvaScience under the MGH License as a result of the sales of Licensed Products or Licensed Process. OvaScience shall have the right, upon reasonable notice, to inspect and audit Licensee’s books and records during normal business hours to confirm the accuracy of all reports provided by Licensee as contemplated by the foregoing sentence.  If OvaScience provides notice under the prior sentence less than one (1) year from its last inspection and/or audit hereunder, OvaScience must provide written basis in such notice for a reasonable belief held by OvaScience that Licensee is in material non-compliance with the reporting requirements of this Section 2.5.

 

2.6                                OvaScience shall have no obligation to provide Licensee with technical information concerning the Licensed Technology nor to provide technical assistance in the development or commercialization of Licensed Products and/or Licensed Processes.  In the event

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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that Licensee requires technical assistance with respect to the activities conducted by Licensee pursuant to this Agreement, obtaining such technical assistance shall be the sole responsibility of Licensee at its sole expense.

 

2.7                                Each party makes the following representations and warranties to the other party as of the Effective Date:

 

2.7.1                      It is an entity duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver and perform this Agreement.

 

2.7.2                      The execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action and will not violate (a) such party’s certificate of incorporation or bylaws (or equivalent charter or organizational documents), (b) any agreement, instrument or contractual obligation to which such party is bound in any material respect, (c) any requirement of any applicable laws, or (d) any order, writ, judgment, injunction, decree, determination or award of any court or governmental agency presently in effect applicable to such party.

 

2.7.3                      This Agreement is a legal, valid and binding obligation of such party enforceable against it in accordance with its terms and conditions.

 

2.8                                Ovascience makes the following representations and warranties to Licensee as of the Effective Date:

 

a.                                       Ovascience is not a party to any agreement or commitment that would prevent it from granting the rights granted or intended to be granted to Licensee under this Agreement, or from performing its obligations under this Agreement.

 

ARTICLE 3.  PATENT PROSECUTION

 

3.1                                Licensee shall have the right, but not the obligation, at its sole expense, to apply for, seek issuance of, and maintain patents for inventions created by or on behalf of Licensee during the Term of this Agreement, including inventions that may be conceived of, reduced to practice, or otherwise developed or invented through the use of the Licensed Technology.  The parties hereby agree to cooperate with each other in connection with the filing, prosecution and maintenance of such Patents under this Agreement, including through the prompt execution and delivery of documents and instruments as may reasonably be required in connection therewith.  Without limiting the foregoing, Licensee shall (i) promptly provide OvaScience with copies of all patent applications filed hereunder with respect to Patents and other material submissions and correspondence with applicable patent offices, in sufficient time to allow for review and comment by OvaScience; (ii) provide OvaScience and its patent counsel with an opportunity to consult with Licensee and its patent counsel regarding the filing and contents of any such application, amendment, submission or response; and (iii) take into consideration in good faith the advice and suggestions of OvaScience and its patent counsel in connection with such filings.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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3.2                                Licensee and its sublicensees shall mark all products covered by Licensed Patent Rights with patent numbers in accordance with the statutory requirements in the countries of manufacture, use, and sale, and pending the issue of any patents, Licensee and its sublicensees shall stamp the products, “Patent Pending,” or the foreign equivalent as appropriate.

 

ARTICLE 4.  INFRINGEMENT

 

4.1                                Each party shall promptly inform the other in writing of any alleged infringement of the Licensed Patent Rights by a third party and of any available evidence thereof.

 

4.2                                Subject to the rights of MGH under the MGH License as set forth on Schedule 4.2, Licensee shall have the first right, but shall not be obligated, to prosecute at its own expense all material infringements in the Field of the Licensed Patent Rights and, in furtherance of such right, OvaScience hereby agrees that Licensee may include OvaScience as a party plaintiff in any such suit. The total cost of any such infringement action commenced or defended solely by Licensee shall be borne by Licensee, and Licensee shall keep any recovery or damages for past infringement derived therefrom to the extent such is limited to infringement within the Field.

 

4.3                                OvaScience shall, in its reasonable discretion, determine whether pursuing remedies against the alleged infringer is warranted or justified or shall be reasonably likely to mitigate the alleged infringement, and shall advise Licensee of its determination in this regard.

 

4.4                                If within [***] months after having been notified of an alleged infringement, (i) Licensee and/or OvaScience shall have been unsuccessful in persuading the alleged infringer to desist, or (ii) OvaScience shall have failed to advise Licensee, in accordance with Section 4.3 , regarding its determination whether to pursue remedies against the alleged infringer, or (iii) OvaScience shall have brought an infringement action against the alleged infringer but is not diligently prosecuting such infringement action, or (iv) if OvaScience shall have determined that pursuing remedies against the alleged infringer is warranted or justified but Licensee shall at any time thereafter notify OvaScience of its intention not to bring or to continue suit against any alleged infringer in the Territory for the Field, then, and in those events only, Licensee shall have the right, but shall not be obligated, to prosecute at its own expense any infringement of the Licensed Patent Rights in the Field in the Territory, and Licensee may, for such purposes, include OvaScience as a party plaintiff in any such suit, without expense to OvaScience.

 

4.5                                No settlement, consent judgment or other voluntary final disposition of any suit under this Article 4 may be entered into without the consent of OvaScience, which consent shall not unreasonably be withheld, conditioned, or delayed.

 

4.6                                Any recovery of damages by Licensee for each such suit under this Article 4 shall be applied first in satisfaction of any unreimbursed expenses and legal fees of Licensee and OvaScience relating to such suit.  The balance remaining from any such recovery shall be divided between Licensee and OvaScience in proportion to the amount of such recovery relating to infringement in the Field (which shall go to Licensee) and the amount of such recovery relating to infringement outside the Field (which shall go to OvaScience).  Licensee and OvaScience agree to make any payments required to one another under this Section 4.6 within

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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[***] days of recovery of any damages.  Any dispute between OvaScience and Licensee regarding the proportions of any recovery due to any party shall be resolved by arbitration in accord with Article 9.

 

4.7                                In any infringement suit that either party may institute to enforce the Licensed Patent Rights pursuant to this Agreement, the other party hereto shall, at the request and expense of the party initiating such suit, cooperate in all respects and, to the extent possible, have its employees and agents testify when requested and make available relevant records, papers, information, samples, specimens, and the like.

 

4.8                                During the Term of this Agreement, and only when Licensee is not in default of its obligations hereunder, Licensee shall have the sole right in accordance with the terms and conditions of this Agreement to sublicense any alleged infringer in the Territory for the Field of Use for prior and future use of the Licensed Patent Rights, subject to the provisions of Section 2.3 and Section 4.5 .

 

ARTICLE 5.  INDEMNIFICATION; INSURANCE; AND LIMITATION OF LIABILITY

 

5.1                                Licensee shall at all times during the Term of this Agreement and thereafter, indemnify, defend and hold OvaScience, and its respective trustees, directors, officers, employees and Affiliates, harmless against all claims, proceedings, demands and liabilities of any kind whatsoever, including legal expenses and reasonable attorneys’ fees, including any claims arising out of the death of or injury to any person or persons or out of any damage to property, resulting from the development, production, manufacture, sale, use, lease, consumption or advertisement of the Licensed Product(s) and/or Licensed Process(es) or arising from any obligation or act of Licensee hereunder, including any breach of this Agreement by Licensee or any of its Affiliates, sublicensees or agents.

 

5.2                                Licensee shall obtain and carry in full force and effect commercial, general liability insurance which shall protect Licensee and OvaScience with respect to events covered by Section 5.1 above.  Without limiting the foregoing, not later than [***] days before the date on which Licensee or any Affiliate or sublicensee of Licensee shall, on a commercial basis, make, use, or sell any Licensed Products or Licensed Processes , and at all times thereafter until the expiration of all applicable statutes of limitation pertaining to any such manufacture, marketing, possession, use, sale of other disposition of any Licensed Products or Licensed Processes, Licensee will, at its expense, obtain and maintain in full force and effect, comprehensive general liability insurance, including product liability insurance and clinical trial insurance in such amounts as each such party customarily maintains with respect to the marketing, manufacture and sale of its other products.  Such insurance shall be written by a reputable insurance company, shall list OvaScience as an additional named insured thereunder, shall be endorsed to include product liability coverage and shall require [***] days written notice to be given to OvaScience prior to any cancellation or material change thereof.  The limits of such insurance shall not be less than the amount considered reasonable in the relevant industry for a similarly situated company.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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5.3                                EXCEPT IN THE CASE OF A BREACH BY EITHER PARTY OF ARTICLE 2 OR ARTICLE 5 OF THIS AGREEMENT, OR IN THE EVENT OF A PARTY’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, IN NO EVENT SHALL SUCH PARTY OR ITS RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES OR AFFILIATES BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING, WITHOUT LIMITATION, ECONOMIC DAMAGE, INJURY TO PROPERTY OR LOST PROFITS, REGARDLESS OF WHETHER THAT PARTY SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW, OF THE POSSIBILITY OF ANY OF THE FOREGOING.

 

ARTICLE 6.  EXPORT CONTROLS

 

6.1                                Licensee acknowledges that it is subject to United States laws and regulations controlling the export of technical data, computer software, laboratory prototypes and other commodities (including the Arms Export Control Act, as amended, and the United States Department of Commerce Export Administration Regulations).  The transfer of such items may require a license from the cognizant agency of the United States Government and/or written assurances by Licensee that Licensee shall not export data or commodities to certain foreign countries without prior approval of such agency.  OvaScience neither represents that a license shall not be required nor that, if required, it shall be issued.

 

ARTICLE 7.  CONFIDENTIALITY AND NON-USE OF NAMES

 

7.1                                The Licensed Technology, any improvements thereof, including any pending patent applications under the Licensed Patent Rights, and any reports and other information exchanged hereunder (hereinafter referred to as “ Confidential Information ”) shall be deemed confidential.  Licensee and its sublicensees, employees, agents and contractors, on the one hand (“ Licensee Parties ”), and OvaScience and its employees, agents, contractors on the other hand (“ OvaScience Parties ”), shall maintain in confidence all such Confidential Information furnished to the Licensee Parties or the OvaScience Parties, by the other party in connection with this Agreement.  Neither Licensee Parties nor OvaScience Parties shall use such Confidential Information for any purpose except in connection with the exercise of its rights hereunder, nor shall Licensee Parties or OvaScience Parties disclose the Confidential Information of the other party without the prior written approval of such party.  Only those Licensee Parties, OvaScience Parties, their respective Affiliates or third parties who are subject to preexisting, written obligations of confidentiality to Licensee or OvaScience, as the case may be, shall receive access to, such Confidential Information.  Each of Licensee and OvaScience shall inform (and Licensee shall require its sublicensees to inform) all of its Affiliates, employees, agents and contractors who are assigned to perform duties involving the use or exploitation of any Confidential Information of the confidentiality obligations created by this Agreement and to obtain their written agreement to be bound by such confidentiality obligations prior to disclosing to such Affiliates, employees, agents and contractors any Confidential Information.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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7.2                                Notwithstanding any provision contained in this Agreement, neither party shall be required to maintain in confidence any of the following information:

 

a.                                       information which, when disclosed to or obtained or learned by the receiving party, is generally known in the field of endeavor;

 

b.                                       information which, after disclosure to the receiving party, is generally known in the field of endeavor, except by breach of this Agreement;

 

c.                                        information which was lawfully in the receiving party’s possession (as reflected in its written records) at the time of disclosure by the disclosing party, and which was not acquired, directly or indirectly, from the disclosing party;

 

d.                                       information which the disclosing party can demonstrate by written documents is the result of its own research and development independent of disclosures hereunder;

 

e.                                        information which the receiving party receives from third parties, provided such information was not obtained by such third parties from the disclosing party on a confidential basis;

 

f.                                         information which the receiving party is required to disclose by law or pursuant to the order of a court or other tribunal of competent jurisdiction, provided the receiving party gives the disclosing party written notice of such order prior to the disclosure thereof and gives the disclosing party an opportunity to seek a protective order from such court or tribunal.  The provisions of this Section 7.2(f)  shall not relieve either party of its obligations of confidentially with regard to Confidential Information in all other respects and circumstances.

 

7.3                                Licensee shall not use the names or trademarks of OvaScience, nor any adaptation thereof, nor the names of any of its employees, in any advertising, promotional or sales literature without prior written consent obtained from OvaScience, or said employee, in each case, except that Licensee may state that it is licensed by OvaScience under one or more of the patents and/or applications comprising the Licensed Patent Rights.

 

ARTICLE 8.  ASSIGNMENT

 

8.1                                This Agreement is not assignable by Licensee without the prior written consent of OvaScience (which shall not be unreasonably withheld) and any attempt to do so, in whole or in part, shall be void.  Notwithstanding the foregoing, Licensee may assign this Agreement to a third party that acquires the Licensee by merger, consolidation, share exchanges, or by acquiring substantially all of Licensee’s assets to which this Agreement relates.

 

ARTICLE 9.  DISPUTE RESOLUTION

 

9.1                                Disputes .  It is the objective of the parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation.  In the event of any disputes, controversies or

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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differences which may arise between the Parties out of or in relation to or in connection with this Agreement including, without limitation, any alleged failure to perform, or breach, of this Agreement, or any issue relating to the interpretation or application of this Agreement, then upon the request of either party by written notice, the parties agree to meet and discuss in good faith a possible resolution thereof, which good faith efforts shall include at least one in-person meeting between the executive officers of each Party.  If the matter is not resolved within [***] days following the written request for discussions, either Party may then invoke the provisions of Section 9.2.

 

9.2                                Arbitration .  Any dispute, controversy, difference or claim which may arise between the parties out of or in relation to or in connection with this Agreement (including, without limitation, arising out of or relating to the validity, construction, interpretation, enforceability, breach, performance, application or termination of this Agreement) shall be settled by binding “baseball arbitration” as follows.  Either party, following the end of the [***] day period referenced in Section 9.1, may refer such issue to arbitration by submitting a written notice of such request to the other party, with the arbitration to be held in the state where the other party’s principal office is located (or some other place as may be mutually agreed by the parties).  Promptly following receipt of such notice, the parties shall meet and discuss in good faith and seek to agree on an arbitrator to resolve the issue, which arbitrator shall be neutral and independent of both parties and all of their respective Affiliates, shall have significant experience and expertise in licensing and partnering agreements in the pharmaceutical and biotechnology industries, and shall have some experience in mediating or arbitrating issues relating to such agreements.  If the parties cannot agree on a single arbitrator within [***] days of request by a party for arbitration, then each Party shall select an arbitrator meeting the foregoing criteria and the two (2) arbitrators so selected shall select within [***] days of their appointment a third arbitrator meeting the foregoing criteria.  Within [***] days after an arbitrator(s) is selected (in the case of the three-person panel, when the third arbitrator is selected), each Party will deliver to both the arbitrator(s) and the other party a detailed written proposal setting forth its proposed terms for the resolution for the matter at issue (the “ Proposed Terms ” of the party) and a memorandum (the “ Support Memorandum ”) in support thereof.  The parties will also provide the arbitrator(s) a copy of this Agreement, as it may be amended at such time.  Within [***] days after receipt of the other party’s Proposed Terms and Support Memorandum, each party may submit to the arbitrator(s) (with a copy to the other party) a response to the other party’s Support Memorandum.  Neither party may have any other communications (either written or oral) with the arbitrator(s) other than for the sole purpose of engaging the arbitrator or as expressly permitted in this Section 9.2; provided that, the arbitrator(s) may convene a hearing if the arbitrator(s) so chooses to ask questions of the parties and hear oral argument and discussion regarding each party’s Proposed Terms.  Within [***] days after the arbitrator’s appointment, the arbitrator(s) will select one of the two Proposed Terms (without modification) provided by the parties that he or she believes is most consistent with the intention underlying and agreed principles set forth in this Agreement.  The decision of the arbitrator(s) shall be final, binding, and unappealable.  For clarity, the arbitrator(s) must select as the only method to resolve the matter at issue one of the two sets of Proposed Terms, and may not combine elements of both Proposed Terms or award any other relief or take any other action.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

9.3                                Governing Law .  This Agreement shall be governed by and construed under the substantive laws of the State of New York, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction.

 

9.4                                Award .  Any award to be paid by one Party to the other party as determined by the arbitrator(s) as set forth above under Section 9.2 shall be promptly paid in United States dollars free of any tax, deduction or offset; and any costs, fees or taxes incident to enforcing the award shall, to the maximum extent permitted by law, be charged against the losing party.  Each party agrees to abide by the award rendered in any arbitration conducted pursuant to this Article 9, and agrees that, subject to the United States Federal Arbitration Act, 9 U.S.C. §§ 1-16, judgment may be entered upon the final award in any United States District Court located in New York and that other courts may award full faith and credit to such judgment in order to enforce such award.  The award shall include interest from the date of any damages incurred for breach of the Agreement, and from the date of the award until paid in full, at a rate fixed by the arbitrator(s).  With respect to money damages, nothing contained herein shall be construed to permit the arbitrator(s) or any court or any other forum to award consequential, incidental, special, punitive or exemplary damages.  By entering into this agreement to arbitrate, the parties expressly waive any claim for consequential, incidental, special, punitive or exemplary damages.  The only damages recoverable under this Agreement are direct compensatory damages.

 

9.5                                Costs .  Each party shall bear its own legal fees.  The arbitrator(s) shall assess his or her costs, fees and expenses against the party losing the arbitration.

 

9.6                                Injunctive Relief .  Nothing in this Article 9 will preclude either party from seeking equitable relief or interim or provisional relief from a court of competent jurisdiction, including a temporary restraining order, preliminary injunction or other interim equitable relief, concerning a dispute either prior to or during any arbitration if necessary to protect the interests of such party or to preserve the status quo pending the arbitration proceeding.

 

9.7                                Confidentiality .  The arbitration proceeding shall be confidential and the arbitrator(s) shall issue appropriate protective orders to safeguard each party’s Confidential Information.  Except as required by law, no party shall make (or instruct the arbitrator(s) to make) any public announcement with respect to the proceedings or decision of the arbitrator(s) without prior written consent of the other party.  The existence of any dispute submitted to arbitration, and the award, shall be kept in confidence by the parties and the arbitrator(s), except as required in connection with the enforcement of such award or as otherwise required by applicable law.

 

9.8                                Survivability .  Any duty to arbitrate under this Agreement shall remain in effect and be enforceable after termination of this Agreement for any reason.

 

9.9                                Jurisdiction .  For the purposes of this Article 9, the parties acknowledge their diversity and agree to accept the jurisdiction of any United States District Court located in New York for the purposes of enforcing or appealing any awards entered pursuant to this Article 9 and for enforcing the agreements reflected in this Article 9 and agree not to commence any action, suit or proceeding related thereto except in such courts.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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9.10                         Patent Disputes .  Notwithstanding any other provisions of this Article 9, any dispute, controversy or claim relating to the scope, validity, enforceability or infringement of any Patents shall be submitted to a court of competent jurisdiction in the country in which such Patent was filed or granted.

 

9.11                         Non-waiver.   Notwithstanding the foregoing, nothing in this Article 9 shall be construed to waive any rights or timely performance of any obligations existing under this Agreement.

 

ARTICLE 10.  TERMINATION

 

10.1                         Upon any material breach or default of this Agreement by Licensee, OvaScience shall have the right to terminate this Agreement and the rights, privileges and license granted hereunder effective on sixty (60) days’ notice to Licensee.  Such termination shall become automatically effective unless Licensee shall have cured any such material breach or default prior to the expiration of the sixty (60) day period.

 

10.2                         Licensee shall have the right to terminate this Agreement at any time on sixty (60) days’ written notice to OvaScience.

 

10.3                         OvaScience shall have the right to terminate this Agreement immediately on written notice to Licensee if Licensee breaches Section 2.3 of this Agreement and fails to cure such breach within sixty (60) days of Licensee’s receipt of written notice from OvaScience.

 

10.4                         OvaScience shall have the right to terminate this Agreement at any time on sixty (60) days’ written notice to Licensee upon the dissolution of Licensee or if Licensee makes an assignment for the benefit of creditors, appoints or suffers appointment of a receiver or trustee over all or substantially all of its property, files a petition under any bankruptcy or insolvency act or has any such petition filed against it which is not discharged within sixty (60) days of the filing thereof.  Notwithstanding the foregoing, the right of termination under this Section 10.4 shall not apply in the event that a change of control of Licensee (such as if one or more equity owners of Licensee are bought out by one or more of the remaining equity owners of Licensee) is deemed to be a dissolution of Licensee absent any other evidence of an intention to dissolve the entity.

 

10.5                         Upon termination of this Agreement for any reason, nothing in this Agreement shall be construed to release either party from any obligation accrued prior to the effective date of such termination and Articles 2 , 5 , 6 , 7 , 9 , Sections 10.3 , 10.4 , and Article 12 shall survive any such termination.

 

10.6                         Upon termination of this Agreement for any reason, Licensee and any sublicensee thereof shall immediately cease all manufacturing and sales of Licensed Products or Licensed Processes.  Notwithstanding the foregoing, after the effective date of the termination of this Agreement, Licensee and any sublicensee thereof may, with the written consent of OvaScience, sell all Licensed Products in its possession, and complete Licensed Products in the process of manufacture at the time of such termination and sell the same.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

10.7                         Upon termination of this Agreement for any reason, any sublicensee not then in default (which default may be imputed through Affiliates) may request and obtain a direct license from OvaScience for the Licensed Technology on comparable terms hereto.

 

10.8                         For clarity, (i) any dispute arising under this Article 10 regarding whether an alleged material breach is in fact a material breach or regarding whether such alleged or actual material breach has in fact been cured shall be subject to dispute resolution in accordance with Article 9, and (ii) OvaScience shall have no right to terminate this Agreement pursuant to this Article 10, and any relevant cure periods herein shall be stayed, during the period any such dispute is subject to such dispute resolution process.

 

ARTICLE 11.  NOTICES AND OTHER COMMUNICATIONS

 

11.1                         Any notice or other communication pursuant to this Agreement shall be sufficiently made or given on the date of mailing if sent to such party by certified first class mail, return receipt requested, postage prepaid, or reputable delivery courier (such as Federal Express, UPS, DHL, etc.), addressed to it at its address below or as it shall designate by written notice given to the other party:

 

In the case of OvaScience:

 

OvaScience, Inc.

215 First Street, Suite 240

Cambridge, MA  02142

Attn: C.E.O., and/or the C.S.O.

 

In the case of Licensee:

 

OvaXon, LLC

215 First Street, Suite 240

Cambridge, MA  02142

Attn: C.E.O., and/or Program Manager

 

ARTICLE 12.  MISCELLANEOUS PROVISIONS

 

12.1                         Notwithstanding the provisions of Article 8 above, in the event that, pursuant to the United States Bankruptcy Code (11 USC§101 et seq.) or any amendment or successor thereto (hereinafter referred to as the “Bankruptcy Code”), a trustee in bankruptcy of Licensee (the “Trustee”), or Licensee as debtor in possession (the “Debtor”), is permitted to assume this Agreement and does so and, thereafter, desires to assign this Agreement to a third party, which assignment satisfies the requirements of the Bankruptcy Code, the Trustee, or the Debtor, as the case may be, will notify OvaScience of same in writing (hereinafter referred to as the “Notice”), specifying the consideration to be paid by the assignee and the other terms of the proposed assignment.  The giving of the Notice will be deemed to constitute the grant of an option to OvaScience to have this Agreement assigned to it or to its designee for such consideration, or its equivalent in money, and upon such terms, as are specified in the Notice.  The aforesaid option

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

may be exercised only by written notice given by OvaScience to the Trustee or the Debtor, as the case may be, within [***] days after OvaScience’s receipt of the Notice from such party or such shorter period of time as may be deemed appropriate by the court in the bankruptcy proceeding.  If OvaScience fails to give its notice to such party within the exercise period, such party may complete the assignment referred to in its Notice but only to the entity named in the Notice and upon the terms specified therein.  Nothing contained herein will be deemed to preclude or impair any rights which OvaScience may have as a creditor in any bankruptcy proceeding or any other rights it may have at law, in equity, or by contract.

 

12.2                         Each of the parties expressly acknowledges that, vis-a-vis the other party hereto, it is an independent contractor, and not the agent, employee or representative of the other.  This Agreement shall, by itself, not be deemed to create a partnership, joint venture or principal-and-agent relationship between OvaScience and Licensee.  Except as expressly permitted in this Agreement, neither party shall have the authority to bind the other to any agreement or obligation whatsoever, and neither party shall represent that it has any such right or authority to any third party.

 

12.3                         The parties hereto acknowledge that this Agreement sets forth the entire agreement and understanding of the parties hereto as to the subject matter hereof, and shall not be subject to any change or modification except by the execution of a written instrument signed by the parties.

 

12.4                         The provisions of this Agreement are severable, and in the event that any provision of this Agreement shall be determined to be invalid or unenforceable under any controlling body of the law, such invalidity or unenforceability shall not in any way affect the validity or enforceability of the remaining provisions hereof.

 

12.5                         The failure of either party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other party.

 

12.6                         Upon the request of the other party, each party shall execute and deliver such additional documents and perform such other acts as the other party may reasonably request, as may be necessary to effect the purposes and intent of this Agreement.

 

12.7                         All titles and article headings contained in this Agreement are inserted only as a matter of convenience and reference and do not define, limit, extend, or describe the scope of this Agreement or the intent of any of its provisions.

 

signatures follow

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

IN WITNESS WHEREOF, the parties have duly executed this Agreement on the Effective Date as set forth in the first paragraph above.

 

OVASCIENCE, INC.

 

OVAXON, LLC

 

 

 

 

 

 

 

 

 

 

 

 

By:

/s/ Michelle Dipp

 

By:

/s/ Arthur Tzianabos

 

Name:

Michelle Dipp, M.D., Ph.D.

 

Name:

Arthur Tzianabos

 

Title:

President and Chief Executive

 

Title:

Program Manager

 

 

Officer

 

 

 

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

APPENDIX A

OvaScience Patent Rights

 

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

[***]

 

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 




Exhibit 10.35

 

CONFIDENTIAL TREATMENT REQUESTED

 

EXECUTION COPY

CONFIDENTIAL

 

EXCLUSIVE CHANNEL COLLABORATION AGREEMENT

 

THIS EXCLUSIVE CHANNEL COLLABORATION AGREEMENT (this “ Agreement ”) is made and entered into effective as of December 18, 2013 (the “ Effective Date ”) by and between INTREXON CORPORATION , a Virginia corporation with offices at 20374 Seneca Meadows Parkway, Germantown, MD 20876 (“ Intrexon ”), and OVASCIENCE, INC., a Delaware corporation having a place of business at 215 First Street, Suite 240, Cambridge, MA  02142 (“ OvaScience ”).  Intrexon and OvaScience may be referred to herein individually as a “ Party ”, and collectively as the “ Parties .”

 

RECITALS

 

WHEREAS Intrexon has expertise in and owns or controls proprietary technology relating to the identification, design and production of genetically modified cells and DNA vectors, and the control of peptide expression; and

 

WHEREAS , OvaScience desires to become Intrexon’s exclusive channel collaborator in the Field with respect to such technology for the purpose of developing Collaboration Products (as defined herein) for use in the Field, and Intrexon is willing to appoint OvaScience as an exclusive channel collaborator in the Field (as defined herein, and subject to amendments to the definition as permitted herein) under the terms and conditions of this Agreement.

 

NOW THEREFORE , in consideration of the foregoing and the covenants and promises contained herein, the Parties agree as follows:

 

ARTICLE 1

 

DEFINITIONS

 

As used in this Agreement, the following capitalized terms shall have the following meanings:

 

1.1                                         Affiliate ” means, with respect to a particular Party, any other person or entity that directly or indirectly controls, is controlled by, or is in common control with such Party.  As used in this Section 1.1, the term “controls” (with correlative meanings for the terms “controlled by” and “under common control with”) means the ownership, directly or indirectly, of fifty percent (50%) or more of the voting securities or other ownership interest of an entity, or the possession, directly or indirectly, of the power to direct the management or policies of an entity, whether through the ownership of voting securities, by contract, or otherwise.  Notwithstanding the foregoing, (i) neither Intrexon nor JV shall be deemed to be an Affiliate of one another, (ii) neither OvaScience nor JV shall be deemed to be an Affiliate of one another, and (ii) Third Security shall be deemed not to be an Affiliate of Intrexon.  In addition, any other person, corporation, partnership, or other entity that would be an Affiliate of Intrexon solely because it and Intrexon are under common control by Randal J. Kirk or by investment funds managed by Third Security or an affiliate of Third Security shall also be deemed not to be an Affiliate of Intrexon.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 



 

CONFIDENTIAL TREATMENT REQUESTED

 

1.2                                         Applicable Laws ” has the meaning set forth in Section 8.2(d)(xii).

 

1.3                                         Applicable Percentage ” has the meaning set forth in Section 5.2.

 

1.4                                         Authorizations ” has the meaning set forth in Section 8.2(d)(xii).

 

1.5                                         Channel-Related Program IP ” has the meaning set forth in Section 6.1.

 

1.6                                         Claims ” has the meaning set forth in Section 9.1.

 

1.7                                         COGS Savings ” means the aggregate amount of COGS directly achieved in connection with the use of Intrexon Channel Technology, Intrexon IP, or the Intrexon Materials to manufacture an Improved Product, determined on the date of first use of such Intrexon Channel Technology, Intrexon IP, or the Intrexon Materials in the manufacture of the Improved Product by subtracting the COGS of the Improved Product from the COGS of the Existing Product.  For purposes of such determination, COGS Savings shall not include the amount of COGS saved in connection with the manufacture of an Improved Product that is attributable to any technology, know-how or materials other than the Intrexon Channel Technology, Intrexon IP, and Intrexon Materials and which was identified, implemented, or selected independent of Intrexon.  OvaScience shall provide written documentation to the JSC identifying, and supplying a supporting calculation reasonably evidencing, any savings amount it believes should be excluded from COGS Savings under the prior sentence, and the actual amount of COGS excluded from COGS Savings will be established by the JSC.  For clarity, the mechanism of the previous sentence for establishing the final amount of any exclusion from COGS Savings is not subject to final decision making authority of the JSC or any other Committee, and if mutual agreement of the Parties cannot be reached any dispute will be resolved in accord with Section 11.2 and any calculation by the Parties of COGS Savings under this Agreement shall be applied consistently to both the Existing Product and the Improved Product.  For purposes of clarity, an example showing how the amount of COGS Savings could be determined is attached hereto as Schedule 1 .

 

1.8                                         Collaboration Product ” means any product in the Field, but not in the JV Field, that is created, produced, developed, or identified during the Term in the conduct of the OPC Program through the use or practice of Intrexon Channel Technology, Intrexon IP, or the Intrexon Materials.

 

1.9                                         Combination Product ” means a single Collaboration Product that consists of one or more elements that would individually qualify themselves as a Collaboration Product in combination with one or more therapeutically-active ingredients that themselves would not qualify as a Collaboration Product, which combination is sold in a single package or as a unit at a single price (whether in fixed dosage forms or separate dosage forms).

 

1.10                                  Committees ” has the meaning set forth in Section 2.2(a).

 

1.11                                  Commercialize ” or “ Commercialization ” (including derivative forms, such as “Commercializing”) means any activities directed to the marketing (including detailing to

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

medical professions in efforts to increase prescribing preferences), manufacturing, promoting, distributing, importing for sale, offering to sell and/or selling of Collaboration Products.

 

1.12                                  Commercial Sale ” means for a given Collaboration Product and country in the Territory, the sale for value of that Collaboration Product by OvaScience (or, as the case may be, by an Affiliate or permitted sublicensee of OvaScience), to a Third Party after regulatory approval (if necessary) has been obtained for such Collaboration Product in such country.

 

1.13                                  Complementary In-Licensed Third Party IP ” has the meaning set forth in Section 3.8(a).

 

1.14                                  Confidential Information ” means each Party’s confidential Information, disclosed by such Party to the other Party pursuant to this Agreement or any other confidentiality agreement between the Parties, regardless of whether in oral, written, graphic or electronic form. For purposes of clarity, all tangible embodiments of OvaScience Cell Platform Technology shall be Confidential Information of OvaScience and all tangible embodiments of Intrexon Technology shall be Confidential Information of Intrexon.

 

1.15                                  Control ” means, with respect to any Information, Patent or other intellectual property right, that a Party owns or has a license from a Third Party to such right and has the ability to grant a license or sublicense as provided for in this Agreement under such right without violating the terms of any agreement or other arrangement with any Third Party.

 

1.16                                  Costs of Goods Sold ” or “ COGS ” means all Manufacturing Costs that are directly and reasonably attributable to the manufacture of an Existing Product or an Improved Product, as the case may be, in accordance with US GAAP for commercial sale in the countries where such product has been launched.

 

1.17                                  Diligent Efforts ” means, (a) with respect to the activities of either Party in the conduct of the OPC Program, the efforts and resources comparable to those undertaken by a company in the research-based pharmaceutical industry in pursuing the research and discovery of products that are at a similar stage of development and have similar market potential as the Collaboration Product and (b) with respect to the activities of OvaScience in the development, manufacture or Commercialization of any Collaboration Product the level of efforts and resources reasonably required to diligently develop, manufacture, and/or Commercialize (as applicable) each Collaboration Product, consistent with the efforts and resources a similarly situated company working in the Field would typically devote to a product of similar market potential, profit potential, strategic value and/or proprietary protection, based on market conditions then prevailing.  For purposes of clarity, (a) Diligent Efforts shall be determined on a market-by-market basis for the Collaboration Product, and it is anticipated that the level of effort may be different for different markets and may change over time, reflecting the market(s) involved and (b) it is the expectation of the Parties in determining whether a Party has used Diligent Efforts with respect to a particular task or obligation, that the applicable Party will promptly assign responsibility for such task and consistently make and implement decisions and allocate resources designed to advance progress with respect to such task or obligation.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

1.18                                  Equity Agreement ” has the meaning set forth in Section 5.1.

 

1.19                                  Excess Product Liability Costs ” has the meaning set forth in Section 9.3.

 

1.20                                  Executive Officer ” means: (a) the Chief Executive Officer of a Party, or (b) another senior executive officer of such Party who has been duly appointed by the Chief Executive Officer to act as the representative of the Party to resolve, as the case may be, (i) a Committee dispute, provided that such appointed officer is not a member of the applicable Committee and occupies a position senior to the positions occupied by the applicable Party’s members of the applicable Committee, or (ii) a dispute described in Section 11.1.

 

1.21                                  Existing Product ” means OvaScience’s autologous germ-line mithochondrial energy transfer product candidate described more fully on Schedule 2 attached hereto and incorporated herein by reference .

 

1.22                                  FDA ” has the meaning set forth in Section 8.2(d)(xii).

 

1.23                                  Field ” means the ex vivo differentiation of OPCs into mature, fertilizable oocytes.

 

1.24                                  Field Option ” has the meaning set forth in Section 2.6.

 

1.25                                  Field Infringement ” has the meaning set forth in Section 6.3(b).

 

1.26                                  FTE ” means a number of hours of work set devoted to or in support of the underlying activities with respect to a Collaboration Product that is carried out by one or more employees, contract personnel or consultants of Intrexon as part of the OPC Program, measured in accordance with Intrexon’s customary time allocation practices.

 

1.27                                  “FTE Cost ” means, for any period, the FTE Rate multiplied by the number of FTEs used in such period.

 

1.28                                  “FTE Rate ” means the per annum rate per FTE set for FTEs engaged in the conduct of activities with respect to a Collaboration Product that is carried out by one or more employees, contract personnel or consultants of Intrexon as part of the OPC Program, which rate shall reflect the direct costs for such Intrexon personnel and overheads reasonably allocable to the provision of such activities.  For purposes of clarity, Intrexon shall provide OvaScience with written notice as to the FTE Rate to be used in the conduct of any FTE activities under the OPC Program prior to commencing any such activities.

 

1.29                                  Fully Loaded Cost ” means all out-of-pocket costs and internal costs incurred by Intrexon (or for its account by an Affiliate or a Third Party) after the Effective Date in accordance with US GAAP in undertaking the activities set forth in the Work Plan as part of the OPC Program and that are attributable to the development of the Collaboration Product as: (a) out-of-pocket costs, which means the actual amounts paid to a Third Party for specific external development activities applicable to the Collaboration Product; or (b) internal labor costs, which means the applicable FTE Costs (the FTE Rate multiplied by the number of FTEs utilized in the

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

4



 

CONFIDENTIAL TREATMENT REQUESTED

 

relevant period on activities under the Work Plan as part of the OPC Program) that are attributable to the development of the Collaboration Product, and internal materials costs, which means direct costs for such Intrexon materials and/or capacities consumed and overheads reasonably allocable to the consumption of such materials and/capacities.  Intrexon may, from time to time but not more than once per calendar year, notify the JSC that the applicable FTE Rate will be adjusted based on changes to Intrexon’s actual fully loaded costs.  Intrexon shall provide the JSC with reasonable documentation indicating the basis for any direct and indirect charges, any allocable overhead, and any such adjustment in the FTE Rate, and any further activities under an applicable Work Plan and/or the OPC Program under the adjusted charges and/or rates shall be subject to budget approval by the JSC.

 

1.30                                  Improved Product ” means any non-genetically modified autologous germ-line mithochondrial energy transfer product in the Field, but not the JV Field, that (a) is created, produced or identified, in whole or in part, by or on behalf of OvaScience during the Term in the conduct of the OPC Program using Intrexon Channel Technology, Intrexon IP, or the Intrexon Materials and (b) constitutes a change to the formulation or production process of the Existing Product.

 

1.31                                  IND Due Date ” means the date that is twenty four (24) months after completion of the initial technology transfer from OvaScience to Intrexon in accord with Section 4.9.  The IND Due Date shall be extended automatically on a day-for-day basis to account for any delay that is reasonably determined to be attributable to an OvaScience Delay.

 

1.32                                  IND-Enabling Package ” means the delivery by Intrexon to OvaScience of the laboratory and animal data deliverables described in the Work Plan in a form and amount reasonably necessary to support the successful filing of an IND by OvaScience with the FDA.

 

1.33                                  IND ” means an investigational new drug application filed with the FDA, or alternatively an equivalent regulatory filing filed with a regulatory agency in Europe, for a Collaboration Product.

 

1.34                                  In-Licensed Program IP ” has the meaning set forth in Section 3.9(a).

 

1.35                                  Information ” means information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including without limitation, databases, inventions, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, biological, chemical, biochemical, toxicological and clinical and pre-clinical test data, analytical and quality control data, stability data, studies and procedures, and patent and other legal information or descriptions.

 

1.36                                  Infringement ” has the meaning set forth in Section 6.3(a).

 

1.37                                  Intrexon Channel Technology ” means any technology, including without limitation the technology embodied in the Intrexon Materials and the Intrexon IP, that is (a) Controlled by Intrexon during the Term, (b) used by Intrexon, or provided by Intrexon for use, in the conduct of the OPC Program and (c) directed towards the design, identification, culturing,

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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and/or production of genetically modified cells.  For purposes of clarity, Intrexon’s Channel Technology shall include Intrexon’s proprietary (1) UltraVector® technology (2) LEAP TM  technology, (3) DNA and RNA MOD engineering technology, (4) protein engineering technology, (5) transcription control chemistry technology, (6) genome engineering technology, and (7) cell system engineering technology.

 

1.38                                  Intrexon Indemnitees ” has the meaning set forth in Section 9.2.

 

1.39                                  Intrexon IP ” means, collectively, the Intrexon Patents and Intrexon Know-How.

 

1.40                                  Intrexon Know-How ” means all Information (other than Intrexon Patents) that (a) is Controlled by Intrexon during the Term and (b) is (i) used by Intrexon, or provided by Intrexon for use, in the conduct of the OPC Program and/or (ii) reasonably necessary or useful for OvaScience to conduct the OPC Program.  For the avoidance of doubt, Intrexon Know-How shall include any Information (other than Intrexon Patents) that constitutes Channel-Related Program IP.

 

1.41                                  Intrexon Materials ” means the proprietary apparatuses, software and biomaterials (including genetic code, associated amino acids and gene constructs, and such other proprietary reagents and biological materials including but not limited to plasmid vectors, virus stocks, cells and cell lines, antibodies, and ligand-related chemistry), in each case that are Controlled by Intrexon and used by Intrexon, or provided by Intrexon for use, in the conduct of the OPC Program, regardless of whether such is used and/or provided for use alone or in combination with materials that are not proprietary to Intrexon.

 

1.42                                  Intrexon Patents ” means all Patents that (a) are Controlled by Intrexon as of the Effective Date or during the Term, and (b) contain one or more claims that cover Intrexon Know-How and/or Channel-Related Program IP.  For the avoidance of doubt, the Intrexon Patents shall include any Patent in the Channel-Related Program IP.  Prior to the Effective Date, Intrexon has provided OvaScience with a listing of all Intrexon Patents existing as of that time that are reasonably expected to be material to the OPC Program.

 

1.43                                  Intrexon Trademarks ” means those trademarks related to the Intrexon Channel Technology that are established from time to time during the Term by Intrexon for use across its channel partnerships or collaborations, as may be identified by Intrexon from time to time by written notice to OvaScience.

 

1.44                                  Inventions ” has the meaning set forth in Section 6.1.

 

1.45                                  IPC ” has the meaning set forth in Section 2.2(b).

 

1.46                                  Joint Program Inventions ” has the meaning set forth in Section 6.1.

 

1.47                                  JSC ” has the meaning set forth in Section 2.2(b).

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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1.48                                  JV ” means OvaXon, LLC, a limited liability company formed under the laws of Delaware and having offices at 215 First Street, Suite 240, Cambridge, MA 02142, which limited liability company as of the Effective Date is owned in equal fifty percent (50%) equity shares by Intrexon and OvaScience and was formed for the purpose of pursuing products in the JV Field.

 

1.49                                  JV ECC Agreement ” means the Exclusive Channel Collaboration Agreement by and between Intrexon and JV of even date herewith .

 

1.50                                  JV Field ” means: (i) genetic modification of the nuclear genome of human EPC cells for the prevention of inheritable disease in humans or animals; (ii) mitochondrial transfer for the treatment of human or companion animal genetic defects or mutations of mitochondrial or nuclear DNA, in which the mitochondria may be genetically modified or non-genetically modified, and autologous or allogeneic; or (iii) artificial reproduction of food and/or research animals using EPCs, in which the EPCs may be genetically modified or non-genetically modified. .  Notwithstanding the foregoing, the JV Field shall not include any human fertility product, and specifically excludes: (a) the Existing Product for use in humans or animals; (b) the ex vivo differentiation of OPCs into mature, fertilizable oocytes for use in humans, wherein such OPCs are not genetically modified; and (c) the in vivo use of OPCs in humans, wherein such OPCs are not genetically modified.

 

1.51                                  Losses ” has the meaning set forth in Section 9.1.

 

1.52                                  Manufacturing Costs ” means, with respect to Existing Products or Improved Products, as the case may be, the full-time equivalent costs (determined under a reasonable accounting mechanism to be agreed upon by the Parties) and out-of-pocket costs that OvaScience or any of its Affiliates incur in manufacturing such products, including costs and expenses incurred in connection with (a) the development or validation of any manufacturing process, formulations or delivery systems, or improvements to the foregoing; (b) manufacturing scale-up; (c) in-process testing, stability testing and release testing; (d) quality assurance/quality control development; (e) internal and Third Party costs and expenses incurred in connection with qualification and validation of Third Party contract manufacturers, including scale up, process and equipment validation, and initial manufacturing licenses, approvals and inspections; (f) packaging development and final packaging and labeling; (g) shipping configurations and shipping studies; (h)  direct labor, including management of Third Party manufacturers and suppliers and allocated supervisory costs of non-manufacturing departments (such as quality and regulatory) attributable to the Existing Products or Improved Products in overseeing the conduct of any of the foregoing; (i) an allocation of depreciation of machinery and equipment used in the manufacture of the Existing Products or Improved Products.  “Manufacturing Costs” shall further include: (i) to the extent that any such Existing Product or Improved Product is manufactured by a Third Party manufacturer, the out-of-pocket costs incurred by OvaScience or any of its Affiliates to the Third Party for the manufacture and supply (including packaging and labeling) thereof, and any reasonable out-of-pocket costs and direct labor costs incurred by OvaScience or any of its Affiliates in managing or overseeing the Third Party relationship determined in accordance with the books and records of OvaScience or its Affiliates maintained in accordance with US GAAP; (ii) to the extent that any such Existing Product or Improved

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

Product is manufactured by OvaScience or any of its Affiliates, direct material and direct labor costs attributable to such product, as well as reasonably allocable overhead expenses, determined in accordance with the books and records of OvaScience or its Affiliates maintained in accordance with US GAAP including any manufacturing royalties paid to any Third Party and (iii) any other reasonable and customary out-of-pocket costs borne by OvaScience for the testing, transport, customs clearance, duty, insurance and/or storage of the Existing Products or Improved Products.

 

1.53                                  Milestone Event ” means the first Commercial Sale of a Collaboration Product anywhere in the Territory.

 

1.54                                  Net Sales ” means revenue, as determined in accordance with US GAAP as consistently applied by the Parties, from sales of Collaboration Products.  In the case of any sale for value, such as barter or counter-trade other than in an arm’s length transaction exclusively for cash, Net Sales shall be deemed to be the net sales at which substantially similar quantities of the product are sold for cash in an arm’s length transaction in the relevant country.  For purposes of determining the royalties payable on Combination Products, Net Sales of Collaboration Products shall be calculated by multiplying the Net Sales of the Combination Product by the fraction A/A+B, where A is the average selling price, during the period in question, of all of the collaboration elements (those elements that, if sold separately, would be Collaboration Products) sold separately in the country in which the sale of the Combination Product is made, and B is the average selling price, during the period in question, of all of the other active ingredients and/or components sold separately.  In the event that A or B cannot be determined under the prior sentence, Net Sales for purposes of determining payments under this Agreement shall be calculated by multiplying the Net Sales of the Combination Product by the fraction (C-D/D) where C is the average selling price, during the period in question, of the Combination Product in the country in which the sale of the Combination Product is made, and D is the average selling price, when sold separately during the period in question, of all the active ingredients and/or components that themselves would not be a Collaboration Product if sold separately.  In the event that the average selling price for D in accord with the prior sentence cannot be determined, the Parties shall negotiate in good faith an appropriate commercial value for the components in the Combination Product and calculate Net Sales of such Combination Product accordingly, with the goal of establishing a fair price in accord with the principles of this Section 1.54.

 

1.55                                  OPC ” means a non-embryonic stem cell that is mitotically competent and expresses Vasa, Oct-4, Dazl, Stella, and, optionally a stage-specific embryonic antigen.

 

1.56                                  OPC Program ” has the meaning set forth in Section 2.1(a).

 

1.57                                  OvaScience Delay ” means, if Intrexon fails to supply an IND-Enabling Package by the IND Due Date, the number of days by which Intrexon fails to meet the IND Due Date that are reasonably attributable to any failure of OvaScience, or any of Third Party contractor or vendor engaged in accord with a JSC-approved Work Plan, to conduct any activities under the OPC Program included in the Work Plan in timely manner, or any negligent act or omission of OvaScience, or of any Third Party contractor or vendor engaged in accord with a JSC-approved Work Plan, in the conduct of any activities under the OPC Program.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

1.58                                  OvaScience Cell Platform Technology ” means the proprietary technology Controlled by OvaScience as of the Effective Date (i) relating to OPCs and the therapeutic use of such OPCs in the field of reproductive biology, or (ii) that covers or relates to the development, manufacture, use or sale of the Existing Product.

 

1.59                                  OvaScience Indemnitees ” has the meaning set forth in Section 9.1.

 

1.60                                  OvaScience Independent IP ” has the meaning set forth in Section 6.1.

 

1.61                                  OvaScience Patents ” means all Patents that (i) are Controlled by OvaScience as of the Effective Date or during the Term and (ii) contain one or more claims that cover OvaScience Cell Platform Technology.

 

1.62                                  OvaScience Platform Inventions ” has the meaning set forth in Section 6.1.

 

1.63                                  OvaScience Program Patent ” has the meaning set forth in Section 6.2(b).

 

1.64                                  OvaScience Termination IP ” means any OvaScience Patents and/or OvaScience Cell Platform Technology that OvaScience or any of its Affiliates Controls as of the date of any notice of termination of this Agreement that cover, or is otherwise necessary or useful for, the development, manufacture or commercialization of a Reverted Product.  OvaScience Termination IP does not include OvaScience Independent IP.

 

1.65                                  OvaTure Product ” means any product or process that is used for the ex vivo differentiation of human OPCs into mature, fertilizable oocytes.

 

1.66                                  Patents ” means (a) all patents and patent applications (including provisional applications), (b) any substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations, requests for continued examination, confirmations, re-examinations, extensions, supplementary protection certificates and the like of the foregoing, and (c) any foreign or international equivalents of any of the foregoing.

 

1.67                                  Product-Specific Program Patent ” means any Intrexon Patent where all the claims are directed to Inventions that solely and specifically cover Collaboration Products.  In the event of a disagreement between the Parties as to whether a particular Intrexon Patent is or is not a Product-Specific Program Patent, the Parties shall seek to resolve the issue through discussions at the IPC; provided that, if the Parties are unable to resolve the disagreement, the issue shall be resolved pursuant to Section 6.1(j) and, if not resolved thereunder, according to Article 11.  Any Intrexon Patent that is subject to such a dispute shall be deemed not to be a Product-Specific Program Patent unless and until (a) Intrexon agrees in writing that such Intrexon Patent is a Product-Specific Program Patent or (b) it is resolved pursuant to the prior sentence that such Intrexon Patent is a Product-Specific Program Patent.

 

1.68                                  Product Sublicense ” has the meaning set forth in Section 3.2(c).

 

1.69                                  Product Sublicensee ” has the meaning set forth in Section 3.2(c).

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

1.70                                  Proposed Terms ” has the meaning set forth in Section 11.2.

 

1.71                                  Prosecuting Party ” has the meaning set forth in Section 6.2(c).

 

1.72                                  Recovery ” has the meaning set forth in Section 6.3(f).

 

1.73                                  Retained Product ” has the meaning set forth in Section 10.4(a).

 

1.74                                  Reverted Product ” has the meaning set forth in Section 10.4(c).

 

1.75                                  SEC ” means the United States Securities and Exchange Commission.

 

1.76                                  Superior Therapy ” means a therapy in the Field, but not the JV Field, for a given indication that, based on the data then available, (a) demonstrably appears to offer either superior efficacy or safety or significantly lower cost of therapy, as compared with both (i) those therapies that are marketed (either by OvaScience or others) at such time for the same indication and (ii) those therapies that are being actively developed by OvaScience for such indication (including any pipeline Collaboration Products); (b) demonstrably appears to represent a substantial improvement over such existing therapies; and (c) has intellectual property protection and a regulatory approval pathway that, in each case, would not present a significant barrier to commercial development.

 

1.77                                  Supplemental In-Licensed Third Party IP ” has the meaning set forth in Section 3.9(a).

 

1.78                                  Support Memorandum ” has the meaning set forth in Section 11.2.

 

1.79                                  Technology Access Fee ” for the purposes of this Agreement has the meaning as set forth in Section 5.1.

 

1.80                                  Term ” has the meaning set forth in Section 10.1.

 

1.81                                  Territory ” means the world.

 

1.82                                  “Third Party ” means any individual or entity other than the Parties or their respective Affiliates.

 

1.83                                  Third Security ” means Third Security, LLC.

 

1.84                                  US GAAP ” means generally accepted accounting principles in the United States.

 

1.85                                  Work Plan ” has the meaning set forth in Section 2.1(a).

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

ARTICLE 2

 

SCOPE OF CHANNEL COLLABORATION; MANAGEMENT

 

2.1                                         Scope.

 

(a)                                  Generally .  The general purpose of the channel collaboration described in this Agreement will be to use the Intrexon Channel Technology, Intrexon IP, and/or the Intrexon Materials to research, develop and Commercialize Collaboration Products for use in the Field, but not the JV Field (the “ OPC Program ”).  As provided below, the JSC shall agree upon the services and activities to be included in each research and development project that is part of the OPC Program (each, a “ Project ”) and monitor and govern the Projects under a work plan (“ Work Plan ”).  Either Party may propose other potential Projects in the Field for review and consideration by the JSC and potential incorporation, at the JSC’s discretion, into the current Work Plan as described in Section 2.2 below.

 

2.2                                         Governance and Committees .

 

(a)                                  Generally .  The Parties desire to establish several committees (collectively, “ Committees ”) to oversee the OPC Program and to facilitate communications between the Parties with respect thereto.  Each of such Committees shall have the responsibilities and authority allocated to it in this Article 2.  Each of the Committees shall have the obligation to exercise its authority consistent with the respective purpose for such Committee as stated herein and in the Work Plan and any decisions of the Committees shall be made by the representatives in good faith.

 

(b)                                  Formation and Purpose .  Promptly following the Effective Date, the Parties shall confer and then create a Joint Steering Committee (“ JSC ”) and an Intellectual Property Committee (“ IPC ”).  The JSC shall have authority, subject to Section 2.5 and except as otherwise delegated by this Section 2.2(b) to the IPC, to establish separate Projects for the OPC Program (including separate project plans and budgets, not less than on an annual basis, for such Projects) under the Work Plan, to oversee manufacturing and controls for Collaboration Products, to review and approve all clinical trials and associated regulatory filings and correspondence conducted or made with respect to Collaboration Products under the OPC Program (including reviewing and approving itemized budgets with respect to the foregoing), to establish and approve separate project plans and budgets for commercialization activities for Collaboration Products under the OPC Program and to approve the projects and plans of any subcommittee it establishes consistent with this authority.  The IPC shall have authority, subject to Section 2.5, to evaluate all intellectual property issues and approve associated collaborative activities that may arise in connection with the OPC Program, including the protection of Inventions or Confidential Information, the filing of Patents, the review and approval of agreements with Third Parties that apply to intellectual property rights used in the conduct of the OPC Program (including in licensing of Third Party intellectual property or entering into research agreements that affect intellectual property rights), the establishment or enforcement of controls concerning the dissemination or use of intellectual property (including Intrexon Channel Technology, Intrexon IP, or Intrexon Materials) for the development or manufacturing of

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

Collaboration Products, and reviewing and approving budgets and action items with respect to the foregoing.

 

(c)                                   JSC Adopted Work Plan .  The JSC shall meet and confer as soon as practical after the Effective Date to draft, finalize, and adopt the Work Plan for the OPC Program, such Work Plan to be monitored and, as appropriate, amended and/or updated by the JSC on an ongoing basis during the Term.  The Work Plan shall set forth, among other things, the activities approved by the JSC to be undertaken by Intrexon in support of the OPC Program under Section 4.6.

 

2.3                                         General Committee Membership and Procedure .

 

(a)                                  Membership .  For each Committee, each Party shall designate an equal number of representatives (not to exceed three (3) for each Party) with appropriate expertise to serve as members of such Committee.  For the JSC, the representatives must all be employees of such Party or an Affiliate of such Party, and for Committees other than the JSC, the representatives must all be employees of such Party or an Affiliate of such Party; provided that each Party may designate for each such other Committee up to one (1) representative who is not an employee if : (i) such non-employee representative agrees in writing to be bound to the terms of this Agreement for the treatment and ownership of Confidential Information and Inventions , and (ii) the other Party consents to the designation of such non-employee representative, which consent shall not be unreasonably withheld.  Each representative as qualified above may serve on more than one (1) Committee as appropriate in view of the individual’s expertise.  Each Party may replace its Committee representatives at any time upon prior written notice to the other Party.  Each Committee shall have a chairperson selected from among the duly appointed representatives; the chairperson of each Committee shall serve for a two-year term and the right to designate a chairperson shall alternate between the Parties, with OvaScience selecting the chairperson first for the JSC, and Intrexon selecting the chairperson first for the IPC. The chairperson of each Committee shall be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting of such Committee, and preparing and issuing minutes of each meeting within a reasonable time thereafter. Each member of the Committee shall have the opportunity to provide comments on the draft minutes.  Draft minutes shall be approved, disapproved and revised as soon as practicable.  Upon approval, final minutes of each meeting shall be circulated to the members of the JSC by the chairperson.

 

(b)                                  Meetings .  Each Committee shall hold meetings at such times as it elects to do so, but in no event shall such meetings be held less frequently than once every six (6) months; provided that, both Parties may agree to suspend activities of the IPC until such time as one Party informs the other Party in writing of its desire to reactivate the IPC, at which point the Parties will thereafter schedule and hold the next meeting for the reactivated IPC within one (1) month. Meetings of any Committee may be held in person or by means of telecommunication (telephone, video, or web conferences).  To the extent that a Committee holds any meetings in person, the Parties will alternate in designating the location for such in-person meetings, with OvaScience selecting the first meeting location for each Committee.  A reasonable number of additional representatives of a Party may attend meetings of a Committee in a non-voting capacity so long as such additional non-voting representatives each either (A) are an employee of

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

a Party or an employee an Affiliate of a Party, or (B) are not an employee of either Party (or Affiliates thereof) but prior to attending any such meeting (i) such additional non-voting representative agrees in writing to be bound to the terms of this Agreement for the treatment and ownership of Confidential Information and Inventions (or is bound by law or contractual agreement with such Party consistent with such terms), and (ii) the other Party consents to the attendance of such non-employee additional representative, which consent shall not be unreasonably withheld.  Each Party shall be responsible for all of its own expenses of participating in any Committee.  For clarity, however, if Intrexon employee or agent both (i) serves as a representative on a Committee, and (ii) contributes under the Work Plan by providing labor in the course of Intrexon’s providing of manufacturing or support services under Sections 4.5 and 4.6, Intrexon shall not be prevented from recouping the Fully Loaded Costs otherwise derived from the labor of that employee or agent in the course of providing manufacturing or support services as set forth in Sections 4.5 and 4.6 below to the extent that such Fully Loaded Costs do not include any time such Intrexon representative spent on Committee activities.

 

(c)                                   Meeting Agendas .  Each Party will disclose to the other Party the proposed agenda items along with appropriate information to be discussed at the meeting at least three (3) business days in advance of each meeting of the applicable Committee; provided, that a Party may provide its agenda items to the other Party within a lesser period of time in advance of the meeting, or may propose that there not be a specific agenda for a particular meeting, so long as such other Party consents to such later addition of such agenda items or the absence of a specific agenda for such Committee meeting.

 

(d)                                  Limitations of Committee Powers .  Each Committee shall have only such powers as are specifically delegated to it hereunder or from time to time as agreed to in writing by the mutual consent of the Parties and shall not be a substitute for the rights of the Parties.  Without limiting the generality of the foregoing, no Committee shall have any power to amend this Agreement.  Any amendment to the terms and conditions of this Agreement shall be implemented pursuant to Section 12.7 below.

 

2.4                                         Committee Decision-Making .  If a Committee is unable to reach unanimous consent on a particular matter within thirty (30) days of its initial consideration of such matter, then either Party may provide written notice of such dispute to the Executive Officer of the other Party.  The Executive Officers of each of the Parties will meet at least once in person or by means of telecommunication (telephone, video, or web conferences) as promptly as possible to discuss the dispute and use their good faith efforts to resolve the dispute within thirty (30) days after submission of such dispute to the Executive Officers.  If any such dispute is not resolved by the Executive Officers within thirty (30) days after submission of such dispute to such Executive Officers, then the dispute shall be resolved as specified in the applicable subsection below.

 

(a)                                  Casting Vote at JSC .  If a dispute at the JSC is not resolved pursuant to Section 2.4 above, then the Executive Officer of OvaScience shall have the authority to finally resolve such dispute.

 

(b)                                  Casting Vote IPC .  If a dispute at the IPC is not resolved pursuant to Section 2.4 above, then the Executive Officer of Intrexon shall have the authority to finally

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

resolve such dispute, provided that such authority shall be shared by the Parties with respect to Product-Specific Program Patents (i.e., neither Party shall have the casting vote on such matters, and any such disputes shall be resolved pursuant to Article 11).

 

(c)                                   Other Committees .  If any additional Committee or subcommittee other than those set forth in Section 2.2(b) is formed, then the Parties shall, at the time of such formation, agree on which Party shall have the authority to finally resolve a dispute that is not resolved pursuant to Section 2.4 above.

 

(d)                                  Restrictions . Neither Party shall exercise its right to finally resolve a dispute at a Committee in accordance with this Section 2.4 in a manner that (i) excuses such Party from any of its obligations specifically enumerated under this Agreement; (ii) expands the obligations of the other Party under this Agreement; (iii) negates any consent rights or other rights specifically allocated to the other Party under this Agreement; (iv) purports to resolve any dispute involving the breach or alleged breach of this Agreement; (v) resolves a matter if the provisions of this Agreement specify that mutual agreement is required for such matter; or (vi) would require the other Party to perform any act that is inconsistent with applicable law.

 

2.5                                Authorization of Committee Representatives.   Each representative serving on a Committee shall be responsible for ensuring that he or she acts only as duly authorized by its respective Party and obtains any advance approvals, delegations, or other authorizations from his or her respective Party in advance of making any Committee votes.

 

2.6                                Option to Expand Field .  At any time during the Term, OvaScience, at its sole discretion, may opt to expand the Field as set forth in Section 2.6(a) below (the “ Field Option ”) by sending Intrexon written notice which shall state that OvaScience is executing its option to expand the Field pursuant to this Section 2.6. Immediately upon receipt by Intrexon of such notice and without any further action by either Party under this Agreement, (a) the Field Option will be deemed exercised for purposes of this Agreement, (b) the definition of Field as used in this Agreement will thereafter be deemed to be defined as set forth below in Section 2.6(a), and (c) all rights and obligations of the Parties set forth in this Agreement defined in part by, or with respect to, the Field (including, without limitation, the license rights granted under Section 3.1, the exclusivity obligations imposed by Section 3.5, and the diligence obligations imposed by Section 4.4) will automatically and immediately change such that from the time of such execution forward those rights and obligations will apply to the Field as so-amended.

 

(a)                                  Upon exercise of the Field Option by OvaScience in accord with Section 2.6 above, the language of Section 1.21 of this Agreement will be struck and replaced with the following language :

 

“Field” means, irrespective of whether such requires regulatory approval, (i) the ex vivo differentiation of OPCs into mature, fertilizable oocytes and/or (ii) the application of any discoveries made by the Parties during the Term under the prior clause (i)  relating to the production and purification technologies to the improvement of the Existing Product and to provide enhanced

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

production and purification of autologous and non-genetically modified human mitochondria for therapeutic use in conjunction with human in vitro fertilization procedures.

 

ARTICLE 3

 

LICENSE GRANTS

 

3.1                                         Licenses to OvaScience .

 

(a)                                  Subject to the terms and conditions of this Agreement, Intrexon hereby grants to OvaScience a license under the Intrexon IP (including any rights Intrexon has in Joint Program Inventions), including the right to grant sublicenses as set forth in Section 3.2, to research, develop, use, make, have made, sell, and offer for sale and otherwise Commercialize Collaboration Products in the Field in the Territory.  Such license shall be exclusive (even as to Intrexon) with respect to any development, selling, offering for sale or other Commercialization of Collaboration Products in the Field (and of Improved Products in the Field should the Field Option be exercised by OvaScience), and shall be otherwise non-exclusive.  Notwithstanding the foregoing in this Section 3.1(a), (i) OvaScience acknowledges the grant of rights in the JV Field to JV under the JV ECC Agreement, and (ii) the Parties agree that OvaScience is not granted any rights under this Agreement under the Intrexon IP (including any rights Intrexon has in Joint Program Inventions) in the JV Field to research, develop, use, make, have made, sell, and offer for sale and otherwise Commercialize Collaboration Products in the JV Field in the Territory.

 

(b)                                  Subject to the terms and conditions of this Agreement, Intrexon hereby grants to OvaScience a non-exclusive, royalty-free license to use and display the Intrexon Trademarks, solely in connection with the Commercialization of Collaboration Products and Improved Products in the promotional materials, packaging, and labeling for Collaboration Products and Improved Products, as provided under and in accordance with Section 4.8.

 

3.2                                         Sublicensing .  Except as provided in this Section 3.2, OvaScience shall not sublicense the rights granted under Section 3.1 to any Third Party, or transfer the Intrexon Materials to any Third Party, or otherwise grant any Third Party the right to research, develop, use, or Commercialize Collaboration Products or use or display the Intrexon Trademarks, in each case except with Intrexon’s written consent, which written consent may be withheld in Intrexon’s sole discretion.  Notwithstanding the foregoing, OvaScience (and its Product Sublicensees only to the extent explicitly set forth in Section 3.2(a) below) shall have a right to sublicense the rights granted under Section 3.1 under the circumstances described in Sections 3.2(a) through 3.2(c).

 

(a)                                  OvaScience may transfer, to the extent reasonably necessary and after providing Intrexon with reasonable advance notice thereof, Intrexon Materials that are or express Collaboration Products or components thereof to a Third Party contractor performing contract manufacturing responsibilities for Collaboration Products, and may in connection therewith grant limited sublicenses necessary to enable such Third Party to perform such activities.  If OvaScience transfers any Intrexon Materials under this Section 3.2(a), OvaScience will include in the agreement executed with each such Third Party contractor restrictions on the use and

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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transfer of such Intrexon Materials and Intrexon IP by the Third Party contractor consistent with the restrictions under the provisions of Articles 6 and 7 of this Agreement.  A Product Sublicensee of OvaScience may transfer, to the extent reasonably necessary and upon the consent of Intrexon, which consent shall not be unreasonably withheld, Intrexon Materials that are or express ingredients for the Collaboration Product sublicensed by the Product Sublicensee to a Third Party contractor performing on behalf of that Product Sublicensee contract manufacturing responsibilities for Collaboration Products, and may in connection therewith grant limited sublicenses to the extent necessary to enable such Third Party to perform such activities.  OvaScience will include in the agreement executed with each such Third Party contractor a provision that provides that if any Product Sublicensee transfers any Intrexon Materials under this Section 3.2(a), that such Product Sublicensee, after obtaining Intrexon’s consent, will take commercially reasonable steps, including contractually obligating any such Third Party contractors, to ensure that the rights of Intrexon in and to the Intrexon Materials and Intrexon IP and under the provisions of Articles 6 and 7 of this Agreement are not violated by any Third Party contractors of such Product Sublicensees.

 

(b)                                  OvaScience may, upon written notice to Intrexon, sublicense the rights granted under Section 3.1 to an Affiliate, or transfer the Intrexon Materials to an Affiliate, or grant an Affiliate the right to display the Intrexon Trademarks, such rights to be effective only for so long as such Affiliate remains an Affiliate of OvaScience.  In the event that OvaScience provides such written notice to Intrexon, OvaScience shall remain responsible for the performance by any such Affiliate and shall cause such Affiliate to comply with the provisions of this Agreement in connection with such performance (as though such Affiliate were OvaScience), including any payment obligations owed to Intrexon hereunder.

 

(c)                                   OvaScience may grant a sublicense of the rights granted under Section 3.1 (and not including a right to sublicense under this Section 3.1(c)) to a Third Party licensee of any Collaboration Product that would qualify as a Retained Product under any of the criteria set forth in Section 10.4 (a) (a “ Product Sublicensee ”) to the extent necessary to permit such Third Party to research, develop, use, import, export, make, have made, sell, and offer for sale that Collaboration Product (a “ Product Sublicense ”), provided, that (i) such Product Sublicense is expressly limited to the appropriate Collaboration Product, (ii) such Product Sublicense does not grant the Product Sublicensee any rights to Intrexon IP other than as incorporated into the Collaboration Product at the time of the Product Sublicense, (iii) such Product Sublicense does not purport to relieve OvaScience of any of its obligations under this Agreement, (iv) the Product Sublicensee agrees in writing, in a document in form reasonably acceptable to Intrexon, to abide by the following provisions of this Agreement: Sections 3.1, 3.3-3.6, 3.8, 3.10, and 3.11 and Articles 6, 7, and 10), and (v) the form of Product Sublicense, containing all material terms, is presented to the JSC by OvaScience before execution by OvaScience and the prospective Product Sublicensee for the purpose of allowing the JSC to reasonably review and comment upon the terms and scope of the Product Sublicense agreement before execution; provided, that, such right to review and comment shall not limit OvaScience’s right to enter into any such Product Sublicense to the extent that such Product Sublicense complies with the terms of this Section 3.2(c).  Intrexon shall not unreasonably withhold its consent with regard to any requests by OvaScience to combine multiple Collaboration Products (or a line of such Collaboration Products) into a single combined license with a Product Sublicensee.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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3.3                                         Limitation on Sublicensees .  Except for the rights with regard to Field Infringement set forth in Section 6.3(b) (and subject to the provisions of Sections 6.3(e) and 6.3(f)), none of the enforcement rights under the Intrexon Patents that are granted to OvaScience pursuant to Section 6.3 shall be transferred to, or exercised by, a Product Sublicensee except with Intrexon’s prior written consent, which Intrexon shall not unreasonably withhold.

 

3.4                                         No Non-Permitted Use .  OvaScience hereby covenants that it shall not, nor shall it permit any Affiliate or, if applicable, (sub)licensee, to, use or practice, directly or indirectly, any Intrexon IP, Intrexon Channel Technology, or Intrexon Materials for any purposes other than those expressly permitted by this Agreement.

 

3.5                                         Exclusivity .

 

(a)                                  Neither Intrexon nor its Affiliates shall grant any license or other rights to, or otherwise make available to any Third Party, any technology or Patents Controlled by Intrexon or any of its Affiliates, including the Intrexon Channel Technology or Intrexon Materials, for the purpose of developing or commercializing products in the Field (except as set forth in Section 3.2), and neither Intrexon nor any Affiliate shall pursue or conduct (either by itself or with a Third Party or Affiliate or for the benefit of, or sponsored by any Third Party) the research, development or Commercialization of any product for purpose of commercial use or sale in the Field, outside of the OPC Program. Notwithstanding the foregoing, it shall not be a violation of this Section 3.5(a) (i) for Intrexon to execute the JV ECC Agreement contemporaneously herewith, including granting a license in the in the JV Field to JV thereunder, and/or (ii) for Intrexon to participate in the business operations of JV according to Intrexon’s rights therein as an equity holder, or to collaborate with JV with regard to the research, development, and Commercialization of products in the JV Field.

 

(b)                                  Neither OvaScience nor its Affiliates shall pursue or conduct (either by itself or with a Third Party or Affiliate or for the benefit of, or sponsored by any Third Party) outside of the OPC Program the research, development or Commercialization of any product for purpose of commercial use or sale in the Field where such products would compete with Collaboration Products (and/or Improved Products, to the extent applicable following execution of the Field Option).  Notwithstanding the foregoing sentence, OvaScience may utilize academic and non-profit Third Parties for the pre-clinical and clinical development of any product, including Collaboration Products, to the extent consistent with Articles 6 and 7 of this Agreement.  For the avoidance of doubt, (A) OvaScience may pursue and conduct the development and implementation of manufacturing changes designed to reduce the COGS of the Existing Product outside of the OPC Program (i) prior to execution of the Field Option, and (ii) after execution of the Field Option so long as such pursuit and conduct does not utilize Inventions or Intrexon IP, or otherwise utilize Third Party genetic or cell processing technology in lieu of using Intrexon Channel Technology and (B) it shall not be a violation of any provision of this Section 3.5 for OvaScience to contract with or otherwise employ a Third Party JSC-approved contractor in lieu of Intrexon for activities described in a Work Plan if OvaScience reasonably concludes that (i) Intrexon cannot meet and will materially exceed the IND Due Date, and (ii) pursuing the development with such Third Party will deliver an IND-Enabling Package materially faster than with Intrexon.  Notwithstanding the foregoing, it shall not be a

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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violation of this Section 3.5(b) (i) for OvaScience to license Patents and intellectual property it Controls to JV for use within the JV Field, and/or (ii) for JV to participate in the business operations of JV according to OvaScience’s rights therein as an equity holder or to collaborate with JV with regard to the research, development, and Commercialization of products in the JV Field.

 

3.6                                         Off Label Use .  For purposes of clarity, (a) the use by direct or indirect purchasers or other users of Collaboration Products or Improved Products outside the Field (an “ off label use ”) shall not constitute a breach by OvaScience of the terms of Section 3.4 , provided that neither OvaScience nor its Affiliate (nor any Third Party under contract with either of them) marketed or promoted Collaboration Products or Improved Products for such off-label use; and (b) an “off-label use by any direct or indirect purchasers or other users of products sold by Intrexon, an Intrexon Affiliate, or a Third Party sublicensee, collaborator, or partner of Intrexon shall not constitute a breach by Intrexon of the terms of Section 3.4, provided that neither Intrexon nor its Affiliate (nor any Third Party under contract with either of them) marketed or promoted such products for such off-label use.

 

3.7                                         No Prohibition on Intrexon .  Except as explicitly set forth in Sections 3.1 and 3.4, nothing in this Agreement shall prevent Intrexon from practicing or using the Intrexon Materials, Intrexon Channel Technology, and Intrexon IP for any purpose, and to grant to Third Parties the right to do the same.  Without limiting the generality of the foregoing, OvaScience acknowledges that Intrexon has all rights, in Intrexon’s sole discretion, to make the Intrexon Materials, Intrexon Channel Technology (including any genetic materials used in a Collaboration Product), and Intrexon IP available to Third Party channel partners or collaborators for use in fields outside of the Field.

 

3.8                                         Rights to Clinical and Regulatory Data .  OvaScience shall own and control all clinical and pre-clinical data and regulatory filings relating to Commercialization of Collaboration Products and Improved Products during the Term.  OvaScience shall provide (or shall cause an applicable Product Sublicensee to provide) to Intrexon at Intrexon’s reasonable request and upon OvaScience’s consent (which consent shall not be unreasonably denied, delayed, or conditioned)  copies of all clinical and non-clinical data and reports, regulatory filings, and communications from regulatory authorities that relate specifically and solely to Intrexon IP that is included in Collaboration Products.  To the extent that there exist any clinical and non-clinical data and reports, regulatory filings, and communications from regulatory authorities owned by OvaScience (or a Product Sublicensee) that relate to Intrexon IP, OvaScience shall provide (or shall cause an applicable Product Sublicensee to provide) to Intrexon copies of the portions of such data, reports, filings, and communications that relate specifically and solely to Intrexon IP.  Subject to Section 3.1 and Section 3.5, Intrexon shall be permitted, directly or in conjunction with or through partners or other channel collaborators, to reference any such data, reports, filings, and communications relating specifically and solely to Intrexon IP in regulatory filings made to obtain regulatory approval for (i) products for use in fields outside the Field, and/or (ii) products of JV for use only in the JV Field. Intrexon shall have the right to provide a written request to OvaScience to use any such information in developing and Commercializing products outside the Field, or products in the JV Field, and to license any Third Parties to do so and OvaScience shall not unreasonably refuse any such request

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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provided that OvaScience reasonably determines that the proposed use by Intrexon will not adversely affect OvaScience’s ongoing business.  Notwithstanding the provisions of this Section 3.7, Intrexon shall not, outside of the OPC Program, utilize any OvaScience clinical and non-clinical data or reports in support of obtaining regulatory approval for a product for use in the Field or for a product that would compete with Collaboration Products in the Field.

 

3.9                                         Third Party Licenses .

 

(a)                                  [***] shall obtain, [***], any licenses from Third Parties that are required in order to practice the Intrexon Channel Technology in the Field to the extent reasonably necessary for Intrexon to conduct genetic and cell engineering and related analytic activities under JSC established plans for the OPC Program (but specifically excluding intellectual property directed to any specific target genes, genetic transformation methodologies, cell lines, active pharmaceutical ingredients or chemical intermediates thereof, or processes or methods for commercially manufacturing Collaboration Products or Improved Products, or to any methods of treating humans with OPCs or OPC derived cells in the Field) (“ Supplemental In-Licensed Third Party IP ”).  Other than with respect to Supplemental In-Licensed Third Party IP, [***] shall be solely responsible for obtaining, [***], any licenses from Third Parties that [***] determines, in its sole discretion, are required in order to lawfully make, use, sell, offer for sale, or import Collaboration Products (“ Complementary In-Licensed Third Party IP ”).  Supplemental In-Licensed Third Party IP and Complementary In-Licensed Third Party IP are collectively referred to as “ In-Licensed Program IP ”.

 

(b)                                  In the event that either Party desires to license from a Third Party any Supplemental In-Licensed Third Party IP or Complementary In-Licensed Third Party IP, such Party shall so notify the other Party, and the IPC shall discuss such In-Licensed Program IP and its applicability to the OPC Program and/or the development and Commercialization of Collaboration Products for use in the Field.  As provided above in Section 3.9(a), [***] shall have the sole right and responsibility to pursue a license to rights under Supplemental In-Licensed Third Party IP, and [***] hereby covenants that it shall not during the Term directly license such Supplemental In-Licensed Third Party IP ; provided, that, [***]  shall have the right (but shall not be obligated to) obtain such a license directly if the Third Party owner or licensee of such Supplemental In-Licensed Third Party IP brings an infringement action against [***] or its Affiliates or threatens to bring such action and, after written notice to [***] of such action, [***] fails to obtain a license to such Supplemental In-Licensed Third Party IP within ninety (90) days after such notice.  Following the IPC’s discussion of any Complementary In-Licensed Third Party IP, subject to Section 3.9(c), [***] shall have the right to pursue a license under any Complementary In-Licensed Third Party IP, at [***].  For the avoidance of doubt, [***] may at any time obtain a license under Complementary In-Licensed Third Party IP to use with any product that is not a Collaboration Product and/or for use outside the Field, at [***]; provided, that, if [***] decides to seek to obtain such a license, it shall use reasonable efforts to coordinate its licensing activities in this regard with [***].

 

(c)                                   [***] shall provide the proposed terms of any license under Complementary In-Licensed Third Party IP and the final version of the definitive license agreement for any Complementary In-Licensed Third Party IP to the IPC for review and

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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discussion prior to signing, and shall consider [***] comments thereto in good faith; provided, that, [***] (i) shall have the sole right to negotiate and execute agreements for any such Complementary In-Licensed Third Party IP and (ii) shall ensure that the terms of such license are not in conflict the terms of this Agreement with respect to the treatment and ownership of, and rights under, Confidential Information and intellectual property (including Inventions) of the Parties and developed under the OPC Program.  To the extent that [***] obtains a license under Complementary In-Licensed Third Party IP, [***] shall provide the final version of the definitive license agreement for such Complementary In-Licensed Third Party IP to the IPC.  Any Party that is pursuing a license to any In-Licensed Program IP with respect to the Field under this Section 3.9 shall keep the other Party reasonably informed of the status of any negotiations relating thereto. For purposes of clarity, (i) any costs incurred by [***] in obtaining and maintaining licenses to Supplemental In-Licensed Third Party IP shall be borne solely by [***], and (ii) any costs incurred by [***] in obtaining and maintaining licenses to Complementary In-Licensed Third Party IP (and, to the limited extent provided in subsection (b), Supplemental In-Licensed Third Party IP) shall be borne solely by [***].

 

(d)                                  For any Third Party license under which OvaScience or its Affiliates obtain a license under Patents claiming material inventions or know-how specific to or used or incorporated into the development, manufacture, and/or Commercialization of Collaboration Products, OvaScience shall use commercially reasonable efforts, but shall not be obligated, if requested by the JSC , to ensure that OvaScience will have the ability, pursuant to Section 10.4(h), to assign such agreement to Intrexon or grant a sublicense to Intrexon thereunder (having the scope set forth in Section 10.4(h)).

 

(e)                                   The licenses granted to OvaScience under Section 3.1 may include sublicenses under Intrexon IP that has been licensed to Intrexon by one or more Third Parties.  Any such sublicenses are subject to the terms and conditions set forth in the applicable upstream license agreement, subject to the cost allocation set forth in Section 3.9(c), provided that Intrexon shall disclose in writing to OvaScience all of such terms and conditions that are applicable to OvaScience.  OvaScience shall not be responsible for complying with any provisions of such upstream license agreements unless, and to the extent that, such provisions have been disclosed to OvaScience as provided in the preceding sentence.

 

(f)                                    If either Party receives notice from a Third Party concerning activities of a Party taken in conjunction with performance of obligations under this Agreement, which notice alleges infringement by a Party of, or offers license under, Patents or other intellectual property rights owned or controlled by that Third Party, the receiving Party shall inform the other Party thereof as promptly as practicable.

 

3.10                                  Licenses to Intrexon.   Subject to the terms and conditions of this Agreement, OvaScience hereby grants to Intrexon a non-exclusive, fully-paid, royalty-free license, under the OvaScience Cell Platform Technology and the OvaScience Patents Controlled by OvaScience solely to the extent necessary for Intrexon to conduct those activities assigned to it as part of the OPC Program as set forth in a Work Plan approved by the JSC , which license shall be sublicensable solely to Intrexon’s Affiliates, to any Intrexon Third Party subcontractors as

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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permitted in accord with Section 4.5 or as otherwise permitted to be used by Intrexon in conjunction with support services under Section 4.5 (subject to JSC research plan approval).

 

3.11                                  Restrictions Relating to Intrexon Materials .  OvaScience and its permitted sublicensees shall use the Intrexon Materials solely for purposes of the OPC Program as set forth in JSC-approved plans and as contemplated by the license granted in Section 3.1 and not for any other purpose without the prior written consent of Intrexon.  With respect to the Intrexon Materials comprising Intrexon’s vector assembly and cell processing technology, OvaScience shall not, and shall ensure that OvaScience personnel do not, and shall include in any agreement with Third Party permitted sublicensees a covenant that shall provide that such sublicensees shall not, except as otherwise permitted in this Agreement (a) distribute, sell or otherwise transfer such Intrexon Materials to any Third Party; (b) co-mingle such Intrexon Materials with any other proprietary biological or chemical materials without Intrexon’s written consent; or (c) analyze such Intrexon Materials or in any way attempt to reverse engineer or sequence such Intrexon Materials.

 

ARTICLE 4

 

OTHER RIGHTS AND OBLIGATIONS

 

4.1                                         Development and Commercialization . Subject to Sections 4.5 and 4.6, OvaScience shall be solely responsible for the development and Commercialization of Collaboration Products and Improved Products.  OvaScience shall be responsible for all costs incurred in connection with the OPC Program to the extent included in a Work Plan approved by the JSC, except that Intrexon shall be responsible for the following:  (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.5 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Collaboration Product or Improved Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials ( i . e ., platform improvements) but, for clarity, excluding research described in Section 4.6 or research requested by the JSC for the development of a Collaboration Product or an Improved Product (which research costs shall be reimbursed by OvaScience); (c) [***]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents.  The costs encompassed within clause (a) of the previous sentence shall include the scale-up of Intrexon Materials for generating data for regulatory approval submissions and Commercialization of Collaboration Products undertaken pursuant to Section 4.5, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or OvaScience (with Intrexon’s consent).

 

4.2                                         Information and Reporting .  OvaScience will keep Intrexon reasonably informed about OvaScience’s efforts to develop and Commercialize Collaboration Products and Improved Products, by providing Intrexon with reasonable and accurate summaries of OvaScience’s (and its Affiliates’ and, if applicable, (sub)licensees’) development plans (as

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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updated), including preclinical, clinical and regulatory plans, marketing plans (as updated), progress towards meeting the goals and milestones in such plans and explanations of any material deviations, significant developments in the development and/or Commercialization of the Collaboration Products and Improved Products, including the initiation or completion of clinical trials, submission of United States or international regulatory filings, receipt of responses to such United States or international regulatory filings, clinical safety events, receipt of Regulatory Approvals, or commercial launches with respect to Collaboration Products and Improved Products.  Intrexon will keep OvaScience reasonably informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for Collaboration Products and Improved Products (and Intrexon Materials relevant thereto) and otherwise perform its manufacturing responsibilities under Section 4.6 and (b) to undertake discovery-stage research for the OPC Program with respect to the Intrexon Channel Technology and Intrexon Materials by providing OvaScience with reasonable and accurate summaries of Intrexon’s (and its Affiliates’ and, if applicable, (sub)licensees’) plans (as updated) established with respect to such manufacturing capabilities and facilities for Collaboration Products and Improved Products and/or discovery-stage research for the OPC Program, including progress towards meeting the goals and milestones in such plans and explanations of any material deviations, significant developments in the development of such manufacturing capabilities and facilities for Collaboration Products and Improved Products and/or discovery-stage research.  Unless otherwise provided herein or directed by the JSC in accord with Section 4.2 above, such disclosures by OvaScience and Intrexon will be coordinated by the JSC and made in connection with JSC meetings at least once every six (6) months while Collaboration Products and Improved Products are being developed or Commercialized, and shall be reflected in the minutes of such meetings.

 

4.3                                         Regulatory Matters .  At all times after the Effective Date, OvaScience shall own and maintain, at its own cost, all regulatory filings and regulatory approvals for Collaboration Products and Improved Products that OvaScience is developing or Commercializing pursuant to this Agreement.  OvaScience shall be responsible for reporting all adverse events related to such Collaboration Products and Improved Products to the appropriate regulatory authorities in the relevant countries, in accordance with the applicable laws and regulations of such countries.  To the extent that Intrexon develops, itself or in collaboration with other third parties, Intrexon Materials for use outside of the Field or for use in the JV Field with JV, Intrexon may request that OvaScience and Intrexon negotiate a separate safety data exchange agreement to address and govern the timely exchange of safety information generated by OvaScience, Intrexon, and relevant third parties with respect to specific Intrexon Materials; provided, that, OvaScience shall be under no obligation to enter into any such agreement.  The decision to list or not list Patents in any regulatory filing for a Collaboration Product (for example, as required by 21 C.F.R. § 314.53(b)), add or delete a Patent from a regulatory filing, or to otherwise identify a Patent to a third party in compliance with laws or regulations relating to regulatory approvals (for example, in compliance with 42 U.S.C. § 262(a)(1)(A)(k) et seq.) shall be determined by mutual agreement of the Parties, after good faith consultation.  To the extent that there is a dispute regarding the same, then the final determination regarding any Patent shall be left up to the Party having ownership of that Patent.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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4.4                                         Diligence .

 

(a)                                  OvaScience shall use, and shall include in any Third Party sublicense permitted under this Agreement a covenant that shall provide that such sublicensee shall, use, Diligent Efforts to develop and Commercialize Collaboration Products and Improved Products.  Intrexon shall use Diligent Efforts to perform any Work Plan support services set forth in Section 4.6.

 

(b)                                  Without limiting the generality of the foregoing, Intrexon may, from time to time, notify OvaScience that it believes it has identified a Superior Therapy, and in such case Intrexon shall provide to OvaScience its then-available information about such therapy and reasonable written support for its conclusion that the therapy constitutes a Superior Therapy.  OvaScience shall have the following obligations with respect to such proposed Superior Therapy:  (i) within sixty (60) days after such notification, OvaScience shall prepare and deliver to the JSC for review and approval a development plan detailing how OvaScience will pursue the Superior Therapy (including a proposed budget); (ii) OvaScience shall revise the development plan as directed by the JSC; and (iii) following approval of the development plan by the JSC, OvaScience shall use Diligent Efforts to pursue the development of the Superior Therapy under the OPC Program in accordance with such development plan.  To the extent that Intrexon has in fact identified a Superior Therapy, Intrexon shall have the termination right set forth in Section 10.2(c) (subject to the final sentence of this Section 4.4(b) and the limitation set forth therein) if OvaScience fails to comply with the foregoing obligations (i)-(iii), or if OvaScience unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days after delivery of the development plan to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapy.  For clarity, (i) any dispute arising under this 4.4, including any dispute as to whether a project proposed by Intrexon in fact constitutes a Superior Therapy (as with any other dispute under this Agreement) shall be subject to dispute resolution in accordance with Article 11, and (ii) Intrexon shall have no right to terminate this Agreement pursuant to Section 10.2(c), and the cure period provided in Section 10.2(c) shall be stayed, during the period any such dispute is subject to such dispute resolution process.

 

(c)                                   The activities of OvaScience’s Affiliates and any permitted sublicensees shall be attributed to OvaScience for the purposes of evaluating OvaScience’s fulfillment of the obligations set forth in this Section 4.4.

 

4.5                                         Manufacturing .  Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the OPC Program that relate to the Intrexon Materials or bulk quantities of other components of Collaboration Products or Improved Products, either itself or through the use of a suitable Third Party contract manufacturer.  To the extent that Intrexon so elects, OvaScience and Intrexon shall negotiate and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials or bulk quantities of other components of Collaboration Products or Improved Products.  Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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terms to be negotiated by the Parties in good faith.  In the event that Intrexon does not elect to manufacture Intrexon Materials or bulk quantities of other components of Collaboration Products or Improved Products, then (a) Intrexon shall provide written notice of same to OvaScience, (b) the Parties will, through the JSC, develop a written work plan (the “Technology Transfer Work Plan” ) describing the activities (the “Technology Transfer Activities” ) to be performed by Intrexon to implement the transfer to OvaScience or a contract manufacturer selected by OvaScience of all Information Controlled by Intrexon that is (i) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of Collaboration Products for use in the Field (but not pertaining solely to the JV Field) and (ii) reasonably necessary to enable OvaScience or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of Collaboration Products, which may include providing OvaScience and/or such Third Party with the training, documentation and other information relating to the manufacturing of such Intrexon Materials or bulk qualities of other components of Collaboration Products for use in the Field and making appropriately trained personnel available for consultation and advice upon the reasonable request of OvaScience and/or such Third Party to the extent reasonably necessary to enable OvaScience and/or such Third Party to manufacture such Intrexon Materials or bulk qualities of other components of Collaboration Products for use in the Field and (c) Intrexon shall promptly undertake the Technology Transfer Activities.  The costs and expenses incurred by Intrexon in carrying out such Technology Transfer Activities shall be borne by OvaScience.  Any manufacturing Information transferred hereunder to OvaScience or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any OvaScience Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit OvaScience to switch manufacturers.

 

4.6                                         Support Services .

 

(a)                                  The JSC will meet promptly following the Effective Date and prepare and approve the initial Work Plan under which Intrexon will provide support services to OvaScience for the research and development of Collaboration Products (and, to the extent OvaScience exercises the Field Option, Improved Products) under the OPC Program, which initial Work Plan may be amended from time to time by the JSC.  The Work Plan shall set forth activities and deliverables to be achieved on or before the IND Due Date) and shall include the timelines, estimated costs (including a detailed budget that shall include all estimated Fully Loaded Costs).  OvaScience will compensate Intrexon for services under this Section 4.6 with cash payments equal to Intrexon’s Fully Loaded Cost in accord with the Work Plan.  Additionally, from time to time, on an ongoing basis, OvaScience may request, or Intrexon may propose, that Intrexon perform certain additional services with respect to researching and developing new Collaboration Products or improving the manufacturing or processing methods for the Existing Product to produce Improved Products. If either Party proposes that Intrexon perform additional Services, not specifically provided for in the applicable Work Plan, Intrexon shall prepare a draft revised Work Plan describing in reasonable detail the nature of such additional Services, and submit such revised Work Plan to the JSC for its review and written approval.  To the extent that the Parties mutually agree that Intrexon should perform such additional services, it is understood that

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Intrexon would be compensated for such additional services by cash payments equal to Intrexon’s Fully Loaded Cost in connection with such services.

 

(b)                                  OvaScience shall not be obligated to pay to Intrexon for the conduct of any support services provided under this Section 4.6 any amounts that exceed by more than [***] percent ([***]%) the budget specifically allocated for the applicable activities in the associated JSC-approved budget under the Work Plan, unless (a) the JSC shall amend the Work Plan and associated budget to accommodate any material overage, or (b) OvaScience otherwise agrees in writing to pay the amounts in material excess to Intrexon.  In the event that, in performance under the Work Plan, Intrexon determines that the JSC-approved budget is in some way insufficient to complete performance of the tasks under the Work Plan, it will notify the JSC as soon as practical after determining such, providing sufficient detail to enable the JSC to promptly review the budget insufficiency and revise the Work Plan and associated budget.  The JSC (i) shall confer and/or meet (including electronically) as soon as practical after receiving such notice from Intrexon to consider amending the Work Plan, and (ii) shall use best efforts to provide a final decision regarding whether, and (if so) how, to amend the Work Plan and associated budget in order to expand the budget and/or minimize the activities under the Work Plan to reconcile budget with the then-current expectations and projections for expenditures under the Work Plan.  Intrexon may discontinue performance under a Work Plan if continuing under the Work Plan to the extent continuing would cause Intrexon to exceed by more than [***] percent ([***]%) the applicable budget, such discontinuance being permissible until such time as the JSC, with the consent of OvaScience, has amended the Work Plan to redress the issue in accord with this Section 4.6(b).  To the extent that the inability of the JSC to approve an amended Work Plan and/or associated budget causes Intrexon to materially discontinue performance under the Work Plan toward producing the IND-Enabling Package, any number of days of discontinuance by Intrexon until JSC approval for amendment is actually granted exceeding [***] business days from Intrexon’s notice under this Section 4.6(b) shall be includable in the determination of OvaScience Delay.

 

4.7                                         Compliance with Law .  Each Party shall comply, and shall ensure that its Affiliates, comply, and shall include in any agreement with any permitted Third Party sublicensee or subcontractor a covenant that shall provide that such Third Party shall comply with, all applicable laws, regulations, and guidelines applicable to the OPC Program, including without limitation those relating to the transport, storage, and handling of Intrexon Materials and Collaboration Products, and Improved Products.

 

4.8                                         Trademarks and Patent Marking.  OvaScience shall ensure that the packaging, promotional materials, and labeling for Collaboration Products and Improved Products, shall carry as appropriate the applicable Intrexon Trademark(s), as required by and/or in compliance with applicable laws and regulations.  Consistent with the U.S. patent laws, OvaScience shall ensure that Collaboration Products and Improved Products, or their respective packaging or accompanying literature as appropriate, bear applicable and appropriate patent markings for Intrexon Patent numbers.  OvaScience shall provide the IPC (or, after termination, Intrexon) with representative samples of all products, product packaging, literature, brochures, signs, and advertising materials prepared by OvaScience which bear, display, or include any reference to the Intrexon Trademarks or patent markings prior to using or disseminating such

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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materials.  OvaScience acknowledges Intrexon’s sole ownership of the Intrexon Trademarks and agrees not to take any action inconsistent with such ownership.  OvaScience covenants that it shall not use any trademark confusingly similar to any Intrexon Trademarks in connection with any products (including any Collaboration Product or Improved Product. OvaScience shall comply with reasonable policies provided in writing by Intrexon from time-to-time to maintain the goodwill and value of the Intrexon Trademarks.

 

4.9                                         Technology Transfer by OvaScience.  As soon as practical following the approval of the original Work Plan by the JSC, OvaScience will provide Intrexon with any Information and proprietary materials Controlled by OvaScience and described in the Work Plan to the extent required for Intrexon to perform its obligations under the Work Plan. For purposes of determining the IND Due Date, the completion of the initial technology transfer from OvaScience to Intrexon shall be considered to have occurred at such time when OvaScience has transferred sufficient Information and proprietary materials under its Control to enable Intrexon to initiate its performance under the Work Plan, and, in any event, no later than [***] ([***]) months from the Effective Date.  For clarity, failures of OvaScience to provide necessary materials, information, or technology required by Intrexon for timely performance and completion of its obligations under the Work Plan shall be eligible for inclusion in any determination of OvaScience Delay (to the extent such failures otherwise would qualify under Section 1.58) irrespective of whether such failure occurs after the completion of the initial technology transfer from OvaScience under the prior sentence.

 

ARTICLE 5

 

COMPENSATION

 

5.1                                         Technology Access Fee .  In [***] consideration for OvaScience’s appointment as an exclusive channel collaborator in the Field and the other rights granted to OvaScience hereunder, OvaScience shall pay to Intrexon a total payment of five million United States dollars ($5,000,000) (the “ Technology Access Fee ”), which shall be payable in two installments of equal amounts.  The first installment payment shall be paid by OvaScience in common stock of OvaScience and the second installment payment shall be paid by OvaScience in cash.  For the first installment of the Technology Access Fee, the payment in common stock of OvaScience shall be due and made in accordance with the terms and conditions of the Stock Issuance Agreement, each by and between the Parties and of even date herewith (collectively, the “ Equity Agreement ”).  For the second installment of the Technology Access Fee, the cash payment shall be due on the one-year anniversary of the Effective Date. The receipt by Intrexon of the full payment of the first installment of the Technology Access Fee is a condition subsequent to the effectiveness of this Agreement.

 

5.2                                         Royalty Payments for Collaboration Products .

 

(a)                                  No later than [***] ([***]) days after each calendar quarter in which there are positive aggregate Net Sales arising from the sale in the Field and Territory of Collaboration Products (but excluding Net Sales arising from any sale of Improved Products), OvaScience shall pay to Intrexon the Applicable Percentage (as defined below) of the aggregate Net Sales for such

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

Collaboration Products (excluding Improved Products).  For purposes of clarity, in the event that there are negative Net Sales for a particular Collaboration Product (excluding Improved Products) in any calendar quarter, (i) neither OvaScience nor Intrexon shall owe any payments hereunder with respect to such Collaboration Product and (ii) any such negative Net Sales that results from Excess Product Liability Costs may be carried forward to future calendar quarters and offset against positive Net Sales in such future calendar quarters for the same Collaboration Product; provided, that, except as set forth in the preceding sentence, OvaScience shall not be permitted to carry forward any negative Net Sales to subsequent quarters.

 

(b)                                  The percentage royalty applicable to each Collaboration Product under Section 5.2(a) above (“ Applicable Percentage ”) shall have an initial rate of [***] percent ([***]%), which shall be adjusted downward as set forth in the subsections (i) through (iii) immediate below, as applicable.

 

(i)                                      In the event that Intrexon does not deliver to OvaScience an IND-Enabling Package for a Collaboration Product by the IND Due Date, the Applicable Percentage for such Collaboration Product shall decrease by (A) [***] ([***])  basis points (i.e., [***]%) for each [***] ([***]) day period between the IND Due Date and the date the IND-Enabling Package is actually received by OvaScience during the first [***] months after the IND Due Date, and (B) [***] ([***]) basis points (i.e., [***]%) for each [***] ([***]) day period thereafter until the IND-Enabling Package is actually received by OvaScience.

 

(ii)                                   In the event that the development and/or Commercialization of any Collaboration Product requires that OvaScience pay royalties to a Third Party, the Applicable Percentage shall decrease by [***] basis points (i.e., [***]%) for every [***] ([***])  basis points (i.e., [***]%) of royalty that is ultimately paid by OvaScience to such Third Party.

 

(iii)                                In no event shall Applicable Percentage applicable to any Collaboration Product (excluding an Improved Product) be reduced by application of Sections 5.2(b)(i) and/or 5.2(b)(ii) to be less than [***] percent ([***]%).

 

5.3                                Royalty Reduction for Failure to Deliver IND-Enabling Package . Notwithstanding the foregoing, the Applicable Percentage for a given Collaboration Product (excluding an Improved Product) shall be [***] percent ([***]%) in the event that OvaScience elects to pursue the development of such Collaboration Product by itself or with a Third Party because OvaScience reasonably concludes that (i) Intrexon cannot meet and shall materially exceed the IND Due Date, and (ii) pursuing the development without Intrexon will deliver an IND-Enabling Package materially faster than with Intrexon.

 

5.4                                         Payments for Improved Products .  No later than [***] ([***]) days after each calendar quarter in which there were COGS Savings realized by OvaScience (including permitted Affiliates and sublicensees thereof) from the sale of any Improved Product in the Field, OvaScience shall pay to Intrexon a royalty equal to [***] percent ([***]%) of the COGS Savings.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

5.5                                         Commercialization Milestone .  OvaScience shall pay Intrexon a milestone payment of [***] United States dollars ($[***]) in cash within three (3) months of the achievement of the Milestone Event.

 

5.6                                Equity Agreement Controls.  All issuances of equity interests to Intrexon in accordance with this Agreement shall be in accordance with the terms and conditions of the Equity Agreement, which Equity Agreement shall control to the extent it may conflict with Section 5.1 of this Agreement.

 

5.7                                         Method of Payment .  Payments due to Intrexon under this Agreement shall be paid in United States dollars by wire transfer to a bank in the United States designated in writing by Intrexon.  All references to “dollars” or “$” herein shall refer to United States dollars.

 

5.8                                         Payment Reports and Records Retention .  Within [***] ([***]) days after the end of each calendar quarter during which positive Net Sales or COGS Savings have been generated, a Milestone Event has been achieved, or a negative Net Sales has occurred, OvaScience shall deliver to Intrexon a written report that shall contain at a minimum for the applicable calendar quarter:

 

(a)                                  gross sales of each Collaboration Product (on a country-by-country basis);

 

(b)                                  itemized calculation of Net Sales of each Collaboration Product, showing all applicable deductions;

 

(c)                                   itemized calculation of COGS Savings, showing the calculation of COGS for the Existing Product prior to being improved under the OPC Program and the COGS calculation for the Improved Product (including any mutually agreed exclusions per Section 1.9);

 

(d)                                  the amount of any negative Net Sales of each Collaboration Product for the applicable calendar quarter, and any negative Net Sales amount carried forward from a prior quarter and applied during the present quarter (as per Section 5.2(a));

 

(e)                                   the amount of the payment (if any) due pursuant to each of Sections 5.2(a) through 5.2(c);

 

(f)                                    the amount of the payment (if any) made by OvaScience, or that has become due by the achievement of the Milestone Event, during the preceding calendar quarter under 5.3;

 

(g)                                  the amount of taxes, if any, withheld to comply with any applicable law; and

 

(h)                                  the exchange rates used in any of the foregoing calculations.

 

For [***] ([***]) years after (a) the sale or other commercial use of each Collaboration Product or Improved Product, or (b) the date on which OvaScience reports to Intrexon any component item OvaScience incorporated into its calculation of Net Sales, COGS, or COGS Savings,

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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OvaScience shall keep (and shall ensure that its Affiliates shall keep and, if applicable, shall include in any agreement with a Third Party permitted sublicensee a covenant that shall provide that such (sub)licensees shall keep) complete and accurate records of such sales, commercial use, or component item in sufficient detail to confirm the accuracy of the payment calculations hereunder.

 

5.9                                         Audits .

 

(a)                                  Audit Rights of Intrexon.

 

(i)                                      Upon the written request of Intrexon, OvaScience shall permit an independent certified public accounting firm of internationally recognized standing selected by Intrexon, and reasonably acceptable to OvaScience, to have access to and to review, during normal business hours and upon not less than [***] ([***]) days prior written notice, the applicable records of OvaScience and its Affiliates to verify the accuracy and timeliness of the reports and payments made by OvaScience under this Agreement.  Such review may cover the records for sales made in any calendar year ending not more than [***] ([***]) years prior to the date of such request.  The accounting firm shall disclose to both Parties whether the payments made by OvaScience are accurate and the amount of any discrepancies.  Such audit may not be conducted more than once in any calendar year or more than once with respect to sales of a particular Collaboration Product or Improved Product in a particular period.

 

(ii)                                   If such accounting firm concludes that additional amounts were owed during such period, OvaScience shall pay additional amounts, with interest from the date originally due as set forth in Section 5.8, within [***] ([***]) days of receipt of the accounting firm’s written report.  If the amount of the underpayment is greater than [***] percent ([***]%) of the total amount actually owed for the period audited, then OvaScience shall in addition reimburse Intrexon for all costs related to such audit; otherwise, Intrexon shall pay all costs of the audit.  In the event of overpayment, any amount of such overpayment shall be fully creditable against amounts payable for the immediately succeeding calendar quarter(s).

 

(iii)                                Intrexon shall (i) treat all information that it receives under this Section 5.6 in accordance with the confidentiality provisions of Article 7 and (ii) cause its accounting firm to enter into an acceptable confidentiality agreement with OvaScience obligating such firm to retain all such financial information in confidence pursuant to such confidentiality agreement, in each case except to the extent necessary for Intrexon to enforce its rights under this Agreement.

 

(b)                                  Audit Right of OvaScience. Intrexon shall keep complete and accurate books and financial records pertaining to the number of FTEs utilized, the applicable FTE Cost and external expenses incurred in conducting the OPC Program, which books and financial records shall be retained by Intrexon until [***] ([***]) years after the end of the calendar year to which they pertain.  Upon [***] ([***]) days written notice, OvaScience shall have the right to appoint at its expense an independent certified public accountant reasonably acceptable to Intrexon to audit the books and financial records of Intrexon relating to the number of FTEs utilized, the applicable FTE Cost and external expenses incurred in conducting the OPC Program

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

during any calendar year; provided, that, OvaScience shall not have the right to audit any calendar year more than once or more than [***] ([***]) years after the end of such calendar year or to conduct more than one such audit in any twelve-month period. All books and financial records made available for audit shall be deemed to be Confidential Information of Intrexon.  The results of each audit, if any, shall be reported in writing to both Parties promptly (but in no event later than [***] ([***]) days) after the audit and shall be binding on both Parties.  In the event there was an error relating to the reported FTEs utilized, the applicable FTE Cost and external expenses incurred in conducting the OPC Program, (a) if the effect of the error resulted in an overpayment by OvaScience, Intrexon shall promptly (but in any event no later than [***] ([***]) days) after Intrexon’s receipt of the report so concluding, make payment to OvaScience of the overpayment and (b) if the effect of the error resulted in an underpayment by OvaScience, then OvaScience shall promptly (but in no event later than [***] ([***]) days after OvaScience’s receipt of the report so concluding) make payment to Intrexon of the underpayment amount.  OvaScience shall bear the full cost of such audit unless such audit discloses an over reporting by Intrexon of more than [***] percent ([***]%) of the aggregate amount of FTE Costs and external expenses reportable in any calendar year, in which case Intrexon shall reimburse OvaScience for all reasonable costs incurred by OvaScience in connection with such audit.

 

5.10                                  Taxes .  The Parties will cooperate in good faith to obtain the benefit of any relevant tax treaties to minimize as far as reasonably possible any taxes which may be levied on any amounts payable hereunder.  OvaScience shall deduct or withhold from any payments any taxes that it is required by applicable law to deduct or withhold.  Notwithstanding the foregoing, if Intrexon believes that it is entitled under any applicable tax treaty to a reduction of the rate of, or the elimination of, applicable withholding tax, it may deliver to OvaScience or the appropriate governmental authority (with the assistance of OvaScience to the extent that this is reasonably required and is expressly requested in writing) the prescribed forms necessary to reduce the applicable rate of withholding or to relieve OvaScience of its obligation to withhold tax, and OvaScience shall provide OvaScience with reasonable assistance so that Intrexon may obtain the reduced rate of withholding tax, or dispense with withholding tax, as the case may be.  If Intrexon provides OvaScience with evidence reasonably satisfactory to OvaScience that Intrexon is entitled to the reduced rate or to dispense with such rate, at least [***] ([***]) days prior to the time that the payment is due, OvaScience shall comply with such adjustment.  If, in accordance with the foregoing, OvaScience withholds any amount, it shall make timely payment to the proper taxing authority of the withheld amount, and send to Intrexon proof of such payment within [***] ([***]) days following that latter payment.

 

5.11                                  Late Payments .  Any amount owed by OvaScience to Intrexon under this Agreement that is not paid within the applicable time period set forth herein shall accrue interest at the lower of (a) [***] percent ([***]) per month, compounded, or (b) [***].

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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ARTICLE 6

 

INTELLECTUAL PROPERTY

 

6.1                                         Ownership .

 

(a)                                  Subject to the license granted under Section 3.1, all rights, technology, and intellectual property, including the Intrexon IP, (A) Controlled by Intrexon as of the Effective Date, or (B) thereafter developed by Intrexon independent of the OPC Program and OvaScience Cell Platform Technology, shall be owned by and remain the sole property of Intrexon.

 

(b)                                  All rights, technology, and intellectual property (A) owned by OvaScience or licensed from a Third Party by OvaScience as of the Effective Date, or (B) thereafter developed by OvaScience independent of the OPC Program, Intrexon Channel Technology, Intrexon IP or Intrexon Materials, shall be owned by and remain the sole property of OvaScience (the “ OvaScience Independent IP ”).  For clarity, the OvaScience Independent IP includes the OvaScience Cell Platform Technology and OvaScience Patents.

 

(c)                                   OvaScience and/or Intrexon may solely or jointly conceive, reduce to practice or develop discoveries, inventions, processes, techniques, and other technology, whether or not patentable, in the course of performing the OPC Program (collectively “ Inventions ”).  Each Party shall promptly provide the IPC with a detailed written description of any such Inventions to enable the IPC to reasonably determine those Inventions that relate to the Field (or the JV Field, as applicable).  Inventorship shall be determined in accordance with United States patent laws.

 

(d)                                  OvaScience shall solely own all right, title and interest in all Inventions (together with all Patent rights and other intellectual property rights therein) that (i) incorporate or solely relate to use of the OvaScience Cell Platform Technology, and (ii) which is not based upon, does not incorporate, or does not require the use of, Intrexon IP, the Intrexon Channel Technology or Intrexon Materials (collectively, “ OvaScience Platform Inventions ”).  Intrexon hereby assigns and agrees to assign to OvaScience all of Intrexon’s interests in and to any and all OvaScience Cell Platform Inventions, and shall perform or have performed any and all acts reasonably necessary to assist OvaScience in perfecting its rights to any and all OvaScience Cell Platform Inventions, including executing or having executed any documents affecting the appropriate assignment to OvaScience.

 

(e)                                   Intrexon shall solely own all right, title and interest in all Inventions (together with all Patent rights and other intellectual property rights therein) that (i) (A) incorporate or solely relate to use of the Intrexon Channel Technology or (B) relate generally to the discovery, design and development of markers, cell processing techniques and lines, complex transgenes and vectors, and production processes, and (ii)  in any case, which is not based upon and does not incorporate or require the use of the OvaScience Cell Platform Technology (collectively, the “ Channel-Related Program IP ”).  OvaScience hereby assigns and agrees to assign to Intrexon all of OvaScience’s interests in and to any and all Channel-Related Program IP, and shall perform or have performed any and all acts reasonably necessary to assist Intrexon in perfecting its rights in and to any and all of the Channel-Related Program IP, including executing or having executed any documents affecting the appropriate assignment to Intrexon.

 

(f)                                    Notwithstanding anything to the contrary in this Agreement, any discovery, invention, process, technique, or other technology, whether or not patentable, that is conceived, reduced to practice or developed by OvaScience solely or jointly through the use of

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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the Intrexon Channel Technology, Intrexon IP, or Intrexon Materials in breach of the terms and conditions of this Agreement, together with all patent rights and other intellectual property rights therein, shall be solely owned by Intrexon and shall be Channel-Related Program IP.

 

(g)                                  All Information disclosed by Intrexon to OvaScience regarding Channel-Related Program IP shall be Confidential Information of Intrexon.  OvaScience shall be under appropriate written agreements with each of its employees, contractors, or agents working on the OPC Program, pursuant to which such person shall grant all rights in the Inventions to OvaScience (so that OvaScience may convey certain of such rights to Intrexon, as provided herein) and agree to protect all Confidential Information relating to the OPC Program.

 

(h)                                  Subject to the foregoing clauses of this Section 6.1, all Inventions (together with all Patent rights and other intellectual property rights therein) that (i) are neither Channel-Related Program IP nor OvaScience Platform Inventions, and (ii) relate solely and specifically to a combination of Intrexon Channel Technology and OvaScience Cell Platform Technology (collectively the “ Joint Program Inventions ”) shall be owned jointly by Intrexon and OvaScience in undivided one-half interests.

 

(i)                                     For clarity, the Parties’ joint ownership of the Joint Program Inventions does not by itself grant either Party rights in any other intellectual property of the other Party, and, except for the explicit licenses set forth in this Agreement (i) Intrexon is not permitted to use any OvaScience intellectual property (except as may be otherwise expressly granted by OvaScience) in the practice of Joint Program Inventions, and (ii) OvaScience is not permitted to use any Intrexon IP (except as may be otherwise expressly granted by Intrexon) in the practice of Joint Program Inventions.

 

(j)                                     Patent Disputes .  In the event the IPC is unable to reach agreement on any matter with respect to ownership of Patents under this Agreement, including with respect to the determination of inventorship under U.S. patent law, the issue shall be submitted to an outside patent counsel reasonably acceptable to the IPC who (and whose firm) is not at the time of the dispute, and was not at any time during the five (5) year period prior to such dispute, performing legal services for either of the Parties, and which did not, at any time, employ any member of the IPC.  Such patent counsel shall provide a non-binding opinion regarding the disputed matter, and the expenses of such outside patent counsel shall be shared equally by the Parties.  If, after obtaining such non-binding opinion, the Parties cannot resolve the dispute under this Section 6.1(j), the dispute resolution procedures of Article 11 will apply.

 

6.2                                         Patent Prosecution .

 

(a)                                  Intrexon shall have the sole right, but not the obligation, to (i) conduct and control the filing, prosecution and maintenance of the Intrexon Patents, and (ii) conduct and control the filing, prosecution, and maintenance of any applications for patent term extension and/or supplementary protection certificates that may be available as a result of the regulatory approval of any Collaboration Product. At the reasonable request of Intrexon, OvaScience shall cooperate with Intrexon in connection with such filing, prosecution, and maintenance, at Intrexon’s expense.  Under no circumstances shall OvaScience (i) file, attempt to file, or assist

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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anyone else in filing, or attempting to file, any Patent application, either in the United States or elsewhere, that claims or uses or purports to claim or use or relies for support upon an Intrexon Invention, (ii) use, attempt to use, or assist anyone else in using or attempting to use, the Intrexon Know-How, Intrexon Materials, or any Confidential Information of Intrexon to support the filing of a Patent application, either in the United States or elsewhere, that contains claims directed to the Intrexon IP, Intrexon Materials, or the Intrexon Channel Technology, or (iii) without prior approval of the IPC, file, attempt to file, or assist anyone else in filing, or attempting to file, any application for patent term extension or supplementary protection certificate, either in the United States or elsewhere, that relies upon the regulatory approval of a Collaboration Product.

 

(b)                                  OvaScience shall have the sole right, but not the obligation, to conduct and control the filing, prosecution and maintenance of any Patents claiming OvaScience Platform Inventions (“ OvaScience Program Patents ”) and any OvaScience Patents.  At the reasonable request of OvaScience, Intrexon shall cooperate with OvaScience in connection with such filing, prosecution, and maintenance, at OvaScience’s expense.

 

(c)                                   The Parties through the IPC shall reasonably cooperate, to the extent such cooperation can be done without substantially compromising any Patents of either Party, to develop a portfolio of Product-Specific Program Patents and Patents for Joint Program Inventions covering relevant Collaboration Products (and including any Improved Products).  Consistent with this Section 6.2(c), the IPC may establish protocols and procedures with respect to the cooperation of the Parties with respect to such, which shall include the right for a Party to request, in its discretion, that the other Party file at the requesting Party’s expense one or more continuation or divisional applications (as appropriate) for Patent for the express purpose of creating Product-Specific Program Patents or otherwise dividing Intrexon IP (including Channel-Related Program IP) and/or OvaScience Platform Inventions from Patents for Joint Program Inventions, which request shall be honored to the extent reasonable, permitted by applicable laws, and otherwise consistent with this Agreement.  During the Term, OvaScience shall have, the first right, but not the obligation, to conduct and direct the filing, prosecution and maintenance of any Patents for Joint Program Inventions consistent with any relevant strategies and determinations set forth by the IPC under the prior sentence with respect to such Patents and other Intrexon IP. To the extent that OvaScience exercises the rights to conduct and direct under the prior sentence, OvaScience shall (i) provide Intrexon in a timely manner with copies of all material correspondence regarding Joint Program Inventions to and from any foreign or domestic patent offices and patent prosecution counsel (including at a minimum any related drafts of patent applications, official responses, and other substantive communications and filings at least fifteen (15) days prior to any applicable deadline for review) for Intrexon review prior to filing; (ii) shall take into account any Intrexon comments or requests relating to relevant draft communications and filings and not submit such communications and filings without Intrexon approval and consent, such approval and consent not to be unreasonably delayed, withheld, or conditioned; (iii) keep Intrexon reasonably apprised regarding the status of any prior art searches, patentability analyses, draft patent applications, and other material information in the possession of OvaScience that would be reasonably useful to Intrexon in assessing the scope and status of such Patents for Joint Program Inventions or otherwise in preventing a loss of rights by Intrexon to any related Inventions that are Intrexon IP; (iv) provide Intrexon with reasonable advance notice if OvaScience decides to abandon (or otherwise not file for or pursue) any such Patents for

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Joint Program Inventions so as to enable Intrexon sufficient lead time to prevent an unwanted loss of rights by Intrexon to Intrexon IP, including allowing Intrexon to file on and prosecute Patents for such; (v) use qualified patent counsel reasonably acceptable to Intrexon; (vi) advise relevant OvaScience employees and agents as necessary to facilitate compliance with the obligations of this Section 6.2(c), including advising outside OvaScience patent counsel regarding the obligations of this sentence or any relevant protocols and procedures established by the IPC; and (vii) be solely responsible for all costs and expenses incurred by OvaScience in connection with the preparation, filing, prosecution and maintenance of Patents for Joint Program Inventions.  To the extent that OvaScience does not exercise the rights to conduct and direct under the prior sentence (including an abandonment under clause (iv) of the prior sentence), Intrexon shall have the option to assume the preparation, filing, prosecution and maintenance of Patents for Joint Program Inventions at its own discretion and expense, subject to Intrexon providing OvaScience in a timely manner with copies of all material correspondence regarding Joint Program Inventions to and from any foreign or domestic patent offices and patent prosecution counsel (including at a minimum any related drafts of patent applications, official responses, and other substantive communications and filings at least fifteen (15) days prior to any applicable deadline for review) for OvaScience comment and review prior to filing.  Intrexon and OvaScience shall reasonably cooperate in connection with such filing, prosecution, and maintenance under this Section 6.2(c), including with respect to executing and submitting and documents necessary to perfect the rights of the Parties.

 

(d)                                  As used in this Section 6.2(d), “ Prosecuting Party ” means Intrexon in the case of Intrexon Patents and OvaScience in the case of OvaScience Program Patents and Patents for Joint Program Inventions prosecuted by it pursuant to Section 6.2(c).  The Prosecuting Party shall be entitled to use patent counsel selected by it and reasonably acceptable to the non-Prosecuting Party (including in-house patent counsel as well as outside patent counsel) for the prosecution of the Intrexon Patents and OvaScience Program Patents, as applicable.  The Prosecuting Party shall:

 

(i)                                      regularly provide the other Party in advance with reasonable information relating to the Prosecuting Party’s prosecution of Patents hereunder, including by providing copies of substantive communications, notices and actions submitted to or received from the relevant patent authorities and copies of drafts of filings and correspondence that the Prosecuting Party proposes to submit to such patent authorities (it being understood that, to the extent that any such information is readily accessible to the public, the Prosecuting Party may, in lieu of directly providing copies of such information to such other Party, provide such other Party with sufficient information that will permit such other Party to access such information itself directly);

 

(ii)                                   consider in good faith and consult with the non-Prosecuting Party regarding its timely comments with respect to the same; provided, however, that if, within fifteen (15) days after providing any documents to the non-Prosecuting Party for comment, the Prosecuting Party does not receive any written communication from the non-Prosecuting Party indicating that it has or may have comments on such document, the Prosecuting Party shall be entitled to assume that the non-Prosecuting Party has no comments thereon;

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(iii)                                consult with the non-Prosecuting Party before taking any action that would reasonably be expected to have a material adverse impact on the scope of claims within the Intrexon Patents and OvaScience Program Patents, as applicable.

 

(e)                                   Without limiting the obligations of confidentiality, non-use, and non-disclosure under this Agreement, neither Party shall file any application for Patent that includes the Confidential Information, including data, Inventions, and other Information, of the other Party without the prior written consent of the other Party, or will publish any Confidential Information of another party or make any reference to another party or its intellectual property or materials as used in connection with any Research Project and/or Project Plan without the prior written consent of the other Party.

 

6.3                                         Infringement of Patents by Third Parties .

 

(a)                                  Except as expressly provided in the remainder of this Section 6.3, Intrexon shall have the sole right to take appropriate action against any person or entity directly or indirectly infringing any Intrexon Patent (or asserting that an Intrexon Patent is invalid or unenforceable) (collectively, “ Infringement ”), either by settlement or lawsuit or other appropriate action.

 

(b)                                  Notwithstanding the foregoing, OvaScience shall have the first right, but not the obligation, to take appropriate action to enforce Product-Specific Program Patents and/or Patents for Joint Program Inventions against any Infringement that in the reasonable judgment of OvaScience involves, or is reasonably expected to involve, a commercially material amount of allegedly infringing activities in the Field (“ Field Infringement ”) but not against any allegedly infringing activities in the JV Field, either by settlement or lawsuit or other appropriate action.  If OvaScience exercises the foregoing right, (i) Intrexon agrees to be named in any such action if required, and (ii) Ovascience agrees to provide Intrexon with a description of its basis for concluding that such Field Infringement exists.  If OvaScience fails to take the appropriate steps to enforce such against any Field Infringement within one hundred eighty (180) days of the date one Party has provided notice to the other Party pursuant to Section 6.3(g) of such Field Infringement, then Intrexon shall have the right (but not the obligation), at its own expense, to enforce such Patents against such Field Infringement, either by settlement or lawsuit or other appropriate action.  If Intrexon exercises the foregoing right with respect to Patents for Joint Program Inventions, OvaScience agrees to be named in any such action if required.

 

(c)                                   With respect to any Field Infringement that cannot reasonably be abated through the enforcement of Patents pursuant to Section 6.3(b) but can reasonably be abated through the enforcement of Intrexon Patent(s) (other than the Product-Specific Program Patents or jointly-owned Patents for Joint Program IP), Intrexon shall be obligated to choose one of the following courses of action: (i) enforce one or more of the applicable Intrexon Patent(s) in a commercially reasonable manner against such Field Infringement, or (ii) [***]. To the extent OvaScience shall be entitled to a share of the Recovery a set forth in Section 6.3(f), Intrexon and OvaScience shall bear the costs and expenses of such enforcement equally.  The determination of which Intrexon Patent(s) to assert shall be made by Intrexon in its sole discretion; provided, however, that Intrexon shall consult in good faith with OvaScience on such determination.  For

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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the avoidance of doubt, Intrexon has no obligations under this Agreement to enforce any Intrexon Patents against, or otherwise abate, any Infringement that is not a Field Infringement.

 

(d)                                  In the event a Party pursues an action under this Section 6.3, the other Party shall reasonably cooperate with the enforcing Party with respect to the investigation and prosecution of any alleged, threatened, or actual Infringement, at the enforcing Party’s expense (except with respect to an action under Section 6.3(c), where all costs and expenses will be shared equally in accordance with terms thereof).

 

(e)                                   OvaScience shall not settle or otherwise compromise any action under this Section 6.3 in a way that diminishes the rights or interests of Intrexon outside the Field (or in the JV Field) or adversely affects any Intrexon Patent (including any rights in a Patent for Joint Program Inventions) without Intrexon’s prior written consent, which consent shall not be unreasonably withheld.  Intrexon shall not settle or otherwise compromise any action under this Section 6.3 in a way that diminishes the rights or interests of OvaScience in the Field or adversely affects any Intrexon Patent (including any rights in a Patent for Joint Program Inventions) with respect to the Field without OvaScience’s prior written consent, which consent shall not be unreasonably withheld.

 

(f)                                    Except as otherwise agreed to by the Parties in writing, any settlements, damages or other monetary awards recovered pursuant to a suit, proceeding, or action brought pursuant to Section 6.3 will be allocated first to the costs and expenses of the Party controlling such action, and second, to the costs and expenses (if any) of the other Party (to the extent not otherwise reimbursed), and any remaining amounts (the “Recovery” ) will be shared by the Parties as follows:  In any action initiated by Intrexon pursuant to Section 6.3(a) that does not involve Field Infringement, or in any action initiated by Intrexon pursuant to Section 6.3(b), Intrexon shall retain one hundred percent (100%) of any Recovery.  In any action initiated by OvaScience pursuant to Section 6.3(b), OvaScience shall retain one hundred percent (100%) of any Recovery, but such Recovery shall be shared with Intrexon as Net Sales.  In any action initiated by Intrexon or OvaScience pursuant to Section 6.3(c), [***].

 

(g)                                  OvaScience shall promptly notify Intrexon of any suspected, alleged, threatened, or actual Infringement of which it becomes aware, and Intrexon shall promptly notify OvaScience of any suspected, alleged, threatened, or actual Field Infringement of which it becomes aware.

 

ARTICLE 7

 

CONFIDENTIALITY

 

7.1                                         Confidentiality .  Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties, each Party agrees that it shall keep confidential and shall not publish or otherwise disclose and shall not use for any purpose other than as provided for in this Agreement any Confidential Information disclosed to it by the other Party pursuant to this Agreement, except to the extent that the receiving Party can demonstrate by competent evidence that specific Confidential Information:

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

(a)                                  was already known to the receiving Party and can be demonstrated by written records, other than under an obligation of confidentiality, at the time of disclosure by the other Party;

 

(b)                                  was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;

 

(c)                                   became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement;

 

(d)                                  was disclosed to the receiving Party, other than under an obligation of confidentiality to a Third Party, by a Third Party who had no obligation to the disclosing Party not to disclose such information to others; or

 

(e)                                   was independently discovered or developed by the receiving Party without the use of Confidential Information belonging to the disclosing Party, as documented by the receiving Party’s written records.

 

The foregoing non-use and non-disclosure obligation shall continue (i) indefinitely, for all Confidential Information that qualifies as a trade secret under applicable law; or (ii) for the Term of this Agreement and for seven (7) years thereafter, in all other cases.

 

7.2                                         Authorized Disclosure .  Notwithstanding the limitations in this Article 7, either Party may disclose the Confidential Information belonging to the other Party to the extent such disclosure is reasonably necessary in the following instances:

 

(a)                                  complying with applicable laws or regulations or valid court orders, provided that the Party making such disclosure provides the other Party with reasonable prior written notice of such request or demand for disclosure and makes a reasonable effort to obtain, or to assist the other Party in obtaining, a protective order preventing or limiting the disclosure and/or requiring that the terms and conditions of this Agreement be used only for the purposes for which the law or regulation required, or for which the order was issued;

 

(b)                                  to regulatory authorities in order to seek or obtain approval to conduct clinical trials, or to gain regulatory approval, of Collaboration Products, Improved Products, or any products being developed by Intrexon or its other licensees and/or channel partners or collaborators to the extent Intrexon has a right to so use such Confidential Information under Sections 4.3 and/or 10.4, provided that the Party making such disclosure (i) provides the other Party with reasonable opportunity to review any such disclosure in advance and to suggest redactions or other means of limiting the disclosure of such other Party’s Confidential Information and (ii) does not unreasonably reject any such suggestions;

 

(c)                                   disclosure to investors and potential investors, acquirers, or merger candidates who agree to maintain the confidentiality of such information, provided that such

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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disclosure is used solely for the purpose of evaluating such investment, acquisition, or merger (as the case may be);

 

(d)                                  disclosure on a need-to-know basis to Affiliates, licensees, sublicensees, employees, consultants or agents (such as CROs and clinical investigators) who agree to be bound by obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Article 7; and

 

(e)                                   disclosure of the terms of this Agreement by either Party to collaborators and other channel partners or collaborators who agree to be bound by obligations of confidentiality, intellectual ownership and assignment, and non-use at least equivalent in scope to those set forth in this Article 7.

 

7.3                                         Publicity; Publications .  The Parties agree that the public announcement of the execution of this Agreement shall be substantially in the form of a press release (the form of which shall be mutually agreed to by the Parties) and/or the filing of a Form 8-K by one or both of the Parties (to the extent required by relevant laws or regulations relating to required disclosure of material information to public markets and/or the SEC).  Each Party will provide the other Party with the opportunity to review and comment, prior to submission or presentation, on external reports, securities filings, publications and presentations (e.g., press releases, reports to government agencies, abstracts, posters, manuscripts and oral presentations) that refer to this Agreement, the OPC Program, Collaboration Products, Improved Products, or programs that are approved by the JSC.  For such reports, publications, and presentations, the disclosing Party will provide the other Party at least fifteen (15) calendar days for review of the proposed submission or presentation.  In the case of a Form 8-K filing, such shall be provided to the non-filing Party by the filing party as soon as practicable prior to filing for review and comment.  For reports and manuscripts, the disclosing Party will provide the other Party at least thirty (30) days for review of the report or manuscript.  The presenting Party will act in good faith to incorporate the comments of the other Party and shall, in any event, redact any Confidential Information of the other Party and cooperate with the other Party to postpone such submissions or presentations if necessary to provide the other Party with sufficient time to prepare and file any related Patent applications before the submission or presentation occurs, as appropriate.

 

7.4                                         Terms of the Agreement .  Each Party shall treat the terms of this Agreement as the Confidential Information of other Party, subject to the exceptions set forth in Section 7.2.  Notwithstanding the foregoing, each Party acknowledges that the other Party may be obligated to file a copy of this Agreement with the SEC, either as of the Effective Date or at some point during the Term.  Each Party shall be entitled to make such a required filing, provided that it requests confidential treatment of certain commercial terms and sensitive technical terms hereof to the extent such confidential treatment is reasonably available to it.  In the event of any such filing, the filing Party shall provide the other Party with a copy of the Agreement marked to show provisions for which the filing Party intends to seek confidential treatment and shall reasonably consider and incorporate the other Party’s comments thereon to the extent consistent with the legal requirements governing redaction of information from material agreements that must be publicly filed.  The other Party shall promptly provide any such comments.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

7.5                                         Proprietary Information and Operational Audits.

 

(a)                                  For the purpose of confirming compliance with the Field-limited licenses granted in Article 3, the diligence obligations of Article 4, and the confidentiality obligations under Article 7, OvaScience acknowledges that Intrexon’s authorized representative(s), during regular business hours may (i) examine and inspect OvaScience’s facilities and (ii) inspect all data and work products relating to this Agreement, subject to restrictions imposed by applicable laws.  Any examination or inspection hereunder shall require five (5) business days written notice from Intrexon to OvaScience.  OvaScience will make itself and the pertinent employees and/or agents available, on a reasonable basis, to Intrexon for the aforementioned compliance review.  Intrexon may not request and examination or inspection under this Section 7.5(a)  more than once per year except if Intrexon has reasonable belief, upon inquiry, that OvaScience is in material non-compliance with the Field-limited licenses granted in Article 3, the diligence obligations of Article 4, and/or the confidentiality obligations under Article 7.  If Intrexon provides notice under this Section 7.5(a) less than one (1) year from its last examination or inspection hereunder, Intrexon must provide written basis in such notice for its reasonable belief of material non-compliance.

 

(b)                                  For the purpose of confirming compliance with the diligence obligations of Section 4.5, and the confidentiality obligations under Article 7, Intrexon acknowledges that OvaScience authorized representative(s), during regular business hours may (i) examine and inspect Intrexon’s facilities and (ii) inspect all data and work products relating to this Agreement.  Any examination or inspection hereunder shall require five (5) business days written notice from OvaScience to Intrexon.  Intrexon will make itself and the pertinent employees and/or agents available, on a reasonable basis, to OvaScience for the aforementioned compliance review.  OvaScience may not request and examination or inspection under this Section 7.5(b)  more than once per year except if OvaScience has reasonable belief, upon inquiry, that Intrexon is in material non-compliance with the diligence obligations of Section 4.5 and/or the confidentiality obligations under Article 7.  If OvaScience provides notice under this Section 7.5(a) less than one (1) year from its last examination or inspection hereunder, OvaScience must provide written basis in such notice for its reasonable belief of material non-compliance.

 

(c)                                   In view of the Intrexon Confidential Information, Intrexon Know-How, and Intrexon Materials transferred to OvaScience hereunder, Intrexon from time-to-time, but no more than quarterly, may request that OvaScience confirm the status of the Intrexon Materials at OvaScience (i.e. how much used, how much shipped, to whom and any unused amounts destroyed (by whom, when) as well as any amounts returned to Intrexon or destroyed).  Within ten (10) business days of OvaScience’s receipt of any such written request, OvaScience shall provide the written report to Intrexon.

 

7.6                                         Intrexon Commitment .  Intrexon shall use reasonable efforts to obtain an agreement with its other licensees and channel partners or collaborators to enable OvaScience to disclose confidential information of such licensees and channel partners or collaborators to regulatory authorities in order to seek or obtain approval to conduct clinical trials, or to gain regulatory approval of, Collaboration Products, in a manner consistent with the provisions of Section 7.2(b).

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

ARTICLE 8

 

REPRESENTATIONS AND WARRANTIES

 

8.1                                         Representations and Warranties of OvaScience .  OvaScience hereby represents and warrants to Intrexon that, as of the Effective Date:

 

(a)                                  Corporate Power .  OvaScience is duly organized and validly existing under the laws of Delaware and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof.

 

(b)                                  Due Authorization .  OvaScience is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the person executing this Agreement on OvaScience’s behalf has been duly authorized to do so by all requisite corporate action.

 

(c)                                   Binding Agreement .  This Agreement is a legal and valid obligation binding upon OvaScience and enforceable in accordance with its terms, except as such enforcement may be limited by applicable bankruptcy, insolvency, reorganization, arrangement, moratorium or other similar laws affecting creditors’ rights, and subject to general equity principles and to limitations on availability of equitable relief, including specific performance.  The execution, delivery and performance of this Agreement by OvaScience does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound.  OvaScience is aware of no action, suit or inquiry or investigation instituted by any governmental agency which questions or threatens the validity of this Agreement.

 

8.2                                         Representations and Warranties of Intrexon .  Intrexon hereby represents and warrants to OvaScience that, as of the Effective Date:

 

(a)                                  Corporate Power .  Intrexon is duly organized and validly existing under the laws of Virginia and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof.

 

(b)                                  Due Authorization .  Intrexon is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the person executing this Agreement on Intrexon’s behalf has been duly authorized to do so by all requisite corporate action.

 

(c)                                   Binding Agreement .  This Agreement is a legal and valid obligation binding upon Intrexon and enforceable in accordance with its terms, except as such enforcement may be limited by applicable bankruptcy, insolvency, reorganization, arrangement, moratorium or other similar laws affecting creditors’ rights, and subject to general equity principles and to limitations on availability of equitable relief, including specific performance.  The execution, delivery and performance of this Agreement by Intrexon does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Intrexon is aware of no action, suit or inquiry or investigation instituted by any governmental agency which questions or threatens the validity of this Agreement.

 

(d)                                  Additional Intellectual Property Representations .

 

(i)                                      Intrexon possesses sufficient rights to enable Intrexon to grant all rights and licenses it purports to grant to OvaScience with respect to the Intrexon Patents under this Agreement;

 

(ii)                                   The Intrexon Patents existing as of the Effective Date constitute all of the Patents Controlled by Intrexon as of such date that are necessary for the development, manufacture and Commercialization of Collaboration Products;

 

(iii)                                Intrexon has not granted, and during the Term Intrexon will not grant, any right or license, to any Third Party under the Intrexon IP that conflicts with the rights or licenses granted or to be granted to OvaScience hereunder;

 

(iv)                               There is no pending litigation, and Intrexon has not received any written notice of any claims or litigation, seeking to invalidate or otherwise challenge the Intrexon Patents or Intrexon’s rights therein;

 

(v)                                  None of the Intrexon Patents is subject to any pending re-examination, opposition, interference or litigation proceedings;

 

(vi)                               All of the Intrexon Patents have been filed and prosecuted in accordance with all Applicable Laws and have been maintained, with all applicable fees with respect thereto (to the extent such fees have come due) having been paid;

 

(vii)                            Intrexon has entered into agreements with each of its current and former officers, employees and consultants involved in research and development work, including development of Intrexon IP, providing Intrexon, to the extent permitted by law, with title and ownership to patents, patent applications, trade secrets and inventions conceived, developed, reduced to practice by such person, solely or jointly with other of such persons, during the period of employment or contract by Intrexon (except where the failure to have entered into such an agreement would not have a material adverse effect on the rights granted to OvaScience herein), and Intrexon is not aware that any of its employees or consultants is in material violation thereof;

 

(viii)                         To Intrexon’s knowledge, there is no infringement, misappropriation or violation by Third Parties of any Intrexon Channel Technology or Intrexon IP in the Field;

 

(ix)                               There is no pending or, to Intrexon’s knowledge, threatened action, suit, proceeding or claim by others against Intrexon that Intrexon infringes, misappropriates or otherwise violates any intellectual property or other proprietary rights of others in connection with the use of the Intrexon Channel Technology or Intrexon IP, and Intrexon has not received any written notice of such claim;

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

(x)                                  To Intrexon’s knowledge, no employee of Intrexon is the subject of any claim or proceeding involving a violation of any term of any employment contract, patent disclosure agreement, invention assignment agreement, non-competition agreement, non-solicitation agreement, non-disclosure agreement or any restrictive covenant to or with a former employer (A) where the basis of such violation relates to such employee’s employment with Intrexon or actions undertaken by the employee while employed with Intrexon and (B) where such violation is relevant to the use of the Intrexon Channel Technology in the Field;

 

(xi)                               None of the Intrexon Patents owned by Intrexon or its Affiliates, and, to Intrexon’s knowledge, the Intrexon Patents licensed to Intrexon or its Affiliates, have been adjudged invalid or unenforceable by a court of competent jurisdiction or applicable government agency, in whole or in part, and there is no pending or, to Intrexon’s knowledge, threatened action, suit, proceeding or claim by others challenging the validity or scope of any such Intrexon Patents; and

 

(xii)                            Except as otherwise disclosed in writing to OvaScience, Intrexon:  (A) is in material compliance with all statutes, rules or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product that is under development, manufactured or distributed by Intrexon in the Field (“ Applicable Laws ”); (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the United States Food and Drug Administration (the “ FDA ”) or any other federal, state, local or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“ Authorizations ”), which would, individually or in the aggregate, result in a material adverse effect on the rights granted to OvaScience hereunder or Intrexon’s ability to perform its obligations hereunder; (C) possesses all material Authorizations necessary for the operation of its business in the Field and such Authorizations are valid and in full force and effect and Intrexon is not in material violation of any term of any such Authorizations; and (D) since January 1, 2011, (1) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any other federal, state, local or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit investigation or proceeding; (2) has not received notice that the FDA or any other federal, state, local or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any other federal, state, local or foreign governmental or regulatory authority is considering such action; (3) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (4) has not, either voluntarily or

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to Intrexon’s knowledge, no third party has initiated, conducted or intends to initiate any such notice or action.

 

except, in each of (ix) through (xii), for any instances which would not, individually or in the aggregate, result in a material adverse effect on the rights granted to OvaScience hereunder or Intrexon’s ability to perform its obligations hereunder.

 

8.3                                         Warranty Disclaimer .  EXCEPT FOR THE EXPRESS WARRANTIES PROVIDED IN THIS ARTICLE 8, EACH PARTY HEREBY DISCLAIMS ANY AND ALL OTHER WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF TITLE, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.

 

ARTICLE 9

 

INDEMNIFICATION

 

9.1                                         Indemnification by Intrexon .  Intrexon agrees to indemnify, hold harmless, and defend OvaScience and its Affiliates and their respective directors, officers, employees, and agents (collectively, the “ OvaScience Indemnitees ”) from and against any and all liabilities, damages, costs, expenses, or losses (including reasonable legal expenses and attorneys’ fees) (collectively, “ Losses ”) resulting from any claims, suits, actions, demands, or other proceedings brought by a Third Party (collectively, “ Claims ”) to the extent arising from (a) the gross negligence or willful misconduct of Intrexon or any of its Affiliates, or their respective employees or agents, (b) the use, handling, storage or transport of Intrexon Materials by or on behalf of Intrexon or its Affiliates, licensees (other than OvaScience) or sublicensees; or (c) the breach by Intrexon of any representation, warranty or covenant in this Agreement.  Notwithstanding the foregoing, Intrexon shall not have any obligation to indemnify the OvaScience Indemnitees to the extent that a Claim arises from (i) the gross negligence or willful misconduct of OvaScience or any of its Affiliates, licensees, or sublicensees, or their respective employees or agents; or (ii) a breach by OvaScience of a representation, warranty, or covenant of this Agreement.

 

9.2                                         Indemnification by OvaScience .  OvaScience agrees to indemnify, hold harmless, and defend Intrexon, its Affiliates and Third Security, and their respective directors, officers, employees, and agents (and any Third Parties which have licensed to Intrexon intellectual property rights within Intrexon IP on or prior to the Effective Date, to the extent required by the relevant upstream license agreement) (collectively, the “ Intrexon Indemnitees ”) from and against any Losses resulting from Claims, to the extent arising from any of the following:  (a) the gross negligence or willful misconduct of OvaScience or any of its Affiliates or their respective employees or agents; (b) the use, handling, storage, or transport of Intrexon Materials by or on behalf of OvaScience or its Affiliates, licensees, or sublicensees; (c) the

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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breach by OvaScience of any material representation, warranty or covenant in this Agreement; or (d) the design, development, manufacture, regulatory approval, handling, storage, transport, distribution, sale or other disposition of any Collaboration Product or Improved Product by or on behalf of OvaScience or its Affiliates, licensees, or sublicensees.  Notwithstanding the foregoing, OvaScience shall not have any obligation to indemnify the Intrexon Indemnitees to the extent that a Claim arises from (i) the gross negligence or willful misconduct of Intrexon or any of its Affiliates, or their respective employees or agents; or (ii) a breach by Intrexon of a representation, warranty, or covenant of this Agreement.

 

9.3                                         Product Liability Claims .  Notwithstanding the provisions of Section 9.2, any Losses arising out of any Claim covered by Section 9.2(d) that exceed the amount (if any) covered by the applicable Party’s product liability insurance (“ Excess Product Liability Costs ”), shall be paid by [***], except to the extent such Losses arise out of any Third-Party Claim based on the gross negligence or willful misconduct of a Party, its Affiliates, or its Affiliates’ sublicensees, or any of the respective officers, directors, employees and agents of each of the foregoing entities, in the performance of obligations or exercise of rights under this Agreement.

 

9.4                                         Control of Defense .  As a condition precedent to any indemnification obligations hereunder, any entity entitled to indemnification under this Article 9 shall give written notice to the indemnifying Party of any Claims that may be subject to indemnification, promptly after learning of such Claim.  If such Claim falls within the scope of the indemnification obligations of this Article 9, then the indemnifying Party shall assume the defense of such Claim with counsel reasonably satisfactory to the indemnified Party.  The indemnified Party shall cooperate with the indemnifying Party in such defense.  The indemnified Party may, at its option and expense, be represented by counsel of its choice in any action or proceeding with respect to such Claim.  The indemnifying Party shall not be liable for any litigation costs or expenses incurred by the indemnified Party without the indemnifying Party’s written consent, such consent not to be unreasonably withheld.  The indemnifying Party shall not settle any such Claim if such settlement (a) does not fully and unconditionally release the indemnified Party from all liability relating thereto or (b) adversely impacts the exercise of the rights granted to the indemnified Party under this Agreement, unless the indemnified Party otherwise agrees in writing.

 

9.5                                         Insurance .  Immediately prior to, and during marketing of Collaboration Products or Improved Products, OvaScience shall maintain in effect and good standing a product liability insurance policy issued by a reputable insurance company in amounts considered standard for the industry.  Immediately prior to, and during the conduct of any clinical trials, OvaScience shall maintain in effect and good standing a clinical trials liability insurance policy issued by a reputable insurance company in amounts considered standard for the industry.  At Intrexon’s reasonable request, OvaScience shall provide Intrexon with all details regarding such policies, including without limitation copies of the applicable liability insurance contracts.  OvaScience shall use reasonable efforts to include Intrexon as an additional insured on any such policies.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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ARTICLE 10

 

TERM; TERMINATION

 

10.1                                  Term .  The term of this Agreement shall commence upon the Effective Date and shall continue until terminated pursuant to Section 10.2 or 10.3 (the “ Term ”).

 

10.2                                  Termination for Material Breach; Termination under Section 4.4(b)

 

(a)                                  Either Party shall have the right to terminate this Agreement upon written notice to the other Party if the other Party commits any material breach of this Agreement that such breaching Party fails to cure within sixty (60) days following written notice from the nonbreaching Party specifying such breach.

 

(b)                                  Intrexon shall have the right to terminate this Agreement, at its sole discretion, if the Technology Access Fee has not been paid in accordance with Section 5.1 (including the obtaining of any necessary shareholder, member, exchange, and/or board of director approvals of OvaScience and issuance of shares per the Equity Agreement should OvaScience elect to issue stock to Intrexon under Section 5.1).

 

(c)                                   Intrexon shall have the right to terminate this Agreement under the circumstances set forth in Section 4.4(b) upon written notice to OvaScience, such termination to become effective sixty (60) days following such written notice unless OvaScience remedies the circumstances giving rise to such termination within such sixty (60) day period.

 

(d)                                  Intrexon shall have the right to terminate this Agreement should OvaScience execute any purported assignment of this Agreement contrary to the prohibitions in Section 12.8, such termination occurring upon Intrexon providing written notice to OvaScience and becoming effective immediately upon such written notice.

 

10.3                                  Termination by OvaScience .  OvaScience shall have the right to voluntarily terminate this Agreement in its entirety upon ninety (90) days written notice to Intrexon at any time.

 

10.4                                  Effect of Termination .  In the event of termination of this Agreement pursuant to Section 10.2 or Section 10.3, the following shall apply:

 

(a)                                  Retained Products .  OvaScience (including any Product Sublicensees) shall be permitted to continue the clinical development and Commercialization in the Field (but not the JV Field) of any product resulting from the OPC Program that, at the time of any termination satisfies at least one of the following criteria (a “ Retained Product ”):

 

(i)                                      the particular product is an Improved Product,

 

(ii)                                   the particular product is a Collaboration Product that is being sold by OvaScience (or, as may be permitted under this Agreement, its Affiliates and, if applicable, (sub)licensees) triggering profit sharing payments therefor under Section 5.2(a) or (b) of this

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Agreement,

 

(iii)                                the particular product is a Collaboration Product that has received regulatory approval,

 

(iv)                               the particular product is a Collaboration Product that is the subject of an application for regulatory approval in the Field (but not the JV Field) that is pending before the applicable regulatory authority,

 

(v)                                  the particular product is a Collaboration Product that is the subject of an effective IND,

 

(vi)                               the particular product is a Collaboration Product that is the subject of an ongoing pivotal animal model efficacy study established by the JSC as being the final pre-clinical animal study prior to preparation and submission of an IND, and such study is reasonably expected to supply all remaining information and data sufficient for successful submission of such IND, or

 

(vii)                            the particular product is an OvaTure Product.

 

(b)                                  Such right to continue development and Commercialization shall be subject to OvaScience’s full compliance with the payment provisions in Article 5, a continuing obligation for OvaScience to use in accord with Sections 4.4(a) and 4.4(c) Diligent Efforts to develop and Commercialize any Retained Products, and all other provisions of this Agreement that survive termination.

 

(c)                                   Termination of Licenses .  Except as necessary for OvaScience to continue to obtain regulatory approval for, develop, use, manufacture and Commercialize the Retained Products in the Field as permitted by Section 10.4(a), all rights and licenses granted by Intrexon to OvaScience under this Agreement shall terminate and shall revert to Intrexon without further action by either Intrexon or OvaScience.  OvaScience’s license with respect to Retained Products shall be exclusive or non-exclusive, as the case may be, on the same terms as set forth in Section 3.1.

 

(d)                                  Reverted Candidates/Products .  Any Collaboration Product that does not qualify as a Retained Product under Section 10.4(a) shall be referred to herein as the “ Reverted Candidates/Products .”  OvaScience shall immediately cease, and shall cause its Affiliates and, if applicable, (sub)licensees to immediately cease, all development and Commercialization of the Reverted Candidates/Products, and OvaScience shall not use or practice, nor shall it cause or permit any of its Affiliates or, if applicable, (sub)licensees to use or practice, directly or indirectly, any Intrexon IP with respect to the Reverted Candidates/Products.  OvaScience shall immediately discontinue making any representation regarding its status as a licensee or channel collaborator of Intrexon with respect to the Reverted Candidates/Products.

 

(e)                                   Intrexon Materials .  OvaScience shall promptly return, or at Intrexon’s request, destroy, any Intrexon Materials in OvaScience’s possession or control at the time of

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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termination other than any Intrexon Materials necessary for the continued development, regulatory approval, use, manufacture and Commercialization of the Retained Products in the Field.

 

(f)                                    Licenses to Intrexon .  OvaScience is automatically deemed to grant to Intrexon a worldwide, fully paid, royalty-free, exclusive (even as to OvaScience and its Affiliates), irrevocable, license (with full rights to sublicense) under the OvaScience Termination IP, to make, have made, import, use, offer for sale and sell Reverted Candidates/Products, subject to any exclusive rights held by OvaScience in Reverted Candidates/Products pursuant to Section 10.4(c).  The Parties shall also take such actions and execute such other instruments and documents as may be reasonably necessary to document such license to Intrexon.

 

(g)                                  Regulatory Filings .  OvaScience shall promptly assign to Intrexon, and will provide full copies of, all regulatory approvals and regulatory filings that relate specifically and solely to Reverted Candidates/Products.  OvaScience shall also take such actions and execute such other instruments, assignments and documents as may be necessary to affect the transfer of rights thereunder to Intrexon.  To the extent that there exist any regulatory approvals and regulatory filings that relate both to Reverted Candidates/Products and other products, OvaScience shall provide copies of the portions of such regulatory filings that relate to Reverted Candidates/Products and shall reasonably cooperate to assist Intrexon in obtaining the benefits of such regulatory approvals with respect to the Reverted Candidates/Products.

 

(h)                                  Data Disclosure .  OvaScience shall provide to Intrexon copies of the relevant portions of all material reports and data, including clinical and non-clinical data and reports, obtained or generated by or on behalf of OvaScience or its Affiliates to the extent that they relate specifically to Reverted Candidates/Products, within sixty (60) days of such termination unless otherwise agreed, and Intrexon shall have the right to use any such Information solely in developing and commercializing Reverted Candidates/Products and to license any Third Parties to do so.

 

(i)                                     Third Party Licenses .  At Intrexon’s request, OvaScience shall promptly provide to Intrexon copies of all Third Party agreements under which OvaScience or its Affiliates obtained a license under Patents claiming inventions or know-how specific to or used or incorporated into the development, manufacture and/or commercialization of the Reverted Candidates/Products.  At Intrexon’s request, OvaScience shall use reasonable commercial efforts to promptly work with Intrexon to either, as appropriate (i) assign to Intrexon the Third Party agreement(s), or (ii) grant a sublicense (with an appropriate scope) to Intrexon under the Third Party agreement(s).  Thereafter Intrexon shall be fully responsible for all obligations due for its actions under the sublicensed or assigned Third Party agreements.  .

 

(j)                                     Remaining Materials .  At the request of Intrexon, OvaScience shall transfer to Intrexon any quantities of Reverted Product (including final products or work-in-process) in the possession of OvaScience or its Affiliates.  OvaScience shall transfer to Intrexon all such quantities of Reverted Candidates/Products without charge, except that Intrexon shall pay the reasonable costs of processing and shipping.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(k)                                  Third Party Vendors .  At Intrexon’s request, OvaScience shall promptly provide to Intrexon copies of all agreements between OvaScience or its Affiliates and Third Party suppliers, vendors, or distributors that relate solely to the supply, sale, or distribution of Reverted Candidates/Products in the Territory.  At Intrexon’s request, OvaScience shall with respect to such Third Party agreements relating solely to the applicable Reverted Candidates/Products and permitting assignment, promptly assign (or cause to be assigned), such agreements to Intrexon.  .  For the avoidance of doubt, Intrexon shall have no obligation to assume any of OvaScience’s obligations under any Third Party agreement.

 

(l)                                     Commercialization .  Nothing in this Agreement shall be deemed to limit the right of Intrexon to develop and commercialize the Reverted Candidates/Products itself or with one or more Third Parties, and/or to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

 

(m)                              Confidential Information .  Each Party shall promptly return, or at the other Party’s request destroy, any Confidential Information of the other Party in such Party’s possession or control at the time of termination; provided, however, that each Party shall be permitted to retain (i) a single copy of each item of Confidential Information of the other Party in its confidential legal files for the sole purpose of monitoring and enforcing its compliance with Article 7, (ii) Confidential Information of the other Party that is maintained as archive copies on the recipient Party’s disaster recovery and/or information technology backup systems, or (iii) Confidential Information of the other Party necessary to exercise such Party’s rights in Retained Products (in the case of OvaScience) or Reverted Candidates/Products (in the case of Intrexon). The recipient of Confidential Information shall continue to be bound by the terms and conditions of this Agreement with respect to any such Confidential Information retained in accordance with this Section 10.4(l).

 

(n)                                  The second installment payment of the Technology Access Fee as set forth in Section 5.1 will not be due to Intrexon if (A) OvaScience terminates this Agreement in accord with the above Section 10.2(a) due to an uncured material breach by Intrexon, and (B) such termination is effective prior to the one-year anniversary of the Effective Date.

 

(o)                                  Any Product Sublicensee that is not itself in material breach of its applicable Product Sublicense (including any terms of this Agreement to which to they are required to comply via such Product Sublicense), may upon any termination of this Agreement have the right to obtain upon request to Intrexon in writing a direct license from Intrexon under the terms and conditions of the Product Sublicense, provided, however, that Intrexon may refuse, in its reasonable discretion, to grant such a direct license to any Product Sublicensee that is an Affiliate of any other entity (including OvaScience, its Affiliates, or its sublicensee) that is itself in material breach.

 

10.5                                  Surviving Obligations .  Termination or expiration of this Agreement shall not affect any rights of either Party arising out of any event or occurrence prior to termination, including, without limitation, any obligation of OvaScience to pay any amount which became due and payable under the terms and conditions of this Agreement prior to expiration or such termination.  The following portions of this Agreement shall survive termination or expiration of

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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this Agreement:  Sections 3.1 (as applicable with respect to 10.4(b)), 5.2-5.11, 6.1, 6.2 (with subsection (c) surviving only to the extent relating to Intrexon Patents that are relevant to Retained Products that, to Intrexon’s knowledge, are being developed or Commercialized at such time, if any), 7.1, 7.2, 7.4, 7.5, 10.4, and 10.5; Articles 9, 11, and 12; and any relevant definitions in Article 1.  Further, Article 7 and Sections 4.4(a), 4.4(c), 5.2 through 5.11, and 9.5 will survive termination of this Agreement to the extent there are applicable Retained Products.

 

ARTICLE 11

 

DISPUTE RESOLUTION

 

11.1                                  Disputes .  It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation.  In the event of any disputes, controversies or differences which may arise between the Parties out of or in relation to or in connection with this Agreement (other than disputes arising from a Committee), including, without limitation, any alleged failure to perform, or breach, of this Agreement, or any issue relating to the interpretation or application of this Agreement, then upon the request of either Party by written notice, the Parties agree to meet and discuss in good faith a possible resolution thereof, which good faith efforts shall include at least one in-person meeting between the Executive Officers of each Party.  If the matter is not resolved within thirty (30) days following the written request for discussions, either Party may then invoke the provisions of Section 11.2.  For the avoidance of doubt, any disputes, controversies or differences arising from a Committee pursuant to Article 2 shall be resolved solely in accordance with Section 2.4.

 

11.2                                  Arbitration .  Any dispute, controversy, difference or claim which may arise between the Parties and not from a Committee, out of or in relation to or in connection with this Agreement (including, without limitation, arising out of or relating to the validity, construction, interpretation, enforceability, breach, performance, application or termination of this Agreement) that is not resolved pursuant to Section 11.1 shall, subject to Section 11.10, be settled by binding “baseball arbitration” as follows.  Either Party, following the end of the thirty (30) day period referenced in Section 11.1, may refer such issue to arbitration by submitting a written notice of such request to the other Party, with the arbitration to be held in the state where the other Party’s principal office is located (or some other place as may be mutually agreed by the Parties).  Promptly following receipt of such notice, the Parties shall meet and discuss in good faith and seek to agree on an arbitrator to resolve the issue, which arbitrator shall be neutral and independent of both Parties and all of their respective Affiliates, shall have significant experience and expertise in licensing and partnering agreements in the pharmaceutical and biotechnology industries, and shall have some experience in mediating or arbitrating issues relating to such agreements.  If the Parties cannot agree on a single arbitrator within fifteen (15) days of request by a Party for arbitration, then each Party shall select an arbitrator meeting the foregoing criteria and the two (2) arbitrators so selected shall select within ten (10) days of their appointment a third arbitrator meeting the foregoing criteria.  Within fifteen (15) days after an arbitrator(s) is selected (in the case of the three-person panel, when the third arbitrator is selected), each Party will deliver to both the arbitrator(s) and the other Party a detailed written proposal setting forth its proposed terms for the resolution for the matter at issue (the “ Proposed Terms ” of the Party)

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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and a memorandum (the “ Support Memorandum ”) in support thereof.  The Parties will also provide the arbitrator(s) a copy of this Agreement, as it may be amended at such time.  Within fifteen (15) days after receipt of the other Party’s Proposed Terms and Support Memorandum, each Party may submit to the arbitrator(s) (with a copy to the other Party) a response to the other Party’s Support Memorandum.  Neither Party may have any other communications (either written or oral) with the arbitrator(s) other than for the sole purpose of engaging the arbitrator or as expressly permitted in this Section 11.2; provided that, the arbitrator(s) may convene a hearing if the arbitrator(s) so chooses to ask questions of the Parties and hear oral argument and discussion regarding each Party’s Proposed Terms.  Within sixty (60) days after the arbitrator’s appointment, the arbitrator(s) will select one of the two Proposed Terms (without modification) provided by the Parties that he or she believes is most consistent with the intention underlying and agreed principles set forth in this Agreement.  The decision of the arbitrator(s) shall be final, binding, and unappealable.  For clarity, the arbitrator(s) must select as the only method to resolve the matter at issue one of the two sets of Proposed Terms, and may not combine elements of both Proposed Terms or award any other relief or take any other action.

 

11.3           Governing Law .  This Agreement shall be governed by and construed under the substantive laws of the State of New York, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction.

 

11.4           Award .  Any award to be paid by one Party to the other Party as determined by the arbitrator(s) as set forth above under Section 11.2 shall be promptly paid in United States dollars free of any tax, deduction or offset; and any costs, fees or taxes incident to enforcing the award shall, to the maximum extent permitted by law, be charged against the losing Party.  Each Party agrees to abide by the award rendered in any arbitration conducted pursuant to this Article 11, and agrees that, subject to the United States Federal Arbitration Act, 9 U.S.C. §§ 1-16, judgment may be entered upon the final award in any United States District Court located in New York and that other courts may award full faith and credit to such judgment in order to enforce such award.  The award shall include interest from the date of any damages incurred for breach of the Agreement, and from the date of the award until paid in full, at a rate fixed by the arbitrator(s).  With respect to money damages, nothing contained herein shall be construed to permit the arbitrator(s) or any court or any other forum to award consequential, incidental, special, punitive or exemplary damages.  By entering into this agreement to arbitrate, the Parties expressly waive any claim for consequential, incidental, special, punitive or exemplary damages.  The only damages recoverable under this Agreement are direct compensatory damages.

 

11.5           Costs .  Each Party shall bear its own legal fees.  The arbitrator(s) shall assess his or her costs, fees and expenses against the Party losing the arbitration.

 

11.6           Injunctive Relief .  Nothing in this Article 11 will preclude either Party from seeking equitable relief or interim or provisional relief from a court of competent jurisdiction, including a temporary restraining order, preliminary injunction or other interim equitable relief, concerning a dispute either prior to or during any arbitration if necessary to protect the interests of such Party or to preserve the status quo pending the arbitration proceeding.  Specifically, the Parties agree that a material breach by either Party of its obligations in Section 3.5 or Article 7 of

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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this Agreement may cause irreparable harm to the other Party, for which damages may not be an adequate remedy.  Therefore, in addition to its rights and remedies otherwise available at law, including, without limitation, the recovery of damages for breach of this Agreement, upon an adequate showing of material breach of such Section 3.5 or Article 7, and without further proof of irreparable harm other than this acknowledgement, such non-breaching Party shall be entitled to seek (a) immediate equitable relief, specifically including, but not limited to, both interim and permanent restraining orders and injunctions, without bond, and (b) such other and further equitable relief as the court may deem proper under the circumstances.  For the avoidance of doubt, nothing in this Section 11.6 shall otherwise limit a breaching Party’s opportunity to cure a material breach as permitted in accordance with Section 10.2.

 

11.7           Confidentiality .  The arbitration proceeding shall be confidential and the arbitrator(s) shall issue appropriate protective orders to safeguard each Party’s Confidential Information.  Except as required by law, no Party shall make (or instruct the arbitrator(s) to make) any public announcement with respect to the proceedings or decision of the arbitrator(s) without prior written consent of the other Party.  The existence of any dispute submitted to arbitration, and the award, shall be kept in confidence by the Parties and the arbitrator(s), except as required in connection with the enforcement of such award or as otherwise required by applicable law.

 

11.8           Survivability .  Any duty to arbitrate under this Agreement shall remain in effect and be enforceable after termination of this Agreement for any reason.

 

11.9           Jurisdiction .  For the purposes of this Article 11, the Parties acknowledge their diversity and agree to accept the jurisdiction of any United States District Court located in New York for the purposes of enforcing or appealing any awards entered pursuant to this Article 11 and for enforcing the agreements reflected in this Article 11 and agree not to commence any action, suit or proceeding related thereto except in such courts.

 

11.10         Patent Disputes .  Notwithstanding any other provisions of this Article 11, and subject to the provisions of Section 6.2, any dispute, controversy or claim relating to the scope, validity, enforceability or infringement of any Intrexon Patents shall be submitted to a court of competent jurisdiction in the country in which such Patent was filed or granted.

 

ARTICLE 12

 

GENERAL PROVISIONS

 

12.1           Use of Name .  No right, express or implied, is granted by this Agreement to either Party to use in any manner the name of the other or any other trade name or trademark of the other in connection with the performance of this Agreement, except that (a) either Party may use the name of the other Party as required by law or regulation and in press releases accompanying quarterly and annual earnings reports approved by the issuer’s Board of Directors, and (b) OvaScience may use the Intrexon Trademarks in accord with licenses and restrictions set forth herein.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

12.2           LIMITATION OF LIABILITY .  NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.  NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS PARAGRAPH IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER ARTICLE 9, OR DAMAGES AVAILABLE FOR BREACHES OF THE OBLIGATIONS SET FORTH IN ARTICLE 7

 

12.3           Independent Parties .  The Parties are not employees or legal representatives of the other Party for any purpose.  Neither Party shall have the authority to enter into any contracts in the name of or on behalf of the other Party.  This Agreement shall not constitute, create, or in any way be interpreted as a joint venture, partnership, or business organization of any kind.

 

12.4           Notice .  All notices, including notices of address change, required or permitted to be given under this Agreement shall be in writing and deemed to have been given when delivered if personally delivered or sent by facsimile (provided that the party providing such notice promptly confirms receipt of such transmission with the other party by telephone), on the business day after dispatch if sent by a nationally-recognized overnight courier and on the third business day following the date of mailing if sent by certified mail, postage prepaid, return receipt requested. All such communications shall be sent to the address or facsimile number set forth below (or any updated addresses or facsimile number communicated to the other Party in writing):

 

If to Intrexon:

Intrexon Corporation

20374 Seneca Meadows Parkway

Germantown, MD 20876

Attention: Chief Legal Officer

email: dlehr@intrexon.com

 

 

If to OvaScience:

OvaScience, Inc.

215 First Street

Suite 240 Cambridge, MA 02142

Attention: Chief Executive Officer

email: mdipp@ovascience.com

 

 

12.5           Severability .  In the event any provision of this Agreement is held to be invalid or unenforceable, the valid or enforceable portion thereof and the remaining provisions of this Agreement will remain in full force and effect.

 

12.6           Waiver .  Any waiver (express or implied) by either Party of any breach of this Agreement shall not constitute a waiver of any other or subsequent breach.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

12.7           Entire Agreement; Amendment .  This Agreement, including any exhibits attached hereto, constitute the entire, final, complete and exclusive agreement between the Parties and supersede all previous agreements or representations, written or oral, with respect to the subject matter of this Agreement (including any prior confidentiality agreement between the Parties).  All information of Intrexon or OvaScience to be kept confidential by the other Party under any prior confidentiality agreement, as of the Effective Date, shall be maintained as Confidential Information by such other Party under the obligations set forth in Article 7 of this Agreement.  This Agreement may not be modified or amended except in a writing signed by a duly authorized representative of each Party.

 

12.8           Non-assignability; Binding on Successors .  Any attempted assignment of the rights or delegation of the obligations under this Agreement shall be void without the prior written consent of the non-assigning or non-delegating Party; provided, however, that either Party may assign its rights or delegate its obligations under this Agreement without such consent (a) to an Affiliate of such Party or (b) to its successor in interest in connection with any merger, acquisition, consolidation, corporate reorganization, or similar transaction, or sale of all or substantially all of its assets to which this Agreement relates, provided that such assignee agrees in writing to assume and be bound by the assignor’s obligations under this Agreement.  This Agreement shall be binding upon, and inure to the benefit of, the successors, executors, heirs, representatives, administrators and permitted assigns of the Parties.  Notwithstanding the foregoing, in the event that either Party assigns this Agreement to its successor in interest by way of merger, acquisition, consolidation, corporate reorganization, or similar transaction, or sale of all or substantially all of its assets to which this Agreement relates (whether this Agreement is actually assigned or is assumed by such successor in interest or its affiliate by operation of law (e.g., in the context of a reverse triangular merger)), the intellectual property rights of such successor in interest or any of its Affiliates other than those licensed in this Agreement shall be automatically excluded from the rights licensed to the other Party under this Agreement.

 

12.9           Force Majeure .  Neither Party shall be liable to the other for its failure to perform any of its obligations under this Agreement, except for payment obligations, during any period in which such performance is delayed because rendered impracticable or impossible due to circumstances beyond its reasonable control, including without limitation earthquakes, governmental regulation, fire, flood, labor difficulties, civil disorder, acts of terrorism and acts of God, provided that the Party experiencing the delay promptly notifies the other Party of the delay.

 

12.10         No Other Licenses .  Neither Party grants to the other Party any rights or licenses in or to any intellectual property, whether by implication, estoppel, or otherwise, except to the extent expressly provided for under this Agreement.

 

12.11         Non-Solicitation . During the Term and for a period of one (1) year following the end of the Term, neither OvaScience nor Intrexon may directly or indirectly solicit in order to offer to employ, engage in any discussion regarding employment with, or hire any employee of the other Party or an individual who was employed by the other party within one (1) year prior to such solicitation, discussion, or hire, without the prior approval of such other Party.  General

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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employment solicitations or advertisements shall not be considered direct or indirect solicitations, and are not prohibited under this Agreement.

 

12.12         Legal Compliance .  The Parties shall review in good faith and cooperate in taking such actions to ensure compliance of this Agreement with all applicable laws.

 

12.13         Counterparts .  This Agreement may be executed in any number of counterparts (including by facsimile, PDF, or other means of electronic communication), each of which taken together will constitute one and the same instrument, and any of the Parties hereto may execute this Agreement by signing any such counterpart.

 

[Remainder of page intentionally left blank.]

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

IN WITNESS WHEREOF, the Parties hereto have duly executed this Exclusive Channel Collaboration Agreement.

 

 

INTREXON CORPORATION

 

OVASCIENCE, INC.

 

 

 

 

 

 

 

 

 

 

By:

/s/ Donald P. Lehr

 

By :

/s/ Michelle Dipp

 

 

 

Name: Donald P. Lehr

 

Name: Michelle Dipp, M.D., Ph.D.

 

 

 

Title: Chief Legal Officer

 

Title: President and Chief Executive Officer

 

SIGNATURE PAGE TO DIRECT EXCLUSIVE CHANNEL COLLABORATION AGREEMENT

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 



 

CONFIDENTIAL TREATMENT REQUESTED

 

Schedule 1

 

Example of Calculation of COGS

 

[***]

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

Schedule 1-1



 

CONFIDENTIAL TREATMENT REQUESTED

 

Schedule 2

 

Description of Existing Product

 

The Existing Product, developed by OvaScience under the trade name AUGMENT SM , is a product designed to improve egg quality and increase the success of in vitro fertilization.  Mitochondria from the woman’s own OPCs are removed and added to her egg during in vitro fertilization. The product described above includes, but is not limited to, the technology described in United States patent application serial number [***].

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

Schedule 2-1




Exhibit 10.36

 

CONFIDENTIAL TREATMENT REQUESTED

 

EXECUTION COPY

CONFIDENTIAL

 

EXCLUSIVE CHANNEL COLLABORATION AGREEMENT

 

THIS EXCLUSIVE CHANNEL COLLABORATION AGREEMENT (this “ Agreement ”) is made and entered into effective as of December 18, 2013 (the “ Effective Date ”) by and between INTREXON CORPORATION , a Virginia corporation with offices at 20374 Seneca Meadows Parkway, Germantown, MD 20876 (“ Intrexon ”), and OVAXON, LLC, a Delaware limited liability company having a place of business at 215 First Street, Suite 240, Cambridge, MA  02142  (“ OvaXon ”).  Intrexon and OvaXon may be referred to herein individually as a “ Party ”, and collectively as the “ Parties .”

 

RECITALS

 

WHEREAS Intrexon has expertise in and owns or controls proprietary technology relating to the identification, design and production of genetically modified cells and DNA vectors, and the control of peptide expression; and

 

WHEREAS , OvaXon desires to become Intrexon’s exclusive channel collaborator in the Field with respect to such technology for the purpose of developing Collaboration Products (as defined herein) for use in the Field, and Intrexon is willing to appoint OvaXon as an exclusive channel collaborator in the Field (as defined herein, and subject to amendments to the definition as permitted herein) under the terms and conditions of this Agreement.

 

NOW THEREFORE , in consideration of the foregoing and the covenants and promises contained herein, the Parties agree as follows:

 

ARTICLE 1

 

DEFINITIONS

 

As used in this Agreement, the following capitalized terms shall have the following meanings:

 

1.1             Affiliate ” means, with respect to a particular Party, any other person or entity that directly or indirectly controls, is controlled by, or is in common control with such Party.  As used in this Section 1.1, the term “controls” (with correlative meanings for the terms “controlled by” and “under common control with”) means the ownership, directly or indirectly, of fifty percent (50%) or more of the voting securities or other ownership interest of an entity, or the possession, directly or indirectly, of the power to direct the management or policies of an entity, whether through the ownership of voting securities, by contract, or otherwise.  Notwithstanding the foregoing, (i) neither Intrexon nor OvaXon shall be deemed to be an Affiliate of one another, (ii) neither OvaXon nor OvaScience shall be deemed to be an Affiliate of one another, and (ii) Third Security shall be deemed not to be an Affiliate of Intrexon.  In addition, any other person, corporation, partnership, or other entity that would be an Affiliate of Intrexon solely because it and Intrexon are under common control by Randal J. Kirk or by investment funds managed by

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 



 

CONFIDENTIAL TREATMENT REQUESTED

 

Third Security or an affiliate of Third Security shall also be deemed not to be an Affiliate of Intrexon.

 

1.2             Applicable Laws ” has the meaning set forth in Section 8.2(d)(xii).

 

1.3             Augment Product ” means OvaScience’s autologous germ-line mithochondrial energy transfer product candidate described more fully on Schedule 1 attached hereto and incorporated herein by reference.

 

1.4             Authorizations ” has the meaning set forth in Section 8.2(d)(xii).

 

1.5             Channel-Related Program IP ” has the meaning set forth in Section 6.1.

 

1.6             Claims ” has the meaning set forth in Section 9.1.

 

1.7             Collaboration Product ” means any product in the Field that is created, produced, developed, or identified during the Term in the conduct of the Collaborative Program through the use or practice of Intrexon Channel Technology, Intrexon IP, or the Intrexon Materials.

 

1.8             Collaborative Program ” has the meaning set forth in Section 2.1(a).

 

1.9             Committees ” has the meaning set forth in Section 2.2(a).

 

1.10           Commercialize ” or “ Commercialization ” (including derivative forms, such as “Commercializing”) means any activities directed to the marketing (including detailing to medical professions in efforts to increase prescribing preferences), manufacturing, promoting, distributing, importing for sale, offering to sell and/or selling of Collaboration Products.

 

1.11           Commercial Sale ” means for a given Collaboration Product and country in the Territory, the sale for value of that Collaboration Product by OvaXon  (or, as the case may be, by an Affiliate or permitted sublicensee of OvaXon), to a Third Party after regulatory approval (if necessary) has been obtained for such Collaboration Product in such country.

 

1.12           Complementary In-Licensed Third Party IP ” has the meaning set forth in Section 3.8(a).

 

1.13           Confidential Information ” means each Party’s confidential Information, disclosed by such Party to the other Party pursuant to this Agreement or any other confidentiality agreement between the Parties, regardless of whether in oral, written, graphic or electronic form. For purposes of clarity, all tangible embodiments of OvaXon Cell Platform Technology shall be Confidential Information of OvaXon and all tangible embodiments of Intrexon Technology shall be Confidential Information of Intrexon.

 

1.14           Control ” means, with respect to any Information, Patent or other intellectual property right, that a Party owns or has a license from a Third Party to such right and has the

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

ability to grant a license or sublicense as provided for in this Agreement under such right without violating the terms of any agreement or other arrangement with any Third Party.

 

1.15           Diligent Efforts ” means, (a) with respect to the activities of either Party in the conduct of the Collaborative Program, the efforts and resources comparable to those undertaken by a company in the research-based pharmaceutical industry in pursuing the research and discovery of products that are at a similar stage of development and have similar market potential as the Collaboration Product and (b) with respect to the activities of OvaXon in the development, manufacture or  Commercialization of any Collaboration Product the level of efforts and resources reasonably required to diligently develop, manufacture, and/or Commercialize (as applicable) each Collaboration Product, consistent with the efforts and resources a similarly situated company working in the Field would typically devote to a product of similar market potential, profit potential, strategic value and/or proprietary protection, based on market conditions then prevailing.  For purposes of clarity, (a) Diligent Efforts shall be determined on a market-by-market basis for the Collaboration Product, and it is anticipated that the level of effort may be different for different markets and may change over time, reflecting the market(s) involved and (b) it is the expectation of the Parties in determining whether a Party has used Diligent Efforts with respect to a particular task or obligation,  that the applicable Party will promptly assign responsibility for such task and consistently make and implement decisions and allocate resources designed to advance progress with respect to such task or obligation.

 

1.16           Excess Product Liability Costs ” has the meaning set forth in Section 9.3.

 

1.17           Executive Officer ” means: (a) the Chief Executive Officer of a Party, or (b) another senior executive officer or duly empowered representative of such Party who has been duly appointed by the Chief Executive Officer, the Board of Directors, or otherwise in accord with the governing provisions of such Party, to act as the representative of the Party to resolve, as the case may be, (i) a Committee dispute, provided that such appointed officer is not a member of the applicable Committee, or (ii) a dispute described in Section 11.1.

 

1.18           FDA ” has the meaning set forth in Section 8.2(d)(xii).

 

1.19           Field ” means: (i) genetic modification of the nuclear genome of human EPC cells for the prevention of inheritable disease in humans or animals; (ii) mitochondrial transfer for the treatment of human or companion animal genetic defects or mutations of mitochondrial or nuclear DNA, in which the mitochondria may be genetically modified or non-genetically modified, and autologous or allogeneic; or (iii) artificial reproduction of food and/or research animals using EPCs, in which the EPCs may be genetically modified or non-genetically modified.  Notwithstanding the foregoing, the Field shall not include any human fertility product, and specifically excludes: ( a)   the Augment Product for use in humans and animals ; (b) the ex vivo differentiation of OPCs into mature, fertilizable oocytes for use in humans, wherein such OPCs are not genetically modified; and (c) the in vivo use of OPCs in humans, wherein such OPCs are not genetically modified.

 

1.20           Field Infringement ” has the meaning set forth in Section 6.3(b).

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

3



 

CONFIDENTIAL TREATMENT REQUESTED

 

1.21           FTE ” means a number of hours of work set devoted to or in support of the underlying activities with respect to a Collaboration Product that is carried out by one or more employees, contract personnel or consultants of Intrexon as part of the Collaborative Program, measured in accordance with Intrexon’s customary time allocation practices.

 

1.22           FTE Cost ” means, for any period, the FTE Rate multiplied by the number of FTEs used in such period.

 

1.23           FTE Rate ” means the per annum rate per FTE set for FTEs engaged in the conduct of activities with respect to a Collaboration Product that is carried out by one or more employees, contract personnel or consultants of Intrexon as part of the Collaborative Program, which rate shall reflect the direct costs for such Intrexon personnel and overheads reasonably allocable to the provision of such activities.  For purposes of clarity, Intrexon shall provide OvaXon with written notice as to the FTE Rate to be used in the conduct of any FTE activities under the Collaborative Program prior to commencing any such activities.

 

1.24           Fully Loaded Cost ” means all out-of-pocket costs and internal costs incurred by Intrexon (or for its account by an Affiliate or a Third Party) after the Effective Date in accordance with US GAAP in undertaking the activities set forth in the Work Plan as part of the Collaborative Program and that are attributable to the development of the Collaboration Product as: (a) out-of-pocket costs, which means the actual amounts paid to a Third Party for specific external development activities applicable to the Collaboration Product; or (b) internal labor costs, which means the applicable FTE Costs (the FTE Rate multiplied by the number of FTEs utilized in the relevant period on activities under the Work Plan as part of the Collaborative Program) that are attributable to the development of the Collaboration Product, and internal materials costs, which means direct costs for such Intrexon materials and/or capacities consumed and overheads reasonably allocable to the consumption of such materials and/capacities.  Intrexon may, from time to time but not more than once per calendar year, notify the JSC that the applicable FTE Rate will be adjusted based on changes to Intrexon’s actual fully loaded costs.  Intrexon shall provide the JSC with reasonable documentation indicating the basis for any direct and indirect charges, any allocable overhead, and any such adjustment in the FTE Rate, and any further activities under an applicable Work Plan and/or the Collaborative Program under the adjusted charges and/or rates shall be subject to budget approval by the JSC.

 

1.25           IND ” means an investigational new drug application filed with the FDA, or alternatively an equivalent regulatory filing filed with a regulatory agency in Europe, for a Collaboration Product.

 

1.26           In-Licensed Program IP ” has the meaning set forth in Section 3.9(a).

 

1.27           Information ” means information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including without limitation, databases, inventions, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, biological, chemical, biochemical,

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

toxicological and clinical and pre-clinical test data, analytical and quality control data, stability data, studies and procedures, and patent and other legal information or descriptions.

 

1.28           Infringement ” has the meaning set forth in Section 6.3(a).

 

1.29           Intrexon Channel Technology ” means any technology, including without limitation the technology embodied in the Intrexon Materials and the Intrexon IP, that is (a) Controlled by Intrexon during the Term, (b) used by Intrexon, or provided by Intrexon for use, in the conduct of the Collaborative Program and (c) directed towards the design, identification, culturing, and/or production of genetically modified cells.  For purposes of clarity, Intrexon’s Channel Technology shall include Intrexon’s proprietary (1) UltraVector® technology (2) LEAP TM  technology, (3) DNA and RNA MOD engineering technology, (4) protein engineering technology, (5) transcription control chemistry technology, (6) genome engineering technology, and (7) cell system engineering technology.

 

1.30           Intrexon Indemnitees ” has the meaning set forth in Section 9.2.

 

1.31           Intrexon IP ” means, collectively, the Intrexon Patents and Intrexon Know-How.

 

1.32           Intrexon Know-How ” means all Information (other than Intrexon Patents) that (a) is Controlled by Intrexon during the Term and (b) is (i) used by Intrexon, or provided by Intrexon for use, in the conduct of the Collaborative Program and/or (ii) reasonably necessary or useful for OvaXon to conduct the Collaborative Program.  For the avoidance of doubt, Intrexon Know-How shall include any Information (other than Intrexon Patents) that constitutes Channel-Related Program IP.

 

1.33           Intrexon Materials ” means the proprietary apparatuses, software and biomaterials (including genetic code, associated amino acids and gene constructs, and such other proprietary reagents and biological materials including but not limited to plasmid vectors, virus stocks, cells and cell lines, antibodies, and ligand-related chemistry), in each case that are Controlled by Intrexon and used by Intrexon, or provided by Intrexon for use, in the conduct of the Collaborative Program, regardless of whether such is used and/or provided for use alone or in combination with materials that are not proprietary to Intrexon.

 

1.34           Intrexon Patents ” means all Patents that (a) are Controlled by Intrexon as of the Effective Date or during the Term, and (b) contain one or more claims that cover Intrexon Know-How and/or Channel-Related Program IP.  For the avoidance of doubt, the Intrexon Patents shall include any Patent in the Channel-Related Program IP.  Prior to the Effective Date, Intrexon has provided OvaXon with a listing of all Intrexon Patents existing as of that time that are reasonably expected to be material to the Collaborative Program.

 

1.35           Intrexon Trademarks ” means those trademarks related to the Intrexon Channel Technology that are established from time to time during the Term by Intrexon for use

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

5



 

CONFIDENTIAL TREATMENT REQUESTED

 

across its channel partnerships or collaborations, as may be identified by Intrexon from time to time by written notice to OvaXon.

 

1.36           Inventions ” has the meaning set forth in Section 6.1.

 

1.37           IPC ” has the meaning set forth in Section 2.2(b).

 

1.38           Joint Program Inventions ” has the meaning set forth in Section 6.1.

 

1.39           JSC ” has the meaning set forth in Section 2.2(b).

 

1.40           OPC ” means a non-embryonic stem cell that is mitotically competent and expresses Vasa, Oct-4, Dazl, Stella, and, optionally a stage-specific embryonic antigen.

 

1.41           OvaScience ” means OvaScience, Inc., a Delaware corporation.

 

1.42           OvaScience ECC Agreement ” means the Exclusive Channel Collaboration Agreement by and between Intrexon and OvaScience of even date herewith.

 

1.43           OvaScience License Agreement ” means the License Agreement by and between OvaXon and OvaScience of even date herewith .

 

1.44           OvaXon Cell Platform Technology ” means the proprietary technology Controlled by OvaXon as of the Effective Date in-licensed by OvaXon from OvaScience under the terms and conditions of the OvaScience License, but excepting any Intrexon IP included in such OvaScience License.

 

1.45           OvaXon Indemnitees ” has the meaning set forth in Section 9.1.

 

1.46           OvaXon Independent IP ” has the meaning set forth in Section 6.1.

 

1.47           OvaXon Patents ” means all Patents that (i) are Controlled by OvaXon as of the Effective Date or during the Term and (ii) contain one or more claims that cover OvaXon Cell Platform Technology.

 

1.48           OvaXon Platform Inventions ” has the meaning set forth in Section 6.1.

 

1.49           OvaXon Program Patent ” has the meaning set forth in Section 6.2(b).

 

1.50           OvaXon Termination IP ” means any OvaXon Patents and/or OvaXon Cell Platform Technology that OvaXon or any of its Affiliates Controls as of the date of any notice of termination of this Agreement that cover, or is otherwise necessary or useful for, the development, manufacture or commercialization of a Reverted Product.  OvaXon Termination IP does not include OvaXon Independent IP.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

1.51           Patents ” means (a) all patents and patent applications (including provisional applications), (b) any substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations, requests for continued examination, confirmations, re-examinations, extensions, supplementary protection certificates and the like of the foregoing, and (c) any foreign or international equivalents of any of the foregoing.

 

1.52           Product-Specific Program Patent ” means any Intrexon Patent where all the claims are directed to Inventions that solely and specifically cover Collaboration Products.  In the event of a disagreement between the Parties as to whether a particular Intrexon Patent is or is not a Product-Specific Program Patent, the Parties shall seek to resolve the issue through discussions at the IPC; provided that, if the Parties are unable to resolve the disagreement, the issue shall be resolved pursuant to Section 6.1(j) and, if not resolved thereunder, according to Article 11.  Any Intrexon Patent that is subject to such a dispute shall be deemed not to be a Product-Specific Program Patent unless and until (a) Intrexon agrees in writing that such Intrexon Patent is a Product-Specific Program Patent or (b) it is resolved pursuant to the prior sentence that such Intrexon Patent is a Product-Specific Program Patent.

 

1.53           Product Sublicense ” has the meaning set forth in Section 3.2(c).

 

1.54           Product Sublicensee ” has the meaning set forth in Section 3.2(c).

 

1.55           Proposed Terms ” has the meaning set forth in Section 11.2.

 

1.56           Prosecuting Party ” has the meaning set forth in Section 6.2(c).

 

1.57           Recovery ” has the meaning set forth in Section 6.3(f).

 

1.58           Retained Product ” has the meaning set forth in Section 10.4(a).

 

1.59           Reverted Product ” has the meaning set forth in Section 10.4(c).

 

1.60           SEC ” means the United States Securities and Exchange Commission.

 

1.61           Superior Therapy ” means a therapy in the Field for a given indication that, based on the data then available, (a) demonstrably appears to offer either superior efficacy or safety or significantly lower cost of therapy, as compared with both (i) those therapies that are marketed (either by OvaXon or others) at such time for the same indication and (ii) those therapies that are being actively developed by OvaXon for such indication (including any pipeline Collaboration Products); (b) demonstrably appears to represent a substantial improvement over such existing therapies; and (c) has intellectual property protection and a regulatory approval pathway that, in each case, would not present a significant barrier to commercial development.

 

1.62           Supplemental In-Licensed Third Party IP ” has the meaning set forth in Section 3.9(a).

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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1.63           Support Memorandum ” has the meaning set forth in Section 11.2.

 

1.64           Term ” has the meaning set forth in Section 10.1.

 

1.65           Territory ” means the world.

 

1.66           Third Party ” means any individual or entity other than the Parties or their respective Affiliates.

 

1.67           Third Security ” means Third Security, LLC.

 

1.68           US GAAP ” means generally accepted accounting principles in the United States.

 

1.69           Work Plan ” has the meaning set forth in Section 2.1(a).

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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ARTICLE 2

 

SCOPE OF CHANNEL COLLABORATION; MANAGEMENT

 

2.1             Scope.

 

(a)           Generally .  The general purpose of the channel collaboration described in this Agreement will be to use the Intrexon Channel Technology, Intrexon IP, and/or the Intrexon Materials to research, develop and Commercialize Collaboration Products for use in the Field (the “ Collaborative Program ”).  As provided below, the JSC shall agree upon the services and activities to be included in each research and development project that is part of the Collaborative Program (each, a “ Project ”) and monitor and govern the Projects under a work plan (“ Work Plan ”).  Either Party may propose other potential Projects in the Field for review and consideration by the JSC and potential incorporation, at the JSC’s discretion, into the current Work Plan as described in Section 2.2 below.

 

2.2             Governance and Committees .

 

(a)           Generally .  The Parties desire to establish several committees (collectively, “ Committees ”) to oversee the Collaborative Program and to facilitate communications between the Parties with respect thereto.  Each of such Committees shall have the responsibilities and authority allocated to it in this Article 2.  Each of the Committees shall have the obligation to exercise its authority consistent with the respective purpose for such Committee as stated herein and in the Work Plan and any decisions of the Committees shall be made by the representatives in good faith.

 

(b)           Formation and Purpose .  Promptly following the Effective Date, the Parties shall confer and then create a Joint Steering Committee (“ JSC ”) and an Intellectual Property Committee (“ IPC ”).  The JSC shall have authority, subject to Section 2.5 and except as otherwise delegated by this Section 2.2(b) to the IPC, to establish separate Projects for the Collaborative Program (including separate project plans  and budgets, not less than on an annual basis, for such Projects) under the Work Plan, to oversee manufacturing and controls for Collaboration Products, to review and approve all clinical trials and associated regulatory filings and correspondence conducted or made with respect to Collaboration Products under the Collaborative Program (including reviewing and approving itemized budgets with respect to the foregoing), to establish and approve separate project plans  and budgets for commercialization activities for Collaboration Products under the Collaborative Program and to approve the projects and plans of any subcommittee it establishes consistent with this authority.  The IPC shall have authority, subject to Section 2.5, to evaluate all intellectual property issues and approve associated collaborative activities that may arise in connection with the Collaborative Program, including the protection of Inventions or Confidential Information, the filing of Patents, the review and approval of agreements with Third Parties that apply to intellectual property rights used in the conduct of the Collaborative Program (including in licensing of Third Party intellectual property or entering into research agreements that affect intellectual property rights), the establishment or enforcement of controls concerning the dissemination or use of intellectual

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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property (including Intrexon Channel Technology, Intrexon IP, or Intrexon Materials) for the development or manufacturing of Collaboration Products, and reviewing and approving budgets and action items with respect to the foregoing.

 

(c)           JSC Adopted Work Plan .  The JSC shall meet and confer as soon as practical after the Effective Date to draft, finalize, and adopt the Work Plan for the Collaborative Program, such Work Plan to be monitored and, as appropriate, amended and/or updated by the JSC on an ongoing basis during the Term.  The Work Plan shall set forth, among other things, the activities approved by the JSC to be undertaken by Intrexon in support of the Collaborative Program under Section 4.6.

 

2.3             General Committee Membership and Procedure .

 

(a)           Membership .  For each Committee, each Party shall designate an equal number of representatives (not to exceed three (3) for each Party) with appropriate expertise to serve as members of such Committee.  For the JSC, the representatives must all be employees of such Party or an Affiliate of such Party, and for Committees other than the JSC, the representatives must all be employees of such Party or an Affiliate of such Party; provided that each Party may designate for each such other Committee up to one (1) representative who is not an employee if : (i) such non-employee representative agrees in writing to be bound to the terms of this Agreement for the treatment and ownership of Confidential Information and Inventions , and (ii) the other Party consents to the designation of such non-employee representative, which consent shall not be unreasonably withheld.  Each representative as qualified above may serve on more than one (1) Committee as appropriate in view of the individual’s expertise.  Each Party may replace its Committee representatives at any time upon prior written notice to the other Party.  Each Committee shall have a chairperson selected from among the duly appointed representatives; the chairperson of each Committee shall serve for a two-year term and the right to designate a chairperson shall alternate between the Parties, with OvaXon selecting the chairperson first for the JSC, and Intrexon selecting the chairperson first for the IPC. The chairperson of each Committee shall be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting of such Committee, and preparing and issuing minutes of each meeting within a reasonable time thereafter. Each member of the Committee shall have the opportunity to provide comments on the draft minutes.  Draft minutes shall be approved, disapproved and revised as soon as practicable.  Upon approval, final minutes of each meeting shall be circulated to the members of the JSC by the chairperson.

 

(b)           Meetings .  Each Committee shall hold meetings at such times as it elects to do so, but in no event shall such meetings be held less frequently than once every six (6) months; provided that, both Parties may agree to suspend activities of the IPC until such time as one Party informs the other Party in writing of its desire to reactivate the IPC, at which point the Parties will thereafter schedule and hold the next meeting for the reactivated IPC within one (1) month. Meetings of any Committee may be held in person or by means of telecommunication (telephone, video, or web conferences).  To the extent that a Committee holds any meetings in person, the Parties will alternate in designating the location for such in-person meetings, with OvaXon selecting the first meeting location for each Committee.  A reasonable number of

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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additional representatives of a Party may attend meetings of a Committee in a non-voting capacity so long as such additional non-voting representatives each either (A) are an employee of a Party or an employee an Affiliate of a Party, or (B) are not an employee of either Party (or Affiliates thereof) but prior to attending any such meeting (i) such additional non-voting representative agrees in writing to be bound to the terms of this Agreement for the treatment and ownership of Confidential Information and Inventions  (or is bound by law or contractual agreement with such Party consistent with such terms), and (ii) the other Party consents to the attendance of such non-employee additional representative, which consent shall not be unreasonably withheld.  Each Party shall be responsible for all of its own expenses of participating in any Committee.  For clarity, however, if Intrexon employee or agent both (i) serves as a representative on a Committee, and (ii) contributes under the Work Plan by providing labor in the course of Intrexon’s providing of manufacturing or support services under Sections 4.5 and 4.6, Intrexon shall not be prevented from recouping the Fully Loaded Costs otherwise derived from the labor of that employee or agent in the course of providing manufacturing or support services as set forth in Sections 4.5 and 4.6 below to the extent that such Fully Loaded Costs do not include any time such Intrexon representative spent on Committee activities.

 

(c)           Meeting Agendas .  Each Party will disclose to the other Party the proposed agenda items along with appropriate information to be discussed at the meeting at least three (3) business days in advance of each meeting of the applicable Committee; provided, that a Party may provide its agenda items to the other Party within a lesser period of time in advance of the meeting, or may propose that there not be a specific agenda for a particular meeting, so long as such other Party consents to such later addition of such agenda items or the absence of a specific agenda for such Committee meeting.

 

(d)           Limitations of Committee Powers .  Each Committee shall have only such powers as are specifically delegated to it hereunder or from time to time as agreed to in writing by the mutual consent of the Parties and shall not be a substitute for the rights of the Parties.  Without limiting the generality of the foregoing, no Committee shall have any power to amend this Agreement.  Any amendment to the terms and conditions of this Agreement shall be implemented pursuant to Section 12.7 below.

 

2.4             Committee Decision-Making .  If a Committee is unable to reach unanimous consent on a particular matter within thirty (30) days of its initial consideration of such matter, then either Party may provide written notice of such dispute to the Executive Officer of the other Party.  The Executive Officers of each of the Parties will meet at least once in person or by means of telecommunication (telephone, video, or web conferences) as promptly as possible to discuss the dispute and use their good faith efforts to resolve the dispute within thirty (30) days after submission of such dispute to the Executive Officers.  If any such dispute is not resolved by the Executive Officers within thirty (30) days after submission of such dispute to such Executive Officers, then the dispute shall be resolved as specified in the applicable subsection below.

 

(a)           Casting Vote at JSC .  If a dispute at the JSC is not resolved pursuant to Section 2.4 above, then the Executive Officer of OvaXon shall have the authority to finally resolve such dispute.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

(b)           Casting Vote IPC .  If a dispute at the IPC is not resolved pursuant to Section 2.4 above, then the Executive Officer of Intrexon shall have the authority to finally resolve such dispute, provided that such authority shall be shared by the Parties with respect to Product-Specific Program Patents (i.e., neither Party shall have the casting vote on such matters, and any such disputes shall be resolved pursuant to Article 11).

 

(c)           Other Committees .  If any additional Committee or subcommittee other than those set forth in Section 2.2(b) is formed, then the Parties shall, at the time of such formation, agree on which Party shall have the authority to finally resolve a dispute that is not resolved pursuant to Section 2.4 above.

 

(d)           Restrictions . Neither Party shall exercise its right to finally resolve a dispute at a Committee in accordance with this Section 2.4 in a manner that (i) excuses such Party from any of its obligations specifically enumerated under this Agreement; (ii) expands the obligations of the other Party under this Agreement; (iii) negates any consent rights or other rights specifically allocated to the other Party under this Agreement; (iv) purports to resolve any dispute involving the breach or alleged breach of this Agreement; (v) resolves a matter if the provisions of this Agreement specify that mutual agreement is required for such matter; or (vi) would require the other Party to perform any act that is inconsistent with applicable law.

 

2.5          Authorization of Committee Representatives.   Each representative serving on a Committee shall be responsible for ensuring that he or she acts only as duly authorized by its respective Party and obtains any advance approvals, delegations, or other authorizations from his or her respective Party in advance of making any Committee votes.

 

ARTICLE 3

 

LICENSE GRANTS

 

3.1             Licenses to OvaXon .

 

(a)           Subject to the terms and conditions of this Agreement, Intrexon hereby grants to OvaXon a license under the Intrexon IP (including any rights Intrexon has in Joint Program Inventions), including the right to grant sublicenses as set forth in Section 3.2, to research, develop, use, make, have made, sell, and offer for sale and otherwise Commercialize Collaboration Products in the Field in the Territory.  Such license shall be exclusive (even as to Intrexon) with respect to any development, selling, offering for sale or other Commercialization of Collaboration Products in the Field, and shall be otherwise non-exclusive.

 

(b)           Subject to the terms and conditions of this Agreement, Intrexon hereby grants to OvaXon a non-exclusive, royalty-free license to use and display the Intrexon Trademarks, solely in connection with the Commercialization of Collaboration Products in the promotional materials, packaging, and labeling for Collaboration Products, as provided under and in accordance with Section 4.8.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

3.2             Sublicensing .  Except as provided in this Section 3.2, OvaXon shall not sublicense the rights granted under Section 3.1 to any Third Party, or transfer the Intrexon Materials to any Third Party, or otherwise grant any Third Party the right to research, develop, use, or Commercialize Collaboration Products or use or display the Intrexon Trademarks, in each case except with Intrexon’s written consent, which written consent may be withheld in Intrexon’s sole discretion.  Notwithstanding the foregoing, OvaXon (and its Product Sublicensees only to the extent explicitly set forth in Section 3.2(a) below) shall have a right to sublicense the rights granted under Section 3.1 under the circumstances described in Sections 3.2(a) through 3.2(c).

 

(a)           OvaXon may transfer, to the extent reasonably necessary and after providing Intrexon with reasonable advance notice thereof, Intrexon Materials that are or express Collaboration Products or components thereof to a Third Party contractor performing contract manufacturing responsibilities for Collaboration Products, and may in connection therewith grant limited sublicenses necessary to enable such Third Party to perform such activities.  If OvaXon transfers any Intrexon Materials under this Section 3.2(a), OvaXon will include in the agreement executed with each such Third Party contractor restrictions on the use and transfer of such Intrexon Materials and Intrexon IP by the Third Party contractor consistent with the restrictions under the provisions of Articles 6 and 7 of this Agreement.  A Product Sublicensee of OvaXon may transfer, to the extent reasonably necessary and upon the consent of Intrexon, which consent shall not be unreasonably withheld, Intrexon Materials that are or express ingredients for the Collaboration Product sublicensed by the Product Sublicensee to a Third Party contractor performing on behalf of that Product Sublicensee contract manufacturing responsibilities for Collaboration Products, and may in connection therewith grant limited sublicenses to the extent necessary to enable such Third Party to perform such activities.  OvaXon will include in the agreement executed with each such Third Party contractor a provision that provides  that if any Product Sublicensee transfers any Intrexon Materials under this Section 3.2(a), that such Product Sublicensee, after obtaining Intrexon’s consent, will take commercially reasonable steps, including contractually obligating any such Third Party contractors, to ensure that the rights of Intrexon in and to the Intrexon Materials and Intrexon IP and under the provisions of Articles 6 and 7 of this Agreement are not violated by any Third Party contractors of such Product Sublicensees.

 

(b)           OvaXon may, upon written notice to Intrexon, sublicense the rights granted under Section 3.1 to an Affiliate, or transfer the Intrexon Materials to an Affiliate, or grant an Affiliate the right to display the Intrexon Trademarks, such rights to be effective only for so long as such Affiliate remains an Affiliate of OvaXon.  In the event that OvaXon provides such written notice to Intrexon, OvaXon shall remain responsible for the performance by any such Affiliate and shall cause such Affiliate to comply with the provisions of this Agreement in connection with such performance (as though such Affiliate were OvaXon), including any payment obligations owed to Intrexon hereunder.

 

(c)           OvaXon may grant a sublicense of the rights granted under Section 3.1 (and not including a right to sublicense under this Section 3.1(c)) to a Third Party licensee of any Collaboration Product that would qualify as a Retained Product under any of the criteria set forth in Section 10.4 (a) (a “ Product Sublicensee ”) to the extent necessary to permit such Third Party

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

to research, develop, use, import, export, make, have made, sell, and offer for sale that Collaboration Product (a “ Product Sublicense ”), provided, that (i) such Product Sublicense is expressly limited to the appropriate Collaboration Product, (ii) such Product Sublicense does not grant the Product Sublicensee any rights to Intrexon IP other than as incorporated into the Collaboration Product at the time of the Product Sublicense, (iii) such Product Sublicense does not purport to relieve OvaXon of any of its obligations under this Agreement, (iv) the Product Sublicensee agrees in writing, in a document in form reasonably acceptable to Intrexon, to abide by the following provisions of this Agreement: Sections 3.1, 3.3-3.6, 3.8, 3.10, and 3.11 and Articles 6, 7, and 10), and (v) the form of Product Sublicense, containing all material terms, is presented to the JSC by OvaXon before execution by OvaXon and the prospective Product Sublicensee  for the purpose of allowing the JSC to reasonably review and comment upon the terms and scope of the Product Sublicense agreement before execution; provided, that, such right to review and comment shall not limit OvaXon’s right to enter into any such Product Sublicense to the extent that such Product Sublicense complies with the terms of this Section 3.2(c).  Intrexon shall not unreasonably withhold consent with regard to any requests by OvaXon to combine multiple Collaboration Products (or a line of such Collaboration Products) into a single combined license with a Product Sublicensee.

 

3.3             Limitation on Sublicensees .  Except for the rights with regard to Field Infringement set forth in Section 6.3(b) (and subject to the provisions of Sections 6.3(e) and 6.3(f)), none of the enforcement rights under the Intrexon Patents that are granted to OvaXon pursuant to Section 6.3 shall be transferred to, or exercised by, a Product Sublicensee except with Intrexon’s prior written consent, which Intrexon shall not unreasonably withhold.

 

3.4             No Non-Permitted Use .  OvaXon hereby covenants that it shall not, nor shall it permit any Affiliate or, if applicable, (sub)licensee, to, use or practice, directly or indirectly, any Intrexon IP, Intrexon Channel Technology, or Intrexon Materials for any purposes other than those expressly permitted by this Agreement.

 

3.5             Exclusivity .

 

(a)           Neither Intrexon nor its Affiliates shall grant any license or other rights to, or otherwise make available to any Third Party, any technology or Patents Controlled by Intrexon or any of its Affiliates, including the Intrexon Channel Technology or Intrexon Materials, for the purpose of developing or commercializing products in the Field (except as set forth in Section 3.2), and neither Intrexon nor any Affiliate shall pursue or conduct (either by itself or with a Third Party or Affiliate or for the benefit of, or sponsored by any Third Party) the research, development or Commercialization of any product for purpose of commercial use or sale in the Field, outside of the Collaborative Program.

 

(b)           Neither OvaXon nor its Affiliates shall pursue or conduct (either by itself or with a Third Party or Affiliate or for the benefit of, or sponsored by any Third Party) outside of the Collaborative Program the research, development or Commercialization of any product for purpose of commercial use or sale in the Field where such products would compete with Collaboration Products.  Notwithstanding the foregoing sentence, OvaXon may utilize academic

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

and non-profit Third Parties for the pre-clinical and clinical development of any product, including Collaboration Products, to the extent consistent with Articles 6 and 7 of this Agreement.

 

3.6             Off Label Use .  For purposes of clarity, (a) the use by direct or indirect purchasers or other users of Collaboration Products outside the Field (an  “ off label use ”) shall not constitute a breach by OvaXon of the terms of Section  3.4 , provided that neither OvaXon nor its Affiliate (nor any Third Party under contract with either of them) marketed or promoted Collaboration Products for such off-label use; and (b) an “off-label use by any direct or indirect purchasers or other users of products sold by Intrexon, an Intrexon Affiliate, or a Third Party sublicensee, collaborator, or partner of Intrexon shall not constitute a breach by Intrexon of the terms of Section 3.4, provided that neither Intrexon nor its Affiliate (nor any Third Party under contract with either of them) marketed or promoted such products for such off-label use.

 

3.7             No Prohibition on Intrexon .  Except as explicitly set forth in Sections 3.1 and 3.4, nothing in this Agreement shall prevent Intrexon from practicing or using the Intrexon Materials, Intrexon Channel Technology, and Intrexon IP for any purpose, and to grant to Third Parties the right to do the same.  Without limiting the generality of the foregoing, OvaXon acknowledges that Intrexon has all rights, in Intrexon’s sole discretion, to make the Intrexon Materials, Intrexon Channel Technology (including any genetic materials used in a Collaboration Product), and Intrexon IP available to Third Party channel partners or collaborators for use in fields outside of the Field.

 

3.8             Rights to Clinical and Regulatory Data .  OvaXon shall own and control all clinical and pre-clinical data and regulatory filings relating to Commercialization of Collaboration Products during the Term.  OvaXon shall provide (or shall cause an applicable Product Sublicensee to provide) to Intrexon at Intrexon’s reasonable request and upon OvaXon’s consent (which consent shall not be unreasonably denied, delayed, or conditioned)  copies of all clinical and non-clinical data and reports, regulatory filings, and communications from regulatory authorities that relate specifically and solely to Intrexon IP that is included in Collaboration Products.  To the extent that there exist any clinical and non-clinical data and reports, regulatory filings, and communications from regulatory authorities owned by OvaXon (or a Product Sublicensee) that relate to Intrexon IP, OvaXon shall provide (or shall cause an applicable Product Sublicensee to provide) to Intrexon copies of the portions of such data, reports, filings, and communications that relate specifically and solely to Intrexon IP .  Subject to Section 3.1 and Section 3.5, Intrexon shall be permitted, directly or in conjunction with or through partners or other channel collaborators, to reference any such data, reports, filings, and communications relating specifically and solely to Intrexon IP in regulatory filings made to obtain regulatory approval for products for use in fields outside the Field. Intrexon shall have the right to provide a written request to OvaXon to use any such information in developing and Commercializing products outside the Field and to license any Third Parties to do so and OvaXon shall not unreasonably refuse any such request provided that OvaXon reasonably determines that the proposed use by Intrexon will not adversely affect OvaXon’s ongoing business.  Notwithstanding the provisions of this Section 3.7, Intrexon shall not, outside of the Collaborative Program, utilize any OvaXon clinical and non-clinical data or reports in support of

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

obtaining regulatory approval for a product for use in the Field or for a product that would compete with Collaboration Products in the Field.

 

3.9             Third Party Licenses .

 

(a)           [***] shall obtain, [***], any licenses from Third Parties that are required in order to practice the Intrexon Channel Technology in the Field to the extent  reasonably necessary for Intrexon to conduct genetic and cell engineering and related analytic activities under JSC established plans for the Collaborative Program (but specifically excluding intellectual property directed to any specific target genes, genetic transformation methodologies, cell lines, active pharmaceutical ingredients or chemical intermediates thereof, or processes or methods for commercially manufacturing Collaboration Products , or to any methods of treating humans and animals in the Field (“ Supplemental In-Licensed Third Party IP ”).  Other than with respect to Supplemental In-Licensed Third Party IP, [***] shall be solely responsible for obtaining, [***], any licenses from Third Parties that [***] determines, in its sole discretion, are required in order to lawfully make, use, sell, offer for sale, or import Collaboration Products (“ Complementary In-Licensed Third Party IP ”).  Supplemental In-Licensed Third Party IP and Complementary In-Licensed Third Party IP are collectively referred to as “ In-Licensed Program IP ”.

 

(b)           In the event that either Party desires to license from a Third Party any Supplemental In-Licensed Third Party IP or Complementary In-Licensed Third Party IP, such Party shall so notify the other Party, and the IPC shall discuss such In-Licensed Program IP and its applicability to the Collaborative Program and/or the development and Commercialization of Collaboration Products for use in the Field.  As provided above in Section 3.9(a), [***] shall have the sole right and responsibility to pursue a license to rights under Supplemental In-Licensed Third Party IP, and [***] hereby covenants that it shall not during the Term  directly license such Supplemental In-Licensed Third Party IP ; provided, that, [***]  shall have the right (but shall not be obligated to) obtain such a license directly if the Third Party owner or licensee of such Supplemental In-Licensed Third Party IP brings an infringement action against [***] or its Affiliates or threatens to bring such action and, after written notice to [***] of such action, [***] fails to obtain a license to such Supplemental In-Licensed Third Party IP within ninety (90) days after such notice.  Following the IPC’s discussion of any Complementary In-Licensed Third Party IP, subject to Section 3.9(c), [***] shall have the right to pursue a license under any Complementary In-Licensed Third Party IP, at [***].  For the avoidance of doubt, [***] may at any time obtain a license under Complementary In-Licensed Third Party IP to use with any product that is not a Collaboration Product and/or for use outside the Field, at [***]; provided, that, if [***] decides to seek to obtain such a license, it shall use reasonable efforts to coordinate its licensing activities in this regard with [***].

 

(c)           [***] shall provide the proposed terms of any license under Complementary In-Licensed Third Party IP and the final version of the definitive license agreement for any Complementary In-Licensed Third Party IP to the IPC for review and discussion prior to signing, and shall consider [***] comments thereto in good faith; provided, that, [***] (i) shall have the sole right to negotiate and execute agreements for any such

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

Complementary In-Licensed Third Party IP and (ii) shall ensure that the terms of such license are not in conflict the terms of this Agreement with respect to the treatment and ownership of, and rights under, Confidential Information and intellectual property (including Inventions) of the Parties and developed under the Collaborative Program.  To the extent that [***] obtains a license under Complementary In-Licensed Third Party IP, [***] shall provide the final version of the definitive license agreement for such Complementary In-Licensed Third Party IP to the IPC.  Any Party that is pursuing a license to any In-Licensed Program IP with respect to the Field under this Section 3.9 shall keep the other Party reasonably informed of the status of any negotiations relating thereto. For purposes of clarity, (i) any costs incurred by [***] in obtaining and maintaining licenses to Supplemental In-Licensed Third Party IP shall be borne solely by [***], and (ii) any costs incurred by [***] in obtaining and maintaining licenses to Complementary In-Licensed Third Party IP (and, to the limited extent provided in subsection (b), Supplemental In-Licensed Third Party IP) shall be borne solely by [***].

 

(d)           For any Third Party license under which OvaXon or its Affiliates obtain a license under Patents claiming inventions or know-how specific to or used or incorporated into the development, manufacture, and/or Commercialization of Collaboration Products, OvaXon shall use commercially reasonable efforts, but shall not be obligated, if requested by the JSC, to ensure that OvaXon will have the ability, pursuant to Section 10.4(h), to assign such agreement to Intrexon or grant a sublicense to Intrexon thereunder (having the scope set forth in Section 10.4(h)).

 

(e)           The licenses granted to OvaXon under Section 3.1 may include sublicenses under Intrexon IP that has been licensed to Intrexon by one or more Third Parties.  Any such sublicenses are subject to the terms and conditions set forth in the applicable upstream license agreement, subject to the cost allocation set forth in Section 3.9(c), provided that Intrexon shall disclose in writing to OvaXon all of such terms and conditions that are applicable to OvaXon.  OvaXon shall not be responsible for complying with any provisions of such upstream license agreements unless, and to the extent that, such provisions have been disclosed to OvaXon as provided in the preceding sentence.

 

(f)            If either Party receives notice from a Third Party concerning activities of a Party taken in conjunction with performance of obligations under this Agreement, which notice alleges infringement by a Party of, or offers license under, Patents or other intellectual property rights owned or controlled by that Third Party, the receiving Party shall inform the other Party thereof as promptly as practicable.

 

3.10           Licenses to Intrexon.   Subject to the terms and conditions of this Agreement, OvaXon hereby grants to Intrexon a non-exclusive, fully-paid, royalty-free license, under the OvaXon Cell Platform Technology and the OvaXon Patents Controlled by OvaXon solely to the extent necessary for Intrexon to conduct those activities  assigned to it as part of the Collaborative Program as set forth in a Work Plan approved by the JSC , which license shall be sublicensable solely to Intrexon’s Affiliates, to any Intrexon Third Party subcontractors as permitted in accord with Section 4.5 or as otherwise permitted to be used by Intrexon in conjunction with support services under Section 4.5 (subject to JSC research plan approval).

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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3.11           Restrictions Relating to Intrexon Materials .  OvaXon and its permitted sublicensees shall use the Intrexon Materials solely for purposes of the Collaborative Program as set forth in JSC-approved plans and as contemplated by the license granted in Section 3.1 and not for any other purpose without the prior written consent of Intrexon.  With respect to the Intrexon Materials comprising Intrexon’s vector assembly and cell processing technology, OvaXon shall not, and shall ensure that OvaXon personnel do not, and shall include in any agreement with Third Party permitted sublicensees a covenant that shall provide that such sublicensees shall not, except as otherwise permitted in this Agreement (a) distribute, sell or otherwise transfer such Intrexon Materials to any Third Party; (b) co-mingle such Intrexon Materials with any other proprietary biological or chemical materials without Intrexon’s written consent; or (c) analyze such Intrexon Materials or in any way attempt to reverse engineer or sequence such Intrexon Materials.

 

ARTICLE 4

 

OTHER RIGHTS AND OBLIGATIONS

 

4.1             Development and Commercialization . Subject to Sections 4.5 and 4.6, OvaXon shall be solely responsible for the development and Commercialization of Collaboration Products.  OvaXon shall be responsible for all costs incurred in connection with the Collaborative Program to the extent included in a Work Plan approved by the JSC, except that Intrexon shall be responsible for the following:  (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.5 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Collaboration Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials ( i . e ., platform improvements) but, for clarity, excluding research described in Section 4.6 or research requested by the JSC for the development of a Collaboration Product (which research costs shall be reimbursed by OvaXon); (c) [***]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents.  The costs encompassed within clause (a) of the previous sentence shall include the scale-up of Intrexon Materials for generating data for regulatory approval submissions and Commercialization of Collaboration Products undertaken pursuant to Section 4.5, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or OvaXon (with Intrexon’s consent).

 

4.2             Information and Reporting .

 

(a)           OvaXon will keep Intrexon reasonably informed about OvaXon’s efforts to develop and Commercialize Collaboration Products by providing Intrexon with  reasonable and accurate summaries of OvaXon’s (and its Affiliates’ and, if applicable, (sub)licensees’) development plans (as updated), including preclinical, clinical and regulatory plans, marketing plans (as updated), progress towards meeting the goals and milestones in such plans and

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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explanations of any material deviations, significant developments in the development and/or Commercialization of the Collaboration Products , including the initiation or completion of clinical trials, submission of United States or international regulatory filings, receipt of responses to such United States or international regulatory filings, clinical safety events, receipt of Regulatory Approvals, or commercial launches with respect to Collaboration Products.  Intrexon will keep OvaXon reasonably informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for Collaboration Products  (and Intrexon Materials relevant thereto) and otherwise perform its manufacturing responsibilities under Section 4.6 and (b) to undertake discovery-stage research for the Collaborative Program with respect to the Intrexon Channel Technology and Intrexon Materials by providing OvaXon with reasonable and accurate summaries of Intrexon’s (and its Affiliates’ and, if applicable, (sub)licensees’) plans (as updated) established with respect to such manufacturing capabilities and facilities for Collaboration Products  and/or discovery-stage research for the Collaborative Program, including progress towards meeting the goals and milestones in such plans and explanations of any material deviations, significant developments in the development of such manufacturing capabilities and facilities for Collaboration Products  and/or discovery-stage research.  Unless otherwise provided herein or directed by the JSC in accord with Section 4.2 above, such disclosures by OvaXon and Intrexon will be coordinated by the JSC and made in connection with JSC meetings at least once every six (6) months while Collaboration Products  are being developed or Commercialized, and shall be reflected in the minutes of such meetings.

 

(b)                                  OvaXon will keep OvaScience reasonably informed about OvaXon’s efforts to develop and Commercialize Collaboration Products by providing OvaScience with copies of any summaries and data described in Section 4.2(a) and provided to Intrexon to the extent reasonably requested by OvaScience and relating to the Collaborative Program. The rights of OvaScience to request, receive and/or have a copy of such data and information under this Section 4.2(b) shall be subject to OvaScience being bound to comply with all provisions of this Agreement relating to the use and ownership of confidential information and intellectual property of OvaXon and Intrexon, solely to the extent it receives such information and data.

 

4.3                                         Regulatory Matters .  At all times after the Effective Date, OvaXon shall own and maintain, at its own cost, all regulatory filings and regulatory approvals for Collaboration Products  that OvaXon is developing or Commercializing pursuant to this Agreement.  OvaXon shall be responsible for reporting all adverse events related to such Collaboration Products  to the appropriate regulatory authorities in the relevant countries, in accordance with the applicable laws and regulations of such countries.  To the extent that Intrexon develops, itself or in collaboration with other third parties, Intrexon Materials for use outside of the Field, Intrexon may request that OvaXon and Intrexon negotiate a separate safety data exchange agreement to address and govern the timely exchange of safety information generated by OvaXon, Intrexon, and relevant third parties with respect to specific Intrexon Materials; provided, that, OvaXon shall be under no obligation to enter into any such agreement.  The decision to list or not list Patents in any regulatory filing for a Collaboration Product (for example, as required by 21 C.F.R. § 314.53(b)), add or delete a Patent from a regulatory filing, or to otherwise identify a Patent to a third party in compliance with laws or regulations relating to regulatory approvals (for example, in compliance with 42 U.S.C. § 262(a)(1)(A)(k) et seq.) shall be determined by

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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mutual agreement of the Parties, after good faith consultation.  To the extent that there is a dispute regarding the same, then the final determination regarding any Patent shall be left up to the Party having ownership of that Patent.

 

4.4                                         Diligence .

 

(a)                                  OvaXon shall use, and shall include in any Third Party sublicense permitted under this Agreement a covenant that shall provide that such sublicensee shall, use, Diligent Efforts to develop and Commercialize Collaboration Products.  Intrexon shall use Diligent Efforts to perform any Work Plan support services set forth in Section 4.6.

 

(b)                                  Without limiting the generality of the foregoing, Intrexon may, from time to time, notify OvaXon that it believes it has identified a Superior Therapy, and in such case Intrexon shall provide to OvaXon its then-available information about such therapy and reasonable written support for its conclusion that the therapy constitutes a Superior Therapy.  OvaXon shall have the following obligations with respect to such proposed Superior Therapy:  (i) within sixty (60) days after such notification, OvaXon shall prepare and deliver to the JSC for review and approval a development plan detailing how OvaXon will pursue the Superior Therapy (including a proposed budget); (ii) OvaXon shall revise the development plan as directed by the JSC; and (iii) following approval of the development plan by the JSC, OvaXon shall use Diligent Efforts to pursue the development of the Superior Therapy under the Collaborative Program in accordance with such development plan.  To the extent that Intrexon has in fact identified a Superior Therapy, Intrexon shall have the termination right set forth in Section 10.2(b) (subject to the final sentence of this Section 4.4(b) and the limitation set forth therein) if OvaXon fails to comply with the foregoing obligations (i)-(iii), or if OvaXon unreasonably exercises its casting vote at the JSC to either (x) prevent the approval of a development plan for a Superior Therapy; (y) delay such approval more than sixty (60) days after delivery of the development plan to the JSC; or (z) approve a development plan that is insufficient in view of the nature and magnitude of the opportunity presented by the Superior Therapy.  For clarity, (i) any dispute arising under this 4.4, including any dispute as to whether a project proposed by Intrexon in fact constitutes a Superior Therapy (as with any other dispute under this Agreement) shall be subject to dispute resolution in accordance with Article 11, and (ii) Intrexon shall have no right to terminate this Agreement pursuant to Section 10.2(c), and the cure period provided in Section 10.2(c) shall be stayed, during the period any such dispute is subject to such dispute resolution process.

 

(c)                                   The activities of OvaXon’s Affiliates and any permitted sublicensees shall be attributed to OvaXon for the purposes of evaluating OvaXon’s fulfillment of the obligations set forth in this Section 4.4.

 

4.5                                         Manufacturing .  Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Collaborative Program that relate to the Intrexon Materials or bulk quantities of other components of Collaboration Products , either itself or through the use of a suitable Third Party contract manufacturer.  To the extent that Intrexon so elects, OvaXon and Intrexon shall

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

negotiate and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials or bulk quantities of other components of Collaboration Products .  Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith.  In the event that Intrexon does not elect to manufacture Intrexon Materials or bulk quantities of other components of Collaboration Products , then (a) Intrexon shall provide written notice of same to OvaXon, (b) the Parties will, through the JSC, develop a written work plan (the “Technology Transfer Work Plan” ) describing the activities (the “Technology Transfer Activities” ) to be performed by Intrexon to implement the transfer to OvaXon or a contract manufacturer selected by OvaXon of all Information Controlled by Intrexon that is (i) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of Collaboration Products for use in the Field and (ii) reasonably necessary to enable OvaXon or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of Collaboration Products, which may include providing OvaXon and/or such Third Party with the training, documentation and other information relating to the manufacturing of such Intrexon Materials or bulk qualities of other components of Collaboration Products for use in the Field and making appropriately trained personnel available for consultation and advice upon the reasonable request of OvaXon and/or such Third Party to the extent reasonably necessary to enable OvaXon and/or such Third Party to manufacture such Intrexon Materials or bulk qualities of other components of Collaboration Products for use in the Field and (c) Intrexon shall promptly undertake the Technology Transfer Activities.  The costs and expenses incurred by Intrexon in carrying out such Technology Transfer Activities  shall be borne by OvaXon.  Any manufacturing Information transferred hereunder to OvaXon or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any OvaXon Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit OvaXon to switch manufacturers.

 

4.6                                         Support Services .

 

(a)                                  The JSC will meet promptly following the Effective Date and prepare and approve the initial Work Plan under which Intrexon will provide support services to OvaXon for the research and development of Collaboration Products under the Collaborative Program, which initial Work Plan may be amended from time to time by the JSC.  The Work Plan shall set forth activities and deliverables and shall include the timelines and estimated costs for such (including a detailed budget that shall include all estimated Fully Loaded Costs).  OvaXon will compensate Intrexon for services under this Section 4.6 with cash payments equal to Intrexon’s Fully Loaded Cost in accord with the Work Plan.  Additionally, from time to time, on an ongoing basis, OvaXon may request, or Intrexon may propose, that Intrexon perform certain additional services with respect to researching and developing new Collaboration Products. If either Party proposes that Intrexon perform additional Services, not specifically provided for in the applicable Work Plan, Intrexon shall prepare a draft revised Work Plan describing in reasonable detail the nature of such additional Services, and submit such revised Work Plan to the JSC for its review and

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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written approval.  To the extent that the Parties mutually agree that Intrexon should perform such additional services, it is understood that Intrexon would be compensated for such additional services by cash payments equal to Intrexon’s Fully Loaded Cost in connection with such services.

 

(b)                                  OvaXon shall not be obligated to pay to Intrexon for the conduct of any support services provided under this Section 4.6 any amounts that exceed by more than [***] percent ([***]%) the budget specifically allocated for the applicable activities in the associated JSC-approved budget under the Work Plan, unless (a) the JSC shall amend the Work Plan and associated budget to accommodate any material overage, or (b) OvaXon otherwise agrees in writing to pay the amounts in material excess to Intrexon.  In the event that, in performance under the Work Plan, Intrexon determines that the JSC-approved budget is in some way insufficient to complete performance of the tasks under the Work Plan, it will notify the JSC as soon as practical after determining such, providing sufficient detail to enable the JSC to promptly review the budget insufficiency and revise the Work Plan and associated budget.  The JSC (i) shall confer and/or meet (including electronically) as soon as practical after receiving such notice from Intrexon to consider amending the Work Plan, and (ii) shall use best efforts to provide a final decision regarding whether, and (if so) how, to amend the Work Plan and associated budget in order to expand the budget and/or minimize the activities under the Work Plan to reconcile budget with the then-current expectations and projections for expenditures under the Work Plan.  Intrexon may discontinue performance under a Work Plan if continuing under the Work Plan to the extent continuing would cause Intrexon to exceed by more than [***] percent ([***]%) the applicable budget, such discontinuance being permissible until such time as the JSC, with the consent of OvaXon, has amended the Work Plan to redress the issue in accord with this Section 4.6(b).  To the extent that the inability of the JSC to approve an amended Work Plan and/or associated budget causes Intrexon to materially discontinue performance under the Work Plan toward producing the IND-Enabling Package, any number of days of discontinuance by Intrexon until JSC approval for amendment is actually granted exceeding ([***]) business days from Intrexon’s notice under this Section 4.6(b) shall be includable in the determination of OvaXon Delay.

 

4.7                                         Compliance with Law .  Each Party shall comply, and shall ensure that its Affiliates, comply, and shall include in any agreement with any permitted Third Party sublicensee or subcontractor a covenant that shall provide that such Third Party shall comply with, all applicable laws, regulations, and guidelines applicable to the Collaborative Program, including without limitation those relating to the transport, storage, and handling of Intrexon Materials and Collaboration Products.

 

4.8                                         Trademarks and Patent Marking.  OvaXon shall ensure that the packaging, promotional materials, and labeling for Collaboration Products , shall carry as appropriate the applicable Intrexon Trademark(s), as required by and/or in compliance with applicable laws and regulations.  Consistent with the U.S. patent laws, OvaXon shall ensure that Collaboration Products , or their respective packaging or accompanying literature as appropriate, bear applicable and appropriate patent markings for Intrexon Patent numbers.  OvaXon shall provide the IPC (or, after termination, Intrexon) with representative samples of all products, product

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

packaging, literature, brochures, signs, and advertising materials prepared by OvaXon which bear, display, or include any reference to  the Intrexon Trademarks or patent markings prior to using or disseminating such materials.  OvaXon acknowledges Intrexon’s sole ownership of the Intrexon Trademarks and agrees not to take any action inconsistent with such ownership.  OvaXon covenants that it shall not use any trademark confusingly similar to any Intrexon Trademarks in connection with any products (including any Collaboration Product . OvaXon shall comply with reasonable policies provided in writing by Intrexon from time-to-time to maintain the goodwill and value of the Intrexon Trademarks.

 

4.9                                         Technology Transfer by OvaXon.  As soon as practical following the approval of the original Work Plan by the JSC, OvaXon will provide Intrexon with any  Information and proprietary materials Controlled by OvaXon and described in the Work Plan to the extent required for Intrexon to perform its obligations under the Work Plan.

 

ARTICLE 5

 

RESERVED

 

5.1                                         Reserved .

 

ARTICLE 6

 

INTELLECTUAL PROPERTY

 

6.1                                         Ownership .

 

(a)                                  Subject to the license granted under Section 3.1, all rights, technology, and intellectual property, including the Intrexon IP, (A) Controlled by Intrexon as of the Effective Date, or (B) thereafter developed by Intrexon independent of the Collaborative Program and OvaXon Cell Platform Technology, shall be owned by and remain the sole property of Intrexon.

 

(b)                                  The following shall be and remain the sole property of OvaXon  (the “ OvaXon Independent IP ”): (i) the OvaXon Cell Platform Technology, and (ii) any technology and intellectual property (including patents and other rights relating therein) developed after the Effective Date by OvaXon independent of the Collaborative Program, Intrexon Channel Technology, Intrexon IP or Intrexon Materials,

 

(c)                                   OvaXon and/or Intrexon may solely or jointly conceive, reduce to practice or develop discoveries, inventions, processes, techniques, and other technology, whether or not patentable, in the course of performing the Collaborative Program (collectively “ Inventions ”).  Each Party shall promptly provide the IPC with a detailed written description of any such Inventions to enable the IPC to reasonably determine those Inventions that relate to the Field.  Inventorship shall be determined in accordance with United States patent laws.

 

(d)                                  OvaXon shall solely own all right, title and interest in all Inventions (together with all Patent rights and other intellectual property rights therein) that (i) incorporate

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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or solely relate to use of the OvaXon Cell Platform Technology, and (ii) which is not based upon, does not incorporate, or does not require the use of, Intrexon IP, the Intrexon Channel Technology or Intrexon Materials (collectively, “ OvaXon Platform Inventions ”).  Intrexon hereby assigns and agrees to assign to OvaXon all of Intrexon’s interests in and to any and all OvaXon Cell Platform Inventions, and shall perform or have performed any and all acts reasonably necessary to assist OvaXon in perfecting its rights to any and all OvaXon Cell Platform Inventions, including executing or having executed any documents affecting the appropriate assignment to OvaXon.

 

(e)                                   Intrexon shall solely own all right, title and interest in all Inventions (together with all Patent rights and other intellectual property rights therein) that (i) (A) incorporate or solely relate to use of the Intrexon Channel Technology or (B) relate generally to the discovery, design and development of markers, cell processing techniques and lines, complex transgenes and vectors, and production processes, and (ii) in any case, which is not based upon and does not incorporate or require the use of the OvaXon Cell Platform Technology (collectively, the “ Channel-Related Program IP ”).  OvaXon hereby assigns and agrees to assign to Intrexon all of OvaXon’s interests in and to any and all Channel-Related Program IP, and shall perform or have performed any and all acts reasonably necessary to assist Intrexon in perfecting its rights in and to any and all of the Channel-Related Program IP, including executing or having executed any documents affecting the appropriate assignment to Intrexon.

 

(f)                                    Notwithstanding anything to the contrary in this Agreement, any discovery, invention, process, technique, or other technology, whether or not patentable, that is conceived, reduced to practice or developed by OvaXon solely or jointly through the use of the Intrexon Channel Technology, Intrexon IP, or Intrexon Materials in breach of the terms and conditions of this Agreement, together with all patent rights and other intellectual property rights therein, shall be solely owned by Intrexon and shall be Channel-Related Program IP.

 

(g)                                  All Information disclosed by Intrexon to OvaXon regarding Channel-Related Program IP shall be Confidential Information of Intrexon.  OvaXon shall be under appropriate written agreements with each of its employees, contractors, or agents working on the Collaborative Program, pursuant to which such person shall grant all rights in the Inventions to OvaXon (so that OvaXon may convey certain of such rights to Intrexon, as provided herein) and agree to protect all Confidential Information relating to the Collaborative Program.

 

(h)                                  Subject to the foregoing clauses of this Section 6.1, all Inventions (together with all Patent rights and other intellectual property rights therein) that (i) are neither Channel-Related Program IP nor OvaXon Platform Inventions, and (ii) relate solely and specifically to a combination of Intrexon Channel Technology and OvaXon Cell Platform Technology (collectively the “ Joint Program Inventions ”) shall be owned jointly by Intrexon and OvaXon in undivided one-half interests.

 

(i)                                     For clarity, the Parties’ joint ownership of the Joint Program Inventions does not by itself grant either Party rights in any other intellectual property of the other Party, and, except for the explicit licenses set forth in this Agreement (i) Intrexon is not permitted to

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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use any OvaXon intellectual property (except as may be otherwise expressly granted by OvaXon) in the practice of Joint Program Inventions, and (ii) OvaXon is not permitted to use any Intrexon IP (except as may be otherwise expressly granted by Intrexon) in the practice of Joint Program Inventions.

 

(j)                                     Patent Disputes .  In the event the IPC is unable to reach agreement on any matter with respect to ownership of Patents under this Agreement, including with respect to the determination of inventorship under U.S. patent law, the issue shall be submitted to an outside patent counsel reasonably acceptable to the IPC who (and whose firm) is not at the time of the dispute, and was not at any time during the five (5) year period prior to such dispute, performing legal services for either of the Parties, and which did not, at any time, employ any member of the IPC.  Such patent counsel shall provide a non-binding opinion regarding the disputed matter, and the expenses of such outside patent counsel shall be shared equally by the Parties.  If, after obtaining such non-binding opinion, the Parties cannot resolve the dispute under this Section 6.1(j), the dispute resolution procedures of Article 11 will apply.

 

6.2                                         Patent Prosecution .

 

(a)                                  Intrexon shall have the sole right, but not the obligation, to (i) conduct and control the filing, prosecution and maintenance of the Intrexon Patents, and (ii) conduct and control the filing, prosecution, and maintenance of any applications for patent term extension and/or supplementary protection certificates that may be available as a result of the regulatory approval of any Collaboration Product. At the reasonable request of Intrexon, OvaXon shall cooperate with Intrexon in connection with such filing, prosecution, and maintenance, at Intrexon’s expense.  Under no circumstances shall OvaXon (i) file, attempt to file, or assist anyone else in filing, or attempting to file, any Patent application, either in the United States or elsewhere, that claims or uses or purports to claim or use or relies for support upon an Intrexon Invention, (ii) use, attempt to use, or assist anyone else in using or attempting to use, the Intrexon Know-How, Intrexon Materials, or any Confidential Information of Intrexon to support the filing of a Patent application, either in the United States or elsewhere, that contains claims directed to the Intrexon IP, Intrexon Materials, or the Intrexon Channel Technology, or (iii) without prior approval of the IPC, file, attempt to file, or assist anyone else in filing, or attempting to file, any application for patent term extension or supplementary protection certificate, either in the United States or elsewhere, that relies upon the regulatory approval of a Collaboration Product.

 

(b)                                  OvaXon shall have the sole right, but not the obligation, to conduct and control the filing, prosecution and maintenance of any Patents claiming OvaXon Platform Inventions (“ OvaXon Program Patents ”) and any OvaXon Patents.  At the reasonable request of OvaXon, Intrexon shall cooperate with OvaXon in connection with such filing, prosecution, and maintenance, at OvaXon’s expense.

 

(c)                                   The Parties through the IPC shall reasonably cooperate, to the extent such cooperation can be done without substantially compromising any Patents of either Party, to develop a portfolio of Product-Specific Program Patents and Patents for Joint Program Inventions covering relevant Collaboration Products .  Consistent with this Section 6.2(c), the

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

IPC may establish protocols and procedures with respect to the cooperation of the Parties with respect to such, which shall include the right for a Party to request, in its discretion, that the other Party file at the requesting Party’s expense one or more continuation or divisional applications (as appropriate) for Patent for the express purpose of creating Product-Specific Program Patents or otherwise dividing Intrexon IP (including Channel-Related Program IP) and/or OvaXon Platform Inventions from Patents for Joint Program Inventions, which request shall be honored to the extent reasonable, permitted by applicable laws, and otherwise consistent with this Agreement.  During the Term, OvaXon shall have, the first right, but not the obligation, to conduct and direct the filing, prosecution and maintenance of any Patents for Joint Program Inventions consistent with any relevant strategies and determinations set forth by the IPC under the prior sentence with respect to such Patents and other Intrexon IP. To the extent that OvaXon exercises the rights to conduct and direct under the prior sentence, OvaXon shall (i) provide Intrexon in a timely manner with copies of all material correspondence regarding Joint Program Inventions to and from any foreign or domestic patent offices and patent prosecution counsel (including at a minimum any related drafts of patent applications, official responses, and other substantive communications and filings at least fifteen (15) days prior to any applicable deadline for review) for Intrexon review prior to filing; (ii) shall take into account any Intrexon comments or requests relating to relevant draft communications and filings and not submit such communications and filings without Intrexon approval and consent, such approval and consent not to be unreasonably delayed, withheld, or conditioned; (iii) keep Intrexon reasonably apprised regarding the status of any prior art searches, patentability analyses, draft patent applications, and other material information in the possession of OvaXon that would be reasonably useful to Intrexon in assessing the scope and status of such Patents for Joint Program Inventions or otherwise in preventing a loss of rights by Intrexon to any related Inventions that are Intrexon IP; (iv) provide Intrexon with reasonable advance notice if OvaXon decides to abandon (or otherwise not file for or pursue) any such Patents for Joint Program Inventions so as to enable Intrexon sufficient lead time to prevent an unwanted loss of rights by Intrexon to Intrexon IP, including allowing Intrexon to file on and prosecute Patents for such; (v) use qualified patent counsel reasonably acceptable to Intrexon; (vi) advise relevant OvaXon employees and agents as necessary to facilitate compliance with the obligations of this Section 6.2(c), including advising outside OvaXon patent counsel regarding the obligations of this sentence or any relevant protocols and procedures established by the IPC; and (vii) be solely responsible for all costs and expenses incurred by OvaXon in connection with the preparation, filing, prosecution and maintenance of Patents for Joint Program Inventions.  To the extent that OvaXon does not exercise the rights to conduct and direct under the prior sentence (including an abandonment under clause (iv) of the prior sentence), Intrexon shall have the option to assume the preparation, filing, prosecution and maintenance of Patents for Joint Program Inventions at its own discretion and expense, subject to Intrexon providing OvaXon in a timely manner with copies of all material correspondence regarding Joint Program Inventions to and from any foreign or domestic patent offices and patent prosecution counsel (including at a minimum any related drafts of patent applications, official responses, and other substantive communications and filings at least fifteen (15) days prior to any applicable deadline for review) for OvaXon comment and review prior to filing.  Intrexon and OvaXon shall reasonably cooperate in connection with such filing,

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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prosecution, and maintenance under this Section 6.2(c), including with respect to executing and submitting and documents necessary to perfect the rights of the Parties.

 

(d)                                  As used in this Section 6.2(d), “ Prosecuting Party ” means Intrexon in the case of Intrexon Patents and OvaXon in the case of OvaXon Program Patents and Patents for Joint Program Inventions prosecuted by it pursuant to Section 6.2(c).  The Prosecuting Party shall be entitled to use patent counsel selected by it and reasonably acceptable to the non-Prosecuting Party (including in-house patent counsel as well as outside patent counsel) for the prosecution of the Intrexon Patents and OvaXon Program Patents, as applicable.  The Prosecuting Party shall:

 

(i)                                      regularly provide the other Party in advance with reasonable information relating to the Prosecuting Party’s prosecution of Patents hereunder, including by providing copies of substantive communications, notices and actions submitted to or received from the relevant patent authorities and copies of drafts of filings and correspondence that the Prosecuting Party proposes to submit to such patent authorities (it being understood that, to the extent that any such information is readily accessible to the public, the Prosecuting Party may, in lieu of directly providing copies of such information to such other Party, provide such other Party with sufficient information that will permit such other Party to access such information itself directly);

 

(ii)                                   consider in good faith and consult with the non-Prosecuting Party regarding its timely comments with respect to the same; provided, however, that if, within fifteen (15) days after providing any documents to the non-Prosecuting Party for comment, the Prosecuting Party does not receive any written communication from the non-Prosecuting Party indicating that it has or may have comments on such document, the Prosecuting Party shall be entitled to assume that the non-Prosecuting Party has no comments thereon;

 

(iii)                                consult with the non-Prosecuting Party before taking any action that would reasonably be expected to have a material adverse impact on the scope of claims within the Intrexon Patents and OvaXon Program Patents, as applicable.

 

(e)                                   Without limiting the obligations of confidentiality, non-use, and non-disclosure under this Agreement, neither Party shall file any application for Patent that includes the Confidential Information, including data, Inventions, and other Information, of the other Party without the prior written consent of the other Party, or will publish any Confidential Information of another party or make any reference to another party or its intellectual property or materials as used in connection with any Research Project and/or Project Plan without the prior written consent of the other Party.

 

6.3                                         Infringement of Patents by Third Parties .

 

(a)                                  Except as expressly provided in the remainder of this Section 6.3, Intrexon shall have the sole right to take appropriate action against any person or entity directly or indirectly infringing any Intrexon Patent (or asserting that an Intrexon Patent is invalid or

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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unenforceable) (collectively, “ Infringement ”), either by settlement or lawsuit or other appropriate action.

 

(b)                                  Notwithstanding the foregoing, OvaXon shall have the first right, but not the obligation, to take appropriate action to enforce Product-Specific Program Patents  and/or Patents for Joint Program Inventions against any Infringement that in the reasonable judgment of OvaXon involves, or is reasonably expected to involve, a commercially material amount of allegedly infringing activities in the Field (“ Field Infringement ”), either by settlement or lawsuit or other appropriate action.  If OvaXon exercises the foregoing right, (i) Intrexon agrees to be named in any such action if required, and (ii) OvaXon agrees to provide Intrexon with a description of its basis for concluding that such Field Infringement exists. If OvaXon fails to take the appropriate steps to enforce such against any Field Infringement within one hundred eighty (180) days of the date one Party has provided notice to the other Party pursuant to Section 6.3(g) of such Field Infringement, then Intrexon shall have the right (but not the obligation), at its own expense, to enforce such Patents against such Field Infringement, either by settlement or lawsuit or other appropriate action.  If Intrexon exercises the foregoing right with respect to Patents for Joint Program Inventions, OvaXon agrees to be named in any such action if required.

 

(c)                                   With respect to any Field Infringement that cannot reasonably be abated through the enforcement of Patents pursuant to Section 6.3(b) but can reasonably be abated through the enforcement of Intrexon Patent(s) (other than the Product-Specific Program Patents or jointly-owned Patents for Joint Program IP), Intrexon shall be obligated to choose one of the following courses of action: (i) enforce one or more of the applicable Intrexon Patent(s) in a commercially reasonable manner against such Field Infringement, or (ii) [***]. To the extent OvaXon shall be entitled to a share of the Recovery a set forth in Section 6.3(f), Intrexon and OvaXon shall bear the costs and expenses of such enforcement equally.  The determination of which Intrexon Patent(s) to assert shall be made by Intrexon in its sole discretion; provided, however, that Intrexon shall consult in good faith with OvaXon on such determination.  For the avoidance of doubt, Intrexon has no obligations under this Agreement to enforce any Intrexon Patents against, or otherwise abate, any Infringement that is not a Field Infringement.

 

(d)                                  In the event a Party pursues an action under this Section 6.3, the other Party shall reasonably cooperate with the enforcing Party with respect to the investigation and prosecution of any alleged, threatened, or actual Infringement, at the enforcing Party’s expense (except with respect to an action under Section 6.3(c), where all costs and expenses will be shared equally in accordance with terms thereof).

 

(e)                                   OvaXon shall not settle or otherwise compromise any action under this Section 6.3 in a way that diminishes the rights or interests of Intrexon outside the Field or adversely affects any Intrexon Patent (including any rights in a Patent for Joint Program Inventions) without Intrexon’s prior written consent, which consent shall not be unreasonably withheld.  Intrexon shall not settle or otherwise compromise any action under this Section 6.3 in a way that diminishes the rights or interests of OvaXon in the Field or adversely affects any Intrexon Patent (including any rights in a Patent for Joint Program Inventions) with respect to the Field without OvaXon’s prior written consent, which consent shall not be unreasonably withheld.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(f)                                    Except as otherwise agreed to by the Parties in writing, any settlements, damages or other monetary awards recovered pursuant to a suit, proceeding, or action brought pursuant to Section 6.3 will be allocated first to the costs and expenses of the Party controlling such action, and second, to the costs and expenses (if any) of the other Party (to the extent not otherwise reimbursed), and any remaining amounts (the “Recovery” ) will be shared by the Parties as follows:  In any action initiated by Intrexon pursuant to Section 6.3(a) that does not involve Field Infringement, or in any action initiated by Intrexon pursuant to Section 6.3(b), Intrexon shall retain one hundred percent (100%) of any Recovery.  In any action initiated by OvaXon pursuant to Section 6.3(b), OvaXon shall retain one hundred percent (100%) of any Recovery.  In any action initiated by Intrexon or OvaXon pursuant to Section 6.3(c), [***].

 

(g)                                  OvaXon shall promptly notify Intrexon of any suspected, alleged, threatened, or actual Infringement of which it becomes aware, and Intrexon shall promptly notify OvaXon of any suspected, alleged, threatened, or actual Field Infringement of which it becomes aware.

 

ARTICLE 7

 

CONFIDENTIALITY

 

7.1                                         Confidentiality .  Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties, each Party agrees that it shall keep confidential and shall not publish or otherwise disclose and shall not use for any purpose other than as provided for in this Agreement any Confidential Information disclosed to it by the other Party pursuant to this Agreement, except to the extent that the receiving Party can demonstrate by competent evidence that specific Confidential Information:

 

(a)                                  was already known to the receiving Party and can be demonstrated by written records, other than under an obligation of confidentiality, at the time of disclosure by the other Party;

 

(b)                                  was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;

 

(c)                                   became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement;

 

(d)                                  was disclosed to the receiving Party, other than under an obligation of confidentiality to a Third Party, by a Third Party who had no obligation to the disclosing Party not to disclose such information to others; or

 

(e)                                   was independently discovered or developed by the receiving Party without the use of Confidential Information belonging to the disclosing Party, as documented by the receiving Party’s written records.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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The foregoing non-use and non-disclosure obligation shall continue (i) indefinitely, for all Confidential Information that qualifies as a trade secret under applicable law; or (ii) for the Term of this Agreement and for seven (7) years thereafter, in all other cases.

 

7.2                                         Authorized Disclosure .  Notwithstanding the limitations in this Article 7, either Party may disclose the Confidential Information belonging to the other Party to the extent such disclosure is reasonably necessary in the following instances:

 

(a)                                  complying with applicable laws or regulations or valid court orders, provided that the Party making such disclosure provides the other Party with reasonable prior written notice of such request or demand for disclosure and makes a reasonable effort to obtain, or to assist the other Party in obtaining, a protective order preventing or limiting the disclosure and/or requiring that the terms and conditions of this Agreement be used only for the purposes for which the law or regulation required, or for which the order was issued;

 

(b)                                  to regulatory authorities in order to seek or obtain approval to conduct clinical trials, or to gain regulatory approval, of Collaboration Products, or any products being developed by Intrexon or its other licensees and/or channel partners or collaborators to the extent Intrexon has a right to so use such Confidential Information under Sections 4.3 and/or 10.4, provided that the Party making such disclosure (i) provides the other Party with reasonable opportunity to review any such disclosure in advance and to suggest redactions or other means of limiting the disclosure of such other Party’s Confidential Information and (ii) does not unreasonably reject any such suggestions;

 

(c)                                   disclosure to investors and potential investors, acquirers, or merger candidates who agree to maintain the confidentiality of such information, provided that such disclosure is used solely for the purpose of evaluating such investment, acquisition, or merger (as the case may be);

 

(d)                                  disclosure on a need-to-know basis to Affiliates, licensees, sublicensees, employees, consultants or agents (such as CROs and clinical investigators) who agree to be bound by obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Article 7; and

 

(e)                                   disclosure of the terms of this Agreement by either Party to collaborators and other channel partners or collaborators who agree to be bound by obligations of confidentiality, intellectual ownership and assignment, and non-use at least equivalent in scope to those set forth in this Article 7.

 

7.3                                         Publicity; Publications .  The Parties agree that the public announcement of the execution of this Agreement shall be substantially in the form of a press release (the form of which shall be mutually agreed to by the Parties) and/or the filing of a Form 8-K by one or both of the Parties (to the extent required by relevant laws or regulations relating to required disclosure of material information to public markets and/or the SEC).  Each Party will provide the other Party with the opportunity to review and comment, prior to submission or presentation,

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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on external reports, securities filings, publications and presentations (e.g., press releases, reports to government agencies, abstracts, posters, manuscripts and oral presentations) that refer to this Agreement, the Collaborative Program, Collaboration Products, or programs that are approved by the JSC.  For such reports, publications, and presentations, the disclosing Party will provide the other Party at least fifteen (15) calendar days for review of the proposed submission or presentation.  In the case of a Form 8-K filing, such shall be provided to the non-filing Party by the filing party as soon as practicable prior to filing for review and comment.  For reports and manuscripts, the disclosing Party will provide the other Party at least thirty (30) days for review of the report or manuscript.  The presenting Party will act in good faith to incorporate the comments of the other Party and shall, in any event, redact any Confidential Information of the other Party and cooperate with the other Party to postpone such submissions or presentations if necessary to provide the other Party with sufficient time to prepare and file any related Patent applications before the submission or presentation occurs, as appropriate.

 

7.4                                         Terms of the Agreement .  Each Party shall treat the terms of this Agreement as the Confidential Information of other Party, subject to the exceptions set forth in Section 7.2.  Notwithstanding the foregoing, each Party acknowledges that the other Party may be obligated to file a copy of this Agreement with the SEC, either as of the Effective Date or at some point during the Term.  Each Party shall be entitled to make such a required filing, provided that it requests confidential treatment of certain commercial terms and sensitive technical terms hereof to the extent such confidential treatment is reasonably available to it.  In the event of any such filing, the filing Party shall provide the other Party with a copy of the Agreement marked to show provisions for which the filing Party intends to seek confidential treatment and shall reasonably consider and incorporate the other Party’s comments thereon to the extent consistent with the legal requirements governing redaction of information from material agreements that must be publicly filed.  The other Party shall promptly provide any such comments.

 

7.5                                         Proprietary Information and Operational Audits.

 

(a)                                  For the purpose of confirming compliance with the Field-limited licenses granted in Article 3, the diligence obligations of Article 4, and the confidentiality obligations under Article 7, OvaXon acknowledges that Intrexon’s authorized representative(s), during regular business hours may (i) examine and inspect OvaXon’s facilities and (ii) inspect all data and work products relating to this Agreement, subject to restrictions imposed by applicable laws.  Any examination or inspection hereunder shall require five (5) business days written notice from Intrexon to OvaXon.  OvaXon will make itself and the pertinent employees and/or agents available, on a reasonable basis, to Intrexon for the aforementioned compliance review.  Intrexon may not request and examination or inspection under this Section 7.5(a)  more than once per year except if Intrexon has reasonable belief, upon inquiry, that OvaXon is in material non-compliance with the Field-limited licenses granted in Article 3, the diligence obligations of Article 4, and/or the confidentiality obligations under Article 7.  If Intrexon provides notice under this Section 7.5(a) less than one (1) year from its last examination or inspection hereunder, Intrexon must provide written basis in such notice for its reasonable belief of material non-compliance.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(b)                                  For the purpose of confirming compliance with the diligence obligations of Section 4.5, and the confidentiality obligations under Article 7, Intrexon acknowledges that OvaXon authorized representative(s), during regular business hours may (i) examine and inspect Intrexon’s facilities and (ii) inspect all data and work products relating to this Agreement.  Any examination or inspection hereunder shall require five (5) business days written notice from OvaXon to Intrexon.  Intrexon will make itself and the pertinent employees and/or agents available, on a reasonable basis, to OvaXon for the aforementioned compliance review.  OvaXon may not request and examination or inspection under this Section 7.5(b)  more than once per year except if OvaXon has reasonable belief, upon inquiry, that Intrexon is in material non-compliance with the diligence obligations of Section 4.5 and/or the confidentiality obligations under Article 7.  If OvaXon provides notice under this Section 7.5(a) less than one (1) year from its last examination or inspection hereunder, OvaXon must provide written basis in such notice for its reasonable belief of material non-compliance.

 

(c)                                   In view of the Intrexon Confidential Information, Intrexon Know-How, and Intrexon Materials transferred to OvaXon hereunder, Intrexon from time-to-time, but no more than quarterly, may request that OvaXon confirm the status of the Intrexon Materials at OvaXon (i.e. how much used, how much shipped, to whom and any unused amounts destroyed (by whom, when) as well as any amounts returned to Intrexon or destroyed).  Within ten (10) business days of OvaXon’s receipt of any such written request, OvaXon shall provide the written report to Intrexon.

 

7.6                                         Intrexon Commitment .  Intrexon shall use reasonable efforts to obtain an agreement with its other licensees and channel partners or collaborators to enable OvaXon to disclose confidential information of such licensees and channel partners or collaborators to regulatory authorities in order to seek or obtain approval to conduct clinical trials, or to gain regulatory approval of, Collaboration Products, in a manner consistent with the provisions of Section 7.2(b).

 

ARTICLE 8

 

REPRESENTATIONS AND WARRANTIES

 

8.1                                         Representations and Warranties of OvaXon .  OvaXon hereby represents and warrants to Intrexon that, as of the Effective Date:

 

(a)                                  Corporate Power .  OvaXon is duly organized and validly existing under the laws of Delaware and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof.

 

(b)                                  Due Authorization .  OvaXon is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the person executing this Agreement on OvaXon’s behalf has been duly authorized to do so by all requisite corporate action.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(c)                                   Binding Agreement .  This Agreement is a legal and valid obligation binding upon OvaXon and enforceable in accordance with its terms, except as such enforcement may be limited by applicable bankruptcy, insolvency, reorganization, arrangement, moratorium or other similar laws affecting creditors’ rights, and subject to general equity principles and to limitations on availability of equitable relief, including specific performance.  The execution, delivery and performance of this Agreement by OvaXon does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound.  OvaXon is aware of no action, suit or inquiry or investigation instituted by any governmental agency which questions or threatens the validity of this Agreement.

 

8.2                                         Representations and Warranties of Intrexon .  Intrexon hereby represents and warrants to OvaXon that, as of the Effective Date:

 

(a)                                  Corporate Power .  Intrexon is duly organized and validly existing under the laws of Virginia and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof.

 

(b)                                  Due Authorization .  Intrexon is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the person executing this Agreement on Intrexon’s behalf has been duly authorized to do so by all requisite corporate action.

 

(c)                                   Binding Agreement .  This Agreement is a legal and valid obligation binding upon Intrexon and enforceable in accordance with its terms, except as such enforcement may be limited by applicable bankruptcy, insolvency, reorganization, arrangement, moratorium or other similar laws affecting creditors’ rights, and subject to general equity principles and to limitations on availability of equitable relief, including specific performance.  The execution, delivery and performance of this Agreement by Intrexon does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound.  Intrexon is aware of no action, suit or inquiry or investigation instituted by any governmental agency which questions or threatens the validity of this Agreement.

 

(d)                                  Additional Intellectual Property Representations .

 

(i)                                      Intrexon possesses sufficient rights to enable Intrexon to grant all rights and licenses it purports to grant to OvaXon with respect to the Intrexon Patents under this Agreement;

 

(ii)                                   The Intrexon Patents existing as of the Effective Date constitute all of the Patents Controlled by Intrexon as of such date that are necessary for the development, manufacture and Commercialization of Collaboration Products;

 

(iii)                                Intrexon has not granted, and during the Term Intrexon will not grant, any right or license, to any Third Party under the Intrexon IP that conflicts with the rights or licenses granted or to be granted to OvaXon hereunder;

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(iv)                               There is no pending litigation, and Intrexon has not received any written notice of any claims or litigation, seeking to invalidate or otherwise challenge the Intrexon Patents or Intrexon’s rights therein;

 

(v)                                  None of the Intrexon Patents is subject to any pending re-examination, opposition, interference or litigation proceedings;

 

(vi)                               All of the Intrexon Patents have been filed and prosecuted in accordance with all Applicable Laws and have been maintained, with all applicable fees with respect thereto (to the extent such fees have come due) having been paid;

 

(vii)                            Intrexon has entered into agreements with each of its current and former officers, employees and consultants involved in research and development work, including development of Intrexon IP, providing Intrexon, to the extent permitted by law, with title and ownership to patents, patent applications, trade secrets and inventions conceived, developed, reduced to practice by such person, solely or jointly with other of such persons, during the period of employment or contract by Intrexon (except where the failure to have entered into such an agreement would not have a material adverse effect on the rights granted to OvaXon herein), and Intrexon is not aware that any of its employees or consultants is in material violation thereof;

 

(viii)                         To Intrexon’s knowledge, there is no infringement, misappropriation or violation by Third Parties of any Intrexon Channel Technology or Intrexon IP in the Field;

 

(ix)                               There is no pending or, to Intrexon’s knowledge, threatened action, suit, proceeding or claim by others against Intrexon that Intrexon infringes, misappropriates or otherwise violates any intellectual property or other proprietary rights of others in connection with the use of the Intrexon Channel Technology or Intrexon IP, and Intrexon has not received any written notice of such claim;

 

(x)                                  To Intrexon’s knowledge, no employee of Intrexon is the subject of any claim or proceeding involving a violation of any term of any employment contract, patent disclosure agreement, invention assignment agreement, non-competition agreement, non-solicitation agreement, non-disclosure agreement or any restrictive covenant to or with a former employer (A) where the basis of such violation relates to such employee’s employment with Intrexon or actions undertaken by the employee while employed with Intrexon and (B) where such violation is relevant to the use of the Intrexon Channel Technology in the Field;

 

(xi)                               None of the Intrexon Patents owned by Intrexon or its Affiliates, and, to Intrexon’s knowledge, the Intrexon Patents licensed to Intrexon or its Affiliates, have been adjudged invalid or unenforceable by a court of competent jurisdiction or applicable government agency, in whole or in part, and there is no pending or, to Intrexon’s knowledge, threatened action, suit, proceeding or claim by others challenging the validity or scope of any such Intrexon Patents; and

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(xii)                            Except as otherwise disclosed in writing to OvaXon, Intrexon:  (A) is in material compliance with all statutes, rules or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product that is under development, manufactured or distributed by Intrexon in the Field (“ Applicable Laws ”); (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the United States Food and Drug Administration (the “ FDA ”) or any other federal, state, local or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“ Authorizations ”), which would, individually or in the aggregate, result in a material adverse effect on the rights granted to OvaXon hereunder or Intrexon’s ability to perform its obligations hereunder; (C) possesses all material Authorizations necessary for the operation of its business in the Field and such Authorizations are valid and in full force and effect and Intrexon is not in material violation of any term of any such Authorizations; and (D) since January 1, 2011, (1) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any other federal, state, local or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit investigation or proceeding; (2) has not received notice that the FDA or any other federal, state, local or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any other federal, state, local or foreign governmental or regulatory authority is considering such action; (3) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (4) has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to Intrexon’s knowledge, no third party has initiated, conducted or intends to initiate any such notice or action.

 

except, in each of (ix) through (xii), for any instances which would not, individually or in the aggregate, result in a material adverse effect on the rights granted to OvaXon hereunder or Intrexon’s ability to perform its obligations hereunder.

 

8.3                                         Warranty Disclaimer .  EXCEPT FOR THE EXPRESS WARRANTIES PROVIDED IN THIS ARTICLE 8, EACH PARTY HEREBY DISCLAIMS ANY AND ALL OTHER WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF TITLE, MERCHANTABILITY, FITNESS FOR A

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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PARTICULAR PURPOSE, OR NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.

 

ARTICLE 9

 

INDEMNIFICATION

 

9.1                                         Indemnification by Intrexon .  Intrexon agrees to indemnify, hold harmless, and defend OvaXon and its Affiliates and their respective directors, officers, employees, and agents (collectively, the “ OvaXon Indemnitees ”) from and against any and all liabilities, damages, costs, expenses, or losses (including reasonable legal expenses and attorneys’ fees) (collectively, “ Losses ”) resulting from any claims, suits, actions, demands, or other proceedings brought by a Third Party (collectively, “ Claims ”) to the extent arising from (a) the gross negligence or willful misconduct of Intrexon or any of its Affiliates, or their respective employees or agents, (b) the use, handling, storage or transport of Intrexon Materials by or on behalf of Intrexon or its Affiliates, licensees (other than OvaXon) or sublicensees; or (c) the breach by Intrexon of any representation, warranty or covenant in this Agreement.  Notwithstanding the foregoing, Intrexon shall not have any obligation to indemnify the OvaXon Indemnitees to the extent that a Claim arises from (i) the gross negligence or willful misconduct of OvaXon or any of its Affiliates, licensees, or sublicensees, or their respective employees or agents; or (ii) a breach by OvaXon of a representation, warranty, or covenant of this Agreement.

 

9.2                                         Indemnification by OvaXon .  OvaXon agrees to indemnify, hold harmless, and defend Intrexon, its Affiliates and Third Security, and their respective directors, officers, employees, and agents (and any Third Parties which have licensed to Intrexon intellectual property rights within Intrexon IP on or prior to the Effective Date, to the extent required by the relevant upstream license agreement) (collectively, the “ Intrexon Indemnitees ”) from and against any Losses resulting from Claims, to the extent arising from any of the following:  (a) the gross negligence or willful misconduct of OvaXon or any of its Affiliates or their respective employees or agents; (b) the use, handling, storage, or transport of Intrexon Materials by or on behalf of OvaXon or its Affiliates, licensees, or sublicensees; (c) the breach by OvaXon of any material representation, warranty or covenant in this Agreement; or (d) the design, development, manufacture, regulatory approval, handling, storage, transport, distribution, sale or other disposition of any Collaboration Product  by or on behalf of OvaXon or its Affiliates, licensees, or sublicensees.  Notwithstanding the foregoing, OvaXon shall not have any obligation to indemnify the Intrexon Indemnitees to the extent that a Claim arises from (i) the gross negligence or willful misconduct of Intrexon or any of its Affiliates, or their respective employees or agents; or (ii) a breach by Intrexon of a representation, warranty, or covenant of this Agreement.

 

9.3                                         Product Liability Claims .  Notwithstanding the provisions of Section 9.2, any Losses arising out of any Claim covered by Section 9.2(d) that exceed the amount (if any) covered by the applicable Party’s product liability insurance (“ Excess Product Liability Costs ”), shall be paid by [***], except to the extent such Losses arise out of any Third-Party Claim based on the gross negligence or willful misconduct of a Party, its Affiliates, or its

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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Affiliates’ sublicensees, or any of the respective officers, directors, employees and agents of each of the foregoing entities, in the performance of obligations or exercise of rights under this Agreement.

 

9.4                                         Control of Defense .  As a condition precedent to any indemnification obligations hereunder, any entity entitled to indemnification under this Article 9 shall give written notice to the indemnifying Party of any Claims that may be subject to indemnification, promptly after learning of such Claim.  If such Claim falls within the scope of the indemnification obligations of this Article 9, then the indemnifying Party shall assume the defense of such Claim with counsel reasonably satisfactory to the indemnified Party.  The indemnified Party shall cooperate with the indemnifying Party in such defense.  The indemnified Party may, at its option and expense, be represented by counsel of its choice in any action or proceeding with respect to such Claim.  The indemnifying Party shall not be liable for any litigation costs or expenses incurred by the indemnified Party without the indemnifying Party’s written consent, such consent not to be unreasonably withheld.  The indemnifying Party shall not settle any such Claim if such settlement (a) does not fully and unconditionally release the indemnified Party from all liability relating thereto or (b) adversely impacts the exercise of the rights granted to the indemnified Party under this Agreement, unless the indemnified Party otherwise agrees in writing.

 

9.5                                         Insurance .  Immediately prior to, and during marketing of Collaboration Products, OvaXon shall maintain in effect and good standing a product liability insurance policy issued by a reputable insurance company in amounts considered standard for the industry.  Immediately prior to, and during the conduct of any clinical trials, OvaXon shall maintain in effect and good standing a clinical trials liability insurance policy issued by a reputable insurance company in amounts considered standard for the industry.  At Intrexon’s reasonable request, OvaXon shall provide Intrexon with all details regarding such policies, including without limitation copies of the applicable liability insurance contracts.  OvaXon shall use reasonable efforts to include Intrexon as an additional insured on any such policies.

 

ARTICLE 10

 

TERM; TERMINATION

 

10.1                                  Term .  The term of this Agreement shall commence upon the Effective Date and shall continue until terminated pursuant to Section 10.2 or 10.3 (the “ Term ”).

 

10.2                                  Termination for Material Breach; Termination under Section 4.4(b)

 

(a)                                  Either Party shall have the right to terminate this Agreement upon written notice to the other Party if the other Party commits any material breach of this Agreement that such breaching Party fails to cure within sixty (60) days following written notice from the nonbreaching Party specifying such breach.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(b)                                  Intrexon shall have the right to terminate this Agreement under the circumstances set forth in Section 4.4(b) upon written notice to OvaXon, such termination to become effective sixty (60) days following such written notice unless OvaXon remedies the circumstances giving rise to such termination within such sixty (60) day period.

 

(c)                                   Intrexon shall have the right to terminate this Agreement should OvaXon execute any purported assignment of this Agreement contrary to the prohibitions in Section 12.8, such termination occurring upon Intrexon providing written notice to OvaXon and becoming effective immediately upon such written notice.

 

10.3                                  Termination by OvaXon .  OvaXon shall have the right to voluntarily terminate this Agreement in its entirety upon ninety (90) days written notice to Intrexon at any time.

 

10.4                                  Effect of Termination .  In the event of termination of this Agreement pursuant to Section 10.2 or Section 10.3, the following shall apply:

 

(a)                                  Retained Products .  OvaXon (including any permitted sublicenses, such as Product Sublicensees) shall be permitted to continue the clinical development and Commercialization in the Field of any product resulting from the Collaborative Program that, at the time of any termination satisfies at least one of the following criteria (a “ Retained Product ”):

 

(i)                                      the particular product is a Collaboration Product that is being sold commercially by OvaXon (or, as may be permitted under this Agreement, its Affiliates and, if applicable, (sub)licensees),

 

(ii)                                   the particular product is a Collaboration Product that has received regulatory approval,

 

(iii)                                the particular product is a Collaboration Product that is the subject of an application for regulatory approval in the Field that is pending before the applicable regulatory authority, or

 

(iv)                               the particular product is a Collaboration Product that is the subject of an effective IND; or

 

(v)                                  the particular product is a Collaboration Product that is the subject of an ongoing pivotal animal model efficacy study established by the JSC as being the final pre-clinical animal study prior to preparation and submission of an IND, and such study is reasonably expected to supply all remaining information and data sufficient for successful submission of such IND.

 

(b)                                  Such right to continue development and Commercialization shall be subject to OvaXon’s full compliance with a continuing obligation for OvaXon to use in accord with Sections 4.4(a) and 4.4(c) Diligent Efforts to develop and Commercialize any Retained Products and all other provisions of this Agreement that survive termination.

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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(c)                                  Termination of Licenses .  Except as necessary for OvaXon to continue to obtain regulatory approval for, develop, use, manufacture and Commercialize the Retained Products in the Field as permitted by Section 10.4(a), all rights and licenses granted by Intrexon to OvaXon under this Agreement shall terminate and shall revert to Intrexon without further action by either Intrexon or OvaXon.  OvaXon’s license with respect to Retained Products shall be exclusive or non-exclusive, as the case may be, on the same terms as set forth in Section 3.1.

 

(d)                                 Reverted Candidates/Products .  Any Collaboration Product that does not qualify as a Retained Product under Section 10.4(a) shall be referred to herein as the “ Reverted Candidates/Products .”  OvaXon shall immediately cease, and shall cause its Affiliates and, if applicable, (sub)licensees to immediately cease, all development and Commercialization of the Reverted Candidates/Products, and OvaXon shall not use or practice, nor shall it cause or permit any of its Affiliates or, if applicable, (sub)licensees to use or practice, directly or indirectly, any Intrexon IP with respect to the Reverted Candidates/Products.  OvaXon shall immediately discontinue making any representation regarding its status as a licensee or channel collaborator of Intrexon with respect to the Reverted Candidates/Products.

 

(e)                                  Intrexon Materials .  OvaXon shall promptly return, or at Intrexon’s request, destroy, any Intrexon Materials in OvaXon’s possession or control at the time of termination other than any Intrexon Materials necessary for the continued development, regulatory approval, use, manufacture and Commercialization of the Retained Products in the Field.

 

(f)                                   Licenses to Intrexon .  OvaXon is automatically deemed to grant to Intrexon a worldwide, fully paid, royalty-free, exclusive (even as to OvaXon and its Affiliates), irrevocable, license (with full rights to sublicense) under the OvaXon Termination IP, to make, have made, import, use, offer for sale and sell Reverted Candidates/Products, subject to any exclusive rights held by OvaXon in Reverted Candidates/Products pursuant to Section 10.4(c).  The Parties shall also take such actions and execute such other instruments and documents as may be reasonably necessary to document such license to Intrexon.

 

(g)                                 Regulatory Filings .  OvaXon shall promptly assign to Intrexon, and will provide full copies of, all regulatory approvals and regulatory filings that relate specifically and solely to Reverted Candidates/Products.  OvaXon shall also take such actions and execute such other instruments, assignments and documents as may be necessary to effect the transfer of rights thereunder to Intrexon.  To the extent that there exist any regulatory approvals and regulatory filings that relate both to Reverted Candidates/Products and other products, OvaXon shall provide copies of the portions of such regulatory filings that relate to Reverted Candidates/Products and shall reasonably cooperate to assist Intrexon in obtaining the benefits of such regulatory approvals with respect to the Reverted Candidates/Products.

 

(h)                                 Data Disclosure .  OvaXon shall provide to Intrexon copies of the relevant portions of all material reports and data, including clinical and non-clinical data and reports, obtained or generated by or on behalf of OvaXon or its Affiliates to the extent that they relate specifically to Reverted Candidates/Products, within sixty (60) days of such termination unless

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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otherwise agreed, and Intrexon shall have the right to use any such Information solely in developing and commercializing Reverted Candidates/Products and to license any Third Parties to do so.

 

(i)                                    Third Party Licenses .  At Intrexon’s request, OvaXon shall promptly provide to Intrexon copies of all Third Party agreements under which OvaXon or its Affiliates obtained a license under Patents claiming inventions or know-how specific to or used or incorporated into the development, manufacture and/or commercialization of the Reverted Candidates/Products.  At Intrexon’s request, OvaXon shall use reasonable commercial efforts to promptly work with Intrexon to either, as appropriate (i) assign to Intrexon the Third Party agreement(s), or (ii) grant a sublicense (with an appropriate scope) to Intrexon under the Third Party agreement(s).  Thereafter Intrexon shall be fully responsible for all obligations due for its actions under the sublicensed or assigned Third Party agreements.

 

(j)                                    Remaining Materials .  At the request of Intrexon, OvaXon shall transfer to Intrexon any quantities of Reverted Product (including final products or work-in-process) in the possession of OvaXon or its Affiliates.  OvaXon shall transfer to Intrexon all such quantities of Reverted Candidates/Products without charge, except that Intrexon shall pay the reasonable costs of processing and shipping.

 

(k)                                 Third Party Vendors .  At Intrexon’s request, OvaXon shall promptly provide to Intrexon copies of all agreements between OvaXon or its Affiliates and Third Party suppliers, vendors, or distributors that relate solely to the supply, sale, or distribution of Reverted Candidates/Products in the Territory.  At Intrexon’s request, OvaXon shall with respect to such Third Party agreements relating solely to the applicable Reverted Candidates/Products and permitting assignment, promptly assign (or cause to be assigned), such agreements to Intrexon. For the avoidance of doubt, Intrexon shall have no obligation to assume any of OvaXon’s obligations under any Third Party agreement.

 

(l)                                    Commercialization .  Nothing in this Agreement shall be deemed to limit the right of Intrexon  to develop and commercialize the Reverted Candidates/Products itself or with one or more Third Parties, and/or  to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

 

(m)                             Confidential Information .  Each Party shall promptly return, or at the other Party’s request destroy, any Confidential Information of the other Party in such Party’s possession or control at the time of termination; provided, however, that each Party shall be permitted to retain (i) a single copy of each item of Confidential Information of the other Party in its confidential legal files for the sole purpose of monitoring and enforcing its compliance with Article 7, (ii) Confidential Information of the other Party that is maintained as archive copies on the recipient Party’s disaster recovery and/or information technology backup systems, or (iii) Confidential Information of the other Party necessary to exercise such Party’s rights in Retained Products (in the case of OvaXon) or Reverted Candidates/Products (in the case of Intrexon). The recipient of Confidential Information shall continue to be bound by the terms and conditions of

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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this Agreement with respect to any such Confidential Information retained in accordance with this Section 10.4(l).

 

(n)                                 Any Product Sublicensee that is not itself in material breach of its applicable Product Sublicense (including any terms of this Agreement to which to they are required to comply via such Product Sublicense), may upon any termination of this Agreement have the right to obtain upon request to Intrexon in writing a direct licensee from Intrexon under the terms and conditions of the Product Sublicense, provided, however, that Intrexon may refuse, in its reasonable discretion, to grant such a direct license to any Product Sublicensee that is an Affiliate of any other entity (including OvaXon, its Affiliates, and sublicenses) that is itself in material breach.

 

10.5                                 Surviving Obligations .  Termination or expiration of this Agreement shall not affect any rights of either Party arising out of any event or occurrence prior to termination, including, without limitation, any obligation of OvaXon to pay any amount which became due and payable under the terms and conditions of this Agreement prior to expiration or such termination.  The following portions of this Agreement shall survive termination or expiration of this Agreement:  Sections 3.1 (as applicable with respect to 10.4(b)),6.1, 6.2 (with subsection (c) surviving only to the extent relating to Intrexon Patents that are relevant to Retained Products that, to Intrexon’s knowledge, are being developed or Commercialized at such time, if any), 7.1, 7.2, 7.4, 7.5, 10.4, and 10.5; Articles 9, 11, and 12; and any relevant definitions in Article 1.  Further, Article 7 and Sections 4.4(a), 4.4(c), and 9.5 will survive termination of this Agreement to the extent there are applicable Retained Products.

 

ARTICLE 11

 

DISPUTE RESOLUTION

 

11.1                                 Disputes .  It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation.  In the event of any disputes, controversies or differences which may arise between the Parties out of or in relation to or in connection with this Agreement (other than disputes arising from a Committee), including, without limitation, any alleged failure to perform, or breach, of this Agreement, or any issue relating to the interpretation or application of this Agreement, then upon the request of either Party by written notice, the Parties agree to meet and discuss in good faith a possible resolution thereof, which good faith efforts shall include at least one in-person meeting between the Executive Officers of each Party.  If the matter is not resolved within thirty (30) days following the written request for discussions, either Party may then invoke the provisions of Section 11.2.  For the avoidance of doubt, any disputes, controversies or differences arising from a Committee pursuant to Article 2 shall be resolved solely in accordance with Section 2.4.

 

11.2                                 Arbitration .  Any dispute, controversy, difference or claim which may arise between the Parties and not from a Committee, out of or in relation to or in connection with this Agreement (including, without limitation, arising out of or relating to the validity, construction,

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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interpretation, enforceability, breach, performance, application or termination of this Agreement) that is not resolved pursuant to Section 11.1 shall, subject to Section 11.10, be settled by binding “baseball arbitration” as follows.  Either Party, following the end of the thirty (30) day period referenced in Section 11.1, may refer such issue to arbitration by submitting a written notice of such request to the other Party, with the arbitration to be held in the state where the other Party’s principal office is located (or some other place as may be mutually agreed by the Parties).  Promptly following receipt of such notice, the Parties shall meet and discuss in good faith and seek to agree on an arbitrator to resolve the issue, which arbitrator shall be neutral and independent of both Parties and all of their respective Affiliates, shall have significant experience and expertise in licensing and partnering agreements in the pharmaceutical and biotechnology industries, and shall have some experience in mediating or arbitrating issues relating to such agreements.  If the Parties cannot agree on a single arbitrator within fifteen (15) days of request by a Party for arbitration, then each Party shall select an arbitrator meeting the foregoing criteria and the two (2) arbitrators so selected shall select within ten (10) days of their appointment a third arbitrator meeting the foregoing criteria.  Within fifteen (15) days after an arbitrator(s) is selected (in the case of the three-person panel, when the third arbitrator is selected), each Party will deliver to both the arbitrator(s) and the other Party a detailed written proposal setting forth its proposed terms for the resolution for the matter at issue (the “ Proposed Terms ” of the Party) and a memorandum (the “ Support Memorandum ”) in support thereof.  The Parties will also provide the arbitrator(s) a copy of this Agreement, as it may be amended at such time.  Within fifteen (15) days after receipt of the other Party’s Proposed Terms and Support Memorandum, each Party may submit to the arbitrator(s) (with a copy to the other Party) a response to the other Party’s Support Memorandum.  Neither Party may have any other communications (either written or oral) with the arbitrator(s) other than for the sole purpose of engaging the arbitrator or as expressly permitted in this Section 11.2; provided that, the arbitrator(s) may convene a hearing if the arbitrator(s) so chooses to ask questions of the Parties and hear oral argument and discussion regarding each Party’s Proposed Terms.  Within sixty (60) days after the arbitrator’s appointment, the arbitrator(s) will select one of the two Proposed Terms (without modification) provided by the Parties that he or she believes is most consistent with the intention underlying and agreed principles set forth in this Agreement.  The decision of the arbitrator(s) shall be final, binding, and unappealable.  For clarity, the arbitrator(s) must select as the only method to resolve the matter at issue one of the two sets of Proposed Terms, and may not combine elements of both Proposed Terms or award any other relief or take any other action.

 

11.3                                 Governing Law .  This Agreement shall be governed by and construed under the substantive laws of the State of New York, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction.

 

11.4                                 Award .  Any award to be paid by one Party to the other Party as determined by the arbitrator(s) as set forth above under Section 11.2 shall be promptly paid in United States dollars free of any tax, deduction or offset; and any costs, fees or taxes incident to enforcing the award shall, to the maximum extent permitted by law, be charged against the losing Party.  Each Party agrees to abide by the award rendered in any arbitration conducted pursuant to this Article 11, and agrees that, subject to the United States Federal Arbitration Act, 9 U.S.C. §§ 1-16,

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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judgment may be entered upon the final award in any United States District Court located in New York and that other courts may award full faith and credit to such judgment in order to enforce such award.  The award shall include interest from the date of any damages incurred for breach of the Agreement, and from the date of the award until paid in full, at a rate fixed by the arbitrator(s).  With respect to money damages, nothing contained herein shall be construed to permit the arbitrator(s) or any court or any other forum to award consequential, incidental, special, punitive or exemplary damages.  By entering into this agreement to arbitrate, the Parties expressly waive any claim for consequential, incidental, special, punitive or exemplary damages.  The only damages recoverable under this Agreement are direct compensatory damages.

 

11.5                                 Costs .  Each Party shall bear its own legal fees.  The arbitrator(s) shall assess his or her costs, fees and expenses against the Party losing the arbitration.

 

11.6                                 Injunctive Relief .  Nothing in this Article 11 will preclude either Party from seeking equitable relief or interim or provisional relief from a court of competent jurisdiction, including a temporary restraining order, preliminary injunction or other interim equitable relief, concerning a dispute either prior to or during any arbitration if necessary to protect the interests of such Party or to preserve the status quo pending the arbitration proceeding.  Specifically, the Parties agree that a material breach by either Party of its obligations in Section 3.5 or Article 7 of this Agreement may cause irreparable harm to the other Party, for which damages may not be an adequate remedy.  Therefore, in addition to its rights and remedies otherwise available at law, including, without limitation, the recovery of damages for breach of this Agreement, upon an adequate showing of material breach of such Section 3.5 or Article 7, and without further proof of irreparable harm other than this acknowledgement, such non-breaching Party shall be entitled to seek (a) immediate equitable relief, specifically including, but not limited to, both interim and permanent restraining orders and injunctions, without bond, and (b) such other and further equitable relief as the court may deem proper under the circumstances.  For the avoidance of doubt, nothing in this Section 11.6 shall otherwise limit a breaching Party’s opportunity to cure a material breach as permitted in accordance with Section 10.2.

 

11.7                                 Confidentiality .  The arbitration proceeding shall be confidential and the arbitrator(s) shall issue appropriate protective orders to safeguard each Party’s Confidential Information.  Except as required by law, no Party shall make (or instruct the arbitrator(s) to make) any public announcement with respect to the proceedings or decision of the arbitrator(s) without prior written consent of the other Party.  The existence of any dispute submitted to arbitration, and the award, shall be kept in confidence by the Parties and the arbitrator(s), except as required in connection with the enforcement of such award or as otherwise required by applicable law.

 

11.8                                 Survivability .  Any duty to arbitrate under this Agreement shall remain in effect and be enforceable after termination of this Agreement for any reason.

 

11.9                                 Jurisdiction .  For the purposes of this Article 11, the Parties acknowledge their diversity and agree to accept the jurisdiction of any United States District Court located in New York for the purposes of enforcing or appealing any awards entered pursuant to this Article 11

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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and for enforcing the agreements reflected in this Article 11 and agree not to commence any action, suit or proceeding related thereto except in such courts.

 

11.10                          Patent Disputes .  Notwithstanding any other provisions of this Article 11, and subject to the provisions of Section 6.2, any dispute, controversy or claim relating to the scope, validity, enforceability or infringement of any Intrexon Patents shall be submitted to a court of competent jurisdiction in the country in which such Patent was filed or granted.

 

ARTICLE 12

 

GENERAL PROVISIONS

 

12.1                                 Use of Name .  No right, express or implied, is granted by this Agreement to either Party to use in any manner the name of the other or any other trade name or trademark of the other in connection with the performance of this Agreement, except that (a) either Party may use the name of the other Party as required by law or regulation and in press releases accompanying quarterly and annual earnings reports approved by the issuer’s Board of Directors, and (b) OvaXon may use the Intrexon Trademarks in accord with licenses and restrictions set forth herein.

 

12.2                                 LIMITATION OF LIABILITY .  NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.  NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS PARAGRAPH IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER ARTICLE 9, OR DAMAGES AVAILABLE FOR BREACHES OF THE OBLIGATIONS SET FORTH IN ARTICLE 7

 

12.3                                 Independent Parties .  The Parties are not employees or legal representatives of the other Party for any purpose.  Neither Party shall have the authority to enter into any contracts in the name of or on behalf of the other Party.  This Agreement shall not constitute, create, or in any way be interpreted as a joint venture, partnership, or business organization of any kind.

 

12.4                                 Notice .  All notices, including notices of address change, required or permitted to be given under this Agreement shall be in writing and deemed to have been given when delivered if personally delivered or sent by facsimile (provided that the party providing such notice promptly confirms receipt of such transmission with the other party by telephone), on the business day after dispatch if sent by a nationally-recognized overnight courier and on the third business day following the date of mailing if sent by certified mail, postage prepaid, return receipt requested. All such communications shall be sent to the address or facsimile number set forth below (or any updated addresses or facsimile number communicated to the other Party in writing):

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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If to Intrexon:

Intrexon Corporation
20374 Seneca Meadows Parkway
Germantown, MD 20876
Attention: Chief Legal Officer
email: dlehr@intrexon.com

 

 

If to OvaXon:

OvaXon, LLC
215 First Street, Suite 240
Cambridge, MA 02142
Attention: CEO or Program Manager
email: atzianabos@ovascience.com

 

12.5                                 Severability .  In the event any provision of this Agreement is held to be invalid or unenforceable, the valid or enforceable portion thereof and the remaining provisions of this Agreement will remain in full force and effect.

 

12.6                                 Waiver .  Any waiver (express or implied) by either Party of any breach of this Agreement shall not constitute a waiver of any other or subsequent breach.

 

12.7                                 Entire Agreement; Amendment .  This Agreement, including any exhibits attached hereto, constitute the entire, final, complete and exclusive agreement between the Parties and supersede all previous agreements or representations, written or oral, with respect to the subject matter of this Agreement (including any prior confidentiality agreement between the Parties).  All information of Intrexon or OvaXon to be kept confidential by the other Party under any prior confidentiality agreement, as of the Effective Date, shall be maintained as Confidential Information by such other Party under the obligations set forth in Article 7 of this Agreement.  This Agreement may not be modified or amended except in a writing signed by a duly authorized representative of each Party.

 

12.8                                 Non-assignability; Binding on Successors .  Any attempted assignment of the rights or delegation of the obligations under this Agreement shall be void without the prior written consent of the non-assigning or non-delegating Party; provided, however, that either Party may assign its rights or delegate its obligations under this Agreement without such consent (a) to an Affiliate of such Party or (b) to its successor in interest in connection with any merger, acquisition, consolidation, corporate reorganization, or similar transaction, or sale of all or substantially all of its assets to which this Agreement relates, provided that such assignee agrees in writing to assume and be bound by the assignor’s obligations under this Agreement.  This Agreement shall be binding upon, and inure to the benefit of, the successors, executors, heirs, representatives, administrators and permitted assigns of the Parties.  Notwithstanding the foregoing, in the event that either Party assigns this Agreement to its successor in interest by way of merger, acquisition, consolidation, corporate reorganization, or similar transaction, or sale of

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

45



 

CONFIDENTIAL TREATMENT REQUESTED

 

all or substantially all of its assets to which this Agreement relates (whether this Agreement is actually assigned or is assumed by such successor in interest or its affiliate by operation of law (e.g., in the context of a reverse triangular merger)), the intellectual property rights of such successor in interest or any of its Affiliates other than those licensed in this Agreement shall be automatically excluded from the rights licensed to the other Party under this Agreement.

 

12.9                                 Force Majeure .  Neither Party shall be liable to the other for its failure to perform any of its obligations under this Agreement, except for payment obligations, during any period in which such performance is delayed because rendered impracticable or impossible due to circumstances beyond its reasonable control, including without limitation earthquakes, governmental regulation, fire, flood, labor difficulties, civil disorder, acts of terrorism and acts of God, provided that the Party experiencing the delay promptly notifies the other Party of the delay.

 

12.10                          No Other Licenses .  Neither Party grants to the other Party any rights or licenses in or to any intellectual property, whether by implication, estoppel, or otherwise, except to the extent expressly provided for under this Agreement.

 

12.11                          Non-Solicitation . During the Term and for a period of one (1) year following the end of the Term, neither OvaXon nor Intrexon may directly or indirectly solicit in order to offer to employ, engage in any discussion regarding employment with, or hire any employee of the other Party or an individual who was employed by the other party within one (1) year prior to such solicitation, discussion, or hire, without the prior approval of such other Party.  General employment solicitations or advertisements shall not be considered direct or indirect solicitations, and are not prohibited under this Agreement.

 

12.12                          Legal Compliance .  The Parties shall review in good faith and cooperate in taking such actions to ensure compliance of this Agreement with all applicable laws.

 

12.13                          Counterparts .  This Agreement may be executed in any number of counterparts (including by facsimile, PDF, or other means of electronic communication), each of which taken together will constitute one and the same instrument, and any of the Parties hereto may execute this Agreement by signing any such counterpart.

 

[Remainder of page intentionally left blank.]

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

46



 

CONFIDENTIAL TREATMENT REQUESTED

 

IN WITNESS WHEREOF, the Parties hereto have duly executed this Exclusive Channel Collaboration Agreement.

 

 

INTREXON CORPORATION

 

OVAXON, LLC

 

 

 

 

 

 

 

 

 

 

By:

/s/ Donald P. Lehr

 

By :

/s/ Arthur Tzianabos

 

 

 

 

 

Name:

Donald P. Lehr

 

Name:

Arthur Tzianabos, Ph.D.

 

 

 

 

 

Title:

Chief Legal Officer

 

Title:

Program Manager

 

SIGNATURE PAGE TO OVAXON EXCLUSIVE CHANNEL COLLABORATION AGREEMENT

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 



 

CONFIDENTIAL TREATMENT REQUESTED

 

IN WITNESS WHEREOF, the Parties hereto have duly executed this Exclusive Channel Collaboration Agreement.

 

 

SOLELY FOR THE PURPOSES OF SECTION 4.2(B):

 

 

 

 

 

OVASCIENCE, INC.

 

 

 

 

 

 

 

By :

/s/ Michelle Dipp

 

 

 

 

Name:

Michelle Dipp, M.D., Ph.D.

 

 

 

 

Title:

President and Chief Executive Officer

 

 

SIGNATURE PAGE TO OVAXON EXCLUSIVE CHANNEL COLLABORATION AGREEMENT

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 



 

CONFIDENTIAL TREATMENT REQUESTED

 

Schedule 1

 

Description of Augment Product

 

The Augment Product, developed by OvaScience under the trade name AUGMENT SM , is a product designed to improve egg quality and increase the success of in vitro fertilization.  Mitochondria from the woman’s own OPCs are removed and added to her egg during in vitro fertilization. The product described above includes, but is not limited to, the technology described in United States patent application serial number [***].

 

Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 




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EXHIBIT 21.1

Subsidiaries of the Registrant

Name of Subsidiary
  Jurisdiction of Organization  
OvaScience Securities Corporation     Massachusetts  



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Subsidiaries of the Registrant

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EXHIBIT 23.1

Consent of Independent Registered Public Accounting Firm

        We consent to the incorporation by reference in the Registration Statements (Form S-3 No. 333-183602, Form S-3 No. 333-187896, Form S-3 No. 333-190939, Form S-8 No. 333-187897 and Form S-8 No. 333-182040) of OvaScience, Inc. and in the related Prospectus of our report dated February 27, 2014, with respect to the consolidated financial statements of OvaScience, Inc., included in this Annual Report (Form 10-K) for the year ended December 31, 2013.

/s/ Ernst & Young LLP    

Boston, Massachusetts
February 27, 2014

 

 



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EXHIBIT 31.1

Certification of Principal Executive Officer pursuant to Section 302
of the Sarbanes-Oxley Act of 2002 by Principal Executive Officer

I, Michelle Dipp, M.D., Ph.D., certify that:

        1.     I have reviewed this Annual Report on Form 10-K of OvaScience, Inc.;

        2.     Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

        3.     Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

        4.     The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

        5.     The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

Date: February 27, 2014    

 

 

/s/ MICHELLE DIPP

Michelle Dipp, M.D., Ph.D.
President and Chief Executive Officer
(Principal executive officer)



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EXHIBIT 31.2

Certification of Principal Financial Officer pursuant to Section 302
of the Sarbanes-Oxley Act of 2002 by Principal Financial Officer

I, Christopher Bleck, certify that:

        1.     I have reviewed this Annual Report on Form 10-K of OvaScience, Inc.;

        2.     Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

        3.     Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

        4.     The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

        5.     The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

Date: February 27, 2014

    /s/ CHRISTOPHER BLECK

Christopher Bleck
Principal financial and accounting officer



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EXHIBIT 32.1

Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002, by Chief Executive Officer

        In connection with the Annual Report on Form 10-K of OvaScience, Inc. (the "Company") for the period ended December 31, 2013, as filed with the Securities and Exchange Commission on the date hereof (the "Report"), the undersigned, Michelle Dipp, M.D., Ph.D., as Chief Executive Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, that:

Dated: February 27, 2014        

 

 

By:

 

/s/ MICHELLE DIPP

Michelle Dipp, M.D., Ph.D.
President and Chief Executive Officer
(Principal executive officer)



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Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, by Chief Executive Officer

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EXHIBIT 32.2

Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 by Principal Financial Officer

        In connection with the Annual Report on Form 10-K of OvaScience, Inc. (the "Company") for the period ended December 31, 2013, as filed with the Securities and Exchange Commission on the date hereof (the "Report"), the undersigned, Christopher Bleck, as principal financial officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, that:

Dated: February 27, 2014

    /s/ CHRISTOPHER BLECK

Christopher Bleck
Principal financial and accounting officer



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Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 by Principal Financial Officer