COLLABORATION AND OPTION AGREEMENT

Exhibit 10.2

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisk denote omissions.

COLLABORATION AND OPTION AGREEMENT

by and between

Infinity Pharmaceuticals, Inc.

and

Novartis International Pharmaceutical Ltd.

 

Collaboration Agreement — Confidential

COLLABORATION AND OPTION AGREEMENT

This Agreement is made this 16 ^th day of November, 2004 (the “ Effective Date ”) by and between Infinity Pharmaceuticals, Inc. (“ Infinity ”), a Delaware corporation with principal offices at 780 Memorial Drive, Cambridge, Massachusetts 02139, and Novartis International Pharmaceutical Ltd. (“ Novartis ”), a Bermuda corporation with principal offices at Hurst Holme, 12 Trott Road, Hamilton, HM LX, Bermuda. Infinity and Novartis are sometimes referred to herein individually as a “ Party ” and together as the “ Parties .”

I NTRODUCTION

WHEREAS, Infinity has developed a proprietary diversity oriented synthesis methodology to design novel, three-dimensional, natural compound-like synthetic compounds;

WHEREAS, Novartis and its Affiliates possess expertise in discovering, developing, manufacturing, marketing, and selling pharmaceuticals worldwide;

WHEREAS, Infinity and Novartis desire to enter into a collaboration, the objectives of which are the joint design by the Parties of Synthetic Pathways, as defined herein, and the synthesis by Infinity, using such Synthetic Pathways, of certain of the Library Compounds, as defined herein (the “ Collaboration ”);

WHEREAS, each of the Parties, together with its respective Affiliates, is interested in screening Library Compounds against Targets with the goal of developing and commercializing drugs for human therapeutic and other purposes;

WHEREAS, in the event that Infinity generates any Lead Programs, as defined herein, using Library Compounds, then Novartis and its Affiliates shall have the option to develop, market and sell the same as drugs upon the terms set forth herein and in a License, Development and Commercialization Agreement identical in substance to Exhibit A hereto; and

WHEREAS, in connection with the Collaboration, Infinity desires to sell, and Novartis Pharma AG, an Affiliate of Novartis, desires to purchase on the Effective Date 3,333,333 shares of Infinity’s Series C Preferred Stock for an aggregate purchase price of U.S.$15 million, in accordance with the terms and conditions of the Stock Purchase Agreement (as defined herein);

 

Collaboration Agreement — Confidential

NOW THEREFORE, in consideration of the mutual covenants set forth in this Agreement, and other good and valuable consideration, the Parties agree as follows:

ARTICLE I

D EFINITIONS

1.1. “Acceptance Criteria” shall mean the minimum acceptable criteria set forth in Section 2.2.4 that each Proposed Compound must meet before such Proposed Compound can be deemed an Actual Compound.

1.2. “Actual Compound” shall mean Proposed Compounds which meet the Acceptance Criteria in Section 2.2.4 and have been deemed an Actual Compound as set forth in Section 2.2.6. For purposes of clarity, an Actual Compound shall also remain a Library Compound.

1.3. “Active Moiety” shall have the meaning assigned to that term under 21 CFR 314.108(a), as such regulation is in effect on the Effective Date, namely: “the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, a chelate or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance.”

1.4. “Affiliate” shall mean, with respect to any Person, any other Person which directly or indirectly, by itself or through one or more intermediaries, controls, or is controlled by, or is under common control with, such Person. The term “control” (as applied to a Person) means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a Person, whether through the ownership of voting securities, by contract or otherwise. Control will be presumed if one Person owns, either of record or beneficially, at least fifty percent (50%) of the voting stock of any other Person. Such other

 

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relationship as in fact results in actual control over the management, business, and affairs of a Person shall also be deemed to constitute control; provided , however , that no Person shall be deemed to exercise control over another Person solely because the latter relies on the former for a majority of its business. A Person will be deemed an Affiliate only so long as such ownership or control relationship continues. In the case of Novartis, “Affiliates” shall also expressly be deemed to include the Novartis Institute for Functional Genomics, Inc. and the Friedrich Miescher Institute for BioMedical Research and their respective Affiliates.

1.5. “Background Intellectual Property” shall have the meaning set forth in Section 7.1.1(a).

1.6. “Collaboration” shall have the meaning set forth in the preamble hereto.

1.7. “Collaboration Intellectual Property” shall mean Compound Related Intellectual Property, Compound Intellectual Property and Non-Compound Related Intellectual Property.

1.8. “Compound Intellectual Property” shall have the meaning set forth in Section 3.2.2.

1.9. “Compound Related Intellectual Property” shall have the meaning set forth in Section 7.1.2.

1.10. “Controlled” shall mean, with respect to an Intellectual Property right, the legal authority or right of a Party (other than by license pursuant to this Agreement) to grant a license or sublicense of such intellectual property rights to the other Party, or to otherwise disclose such proprietary or trade secret information to such other Party, as applicable, without breaching the terms of any agreement with a Third Party.

1.11. “Data Package” shall have the meaning set forth in Section 3.3.3.

1.12. “Data Receipt Notice” shall have the meaning set forth in Section 3.3.4(a).

 

Collaboration Agreement — Confidential – Page 3

1.13. “Derivative Compounds” shall mean any and all compounds that are modified by chemical and/or molecular-genetic means from a Library Compound. Analogues of such compounds and their derivatives shall be included within the scope of Derivative Compounds.

1.14. “Effective Date” shall mean the effective date of this Agreement as set forth on the first page.

1.15. “Field” shall mean all human and veterinary health-care applications including, but not limited to, research, diagnosis, therapeutics, and prophylaxis with respect to any indication, together with all agricultural purposes.

1.16. “Genus License” shall have the meaning set forth in Section 3.2.1.

1.17. “Infinity Compound” shall have the meaning set forth in Section 3.4(b) and/or Section 3.5, as applicable.

1.18. “Infinity Compound Patent” shall have the meaning set forth in Section 3.2.3.

1.19. “Intellectual Property” shall mean all confidential and proprietary data, technical information, know-how, experience, inventions (whether or not patented and all Patents claiming such inventions), and trade secrets Controlled by a Party or its Affiliates.

1.20. “Investors’ Rights Agreement” shall mean that certain Third Amended and Restated Investors’ Rights Agreement dated as of the Effective Date.

1.21. “Joint Steering Committee” shall have the meaning set forth in Section 2.3.1.

1.22. “Lead Criteria” shall have the meaning set forth in Section 3.3.2.

1.23. “Lead Program” shall mean any Library Compounds, together with all Derivative Compounds (and together with any and all compounds having the same Active Moiety as such Library Compounds or Derivative Compounds), which: (a) are discovered during the course of screening and initial optimization of the Library Compounds against a Target by Infinity or its Affiliates; (b) meet the Lead Criteria; and (c) Infinity wishes to further optimize. A Lead Program may be composed of one or more Lead Series.

 

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1.24. “Lead Series” shall mean the structurally-related Derivative Compounds contained in a Lead Program. Each Lead Series shall contain at least [**] chemical entities.

1.25. “Library Compound” shall mean any chemical entity that may be synthesized through the synthetic transformations defining a Synthetic Pathway.

1.26. “License Agreement” shall mean the License, Development and Commercialization Agreement, identical in substance to Exhibit A hereto, to be executed by Infinity and Novartis with respect to Optioned Lead Program(s).

1.27. “Non-Acceptance Notice” shall have the meaning set forth in Section 2.2.5(a).

1.28. “Non-Acceptance Notice Period” shall have the meaning set forth in Section 2.2.5(a).

1.29. “Non-Compound Related Intellectual Property” shall have the meaning set forth in Section 7.1.3.

1.30. “Novartis Reserved Target” shall have the meaning set forth in Section 3.1.2(b)(iii).

1.31. “Option” shall have the meaning set forth in Section 3.3.1.

1.32. “Optioned Lead Program” shall mean any Lead Program as to which Novartis has exercised its Option.

1.33. “Patents” means all existing patents and patent applications and all patent applications hereafter filed, including any continuation, continuation-in-part, divisional, provisional or any substitute applications, any patent issued with respect to any such patent applications, any reissue, reexamination, renewal or extension (including any supplementary protection certificate) of any of the foregoing patents, and any confirmation patent or registration patent or patent of addition based on any of the foregoing patents, and all foreign counterparts of any of the foregoing.

 

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1.34. “Person” means any individual, corporation, partnership, association, joint-stock company, trust, unincorporated organization or government or political subdivision thereof.

1.35. “Proposed Compounds” shall mean that subset of Library Compounds that the Joint Steering Committee determines are to be synthesized by Infinity during the Collaboration pursuant to Section 2.2.3.

1.36. “Scaffold” shall mean a skeletal core of a molecule with designated chemical functionality through which variable substituents can be attached through standard organic chemical transformations, and that the Joint Steering Committee designates as part of the Collaboration. Stereochemical variations in the Scaffold shall be considered the same Scaffold. For clarity, representative examples of compounds that would be inside or outside of a particular Scaffold are described in Exhibit B .

1.37. “Stock Purchase Agreement” shall mean that Stock Purchase Agreement dated as of the Effective Date by and between Infinity and Novartis Pharma AG, an Affiliate of Novartis.

1.38. “Synthetic Pathway” shall mean any sequence of chemical transformations that create a Scaffold, and that the Joint Steering Committee designates as part of the Collaboration.

1.39. “Target” shall mean any biological entity identified as being potentially involved in one or more disease states.

1.40. “Third Party” shall mean any Person that is not a Party or an Affiliate of any Party.

1.41. “Threshold Date” shall have the meaning set forth in Section 3.1.2(b).

 

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ARTICLE II

T HE C OLLABORATION

2.1. Commencement; Direction.

The Collaboration shall commence on the Effective Date. The Joint Steering Committee shall direct the conduct of the Collaboration.

2.2. Library Design and Synthesis.

2.2.1. Synthetic Pathways . During the course of the Collaboration, the Joint Steering Committee shall design, and Infinity shall deliver Actual Compounds from, no fewer than [**] and no more than [**] Synthetic Pathways.

2.2.2. Library Compounds . The Joint Steering Committee shall design Synthetic Pathways, Scaffolds and their associated Library Compounds so as not to overlap with compounds outside the scope of the Collaboration that are then in or under development for the compound collection of a Party or its Affiliates. The vote by each Party’s representatives to the Joint Steering Committee approving the designation of a Synthetic Pathway and Scaffold shall be deemed a representation by such Party that such Synthetic Pathway and Scaffold do not overlap with compounds outside the scope of the Collaboration that are then in or under development for the compound collection of such Party or its Affiliates. Upon approval, each Synthetic Pathway and Scaffold, together with representative examples and any written descriptions shall be attached and incorporated hereto as Exhibit C .

2.2.3. Proposed Compounds . The Joint Steering Committee shall identify the chemical entities to be synthesized by Infinity (the “ Proposed Compounds ”). Infinity shall not synthesize more than [**] Actual Compounds using any [**] Synthetic Pathway. Infinity shall synthesize, on average, between [**] and [**] micromoles of each Proposed Compound. It is the expectation of the Parties that Infinity will provide Novartis with [**] micromoles of each Proposed Compound; provided , however , that for no more than [**] percent ([**]%) of the Proposed Compounds generated in connection with any Synthetic Pathway, Infinity may provide Novartis with an amount greater than or equal to [**], but less than [**], micromoles of each such Proposed Compound. In no event will Infinity provide Novartis with fewer than [**] micromoles of any Proposed Compound.

 

Collaboration Agreement — Confidential – Page 7

2.2.4. Acceptance Criteria . Infinity will deliver to Novartis only Proposed Compounds that, in Infinity’s reasonable judgment, meet the following Acceptance Criteria:

(a) The quantities of Proposed Compounds delivered to Novartis shall be no less than as set forth in Section 2.2.3.

(b) Each Proposed Compound shall be at least [**] percent ([**]%) pure, as defined by HPLC-MS UV at 210 nm. In the event that the Joint Steering Committee determines that HPLC-MS UV is not an appropriate detection method for a Proposed Compound, its purity shall instead be determined by HPLC-MS ELSD.

(c) Infinity will provide Proposed Compounds to Novartis in barcoded Whatman plates (96-deepwell, 1 ml) with Platelock™ heat-sealed foil covers from Velocity11 (or other comparable sealing, mutually agreed by the Parties). Novartis shall provide the Whatman plates to Infinity. If the Platelock™ heat-sealed foil covers from Velocity11 are used, Infinity shall provide them. If other materials are used, the Parties will mutually agree on which Party shall supply such other materials. The Proposed Compounds shall be provided in [**] with eighty-eight (88) Proposed Compounds per plate in columns 1-11 and with column 12 empty.

(d) The plates will be shipped on dry ice to the shipping destination indicated by Novartis, via a carrier selected in advance by Novartis, FOB Infinity’s facility in Cambridge, the cost of which shall be borne by Novartis.

(e) Contemporaneously with its delivery of the Proposed Compounds, Infinity shall deliver to Novartis an accurate structural description for each Proposed Compound in an electronic format reasonably acceptable to Novartis.

(f) Contemporaneously with its delivery of the Proposed Compounds, Infinity will also deliver electronic copies of its production notebooks which contain Synthetic Pathway information related to the Proposed Compounds that is reasonably necessary to allow Novartis to

 

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synthesize the Proposed Compounds, which production notebooks include without limitation all information regarding the reaction conditions, necessary reagents, materials, and the like used by Infinity to synthesize the Library Compounds and any intermediates made by Infinity. Such notebooks shall be delivered in an electronic format reasonably acceptable to Novartis.

2.2.5. Non-Acceptance of a Proposed Compound .

(a) In the event that Novartis, in its reasonable discretion, determines that a Proposed Compound does not meet the Acceptance Criteria, it shall so notify Infinity in writing (the “ Non-Acceptance Notice ”) within [**] calendar days of the delivery of such Proposed Compound (the “ Non-Acceptance Notice Period ”).

(b) Novartis shall disclose in any Non-Acceptance Notice which Acceptance Criteria were not achieved. The Parties will share the data necessary to resolve differences over whether the Acceptance Criteria were met and shall refer any unresolved disputes to the Joint Steering Committee pursuant to Section 2.4.2.

(c) Infinity may, in its sole discretion, attempt to address the unachieved Acceptance Criteria disclosed in the Non-Acceptance Notice, and may then resubmit the relevant Proposed Compound to Novartis, along with other Proposed Compounds, in accordance with the procedure specified in Section 2.2.4. The timetable set forth in subsection (a) shall apply to the resubmitted Proposed Compound as if it were being submitted to Novartis for the first time.

(d) If a Proposed Compound is ultimately rejected by the Joint Steering Committee, then Novartis shall delete structural and related information with respect to such Proposed Compound from Novartis’ databases and return to Infinity all remaining Proposed Compound material which is not in Novartis’ screening format. Novartis may continue to include such material in screens; provided , however , that Novartis shall not conduct research on such rejected Proposed Compounds nor determine the structure of such Proposed Compound through any analytical or other method.

 

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(e) Notwithstanding the foregoing, any Proposed Compound that is the subject of a Non-Acceptance Notice or has been rejected by the Joint Steering Committee shall remain a Library Compound for purposes of this Agreement.

2.2.6. Acceptance as an Actual Compound . In the event that Novartis does not provide Infinity with a Non-Acceptance Notice in respect of a particular Proposed Compound within the relevant Non-Acceptance Notice Period, such Proposed Compound, upon expiration of the Non-Acceptance Notice Period, shall automatically be deemed to be an Actual Compound.

2.2.7. Diligence Obligations . Prior to the [**] anniversary of the Effective Date, Infinity shall synthesize and deliver to Novartis [**] Actual Compounds; provided , however , that should Infinity not deliver [**] Actual Compounds to Novartis by such anniversary date, then Infinity shall not be in breach of this diligence obligation; provided further that Infinity shall continue using commercially reasonable efforts to synthesize Actual Compounds thereafter until Infinity shall have synthesized and delivered [**] Actual Compounds to Novartis, unless otherwise agreed upon in writing between the Parties.

2.2.8. Payment for Actual Compounds . Upon submission by Infinity of a corresponding invoice, Novartis shall pay Infinity U.S.$[**] per Actual Compound, which amount shall be payable within [**] calendar days of receipt of such invoice; provided , however , that in each case, Infinity shall not submit any invoices (other than the final invoice of the Collaboration) until the aggregate amount owed by Novartis equals or exceeds U.S.$[**].

2.3. Joint Steering Committee.

2.3.1. Composition . Upon execution of this Agreement, Infinity and Novartis will establish a Joint Steering Committee (the “ Joint Steering Committee ”), which shall consist of an equal number of executives or scientists as may be designated by each Party from time to time. The Joint Steering Committee shall initially have six (6) members. The Committee Chair will be appointed from among the members of the Joint Steering Committee designated by Novartis.

 

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2.3.2. Meetings; Purposes . The Joint Steering Committee shall hold its first meeting within thirty (30) calendar days after the Effective Date. At its first meeting, the Joint Steering Committee shall outline a process to ensure that the first Synthetic Pathway(s), the scope of the resulting Library Compounds and the Proposed Compounds to be synthesized by Infinity from such Synthetic Pathways are approved as quickly as possible so that Infinity can initiate synthesis of such Proposed Compounds. Thereafter, the Joint Steering Committee shall meet quarterly, or with such other frequency, and at such times, as may be established by the Joint Steering Committee, at the offices of Infinity in Cambridge, Massachusetts or Novartis in Basel, Switzerland or Cambridge, Massachusetts ( provided that no more than one meeting per calendar year shall be held in Basel, Switzerland without the consent of the Parties), for the following purposes:

(a) Determining the number of Synthetic Pathways,

(b) Determining the design of Synthetic Pathways, Scaffolds, the resulting Library Compounds, and the Proposed Compounds to be synthesized by Infinity;

(c) Ensuring that Library Compounds will be designed so as not to overlap with compounds then in, or under development for, either Party’s (or its Affiliates’) compound collections outside of the Collaboration;

(d) Determining the Lead Criteria and the Data Package, on a Target by Target basis, for each Target screened by Infinity pursuant to Article III for which the Option applies (it being understood that such determinations shall be made, whenever possible, at regularly scheduled meetings of the Joint Steering Committee, but in no event more than [**] days after Infinity has proposed such Target to Novartis in writing; and provided , however , that if the Lead Criteria and Data Package are not determined within such [**] day period, then the criteria specified in Sections 3.3.2 and 3.3.3, respectively, shall apply);

(e) Providing general oversight of the entire Collaboration between Infinity and Novartis, including periodic review of the overall goals and strategy of the Collaboration;

 

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(f) Attempting to resolve any disagreement between the Parties hereunder, including disputes relating to an assertion pursuant to a Non-Acceptance Notice that a Proposed Compound has failed to meet Acceptance Criteria, and discussion and resolution, if possible, of any other deadlocked issues submitted to it;

(g) Addressing any matters raised under relevant provisions of the License Agreement;

(h) With respect to a Lead Series which is subject to the Option, determining whether Infinity shall have the right, if Infinity requests such right, to file Patent applications, under Infinity’s name and at Infinity’s expense, directed to such Lead Series, including any Actual Compounds in such Lead Series, prior to the expiration of the [**] day Option exercise period or Novartis’ declining the Option for such Lead Series, it being understood that: (i) Novartis and Infinity shall cooperate in the drafting and filing of such Patent application; (ii) such Patent application shall be subject to the conditions set forth in Section 3.2.3 (except if Novartis shall decide otherwise); and (iii) if Novartis exercises its Option with respect to such Lead Program, such Patent applications shall be assigned to Novartis, and Infinity shall cause its Affiliates, employees and/or consultants to so assign such Patent applications;

(i) Determining whether HPLC-MS UV at 210 nm is the appropriate purity detection method for a synthesized compound described in Sections 2.2.4(b), 3.3.2(a) or 3.3.4(c);

(j) Determining whether to protect (through filing for and maintenance of intellectual property protection and/or the enforcement or defense thereof, as applicable) the Compound Related Intellectual Property; and

(k) Making any changes to the Acceptance Criteria set forth in Section 2.2.4.

2.4. Decisions of the Joint Steering Committee; Resolution of Disputes.

2.4.1. The Joint Steering Committee shall make decisions unanimously where possible, but at least by majority vote, with respect to the matters described in Sections 2.3.2(d), (h) and (j). In the event of a deadlock with respect to such matters, Novartis shall have the deciding vote.

 

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2.4.2. The unanimous vote of the Joint Steering Committee shall be required in order to make decisions with respect to the matters described in Sections 2.3.2(a), (b), (c), (e), (f), (i) and (k). In the event that the Joint Steering Committee is deadlocked as to any of these issues, then the Parties may have the issue referred to the Chief Scientific Officer of Infinity and the Vice President of Global Discovery Chemistry of the Novartis Institutes for BioMedical Research, Inc. (or their equivalent) for good faith resolution. Notwithstanding the foregoing, with respect to Section 2.3.2(c), in no event shall either Party have the right to force the other Party to accept the design of a Synthetic Pathway or Scaffold which such other Party represents would overlap with compounds then in, or under development for, such other Party’s (or its Affiliates’) compound collections outside of the Collaboration.

2.4.3. The unanimous vote of the Joint Steering Committee shall be required in order to make decisions with respect to the matter described in Section 2.3.2(g). In the event that the Joint Steering Committee is deadlocked as to this issue, then the Parties may have the issue referred to the Chief Executive Officer of Infinity and the President of the Novartis Institutes for BioMedical Research, Inc. (or their equivalent) for good faith resolution.

2.5. Additional Assistance by Infinity.

2.5.1. Third Party Improvements . In the event that a Third Party, for or on behalf of Infinity, makes any improvements to reagents, materials, and the like which are necessary for Novartis to synthesize an Actual Compound, Infinity shall, at no cost to Novartis, grant Novartis any required permissions or licenses from Infinity to use such improvements to the extent Infinity Controls such improvements and will use reasonable efforts to help Novartis secure access to such improvements from such Third Party on business terms comparable to those afforded Infinity.

2.5.2. Hosting of Novartis Scientists . Infinity shall, [**], provide work space and support on its premises for up to [**] Novartis scientists for an aggregate of up to [**] calendar days each (it being understood that such period shall refer to the total number of days each scientist is hosted on the Infinity premises, and not necessarily a period of [**] consecutive calendar days), in increments of at least [**] calendar days per visit, in order to assist Novartis in

 

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connection with the resynthesis of Actual Compounds; provided that Novartis shall reimburse Infinity for any reasonable, documentable expense for reagents and consumables used by such Novartis scientists in connection with such resynthesis. Each such visit by a Novartis scientist shall be scheduled at least [**] weeks in advance.

2.5.3. Provision of Infinity Chemist . At the request of Novartis and on Novartis’ premises, Infinity shall provide a chemist, reasonably acceptable to Novartis, for up to [**] per Synthetic Pathway, to assist Novartis with the resynthesis of Actual Compounds related to such Synthetic Pathway. The provision of such chemist shall be [**], provided that Novartis shall reimburse Infinity for any reasonable, documentable out-of-pocket and travel expenses incurred by such chemist in connection therewith. Each such visit by an Infinity chemist shall be scheduled at least [**] weeks in advance.

2.6. Exchange of Information.

2.6.1. Status of Collaboration . Infinity and Novartis will share information with the Joint Steering Committee, no less frequently than at the quarterly meetings of the Joint Steering Committee, reasonably necessary to facilitate mutual understanding of the status of the Collaboration and decision-making in connection therewith.

2.6.2. Misuse of Background Intellectual Property . Neither Party shall use the Background Intellectual Property of the other (excluding information which is no longer subject to confidentiality restrictions under Article IV by reason of the exceptions set forth in Sections 4.2(a), (c), (d) and (e)) for any purpose, including the filing of Patents containing such information, without the other Party’s written consent, other than for carrying out the Collaboration or discharging its responsibilities under the License Agreement, or as otherwise permitted hereunder or under the License Agreement.

2.6.3. Restrictions on Rights . Neither Party shall be entitled to receive information from the other Party concerning Intellectual Property discovered or developed by that Party outside the Collaboration or otherwise unrelated to design and synthesis of Synthetic Pathways, Scaffolds, Library Compounds, or Lead Programs under this Agreement or the

 

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License Agreement; except that, with respect to each Proposed Compound, Infinity shall also disclose to Novartis in a timely manner any and all Intellectual Property (including, without limitation, know-how and/or technology which it discovers or develops regarding the Synthetic Pathways and/or Scaffolds) which Infinity used to synthesize such Proposed Compound.

2.7. Exclusivity; Freedom of Action.

Infinity will collaborate on the Synthetic Pathways with Novartis solely. For the avoidance of doubt, and except as otherwise set forth in this Agreement or the License Agreement, either Party and any of its Affiliates shall be free, alone or together with Third Parties, to pursue the identification, development or commercialization of chemical entities that modulate any Target, free of any obligation to the other Party not expressly stated in this Agreement or the License Agreement (but subject to any Intellectual Property rights of such other Party not expressly granted in this Agreement or the License Agreement).

ARTICLE III

I NTELLECTUAL P ROPERTY R IGHTS ;

O PTION TO D EVELOP AND C OMMERCIALIZE

3.1. Use Rights with Respect to Library Compounds.

3.1.1. Novartis’ Ownership and Use Rights with Respect to Library Compounds . Novartis shall be the sole owner of all Actual Compounds, including Infinity Compounds. Subject to the other terms and conditions of this Agreement, Novartis and its Affiliates shall have the right, alone or with Third Parties, to make, use, sell, offer to sell, export, import, license and distribute any and all Library Compounds for research, development, and commercialization purposes; provided that during the term of this Agreement, Novartis and its Affiliates may not sell, offer to sell, export, import, license or distribute the Library Compounds as libraries per se. Notwithstanding the foregoing, a sale, an offer for sale, an exportation, an importation, a license or a distribution of the Library Compounds as part of a larger asset transfer or transaction shall not be deemed “a sale, an offer for sale, an exportation, an importation, a license or a distribution as a library” hereunder.

 

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3.1.2. Infinity’s Use Rights with Respect to Library Compounds .

(a) Subject to the other terms and conditions of this Agreement (including, without limitation, Section 3.3.5), Infinity shall have the right to screen Library Compounds against any Target; provided that Infinity may not sell or otherwise provide such Library Compounds to any Third Party (except that Infinity may (i) provide Library Compounds to subcontractors working on Infinity’s behalf to fulfill Infinity’s obligations under this Agreement and (ii) sell, license or otherwise distribute to Third Parties Library Compounds specifically identified as included in a Lead Program with respect to a Target (other than a Novartis Reserved Target) for which Novartis has declined its Option, for which the relevant [**] day Option exercise period has expired, or for which Novartis does not have an Option).

(b) Prior to the [**] anniversary of the Effective Date or the [**] anniversary of the acceptance by Novartis of the [**] Actual Compound, whichever is later (the “ Threshold Date ”), Infinity shall be restricted with respect to screening Library Compounds, as follows:

 

(i)

Infinity shall offer all Lead Programs to Novartis pursuant to the Option.

 

(ii)

Prior to screening, Infinity must disclose the Target proposed to be screened or the other screening efforts to be undertaken, as applicable, in writing to a Novartis representative selected by the Joint Steering Committee. In the event that such screening efforts are not directed to a particular Target, then Infinity shall notify the Novartis representative selected by the Joint Steering Committee promptly upon the identification of the modulated Target(s) resulting from such screening efforts, and the conditions set forth in Section 3.3 shall apply regardless of when such Target(s) is identified.

 

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(iii)

If, at the time of disclosure, Novartis has a discovery program or proposed program regarding the proposed Target, or if Novartis is screening or otherwise committing scientific effort and resources to study the Target which effort and resources are consistent with Novartis’ other Target programs or is planning to screen or otherwise study the Target during the next [**] months, then Novartis will so notify Infinity in writing within [**] calendar days after such disclosure that the proposed Target of such screening is a “ Novartis Reserved Target ,” in which case the provisions of Section 3.3.5(b) with respect to Novartis Reserved Targets shall apply.

(c) For the avoidance of doubt, Lead Programs resulting from screening Library Compounds prior to the Threshold Date shall be subject to Sections 3.3.5.

3.2. Patent Rights and License Grants with Respect to Library Compounds, Actual Compounds and Infinity Compounds.

3.2.1. Patent Rights and License Grants to Library Compounds that are not Actual Compounds or Infinity Compounds . At any time, either Party or its Affiliates may file or obtain Patents with respect to claims (specific or generic) covering Library Compounds that are not Actual Compounds or Infinity Compounds (including claims as to the use or manufacture thereof), subject to an automatic grant to the other Party and its Affiliates under such Patents of a worldwide, perpetual (subject to the last sentence of this Section 3.2.1), non-exclusive, fully-paid, royalty-free license (with the right to sublicense) to conduct research with respect to such Library Compounds in the Field, it being understood that the purpose of such research is the development of products in the Field. In the case of Library Compounds that are not Infinity Compounds, Infinity shall automatically grant Novartis and its Affiliates, under the genus claims of Infinity’s composition of matter claims in such Patents covering such Library Compounds and their manufacture, a perpetual (subject to the last sentence of this Section 3.2.1), worldwide, non-exclusive, fully-paid, royalty-free license (with right to sublicense), to research, develop,

 

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commercialize, make, use, manufacture, export, import, offer to sell and sell such Library Compounds in the Field (the “ Genus License ”); provided , however , that: (a) this license shall not apply with respect to uses against any Target that was the basis of a Lead Program for which Novartis has declined to exercise its Option or for which the relevant [**] day Option exercise period has expired; and (b) for such Infinity programs arising from screening Library Compounds after the Threshold Date (and therefore for which no Option applies), this license shall not apply with respect to Targets for which one or more Library Compounds are exemplified in such Patents, by way of actual examples, to modulate such Targets as their primary mechanism of action. The foregoing licenses shall survive any termination or expiration of this Agreement, except if such termination is caused by the breach of the Party receiving such license.

3.2.2. Patent Rights and License Grants with Respect to Actual Compounds . Novartis or its Affiliates shall have the sole right to obtain Patents with respect to claims (whether specific or generic) covering Actual Compounds (including, without limitation, claims as to the manufacture or use thereof) that are not Infinity Compounds (the “ Compound Intellectual Property ”), except as set forth in Section 2.3.2(h), subject to an automatic grant to Infinity and its Affiliates under such Patents of a perpetual, worldwide, non-exclusive, fully-paid, royalty-free license (with the right to sublicense) to conduct research with respect to such Actual Compounds in the Field. The foregoing license shall survive any termination or expiration of this Agreement, except if such termination is caused by Infinity’s breach.

3.2.3. Patent Rights and License Grants with Respect to Infinity Compounds . In the event that Infinity designates an Actual Compound as an Infinity Compound pursuant to the terms of Section 3.4(b) or Section 3.5, as applicable, Novartis shall automatically assign to Infinity, for patenting purposes only, Novartis’ rights in such Infinity Compound, and shall automatically grant Infinity and its Affiliates a worldwide, exclusive even as to Novartis, fully-paid, royalty-free license (with the right to sublicense) under its interest in the Collaboration Intellectual Property to research, develop, commercialize, use, manufacture, import, export, offer to sell and sell such Infinity Compounds in the Field. Infinity shall have the sole right, at

 

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Infinity’s expense, to file, prosecute and maintain Patents with respect to claims covering Infinity Compounds (including claims as to the manufacture or use thereof) (an “ Infinity Compound Patent ”); provided that: (i) each individual Infinity Compound Patent shall not claim Infinity Compounds (including claims as to the manufacture or use thereof) derived from more than [**] Synthetic Pathway and shall respect the conditions set forth in Section 3.4(b)(i) through (v); and (ii) in the event an Infinity Compound Patent erroneously covers an Actual Compound, Infinity shall grant to Novartis and its Affiliates under such Infinity Compound Patent a worldwide, exclusive even as to Infinity, fully-paid, royalty-free license (with right to sublicense) to research, develop, commercialize, use, manufacture, import, export, offer to sell and sell such Actual Compounds in the Field, and the research license granted to Infinity pursuant to Section 3.2.2 shall not be applicable with respect to such Actual Compound. For the avoidance of doubt, any claims covering an Actual Compound: (a) in a Lead Series which is subject to the Option for which the relevant [**] day Option exercise period has not yet expired nor been declined by Novartis shall not be considered erroneous if: (1) Infinity has been permitted the right to file and obtain Patents with respect to such Lead Series pursuant to Section 2.3.2(h), and (2) Infinity designates such Actual Compounds as Infinity Compounds within [**] days after Novartis has declined its Option with respect to such Lead Series or for which the relevant [**] day Option exercise period has expired; (b) in a Lead Series which was subject to the Option which Option Novartis had declined or for which the relevant [**] day Option exercise period has expired shall not be considered erroneous if Infinity designates such Actual Compounds as Infinity Compounds pursuant to Section 3.4(b); or (c) with respect to Infinity’s screening activities directed at the Library Compounds which are conducted after the Threshold Date shall not be considered erroneous if Infinity designates such Actual Compounds as Infinity Compounds pursuant to Section 3.5. In addition, Infinity shall automatically grant to Novartis and its Affiliates a worldwide, non-exclusive, full-paid, royalty-free license (with the right to sublicense) under its interest in the Infinity Compound Patents, the Collaboration Intellectual Property and the Background Intellectual Property to conduct research with respect to the relevant Infinity Compound in the Field. For the avoidance of doubt, the Genus License shall be applicable to its related Infinity Compound Patent with respect to claims covering Library

 

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Compounds that are not Actual Compounds or Infinity Compounds. The foregoing licenses shall survive any termination or expiration of this Agreement, except if such termination is caused by the breach of the Party receiving the license.

3.3. Option with Respect to Lead Programs.

3.3.1. Exclusivity . For Lead Programs developed from screening Library Compounds prior to the Threshold Date, Novartis shall have the exclusive right (the “ Option ”) to obtain a worldwide, exclusive license (with right to sublicense) on a Target-by-Target basis, to develop and commercialize any such Lead Program in the Field, under the terms and conditions set forth in the License Agreement.

3.3.2. Lead Criteria . Prior to the Threshold Date, and before Infinity commences screening a Target (or when a Target is identified as set forth in 3.1.2(b)(ii)), the Joint Steering Committee shall determine, pursuant to Section 2.3.2(d), the appropriate assays and criteria (the “ Lead Criteria ”) that will trigger Novartis’ Option with respect to such Lead Program comprised of one or more Lead Series, such Lead Criteria to include at least the following:

(a) [**], as applicable, and purification (>[**]% purity by HPLC-MS UV 210 nm; in the event that the Joint Steering Committee determines that HPLC-MS UV is not an appropriate detection method, then purity shall instead be determined by HPLC-MS ELSD), in each case, of at least [**] chemical entities per Lead Series;

(b) [**] in an enzymatic assay or other primary assay;

(c) [**] in a cellular or functional assay than that found in the enzymatic assay or other primary assay;

(d) evidence of [**]; and

(e) evidence of [**].

3.3.3. Data Package . Infinity shall deliver to Novartis the following information and materials with respect to such Lead Program (collectively, the “ Data Package ”):

(a) Data evidencing achievement of all Lead Criteria set forth in Section 3.3.2; and

 

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(b) The following data for the most potent compound of each Lead Series: (i) [**]; (ii) [**]; (iii) [**]; (iv) [**]and (v) [**].

3.3.4. Exercise of an Option .

(a) Novartis shall have [**] calendar days after receipt of the Data Package in which to provide written notice to Infinity (the “ Data Receipt Notice ”) as to whether the Data Package is complete and whether the Lead Criteria have been achieved with respect to the relevant Lead Program, each as reasonably determined by Novartis. If Novartis has not provided a Data Receipt Notice to Infinity within such [**] day period, the Data Package shall be deemed to be complete and the Lead Criteria shall be deemed to have been achieved with respect to the Lead Program.

(b) If Novartis reasonably determines that the Data Package is incomplete or that the Lead Criteria have not been achieved, then Infinity may perform additional research as necessary and resubmit the Data Package; provided that Novartis shall have additional [**] calendar day periods to evaluate each such resubmission.

(c) If Novartis determines that the Data Package is complete and that the Lead Criteria have been achieved, then, in the Data Receipt Notice, Novartis may select chemical entities in each Lead Program as set forth in 3.3.2(a) for synthesis (up [**] milligrams of purified material) and delivery by Infinity to Novartis for further biological testing which may include the following: (i) confirmation of activity in primary and cellular systems; (ii) hERG channel inhibition using patch clamp assay; (iii) in vivo efficacy and PK; (iv) detailed metabolism studies; and (v) other studies at Novartis’ discretion. In addition, Infinity will provide access to screening data, if required by Novartis. Within [**] business days after receipt of the request, Infinity will provide Novartis with a quote for the expected length of time and the cost to provide each such chemical entity. Infinity will base such quotation on an FTE rate of U.S.$[**] per month to synthesize and deliver such chemical entities and in no case shall the quotation exceed

 

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U.S.$[**] per chemical entity. Novartis shall have [**] calendar days in which to accept or reject such quote in writing. If Novartis does not accept such quote within such [**] day period, Infinity shall have no obligation to synthesize such compounds and deliver the related information. If Novartis accepts such quote within such [**] day period, Infinity will use its commercially reasonable efforts to provide such synthesized compounds within [**] weeks after receipt of Novartis’ written acceptance of such quote. Each such synthesized compound shall be greater than [**] percent ([**]%) pure as determined by HPLC-MS UV 210 nm. In the event that the Joint Steering Committee determines that HPLC-MS UV is not an appropriate detection method, then purity shall instead be determined by HPLC-MS ELSD. With each such synthesized compound delivered, Infinity shall also contemporaneously provide a certificate of analysis including the HPLC chromatogram, proton and carbon NMR spectra and detailed synthetic protocol used for the synthesis.

(d) It shall be the responsibility of the Novartis representatives of the Joint Steering Committee to communicate to Infinity if Novartis chooses, in its sole discretion, to exercise the Option. The Novartis representatives of the Joint Steering Committee may involve other employees or consultants of Novartis and its Affiliates in this process, on a need-to-know basis and subject to the provisions of Article IV, as is reasonably necessary to determine whether or not to exercise the Option.

(e) Novartis shall have [**] calendar days from receipt of the last requested samples meeting the criteria described in subsection (c), or, if either no samples are requested or samples are requested but Novartis does not accept Infinity’s quote therefor pursuant to subsection (c), [**] calendar days from receipt of the Data Receipt Notice, to exercise its Option with respect to the relevant Lead Program. Novartis may exercise such Option by delivery to Infinity of written notice of exercise, specifying the Lead Program as to which such Option is being exercised, in which case, once the License Agreement is executed, Novartis shall have the exclusive right to file, prosecute and maintain Patents in its name covering inventions relating to the Lead Program as provided in the License Agreement. The Parties shall then promptly execute the License Agreement, the terms of which, upon such execution, shall be incorporated

 

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by reference into, and shall be a part of, this Collaboration Agreement, pursuant to which terms, Infinity will grant Novartis and its Affiliates a worldwide, exclusive even as to Infinity license (with the right to sublicense), to develop and commercialize the Lead Program as an Optioned Lead Program under Infinity’s Background Intellectual Property and under Infinity’s rights and interest in the Collaboration Intellectual Property in the Field. If an Option has previously been exercised with respect to another Lead Program and a License Agreement is in effect with respect to that Lead Program, then the License Agreement will be amended to reflect the addition of another Lead Program as an Optioned Lead Program.

3.3.5. Restrictions on Commercialization or Partnering .

(a) Any Target . Until such time as Novartis affirmatively declines its Option for a Lead Program, or until the expiration of the relevant [**] day Option exercise period, whichever comes first, Infinity shall not, subject to Section 2.3.2(h), file any Patent covering such Lead Program, commercialize such Lead Program or collaborate with a Third Party (except subcontractors working on Infinity’s behalf in connection with its obligations hereunder) with respect to the development or commercialization of such Lead Program.

(b) Novartis Reserved Targets . If Novartis does not exercise its Option for a Lead Program with respect to any Target that is a Novartis Reserved Target, then Infinity shall not, subject to Section 2.3.2(h), file any Patent covering such Lead Program (or otherwise shall assign such Patent to Novartis), or pursue further development or commercialization of such Lead Program, including any Derivative Compounds of such Lead Program, whether alone or with a Third Party.

3.4. Declined Options on Targets Other Than Novartis Reserved Targets.

If Novartis does not exercise its Option with respect to any Target that is not a Novartis Reserved Target during the [**] day Option exercise period or Novartis affirmatively declines such Option, then the following shall apply:

(a) Upon request from Infinity, Novartis shall provide Infinity any data it has generated in connection with evaluation of such Lead Program pursuant to Section 3.3.4(c), and

 

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shall automatically grant to Infinity a non-exclusive license to use such data for research, development and commercialization purposes, and shall return to Infinity any remaining amounts of compounds that had been provided by Infinity under Section 3.3.4(c) for evaluation of such Lead Program.

(b) Prior to initiating further lead optimization activities with respect to such Lead Program or from time to time thereafter during the term of this Agreement, and to the extent necessary to protect Infinity’s intellectual property rights in such Lead Program, Infinity may select and designate Actual Compounds within such Lead Program as “ Infinity Compounds ,” provided that Infinity notifies Novartis of the same in writing and provides Novartis an electronic data file containing each such proposed Infinity Compound and Novartis has not, within [**] days of such notification, represented to Infinity in writing that such Actual Compounds are already covered, specifically or generically, by a Novartis Patent claiming inventions created before Novartis’ receipt of the Data Package for such Lead Program; and provided , further , that:

 

(i)

Prior to the [**] anniversary of the Effective Date, there shall be no more than [**] Infinity Compounds at any time;

 

(ii)

After the [**] but prior to the [**] anniversary of the Effective Date, there shall be no more than [**] Infinity Compounds at any time;

 

(iii)

After the [**] anniversary of the Effective Date, there shall be no more than [**] Infinity Compounds at any time (including after the Threshold Date);

 

(iv)

In no event may more than [**] Infinity Compounds be derived from any single Synthetic Pathway (including after the Threshold Date); and

 

(v)

Infinity may redesignate Infinity Compounds as Actual Compounds by providing written notice and an electronic data file containing each such Infinity Compound of the same to Novartis, in which case the total number of Infinity Compounds shall be reduced by those redesignated as Actual Compounds.

 

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(c) For purposes of clarity, Infinity Compounds also remain Actual Compounds.

3.5. Designation of Infinity Compounds During the Term of this Agreement and After The Threshold Date.

Infinity may select and designate as Infinity Compounds those Actual Compounds necessary to protect Infinity’s intellectual property rights in lead optimization efforts resulting from screening activities directed at the Library Compounds which are conducted after the Threshold Date; provided that Infinity notifies Novartis of the same in writing and provides Novartis an electronic data file containing each such proposed Infinity Compound and Novartis has not, within [**] days of such notification, represented to Infinity in writing that such Actual Compounds are already covered, whether with generic or specific claims, by a Patent Controlled by Novartis or its Affiliates that was filed before Novartis’ receipt of such notification; and provided further that there shall be neither more than [**] Infinity Compounds at any time nor shall more than [**] Infinity Compounds be derived from any single Synthetic Pathway. Infinity may redesignate Infinity Compounds as Actual Compounds by providing written notice and an electronic data file containing each such Infinity Compound of the same to Novartis, in which case the total number of Infinity Compounds shall be reduced by those redesignated as Actual Compounds.

3.6. No Designation of Infinity Compounds After the Term of this Agreement.

After expiration or termination of this Agreement, (a) Infinity shall no longer have the right to select and designate any Actual Compounds as Infinity Compounds, and (b) Infinity shall not patent (whether with generic or specific claims) any Actual Compounds. After expiration or termination of this Agreement, Infinity shall have the right to screen Library Compounds against any Target; provided that Infinity may not sell or otherwise provide such Library Compounds to any Third Party (except to subcontractors working on Infinity’s behalf).

 

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ARTICLE IV

C ONFIDENTIALITY

4.1. Undertaking.

During the term of this Agreement, each Party (the “ Receiving Party ”) shall keep confidential, and other than as provided herein shall not use or disclose, directly or indirectly, any trade secrets, confidential or proprietary information, or any other knowledge, information, documents or materials, disclosed to the Receiving Party by the other Party (the “ Proprietary Party ”), whether in tangible or intangible form, the confidentiality of which such Proprietary Party takes reasonable measures to protect, including but not limited to Collaboration Intellectual Property.

(a) The Receiving Party shall take any and all lawful, reasonable measures to prevent the unauthorized use and disclosure of such information, and to prevent unauthorized Persons from obtaining or using such information. With the prior written consent of the Proprietary Party, the Receiving Party may, however, use and disclose such information to exercise its rights to file, prosecute and maintain Patents within the Collaboration Intellectual Property as permitted by this Agreement.

(b) The Receiving Party further agrees to refrain from directly or indirectly taking any action which would constitute or facilitate the unauthorized use or disclosure of such information. The Receiving Party may disclose such information to its Affiliates, officers, employees and agents, to authorized licensees and sublicensees, and to subcontractors in connection with the Receiving Party’s obligations hereunder, to the extent necessary to enable such Persons to perform their obligations hereunder or under the applicable license, sublicense or subcontract, as the case may be; provided that such Affiliates, officers, employees, agents, licensees, sublicensees and subcontractors have entered into appropriate confidentiality agreements for secrecy and non-use of such information which by their terms shall be enforceable by injunctive relief. In the event any such Persons violate such agreements with respect to such information, the Receiving Party shall enforce such agreements.

 

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(c) The Receiving Party shall be liable for any unauthorized use and disclosure of such information by its Affiliates, officers, employees and agents and any such licensees, sublicensees and subcontractors.

4.2. Exceptions.

Notwithstanding the foregoing, the provisions of Section 4.1 shall not apply to knowledge, information, documents or materials that the Receiving Party can conclusively establish:

(a) were generally available to the public at the time of disclosure or become generally available to the public without the Receiving Party’s breach of any obligation owed to the Proprietary Party;

(b) are permitted to be disclosed by the prior written consent of the Proprietary Party;

(c) were known by the Receiving Party at the time of disclosure, or have become known to the Receiving Party from a source other than the Proprietary Party, other than by breach of an obligation of confidentiality owed to the Proprietary Party;

(d) are disclosed by the Proprietary Party to a Third Party without restrictions on its disclosure;

(e) are independently developed by the Receiving Party without breach of this Agreement or any other confidentiality agreement between the Parties or between a Party and an Affiliate of the other Party, without reference to or reliance upon knowledge, information or materials of the Proprietary Party; or

(f) are required to be disclosed by the Receiving Party to comply with applicable laws or regulations, to submit registration filings, to defend or prosecute litigation or patents or to comply with governmental regulations, provided that the Receiving Party provides prior written notice of such disclosure to the Proprietary Party and takes reasonable and lawful actions to avoid or minimize the degree of such disclosure.

 

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4.3. Publicity.

The Parties have agreed upon the timing and content of the initial press release relating to this Agreement and the transactions contemplated herein. The Parties will agree upon the timing and content of any other press release or other public communications relating to this Agreement and the transactions contemplated herein.

Except to the extent already disclosed in that initial press release or other public communication, no public announcement concerning the existence or the terms of this Agreement or concerning the transactions described herein shall be made, either directly or indirectly, by Infinity or Novartis, except as may be legally required by applicable laws, regulations, or judicial order, without first obtaining the approval of the other Party and agreement upon the nature, text, and timing of such announcement.

The Party desiring to make any such public announcement shall provide the other Party with a written copy of the proposed announcement in sufficient time prior to public release to allow such other Party to comment upon such announcement, prior to public release.

Notwithstanding the foregoing, either Party may disclose: (a) to bona fide potential or actual licensees or sublicensees only those terms of this Agreement that are reasonably necessary to disclose in connection with a license or sublicense as permitted this Agreement; and (b) to bona fide potential or actual investors, lenders, investment bankers, acquirors, acquirees, or merger partners, and to such Party’s consultants and advisors, only those terms of this Agreement that are reasonably necessary in connection with a proposed equity or debt financing, acquisition or business combination of such Party.

4.4. Survival.

The provisions of this Article IV shall survive for [**] years after the termination or expiration of this Agreement.

 

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4.5. Equitable Relief.

The Receiving Party agrees that any breach of this Article IV may cause the Proprietary Party substantial and irreparable injury and, therefore, in the event of any such breach, in addition to other remedies that may be available, the Proprietary Party shall have the right to specific performance and other injunctive and equitable relief.