Common use of Research Plan Clause in Contracts

Research Plan. Within [**] of the establishment of each Exclusive Target pursuant to Section 2.10 below (or within such longer period as is mutually agreed upon by the Parties), Arvinas and Genentech, through the JPT, shall prepare and, through the JRC, agree upon a research plan consistent (unless otherwise agreed by both Parties in writing) with the general research plan outline attached hereto under Appendix A (Research Plan Outline), including a Budget equal to the general budget set forth under Appendix A, for such Exclusive Target (each, a “Research Plan”). The Research Plan shall set forth in reasonable detail the activities, including timelines and budgets therefor (including any relevant FTE requirements for Arvinas), of each of the Parties to use Diligent Efforts in order to identify Licensed PROTACs that demonstrate (a) in vitro protein degradation of the Exclusive Target (“Stage I”) and (b) certain in vitro[**]and in vivo[**]activity (“Stage II”). For each of Stage I and Stage II of the Research Program, the Research Plan shall include scope of activities (“Work Plan”), timeline (“Schedule”), estimated costs and expenses (“Budget”), criteria for completion (“Completion Criteria”) and deliverables to be provided, including the Evaluation Materials (as may be provided under Section 3.2.1) and the Lead PROTAC Dossier (as may be provided under Section 3.2.4) (collectively, the “Deliverables”). It is understood the Research Plan shall not include IND enabling activities, such as preparation for regulatory filings and the like, except as the Parties may agree on a case-by-case basis and in writing to collaborate on such IND enabling activities and include such activities in reasonable detail in the Research Plan. Notwithstanding the foregoing, Arvinas shall provide any authorizations, consents, references, or other documentation, including permission to cross-reference any relevant INDs previously filed by Arvinas, as necessary to support IND enabling activities in the Field in the Territory for a particular Licensed Product for which Genentech has exercised its Option under Section 3.2. As referenced throughout this Agreement, the “Research Plan” shall include the initial Research Plan prepared in accordance with this Section 2.3 and any revisions to such Research Plan as expressly contemplated under this Agreement or as otherwise agreed upon by the Parties in writing. The Research Plans for the two (2) Initial Targets were approved by the Parties on the Original Effective Date and were attached as Exhibits 2.3(a) and 2.3(b) to the Original Agreement.

Appears in 4 contracts

Sources: Option, License, and Collaboration Agreement, Option, License, and Collaboration Agreement (Arvinas Holding Company, LLC), Option, License, and Collaboration Agreement (Arvinas Holding Company, LLC)

Research Plan. Within [**] sixty (60) days following its formation, the JSC will develop and approve a written research plan setting forth the research obligations of each of the establishment Parties under the Collaboration until the filing of each Exclusive Target pursuant to Section 2.10 below the first IND for a Lead Product utilizing Systemic Delivery in a Major Market or the earlier termination of this Agreement in accordance with Article 13 hereof (or within such longer period as is mutually agreed upon by the Parties), Arvinas and Genentech, through the JPT, shall prepare and, through the JRC, agree upon a research plan consistent (unless otherwise agreed by both Parties in writing) with the general research plan outline attached hereto under Appendix A (Research Plan Outline), including a Budget equal to the general budget set forth under Appendix A, for such Exclusive Target (each, a “Research Plan”), which will be deemed a part of, and is hereby incorporated by reference in, this Agreement. The Parties anticipate that the Research Plan shall will include the research responsibilities of Curis set forth in reasonable detail the activities, including timelines and budgets therefor (including any relevant FTE requirements for Arvinas), of each of the Parties to use Diligent Efforts in order to identify Licensed PROTACs that demonstrate (a) in vitro protein degradation of the Exclusive Target (“Stage I”) and (b) certain in vitro[**]and in vivo[**]activity (“Stage II”). For each of Stage I and Stage II of the Research Program, the Research Plan shall include scope of activities (“Work Plan”), timeline (“Schedule”), estimated costs and expenses (“Budget”), criteria for completion (“Completion Criteria”) and deliverables to be provided, including the Evaluation Materials (as may be provided under Section 3.2.1) and the Lead PROTAC Dossier (as may be provided under Section 3.2.4) (collectively, the “Deliverables”). It is understood the Research Plan shall not include IND enabling activities, such as preparation for regulatory filings and the like, except as the Parties may agree on a case-by-case basis and in writing to collaborate on such IND enabling activities and include such activities in reasonable detail in the Research Plan. Notwithstanding the foregoing, Arvinas shall provide any authorizations, consents, references, or other documentation, including permission to cross-reference any relevant INDs previously filed by Arvinas, as necessary to support IND enabling activities in the Field in the Territory for a particular Licensed Product for which Genentech has exercised its Option under Section 3.2. As referenced throughout this Agreement, the “Research Plan” shall include the initial Research Plan prepared in accordance with this Section 2.3 and any revisions to such Research Plan as expressly contemplated under this Agreement or as otherwise research program outline agreed upon by the Parties in writingas of the Effective Date. The Research Plans for Plan will also include a detailed list of the two materials to be provided by Curis to Genentech (2) Initial Targets were the “Materials”), which may include, without limitation, Compound samples, assays, reagents, cell lines and relevant animal models. Curis and Genentech will each conduct research in accordance with the Research Plan, as it may be amended from time to time upon unanimous approval of the JSC, or as reasonably directed by the JSC, subject to the provisions of Section 2.2. Curis shall use commercially reasonable and diligent efforts to advance and complete the foregoing research in a timely manner. In furtherance of that obligation, Curis will assign no fewer than 8 FTE’s approved by the Parties on JSC (such approval not to be unreasonably withheld or delayed) for a period of no less than 2 years following the Original Effective Date and were attached as Exhibits 2.3(a) and 2.3(b(unless this Agreement is earlier terminated) to complete the Original Agreementtasks described above. The Parties agree that up to 4 of such FTE’s assigned to the research may be Evotec OAI employees. If and to the extent that Genentech wishes to have more than 4 of such FTE’s be Evotec OAI employees, Genentech shall be responsible for the FTE costs charged by Evotec OAI with respect to the number of Evotec OAI FTE’s that is in excess of 4. Curis shall cause the Evotec Agreement to be renewed until at least April 30, 2005 and during such time shall not, without the prior written consent of Genentech, amend the Evotec Agreement in a manner that would diminish the rights granted to Genentech hereunder or otherwise be detrimental to Genentech.

Appears in 4 contracts

Sources: Collaborative Research, Development and License Agreement, Collaborative Research, Development and License Agreement (Curis Inc), Collaborative Research, Development and License Agreement (Curis Inc)

Research Plan. Within [**] (a) As of the establishment Effective Date, the Parties have agreed on the initial Research Plan, and such Research Plan, together with an outline of each Exclusive Target pursuant the POC Studies, is attached to this Agreement as Exhibit E. From time to time after the Effective Date, the JRC may propose any amendment to the Research Plan, which shall be made in good faith, based on scientific and regulatory judgment and shall not materially modify the purpose of the Research Plan or materially modify the aggregate effort of MyoKardia thereunder. Such amendment shall become effective upon the approval of the ESC, with MyoKardia having the final decision making authority on any such amendment, subject to Section 2.10 below (or within such longer period as is mutually agreed upon by the Parties), Arvinas 2.9 and Genentech, through the JPT, shall prepare and, through the JRC, agree upon a research plan consistent (unless otherwise agreed by both Parties in writing) with the general research plan outline attached hereto under Appendix A (Research Plan Outline), including a Budget equal to the general budget set forth under Appendix A, for such Exclusive Target (each, a “Research Plan”Section 4.3(a). The Research Plan shall set forth forth: (a) the Research activities to be conducted by MyoKardia in reasonable detail the activities, including timelines and budgets therefor (including any relevant FTE requirements for Arvinas), of each of the Parties to use Diligent Efforts in order to identify Licensed PROTACs that demonstrate HCM1 Program, HCM2 Program and DCM1 Program (a) in vitro protein degradation of the Exclusive Target (Stage IMyoKardia Research Activities) and ); (b) certain the Sanofi Research Activities as described in vitro[**]and Section 4.3 below; (c) the estimated timelines for such MyoKardia Research Activities and Sanofi Research Activities; and (d) the estimated internal and external costs to be incurred by or on account of each Party in vivo[**]activity (“Stage II”connection with such activities, provided that such estimated costs shall not exceed the allotted Sanofi R&D Costs in a given period set forth in the table in Section 9.4(a) and any carryover amounts permitted for such period under Section 9.4(b)(i). For each of Stage I * Confidential Information, indicated by [***], has been omitted from this filing and Stage II filed separately with the Securities and Exchange Commission (b) If the terms of the Research ProgramPlan contradict, or create inconsistencies or ambiguities with, the Research Plan shall include scope terms of activities (“Work Plan”), timeline (“Schedule”), estimated costs and expenses (“Budget”), criteria for completion (“Completion Criteria”) and deliverables to be provided, including the Evaluation Materials (as may be provided under Section 3.2.1) and the Lead PROTAC Dossier (as may be provided under Section 3.2.4) (collectively, the “Deliverables”). It is understood the Research Plan shall not include IND enabling activities, such as preparation for regulatory filings and the like, except as the Parties may agree on a case-by-case basis and in writing to collaborate on such IND enabling activities and include such activities in reasonable detail in the Research Plan. Notwithstanding the foregoing, Arvinas shall provide any authorizations, consents, references, or other documentation, including permission to cross-reference any relevant INDs previously filed by Arvinas, as necessary to support IND enabling activities in the Field in the Territory for a particular Licensed Product for which Genentech has exercised its Option under Section 3.2. As referenced throughout this Agreement, then the “Research Plan” shall include the initial Research Plan prepared in accordance with this Section 2.3 and any revisions to such Research Plan as expressly contemplated under terms of this Agreement or as otherwise agreed upon by the Parties in writing. The Research Plans for the two (2) Initial Targets were approved by the Parties on the Original Effective Date and were attached as Exhibits 2.3(a) and 2.3(b) to the Original Agreementshall govern.

Appears in 2 contracts

Sources: License and Collaboration Agreement (MyoKardia Inc), License and Collaboration Agreement (MyoKardia Inc)