UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K/A

AMENDMENT NO. 1

TO CURRENT REPORT

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 30, 2013 (September 30, 2013)

 

 

INTREXON CORPORATION

(Exact Name of Registrant as Specified in Charter)

 

 

 

Virginia   001-36042   26-0084895

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

20374 Seneca Meadows Parkway, Germantown, Maryland 20876

(Address of Principal Executive Offices) (Zip Code)

(301) 556-9900

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Explanatory Note

On October 4, 2013, Intrexon Corporation (“Intrexon”) filed a Current Report on Form 8-K to disclose Intrexon’s entry into a worldwide Exclusive Channel Collaboration Agreement (the “ECC”) with S & I Ophthalmic, LLC (“JV”), a joint venture between Intrexon and an indirect subsidiary (“Sun Pharmaceutical Subsidiary”) of Sun Pharmaceutical Industries Ltd., an international specialty pharmaceutical company focused on chronic diseases.

Intrexon is filing this Current Report on 8-K/A to file under Item 9.01 the ECC and the Limited Liability Agreement of JV. Except for the filing of the exhibits under Item 9.01, the Current Report on Form 8-K filed on October 4, 2013 is not being amended or updated in any manner.


Item 9.01 Financial Statements and Exhibits.

 

  (d) Exhibits

 

Exhibit
No.

 

Description

10.1*   Exclusive Channel Collaboration Agreement, dated as of September 30, 2013, between Intrexon and S & I Ophthalmic, LLC.
10.2*   Limited Liability Company Agreement of S & I Ophthalmic, LLC, dated September 30, 2013, between Intrexon and Caraco Pharmaceutical Laboratories Ltd.
99.1**   Press release of Intrexon Corporation and Sun Pharmaceutical Industries Ltd. dated October 1, 2013.

 

* Portions of this exhibit have been omitted pursuant to a request for confidential treatment and this exhibit has been submitted separately to the Securities and Exchange Commission.
** Previously filed.


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.

Date: October 30, 2013

 

INTREXON CORPORATION
By:  

/s/ Donald P. Lehr

  Donald P. Lehr
  Chief Legal Officer


EXHIBIT INDEX

 

Exhibit
No.

 

Description

10.1*   Exclusive Channel Collaboration Agreement, dated as of September 30, 2013, between Intrexon and S & I Ophthalmic, LLC.
10.2*   Limited Liability Company Agreement of S & I Ophthalmic, LLC, dated September 30, 2013, between Intrexon and Caraco Pharmaceutical Laboratories Ltd.
99.1**   Press release of Intrexon Corporation and Sun Pharmaceutical Industries Ltd. dated October 1, 2013.

 

* Portions of this exhibit have been omitted pursuant to a request for confidential treatment and this exhibit has been submitted separately to the Securities and Exchange Commission.
** Previously filed.

Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

Exhibit 10.1

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E XCLUSIVE C HANNEL C OLLABORATION A GREEMENT

T HIS E XCLUSIVE C HANNEL C OLLABORATION A GREEMENT (the “ Agreement ”) is made and entered into effective as of September 30, 2013 (the “ Effective Date ”) by and between I NTREXON C ORPORATION , a Virginia corporation with offices at 20374 Seneca Meadows Parkway, Germantown, MD 20876 (“ Intrexon ”), and S & I Ophthalmic, LLC, a Delaware limited liability company having a registered office at Corporation Trust Center, 1209 Orange St., Wilmington, DE 19801 (“ JV ”). Intrexon and JV may be referred to herein individually as a “ Party ”, and collectively as the “ Parties .”

R ECITALS

W HEREAS , 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

W HEREAS , JV now desires to become Intrexon’s exclusive channel collaborator with respect to such technology for the purpose of developing the Ophthalmic Program (as defined herein), and Intrexon is willing to appoint JV as a 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.

N OW T HEREFORE , in consideration of the foregoing and the covenants and promises contained herein, the Parties agree as follows:

ARTICLE 1

D EFINITIONS

As used in this Agreement, the following capitalized terms shall have the following meanings:

1.1 “Affiliate” means, with respect to a particular person or entity, any other person or entity that directly or indirectly controls, is controlled by, or is in common control with such particular person or entity. 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, Intrexon and its Parents and Subsidiaries shall be deemed not to be an Affiliate of JV, and conversely JV shall be deemed not to be an Affiliate of Intrexon or Intrexon’s Parents and Subsidiaries.

1.2 Applicable Laws ” has the meaning set forth in Section 8.2(d)(xiii).


Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

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1.3 Authorizations ” has the meaning set forth in Section 8.2(d)(xiii).

1.4 Business Day ” means Monday through Friday of each week, except that a legal holiday recognized as such by the Federal Government of the United States shall not be regarded as a Business Day.

1.5 CC ” has the meaning set forth in Section 2.2(b).

1.6 Channel-Related Program IP ” has the meaning set forth in Section 6.1(c).

1.7 Claims ” has the meaning set forth in Section 9.1.

1.8 CMCC ” has the meaning set forth in Section 2.2(b).

1.9 Collaborator ” means Caraco Pharmaceutical Laboratories, Ltd., a Michigan corporation, which is an indirect Subsidiary of Sun Pharmaceutical Industries Limited, an Indian corporation headquartered in India.

1.10 Committees ” has the meaning set forth in Section 2.2(a).

1.11 Commercialize ” or “ Commercialization ” means any activities directed to marketing, promoting, distributing, importing for sale, offering to sell and/or selling JV Products.

1.12 Commercial Sale ” means, for a given product and country, the sale for value of that product by a Party (or, as the case may be, by a Subsidiary, a Parent, a permitted Affiliate, or a permitted sublicensee of a Party) to a Third Party after regulatory approval (if necessary) has been obtained for such 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 pursuant to this Agreement or any other confidentiality agreement between the Parties, regardless of whether in oral, written, graphic or electronic form.

1.15 Control ” means, with respect to Information, a Patent or other intellectual property right, that a Party (or its Subsidiary) 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 Diligent Efforts ” means, with respect to a Party’s obligation under this Agreement, the level of efforts and resources reasonably required to diligently develop, manufacture, and/or Commercialize (as applicable) each JV Product in a sustained manner, 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. With respect to a particular task or obligation, Diligent Efforts requires that the applicable Party 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.

 

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Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

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1.17 Empowered Representative ” means at each Party’s election : (a) the Chief Executive Officer or Managing Director of the applicable Party, or (b) another senior executive officer, board member, or other duly-authorized representative of such Party who has been duly appointed and authorized by such Party (such as by, as applicable to the specific party, its Chief Executive Officer, Managing Director, or Board of Directors, or otherwise in accord with its applicable procedures) to act as the representative of the Party to resolve fully, as the case may be, (i) a Committee dispute or (ii) a dispute described in Section 11.1.

1.18 Excess Product Liability Costs ” has the meaning set forth in Section 9.3.

1.19 FDA ” has the meaning set forth in Section 8.2(d)(xiii).

1.20 Field ” means in humans (i) the treatment of Ophthalmic-Local Diseases via administration of a Gene Therapeutic, and/or (ii) the treatment of Ophthalmic-Systemic Diseases via administration of a Gene Therapeutic without treating any broader systemic disease, including any systemic diseases associated with or causing such Ophthalmic-Systemic Disease. For clarity, the Field includes the administration of an activator molecule to induce controlled expression by the Gene Therapeutic. Notwithstanding the foregoing, the Field expressly excludes the in vivo expression of an anti-cancer effector for cancer treatment.

1.21 Field Infringement ” has the meaning set forth in Section 6.3(b).

1.22 Fully Loaded Cost ” means the direct cost of the applicable good, product or service plus indirect charges and overheads reasonably allocable to the provision of such good, product or service in accordance with US GAAP. Subject to the approval of a project and its associated budget by the JSC and the terms of Sections 4.7 and 4.8 (as appropriate), Intrexon and Collaborator and\or its Affiliates each will bill for its respective internal direct costs incurred through the use of standard full-time equivalents; such rate shall be based upon the fully loaded costs of those personnel directly involved in the provision of such good, product or service. Intrexon and Collaborator may, from time to time, adjust their respective full-time equivalent rate based on changes to their actual fully loaded costs and will review the accuracy of the full-time equivalent rate at least quarterly. Intrexon and Collaborator shall each provide JV with reasonable documentation indicating the basis for any direct and indirect charges, any allocable overhead, and any such adjustment in full-time equivalent rate.

1.23 [*****]

 

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1.24 Gene Therapeutic ” means genetically modified (i) cells, (ii) DNA or (iii) viral vectors that, when delivered to humans, will cause in-vivo expression of one or more therapeutic proteins and/or bioactive RNA species. For clarity, a Gene Therapeutic may include a gene program that provides controllable expression under the operation of an inducible genetic switch, which switch may be activated by the administration of an activator molecule.

1.25 In-Licensed Program IP ” has the meaning set forth in Section 3.8(a).

1.26 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 regulatory test data, analytical and quality control data, stability data, studies and procedures, and patent and other legal information or descriptions.

1.27 Infringement ” has the meaning set forth in Section 6.3(a).

1.28 Intrexon Channel Technology ” means Intrexon’s current and future technology directed towards the design, identification, culturing, and/or production of genetically modified cells, including without limitation the technology embodied in the Intrexon Materials and the Intrexon IP, and specifically including without limitation the following of Intrexon’s platform areas and capabilities: (1) UltraVector®, (2) LEAP TM , (3) DNA and RNA MOD engineering, (4) protein engineering, (5) transcription control chemistry, (6) genome engineering, and (7) cell system engineering.

1.29 Intrexon Indemnitees ” has the meaning set forth in Section 9.2.

1.30 Intrexon IP ” means the Intrexon Patents and Intrexon Know-How.

1.31 Intrexon Know-How ” means all Information (other than Intrexon Patents) that (a) is Controlled by Intrexon as of the Effective Date or during the Term and (b) is reasonably required or useful for JV to conduct the Ophthalmic Program. For the avoidance of doubt, the Intrexon Know-How shall include any Information (other than Intrexon Patents) in the Channel-Related Program IP.

1.32 Intrexon Materials ” means the genetic code and associated amino acids and gene constructs, in each case that are Controlled by Intrexon, used alone or in combination 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 reasonably required or provided to JV by or on behalf of Intrexon to conduct the Ophthalmic Program.

1.33 Intrexon Patents ” means all Patents that (a) are Controlled by Intrexon as of the Effective Date or are Controlled by Intrexon anytime during the Term; and (b) are reasonably required or useful for JV to conduct the Ophthalmic Program. For the avoidance of doubt, the Intrexon Patents shall include any Patent in the Channel-Related Program IP.

 

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Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

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1.34 Intrexon Trademarks ” means those trademarks related to the Intrexon Channel Technology that are established from time to time by Intrexon for use across its channel partnerships or collaborations.

1.35 Inventions ” has the meaning set forth in Section 6.1(b).

1.36 IPC ” has the meaning set forth in Section 2.2(b).

1.37 JSC ” has the meaning set forth in Section 2.2(b).

1.38 JV Indemnitees ” has the meaning set forth in Section 9.1.

1.39 JV Independent IP ” has the meaning set forth in Section 6.1(f).

1.40 JV Product ” means any product in the Field that is created, produced, developed, or identified in whole or in part, directly or indirectly, by or on behalf of JV during the Term through use or practice of Intrexon Channel Technology, Intrexon IP, or the Intrexon Materials.

1.41 JV Program Patent ” has the meaning set forth in Section 6.2(b).

1.42 JV Termination IP ” means all Patents or other intellectual property that JV or any of its Parents or Subsidiaries Controls as of the Effective Date or during the Term that cover, or is otherwise necessary or useful for, the development, manufacture or Commercialization of a Reverted Product or necessary or useful for Intrexon to operate in the Field.

1.43 Losses ” has the meaning set forth in Section 9.1.

1.44 Material Adverse Effect ” means with respect to a specific Party any change, event or effect directly resulting from particular actions or occurrences that individually or in the aggregate (taking into account all other such changes, events or effects) has had, or would be reasonably likely to have, a material adverse effect on the consolidated business, results of operations, or financial condition of such Party and its Subsidiaries, if any, taken as a whole, except to the extent that any such change, event or effect is attributable to or results from (i) the direct effect of the authorized public announcement or pendency of the transactions contemplated under this Agreement on current or prospective customers or revenues of the Party to the extent that such announcement is made in accord with the terms of this Agreement, (ii) material changes in general economic conditions or changes affecting the industry generally in which such Party operates or (iii) shareholder class action litigation arising from allegations of a breach of fiduciary duty relating to this Agreement; provided, however, that with respect to clause (i) of this sentence, the Party claiming the benefit of such clause shall bear the burden of proof in any dispute resolution proceeding between the Parties with regard to establishing that any change, event or effect is attributable to or results from the direct effect of the public announcement or pendency of the transactions contemplated under this Agreement.

1.45 Net Sales ” means the gross invoiced sales price charged for all JV Products that are sold by JV (or its permitted Affiliate) to any Third Party (as defined below), less the following deductions to the extent included in the gross invoiced sales price for JV Products sold

 

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Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

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by JV or otherwise directly paid or incurred by JV (or its permitted Affiliate) with respect to the sale of JV Product; provided that in all cases such deductions shall not exceed what is reasonable and customary (taking into account customary practice, if any, of the pharmaceutical industry, JV and its Affiliates, or the nature of the sale in question, in the Territory in which the sale occurs) and shall be directly attributable to the sale of JV Product:

(a) one time per customer stocking allowances, any and all chargebacks, trade, quantity & cash discounts or refunds or other discounts, incentives to customers, credits, rebates, allowances, adjustments, rejections, recalls and returns, fees for service, administration fees, shelf stock adjustments, promotional payments;

(b) price reductions or rebates, retroactive or otherwise, imposed by government or regulatory authorities;

(c) sales, excise, use taxes, inventory, turnover, value-added, and similar taxes assessed on the royalty-bearing sale of JV Product (but excluding income taxes);

(d) transportation, freight, shipping, postage, duties, importation, handling charges and insurance directly chargeable to the royalty-bearing sale of JV Product;

(e) charge backs granted to drug wholesalers based upon sales to their customers where there are no direct shipments to such customers by JV (or its permitted Affiliate);

(f) bad debt actually written off attributable to sales of JV Product; and

(g) compulsory payments and cash rebates related to the sales of such JV Product paid to a government authority (or agent thereof) pursuant to governmental regulations by reason of any national or local health insurance program or similar program (such as Medicaid and Supplemental State Program rebates, Medicare Part D “Donut Hole” Coverage Gap rebates and “Industry Fees” for Brand Drugs as required by the Patient Protection and Affordable Care Act as amended by the Health Care Education Affordability Reconcilation Act), to the extent allowed and taken.

All of the foregoing deductions from the gross invoiced sales prices of JV Product shall be determined, to the extent possible, in accordance with US GAAP applied in a manner consistent with JV’s or its relevant Affiliate’s, distributors, marketing partner’s or agent’s customary practices. For the avoidance of doubt, to the extent in accord with US GAAP, sales of the JV Products, as applicable, between JV and its permitted Affiliates, distributors, marketing partners or agents for resale shall not be included within Net Sales; however, to the extent in accord with US GAAP, any subsequent sale of such JV Products by JV or such permitted Affiliates, distributors, marketing partners or agents to a Third Party, or any other payment received by JV or its permitted Affiliates, distributors, marketing partners or agents from such Third Parties relating to such JV Product shall be included within Net Sales as and when such sales to Third Party takes place.

1.46 Ophthalmic-Local Diseases ” means diseases specifically relating to, and manifesting locally in, the eye (including, but not limited to, macular degeneration and cataracts

 

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Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

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associated with advanced age), but excluding systemic diseases having symptoms or complications that manifest in the eye (including, but not limited to, diabetic retinopathy caused by diabetes and lens opacities and other eye abnormalities caused by genetic disorders).

1.47 Ophthalmic-Systemic Diseases ” means diseases having symptoms or complications that manifest in the eye that are caused by a separate broader systemic disease (including, but not limited to, diabetic retinopathy caused by diabetes and lens opacities and other eye abnormalities caused by genetic disorders), but excluding diseases specifically relating to, and manifesting locally in, the eye (including, but not limited to, macular degeneration and cataracts associated with advanced age).

1.48 Ophthalmic Program ” has the meaning set forth in Section 2.1(a).

1.49 Parent ” means, with respect to an entity, any person or entity that wholly owns the entity.

1.50 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.

1.51 Product-Specific Program Patent ” means any issued Intrexon Patent where all the claims are directed to Inventions that relate solely and specifically to JV 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 submitted to arbitration pursuant to Section 11.2. 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 Patent is a Product-Specific Program Patent or (b) an arbitrator or arbitration panel determines, pursuant to Article 11, that such Intrexon Patent is a Product-Specific Program Patent.

1.52 Proposed Terms ” has the meaning set forth in Section 11.2.

1.53 Prosecuting Party ” has the meaning set forth in Section 6.2(c).

1.54 RC ” has the meaning set forth in Section 2.2(b).

1.55 Recovery ” has the meaning set forth in Section 6.3(f).

1.56 Retained Product ” has the meaning set forth in Section 10.4(a).

1.57 Reverted Product ” has the meaning set forth in Section 10.4(c).

1.58 SEC ” means the United States Securities and Exchange Commission.

 

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Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

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1.59 Subsidiary ” means, with respect to a particular Party, any wholly-owned subsidiary of such Party.

1.60 Superior Therapy ” means a therapy in the Field that, based on the data then available, (a) demonstrably reasonably 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 JV or others) at such time for the indication and (ii) those therapies that are being actively developed by JV for such indication; (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.

1.61 Supplemental In-Licensed Third Party IP ” has the meaning set forth in Section 3.8(a).

1.62 Support Memorandum ” has the meaning set forth in Section 11.2.

1.63 Term ” has the meaning set forth in Section 10.1.

1.64 Territory ” means the world.

1.65 Third Party ” means any individual or entity other than the Parties or their respective Affiliates.

1.66 Third Security ” means Third Security, LLC.

1.67 US GAAP ” means generally accepted accounting principles in the United States.

ARTICLE 2

S COPE OF C HANNEL C OLLABORATION ; M ANAGEMENT

2.1 Scope.

(a) Generally . The general purpose of the exclusive channel collaboration described in this Agreement will be to use the Intrexon Channel Technology to research, develop and Commercialize products for use in the Field (collectively, the “ Ophthalmic Program ”). As provided below, the JSC shall establish, monitor, make budgets and govern projects for the Ophthalmic Program. Either Party may propose potential projects in the Field for review and consideration by the JSC.

2.2 Committees .

(a) Generally . The Parties desire to establish several committees (collectively, “ Committees ”) to oversee the Ophthalmic 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 any such decisions shall be made in good faith.

 

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(b) Formation and Purpose . Promptly following the Effective Date, the Parties shall confer and then create the JSC and the IPC, and, optionally, create one or more of the other Committees listed in the chart below. Each Committee shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree to not create a Committee (other than the JSC and the IPC), the creation of such Committee shall be deferred until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee.

 

Committee

  

Purpose

Joint Steering Committee (“ JSC ”)    Establish projects for the Ophthalmic Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee projects and plans (except for decisions of the IPC). The JSC shall establish budgets not less than on a quarterly basis.
Chemistry, Manufacturing and Controls Committee (“ CMCC ”)    Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Ophthalmic Program.
Regulatory Approval Committee (“ RC ”)    Review and approve all research and development plans and projects, including clinical projects, associated with any necessary regulatory approvals, all associated publications, and all regulatory filings and correspondence relating to gaining regulatory approval for new JV Products under the Ophthalmic Program; and review and approve itemized budgets with respect to the foregoing.
Commercialization Committee (“ CC ”)    Establish project plans and review and approve activities and budgets for Commercialization activities under the Ophthalmic Program.
Intellectual Property Committee (“ IPC ”)    Evaluate all intellectual property issues in connection with the Ophthalmic Program; review and approve itemized budgets with respect to the foregoing.

 

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Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

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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 Committees, each representative must either (i) be an employee of such Party or employee of a Parent or Subsidiary of such Party, or (ii) a qualified non-employee. A non-employee is qualified under the prior sentence if : (i) such non-employee representative is bound to the terms of this Agreement for the treatment and ownership of Confidential Information and Inventions of the Parties, 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 written notice to the other Party. Each Committee shall have a chairperson; the chairperson of each committee shall serve for a two-year term and the right to designate which representative to the Committee will act as chairperson shall alternate between the Parties, with JV selecting the chairperson first for the JSC, RC and CC, and Intrexon selecting the chairperson first for the CMCC and 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 fifteen (15) days thereafter. Such a chairperson (solely in capacity as a chairperson) in any of the Committees shall have no additional voting rights beyond those held by any other Committee representatives and shall not be able to break ties.

(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, with the caveat that both Parties may agree to suspend activities of a given Committee other than the JSC until such time as one Party informs the other Party of its then desire to reactivate the so-suspended Committee, at which point the Parties will thereafter schedule and hold the next meeting for the reactivated Committee 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 JV selecting the first meeting location for each Committee. A reasonable number of additional representatives of a Party (to the extent each such additional representative is duly bound to the terms of this Agreement for the treatment and ownership of Confidential Information and Inventions of the Parties) may attend meetings of a Committee in a non-voting capacity. Each Party shall be responsible for all of its own expenses of participating in any Committee except that an Intrexon or Collaborator employee or agent serving on a Committee shall not prevent Intrexon or Collaborator, as applicable, 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 4.7 and 4.8 below.

(c) Meeting Agendas . Each Party will disclose to the other proposed agenda items along with appropriate information 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.

 

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Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

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(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 Empowered Representative of the other Party. The Empowered Representatives of each of the Parties will meet at least once in person or by means of telecommunication (telephone, video, or web conferences) 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 Empowered Representatives. If any such dispute is not resolved by the Empowered Representatives within thirty (30) days after submission of such dispute to such Empowered Representatives, then the Empowered Representative of the Party specified in the applicable subsection below shall have the authority to finally resolve such dispute acting in good faith.

(a) Casting Vote at JSC . If a dispute at the JSC is not resolved pursuant to Section 2.4 above, then the Empowered Representative of JV shall have the authority to finally resolve such dispute.

(b) Casting Vote at CMCC . If a dispute at the CMCC is not resolved pursuant to Section 2.4 above, then (i) in the case of any disputes relating to the Intrexon Materials, the manufacture of a JV Product through the use of Intrexon Channel Technology or Intrexon IP, or the manufacturing of other components of JV Products contracted for or manufactured by Intrexon or reasonable controls regarding the dissemination of Intrexon Technology, Intrexon IP or Intrexon Materials, the Empowered Representative of Intrexon shall have the authority to finally resolve such dispute; and (ii) in the case of any other disputes, the Empowered Representative of JV shall have the authority to finally resolve such dispute.

(c) Casting Vote at RC . If a dispute at the RC is not resolved pursuant to Section 2.4 above, then the Empowered Representative of JV shall have the authority to finally resolve such dispute.

(d) Casting Vote at CC . If a dispute at the CC is not resolved pursuant to Section 2.4 above, then the Empowered Representative of JV shall have the authority to finally resolve such dispute.

(e) Casting Vote at IPC . If a dispute at the IPC is not resolved pursuant to Section 2.4 above, then the Empowered Representative 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).

 

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(f) 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.

(g) 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.

ARTICLE 3

L ICENSE G RANTS

3.1 Licenses to JV .

(a) Subject to the terms and conditions of this Agreement, Intrexon hereby grants to JV a world-wide and fully-paid (subject to the obligations under Section 5.1 for any JV Products, including Retained Products, set forth herein) license under the Intrexon IP to research, develop, use, make, have made, import, export, market, sell, and offer for sale JV Products in the Field in the Territory. Such license shall be exclusive (even as to Intrexon and its Affiliates) with respect to any Commercialization (such as selling or offering for sale, or otherwise for Commercialization purposes making, having made, importing, exporting, or marketing) of JV Products in the Field, and shall be otherwise non-exclusive. For clarity, JV shall be permitted to use the license rights granted in this Section 3.1 during the Term for the development of JV Products and related Confidential Information, Inventions, other Information and intellectual property in accord with the terms of this Agreement.

(b) Subject to the terms and conditions of this Agreement, Intrexon hereby grants to JV a non-exclusive, royalty-free license to use and display the Intrexon Trademarks, solely in connection with the Commercialization of JV Products in the promotional materials, packaging, and labeling for JV Products, as provided under and in accordance with Section 4.9.

(c) The licenses granted under this Section 3.1 shall remain in full force and effect for the Term and shall survive termination of the Agreement to the extent expressly provided under this Agreement. Intrexon shall not grant any rights under any of the Intrexon Channel Technology, Intrexon Materials, Intrexon Trademarks, Intrexon IP or Intrexon Patents to any other person which in any manner conflicts with or negatively affects with Material Adverse Effect the rights of JV under this Agreement.

3.2 Sublicensing . Except as provided in this Section 3.2, JV shall not sublicense the rights granted under Section 3.1 to any Third Party or Affiliate that is not a Subsidiary, or transfer the Intrexon Materials to any Third Party, or otherwise grant any Third Party the right to

 

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research, develop, use, or Commercialize JV 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, JV shall have a limited right to sublicense under the circumstances described in Sections 3.2(a) and 3.2(b).

(a) JV may transfer, to the extent reasonably necessary and after providing Intrexon with reasonable advance notice thereof, Intrexon Materials that are or express JV Products to a Third Party contractor performing contract manufacturing, fill, and/or finish responsibilities for JV Products, and may in connection therewith grant limited sublicenses necessary to enable such Third Party to perform such activities. If JV transfers any Intrexon Materials under this Section 3.2(a), JV will remain obligated 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 such Third Party contractor.

(b) JV may, with Intrexon’s written consent, which consent shall not be unreasonably withheld, 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. In the event that Intrexon consents to any such grant or transfer to an Affiliate, JV shall remain responsible for, and be guarantor of, 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 JV), including any payment obligations owed to Intrexon hereunder.

3.3 Limitation on Sublicensees . None of the enforcement rights under the Intrexon Patents that are granted to JV pursuant to Section 6.3 shall be transferred to, or exercised by, a sublicensee except with Intrexon’s prior written consent, which may be withheld in Intrexon’s sole discretion.

3.4 No Non-Permitted Use . JV 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 . Neither Intrexon nor its Affiliates shall outside of the Ophthalmic Program make directly or indirectly the Intrexon Channel Technology or Intrexon Materials or Intrexon IP available to any Third Party or Affiliate, without prior written JSC approval, for the purpose of developing or Commercializing products in the Field (except as set forth in Section 3.2), and neither Intrexon nor its Parents or Subsidiaries shall pursue directly or indirectly (either by itself or with a Third Party or Affiliate) the research, development or Commercialization of any product for purpose of commercial use or sale in the Field. Further, neither JV nor its Parents or Subsidiaries shall pursue (either by itself or with a Third Party or Affiliate) utilization of any synthetic biology platform for the development or commercialization of a product [*****] for purpose of commercial use or sale in the Field, outside of the Ophthalmic Program where such products would compete with JV Products. It shall not be a violation of this Section 3.5 for an Affiliate (other than a Subsidiary) of either Party to acquire a Third Party entity that, prior to acquisition by such Affiliate (other than a Subsidiary), is in the business of utilization of any synthetic biology platform for the

 

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development or commercialization of products for purpose of commercial use or sale in the Field, if : (i) such Third Party entity following such acquisition continues its business independently of relevant Party and its Parents and Subsidiaries, and (ii) the primary purpose of such acquisition by such Affiliate is unrelated to the acquired Third Party’s activities with respect to the Field. It shall be a violation of this Section 3.5 if (i) an Affiliate of either Party after participating in, or obtaining material Confidential Information from, the Ophthalmic Program, Commercializes products by utilization of any synthetic biology platform for the development or commercialization of any product [*****] for purpose of commercial use or sale in the Field, outside of the Ophthalmic Program, (ii) either Party, or its Parent or Subsidiary, exercises its discretionary control over an Affiliate to cause such Affiliate to act in violation of the preceding clause (i), or (iii) any Party attempts to circumvent the obligations of this Section 3.5 by contractual or corporate arrangement.

3.6 No Prohibition on Intrexon . Except as explicitly set forth in Section 3.1, in Section 3.5, or otherwise under this Agreement, nothing in this Agreement shall prevent Intrexon from practicing or using the Intrexon Materials, Intrexon Channel Technology, Intrexon Trademarks, 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, JV 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 JV Product), and Intrexon IP available to Third Parties for license or use outside the Field.

3.7 Rights to Regulatory Data . JV shall own and control all regulatory trial data and regulatory filings relating to Commercialization of JV Products (except to the extent such become Reverted Products). JV shall provide to Intrexon at Intrexon’s reasonable request full copies of all trial data and reports, regulatory filings, and communications from regulatory authorities that relate specifically and solely to JV Products. To the extent that there exist any trial data and reports, regulatory filings, and communications from regulatory authorities owned by JV that relate both to JV Products and other products produced by JV outside the Field or outside the Ophthalmic Program, upon Intrexon’s reasonable request JV shall provide to Intrexon copies of the portions of such data, reports, filings, and communications that relate to a JV Product. Subject to its ongoing obligations of exclusivity under Section 3.5, Intrexon shall be permitted, directly or in conjunction with or through partners or other channel collaborators, to reference this data, reports, filings, and communications relating to JV Products in regulatory filings made to obtain regulatory approval for products for use in fields outside the Field. Intrexon shall have the right to use any such information in developing and Commercializing products outside the Field and to license any Third Parties to do so. Notwithstanding the provisions of this Section 3.7, Intrexon shall not, outside of the Ophthalmic Program, utilize any JV trial data or reports in support of obtaining regulatory approval for a product for use in the Field. Intrexon shall keep the JSC apprised of any regulatory data that is shared with a Third Party or Affiliate pursuant to this Section 3.7. To the extent that Intrexon Controls, or has such contractual rights with Third Parties to use for such purposes, regulatory trial data or filings that relate to the use of JV Products in the Field, subject to its ongoing obligations of exclusivity under Section 3.5, JV shall be permitted to reference such data, reports, filings, and communications to obtain regulatory approval for JV Products for use in the Field.

 

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3.8 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 where the licensed intellectual property is reasonably necessary for Intrexon to conduct genetic and cell engineering and related analytic activities under JSC established plans for the Ophthalmic Program (but specifically excluding intellectual property directed to any specific target genes, methods of treatment or therapy, cell lines, active pharmaceutical ingredients, delivery or packaging methods or apparatuses, or processes or methods for commercially manufacturing JV Products) (“ 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 JV 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 In-Licensed Program IP, such Party shall so notify the other Party, and the IPC shall discuss such In-Licensed Program IP and its applicability to the JV Products and to the Field. As provided above in Section 3.8(a), [*****] shall have the sole right and responsibility to pursue a license under Supplemental In-Licensed Third Party IP, and [*****] hereby covenants that it shall not itself directly license such Supplemental In-Licensed Third Party IP at any time, provided that [*****] may (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 (to the extent such threats would reasonably be considered to subject the Third Party owner or licensee to declaratory judgment jurisdiction) 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 3.8(c), [*****] shall have the right to pursue a license under Complementary In-Licensed Third Party IP, [*****] For the avoidance of doubt, [*****] may at any time obtain a direct license from the Third Party under Complementary In-Licensed Third Party IP for use outside the Field, [*****], provided that if [*****] decides to seek to obtain such a license, it shall notify the JSC of such, shall use reasonable efforts to coordinate its licensing activities in this regard with [*****], and shall ensure that any license obtained from such licensing activities does not conflict with the rights granted to [*****] under this Agreement.

(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. To the extent that [*****] obtains a license under Supplemental In-Licensed Third Party IP, [*****] shall provide the final version of the definitive license agreement for such Supplemental In-Licensed Third Party IP to the IPC. If [*****] acquires rights under any In-Licensed Program IP outside the Field, it will do so on a non-exclusive basis unless it obtains the prior written consent of [*****] for such license outside the Field to be exclusive. Any Party that is pursuing a license to any In-Licensed Program IP with respect to the Field under this Section 3.8 shall keep the

 

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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 JV or its Subsidiaries obtain a license under Patents claiming inventions or know-how specific to or used or incorporated into the development, manufacture, and/or Commercialization of JV Products, JV shall use commercially reasonable efforts to ensure that JV 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 JV under Section 3.1 may include sublicenses under Intrexon IP that has been licensed (which are eligible for sublicensing) 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 3.8(c), provided that Intrexon shall either provide unredacted copies of such upstream license agreements to JV or shall disclose in writing to JV all of such terms and conditions that are applicable to JV. JV 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 JV as provided in the preceding sentence and JV has consented to use of relevant sublicensed rights in the Ophthalmic Program.

(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 within five (5) Business Days.

3.9 Licenses to Intrexon. Subject to the terms and conditions of this Agreement, JV hereby grants to Intrexon a non-exclusive, worldwide, fully-paid, royalty-free license, under any applicable Patents or other intellectual property Controlled by JV, solely to the extent necessary for Intrexon to conduct those responsibilities assigned to it under this Agreement as set forth in JSC approved projects and plans, which license shall be sublicensable solely to Intrexon’s Affiliates or to any Intrexon subcontractors as permitted in accord with Section 4.7 or as otherwise permitted to be used by Intrexon in conjunction with support services under Section 4.8 (subject to JSC research plan approval).

3.10 Restrictions Relating to Intrexon Materials . JV and its permitted sublicensees shall use the Intrexon Materials solely for purposes of the Ophthalmic Program and not for any other purpose without the prior written consent of Intrexon. With respect to the Intrexon Materials comprising Intrexon’s vector assembly technology, JV shall not, and shall ensure that JV personnel and permitted sublicensees do not, except as otherwise permitted in this Agreement (a) distribute, sell, lend 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.

 

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ARTICLE 4

O THER R IGHTS AND O BLIGATIONS

4.1 Development and Commercialization . Subject to Sections 4.7 and 4.8, JV shall be solely responsible for the development and Commercialization of JV Products. JV shall be responsible for all costs incurred in connection with the Ophthalmic Program 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 4.7 (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 JV 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 research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but excluding research described in Section 4.8 or research requested by the JSC for the development of a JV Product (which research costs shall be reimbursed by JV); (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 JV Products undertaken pursuant to Section 4.7, 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 JV (with Intrexon’s consent).

4.2 Transfer of Technology and Information . The JSC shall develop a plan and protocol for each project and timing for the transfer of relevant data and materials between the Parties.

4.3 Information and Reporting . JV shall provide Intrexon with certain information, reporting and access rights for so long as the Ophthalmic Program remains in effect and for so long as a JV Product is under development or commercialization. Notwithstanding the foregoing, such rights may be fulfilled through JV directly in the event Intrexon holds an equity interest in JV of at least 25%. The specific rights and obligations are as follows:

(a) JV will keep Intrexon informed about JV’s efforts to develop and Commercialize JV Products, including reasonable and accurate summaries of JV’s (and, as applicable to the Ophthalmic Program, its Affiliates’ and (sub)licensees’) development plans (as updated), including 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 JV Products, including initiation or completion of a regulatory trial, submission of a United States or international regulatory filing, receipt of a response to such United States or international regulatory filing, product safety event, receipt of Regulatory Approval, or commercial launch, and manufacturing costs and pricing information. As set forth in Section 3.7 above, JV shall also provide to Intrexon copies of all final regulatory trial protocols and reports, and regulatory correspondence

 

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and filings generated by JV as soon as practical after they become available. Intrexon will keep JV informed about Intrexon’s efforts (a) to establish manufacturing capabilities and facilities for JV Products (and Intrexon Materials relevant thereto) and otherwise perform its manufacturing responsibilities under Section 4.7 and (b) to undertake discovery-stage research for the Ophthalmic Program with respect to the Intrexon Channel Technology and Intrexon Materials. Unless otherwise provided herein or directed by the JSC in accord with Section 4.2 above, such disclosures by JV and Intrexon will be coordinated by the JSC and made in connection with JSC meetings at least once every six (6) months while JV Products are being developed or Commercialized anywhere in the world, and shall be reflected in the minutes of such meetings.

(b) Payment Reports and Records Retention . Within thirty (30) days after the end of each calendar quarter during which Net Sales have been generated, or during which a negative Net Sales has occurred, JV shall deliver to Intrexon a written report that shall contain at a minimum for the applicable calendar quarter:

(i) gross sales of each JV Product on a country-by-country basis;

(ii) itemized calculation of Net Sales on a county-by-country basis, showing all applicable deductions;

(iii) the amount of any negative Net Sales for the applicable calendar quarter;

(iv) the amount of the payment (if any) due pursuant to Section 5.1;

(v) the amount of taxes, if any, withheld to comply with any applicable law; and

(vi) the exchange rates used in any of the foregoing calculations.

For three (3) years after each sale or other commercial use of JV Product, or after incurring any component item JV incorporated into its calculation of Net Sales, or otherwise impacting JV’s calculations with regard to payments made to Intrexon in accord with Section 5.1, JV shall keep (and shall ensure that, as applicable to their participation in the Ophthalmic Program, its Affiliates and (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.

(c) Audits .

(i) Upon the written request of Intrexon, JV shall permit an independent certified public accounting firm of internationally recognized standing selected by Intrexon, and reasonably acceptable to JV, to have access to and to review, during normal business hours and upon no less than thirty (30) days prior written notice, the applicable records of JV and its Affiliates (to the extent applicable to the participation of such Affiliates in the Ophthalmic Program) to verify the accuracy and timeliness of the reports and payments made by JV under this Agreement. Such review may cover the records for sales made in any calendar year ending not more than three (3) years prior to the date of such request. The accounting firm

 

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shall disclose to both Parties whether the applicable reports and payments conform to the provisions of this Agreement and/or US GAAP, as applicable, and the specific details concerning any discrepancies. Such audit may not be conducted more than once in any calendar year.

(ii) If such accounting firm concludes that additional amounts were owed during such period, JV shall pay additional amounts, with interest from the date originally due as set forth in Section 5.4, within thirty (30) days of receipt of the accounting firm’s written report. If the amount of the underpayment is greater than ten percent (10%) of the total amount actually owed for the period audited, then JV 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 4.3(c) in accordance with the confidentiality provisions of Article 7 and (ii) cause its accounting firm to enter into an acceptable confidentiality agreement with JV 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.

(d) Infringement . JV shall promptly notify Intrexon of any suspected, alleged, threatened, or actual Infringement of which it becomes aware, and Intrexon shall promptly notify JV of any suspected, alleged, threatened, or actual Field Infringement of which it becomes aware.

(e) Proprietary Information and Operational Audits.

(i) 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, JV acknowledges that Intrexon’s authorized representative(s), during regular business hours may (i) examine and inspect JV’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 JV. JV will make itself and the pertinent employees and/or agents available, on a reasonable basis, to Intrexon for the aforementioned compliance review.

(ii) In view of the Intrexon Confidential Information, Intrexon Know-How, and Intrexon Materials transferred to JV hereunder, Intrexon from time-to-time, but no more than quarterly, may request that JV confirm the status of the Intrexon Materials at JV (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 JV’s receipt of any such written request, JV shall provide the written report to Intrexon.

4.4 Information to JV. Intrexon shall provide to JV all reasonable data as requested by JV and relating to the Ophthalmic Program. Additionally, Intrexon shall provide to Collaborator a copy of all reasonable data as requested by JV and relating to the Ophthalmic Program, and shall also provide to Collaborator all reasonable data as requested by Collaborator

 

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and relating to the Ophthalmic Program. The rights of the Collaborator to request, receive and/or have a copy of data and information under this Section 4.4 shall (i) continue until such time and extent that Collaborator or any of its Affiliates maintains an equity interest in JV of at least 25%, and (ii) be subject to Collaborator being bound to comply with all provisions of this Agreement relating use of such information to identification, ownership and use of confidential information and intellectual property of Intrexon, including without limitation, Section 4.3(e) and Articles 6 and 7, as if Collaborator was JV, solely to the extent it receives such information.

4.5 Regulatory Matters . At all times after the Effective Date, JV shall own and maintain, at its own cost, all regulatory filings and regulatory approvals for JV Products that JV is developing or Commercializing pursuant to this Agreement. As such, JV shall be responsible for reporting all adverse events related to such JV 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 will itself develop, or in collaboration with its Affiliates or Third Parties develop, Intrexon Materials outside of the Field, and to the extent that JV will develop uses of Intrexon Materials inside the Field, either Party may request that JV and Intrexon establish and execute a separate safety data exchange agreement, which agreement will address and govern the timely exchange of safety information generated by JV, Intrexon, and relevant Third Parties with respect to specific Intrexon Materials.

4.6 Diligence .

(a) JV shall use, and shall require its sublicensees to use, Diligent Efforts to develop and Commercialize JV Products.

(b) Without limiting the generality of the foregoing, Intrexon may, from time to time, notify JV that it believes it has identified a Superior Therapy, and in such case Intrexon shall provide to JV its then-available information about such therapy and related product and reasonable written support for its conclusion that the product constitutes a Superior Therapy. JV shall have the following obligations with respect to such proposed Superior Therapy: (i) within sixty (60) days after such notification, JV shall prepare and deliver to the JSC for review and approval a development plan detailing how JV will pursue the Superior Therapy (including a proposed budget); (ii) JV shall revise and update the development plan as directed by the JSC; and (iii) following approval of the development plan by the JSC, JV shall use Diligent Efforts to pursue the development of the Superior Therapy under the Ophthalmic Program in accordance with such development plan. If JV fails to comply with the foregoing obligations, or if JV 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, then Intrexon shall have the termination right set forth in Section 10.2(b) (subject to the limitation set forth therein). For clarity, any dispute arising under this 4.5, including any dispute as to whether a proposed project constitutes a Superior Therapy (as with any other dispute under this Agreement) shall be subject to dispute resolution in accordance with Article 11. For the purpose of clarity, any action taken by the JSC with respect to repairing and/or adopting a revised development plan, such as to address a Superior Therapy or otherwise, shall not constitute an amendment of any of the terms under this Agreement, including those relating to royalty payments to Intrexon.

(c) The activities of JV’s Affiliates and any permitted sublicensees shall be attributed to JV for the purposes of evaluating JV’s fulfillment of the obligations set forth in this Section 4.6.

 

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4.7 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 Ophthalmic Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that JV and Intrexon establish 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. 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 manufacture Intrexon Materials or bulk quantities of other components of JV Products, then Intrexon shall provide to JV or a contract manufacturer selected by JV and approved by Intrexon (such approval to be deemed to have been given if Intrexon holds at least 50% of the equity of JV and in no event to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of JV Products for use in the Field and (b) reasonably necessary to enable JV or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of JV Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to JV or its contract manufacturer shall not be further transferred to any Third Party, including any sublicensee of JV or any JV Affiliate, without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit JV to switch manufacturers.

4.8 Support Services . The JSC will meet promptly following the Effective Date and establish a plan under which Intrexon and Collaborator will provide support services to JV for the research and development of JV Products under the Ophthalmic Program, which initial plan may be amended from time to time by the JSC. JV will compensate Intrexon and Collaborator for such support services with cash payments equal to Intrexon’s or Collaborator’s, as the case may be, respective Fully Loaded Cost in connection with such services. Additionally, from time to time, on an ongoing basis, JV shall choose to request, or Intrexon or Collaborator may propose, that Intrexon or Collaborator perform certain additional support services with respect to researching and developing new JV Products or improving the manufacturing or processing methods for any existing JV Products. To the extent that the Parties mutually agree that Intrexon or Collaborator should perform such additional services, the Parties shall negotiate in good faith and consistent with this Agreement the terms under which services would be performed, it being understood that Intrexon and Collaborator each would be compensated for such services by cash payments equal to Intrexon’s or Collaborator’s, as the case may be, respective Fully Loaded Cost in connection with such services. For the purposes of this Section 4.8, support services may be conducted by Affiliates of Intrexon or Collaborator, as the case may be, to the extent such Affiliate is bound to comply with the terms of this agreement and is reasonably acceptable to Intrexon (in the case of an Affiliate of Collaborator) and JV (in the case of an Affiliate of Intrexon).

 

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4.9 Compliance with Law . Each Party shall comply, and shall ensure that its Affiliates, (sub)licensees and Third Party contractors comply, with all applicable laws, regulations, and guidelines applicable to the Ophthalmic Program, including without limitation those relating to the transport, storage, and handling of Intrexon Materials and JV Products.

4.10 Trademarks and Patent Marking. To the extent permitted by applicable law and regulations, JV shall ensure that the packaging, promotional materials, and labeling for JV Products, as appropriate, shall carry, in a conspicuous location, the applicable Intrexon Trademark(s), subject to JV’s reasonable approval of the size, position, and location thereof. Consistent with the U.S. patent laws, JV shall ensure that JV Products, or their respective packaging or accompanying literature as appropriate, bear applicable and appropriate patent markings for Intrexon Patent numbers. JV shall provide Intrexon with copies of any materials containing the Intrexon Trademarks or patent markings prior to using or disseminating such materials, in order to obtain Intrexon’s approval thereof. JV’s use of the Intrexon Trademarks and patent markings shall be subject to prior review and approval of the IPC. JV acknowledges Intrexon’s sole ownership of the Intrexon Trademarks and agrees not to take any action inconsistent with such ownership. JV covenants that it shall not use any trademark confusingly similar to any Intrexon Trademarks in connection with any products (including any JV Product). From time to time during the Term, Intrexon shall have the right to obtain from JV samples of JV Product sold by JV or its Affiliates or sublicensees, or other items which reflect public uses of the Intrexon Trademarks or patent markings, for the purpose of inspecting the quality of such JV Products, the use of the Intrexon Trademarks, or the accuracy of the patent markings. In the event that Intrexon inspects under this Section 4.9, Intrexon shall notify the result of such inspection to JV in writing thereafter. JV shall comply with reasonable policies provided by Intrexon from time-to-time to maintain the goodwill and value of the Intrexon Trademarks.

ARTICLE 5

C OMPENSATION

5.1 Revenue Sharing . No later than thirty (30) days after each calendar quarter in which there are positive Net Sales arising from the sale of any JV Product in the Field in the Territory, JV shall pay to Intrexon on a JV Product-by-JV Product basis [*****] royalty on the first [*****] of annual Net Sales, [*****] royalty on the portion of annual Net Sales exceeding [*****] up to and including [*****] of annual Net Sales, [*****] royalty on the portion of annual Net Sales exceeding [*****] up to and including [*****] of annual Net Sales, and [*****] royalty on the portion of annual Net Sales exceeding [*****]. Commencing with the Effective Date, in the event that are negative Net Sales for a particular JV Product in any calendar quarter, neither JV nor Intrexon shall owe any payments hereunder with respect to such JV Product.

 

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5.2 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.

5.3 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. JV 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 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 JV or the appropriate governmental authority (with the assistance of JV 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 JV of its obligation to withhold tax, and JV shall apply the reduced rate of withholding tax, or dispense with withholding tax, as the case may be, provided that JV has received to its reasonable satisfaction evidence of Intrexon’s delivery of all applicable forms (and, if necessary, its receipt of appropriate governmental authorization) at least fifteen (15) days prior to the time that the payment is due. If, in accordance with the foregoing, JV does not withhold any amount, Intrexon shall make timely payment in the event a taxing authority claims such a payment from JV, and if JV 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 forty-five (45) days following that latter payment. In the event JV does not deduct and withhold any taxes of Intrexon, Intrexon shall remain liable and responsible for such taxes.

5.4 Late Payments . Any amount owed by JV to Intrexon under this Agreement, excluding any amount that is under reasonable dispute, that is not paid within the applicable time period set forth herein shall accrue interest at the lower of (a) [*****] per month, compounded, or (b) the highest rate permitted under applicable law.

ARTICLE 6

I NTELLECTUAL P ROPERTY

6.1 Ownership .

(a) Subject to the licenses granted under Section 3.1 or as otherwise granted in this Agreement, all rights in the Intrexon IP shall remain with Intrexon.

(b) JV 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 Ophthalmic Program (collectively “ Inventions ”). Each Party shall promptly provide the other Party with a detailed written description of any such Inventions that relate to the Field. Inventorship shall be determined in accordance with United States patent laws.

(c) Intrexon shall solely own all right, title and interest in all Inventions made with, using, or otherwise incorporating Intrexon Channel Technology, together with all Patent rights and other intellectual property rights therein (the “ Channel-Related Program IP ”). JV

 

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hereby assigns all of its right, title and interest in and to the Channel-Related Program IP to Intrexon. JV agrees to execute such documents and perform such other acts as Intrexon may reasonably request to obtain, perfect and enforce its rights to the Channel-Related Program IP and the assignment thereof.

(d) 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 JV 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 included in the Channel-Related Program IP.

(e) All Information regarding Channel-Related Program IP shall be Confidential Information of Intrexon. JV shall be under appropriate written agreements with each of its employees, contractors, or agents working on the Ophthalmic Program, pursuant to which such person shall grant all rights in the Inventions to JV (so that JV may convey certain of such rights to Intrexon, as provided herein) and agree to protect all Confidential Information relating to the Ophthalmic Program.

(f) All rights, technology, and intellectual property (A) owned by JV or licensed from a Third Party by JV as of the Effective Date, or (B) thereafter developed by JV independent of the Ophthalmic Program, Intrexon Channel Technology, Intrexon IP or Intrexon Materials, shall be owned by and remain the property of JV (the “ JV Independent IP ”).

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 JV Product. At the reasonable request of Intrexon, JV shall cooperate with Intrexon in connection with such filing, prosecution, and maintenance, at Intrexon’s expense. Under no circumstances shall JV (A) 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 Invention owned by Intrexon, (B) 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 (C) 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 JV Product.

(b) JV shall have the sole right, but not the obligation, to conduct and control the filing, prosecution and maintenance of JV Independent IP or any Patents claiming Inventions that are owned by JV or its Subsidiaries and not assigned to Intrexon under Section 6.1(c) (“ JV Program Patents ”). At the reasonable request of JV, Intrexon shall cooperate with JV in connection with such filing, prosecution, and maintenance, at JV’s expense.

 

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(c) As used in this Section, “ Prosecuting Party ” means Intrexon in the case of Intrexon Patents and JV in the case of JV Program Patents. 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 JV 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 JV Program Patents, as applicable.

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 and at its own cost 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, JV shall have the first right, but not the obligation, to take appropriate action to enforce Product-Specific Program Patents against any Infringement that involves a commercially material amount of allegedly infringing activities in the Field (“ Field Infringement ”), either by settlement or lawsuit or other appropriate action. If JV exercises the foregoing right, Intrexon agrees to be named in any such action if required. If JV fails to take the appropriate steps to enforce Product-Specific Program Patents 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 6.4 of such Field Infringement, then Intrexon shall have the right (but not the obligation), at its own expense, to enforce Product-Specific Program Patents against such Field Infringement, either by settlement or lawsuit or other appropriate action.

 

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(c) With respect to any Field Infringement that cannot reasonably be abated through the enforcement of Product-Specific Program 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), 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 JV shall be entitled to a share of the Recovery a set forth in Section 6.3(f), Intrexon and JV 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 JV 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 (including, if legally required, being named as a party to such action), 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) JV 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 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 JV in the Field or adversely affects any Intrexon Patent with respect to the Field without JV’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 JV pursuant to Section 6.3(b), JV shall retain one hundred percent (100%) of any Recovery, [*****]. Likewise, in any action initiated by Intrexon or JV pursuant to Section 6.3(c), [*****].

6.4 Cooperative Intellectual Property Obligations of the Parties . Notwithstanding anything else in this Article 6, (i) Intrexon shall protect Inventions that are Channel-Related Program IP Program through the reasonable filing, protection and pursuit of Patents, and shall reasonably cooperate with JV to enforce Patents against Field Infringement by Third Parties; (ii) JV shall protect Inventions through the reasonable filing and pursuit of JV

 

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Program Patents; and (iii) to the extent reasonable and practical, and unless otherwise agreed, the Parties shall coordinate activities relating to Patents and other intellectual property of relevance to the Ophthalmic Program though the IPC, including notifying each other of potential infringement of intellectual Property relevant to the Ophthalmic Program.

ARTICLE 7

C ONFIDENTIALITY

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.

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;

 

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(b) to regulatory authorities in order to seek or obtain approval to conduct regulatory trials, or to gain regulatory approval, of JV Products or any products being developed by Intrexon or its other licensees and/or channel partners or collaborators, 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 (including officers and directors), consultants or agents (such as CROs) who are participating in, or working on behalf of) the Ophthalmic Program as authorized under this agreement and who are legally or contractually bound to comply with the terms of this Agreement with respect to the treatment and ownership of Confidential Information and Inventions, including, without limitation, Section 4.3(e) and Articles 6 and 7; and

(e) disclosure of the terms of this Agreement by Intrexon to collaborators (including other channel partners or collaborators) 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.

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, which shall be mutually agreed to by the Parties. Each Party will provide the other Party with the opportunity to review and comment, prior to submission or presentation, on external reports, publications and presentations (e.g., press releases, reports to government agencies, abstracts, posters, manuscripts and oral presentations) that refer to the Ophthalmic Program 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. 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 or other similar regulatory body, either as of the

 

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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 Intrexon Commitment . Intrexon shall use reasonable efforts to obtain an agreement with its other licensees and channel partners or collaborators to enable JV to disclose confidential information of such licensees and channel partners or collaborators to regulatory authorities in order to seek or obtain approval to conduct regulatory trials, or to gain regulatory approval of, JV Products, in a manner consistent with the provisions of Section 7.2(b).

ARTICLE 8

R EPRESENTATIONS A ND W ARRANTIES

8.1 Representations and Warranties of JV . JV hereby represents and warrants to Intrexon that, as of the Effective Date:

(a) Corporate Power . JV 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 . JV is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the person executing this Agreement on JV’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 JV 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 JV 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. JV 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 JV 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.

 

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(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 JV with respect to the Intrexon Channel Technology, Intrexon IP, Intrexon Trademarks, and Intrexon Patents under this Agreement;

(ii) The Intrexon IP and Intrexon Know-How existing as of the Effective Date constitute all of the intellectual property Controlled by Intrexon as of such date that are necessary for the development, manufacture and Commercialization of JV Products;

(iii) Intrexon has not granted 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 JV hereunder;

(iv) There has been no adversely resolved litigation since their respective acquisition or development by Intrexon, and 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) Except as otherwise identified in writing prior to the Effective Date, there has been no re-examination, opposition, interference or litigation proceedings in the past pertaining to Intrexon Channel Technology, Intrexon Trademark and Intrexon IP since their respective acquisition or development by Intrexon, and none of the Intrexon Channel Technology and 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’s products and technology providing Intrexon, to the extent

 

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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 JV 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, Intrexon Trademarks, or Intrexon IP in the Field;

(ix) To Intrexon’s knowledge, there is no material infringement, misappropriation or violation by Third Parties of any Intrexon Channel Technology, Intrexon Trademark or Intrexon IP outside the Field;

(x) 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;

(xi) 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;

(xii) 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

(xiii) Except as otherwise disclosed in writing to JV, 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 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

 

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Material Adverse Effect; (C) possesses all Authorizations necessary for the operation of its business as described 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, 2008 and to the knowledge of Intrexon, (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 the FDA, nor any other federal, state, local or foreign governmental or regulatory authority or Third Party, is not 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 the FDA, nor any other federal, state, local or foreign governmental or regulatory authority, is not considering any 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, 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 no Third Party has initiated, conducted or intends to initiate any such notice or action.

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

I NDEMNIFICATION

9.1 Indemnification by Intrexon . Intrexon agrees to indemnify, hold harmless, and defend JV and its Affiliates and their respective directors, officers, employees, JV non-employee representatives on Committees, and agents (collectively, the “ JV 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 JV) or sublicensees; or (c) breach by Intrexon of any representation, warranty or covenant in this Agreement. Notwithstanding the foregoing, Intrexon shall not have any obligation to indemnify the JV Indemnitees to the extent that a Claim arises from (i) the gross negligence or willful misconduct

 

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of JV or any of its Affiliates, licensees, or sublicensees, or their respective employees or agents; (ii) a breach by JV of a representation, warranty, or covenant of this Agreement which directly resulted in the subject indemnification Claim; or (iii) the direct consequence of an action undertaken pursuant to, and in accordance with, a JSC-approved research plan for which JV’s representative voted in favor at the JSC.

9.2 Indemnification by JV . JV agrees to indemnify, hold harmless, and defend Intrexon, its Affiliates and Third Security, and their respective directors, officers, employees, Intrexon non-employee representatives on Committees, 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 JV 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 JV or its Affiliates, licensees, or sublicensees; (c) breach by JV of any 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 JV Product by or on behalf of JV or its Affiliates, licensees, or sublicensees. Notwithstanding the foregoing, JV 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; (ii) a breach by Intrexon of a representation, warranty, or covenant of this Agreement which directly resulted in the subject indemnification Claim; or (iii) the direct consequence of an action undertaken pursuant to, and in accordance with, a JSC-approved research plan for which Intrexon’s representative voted in favor at the JSC. Further, the JV shall have no indemnification obligations if the Claim is arising on account of infringement by JV of Third Party owned intellectual property by the practice of Intrexon Channel Technology or Intrexon IP, or use of Intrexon Materials, to the extent such Intrexon Channel Technology or Intrexon IP, or use of Intrexon Materials, is not an Invention developed under the Ophthalmic Program.

9.3 Product Liability Claims . Notwithstanding the provisions of Section 9.2, any Losses arising out of any Third Party claim, suit, action, proceeding, liability or obligation involving any actual or alleged death or bodily injury arising out of or resulting from the development, manufacture or Commercialization of any JV Products for use or sale in the Field, to the extent that such Losses 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

 

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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 JV Products, JV 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 human clinical trials, JV 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, JV shall provide Intrexon with all details regarding such policies, including without limitation copies of the applicable liability insurance contracts. JV shall use reasonable efforts to include Intrexon as an additional insured on any such policies.

ARTICLE 10

T ERM ; T ERMINATION

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 4.6(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, provided, that the foregoing cure period shall not apply to JV’s breach of the prohibitions of Section 12.8.

(b) Intrexon shall have the right to terminate this Agreement under the circumstances set forth in Section 4.6(b) upon written notice to JV, such termination to become effective sixty (60) days following such written notice unless JV remedies the circumstances giving rise to such termination within such sixty (60) day period.

10.3 Termination by JV . JV 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 . JV (or, if applicable, the JV’s successor-in-interest with respect to an applicable Retained Product, which successor shall be included in the

 

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definition of “JV” for purposes of this Section 10.4) shall be permitted to continue the development and Commercialization in the Field of any product resulting from the Ophthalmic Program that, at the time of termination, satisfies at least one of the following criteria (a “ Retained Product ”):

(i) the particular product is a JV Product that is being sold by JV (or, as may be permitted under this Agreement, its Affiliates and, if applicable, (sub)licensees) triggering revenue sharing payments therefor under Section 5.1 of this Agreement,

(ii) the particular product is a JV Product that has received regulatory approval,

(iii) the particular product is a JV Product that is the subject of an application for regulatory approval in the Field that is pending before the applicable regulatory authority,

(iv) the particular product is a JV Product that is the subject of at least an ongoing Phase 2 clinical trial in the Field, or

(v) solely in the event of a termination by JV under Section 10.2(a) following a material and uncured breach by Intrexon of this Agreement, the particular product is a JV Product that is the subject of an Investigational New Drug application with the FDA, or an equivalent filing with a foreign regulatory agency.

Such right to continue development and Commercialization shall be subject to JV’s full compliance with the payment provisions in Article 5, a continuing obligation for JV to use in accord with Sections 4.6(a) and 4.6(c) Diligent Efforts to develop and Commercialize any Retained Products, and all other provisions of this Agreement that survive termination.

(b) Termination of Licenses . Except as necessary for JV 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 JV under this Agreement shall terminate and shall revert to Intrexon without further action by either Intrexon or JV. JV’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.

(c) Reverted Products . All JV Products other than the Retained Products shall be referred to herein as the “ Reverted Products .” JV shall immediately cease, and shall cause its Affiliates and, if applicable, (sub)licensees to immediately cease, all development and Commercialization of the Reverted Products, and JV 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 Products. JV shall immediately discontinue making any representation regarding its status as a licensee or channel collaborator of Intrexon with respect to the Reverted Products.

(d) Intrexon Materials . JV shall promptly return, or at Intrexon’s request, destroy, any Intrexon Materials in JV’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.

 

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(e) Licenses to Intrexon . JV is automatically deemed to grant to Intrexon a worldwide, fully paid, royalty-free, non-exclusive (even as to JV and its Affiliates), irrevocable, license (with full rights to sublicense) under the JV Termination IP, to make, have made, import, use, offer for sale and sell Reverted Products and to use the Intrexon Channel Technology, the Intrexon Materials, and/or the Intrexon IP in the Field, subject to any exclusive rights held by JV in Reverted 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. For clarity, nothing in this Section 10.2(e) or anywhere under this Agreement shall be deemed to grant to Intrexon any intellectual property right that is not Controlled by JV, including in and to any intellectual property right owned by an equity owner in JV.

(f) Regulatory Filings . JV shall promptly assign to Intrexon, and will provide full copies of, all regulatory approvals and regulatory filings that relate specifically and solely to Reverted Products. JV 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 Products and other products, JV shall provide copies of the portions of such regulatory filings that relate to Reverted Products and shall reasonably cooperate to assist Intrexon in obtaining the benefits of such regulatory approvals with respect to the Reverted Products. All reasonable costs in this relation shall be borne by Intrexon.

(g) Data Disclosure . JV shall provide to Intrexon as reasonably requested copies of the relevant portions of all material reports and data, including clinical and non-clinical trial data and reports, obtained or generated by or on behalf of JV or its Affiliates to the extent that they relate to Reverted Products, within sixty (60) days of such termination unless otherwise agreed, and Intrexon shall have the right to use any such Information in developing and Commercializing Reverted Products and to license any Third Parties to do so.

(h) Third Party Licenses . At Intrexon’s request, JV shall promptly provide to Intrexon copies of all Third Party agreements under which JV 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 Products. At Intrexon’s request such that Intrexon may Commercialize the Reverted Products, JV shall 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. Notwithstanding the above, if Intrexon does not wish to assume any financial or other obligations associated with a particular Third Party agreement identified to Intrexon under this Section 10.4(h), then Intrexon shall so notify JV and JV shall not make such assignment or grant such sublicense (or cause it to be made or granted).

(i) Remaining Materials . At the request of Intrexon, JV shall transfer to Intrexon all quantities of Reverted Product (including final products or work-in-process) in the possession of JV or its Affiliates. JV shall transfer to Intrexon all such quantities of Reverted Products at cost, including the reasonable costs of shipping.

 

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(j) Third Party Vendors . At Intrexon’s request, JV shall promptly provide to Intrexon copies of all agreements between JV or its Affiliates and Third Party suppliers, vendors, or distributors that relate to the supply, sale, or distribution of Reverted Products in the Territory. At Intrexon’s request, JV shall promptly: (i) with respect to such Third Party agreements relating solely to the applicable Reverted Products, immediately assign (or cause to be assigned), such agreements to Intrexon, and (ii) with respect to all other such Third Party agreements, JV shall reasonably cooperate to assist Intrexon in obtaining the benefits of such agreements. JV shall be not be liable for any costs associated with assigning a Third Party agreement to Intrexon or otherwise obtaining the benefits of such agreement for Intrexon; however JV shall remain liable for any costs incurred prior to such assignment for JV’s breach of such Third Party agreement. For the avoidance of doubt, from the time after any assignment of a Third Party contract to Intrexon, Intrexon shall assume all obligations of JV under any such assigned Third Party agreements.

(k) Commercialization . Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to JV, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

(l) 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 JV) or Reverted 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).

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 JV 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 (but only to the extent the license therein continues pursuant to Section 10.4(b)), 5.3 through 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 4.3, 4.6(a), 4.6(c), 5.1 through 5.4, and 9.5 will survive termination of this Agreement to the extent there are applicable Retained Products.

 

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ARTICLE 11

D ISPUTE R ESOLUTION

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, 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 Empowered Representatives 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.

11.2 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) 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 choose one arbitrator from a list of arbitrators provided by the American Arbitration Association in accordance with its Commercial Arbitration Rules (the “ AAA Rules ”) as being suitable to arbitrate the Parties’s dispute. The Parties agree that the chosen arbitrator shall be neutral and independent of both Parties and all of their respective Affiliates, and shall have significant experience and expertise in licensing and partnering agreements in the pharmaceutical and biotechnology industries and concerning related intellectual property rights (as appropriate in light of the subject matter of the Parties’ disputed issues), and shall have some experience in mediating or arbitrating issues relating to such agreements and/or related intellectual property rights. The AAA Rules shall govern the arbitration between the Parties except as set forth in, and to the extent not inconsistent with, this Section 11.2, Within twenty (20) Business Days after an arbitrator(s) is selected, each Party will deliver to both the arbitrator 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 a copy of this Agreement, as it may be amended at such time. Within twenty (20) Business Days after receipt of the other Party’s Proposed Terms and Support Memorandum, each Party may submit to the arbitrator (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 other than for the sole purpose of engaging the arbitrator or as expressly permitted in this Section 11.2; provided that, the arbitrator may convene a hearing if the arbitrator 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

 

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the arbitrator’s appointment, the arbitrator 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 shall be final, binding, and unappealable. For clarity, the arbitrator 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 Delaware, 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 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. With respect to money damages, nothing contained herein shall be construed to permit the arbitrator 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 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.

 

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11.7 Confidentiality . The arbitration proceeding shall be confidential and the arbitrator 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 to make) any public announcement with respect to the proceedings or decision of the arbitrator 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, 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

G ENERAL P ROVISIONS

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 regulations and in press releases accompanying quarterly and annual earnings reports approved by the issuer’s Board of Directors, and (b) JV 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. Also, for purposes of this Agreement, neither Party shall be deemed to be an agent of the other Party. 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.

 

40


Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

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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

20358 Seneca Meadows Parkway

Germantown, MD 20876

Attention: Health Sector

Fax: (301) 556-9901

with a copy to:   

Intrexon Corporation

20358 Seneca Meadows Parkway

Germantown, MD 20876

Attention: Legal Department

Fax: (301) 556-9902

If to JV:   

S & I Ophthalmic, LLC

Corporation Trust Center

1209 Orange Street

Wilmington, DE 19801

Attention: Chief Executive Officer

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 JV to be kept confidential by the other Party under any prior confidentiality agreement, as of the Effective Date, shall be maintained as Confidential

 

41


Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

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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, provided that such assignee agrees in writing to assume and be bound by the assignor’s obligations under this Agreement. Notwithstanding the foregoing, to the extent that JV is controlled (as that term is used under Section 1.1) jointly by Intrexon and Collaborator, any attempted assignment of the rights or delegation of the obligations under this Agreement by JV shall be void without the prior written consent of both Intrexon (which may be withheld in Intrexon’s sole discretion) and Collaborator (which may be withheld in Collaborator’s sole discretion). 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 (in accordance with the terms hereof) 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 (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 JV 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.

 

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Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

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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.]

 

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Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

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I N W ITNESS W HEREOF , the Parties hereto have duly executed this Exclusive Channel Collaboration Agreement.

 

I NTREXON C ORPORATION     S & I O PHTHALMIC , LLC, BY ALL OF ITS M EMBERS
By:  

/s/ Krish S. Krishnan

    C ARACO P HARMACEUTICAL L ABORATORIES , L TD .

 

Name:

 

Title

 

 

Krish S. Krishnan

 

Chief Operating Officer

     

 

By:

 

Name:

 

 

/s/ Mukul Rathi

 

Mukul Rathi

       

 

Title:

 

 

Chief Financial Officer

      I NTREXON C ORPORATION
        By:  

/s/ Krish S. Krishnan

        Name:  

Krish S. Krishnan

        Title:  

Chief Operating Officer

SIGNATURE PAGE FOR EXCLUSIVE CHANNEL COLLABORATION AGREEMENT

 

44

Exhibit 10.2

Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

 

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L IMITED L IABILITY C OMPANY A GREEMENT

OF

S & I O PHTHALMIC , LLC

T HIS L IMITED L IABILITY C OMPANY A GREEMENT (this “ Agreement ”) is entered into effective as of September 30, 2013 (the “ Effective Date ”), by and between I NTREXON C ORPORATION , a Virginia corporation with offices at 20374 Seneca Meadows Parkway, Germantown, MD 20876 (“ Intrexon ”), C ARACO P HARMACEUTICAL L ABORATORIES L TD ., a Michigan corporation with offices at 1150 Elijah McCoy Drive, Detroit, Michigan, 48202 (“ Caraco ”), and S & I Ophthalmic, LLC, a limited liability company with a registered office at Corporation Trust Center, 1209 Orange St., Wilmington, DE 19801 (the “ Company ”). (Intrexon, Caraco, and any other person who may be admitted to the Company as a member in the future in accordance with this Agreement are sometimes referred to in this Agreement, collectively, as the “ Members ” and, individually, as a “ Member ”).

R ECITALS

W HEREAS , Donald P. Lehr, as an authorized person, executed and caused to be filed a Certificate of Formation, dated September 27, 2013 (the “ Certificate ”), to form the Company as a limited liability company pursuant to and in accordance with the Delaware Limited Liability Company Act, as amended (6 Del. C. § 18-101, et seq.) (the “ LLC Act ”), and the powers of the authorized person terminated upon the filing of the Certificate;

W HEREAS , Intrexon and Caraco have agreed to form a collaboration to use certain Intrexon technology to research, develop and commercialize technologies and products in the Field (the “ Venture ”), as more specifically set forth in the ECC (as defined below);

W HEREAS , Intrexon and Caraco have caused the Company to be organized under the LLC Act in order to conduct the Venture and Intrexon and the Company are entering into an Exclusive Channel Collaboration Agreement (“ ECC ”), as of the Effective Date, which sets forth certain terms and conditions with respect to the Venture; in addition, in order to facilitate the further development of the Venture, Intrexon and Caraco may enter into Services Agreements with the Company (“ Services Agreements ”) pursuant to which Intrexon and Caraco may provide certain administrative services to the Company and make certain of their employees available to the Company to assist with the conduct of the Company’s business; and

W HEREAS , by executing this Agreement, the Members hereby ratify the Certificate and adopt this Agreement to set forth the terms governing the affairs of the Company and the conduct of its business, and ratify and approve all actions that may have been taken previously by the Company or its representatives or designees in the name or on behalf of the Company.


Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

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N OW T HEREFORE , in consideration of the foregoing and the covenants and promises contained herein, the Members and the Company agree as follows:

 

  1. DEFINITIONS; INTERPRETATION

 

  1.1. Certain Defined Terms

As used in this Agreement, the following capitalized terms shall have the following meanings:

“Adjusted Capital Account” means the Capital Account maintained for each Member as of the end of each Fiscal Year (i) increased by any amounts which such Member is obligated to restore pursuant to any provision of this Agreement or is deemed to be obligated to restore pursuant to the penultimate sentences of Treasury Regulations Sections 1.704-2(g)(1) and 1.704-2(i)(5) and (ii) decreased by the items described in Treasury Regulations Sections 1.704-1(b)(2)(ii)(d)(4), 1.704-1(b)(2)(ii)(d)(5), and 1.704-1(b)(2)(ii)(d)(6). The foregoing definition of Adjusted Capital Account is intended to comply with the provisions of Treasury Regulations Section 1.704-1(b)(2)(ii)(d) and shall be interpreted consistently therewith.

“Adjusted Capital Account Deficit” means, with respect to any Member, the deficit balance, if any, in such Member’s Adjusted Capital Account as of the end of the relevant Fiscal Year.

“Affiliate” means, with respect to any Person, any other Person that, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with, such Person; and the term “control” (including the terms “controlled by” and “under common control with”) means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through ownership of voting securities, by contract or otherwise. Notwithstanding the foregoing, for purposes of this Agreement, (a) no Member or beneficial owner of any ownership interests in such Member shall, solely by reason of such ownership, be considered an Affiliate of the Company or any subsidiary of the Company and (b) no Member or beneficial owner of any ownership interests in such Member shall, solely by reason of such ownership, be considered an Affiliate of any other Member or any beneficial owner of any ownership interests in such other Member solely because such first Member is a party to this Agreement.

“Agreement” has the meaning set forth in the Preamble, and includes this Limited Liability Company Agreement, as it may be amended or supplemented from time to time.

“Allocable Income Item” has the meaning set forth in Section 6.3(b) .

“Approved Sale” has the meaning set forth in Section 9.3(a) .

“Board” has the meaning set forth in Section 7.2(a) .

“Board Member” means an individual serving as a member of the Board.

“Business Day” means Monday through Friday of each week, except that a legal holiday recognized as such by the Government of the United States shall not be regarded as a Business Day.

 

2


Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

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“Capital Account” has the meaning set forth in Section 5.2 .

“Capital Contribution” means any property (including cash) contributed to the Company by or on behalf of a Member.

“Caraco” has the meaning set forth in the Preamble.

“Caraco Designee” has the meaning set forth in Section 7.2(c)(ii) .

“Certificate means the Certificate of Formation of the Company, and any and all amendments thereto, filed on behalf of the Company with the Secretary of State for the State of Delaware as required under the LLC Act.

“Code” means the Internal Revenue Code of 1986, as in effect and hereafter amended or successor statute, and, unless the context otherwise requires, applicable regulations thereunder. Any reference herein to a specific section or sections of the Code shall be deemed to include a reference to any corresponding provision of future law.

“Company” has the meaning set forth in the Recitals.

“Company Assets” means all assets and property, whether tangible or intangible and whether real, personal, or mixed, at any time owned by or held for the benefit of the Company.

Company First Refusal Right ” has the meaning set forth in Section 9.2(a) .

“Confidential Information” has the meaning set forth in Section 8.7(a) .

“Counteroffer” has the meaning set forth in Section 9.4 .

“Default Rule” means a provision of the LLC Act that would apply to the Company unless otherwise provided in, or modified by, this Agreement.

“Distributable Cash Flow” means, with respect to any Fiscal Year, cash or property of the Company realized from its operations (excluding any capital proceeds from a sale of all or substantially all of the Company’s assets or a merger, business combination or similar transaction not in the ordinary course of business) that is available for distribution to the Members for such Fiscal Year.

“ECC” has the meaning set forth in the Recitals.

“Effective Date” has the meaning set forth in the Preamble.

“Field” has the meaning defined in the ECC.

“Fiscal Year” has the meaning set forth in Section 8.6 .

“Generic Drug Product” means a regulated drug product that qualifies, under applicable laws and/or regulations, for an expedited regulatory approval process in the relevant market because such drug product has substantially the same or similar active ingredient and/or

 

3


Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

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formulation as, and is indicated for substantially the same or similar indication as, another regulated drug product that has already been approved for commercial sale by the United States Food and Drug Administration, or by a similar regulatory authority in the relevant market.

“Indemnitee” has the meaning set forth in Section 7.7(a) .

Initial Capital Contributions ” has the meaning set forth in Section 5.1(e) .

“Intrexon” has the meaning set forth in the Preamble.

“Intrexon Designees” has the meaning set forth in Section 7.2(c)(i) .

“LLC Act” has the meaning set forth in the Recitals.

“Major Decision” has the meaning set forth in Section 7.1(f) .

“Majority of the Voting Interests” means Voting Interests that collectively represent a majority of the Member Votes at the time any vote, consent, approval or action is sought.

“Member” has the meaning set forth in the Preamble.

“Member Loan” means any loan made to the Company pursuant to Section 5.6 .

“Member Votes” means the number of votes entitled to be cast by holders of Voting Interests on matters presented to the Members for a vote, with the number of such votes calculated in accordance with Section 7.1(c) .

“Membership Interest” means, as to any Member, all of the interest of that Member in the Company, including, without limitation, such Member’s (i) right to a distributive share of the income, gain, losses and deductions of the Company in accordance with this Agreement, and (ii) right to a distributive share of Company Assets.

“Nonvoting Interests” means any Membership Interest designated as a “Nonvoting Interest” pursuant to this Agreement. Members holding Nonvoting Interests shall not be entitled to vote on matters presented to the Members for a vote on account of their Nonvoting Interests.

“Offeree” has the meaning set forth in Section 9.4 .

“Offeror” has the meaning set forth in Section 9.4 .

Parent ” means, with respect to first Person, any other Person that wholly owns the first Person.

“Percentage Interest” means, (i) in the case of the initial Members at the Effective date or a Person acquiring the Membership Interest thereof, the percentage specified for that Member as its Percentage Interest on Schedule A as otherwise amended from after the Effective Date time-to-time in accordance with the provisions under this Agreement; and (ii) in the case of Membership Interests issued new Members pursuant to Section 5.1(c) , the Percentage Interest established pursuant thereto; subject in all cases to adjustments on account of dispositions of Membership Interests permitted by this Agreement or as otherwise provided herein.

 

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Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

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“Permitted Transferee” has the meaning set forth in Section 9.2(a) .

“Person” means any individual, corporation, association, partnership, limited liability company, joint venture, trust, estate, or other entity or organization.

“Proposed Terms” has the meaning set forth in Section 11.12(b) .

“Proposed Transferee” has the meaning set forth in Section 9.2(b) .

“Purchase Offer” has the meaning set forth in Section 9.4 .

“Regulatory Allocations” has the meaning set forth in Section 6.4(b) .

“Sale of the Company” means any transaction or series of transactions pursuant to which any Person(s) in the aggregate acquire(s) (i) securities of the Company representing a two-thirds of the voting power (other than voting rights accruing only in the event of a default, breach or event of noncompliance) of the Company’s issued and outstanding securities (whether by merger, consolidation, reorganization, combination, sale or transfer of the Company’s Membership Interests, member or voting agreement, proxy, power of attorney or otherwise) or (ii) all or substantially all of the Company’s assets determined on a consolidated basis.

“Services Agreements” has the meaning set forth in the Recitals.

Subsidiary ” means, with respect to a Person, any wholly-owned subsidiary of such Person.

“Caraco Designees” has the meaning set forth in Section 7.2(c)(ii) .

“Support Memorandum” has the meaning set forth in Section 11.12(b) .

“Tax Distribution Amount” has the meaning set forth in Section 6.3(b) .

“Transfer” has the meaning set forth in Section 9.1(a) .

“Treasury Regulations” means the regulations issued by the United States Department of the Treasury under the Code as now in effect and as they may be amended from time to time, and any successor regulations.

“Venture” has the meaning set forth in the Recitals.

“Voting Interests” means all Membership Interests that have voting rights on matters presented to the Members for a vote under this Agreement.

 

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Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

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  1.2. Interpretation

(a) Unless the context of this Agreement otherwise specifies or requires: (i) the singular form of nouns, pronouns and verbs shall include the plural and vice versa; (ii) any pronoun also includes the corresponding masculine, feminine or neuter forms; (iii) the terms “hereof,” “herein,” “hereby” and derivative or similar words refer to this entire Agreement; (iv) all references herein to “Sections” or “Schedules” are to the Sections or Schedules hereof unless otherwise indicated; (v) the term “or” has, except as otherwise indicated, the inclusive meaning represented by the phrase “and/or”; and (vi) the words “include,” “includes” and “including” shall be deemed to be followed by the phrase “without limitation.”

(b) The headings and other titles contained herein are inserted only as a matter of convenience and in no way define, limit, extend or interpret the scope of this Agreement or any particular Section or subsection. Regardless of whether this Agreement specifically refers to a particular Default Rule, (i) if any provision of this Agreement conflicts with a Default Rule, the provision of this Agreement controls and such Default Rule is hereby modified or negated accordingly, and (ii) if it is necessary to construe a Default Rule as modified or negated in order to effectuate any provision of this Agreement, such Default Rule is hereby modified or negated accordingly.

 

  2. FORMATION; NAME; PLACE OF BUSINESS

 

  2.1. Formation of the Company

The Members hereby:

(a) acknowledge, ratify and approve the organization of the Company as a limited liability company pursuant to the LLC Act by virtue of the filing of the Certificate;

(b) confirm and agree to their status as Members of the Company;

(c) agree that this Agreement governs the rights, duties, and relationship of the Members;

(d) agree that if the laws of any jurisdiction in which the Company transacts business so require, the Board shall cause to be filed, with the appropriate office in that jurisdiction, any documents necessary for the Company to qualify to transact business under such laws, and agree and obligate themselves to execute, acknowledge, and cause to be filed for record, in the place or places and manner prescribed by law, any amendments to the Certificate as may be required, either by the LLC Act, by the laws of any jurisdiction in which the Company transacts business, or by this Agreement, to reflect changes in the information contained therein or otherwise to comply with the requirements of law for the continuation, preservation, and operation of the Company as a limited liability company under the LLC Act;

(e) approve the Company entering into the ECC and the Services Agreements; and

(f) each represents and warrants that this Agreement is binding on and enforceable against such Member in accordance with its terms.

 

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Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

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  2.2. Name of Company

The name under which the Company shall conduct its business is S & I O PHTHALMIC , LLC. The business of the Company may be conducted under any other name permitted by the LLC Act that is deemed necessary or desirable by the Board. The Board shall cause to be executed, filed and recorded, any assumed or fictitious name certificates required by the laws of the State of Delaware or any state in which the Company conducts business.

 

  2.3. Place of Business

The initial location of the principal place of business of the Company is 20358 Seneca Meadows Parkway, Germantown, MD 20876. The Board may hereafter change the principal place of business of the Company and may establish and maintain such other offices and additional places of business of the Company, either within or without the State of Delaware, as the Board may from time to time determine.

 

  2.4. Registered Office and Registered Agent

The street address of the registered office of the Company is 1209 Orange Street, Wilmington, Delaware 19801, and the Company’s registered agent at such address is The Corporation Trust Company. The registered office and the registered agent of the Company may be changed by the Board from time to time in accordance with the then applicable provisions of the LLC Act and any other applicable laws.

 

  3. PURPOSES AND POWERS OF COMPANY

 

  3.1. Purposes

The purposes of the Company are to (a) enter into the ECC and undertake the activities associated with the Venture, and to enter into and perform all agreements and contracts, and undertake and perform all other actions, as may be required by, desirable for or related to the Venture and are approved in accordance with this Agreement and permitted by the LLC Act or laws of any jurisdiction in which the Company may do business; (b) research, develop, own and commercialize technologies and products in the Field; (c) perform and carry on any business activities that the Members may mutually agree upon; and (d) enter into any lawful transaction and engage in any lawful activities in furtherance of the foregoing purposes and as may be necessary, incidental or convenient to carry out the business of the Company or the Venture as contemplated by this Agreement.

 

  3.2. Powers

Subject to all of the provisions of this Agreement, the Company shall have the power to do any and all acts and things necessary, appropriate, advisable, or convenient for the furtherance and accomplishment of the purposes of the Company, including, without limitation, to engage in any kind of activity and to enter into and perform obligations of any kind necessary to or in connection with, or incidental to, the accomplishment of the purposes of the Company, so long as said activities and obligations may be lawfully engaged in or performed by a limited liability company under the LLC Act.

 

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Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

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  4. TERM OF COMPANY

The existence of the Company commenced on the date upon which the Certificate was duly filed with the Secretary of State of the State of Delaware and shall continue until dissolved and liquidated in accordance with the provisions of Section 10 .

 

  5. MEMBERS, MEMBERSHIP INTERESTS, CAPITAL CONTRIBUTIONS AND CAPITAL ACCOUNTS

 

  5.1. Members, Membership Interests, and Capital Contributions

(a) Initial Membership Interests . As of the Effective Date, all Members and Membership Interests are in one class and all Membership Interests are Voting Interests. The initial Percentage Interests for each initial Member are set forth opposite each Member’s name below:

 

Member

   Percentage
Interest
 

Intrexon

     50

Caraco

     50

(b) Membership Record . The Members and their Percentage Interests shall be set forth on Schedule A attached hereto, which schedule shall be updated by the Company from time to time to reflect any change to the information contained therein. In addition, the Company shall issue to each Member a certificate in form approved by the Board setting forth the Membership Interests held by such Member. The Company shall distribute any such updated Schedule A to the Members. Without limiting the foregoing, the Company shall maintain a record of the names, addresses, Percentage Interests and capital contributions of all persons admitted to the Company as Members.

(c) Additional Membership Interests . The Company from time to time may admit one or more additional Members to the Company in accordance with this Agreement, including Sections 7.1(f) and Section 7.2(e) , upon the making of such Capital Contribution, if any, and the fulfillment of such other conditions as the Company may require from such Person. In such event, the Percentage Interests of the existing Members shall be adjusted pro rata, as the case may be, to reflect the Capital Contribution, if any, of such additional Members. Additional Membership Interests may be issued as Voting Interests or Nonvoting Interests, and in one or more classes, with such designations, preferences and relative participating, optional or other special rights, powers and duties, including rights, powers and duties senior to the then-existing Membership Interests, as determined by the Board and approved by a requisite vote of the Members in accordance with Section 7.1(f) . As a condition to being admitted to the Company, each additional Member shall execute a joinder or signature page to this Agreement to evidence such additional Member’s agreement to be bound by the terms and conditions of this Agreement, but the failure of any additional Member to do so shall not affect this Agreement, which shall nonetheless be effective and binding on all Members. The Board from time to time may amend this Agreement to reflect the admission of any additional Members admitted to the Company in accordance with this Section.

 

8


Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

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(d) Certificates . Each Member shall, upon written request to the Company, receive a certificate in such form as prescribed by the Board and by any applicable law, which certificate shall certify the Membership Interest of such Member in the Company. Any certificate representing a Membership Interest may bear such legend(s) as determined by the Board.

(e) Initial Capital Contributions . In consideration for the initial Membership Interests reflected herein, Intrexon will make an initial Capital Contribution to the Company of an amount of US$5 million and Caraco will make an initial Capital Contribution to the Company of an amount of US$5 million (together, the “ Initial Capital Contributions ”). The Initial Capital Contributions shall be wired in full to an account established by the Company within ten (10) Business Days from the Effective Date, unless otherwise delayed by mutual agreement of Intrexon and Caraco but in no event later than thirty (30) days from the Effective Date. Other than with respect to the Initial Capital Contributions, the Members shall have no obligation to make any additional Capital Contributions or loans to the Company except as mutually agreed between the Member and the Company, as may be provided in a separate written agreement between the Member and the Company, or as required under the LLC Act.

(f) Additional Capital Contributions .

(i) Additional Capital Contributions Required Under JSC-approved Budgets: If the Board determines that such is necessary in order for the Company to comply with its obligations under the ECC to pursue diligently a research plan(s) or project(s) approved by the “JSC” (as defined under the ECC) having a corresponding JSC-approved budget(s), the Board may vote, in accord with Section 5.1(c) , Section 7.2(c)(iv) and Section 7.2(e) , specifically under this Section 5.1(f)(i) to: (A) solicit additional Capital Contributions from the Members in a total amount the Board deems is sufficient solely for Company to meet the liquidity needs of the Company over the next twelve (12) months under such JSC-approved budget(s), and (B) cause the Company to accept such additional Capital Contributions up to the solicited amount from the Members. In such event, each Member shall have the pro-rata opportunity, but not the obligation, to subscribe to the offered contribution or part thereof (and not in part) and participate in such capital raise on a proportionate basis (or part thereof) by making additional Capital Contributions in proportion to its Percentage Interest. Each Member may do so by notifying the Board within fifteen (15) Business Days from the offer by the Company, of its interest to participate in such capital raise, and the amount of participation (up to its pro-rata Percent Interest in Company). If one or more Members notify the Board that they will make additional Capital Contributions under this Section 5.1(f)(i) , and if each Member has not notified the Board that it will participate fully up to its Percentage Interest, then (A) any Members making additional Capital Contributions that did notify the Board of its intent to participate fully up to its Percentage Interest may elect to absorb, pro-rata, any portion of the solicited amount left over by other Members until such time as no Member is willing to participate further in the solicited capital raise or the entire capital raise is fulfilled, (B) the Board shall thereafter collect the additional Capital Contributions from the participating Members in accord with the final amounts established under the preceding clause “(A)”, and (C) the

 

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Percentage Interests of all then-existing Members shall thereafter be adjusted pro rata to reflect the additional Capital Contribution(s) of the Member(s). In the event of any adjustments to the Percentage Interests of the Members under this Section 5.1(f)(i) , the Company shall amend Schedule A to reflect such adjustments and deliver a copy of such updated Schedule A to each Member. For clarity, if each Member makes an additional Capital Contribution under this Section 5.1(f)(i) in proportion to its Percentage Interest, then the Percentage Interests of the Members shall not be adjusted on account of such Capital Contributions.

(ii) Additional Capital Contributions, Generally: In addition, if the Board, acting in accordance with Section 5.1(c) , Section 7.1(f) and Section 7.2(e), at its sole discretion determines that it is necessary, desirable or in the best interests of the Venture, including if it is necessary for the Company to comply with its obligations under the ECC, the Board may from time to time solicit additional Capital Contributions from the Members and cause the Company to accept such additional Capital Contributions. In such event, each Member shall have the pro-rata opportunity to subscribe to the entire offered contribution, but not the obligation, to elect to participate in such capital raise on a proportionate basis and make additional Capital Contributions in proportion to its Percentage Interest by notifying the Board within fifteen (15) Business Days from the offer by the Company, of its interest to participate in such capital raise. If one or more Members notify the Board that they will make additional Capital Contributions under this Section 5.1(f)(ii) , and if each Member has not notified the Board that it will participate fully up to its Percentage Interest, then (A) any Members making additional Capital Contributions that did notify the Board of its intent to participate fully up to its Percentage Interest may elect to absorb, pro-rata, any portion of the solicited amount left over by other Members until such time as no Member is willing to participate further in the solicited capital raise or the entire capital raise is fulfilled, (B) the Board shall thereafter collect the additional Capital Contributions from the participating Members in accord with the final amounts established under clause (A), and (C) the Percentage Interests of all then-existing Members shall thereafter be adjusted pro rata to reflect the additional Capital Contribution(s) of the Member(s). In the event of any adjustments to the Percentage Interests of the Members under this Section 5.1(f)(ii) , the Company shall amend Schedule A to reflect such adjustments and deliver a copy of such updated Schedule A to each Member. For clarity, if each Member makes an additional Capital Contribution under this Section 5.1(f)(ii) in proportion to its Percentage Interest, then the Percentage Interests of the Members shall not be adjusted on account of such Capital Contributions.

(iii) Additional Capital Contributions, New Members: The Board, acting in accordance with Section 5.1(c) , Section 7.1(f) and Section 7.2(e) , from time to time may cause the Company to accept additional Capital Contributions and/or issue additional Membership Interests of an existing class or a new class to such other Persons, for such consideration (or no consideration), and with such terms and rights (including voting rights), and taking into account such factors (such as future contributions), as the Board, in its discretion, shall determine. Acting in accordance with Section 7.1(f) and Section 7.2(e) the Board from time to time may amend this Agreement to reflect the creation of any additional class of Membership Interests pursuant to this Section.

(iv) Each of Intrexon and Caraco agrees that, for so long as it is a Member and to the extent the Board solicits from Members additional Capital Contributions in

 

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accord with Section 5.1(f)(ii) , Intrexon and Caraco shall each be required to participate in each such capital raise by contributing, in accord with the procedures of Section 5.1(f)(ii) , its pro rata portion of the total amount solicited by Company. Notwithstanding the foregoing commitment, neither Intrexon nor Caraco shall be obligated by this Section 5.1(f)(iv) to contribute more than US$5 million in any calendar year and not more than US$25 million in aggregate, counting all prior additional Capital Contributions by the relevant Member under this Section 5.1 to date or within the present calendar year (as applicable). In the event the Board solicits under Section 5.1(f)(ii) more than the foregoing limits, the members shall have the opportunity to respond or not in accordance with Section 5.1(f)(ii) . Should either Intrexon or Caraco fail to satisfy its commitment under this Section 5.1(f)(iv) , the other member shall have the right, but not the obligation, to satisfy the portion of the solicitation not satisfied by the other.

(v) Unless agreed upon to the contrary by both Intrexon and Caraco, for the purposes of adjusting the Percentage Interests of the then-existing Members under Section 5.1(f)(i), 5.1(f)(ii) or 5.1(f)(f)(iv), the Percentage Interests of such then-existing Members shall be adjusted based on [*****]. For clarity, at any time after completion of the Initial Capital Contribution; the Percentage Interests of Intrexon and Caraco shall be, as between Intrexon and Caraco, based on [*****].

 

  5.2. Capital Accounts

The Company shall establish and maintain a separate Capital Account for each Member in accordance with Treasury Regulations Sections 1.704-1(b)(2)(iv) (a “ Capital Account ”). The provisions of this Agreement relating to the maintenance of Capital Accounts are intended to comply with Treasury Regulations Sections 1.704-1(b), and will be interpreted and applied in a manner consistent with such regulations. From time to time the Board may value the Company and restate the Members’ Capital Account balances to reflect such value in connection with the issuance of Membership Interests and other equity securities pursuant to this Agreement to the extent required or permitted by the Treasury Regulations. Any such adjustment shall be based on the fair market value of the Company’s assets as determined by the Board; provided , that no Company asset shall be valued at an amount less than any non-recourse indebtedness to which such Company asset is subject on the date of adjustment, and shall reflect the manner in which the unrealized income, gain, loss, or deduction inherent in such Company assets (that has not been reflected in a Capital Account previously) would be allocated among the Members if there were a taxable disposition of such Company assets for such fair market value on that date.

 

  5.3. Additional Capital Contributions; Negative Capital Accounts

Other than the Initial Capital Contributions, contributions that a Member has expressly agreed to make or as provided by the LLC Act, no Member shall be required to make any Capital Contributions to the Company or to pay to the Company or to the other Members any deficit or negative balance which may exist from time to time in such Member’s Capital Account.

 

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  5.4. Transfers of Membership Interests

In the event any Member transfers any Membership Interests in accordance with the Section 9 of this Agreement, the transferee shall succeed to the Capital Account and Capital Contributions of the transferor to the extent it relates to the transferred Membership Interest. Such a transferee shall execute a deed of adherence or other equivalent documentation or instrument to the satisfaction of the Company and the other Member for its compliance and agreement to the terms of this Agreement, the ECC, and applicable laws and regulations.

 

  5.5. No Interest on Capital Contributions or Capital Accounts

No Member shall be entitled to receive any interest on their Capital Contributions or their outstanding Capital Account balance.

 

  5.6. Advances to Company

A Member may advance funds to the Company in excess of the amounts the Member is required to contribute to the capital of the Company in any amount and on terms not less favorable to the Company than those generally prevailing with respect to comparable transactions between unrelated parties and are approved by the Members pursuant to Section 7.1(f) and the Board pursuant to Section 7.2(e) . Any such advances by a Member shall not result in any increase in the amount of such Member’s Capital Account or entitle it to any increase in its Membership Interest or the Percentage Interest represented by such Member’s Membership Interest. The amounts of such advances shall be a debt of the Company to such Member and shall be payable or collectible only out of the Company Assets in accordance terms and conditions agreed upon by such advancing Member and the Board, subject to Section 7.2(e) . All Members need to be offered a pro-rata opportunity to participate in loans made to the Company by one or more Members. However, it will not be an obligation on any Member to grant the advance as requested by the Company.

 

  5.7. Liability of Members

Except as otherwise provided in the LLC Act, the debts, obligations and liabilities of the Company, whether arising in contract, tort or otherwise, shall be solely the debts, obligations and liabilities of the Company, and none of the Members or Members of the Board shall be obligated personally for any such debt, obligation or liability of the Company solely by reason of being a Member or Board Member. The failure of the Company to observe any formalities or requirements relating to the exercise of its powers or management of its business or affairs under the LLC Act or this Agreement shall not be grounds for imposing personal liability on any Member or Board Member for liabilities of the Company.

 

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  5.8. Return of Capital

Except upon the dissolution of the Company or as may be specifically provided in this Agreement, no Member shall have the right to demand or to receive the return of all or any part of their Capital Account or Capital Contributions to the Company.

 

  6. ALLOCATION OF PROFITS AND LOSSES; DISTRIBUTIONS

 

  6.1. Allocation of Net Income or Net Loss

Subject to Section 6.4 , the net income or net loss of the Company (including all income, gain or loss as computed for federal income tax purposes), if any, for each Fiscal Year (or portion thereof) shall be allocated for both book and tax accounting purposes to the Members in accordance with their respective Percentage Interests.

 

  6.2. Allocation of Income and Loss With Respect to Membership Interests Transferred

If any Membership Interest is transferred during any Fiscal Year in accordance with this Agreement, the net income or net loss attributable to such Membership Interest for such Fiscal Year shall be allocated between the transferor and the transferee by closing the books of the Company as of the effective date of the transfer or such other method as the Board reasonably determines is appropriate.

 

  6.3. Distributions

(a) General . Subject to Section 7.1(f) and Section 7.2(e) , the Board shall determine the amount of cash and in-kind property available for distribution by the Company to the Members for each Fiscal Year. Except as provided in Section 6.3(b) and Section 10.4 , all distributions to the Members shall be made in accordance with their respective Percentage Interests. For the avoidance of doubt, payments to Intrexon under the ECC and payments to any Member for services provided to the Company under the Services Agreements or this Agreement shall not constitute distributions of Distributable Cash Flow or other Company Assets for purposes of this Section 6.3 .

(b) Tax Distributions . Subject to any restrictions or covenants contained in any loan agreements (including agreements for any Member Loans) or other debt instruments or agreements to which the Company is then a party, the Board shall cause the Company to make distributions of Distributable Cash Flow to the Members pursuant to Section 6.3(a) in respect of each Fiscal Year, in cash, in amounts such that each Member receives an aggregate amount of distributions at least equal to the sum of the products obtained by multiplying (i) the amount of each item of taxable income or gain of the Company for such period (excluding items of income or gain realized as a result of any sale of the Company) allocated to the Member pursuant to this Agreement (an “ Allocable Income Item ”), reduced by any offsetting items of loss or deduction (of the same character) of the Company allocated to such Member pursuant to this Agreement for the current and all prior periods to the extent not previously taken into account under this provision, by (ii) the highest combined marginal rate of tax applicable to any Member (or in the case of any Member that is a pass-through entity for tax

 

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purposes, any person who is liable for tax with respect to such Allocable Income Item) with respect to such Allocable Income Item, taking into account its character and all applicable federal, state, provincial, local and municipal taxes (the amount to be distributed to each Member pursuant to this provision is referred to as the “ Tax Distribution Amount ”), as determined by the Board in good faith in consultation with the accounting firm that prepares the federal income tax information return (Form 1065) of the Company for such Fiscal Year. In the event the amount of Distributable Cash Flow that may be distributed pursuant to Section 6.3(a) with respect to a Fiscal Year is less than the Members’ aggregate Tax Distribution Amounts, distributions shall be made pursuant to this provision only to the extent of the Distributable Cash Flow that may be distributed and the shortfall shall not constitute a debt or other liability of the Company to the Members; provided, however, that such shortfall shall be paid if and to the extent the Company has Distributable Cash Flow in a subsequent Fiscal Year. The Company shall distribute the Tax Distribution Amounts to the Members with respect to any Fiscal Year as soon as practical after the end of such Fiscal Year but not later than April 10 of the following Fiscal Year. All tax distributions to the Members shall be made in proportion to their respective Percentage Interests.

 

  6.4. Allocations Required by Tax Regulations

(a) Allocation of Nonrecourse Deductions . Notwithstanding any other provision of this Agreement, (i) “partner nonrecourse deductions” (as defined in Treasury Regulations Section 1.704-2(i)), if any, of the Company shall be allocated to the Member which bears the economic risk of loss within the meaning of Treasury Regulations Section 1.704-2(i), and (ii) “nonrecourse deductions” (as defined in Treasury Regulations Section 1.704-2(b)) of the Company shall be allocated to the Members in accordance with their Percentage Interests.

(b) Allocations in Accordance with Section 704(b) . This Agreement shall be deemed to include “qualified income offset,” “minimum gain chargeback” and “partner nonrecourse debt minimum gain chargeback” provisions within the meaning of the Treasury Regulations under Section 704(b) of the Code. Accordingly, notwithstanding any other provision of this Agreement, items of gross income shall be allocated to the Members on a priority basis to the extent and in the manner required by such provisions. In addition, if the amount of net loss for any Fiscal Year that otherwise would be allocated to a Member under Section 6.1 would cause or increase an Adjusted Capital Account Deficit of such Member as of the last day of such Fiscal Year (after all other allocations have been made pursuant to this Section 6 ), then such Member shall be allocated that amount of net loss (or items of loss and expense) which does not cause or increase such Adjusted Capital Account Deficit, and the remainder of such net loss (or items of loss and expense) that would have been allocated to such Member shall be allocated to the other Members (to the extent it would not cause or increase an Adjusted Capital Account Deficit for a Member). Any allocations required to be made pursuant to this Section 6.4(b) (the “ Regulatory Allocations ”) shall be offset, to the extent possible, by special allocations of other items of Company income, gain, loss, or deduction pursuant to this Section 6.4(b) , so that, after such special offsetting allocations have been made, each Member’s Capital Account balance will be equal to the Capital Account balance such Member would have had if the Regulatory Allocations had not been made.

 

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  7. MANAGEMENT

 

  7.1. Members

(a) Participation . Unless otherwise classified as Nonvoting Interests in accordance with this Agreement, all Membership Interests shall be considered Voting Interests and shall entitle the Members holding such Voting Interests to participate in all matters to be decided by Members and all meetings of Members pursuant to this Agreement and the LLC Act. Except as otherwise expressly provided in this Agreement, Nonvoting Interests shall be nonvoting for all purposes and Members owning only Nonvoting Interests shall have no rights to vote on, consent to, participate in the consideration of, or approve any action or matter that the Members are required or permitted to vote on, consent to, participate in the consideration of, or approve under this Agreement or the LLC Act. References in this Section 7 to “Members” shall mean only Members holding Voting Interests and shall exclude Members holding only Interests classified as Nonvoting Interests. All Voting Interests shall entitle the Members holding such Voting Interests to participate in all matters to be decided by Members and all meetings of Members pursuant to this Agreement and the LLC Act.

(b) Meetings . Members need not hold annual meetings. Special meetings of the Members holding Voting Interests shall be held at the discretion of the Board or the written request of any one or more Members with Voting Interests representing at least twenty percent (20%) of the Member Votes, at such time and location, reasonably selected to maximize participation amongst all Members, as may be fixed by the Board for the transaction of such lawful business as may come before the meeting. Meetings of Members may be held by telephone or any other communications equipment by means of which all participating Members can simultaneously speak with and hear each other during the meeting.

(c) Voting Rights; Vote Required . On any matter presented to the Members for a vote, consent, consideration or approval, each Member holding Voting Interests shall be entitled to cast that number of votes equal to their Percentage Interest multiplied by 100. Except as otherwise expressly provided in this Agreement, any action required or permitted to be taken by the Members must be approved by the affirmative vote or consent of Members holding Voting Interests representing a Majority of the Voting Interests.

(d) Waiver of Notice . Whenever the giving of any notice to Members is required by statute or this Agreement, a waiver thereof, in writing and delivered to the Company signed by the Person or Persons entitled to said notice, whether before or after the event as to which such notice is required, shall be deemed equivalent to notice. Attendance of a Member at a meeting or execution of a written consent to any action shall constitute a waiver of notice of such meeting or action. Notwithstanding the foregoing, a Member’s attendance at a meeting shall not constitute a waiver of notice hereunder if the Member’s sole purpose in attending the meeting is to protest the failure to provide notice or other procedural defect.

(e) Action By Written Consent . Any action that may be taken by the Members under this Agreement may be taken without a meeting if consents in writing setting forth the action so taken are signed by Members who own, collectively, Voting Interests representing at least the minimum number of Member Votes that would be required to take such

 

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action if such action were taken by the Members at a meeting at which all Members were present, and delivered to the Company. All Members entitled to participate in such action but who do not participate in the written consent shall be given written notice thereof by the Company promptly after such action has been taken.

(f) Required Member Votes . Notwithstanding anything contained in this Agreement to the contrary, the Company shall not and shall not permit any subsidiary to, either directly or indirectly (by amendment, merger, consolidation, recapitalization, consolidation or otherwise), in a single transaction or in a series of related transactions, without (in addition to any other vote required by law or this Agreement) first obtaining the approval by affirmative vote or written consent of Members holding at two-thirds (2/3) of the Member Votes (each, a “ Major Decision ”):

(i) sell, lease, license, assign, transfer or otherwise dispose of all, or a substantial portion of, the assets or ownership of the Company or any subsidiary, or approve the consolidation, merger, recapitalization, incorporation or similar transaction of or involving the Company or any subsidiary;

(ii) acquire, transfer, or license assets, including any license of intellectual property, outside the ordinary course of business exceeding in the aggregate a value of five hundred thousand United States dollars ($500,000), unless approved by the Board (including, at such time and for so long as Intrexon and Caraco have the right to appoint Intrexon Designees and Caraco Designees, at least one Intrexon Designee and at least one Caraco Designee);

(iii) admit a new Member, or issue one or more additional classes of Membership Interests to new members;

(iv) issue one or more additional classes of Membership Interests to existing Members; other than those issued in compliance with requirements of Section 5.1(f)(i) ;

(v) redeem, purchase or otherwise acquire any Membership Interest, in whole or in part;

(vi) approve any transfer of a Membership Interest to a third party, unless approved by the Board (including, at such time and for so long as Intrexon and Caraco have the right to appoint Intrexon Designees and Caraco Designees, at least one Intrexon Designee and at least one Caraco Designee);

(vii) permit the Company or any subsidiary to enter into any credit facility, incur any indebtedness for borrowed money, guarantee the indebtedness of any Person, or any other encumbrance or make any loans over $50,000 with respect to a single transaction or over $150,000 with respect to a series of transactions;

(viii) approve the liquidation, dissolution or winding up of the Company or any subsidiary, or declare bankruptcy of the Company or any subsidiary;

 

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(ix) convert the Company to any other form of business;

(x) approve distributions pursuant to Section 6.3(a) to any Member with respect to any Fiscal Year in excess of the Tax Distribution Amounts for such Fiscal Year;

(xi) approve the terms of any transactions described in Section 7.8 or enter into any agreement providing therefor, except for the ECC and any documents or transactions contemplated thereby;

(xii) increase or decrease the authorized number of Board Members constituting the Board;

(xiii) issue Membership Interests or other forms of equity or instruments convertible into or exerciseable for equity in the Company to the Company’s officers or employees;

(xiv) make any appointment of, or change in the appointment of, the Company’s independent auditor;

(xv) enter into a transaction with any Member or its Affiliates, officer or employee of the Company;

(xvi) make any amendment or change to the terms of the ECC Agreement;

(xvii) make any amendment or change to charter documents of the Company;

(xviii) except as expressly permitted hereunder, amend, modify, repeal, or waive any provision of this Agreement;

(xix) incorporate or subscribe to shares or other securities of any other company or subsidiary; and

(xx) create a charge, lein or otherwise encumbrance on any of the assets of the Company exceeding in the aggregate a value of fifty thousand United States dollars ($50,000).

 

  7.2. Management of the Company by the Board

(a) Management by Board . Except for matters expressly reserved to the Members under this Agreement or the LLC Act or otherwise restricted under this Agreement, responsibility for management of the business and affairs of the Company shall be delegated to and vested in a board of managers (the “ Board ”) pursuant to Section 18-402 of the LLC Act. The Board shall have all of the authority of a “manager” under the LLC Act, and, except to the extent expressly provided for in this Agreement or the LLC Act or otherwise restricted under this Agreement, no Member shall have any authority, right or power, by virtue of being a Member, to

 

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bind the Company, or to manage or control, or to participate in the management or control of, the business and affairs of the Company in any manner whatsoever. Except for matters expressly reserved to the Members under this Agreement or the LLC Act, the Board shall have full and complete authority, power and discretion to manage and control the business and affairs of the Company, to make all decisions with respect thereto and to perform any and all other acts or activities customary or incident to the management of the Company’s business and affairs. The Board (acting on behalf of the Company) shall have the right, power and authority, in the management of the business and affairs of the Company, to do or cause to be done any and all acts, at the expense of the Company, deemed by the Board to be necessary or appropriate to effectuate the purposes of the Company, including the power and authority on behalf of the Company:

(i) to develop, review and approve annual budgets, policies, operating guidelines and other operational items for the Company;

(ii) to arrange for the engagement of such personnel and agents of the Company as may be necessary or convenient to carry out the business and affairs of the Company, and to adopt plans for the compensation of such personnel and agents;

(iii) to establish such reasonable cash reserves to provide for anticipated expenses of the Company as the Board determines to be necessary for timely payment of such expenses; and

(iv) to authorize, approve, make, execute, assign, acknowledge and file on behalf of the Company any and all agreements, documents or instruments of any kind which the Board may deem necessary or appropriate in carrying out the business and affairs of the Company, and no Person dealing with the Board shall be required to determine or inquire into the authority or power of the Board to bind the Company.

(v) to authorize on behalf of the Company, issue of Membership Interests in accordance with the requirements of Section 5.1(f)(i) .

Except for the Program Manager as set forth in Section 7.3(a) and as may be approved by the Members or the Board, no Board Member, acting individually, shall have any authority, right or power, by virtue of being a Board Member, to bind the Company. The Board Members shall devote such time to the management of the business and affairs of the Company as they determine to be reasonably necessary.

(b) Size and Constitution of Board . The Board shall consist of four (4) Board Members, who shall be appointed in accordance with Section 7.2(c) . Any vacancy in the Board resulting from the death, disability, retirement, resignation or removal of any Board Member shall be filled in the manner provided for in Section 7.2(c) .

(c) Composition of Board .

(i) At such time and for so long as Intrexon and any of its Affiliates is a Member and holds a Percentage Interest in excess of [*****], (A) Intrexon shall be entitled to appoint two (2) individuals (the “ Intrexon Designees ”) as Board

 

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Members in accordance with this Section 7.2(c)(i) ; (B) in the event of the death, disability, retirement, resignation or removal of any Intrexon Designee, Intrexon shall have the sole and exclusive right to appoint an individual to fill the Board seat formerly occupied by such Intrexon Designee; and (C) any Intrexon Designee may be removed from the Board, with or without cause, solely by Intrexon. The initial Intrexon Designees, who have been appointed as of the Effective Date, shall be intimated by Intrexon to the JV (with a copy to Caraco) within seven (7) Business Days from Effective Date.

(ii) At such time and for so long as Caraco and any of its Affiliates is a Member and holds a Percentage Interest in excess of [*****], (A) Caraco shall be entitled to appoint two (2) individuals (the “ Caraco Designees ”) as Board Members in accordance with this Section 7.2(c)(ii) ; (B) in the event of the death, disability, retirement, resignation or removal of any Caraco Designee, Caraco shall have the sole and exclusive right to appoint an individual to fill the Board seat formerly occupied by such Caraco Designee; and (C) any Caraco Designee may be removed from the Board, with or without cause, solely by Caraco. The initial Caraco Designees, who have been appointed as of the Effective Date, shall be intimated by Caraco to the JV (with a copy to Intrexon) within seven (7) Business Days from Effective Date.

(iii) In the event that Intrexon and Caraco do not have the right to appoint four (4) Board Members pursuant to the provisions of Sections 7.2(c)(i)-(ii)  above, the applicable provisions of such Sections shall continue to apply, and the remaining Board Members shall be elected by Members holding a Majority of the Voting Interests.

(iv) The Program Manager, or in the absence of a Program Manager, a Board Member elected by the Board, shall serve as Board Chair. The Board Chair (to the extent that such Board Chair is a Board Member) shall have no additional voting rights beyond those held by any other Board Member and shall not be able to break ties. However, solely in consideration of transacting business by the Board in accordance with the requirements of Section 5.1(f)(i), in the event the members of the Board are unable to reach a majority conclusion, the Board Members as appointed by Caraco collectively shall have a single additional vote that they may collectively cast to ultimately decide and break ties.

(d) Meetings . Meetings of the Board shall be held at such places within or outside the State of Delaware and at such dates and times as may be fixed from time to time by the Program Manager or by majority vote of the Board. Without limiting the generality of the foregoing, meetings of the Board shall be held at least on a quarterly basis. Notice of any meeting of the Board may be given orally in person or in writing or by mail, telephone, telegram, facsimile, electronic mail or other means of electronic transmission at least five (5) Business Days prior to the time of commencement of such meeting. No notice of any meeting of the Board need be given to any Board Member if such Board Member, by a writing (including a writing by facsimile or electronic mail) filed with the records of the meeting (and whether executed before or after such meeting), waives such notice, or if such Board Member attends such meeting without protesting prior thereto or at its commencement the lack of notice to such Board Member. Meetings of the Board or any committee thereof may be held by conference telephone or other communications equipment by means of which all participating Board Members can hear and speak to each other during the meeting. The Board may adopt rules and

 

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procedures consistent with the terms of this Agreement for meeting and conducting its business. The Program Manager shall furnish to all Board Members prior to each meeting of the Board and at such other times as any Board Member shall request copies of such books, records, accounts and other information of or relating to the Company and its business and affairs as any Board Member shall require, in the reasonable judgment of such Board Member, to discharge fully its duties and responsibilities as a Board Member.

(e) Quorum . For so long as each of Caraco and Intrexon have the right to appoint Board Members pursuant to the provisions of Sections 7.2(c)(i)-(ii) , attendance of at least two Board Members, including at least one Intrexon Designee and at least one Caraco Designee, shall constitute a quorum for the transaction of any business, but if upon a call of a meeting a quorum is not present, any Board Member present may adjourn from time to time until a quorum shall be present. However, solely in the event of any meeting convened specifically for transacting business under Section 5.1 (f)(i), if a quorum as set forth above in this Section 7.2(e) is not present, such a meeting shall be automatically adjourned and set to reconvene on the earliest Business Day falling 7 (Seven) days after the date of the original adjourned meeting. In the event that a quorum is also not present at such reconvened meeting, the Board Members present shall constitute a quorum for the sole purposes of transacting business under Section 5.1 (f)(i).(f) Voting Rights; Major Decisions . Each Board Member shall be entitled to participate and to cast one vote with respect to any matter before the Board. Any action required or permitted to be taken by the Board must be approved by the affirmative vote or consent of a majority of the Board Members then serving; provided , however , that each Major Decision shall require the approval of a majority of the Board Members then serving including at least one Intrexon Designee and at least one Caraco Designee.

(g) Action by Written Consent . Any action that may be taken by the Board under this Agreement may be taken without a meeting, without a vote and without prior notice, if a written consent or consents, including consents by facsimile and electronic mail, setting forth the action so taken are signed by the minimum number of Board Members who would be required to take such action if such action were taken by the Board at a meeting at which all Board Members were present. The Board shall ensure the recording of minutes of all meetings that have taken place, and will therein accurately describe all material matters that have been so reviewed and/or so decided.

(h) Expenses . The Board may authorize the payment to Board Members of expenses of attendance, if any, at each regular or special meeting of the Board attended by such Board Members.

(i) Resignation . Any Board Member may resign at any time by giving written notice to the Board. Any such resignation shall take effect at the time specified therein, or, if no time is specified, upon receipt thereof; and unless otherwise specified therein, acceptance of such resignation shall not be necessary to make it effective.

(j) Committees . The Board shall have the power and authority to constitute and dissolve one or more committees of the Board, including an audit committee and a compensation committee, to determine the duties, responsibilities and operating procedures for any such committee, and to appoint and remove the members of any such committee. Each

 

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committee of the Board may determine the procedural rules for meeting and conducting its business and shall act in accordance therewith, provided , however , that each committee shall keep minutes of its meetings and report its proceedings to the Board as and when required by the Board. Notwithstanding anything herein to the contrary, no such committee shall have any power or authority greater than that of the Board and no committee shall be authorized to approve or take any action that would constitute a Major Decision.

 

  7.3. Officers

(a) Initial Officers; Program Manager . Initially, the Company shall have one officer, a Program Manager, who shall be a Board Member. Subject to Section 7.10(c) and Section 7.10(d) , the Program Manager shall have all the duties and authority to act on behalf of the Company as a President and Chief Executive Officer of a Delaware corporation. The Program Manager shall have overall responsibility and authority for the Company’s business operations and financial affairs, subject to the oversight of the Board. A Program Manager shall serve in such office until such time as the Board determines to replace the Program Manager with one or more officers who are not Board Members. For such time and so long as Intrexon and Caraco have the right to appoint Intrexon Designees and Caraco Designees, such Board determination shall require the consent or affirmative vote of a majority of the Board including at least one Intrexon Designee and at least one Caraco Designee. Except as provided in this Section 7.3(a) , each Program Manager shall serve for an annual term. The right to appoint the Program Manager shall alternate between Intrexon and Caraco; provided , that (a) each Program Manager designated by a Member shall be reasonably acceptable to the other Members (such acceptance not to be unreasonably withheld or delayed) and (b) the initial Program Manager shall be designated by Caraco and shall serve until the first anniversary of the Effective Date, or until such later date as may be mutually agreed by the Members. The Program Manager shall hold such office until his or her death, disability, retirement, resignation or removal from such officer. The initial Program Manager, who has been designated and appointed as of the Effective Date in accordance with this Section 7.3(a) , shall be intimated by Caraco to the JV (with a copy to Intrexon) within seven (7) Business Days from Effective Date.

(b) Authority to Appoint and Remove; Additional Officers . Subject to Section 7.10(c) and Section 7.10(d) the Board shall have the power and authority to appoint from time to time one or more individuals to serve as officers and agents of the Company and/or any subsidiary of the Company, with such titles, duties and authority as the Board shall approve, to carry out the business of the Company and any such subsidiary upon such terms and conditions as the Board shall determine; provided , that for such time and so long as Intrexon and Caraco have the right to appoint Intrexon Designees and Caraco Designees, a decision to hire fulltime executive officers, or otherwise appoint a President or Chief Executive Officer, shall require the consent or affirmative vote of a majority of the Board including at least one Intrexon Designee and at least one Caraco Designee. Any number of offices may be held by the same person. Any such officer or agent shall hold office until the death, disability, retirement, resignation or removal of such officer or agent.

(c) Authority of Officers . Unless otherwise specified by the Board or this Agreement, the duties (including fiduciary duties) and authority to act on behalf of the Company of an officer of the Company shall include the same duties and authority to act on

 

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behalf of a Delaware corporation as an officer of a Delaware corporation with the same title would have under the Delaware General Corporation Law in the absence of a specific delegation of authority. Without limiting the foregoing, the President or Chief Executive Officer shall have overall responsibility and authority for the Company’s business operations and financial affairs, subject to the oversight of the Board. All other officers and all employees and agents shall report directly or indirectly to the President or Chief Executive Officer. Subject to guidelines and policies as may be approved by the Board, the President or Chief Executive Officer may execute agreements and contracts on behalf of the Company. In the event the President or Chief Executive Officer are unable to agree on any matter, he or she shall refer it to the Board for resolution.

(d) Resignation . Unless otherwise agreed-upon in the written terms of his\her appointment, any officer or agent of the Company may resign at any time by giving written notice to the Board. Any such resignation shall take effect at the time specified therein or, if no time is specified, upon receipt thereof, and unless otherwise specified therein, acceptance of such resignation shall not be necessary to make it effective.

(e) Removal; Vacancies; Transfer of Duties . Any officer of the Company may be removed from office, with or without cause, by the Board. The power and duties of any officer may be transferred in whole or in part by the Board to any other officer or other individual, notwithstanding the other provisions of this Agreement.

(f) Third Party Reliance . Third parties dealing with the Company shall be entitled to rely conclusively upon the power and authority of the officers of the Company as set forth herein.

 

  7.4. Fiduciary Relationship

Board Members and officers of the Company shall owe fiduciary duties to the Company and its Members to the same extent as the fiduciary duties owed by members of the board of directors and officers of a Delaware corporation to the corporation and its stockholders, subject to the other provisions of this Agreement. For clarity, actions taken by Intrexon Designees in their respective capacity as fiduciary Board Members do not reflect the position of Intrexon or otherwise bind Intrexon, and actions taken by Caraco Designees in their respective capacity as fiduciary Board Members does not reflect the position of Caraco or otherwise bind Caraco. To the extent that the official position of Caraco on an issue differs from or is contrary to the vote or position of a Caraco Designee acting in their official fiduciary capacity as a Board Member, Caraco shall be required to notify Company and Intrexon as soon as practicable after learning of said differing or contrary vote or position. To the extent that the official position of Intrexon on an issue differs from or is contrary to the vote or position of an Intrexon Designee acting in their official fiduciary capacity as a Board Member, Intrexon shall be required to notify Company and Caraco as soon as practicable after learning of said differing or contrary vote or position.

 

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  7.5. Reimbursement

The Company shall be solely responsible for paying all reasonable expenses associated with the administration, operation, and business of the Company and its operations, including legal, accounting, and other third-party expenses to the extent such expenses are related to the administration of the Company or its operations. The Members, Board Members, and officers shall be entitled to reimbursement from the Company for reasonable expenses incurred by them that are attributable to the organization, operation, and management of the Company, prior to making any distributions to the Members.

 

  7.6. Other Activities of Members, Board Members and Related Parties; Company Opportunities; Exclusivity

As long as its activities are otherwise consistent with this Agreement, any Member or Board Member or any related party thereof may have other business interests or may engage in other business ventures of any nature or description whatsoever, whether currently existing or hereafter created, and the doctrine of corporate opportunity, or any analogous doctrine, shall not apply to any such person. Except as specifically provided herein, no Member, Board Member, or related party thereof shall incur any liability to the Company as a result of such Member’s, Board Member’s, or related party’s pursuit of such other permitted business interests, ventures and competitive activities, and neither the Company nor the other Members shall have any right to participate in such other permitted business ventures or to receive or share in any income or profits derived therefrom. Notwithstanding the foregoing or anything else in this Agreement to the contrary, none of the Company, Intrexon, or Caraco, nor their Parents or Subsidiaries, shall pursue (either directly or indirectly, by itself or with a third party or Affiliate) utilization of any synthetic biology platform for the development or commercialization of any product (other than a Generic Drug Product of a third party product) for purpose of commercial use or sale in the Field, outside the Venture. In the event Caraco or any of its Affiliates acquires a third party entity or assets that, prior to acquisition by Caraco or any of its Affiliates, is in the business of utilization of any synthetic biology platform for the development or commercialization of products for purpose of commercial use or sale in the Field, it shall not be a violation for such acquired third party entity or asset to continue its business independently of Caraco or its Parents or Subsidiaries if the primary purpose of such acquisition by Caraco or its Affiliates is unrelated to the acquired third party’s activities with respect to the Field.

 

  7.7. Indemnification of the Members, Board Members, Officers, and Others

(a) In accordance with Section 18-108 of the LLC Act, the Company shall indemnify and hold harmless any Member, Board Member, officer, agent of the Company, or Affiliate thereof (individually, in each case, an “ Indemnitee ”) to the fullest extent permitted by law from and against any and all losses, claims, demands, costs, damages, liabilities (joint or several), expenses of any nature (including attorneys’ fees and disbursements), judgments, fines, settlements, and other amounts arising from any and all claims, demands, actions, suits, or proceedings, whether civil, criminal, administrative or investigative, in which the Indemnitee may be involved, or threatened to be involved, as a party or otherwise, arising out of or incidental to the business or activities of or relating to the Company, regardless of whether the Indemnitee continues to be a Member, Board Member, officer, agent, or Affiliate thereof at the time any such liability or expense is paid or incurred; provided , however , that this provision shall

 

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not eliminate or limit the liability of an Indemnitee (i) for any breach of the Indemnitee’s duty of loyalty to the Company or its Members, (ii) for acts or omissions which involve intentional misconduct or a knowing violation of law, (iii) for any transaction from which the Indemnitee received any personal benefit inconsistent with this Agreement or any authorization of the Board, (iv) for any knowing violations of this Agreement, or (v) for any act for which indemnification would not be permitted for an officer or director of a Delaware corporation; and provided further , that notwithstanding this Section 7.7 , no Board Member who is a designee of a Member shall be entitled to any form of indemnification by the Company with respect to claims arising out of a breach of such Board Member’s fiduciary duties to the Company or to a Member other than the designating Member.

(b) Expenses incurred by an Indemnitee in defending any claim, demand, action, suit, or proceeding subject to this Section 7.7 shall, from time to time, upon request by the Indemnitee be advanced by the Company prior to the final disposition of such claim, demand, action, suit, or proceeding upon receipt by the Company of an undertaking by or on behalf of the Indemnitee to repay such amount if it shall be determined in a judicial proceeding or a binding arbitration that such Indemnitee is not entitled to be indemnified as authorized in this Section 7.7 .

(c) The indemnification provided by this Section 7.7 shall be in addition to any other rights to which an Indemnitee may be entitled under any agreement, vote of the Members, as a matter of law or equity, or otherwise, both as to an action in the Indemnitee’s capacity as a Member, a Board Member, an officer, or any Affiliate thereof, and as to an action in another capacity, and shall continue as to an Indemnitee who has ceased to serve in such capacity and shall inure to the benefit of the heirs, successors, assigns, and administrators of the Indemnitee.

(d) The Company may purchase and maintain insurance on behalf of the Board and such other Persons as the Board shall determine against any liability that may be asserted against or expense that may be incurred by such Persons in connection with the offering of interests in the Company or the business or activities of the Company, regardless of whether the Company would have the power to indemnify such Persons against such liability under the provisions of this Agreement.

(e) The provisions of this Section 7.7 are for the benefit of the Indemnitees, their heirs, successors, assigns and administrators and shall not be deemed to create any rights for the benefit of any other Persons.

 

  7.8. Certain Transactions

Subject to compliance with provisions of 7.1 (f), the Company is expressly permitted in the normal course of its business to enter into transactions with any or all Members or with any related party of any or all Members provided that the price and other terms of such transactions are not less favorable to the Company than those generally prevailing with respect to comparable transactions between unrelated parties and are approved by the Board. Without limiting the foregoing, it is expected that Intrexon and Caraco will provide certain services to the Company for management and administration. The terms for such services shall be set forth in

 

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separate Services Agreements between the Company and each such Member, which will specify the services to be provided, the compensation for such services, and the payment terms. The Services Agreements shall be in a form or forms approved by the Board and the Member providing services, in its sole discretion.

 

  7.9. Appointment of Company Representatives to ECC Committees

For so long as Caraco and\or any of its Affiliates is a Member and holds a Percentage Interest that is higher than or at least equal to the Percentage Interest held by Intrexon and\or its Affiliates, then Caraco will have the sole authority to select and appoint on behalf of Company each of the persons that shall serve as representatives of Company on all committees authorized and established under Section 2.2 or otherwise under the ECC. For so long as Caraco and\or any of its Affiliates is a Member and holds a Percentage Interest of less than that of Intrexon and\or its Affiliates but at least twenty five percent (25%), then Caraco will have the sole authority to select and appoint on behalf of Company one person who shall serve as one of the representatives of Company on each committee authorized and established under Section 2.2 or otherwise under the ECC. The representatives of Company appointed by Caraco under the power of this Section 7.9 may include employees of Caraco and\or its Affiliates (to the extent such employees are contractually bound to their employer consistent with the obligations imposed upon Company with respect to its employees under Section 6.1(e) of the ECC), and, to the extent such agree in writing to be bound to the terms of the ECC with respect to the treatment and ownership of confidential information and inventions under the ECC, contractors, advisors and other agents of Caraco or any of its Affiliates without regard to the limitations of Section 2.2 of the ECC concerning.

 

  7.10. Additional ECC Related Rights and Obligations of Members

(a) For so long as Caraco and\or any of its Affiliates is a Member and holds a Percentage Interest that is higher than or at least equal to the Percentage Interest held by Intrexon and\or its Affiliates, this Section 7.10 will apply.

(b) Intrexon will send to Caraco a simultaneous courtesy copy of any notices it sends to Company under Section 4.3 of the ECC or other clauses of the of the ECC, such courtesy copy being sent to Caraco at the address set forth in the Schedule A attached hereto.

(c) One of Caraco’s appointees to the committees under Article 2 of the ECC shall be deemed to be the “Empowered Representative” (as that term is defined in the ECC) of the Company and shall be solely permitted to finally resolve any disputes, ties and\or deadlocks for which Section 2.4 of the ECC or other clauses of the ECC grants such authority to the Executive Officer of the Company.

(d) Any disputes between Intrexon and Company arising under or relating to the ECC to be resolved by and between Intrexon and Company under Article 11 of the ECC, and all references to powers, actions and rights of the Company in Article 11 for purposes of such dispute resolution shall be deemed to refer to Caraco and be available solely to Caraco. However, for clarity, any liability, claim, settlement, obligation, or indemnity arising under the ECC by and between Intrexon and Company shall continue to be attributable to and borne by the Company.

 

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(e) Company, or Caraco on behalf of Company, may satisfy the information and reporting requirements of Section 4.3 of the ECC by providing any requisite materials (including summaries, reports, plans, regulatory documents and data, or other applicable documentation) to employees of Intrexon through the regular course of the operations of Company so long as such Intrexon representatives would not be prevented, by fiduciary duties, confidentiality obligations, or otherwise by operation of this Agreement or applicable laws and regulations, from disclosing such materials to Intrexon for Intrexon’s use in accord with the ECC. For clarity, this Section 7.10(e) does not release Intrexon or Company from their respective obligations to attend committee meetings and manage collaborative activities under the ECC through committees in accord with Article 2 of the ECC.

(f) Subject to Section 7.4 of this Agreement, Intrexon shall use reasonable efforts to, when practicable, consistent with Intrexon’s fiduciary obligations, and not prejudicial to Intrexon’s rights under the ECC, cooperate with Caraco to establish procedures and protocols for addressing redundant reporting, meeting, voting and other compliance obligations of Caraco and Company created by the simultaneous operation of this Agreement and the ECC.

(g) At the written request of Caraco, any specific direction, request, notice, consent, approval or other action of the Company under the ECC shall require the approval of the Board.

(h) Subject to Section 7.4 of this Agreement, it shall be considered that Intrexon has provided a deemed approval as a Member to any matter under consideration under this Agreement in the event that substantially the same matter has been officially approved by Intrexon under Article 2 of the ECC Agreement.

 

  7.11. Recovery

For so long as Intrexon holds a Percentage Interest as a Member, Intrexon waives any rights it may have under Section 6.3(f) of the ECC to receive any payment from Company on the basis of treating a “Recovery” (as that term is defined in the ECC) as Net Sales.

 

  7.12. Compliance with ECC

Although not a party to the ECC, Caraco is and its Affiliates are given certain information rights under the ECC to receive information directly from Intrexon. Solely to the extent it receives such information, Caraco agrees that Caraco and its Affiliates shall be bound to comply with all provisions of the ECC relating to use of such information pertaining to identification, ownership and use of confidential information and intellectual property of Intrexon, including without limitation Section 4.3(e) and Articles 6 and 7 of the ECC, as if Caraco was Company under the ECC.

 

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  8. BANK ACCOUNTS; BOOKS AND RECORDS; STATEMENTS; FISCAL YEAR

 

  8.1. Bank Accounts

All funds of the Company shall be deposited in its name in such checking and savings accounts, time deposits or certificates of deposit, or other accounts at such banks as shall be designated by the Board from time to time.

 

  8.2. Books and Records

The Company shall maintain, or cause to be maintained, accurate, full and complete books and accounts showing assets, liabilities, income, operations, transactions and the financial condition of the Company. Any Member, or its respective designee, shall have reasonable access to the books and records of the Company at any reasonable time during regular business hours and shall have the right to copy said records at its expense. Unless otherwise designated by the Board from time to time, Intrexon shall maintain such books and accounts and Intrexon shall be reimbursed for its reasonable documented costs of maintaining the Company’s books and records.

 

  8.3. Reports and Information

The Company shall provide to the Members such reports and information concerning the business and affairs of the Company as the Members may request or as may be required by the LLC Act or by any other law or regulation of any regulatory body applicable to the Company.

 

  8.4. Accounting Decisions

All decisions as to accounting matters, except as specifically provided to the contrary herein, shall be made by the Board.

 

  8.5. Tax Returns

(a) The Board shall, at the expense of the Company, cause to be prepared and delivered to the Members, in a timely fashion after the end of each Fiscal Year, copies of all federal and state income tax returns for the Company for such Fiscal Year, one copy of which shall be filed by the Board. Intrexon shall be the “tax matters partner” (as defined in the Code) of the Company and is authorized and required to represent the Company (at the expense of the Company) in connection with all examinations of the affairs of the Company by any federal, state, or local tax authorities, including any resulting administrative and judicial proceedings, and to expend funds of the Company for professional services and costs associated therewith.

(b) The Board shall keep all Members informed of the progress of any such examination, audit or other proceeding, and any Member with a Percentage Interest of at least [*****] (and any person that was a Member with a Percentage Interest of at least [*****] in the Fiscal Year to which such examination, audit or other

 

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proceeding relates) shall have the right to participate in such examination, audit or other proceeding. Each Member and former Member agrees to cooperate with the Board and to do or refrain from doing any or all things reasonably required by the Board in connection with the conduct of such proceedings.

 

  8.6. Fiscal Year

Unless the Board determines otherwise, the fiscal year of the Company for financial, accounting, federal, state and local income tax purposes shall end on March 31 (the “ Fiscal Year ”).

 

  8.7. Confidentiality of Information

(a) Each Member agrees not to use Confidential Information (as hereinafter defined) of the Company for its own use or for any purpose except in connection with its interest in the Company. Each Member shall undertake to treat such Confidential Information in a manner consistent with the treatment of its own information of such proprietary nature and agrees that it shall protect the confidentiality of and use reasonable best efforts to prevent disclosure of the Confidential Information to prevent it from falling into the public domain or the possession of unauthorized persons. Each transferee of any Member who receives Confidential Information shall agree to be bound by such provisions. For purposes of this Section, “ Confidential Information ” means any information, technical data, or know-how, including, but not limited to, the Company’s research, clients, products, services, business plans, budgets, inventions, processes, designs, drawings, engineering, marketing, or finances, whether owned or controlled by the Company or generated on its behalf, that is disclosed by the Company, whether in writing or orally, that is understood at the time of its disclosure to be proprietary and/or confidential, except as provided in Section 8.7(b) .

(b) Confidential Information does not include information, technical data or know-how which (i) was in the Member’s possession at the time of disclosure as shown by Member’s files and records immediately prior to the time of disclosure; (ii) before or after it has been disclosed to the Member, is part of the public knowledge or literature, not as a result of any action or inaction of the Member; or (iii) is disclosed to a Member on a non-confidential basis by a third party having a legal right to such information; (iv) is independently developed by the Member, as properly documented by the Member; or (v) is approved for release by written authorization of the Board. The provisions of this Section shall not apply (1) to the extent that a Member is required to disclose Confidential Information pursuant to any law, statute, rule or regulation or any order of any court or governmental authority; (2) to the disclosure of Confidential Information to a Member’s employees, counsel, accountants or other professional advisors under confidentiality restrictions no less restrictive than those set forth herein; or (3) to the disclosure of Confidential Information to a prospective transferee of securities that agrees to be bound by the provisions of this Section in connection with the receipt of such Confidential Information.

 

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  9. TRANSFERS OF MEMBERSHIP INTERESTS; SALE OF THE COMPANY

 

  9.1. Transfer of Membership Interests

(a) The term “ transfer ,” when used in this Section 9 with respect to a Membership Interest, shall include any sale, assignment, gift, pledge, hypothecation, mortgage, exchange, or other disposition, except that such term shall not include any pledge, mortgage, or hypothecation of or granting of a security interest in a Membership Interest in connection with any financing obtained on behalf of the Company.

(b) No Membership Interest shall be transferred, in whole or in part, except in accordance with the terms and conditions set forth in this Section 9 . Any transfer or purported transfer of any Membership Interest not made in accordance with this Section 9 shall be void ab initio. For the avoidance of doubt, a Member shall be permitted to transfer its Membership Interest to a Permitted Transferee, as defined below.

 

  9.2. Restrictions on Transfers

(a) Prohibited Transfers . Except as provided in Section 9.2(b) , no Member shall transfer its Membership Interest or any portion thereof.

(b) Permitted Transfers . Notwithstanding Section 9.2(a) , the prohibitions of this Section 9.2 shall not apply to any of the following: (i) any transfer by a Member of any Membership Interest to an entity eighty percent (80%) of the voting interests of which are owned by the Member or any of its Affiliates (each such transferee, a “ Permitted Transferee ”); or (ii) any transfer made in connection with an Approved Sale pursuant to Section 9.3(a) or made in accordance with Section 9.3(b) .

(c) Transferee Becoming Substitute Member . Any transferee of a Membership Interest who is not already a Member (including any Permitted Transferee) shall become a substituted or additional Member only upon executing a revised form of this Agreement to be agreed upon by the transferee and the Board (such Agreement to include the Permitted Transferee’s agreement to abide by the restrictions of Section 7.6). Upon such execution, the transferee of a Membership Interest shall become a substituted or additional Member, as applicable. Unless and until a transferee is admitted as a substituted or additional Member, the transferee shall have no right to exercise any of the powers, rights, and privileges of a Member hereunder. A Member who has transferred its entire Membership Interest in accordance with Section 9.2 to a transferee who is admitted as a substituted Member hereunder shall cease to be a Member upon the effective date of such admission and thereafter shall have no further powers, rights, and privileges as a Member hereunder. Notwithstanding the foregoing, such former Member shall remain obligated for the fulfillment by the transferee of any obligations of such transferee as a replacement Member under this Agreement.

 

  9.3. Sale of the Company

(a) If the Board (including, for such time and so long as Intrexon and Caraco have the right to appoint Intrexon Designees and Caraco Designees, the consent or

 

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affirmative vote of at least one Intrexon Designee and at least one Caraco Designee) approves a Sale of the Company in accordance with Section 7.1(f) (an “ Approved Sale ”), each Member shall vote for, and each Member shall consent to and raise no objections against, such Approved Sale. If the Approved Sale is structured (i) as a merger or consolidation, each Member shall waive any dissenters’ rights, appraisal rights or similar rights in connection with such merger or consolidation or (ii) as a sale of Membership Interests, each Member agrees to sell all of his, her or its Membership Interest and any rights to acquire Membership Interests on the terms and conditions approved by the Board and the approving Members. Each Member shall take all necessary or desirable actions in connection with the consummation of the Approved Sale as requested by the Company.

(b) The obligations of the Members with respect to the Approved Sale of the Company are subject to the satisfaction of the following conditions: (i) each Member shall be entitled to participate in such Approved Sale; and (ii) upon the consummation of the Approved Sale, each Member shall receive with respect to such Member’s Membership Interest consideration based on the amount the Member would receive with respect to such Membership Interest if the Company were to (A) sell all of its assets for an amount equal to the total purchase price to be paid for Membership Interests in the sale transaction and (B) distribute such amount to the Members in liquidation of the Company in accordance with this Agreement, as determined by the Board.

 

  9.4. Purchase Offer and Counteroffer

Upon the seventh (7 th ) anniversary of the Effective Date, and upon every second (2 nd ) anniversary thereafter, each of Intrexon and Caraco (the “ Offeror ”) shall have the right to tender within fifteen (15) Business Days thereupon to the other such Member (the “ Offeree ”) an offer to purchase, in cash, one hundred percent (100%) of the Offeree’s Membership Interest (a “ Purchase Offer ”), for an amount set forth in the Offeror’s Purchase Offer. Within thirty (30) days following receipt of such Purchase Offer, the Offeree (Intrexon or Caraco, as the case may be) shall either (i) agree to accept such Purchase Offer, or (ii) submit to the Offeror a counteroffer to purchase, in cash, one hundred percent (100%) of the Offeror’s Membership Interest (a “ Counteroffer ”), for an amount equal to at least one hundred ten percent (110%) of the original Purchase Offer price as proportionately adjusted to difference in percentage interests. Both Offeror and Offeree shall have the right to continue increasing their respective offer prices in increments of no less than ten percent (10%), until either the Offeror or Offeree has accepted an offer or the Offeror and Offeree mutually agree to hold their Membership Interests and continue operate the Company as Members thereof. On final acceptance of any Offer or Counteroffer by either Caraco or Intrexon, each of the other Members (being other than Caraco and Intrexon) shall also be bound to tender their Membership Interests to the successful Member at the final offered price towards transfer of all of their Membership Interests in the Company. For the sake of clarity, if either of Caraco or Intrexon initiate a Purchase Offer, the transfer amongst the Members shall mandatorily happen in accordance with the above procedure in a manner such that either Caraco or Intrexon shall own 100% of the Membership Interests in the Company. If Caraco and Intrexon, both, do not initiate a Purchase Offer, the same opportunity to transact shall be available after a period of two years.

 

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  9.5. Specific Performance

Each Member acknowledges that the provisions of this Article 9 are reasonable, fair and equitable in scope, protect the legitimate business interests of all of the Members, and are a material inducement to the Members to enter into this Agreement and the transactions contemplated by this Agreement. Each Member further acknowledges that irreparable harm would occur in the event any Member fails to comply fully with the provisions of this Article 9 and that monetary damages would be an inadequate remedy for any such failure because of the difficulty of ascertaining and quantifying the amount of damage that would be suffered by the other Members. Accordingly, each Member agrees that the Company and each other Member shall be entitled to seek an injunction or injunctions to restrain, enjoin and prevent breaches of the undertakings and provisions of this Article 9 and to enforce specifically the undertakings and provisions hereof in any court of the United States or any state having jurisdiction over the matter and the parties; it being understood that such remedies shall be in addition to, and not in lieu of, any other rights and remedies available at law or in equity, including, without limitation, rights to recover damages by reason of any breach of any provision of this Agreement.

 

  10. DISSOLUTION AND LIQUIDATION

 

  10.1. Events Causing Dissolution

Subject to the provisions of Section 10.2 below, the Company shall be dissolved and its affairs wound up upon the occurrence of any of the following events:

(a) approval of the Board, subject to Section 7.1(f) and Section 7.2(e) , to dissolve and wind up the affairs of the Company;

(b) the occurrence of any other event that, under the LLC Act, would cause the dissolution of the Company or that would make it unlawful for the business of the Company to be continued.

 

  10.2. Right to Continue Business of Company

Upon an event described in Section 10.1(b) (but not an event described in Section 10.1(b) that makes it unlawful for the business of the Company to be continued), the Company thereafter shall be dissolved and liquidated unless, within ninety (90) days after the event described in such Section, an election to continue the business of the Company shall be made in writing by the Board (including, for such time and so long as Intrexon and Caraco have the right to appoint Intrexon Designees and Caraco Designees, the consent or affirmative vote of at least one Intrexon Designee and at least one Caraco Designee). If such an election to continue the Company is made, then the Company shall continue until another event causing dissolution in accordance with this Section 10 shall occur.

 

  10.3. Cancellation of Certificate

Upon the dissolution and completion of winding up of the Company, the Certificate shall be canceled in accordance with the provisions of Section 18-203 of the LLC Act.

 

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  10.4. Distributions Upon Dissolution

Upon the dissolution of the Company, the Board (or any Person appointed by the Board to be responsible for winding up the affairs of the Company) shall proceed without any unnecessary delay to pay or make due provision for the payment of all debts, liabilities and obligations of the Company (including, without limitation, all amounts owing to a Member under this Agreement or under any agreement between the Company and a Member entered into by the Member other than in its capacity as a Member in the Company), the payment of expenses of liquidation of the Company, and the establishment of a reasonable reserve in an amount estimated by the Board or appointed Person to be sufficient to pay any amounts reasonably anticipated to be required to be paid by the Company. All remaining Company Assets shall be distributed to the Members (or to a Member’s successors, heirs or assigns in the event of such Member’s death) pro rata, in proportion to the positive balances, if any, in their respective Capital Accounts until such Capital Accounts are reduced to zero amounts, and thereafter, pro rata, in proportion to their respective Percentage Interests.

 

  10.5. Reasonable Time for Winding Up

A reasonable time shall be allowed for the orderly winding up of the business and affairs of the Company and the distribution of its assets pursuant to Section 10.4 in order to minimize any losses otherwise attendant upon such a winding up.

 

  11. MISCELLANEOUS PROVISIONS

 

  11.1. Compliance with LLC Act

Each Member agrees not to take any action or fail to take any action in contravention of this Agreement that, considered alone or in the aggregate with other actions or events, would result in the termination of the Company under the LLC Act.

 

  11.2. Additional Actions and Documents

Each Member hereby agrees to take or cause to be taken such further actions, to execute, acknowledge, deliver and file or cause to be executed, acknowledged, delivered and filed such further documents and instruments, and to use commercially reasonable efforts to obtain such consents, as may be necessary or as may be reasonably requested in order to fully effectuate the purposes, terms and conditions of this Agreement.

 

  11.3. Notices

All notices, demands, requests or other communications which may be or are required to be given, served, or sent pursuant to this Agreement shall be in writing and shall be hand delivered (including delivery by courier), mailed by first-class, registered or certified mail, return receipt requested, postage prepaid, or transmitted by facsimile or confirmed electronic mail, and addressed, if to the Company, to the attention of Program Manager and Chief Executive Officer at its principal place of business and if to a Member, to the address for such Member set forth on Schedule A attached hereto. Each Member may designate by notice in writing to the Company and the other Members a new address to which any notice, demand,

 

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request or communication may thereafter be so given, served or sent. Each notice, demand, request or communication which shall be delivered, mailed or transmitted in the manner described above shall be deemed sufficiently given, served, sent or received for all purposes at such time as it is delivered to the addressee (with an affidavit of personal delivery, the return receipt, the delivery receipt, or facsimile confirmation being deemed conclusive evidence of such delivery) or at such time as delivery is refused by the addressee upon presentation.

 

  11.4. Severability

The invalidity of any one or more provisions hereof or of any other agreement or instrument given pursuant to or in connection with this Agreement shall not affect the remaining portions of this Agreement or any such other agreement or instrument or any part thereof, all of which are inserted conditionally on their being held valid in law; and in the event that one or more of the provisions contained herein or therein should be invalid, or should operate to render this Agreement or any such other agreement or instrument invalid, this Agreement and such other agreements and instruments shall be construed as if such invalid provisions had not been inserted.

 

  11.5. Survival

It is the express intention and agreement of the Members that all covenants, agreements, statements, representations, warranties and indemnities made in this Agreement shall survive the execution and delivery of this Agreement.

 

  11.6. Waivers

Neither the waiver by the Company or a Member of a breach of or a default under any of the provisions of this Agreement, nor the failure of the Company or a Member, on one or more occasions, to enforce any of the provisions of this Agreement or to exercise any right, remedy or privilege hereunder, shall thereafter be construed as a waiver of any subsequent breach or default of a similar nature, or as a waiver of any such provisions, rights, remedies or privileges hereunder.

 

  11.7. Exercise of Rights

No failure or delay on the part of a Member or the Company in exercising any right, power or privilege hereunder and no course of dealing between the Members or between a Member and the Company shall operate as a waiver thereof; nor shall any single or partial exercise of any right, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege. The rights and remedies herein expressly provided are cumulative and not exclusive of any other rights or remedies which a Member or the Company would otherwise have at law or in equity or otherwise.

 

  11.8. Binding Effect

Subject to any provisions hereof restricting assignment, this Agreement shall be binding upon and shall inure to the benefit of the Members and their respective heirs, devises, executors, administrators, legal representatives, successors and assigns.

 

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  11.9. Limitation on Benefits of this Agreement

No person or entity other than the Members and the Company is or shall be entitled to bring any action to enforce any provision of this Agreement against any Member or the Company, and that the covenants, undertakings and agreements set forth in this Agreement shall be solely for the benefit of, and shall be enforceable only by, the Members (or their respective successors and assigns as permitted hereunder), and the Company. Subject to Section 7.4 , neither Intrexon and its Affiliates nor Caraco and its Affiliates shall be able to enforce rights or indemnity provisions under this Agreement in the event that Intrexon and/or Caraco (as the case may be) has explicitly and officially in writing consented to, agreed with, or proposed such an act or action under the operation of the ECC.

 

  11.10. Amendment Procedure

Subject to Section 7.1(f) and Section 7.2(e) , the Board shall have the authority to amend this Agreement, including the Schedules hereto, as it determines to be necessary or appropriate to reflect actions taken in accordance with this Agreement, including without limitation the issuance of additional Membership Interests of any class and the terms thereof, to correct or clarify and mistake, inconsistency, or ambiguity, or to comply with any tax or legal requirements. All other amendments shall require the written consent of Members holding Voting Interests representing a majority of the Member Votes.

 

  11.11. Entire Agreement

This Agreement (including the Schedules hereto) and the ECC contain the entire agreement between the Members with respect to the matters contemplated hereby and thereby, and supersede all prior oral or written agreements, commitments or understandings with respect to the matters provided for herein and therein.

 

  11.12. Dispute Resolution

(a) Disputes . It is the objective of the Members 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 Members out of or in relation to or in connection with this Agreement, including 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 any Member by written notice, the Members and the Company 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 the Company and each Member. If the matter is not resolved within thirty (30) days following the written request for discussions, either Member may then invoke the provisions of Section 11.12(b) .

(b) Arbitration . Any dispute, controversy, difference or claim which may arise between the Members, 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) (a “ Dispute ”) that is not resolved pursuant to Section 11.12(a) shall be settled by binding

 

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“baseball arbitration” as follows. Either Member, following the end of the thirty (30) day period referenced in Section 11.12(a) , may refer such issue to arbitration by submitting a written notice of such request to the other Member(s), with the arbitration to be held in the state where the Company’s principal office is located (or some other place as may be mutually agreed by the Members). Promptly following receipt of such notice, the Members and the Company shall meet and discuss in good faith and choose one arbitrator from a list of arbitrators provided by the American Arbitration Association in accordance with its Commercial Arbitration Rules (the “ AAA Rules ”) as being suitable to arbitrate the Parties’s dispute. The Parties agree that the chosen arbitrator shall be neutral and independent of all Members and of their respective Affiliates, and shall have significant experience and expertise in licensing, partnering and joint venture agreements in the pharmaceutical and biotechnology industries, and concerning related intellectual property rights (as appropriate in light of the subject matter of the Parties’ disputed issues), and shall have some experience in Delaware law and mediating or arbitrating issues relating to such agreements and/or related intellectual property rights. The AAA Rules shall govern the arbitration between the Parties except as set forth in, and to the extent not inconsistent with, this Section 11.2. Within twenty (20) Business Days after an arbitrator(s) is selected, each Member will deliver to both the arbitrator and the other Members a detailed written proposal setting forth its proposed terms for the resolution for the matter at issue (the “ Proposed Terms ” of the Member) and a memorandum (the “ Support Memorandum ”) in support thereof. The Members will also provide the arbitrator a copy of this Agreement, as it may be amended at such time. Within twenty (20) days after receipt of the other Members’ Proposed Terms and Support Memorandum, each Member may submit to the arbitrator) (with a copy to the other Member and the Company) a response to the other Members’ Support Memoranda. Neither Member may have any other communications (either written or oral) with the arbitrator other than for the sole purpose of engaging the arbitrator or as expressly permitted in this Section 11.12(b) ; provided , that the arbitrator may convene a hearing if the arbitrator so chooses to ask questions of the Members and hear oral argument and discussion regarding each Member’s Proposed Terms. Within sixty (60) days after the arbitrator’s appointment, the arbitrator will select one of the Proposed Terms (without modification) provided by the Members 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 shall be final, binding, and unappealable. For clarity, the arbitrator must select as the only method to resolve the matter at issue (one of the Proposed Terms), and may not combine elements of multiple Proposed Terms or award any other relief or take any other action.

(c) Award . Any award to be paid by one Member to another Member or the Company as determined by the arbitrator as set forth above under Section 11.12(b) 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 Member. Each Member agrees to abide by the award rendered in any arbitration conducted pursuant to this Section 11.12 , 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 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. With respect to money damages, nothing contained herein shall be construed to permit the arbitrator or any court or any other forum to award incidental, special, punitive or exemplary damages. By entering into this agreement to arbitrate, the Members expressly waive any claim for incidental, special, punitive or exemplary damages.

 

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(d) Costs . Each Member shall bear its own legal fees in connection with any such arbitration under this Section 11.12. The arbitrator shall assess his or her costs, fees and expenses against the Member(s) losing the arbitration.

(e) Injunctive Relief . Nothing in this Section 11.12 will preclude any Member or the Company 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 Member or the Company or to preserve the status quo pending the arbitration proceeding.

 

  11.13. Governing Law

This Agreement, the rights and obligations of the parties hereto, and any claims or disputes relating thereto, shall be governed by and construed in accordance with the laws of the State of Delaware (but not including the choice of law rules thereof that would result in the application of the law of any other jurisdiction).

 

  11.14. Execution in Counterparts

To facilitate execution, this Agreement may be executed in one or more counterparts, including by facsimile, .pdf or electronic signature, or signatures delivered by electronic transmission. All counterparts shall collectively constitute a single agreement.

[ signature page follows ]

 

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IN WITNESS WHEREOF , the Members and the Company have caused this Limited Liability Company Agreement to be duly executed on their behalf as of the Effective Date.

 

Intrexon Corporation
By:  

/s/ Krish S. Krishnan

  Name:  

Krish S. Krishnan

  Title:  

Chief Operating Officer

Caraco Pharmaceutical Laboratories, Ltd.
By:  

/s/ Mukul Rathi

  Name:  

Mukul Rathi

  Title:  

Chief Financial Officer

S & I Ophthalmic, LLC, by all of its Members
Caraco Pharmaceutical Laboratories, Ltd.
By:  

/s/ Mukul Rathi

  Name:  

Mukul Rathi

  Title:  

Chief Financial Officer

Intrexon Corporation
By:  

/s/ Krish S. Krishnan

  Name:  

Krish S. Krishnan

  Title:  

Chief Operating Officer

SIGNATURE PAGE FOR LIMITED LIABILITY COMPANY AGREEMENT OF S & I OPHTHALMIC, LLC

 

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THE LIMITED LIABILITY COMPANY INTERESTS EVIDENCED BY THIS AGREEMENT HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ ACT ”), OR UNDER APPLICABLE STATE SECURITIES LAWS (THE “ STATE ACTS ”), AND MAY BE OFFERED OR SOLD BY A PURCHASER OF THE LIMITED LIABILITY COMPANY INTERESTS ONLY (1) UPON REGISTRATION OF THE LIMITED LIABILITY COMPANY INTERESTS UNDER THE ACT AND THE STATE ACTS OR PURSUANT TO AN EXEMPTION THEREFROM, AND (2) AFTER COMPLIANCE WITH ALL RESTRICTIONS ON TRANSFER OF LIMITED LIABILITY COMPANY INTERESTS IMPOSED BY THIS AGREEMENT, INCLUDING (WITHOUT LIMITATION) THE PROVISIONS OF SECTION 9 .

*    *    *    *    *

LIMITED LIABILITY COMPANY AGREEMENT

OF

S & I Ophthalmic, LLC

 

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SCHEDULE A

Members

 

Member

   Percentage Interest  

Intrexon Corporation

 

Address for notices:

 

Intrexon Corporation

20358 Seneca Meadows Parkway

Germantown, MD 20876

     50

Caraco Pharmaceutical Laboratories, Ltd.

 

Address for notices:

 

Caraco Pharmaceutical Laboratories, Ltd.

1150 Elijah McCoy Drive

Detroit, MI 48202

     50

 

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