EXHIBIT 10.41 AMENDED AND RESTATED CANCER COLLABORATION AGREEMENT BETWEEN EXELIXIS, INC. AND BRISTOL-MYERS SQUIBB COMPANYCollaboration Agreement |
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EXHIBIT 10.41
AMENDED AND RESTATED
CANCER COLLABORATION AGREEMENT
BETWEEN
EXELIXIS, INC.
AND
BRISTOL-MYERS SQUIBB COMPANY
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
TABLE OF CONTENTS
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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
AMENDED AND RESTATED CANCER COLLABORATION AGREEMENT
THIS AMENDED AND RESTATED CANCER COLLABORATION AGREEMENT (the “Amended and Restated Agreement”) is made and entered into as of December 15, 2003 (the “Amendment Effective Date”) by and between EXELIXIS, INC., a Delaware corporation having its principal place of business at 170 Harbor Way, P.O. Box 511, South San Francisco, California 94083-0511 (“Exelixis”), and BRISTOL-MYERS SQUIBB COMPANY, a Delaware corporation headquartered at 345 Park Avenue, New York, New York, 10154 (“BMS”). Exelixis and BMS are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
RECITALS
A. BMS is a multinational health care company that has expertise and capability in developing and marketing human pharmaceuticals and has research and development programs.
B. Exelixis is a multinational biotechnology company that has expertise and proprietary technology relating to genetic model systems, functional genomics and computational biology and is applying such technology to discover and validate targets for drug discovery in a variety of disease areas.
C. BMS and Exelixis desire to establish a collaboration to apply such Exelixis technology and expertise to the identification and characterization of biochemical pathways and targets in specific research areas relevant to cell growth and proliferation, to generate small molecule therapeutic or prophylactic compounds directed against such targets, and to provide for the development and commercialization of novel therapeutic and prophylactic products based on such research.
D. Exelixis and BMS entered into the Cancer Collaboration Agreement (the “Agreement”) on July 17, 2001 (the “Effective Date”) and subsequently amended the Agreement pursuant to a Letter Amendment effective December 7, 2001 (the “First Amendment”).
E. Exelixis and BMS now wish to amend further the Agreement and to restate the amended agreement.
NOW, THEREFORE, the Parties agree as follows:
1. DEFINITIONS
The following terms shall have the following meanings as used in this Amended and Restated Agreement:
1.1 “Abandoned DVT” means [ * ] .
1.2 “Abandoned ET” means [ * ] .
1.3 “Abandoned Target” means an Abandoned DVT or an Abandoned ET.
1.4 “Affiliate” means, with respect to a particular Party, a person, corporation, partnership, or other entity that controls, is controlled by or is under common control with such Party. For the purposes of the definition in this Section 1.4, the word “control” (including, with correlative meaning, the terms “controlled by” or “under the common control with”) means the actual power, either directly or indirectly through one (1) or more intermediaries, to direct or cause the direction of the management and policies of such entity, whether by the ownership of at least fifty percent (50%) of the voting stock of such entity, or by contract or otherwise.
1.5 “Assay” means [ * ] .
1.6 “Back-up Compound” means, [ * ] .
1.7 “BMS Collaboration Product” means [ * ] .
1.8 “BMS DVT Product” means [ * ] .
1.9 “BMS ET Product” means [ * ] .
1.10 “BMS Know-How” means all Information Controlled by BMS (other than BMS Patents) and its Affiliates during the term of the Agreement or this Amended and Restated Agreement that is necessary or reasonably useful for Exelixis to exercise the rights licensed or granted to it under Sections 5.3 and 5.5 hereof and/or to perform its obligations to the Collaboration under this Amended and Restated Agreement.
1.11 “BMS Patents” means all Patents Controlled by BMS and its Affiliates, including Patents Controlled jointly with Exelixis, during the term of the Agreement or this Amended and Restated Agreement that are necessary or reasonably useful for Exelixis to exercise the rights licensed or granted to it under Section 5.3 (or which may be acquired by it under Section 5.5 hereof) and/or to perform its obligations to the Collaboration under this Amended and Restated Agreement.
1.12 “BMS Product” means [ * ] .
1.13 “BMS Selected DVT” means [ * ] .
1.14 “BMS Selected ET” means [ * ] .
1.15 “BMS Selected Target” means [ * ] .
1.16 “BMS Sole Product” means [ * ] .
1.17 “Collaboration” means all the activities performed by or on behalf of Exelixis or BMS in the course of performing work contemplated in Article 2 or Section 3.1 or 3.5.
1.18 “Collaboration Compound” means [ * ].
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For clarity, any compound licensed in by BMS from Third Parties for activity against a BMS Selected Target shall not be deemed to be a Collaboration Compound for milestone and royalty purposes hereunder unless such compound is (A) acquired as a result of the use or subsequently developed through the use, to any material extent, of any Information relating to such BMS Selected Target that Remained Confidential to Exelixis at the time of use or (B) developed in a manner or acquired as a result of activity that would otherwise have infringed a claim of an issued or published (and subsequently issued) Exelixis Patent.
BMS shall not have any development or commercialization license rights under Section 5.1(a)(iv) with respect to any compound that fails to meet the definition of a Collaboration Compound. The preceding sentence shall not be interpreted as preventing BMS from developing or commercializing, on account of its ability to modulate a target other than a BMS Selected Target, a derivative of a Lead Compound or a Back-up Compound wherein such derivative (A) was made by BMS pursuant to its license in Section 5.1(a)(iv), (B) is not a Collaboration Compound and (C) (1) for which the manufacture and use of such derivative would not infringe an EXEL Patent and (2) is not manufactured, developed or commercialized through the use of EXEL Know-How that Remains Confidential at the time of use.
1.19 “Controlled” means, with respect to any gene, protein, compound, material, Information or intellectual property right, that the Party owns or has a license to such gene, protein, compound, material, Information or intellectual property right and has the ability to grant to the other Party access, a license or a sublicense (as applicable) to such gene, protein, compound, material, Information or intellectual property right as provided for herein without violating the terms of any agreement or other arrangements with any Third Party existing at the time such Party would be first required hereunder to grant the other Party such access, license or sublicense.
1.20 “Decision Point 1 (DP1) Approval” means [ * ] .
1.21 “Decision Point 2 (DP2) Approval” means [ * ] .
1.22 “Decision Point 3 (DP3) Approval” means [ * ] .
1.23 “Designated Target” means [ * ] .
1.24 “Designated Validated Target” means [ * ] .
1.25 “Development Field” means [ * ] .
1.26 “Diligent Efforts” means [ * ] .
1.27 “DP1 Orthologue” means [ * ] .
1.28 “Draft Target Pool” means [ * ] .
1.29 “Draft Validated Target Pool” means [ * ] .
1.30 “Eligible Target” means [ * ].
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1.31 “EXEL Compound” means [ * ] .
1.32 “EXEL DP1 Equivalent” means [ * ].
1.33 “EXEL Know-How” means all Information Controlled by Exelixis (other than EXEL Patents or Target Inventions invented solely or jointly by BMS) and its Affiliates during the term of the Agreement or this Amended and Restated Agreement that is necessary or reasonably useful for BMS to exercise the rights licensed or granted to it under Sections 5.1 and 5.2 hereof and/or to perform its obligations to the Collaboration under this Amended and Restated Agreement.
1.34 “EXEL Patents” means all Patents Controlled by Exelixis and its Affiliates (other than Patents claiming Target Inventions invented solely by BMS or jointly by BMS with Exelixis, but including Patent claiming Target Inventions invented solely by Exelixis), including Patents Controlled jointly with BMS, during the term of the Agreement or this Amended and Restated Agreement that are necessary or reasonably useful for BMS to exercise the rights licensed or granted to it under Section 5.1 hereof (or which may be acquired by it under Sections 5.2(b) and 5.5 hereof) and/or to perform its obligations to the Collaboration under this Amended and Restated Agreement.
1.35 “EXEL Product” means [ * ] .
1.36 “EXEL Selected ET” means [ * ] .
1.37 “EXEL Selected Target” means [ * ] .
1.38 “Gene Family” means (a) a group of at least [ * ] that meet the [ * ] regarding [ * ] or (b) a group of at least [ * ] that [ * ] .
1.39 “Genetic Entry Point” means [ * ] .
1.40 “Genetic Screen” means [ * ] .
1.41 “IND” means an Investigational New Drug Application filed with the United States Food and Drug Administration in conformance with applicable laws and regulations, or the foreign equivalent of any such application in any other country.
1.42 “Information” means information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including without limitation, databases, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, and patent and other legal information or descriptions.
1.43 “Initial Research Term” means the period commencing on the Effective Date and ending on the third (3 rd ) anniversary of the Effective Date.
1.44 “Invention” means [ * ] .
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1.45 “Joint Invention” means [ * ] .
1.46 “Joint Management Team” or “JMT” means the committee described in Section 2.3.
1.47 “Joint Scientific Committee” or “JSC” means the committee described in Section 2.4.
1.48 “Lead Compound” means [ * ] .
1.49 “Major Market” means [ * ] .
1.50 “MOA Agreement” means the Research Collaboration and Technology Transfer Agreement between Exelixis and BMS dated September 14, 1999, as heretofore amended and as may be amended from time to time hereafter.
1.51 “Model System Target” means [ * ].
1.52 “NDA” means a New Drug Application filed with the United States Food and Drug Administration in conformance with applicable laws and regulations, or the foreign equivalent of any such application in any other country.
1.53 “Net Sales” means [ * ].
In the event a Product or Pharmacogenomic Product is sold as an end-user product consisting of a combination of active functional elements or as a combined product and/or service, Net Sales, for purposes of determining royalty payments on such Product or Pharmacogenomic Product, shall be calculated by multiplying the Net Sales of the end-user product and/or service by the fraction A over A+B, in which A is the gross selling price of the Product or Pharmacogenomic Product portion of the end-user product and/or service when such Product or Pharmacogenomic Product is sold separately during the applicable accounting period in which the sales of the end-user product were made, and B is the gross selling price of the other active elements and/or service, as the case may be, of the end-user product and/or service sold separately during the accounting period in question. All gross selling prices of the elements of such end-user product and/or service shall be calculated as the average gross selling price of the said elements during the applicable accounting period for which the Net Sales are being calculated. In the event that, in any country or countries, no separate sale of either such above-designated Product or Pharmacogenomic Product or such above designated elements of the end-user product and/or service are made during the accounting period in which the sale was made or if gross retail selling price for an active functional element, component or service, as the case may be, cannot be determined for an accounting period, Net Sales allocable to the Product or Pharmacogenomic Product in each such country shall be determined by mutual agreement reached in good faith by the Parties prior to the end of the accounting period in question based on an equitable method of determining same that takes into account, on a country by country basis, variations in potency, the relative contribution of each active agent, component or service, as the case may be, in the combination, and relative value to the end user of each active agent, component or service, as the case may be.
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Notwithstanding the foregoing, it is agreed that drug delivery vehicles, adjuvants, and excipients shall not be deemed to be “active ingredients” or “active functional elements,” the presence of which in a Product or Pharmacogenomic Product would be deemed to create a combination product subject to the terms of the preceding paragraph.
1.54 “Nonselected Target” shall have the meaning set forth in Section 3.3(h).
1.55 “Patent” means (a) unexpired letters patent (including inventor’s certificates) which have not been held invalid or unenforceable by a court of competent jurisdiction from which no appeal can be taken or has been taken within the required time period (and which have not been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise, or been abandoned in accordance with or as permitted by the terms of this Amended and Restated Agreement or by mutual written agreement), including without limitation any substitution, extension, registration, confirmation, reissue, re-examination, supplementary protection certificates, confirmation patents, patent of additions, renewal or any like filing thereof and (b) pending applications for letters patent which have not been canceled, withdrawn from consideration, finally determined to be unallowable by the applicable governmental authority for whatever reason (and from which no appeal is or can be taken), and/or abandoned in accordance with or as permitted by the terms of this Amended and Restated Agreement or by mutual written consent, including without limitation any continuation, division or continuation-in-part thereof and any provisional applications.
1.56 “ Pharmacogenomic Product ” means [ * ] .
1.57 “Phase I Clinical Trial” means a trial on sufficient numbers of normal volunteers and patients that is designed to establish that a pharmaceutical product is safe for its intended use, and to support its continued testing in Phase II Clinical Trials.
1.58 “Phase II Clinical Trial” means a trial on sufficient numbers of patients that is designed to establish the safety and biological activity of a pharmaceutical product for its intended use, and to define warnings, precautions and adverse reactions that are associated with the pharmaceutical product in the dosage range to be prescribed.
1.59 “Phase III Clinical Trial” means a trial on sufficient numbers of patients that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with the pharmaceutical product in the dosage range to be prescribed, and to support Regulatory Approval of such pharmaceutical product or label expansion of such pharmaceutical product.
1.60 “Phenotypic Screen” means [ * ] .
1.61 “PreDesignated Target” means [ * ].
1.62 “Product” means [ * ] .
1.63 “PTP” means [ * ] .
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1.64 “Regulatory Approval” means any and all approvals (including supplements, amendments, pre- and post-approvals, pricing and reimbursement approvals), licenses, registrations or authorizations of any national, supra-national (e.g., the European Commission or the Council of the European Union), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, that are necessary for the manufacture, distribution, use or sale of a Product in a regulatory jurisdiction.
1.65 “Remains Confidential” means, with respect to Information generated pursuant to the Collaboration that is used by or on behalf of a Party or its Affiliate or sublicensee, that such Information, at the time of such use, was not then in the public domain and was not then known to a Party or any of its Affiliates or licensees as a result of disclosure by a Third Party entitled to disclose same without restriction as to confidentiality.
1.66 “Research Field” means cancer research [ * ] .
1.67 “Research Plan” shall have the meaning set forth in Section 2.7.
1.68 “Research Term” “ means the Initial Research Term plus the Subsequent Research Term.
1.69 “Reverted Target” shall have the meaning set forth in Section 3.1.
1.70 “Selected DVT” means [ * ] .
1.71 “Selected ET” means [ * ] .
1.72 “Selected Target” means a Selected ET or a Selected DVT.
1.73 “Sole Invention” means [ * ] .
1.74 “Subsequent Research Term” means the period commencing on the third (3 rd ) anniversary of the Effective Date and ending, unless earlier terminated pursuant to Sections 2.6(a), [ * ] or 10.2, [ * ] , on the eighth (8 th ) anniversary of the Effective Date.
1.75 “Target” means [ * ] .
1.76 “Target Invention” means [ * ] .
1.77 “Third Party” means any entity other than (i) Exelixis, (ii) BMS or (iii) an Affiliate of either Party.
1.78 “ Threshold BMS Product ” means [ * ] .
1.79 “Tier 1 Validation” means [ * ] .
1.80 “Tier 2 Validation” means [ * ] .
1.81 “Tier 2 Validation Criteria” means [ * ] .
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1.82 “Valid Claim” means (a) a claim in an issued Patent, as described in Section 1.55(a), which has not (i) expired or been canceled, (ii) been declared invalid by an unreversed and unappealable decision of a court or other appropriate body of competent jurisdiction, (iii) been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise, or (iv) been abandoned in accordance with or as permitted by the terms of this Amended and Restated Agreement or by mutual written agreement, or (b) a claim under a pending application for a Patent, as described in Section 1.55(b), that has been pending five (5) years or less from its date of filing, and which have not been canceled, withdrawn from consideration, finally determined to be unallowable by the applicable governmental authority for whatever reason (and from which no appeal is or can be taken), or abandoned.
1.83 “VBP” means the Third Party with whom Exelixis, as of the Amendment Effective Date, has an alliance to discover, develop and commercialize therapeutics in the areas of [ * ] .
2. RESEARCH PROGRAM
2.1 Overview. The general goals and intent of the Collaboration are to apply the Exelixis technology to discovering Eligible Targets and Designated Validated Targets that may be useful for the discovery and development of small molecule drugs for the prevention, treatment or cure of cancer. One of the goals of the research to be conducted during the Subsequent Research Term is the identification of [ * ] using technologies that (a) subject to Section 2.7, are [ * ] , and (b) the JSC believes will [ * ] ; provided that when the JMT and JSC allocate resources and set research priorities, they take into account [ * ] in the course of the Collaboration. [ * ] . The genes arising from such research shall be used to identify human genes which encode proteins likely to be suitable for the development of a small molecule therapeutic or prophylactic products for the treatment of cancer. As set forth in more detail in Section 3.3, each Party shall [ * ] choose those human genes that qualify as Eligible Targets and Designated Validated Targets for development of a small molecule cancer drug.
2.2 Management Structure . The Parties agree to establish a multi-level committee structure to manage and direct the Collaboration and the relationship of the Parties in pursuing the research and development goals of this Amended and Restated Agreement. The committee structure is intended to facilitate decision making and management of the various Collaboration activities of the Parties, and each Party agrees to use good faith, cooperative efforts to facilitate and assist the efforts of such committees. The overall management of the Collaboration with respect to work performed by the Parties under the Research Plan shall be vested in the Joint Management Team (the “JMT”), with responsibility, as further discussed in Section 2.3, for establishing the strategic direction of the Collaboration and for managing and directing the research efforts of the Parties under the Collaboration. The day-to-day management and direction of the Research Program shall be managed by the Joint Scientific Committee (the “JSC”), which shall report to and be managed by the JMT. [ * ] . Any dispute that cannot be resolved by the JSC for matters that come before it shall be resolved by the JMT.
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2.3 Joint Management Team .
(a) Membership . The Joint Management Team (the “JMT”) shall be composed of four members, two members appointed by each Party. [ * ] , each Party shall appoint two representatives from its senior management team to the JMT. Each Party may replace its JMT representatives at any time upon written notice to the other Party. Exelixis shall designate one of its representatives as Chairperson for the period from the Effective Date until the first anniversary of the Effective Date. Thereafter, the Parties shall alternately designate a Chairperson of the JMT for each subsequent contract year. The Chairperson shall be responsible for scheduling meetings, preparing and circulating an agenda in advance of each meeting, and preparing and issuing minutes of each meeting within thirty (30) days thereafter. Any JMT member may add topics to the draft agenda.
(b) Responsibilities . During [ * ] , the JMT shall meet a minimum of [ * ] as provided in Section 2.5; thereafter, the JMT shall meet at the request of either Party, which request may be made by each Party not more than [ * ] , unless otherwise agreed to by [ * ] . The JMT shall supervise and direct the JSC, evaluate the progress of research under the Research Plan and monitor compliance with the diligence provisions set forth in Sections 2.7 and 3.4, and it will make the final decisions regarding [ * ] . To the extent necessary to carry out its responsibilities, a Party’s JMT members shall be granted access to the other Party’s Confidential Information relevant to any decision required to be made by the JMT. Thus, it may be that members of the JMT, in assessing modifications to the Research Plan, assessing the results generated in the course of carrying out the Research Plan, or making determinations as required in this Section 2.3, may need to be granted access to higher levels of the proprietary or Confidential Information of the other Party than is provided to the JSC or to the employees of such Party working on the Collaboration. The JMT shall discuss in good faith and agree on the level of such access that is needed to achieve the goals and intent of the Parties.
2.4 Joint Scientific Committee.
(a) Membership . The Joint Scientific Committee (the “JSC”) shall be composed of four members. Each Party may invite, with the approval of the other Party (which shall not be unreasonably withheld), additional employees or consultants (provided such employees and consultants have contractual confidentiality obligations to such Party that are at least as stringent as those set forth in this Amended and Restated Agreement) to attend one (1) or more meetings of the JSC as ad hoc, non-voting guests. [ * ] , each Party shall appoint two representatives to the JSC, one such representative being the individual at the Party with primary responsibility for the day-to-day management and execution of the Research Plan. The JSC will report directly to the JMT and shall take its direction from the JMT. Each Party may replace its appointed JSC representatives at any time upon written notice to the other Party. Exelixis shall designate one of its representatives as Chairperson of the JSC. The Chairperson shall be responsible for scheduling meetings, preparing and circulating an agenda in advance of each meeting, and preparing and issuing minutes of each meeting within thirty (30) days thereafter. Any JSC member may add topics to the draft agenda.
(b) Responsibilities . During [ * ] , the JSC shall meet at a minimum [ * ] . Except for decisions made by the BMS members of the JSC pursuant to Section 1.30(c), the JSC
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shall operate by [ * ] . It shall be responsible for the planning and execution of the Research Program. At its meetings, the JSC shall evaluate the data generated by the Parties in the course of carrying out the Research Plan, shall prioritize the Genetic Entry Points, shall perform those activities specifically described in this Article 2 and Article 3 and may consider modifying the Research Plan. At the next JMT meeting, the JSC shall summarize for the JMT the progress in carrying out the Research Plan since the last JMT meeting, bring to the attention of the JMT any overarching issues or significant changes in a Research Plan, and address any issues raised by the JMT at its previous meeting. The JSC shall also prioritize projects within the Research Plan. To the extent necessary to carry out its responsibilities, a Party’s JSC members shall be granted access to the other Party’s Confidential Information relevant to any decision required to be made by the JSC.
2.5 Meetings . The Parties shall endeavor to schedule meetings of the JMT and the JSC [ * ] . Meetings for the JSC shall be held on an alternating basis in New Jersey and in San Francisco. When possible, the meeting of the JMT should occur at the same location as the JSC meeting, with the JMT meeting occurring after the meeting of the JSC. With the consent of the representatives of each Party serving on a particular committee, other representatives of each Party may attend meetings of that committee as nonvoting observers. A meeting of a committee may be held by audio or video teleconference with the consent of each Party, provided that at least half of the minimum number of meetings for that committee shall be held in person. Meetings of a committee shall be effective only if at least one representative of each Party is present or participating. Each Party shall be responsible for all of its own expenses of participating in the committee meetings.
2.6 Research Term.
(a) BMS may terminate the Subsequent Research Term early by providing written notice thereof to Exelixis [ * ] prior to the fifth anniversary of the Effective Date. If BMS provides such notice to Exelixis, then the Subsequent Research Term shall terminate on the [ * ] fifth anniversary of the Effective Date. The research funding commitments of BMS set forth in Section 7.2(a) shall remain in force throughout the Initial Research Term, and the research funding commitments of BMS set forth in Section 7.2(b) shall remain in force until the termination of the Subsequent Research Term pursuant to this Section 2.6(a), [ * ] or the effective date of any termination of this Amended and Restated Agreement pursuant to Section 10.2.
(b) If, during [ * ] , Exelixis or any Exelixis Affiliate controlling Exelixis, [ * ] .
(c) For purposes of this Amended and Restated Agreement, [ * ] .
(d) The Parties may extend the Subsequent Research Term for [ * ] upon their mutual written agreement executed at least [ * ] .
2.7 Research Plan. The Parties have agreed in writing upon a detailed plan for the research to be carried out by the Parties during [ * ] and prior to the selection of each Eligible Target or Designated Validated Target as a Selected Target (the “Research Plan”). The JSC shall review the Research Plan [ * ] and may propose to the JMT revised versions of the Research Plan
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that are consistent with the terms of this Amended and Restated Agreement. The JMT shall review, revise (if necessary) and approve all such proposals for revising the Research Plan. Once approved by the JMT, such revised Research Plan shall replace the prior Research Plan. During [ * ] , each Party shall use Diligent Efforts to perform the tasks assigned to it in the Research Plan then in effect. The Parties acknowledge and understand that the Research Plan can only be changed to add new Genetic Entry Points if the procedures set forth in Section 2.8 have been carried out. At its first meeting after the Amendment Effective Date, the JSC shall discuss the Parties’ proposals for revising the Research Plan to cover [ * ] . Such revised Research Plan shall be approved by the JMT no later than [ * ] . The Parties anticipate that such Research Plan and the Research Plan for such [ * ] will include new target identification work by Exelixis. The JSC may authorize additional target identification work during [ * ] if the JSC believes that [ * ] is unlikely [ * ] . The Parties anticipate that the Research Plans for the [ * ] will be focused on [ * ] . In the course of revising the Research Plan, the JSC shall consider [ * ] .
2.8 Genetic Entry Points. The Genetic Entry Points on which research may be conducted by Exelixis during the Initial Research Term are listed on Exhibit 1.39A. Potential additional Genetic Entry Points on which research may be conducted by Exelixis during the Subsequent Research Term are listed in Exhibit 1.39B. The JSC shall decide whether genes listed or described in Exhibits 1.39A and 1.39B shall become Genetic Entry Points, and shall determine the priority of the research to be conducted on each of the Genetic Entry Points listed on Exhibits 1.39A and 1.39B. Further additional Genetic Entry Points may be designated as set forth in this Section 2.8. Prioritization of work on the Genetic Entry Points shall be determined by the JSC. [ * ] , the JSC shall review the Genetic Entry Points [ * ] , and shall determine when a Genetic Entry Point should be re-prioritized, or removed from further research, under the Research Plan. At its sole discretion, Exelixis may designate new Genetic Entry Points in the Research Field upon which Exelixis shall commence research pursuant to the Collaboration, if consistent with the relative priority given such new Genetic Entry point by the JSC. [ * ] .
2.9 Identification of Model System Targets. During [ * ] , Exelixis shall use Diligent Efforts to identify, in accordance with the Research Plan, Model System Targets [ * ] .
2.10 Identification of Human Orthologues of Model System Targets.
(a) Exelixis shall conduct a good faith search of publicly available databases for mammalian orthologues of each Model System Target it identifies pursuant to Section 2.9. [ * ] , Exelixis shall present to the BMS members of the JSC a list of all human orthologues newly identified by Exelixis pursuant to the preceding sentence. [ * ] .
(b) At each JSC meeting, for each human orthologue [ * ] , Exelixis shall present to the JSC the sequence of and a summary of the data [ * ] .
(c) If no human orthologue has been identified for a non-human Model System Target at the time Exelixis presents such Model System Target to the JSC, then the JSC shall decide whether further research should be done [ * ] .
(d) Upon termination of the Initial Research Term (other than due to termination of the Amended and Restated Agreement), if any Model System Targets for which
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no human orthologue has been identified remain, then, unless otherwise provided in the Research Plan approved by the JSC for the first year of the Subsequent Research Term, either Party may at its own discretion and expense perform, [ * ] research intended to identify one (1) or more human orthologues of such Model System Target. [ * ] .
(e) [ * ] .
(f) [ * ] .
(g) [ * ] .
(h) [ * ] .
(i) [ * ] .
2.11 Identification of Eligible Targets.
(a) The Parties will use reasonable efforts to mutually agree [ * ] . [ * ] shall bear the costs it incurs in the course of performing the responsibilities allocated to it. [ * ] shall share all resulting information from such work with the other Party at or prior to the next meeting of the JSC. Upon completion of the work reasonably necessary to determine whether a human orthologue meets the Eligible Target criteria, [ * ] shall promptly decide and record in writing whether each such human orthologue qualifies as an Eligible Target. [ * ] .
(b) If during any JSC meeting during [ * ] , a Party selects as a Selected ET any Eligible Target that was designated by the JSC or JMT as [ * ] prior to such selection, then such Party shall, as a result of such selection, [ * ] with respect to [ * ] . Such selection shall nevertheless [ * ] as a result of such selection. If, after a BMS Collaboration Compound has achieved PTP status with respect [ * ] , another BMS Collaboration Compound achieves PTP status with respect [ * ] , then BMS agrees thereafter to [ * ] , and such [ * ] for all purposes, including milestone and royalty payments set forth in Article 7, provided, that (i) [ * ] , and (ii) such [ * ] during the Initial Research Term.
(c) [ * ] .
(d) Commencing on the Amendment Effective Date, the Parties shall limit their work pursuant to this Section 2.11 to [ * ] . All work pursuant to this Section 2.11 shall cease [ * ] . During the Subsequent Research Term, the Parties shall devote their efforts to [ * ] .
2.12 Interaction with MOA Agreement.
(a) After the Effective Date, BMS agrees that it will not provide any oncology compounds to Exelixis pursuant to the MOA Agreement (it being understood that BMS may provide such compounds pursuant to this Amended and Restated Agreement if the JMT so requests for the purpose of determining Genetic Entry Points or identifying PreDesignated Targets). [ * ] .
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(b)
(i) [ * ] .
(ii) [ * ] .
(iii) [ * ] .
(c) [ * ] .
(d) [ * ] .
(e) The agreements of the Parties set forth in this Section 2.12 shall bind the Parties with respect to this Amended and Restated Agreement and the MOA Agreement. If the Parties decide that it would be helpful to execute a formal amendment of the MOA Agreement that reflects any of these agreements, then the Parties shall draft and execute such amendment in good faith and such amendment shall be consistent with the terms of this Section 2.12.
2.13 Obligations of Parties. Exelixis and BMS shall provide the JSC and its authorized representatives with [ * ] .
2.14 Collaboration Guidelines. Subject to the terms of this Amended and Restated Agreement, the activities and resources of each Party shall be managed by such Party, acting independently and in its individual capacity. The relationship between Exelixis and BMS is that of independent contractors, and neither Party shall have the power to bind or obligate the other Party in any manner, other than as is expressly set forth in this Amended and Restated Agreement.
2.15 Conduct of Research. The Parties shall use Diligent Efforts to conduct their respective tasks throughout the Collaboration and shall conduct the Collaboration in good scientific manner, and in compliance in all material respects with the requirements of applicable laws, rules and regulations and all applicable good laboratory practices to attempt to achieve their objectives as efficiently and expeditiously as reasonably practicable.
2.16 Records. Each Party shall maintain complete and accurate records of all work conducted under the Collaboration and all results, data and developments made pursuant to its efforts under the Collaboration. Such records shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of the Collaboration in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes.
2.17 Reports. During [ * ] , each Party shall report to the JSC no less than [ * ] and will submit to the other Party and the JSC a [ * ] written progress report summarizing the work performed under the Research Program. If reasonably necessary for a Party to perform its work under the Collaboration or to exercise its rights under the Amended and Restated Agreement, such Party may request that the other Party provide more detailed information and data regarding such results reported by such other Party, and such other Party shall promptly provide the requesting Party with information and data as is reasonably related to such request. All such reports shall be considered Confidential Information of the Party providing same.
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2.18 Non-Solicitation . During [ * ] , each Party and its Affiliates shall not: [ * ] .
2.19 Targets Previously Pursued by Entity Acquired by a Party . Subject to Section 3.3(d):
(a) The provisions set forth in this Section 2.19 shall apply in the event that either Party (the “Acquiring Party”) or an Affiliate of an Acquiring Party acquires or merges with another company (the “Acquired Entity”) [ * ] .
(b) [ * ] .
(c) [ * ] .
(d) [ * ] .
(e) [ * ] .
(f) [ * ] .
(g) [ * ] .
2.20 Identification of Designated Validated Targets.
(a) The JSC may designate based on the research under Section 2.8, as a PreDesignated Target, [ * ] .
(b) The JSC will use reasonable efforts to mutually agree upon [ * ] . [ * ] shall [ * ] in the course of [ * ] . [ * ] shall [ * ] with the other Party at or prior to the next meeting of the JSC. [ * ] .
(c) Upon completion of the [ * ] , the JSC shall promptly decide whether to designate such [ * ] . In the course of making such decision, the JSC shall consider [ * ] The Parties will use reasonable efforts to [ * ] associated with performing [ * ] . [ * ] shall bear [ * ] in the course of [ * ] . Subject to this Section 2.20(c), [ * ] shall share [ * ] at or prior to the next meeting of the JSC.
(d) Upon completion of the work reasonably necessary to determine [ * ] , the JSC shall promptly decide and record in writing [ * ] . The Parties understand and agree that, in a given circumstance, the [ * ] need not be sole determining factors regarding whether [ * ] .
(e) BMS will be entitled to [ * ] . BMS may [ * ] if the JMT agrees that [ * ] without unreasonably jeopardizing [ * ] . BMS’ obligation to [ * ] . During the period of time that a BMS Selected ET is [ * ] , such Target shall be treated as, and BMS shall retain the rights, benefits and privileges previously granted hereunder with respect to such BMS Selected ET, provided that Exelixis shall be deemed to have sufficient rights under the EXEL Patents, EXEL Know-How, Target Inventions, BMS Patents and BMS Know-How to perform its obligations under the Research Plan with respect to such BMS Selected ET.
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(f) If a BMS Selected ET [ * ] by BMS pursuant to Section 2.20(e) does not [ * ] , then [ * ] .
(g) [ * ] .
(h) [ * ] .
3. SELECTION, PURSUIT AND ABANDONMENT OF TARGETS
3.1 Target Pools.
(a) Draft Target Pool. Subject to Section 2.12, each Eligible Target shall be added to the Draft Target Pool upon its designation as an Eligible Target by the JSC, [ * ] .
(b) Draft Validated Target Pool. [ * ] .
3.2 Disclosure of Data Prior to Draft Choice .
(a) To ensure that each Party has access to all pertinent data being developed by the other Party relating to each Eligible Target and Designated Validated Target in sufficient time to enable each Party to evaluate such Eligible Target and Designated Validated Target before a JSC meeting in which such Eligible Target and Designated Validated Target can be selected pursuant to Section 3.3, each Party shall provide a written, reasonably detailed summary of primary data arising from its research on such Eligible Target and Designated Validated Target in the performance of its obligations to the Collaboration [ * ] to the other Party’s JSC members at least [ * ] before such JSC meeting. [ * ] .
(b) [ * ] .
3.3 Draft Choice Procedures.
(a) At each JSC meeting [ * ] , the Parties shall, subject to Section 2.10(g), select Eligible Targets from the Draft Target Pool as Selected ETs. [ * ] .
(b) [ * ] .
(i) [ * ] .
(ii) [ * ] .
(c)
(i) [ * ] .
(ii) [ * ] .
(d) If BMS decides to deem, as an Eligible Target, a human orthologue of a Model System Target that would not otherwise qualify as an Eligible Target solely on account of Exelixis’ previous grant of an non-exclusive license of the scope described in Section 1.30(c),
15
and BMS selects such Eligible Target as a BMS Selected ET pursuant to Section 3.3, then BMS shall have all of the rights and obligations set forth in this Amended and Restated Agreement with respect to BMS Selected ETs, except that all exclusive licenses granted by Exelixis under Section 5.1 with respect to such BMS Selected ET shall, except for the grant under Section 5.1(a)(iii), become non-exclusive (although Exelixis shall endeavor thereafter not to grant, subject to Article 6, additional rights with respect to small molecule modulators of such BMS Selected ET in the Development Field). The principles of this Section 3.3(d) shall also apply to Designated Validated Targets that arose from PreDesignated Targets that would not otherwise have qualified as such solely on account of Exelixis’ previous grant of a non-exclusive license of the scope described in part (c) of the definition of PreDesignated Target. [ * ] .
(e) At the JSC meeting [ * ] , the Parties shall select any remaining Eligible Targets from the Draft Target Pool or ET Validation Pool as Selected ETs. [ * ] .
(f) The Parties may modify, by mutual written agreement, the draft choice procedures set forth in this Section 3.3.
(g) Subject to Sections 3.3(h) and 3.3(i), at each JSC meeting [ * ] , the Parties shall, subject to Section 2.10(g), select Designated Validated Targets from the Draft Validated Target Pool as Selected DVTs. [ * ] .
(h) At the final JSC meeting [ * ] . Neither Party may select any Designated Validated Targets as Selected DVTs after such JSC meeting. All Designated Validated Targets that are in the Draft Validated Target Pool immediately following such final JSC meeting shall be [ * ] , and the Draft Validated Target Pool shall thereafter cease to exist. [ * ] .
(i) If a Party selects [ * ] , such Party shall, as a result of such selection, [ * ] .
(j) Within [ * ] of a Party’s selection of a Selected DVT, the Parties shall enter into a Materials Transfer Agreement, such Material Transfer Agreement to be negotiated prior to [ * ] and attached as Exhibit 3.3(j), under which the non-selecting Party shall provide the selecting Party with the [ * ] agreed upon [ * ] .
(k) At the final JSC meeting [ * ] , the Parties shall select any remaining Designated Targets [ * ] .
(l) At the final JSC meeting [ * ] .
3.4 Pursuit of Selected Targets.
(a) General Diligence. For each Selected Target selected by a particular Party, such Party shall use good faith Diligent Efforts [ * ] .
(b) Specific Diligence for Selected ETs. If a Party or its sublicensee [ * ] , then such Party shall be deemed to have demonstrated Diligent Efforts with respect to [ * ] .
(c) Specific Diligence for Selected DVTs. If a Party or its sublicensee, [ * ] , then such Party shall be deemed to have demonstrated Diligent Efforts with respect to [ * ] .
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(d) Breach of Diligence. Breach of the diligence obligations set forth in this Section 3.4 shall not constitute a breach of this Amended and Restated Agreement. The sole remedy available to each Party upon the other Party’s breach of the diligence obligations is that the relevant Target ceases to be a Selected Target and becomes an Abandoned Target.
3.5 Exelixis Participation in Development of BMS Products.
(a) During [ * ] , BMS may request in writing that Exelixis develop a high throughput assay to assess the activity of small molecule compounds with respect to a Selected Target chosen by BMS; provided, that [ * ] shall not be [ * ] for purposes of this Section 3.5. Such request shall specify (i) the desired formatting criteria for the assay and all other material specifications for the assay and (ii) the date by which delivery, even if (i) is met, would be too late for BMS’ needs (the “Assay Delivery Date”). If Exelixis wishes to develop such an assay, it shall notify BMS in writing [ * ] and shall indicate the date on which Exelixis anticipates commencing such work. The Parties shall agree in writing on the specific formatting criteria for the assay and all other material specifications for the assay (including without limitation, if appropriate, the acceptance period and a range of variances that is mutually agreed upon by the Parties). Unless otherwise set forth in such writing, the Assay Delivery Date shall be the date originally requested by BMS. Exelixis shall use good faith Diligent Efforts to develop such an assay and deliver it to BMS within [ * ] of the Assay Delivery Date.
(i) If, prior to the Assay Delivery Date, Exelixis notifies BMS that it will not be able to deliver the assay within [ * ] of the Assay Delivery Date and identifies a new date by which it intends to deliver the assay (the “Substitute Delivery Date”), then BMS shall have [ * ] to notify Exelixis in writing if it wants Exelixis to terminate development of the assay. If BMS does not so notify Exelixis, then BMS shall not reject the assay or refuse to make the milestone payment set forth in Section 7.3(b) due to the fact that the assay was not delivered within [ * ] of the Assay Delivery Date. BMS may nevertheless reject such assay if it is not delivered within [ * ] of the Substitute Delivery Date.
(ii) BMS shall have [ * ] following Exelixis’ delivery of an assay pursuant to this Section 3.5(a), to notify Exelixis in writing if BMS has determined that the delivered assay does not meet the specifications mutually agreed by the Parties pursuant to Section 3.5(a). If BMS does not so notify Exelixis within such [ * ] period, then the assay will be considered accepted and shall be deemed an “Assay” and BMS shall make the milestone payment set forth in Section 7.3(b) with respect to such Assay.
(iii) Any and all disagreements between the Parties regarding whether a particular assay delivered by Exelixis meets the specifications mutually agreed by the Parties pursuant to Section 3.5(a) shall be handled [ * ] .
(iv) Exelixis covenants that it will not [ * ] . The foregoing covenant shall not be interpreted to restrict Exelixis’ ability to use Information it generated in the development of an Assay for the purposes of developing other assays, [ * ] .
(b) During [ * ] , BMS may request in writing that Exelixis perform high throughput screening of EXEL Compounds in one (1) or more assays (whether developed by
17
BMS or EXEL) that assess the activity of such compounds with respect to a Selected Target chosen by BMS and subsequently conduct lead optimization of EXEL Compounds until Exelixis identifies an analog or derivative of such compound that qualifies as a Lead Compound (it being understood that [ * ] shall not [ * ] the foregoing). Such request shall specify the assay(s) to be used, whether the entire Exelixis library or certain subsets thereof should be screened, and the criteria (including without limitation, if appropriate, a range of variances that is mutually agreed upon by the Parties) that an EXEL Compound must meet in order to be considered either a Lead Compound or a Back-up Compound for such Lead Compound. If Exelixis wishes to perform such work, it shall present BMS with a proposed detailed work plan (including specific deliverables, timetable and date on which Exelixis anticipates commencing work, and acceptance procedures) and budget for such work plan (including payment schedules) within [ * ] of BMS’ request. If BMS wishes Exelixis to perform such work pursuant to such budget, it shall notify Exelixis within [ * ] of receipt of such budget. The final detailed work plan and budget for such work plan (the “Work Plan”) shall be signed by both Parties before any work is undertaken. Exelixis shall use good faith Diligent Efforts to complete the work set forth in the Work Plan; provided, that any payment that is conditioned on the performance or delivery of certain deliverables and/or performance by a certain date must be met before payment will be owed, whether or not Exelixis shall have used good faith Diligent Efforts. If such work results in the development of a Lead Compound, Exelixis shall deliver to BMS such Lead Compounds and all Back-up Compounds for such Lead Compound. In addition to all payments made by BMS pursuant to any budget agreed upon in accordance with this Section 3.5(b) (such payments shall be noncreditable and nonrefundable), BMS shall make the milestone payment set forth in Sections 7.3(c), (e) and (f) upon occurrence of the events specified therein and BMS shall make royalty payments in accordance with Section 7.4. Exelixis covenants that, with respect to each BMS Selected Target against which Exelixis screens its libraries pursuant to this Section 3.5(b), Exelixis will not [ * ] .
3.6 Target Abandonment.
(a) A Selected Target will become an Abandoned Target if any of the following circumstances arise: [ * ] .
(b) If BMS [ * ] . If Exelixis [ * ] .
(c) Each Target that becomes an Abandoned Target [ * ] .
3.7 Targets Other Than Selected Targets. Except as set forth in Section 3.3(k) or 3.3(l), Exelixis has no obligations to BMS with respect to and grants no licenses to BMS with respect to [ * ] . All such targets shall not be subject to any terms of this Amended and Restated Agreement except for Section 5.2(a)(ii) (with respect to [ * ] ), Section 3.1 (with respect to [ * ] ) and Section 3.3(h) (with respect to [ * ] ).
3.8 Records. Each Party shall maintain complete and accurate records of all scientific and development work conducted on its Selected Targets, Collaboration Compounds and Products and all results, data and developments made pursuant to its research and development efforts under this Amended and Restated Agreement. Such records shall be
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complete and accurate and shall fully and properly reflect all work done and results achieved in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes.
3.9 Reports. Every [ * ] , each Party will submit to the other Party a written progress report summarizing the research and development work performed by such Party on its Selected Targets.
3.10 Expenses. Except as set forth in Sections 3.5 and 7.2, [ * ] shall bear [ * ] associated with performing the research, development and commercialization described in Articles 2 and 3.
3.11 Target Status. The Parties agree that Exhibit 3.11 provides the status, as of the Amendment Effective Date, of [ * ] .
4. ADDITIONAL CONSIDERATION
4.1 Stock Purchase Agreement . The Parties acknowledge that BMS made an equity investment in Exelixis equal to a total of twenty million dollars ($20,000,000) in accordance with the terms set forth in the Stock Purchase Agreement between the Parties of even date with the Effective Date.
4.2 Rebeccamycin Analog License Agreement . BMS shall grant Exelixis an exclusive license to the rebeccamycin analog (“Rebeccamycin Analog”) known as BMY-027557 (with the CAS Identification No. CAS-119673-08-4) in accordance with the terms set forth in the License Agreement between the Parties of even date with the Effective Date.
5. LICENSES AND RELATED RIGHTS
5.1 Licenses to BMS.
(a) EXEL Know-How and EXEL Patents . Subject to the terms of this Amended and Restated Agreement (including without limitation Section 5.2 and Article 6):
(i) Research . Exelixis hereby grants BMS a non-exclusive, worldwide, royalty-free license (with the right to sublicense to its Affiliates, but without the right to sublicense to Third Parties except with prior written consent of Exelixis), under any EXEL Know-How and EXEL Patents solely (A) to perform the research tasks assigned to it pursuant to Sections 2.10(c), 2.11, 2.20 and 3.1(a), and (B) to perform research, during [ * ] and in accordance with Sections 2.10(d) and 2.11, upon mammalian orthologues of certain Model System Targets.
(ii) BMS Selected Targets . Exelixis hereby grants BMS an exclusive, worldwide, royalty-bearing (solely to the extent provided in Section 7.4) license (with the right to sublicense), under any EXEL Know-How and EXEL Patents covering the composition, manufacture, or use of one (1) or more BMS Selected Targets, to make and use each such BMS Selected Target (A) to perform research within the Research Field upon each such BMS Selected Target, including using such BMS Selected Target to search for Collaboration Compounds, (B) to develop, and make or have made for use in the Development Field, BMS Products comprising
19
or incorporating Collaboration Compounds, (C) to develop, following the commencement of a clinical trial of a BMS Product in the Development Field, such BMS Product for any human indication, and (D) to make, have made, use, import, sell, offer to sell and have sold BMS Products.
(iii) Assays . Exelixis hereby grants BMS an exclusive, worldwide, royalty-bearing (solely to the extent provided in Section 7.4) license (with the right to sublicense), under any EXEL Know-How and EXEL Patents covering the composition or use of one (1) or more Assays, (A) to make and have made such Assay, (B) to use each such Assay to search for, make and have made (1) Collaboration Compounds with activity against the BMS Selected Target for which such Assay was developed, and (2) compounds that lack activity against the BMS Selected Target for which such Assay was developed, (C) to develop, and make or have made, for use in the Development Field (and in any defined field licensed by BMS under Section 5.2(b)(iii)), BMS Collaboration Products, and (D) to develop, following the commencement of a clinical trial of a BMS Collaboration Product in the Development Field, such BMS Collaboration Product for any human indication. Such license shall convert to a non-exclusive license, on an Assay-by-Assay basis, on the earlier of (x) the date that is [ * ] after the end of the Research Term, or (y) the BMS Selected Target relating to such Assay becomes an Abandoned Target and is selected by Exelixis as an EXEL Selected Target.
(iv) Lead Compounds/Back-Up Compounds . Exelixis hereby grants BMS a worldwide, royalty-bearing (solely to the extent provided in Section 7.4) license (with the right to sublicense), under any EXEL Know-How and EXEL Patents during the term of this Amended and Restated Agreement covering the composition, manufacture, or use of a Lead Compound delivered to BMS pursuant to Section 3.5(b) or a Back-up Compound for such Lead Compound, (A) to make derivatives of such Lead Compounds and Back-up Compounds, (B) to research, develop, and make or have made for use in the Development Field, BMS Collaboration Products comprising or incorporating such a Lead Compound or Back-up Compound or derivative thereof, (C) to develop, following commencement of a clinical trial of such a BMS Collaboration Product in the Development Field, such BMS Collaboration Product for any human indication, and (D) to make, have made, use, import, sell, offer to sell and have sold such BMS Collaboration Products. The foregoing license shall be (x) exclusive with respect to Lead Compound and Back-up Compounds delivered to BMS pursuant to Section 3.5(b) and BMS Collaboration Products containing such Lead Compounds or Back-up Compounds and (y) non-exclusive with respect to derivatives of Lead Compounds and Back-up Compounds delivered to BMS pursuant to Section 3.5(b) and BMS Collaboration Products containing derivatives of such Lead Compounds and Back-up Compounds. [ * ] .
(v) Pharmacogenomic Uses . Exelixis hereby grants BMS a non-exclusive, worldwide, royalty-bearing (solely to the extent provided in Section 7.4) license (with the right to sublicense), under the EXEL Know-How and EXEL Patents covering the composition, manufacture or use of any Selected Target of either Party, to use such Selected Target in the research, development, manufacture, use, import, sale and offer for sale of a Pharmacogenomic Product for use (A) in connection with the research, development, manufacture, use, import, sale and offer for sale, for any indication, of a (i) BMS Product or (ii) a product that modulates the same Selected Target as such BMS Product via substantially the same molecular mechanism of action (a “Target Product”), and (B) in the labeling, promotion, and
20
registration of any BMS Product or Target Product for any indication. Such license for a particular Pharmacogenomic Product shall be sublicensable solely (x) together with a sublicense under Section 5.1(a)(ii) with respect to a related BMS Product or (y) by BMS or its sublicensee, for the purpose of developing or commercializing a Pharmacogenomic Product for use in conjunction with a related BMS Product that BMS or its sublicensee is developing or commercializing. Provided that a sublicense is granted in accordance with the restrictions set forth in the previous sentence and such sublicense does not further limit the scope of the sublicensee’s practice of the EXEL Know-How and EXEL Patents, such sublicensee may practice the full extent of the license set forth in this Section 5.1(a)(v), including making, providing, and selling Pharmacogenomic Products for use with Target Products. [ * ] .
(vi) Negative Screening Using EXEL Targets. Exelixis hereby grants to BMS a non-exclusive, worldwide, non-royalty bearing license (without the right to sublicense except to its Affiliates) under any EXEL Patents and EXEL Know-How covering the composition, manufacture, or use of an EXEL Selected Target, to use such EXEL Selected Target solely in secondary screening assays developed by or for BMS to identify, research and develop Collaboration Compounds and BMS Products that lack the ability to inhibit, activate or otherwise modulate the activity of such EXEL Selected Target. The foregoing license does not include the right of BMS to use any assays developed by or on behalf of Exelixis with respect to EXEL Selected Targets, other than [ * ] .
(vii) Exelixis Validation Protocols and Reagents . Exelixis hereby grants to BMS a non-exclusive, worldwide, royalty-free license (without the right to sublicense except to its Affiliates) under the EXEL Know-How and EXEL Patents relating to (A) the Exelixis validation protocols and reagents listed on Exhibit 5.1(a)(vii) (as updated from time to time by the JSC) and (B) all validation protocols and reagents that are developed by Exelixis in the course of performing its duties under the Research Plan, to use same for all purposes.
(viii) Improvements to BMS Validation Protocols and Reagents . Exelixis hereby grants to BMS a non-exclusive, worldwide, royalty-free license (with the right to sublicense) under the EXEL Know-How and EXEL Patents to use for all purposes, all improvements to the validation protocols and reagents licensed by BMS under Section 5.3(d) that incorporate or contain any of such validation protocols and reagents licensed by BMS.
(b) Target Inventions.
(i) Subject to the terms of this Amended and Restated Agreement, Exelixis hereby grants BMS an exclusive, worldwide, royalty-free license (with the right to sublicense), under the Target Inventions invented solely by BMS and all Patents Controlled by Exelixis that claim such Target Inventions, to use such Target Inventions for all purposes other than those for which Exelixis has exclusive rights pursuant to Section 5.3.
(ii) Subject to the terms of this Amended and Restated Agreement, Exelixis hereby grants BMS a worldwide, royalty-free license (with the right to sublicense), under the Target Inventions invented jointly by BMS and Exelixis and all Patents Controlled by Exelixis that claim such Target Inventions, to use, without any accounting or obligation to, or consent required of, Exelixis, such Target Inventions for all purposes other than those for which
21
Exelixis has exclusive rights pursuant to Section 5.3. The foregoing license is exclusive, with respect to BMS Selected Targets, for those purposes for which BMS has exclusive rights pursuant to Section 5.1(a)(ii); such license is co-exclusive for all other permitted purposes.
(iii) The license rights to a Target Invention (or Patent obtained thereon) granted under 5.1(b)(i) and (b)(ii) above shall last until the expiration of the last to expire Patent claiming a Target Invention or, if no Patent is obtained thereon, for the useful life thereof.
5.2 License Limitations and Option.
(a) License Limitations.
(i) BMS hereby covenants that it will not use any EXEL Know-How (to the extent the same Remains Confidential to Exelixis at the time of use by BMS), Target Invention or EXEL Patents for a purpose other than that expressly permitted in Section 5.1. [ * ] .
(ii) Subject to Section 6.2, for each BMS Selected Target, Exelixis hereby covenants [ * ] .
(iii) For purposes of Sections 5.1(a)(ii), 5.1(a)(v) and 5.1(a)(vi), EXEL Know-How shall be limited to Information developed by or on behalf of Exelixis prior to the Effective Date or in the performance of the Collaboration and prior to the first selection by either Party of such Target as a Selected Target, and the EXEL Patents shall be limited to those that cover Inventions made by or on behalf of Exelixis prior to the Effective Date or in the performance of the Collaboration and prior to the first selection by either Party of such Target as a Selected Target. For purposes of Section 5.1(a)(i) and 5.1(a)(vii)(B), the EXEL Know-How shall be limited to Information developed by or on behalf of Exelixis prior to the Effective Date or in the performance of the Collaboration and prior to the end of the Research Term, and the EXEL Patents shall be limited to those that cover Inventions made by or on behalf of Exelixis prior to the Effective Date or in the performance of the Collaboration and prior to the end of the Research Term. For purposes of Section 5.1(a)(iii), the EXEL Know-How shall be limited to that Information developed by Exelixis in the performance of the Collaboration and prior to delivery of the Assay to BMS, and the EXEL Patents shall be limited to those that cover Inventions made in the performance of the Collaboration and prior to the delivery of the Assay to BMS. With respect solely to the derivatives non-exclusively licensed under Section 5.1(a)(iv), the EXEL Know-How so licensed shall be limited to Information developed by Exelixis in the performance of the Collaboration and prior to delivery of the relevant Lead Compound or Back-Up Compound to BMS, and the EXEL Patents so licensed shall be limited to those that cover Inventions made in the performance of the Collaboration and prior to the delivery of the relevant Lead Compound or Back-Up Compound to BMS. For clarity, the term “Invention” for purposes of this subsection (iii) shall not be construed to preclude any [ * ] .
(iv) Each sublicense granted by BMS, pursuant to Section 5.1(a), to a party who is an Affiliate at the time such license is granted shall terminate immediately upon such party ceasing to be an Affiliate.
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(b) Option for Non-exclusive License.
(i) [ * ] .
(ii) [ * ] .
(iii) [ * ] .
(iv) [ * ] .
(v) [ * ] .
5.3 Licenses to Exelixis. Subject to the terms of this Amended and Restated Agreement (including without limitation Section 5.4):
(a) Research. BMS hereby grants Exelixis a non-exclusive, worldwide, royalty-free license (with the right to sublicense to Affiliates, but without the right to sublicense to Third Parties except with prior written consent of BMS) under the BMS Know-How and BMS Patents, solely (A) to perform research during the Research Term in accordance with Articles 2 and 3, and (B) to perform research, during [ * ] and in accordance with Sections 2.10(d) and 2.11, upon mammalian orthologues of certain Model System Targets.
(b) EXEL Selected Targets. BMS hereby grants Exelixis an exclusive, worldwide, royalty-free license (with the right to sublicense), under the BMS Know-How and BMS Patents covering the composition, manufacture, or use of one (1) or more EXEL Selected Targets, to make and use each such EXEL Selected Targets (A) to perform research within or outside the Research Field upon each EXEL Selected Target, including using such EXEL Selected Target to search for Collaboration Compounds, and (B) to research, develop, make, have made, use, import, sell, offer to sell and have sold, for use within or outside the Development Field, EXEL Products comprising or incorporating such Collaboration Compounds. Such license shall be subject to a retained right in BMS (sublicensable to its Affiliates only) to use and practice same for research outside the Research Field upon such EXEL Selected Target and to make and have made, and to use same, to develop BMS compounds for use outside the Development Field.
(c) Targets . BMS hereby grants to Exelixis a worldwide, royalty-free license (with the right to sublicense) under the BMS Know-How and BMS Patents covering the composition, manufacture, or use of a Target, to make and use each such Target: [ * ] . Such licenses shall be exclusive for purposes of subparts (i)-(iii) and non-exclusive for purposes of subpart (iv), and [ * ] . Such licenses in subparts (i) and (iv), to the extent they apply to Sole Inventions of BMS, shall be sublicensable to a Third Party for a given BMS Selected Target only if the Third Party grants or agrees to grant to Exelixis a worldwide license (with the right to sublicense), under such Third Party’s know-how and patents covering the composition, manufacture, or use in oncology of such BMS Selected Target, to make and use each such BMS Selected Target to research, develop, make, have made, use, sell, offer to sell, have sold and import, for use within the Development Field, products containing small molecule modulators of such BMS Selected Target. The foregoing sublicensing limitation shall not apply to sublicensing of BMS Know-How and BMS Patents that are not Sole Inventions of BMS.
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(d) Validation Protocols and Reagents .
(i) BMS hereby grants to Exelixis a non-exclusive, worldwide, royalty-free license (without the right to sublicense except to its Affiliates) under the BMS Know-How and BMS Patents directly relating to: (A) the BMS validation protocols and reagents listed on Exhibit 5.3(d), as updated from time to time by the JSC, and (B) all validation protocols and reagents that are developed by BMS in the performance of its duties under the Research Plan to use same for all purposes.
(ii) BMS hereby grants to Exelixis a non-exclusive, worldwide, royalty-free license (with the right to sublicense) under the BMS Know-How and BMS Patents to use for all purposes, all improvements to the validation protocols and reagents licensed by Exelixis under Section 5.1(a)(vii) that incorporate or contain any of such validation protocols and reagents licensed by Exelixis.
(e) Assays . So long as BMS’ rights under Section 5.1(a)(iii) remain exclusive, BMS hereby grants Exelixis a non-exclusive, worldwide royalty-free license (without the right to sublicense except to its Affiliates), under the EXEL Know-How and EXEL Patents covering the composition or use of a given Assay solely to use such Assay pursuant to a | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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