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.

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.

Research Plan. Within No later than [***] of after the establishment of each Exclusive Target pursuant to Section 2.10 below Effective Date (or within such longer period as is mutually agreed upon by in the case of any Research Program and corresponding Selected Target(s) added after the Effective Date, no later than [***] after the Parties’ written agreement on such additional Research Program and corresponding Selected Target(s)), Arvinas and Genentechthe Parties will agree on a research plan, through to the JPT, shall prepare and, through the JRC, agree upon extent a research plan consistent (unless otherwise has not been previously agreed by both Parties in writing) with upon, for each Research Program added under this Agreement as of or following the general Effective Date, which research plan outline attached hereto under Appendix A will include design, modeling, synthesis, evaluation, and other mutually agreed activities (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 also provide for the use of any Paragon In-Licensed IP and the performance of any CMC Activities that have been agreed by the Parties for a Research Program. For clarity, if at the end of such [***] period (or any extension thereof mutually agreed in writing) (i) the Parties have not agreed on a Research Plan, or (ii) Damora has not paid Paragon the Research Initiation Fee, the applicable Target(s) (or the applicable combination of Targets with respect to Bispecific Antibodies in the case of the Bispecific Research Program) shall cease to be Selected Target(s) and Paragon shall have no obligations with respect thereto. Once the Parties agree on a Research Plan and Damora pays the Research Initiation Fee for a Research Program, Paragon and Paramora shall conduct research under such Research Program during the applicable Research Term in an effort to (1) produce Project Antibodies Directed To the applicable Selected Target(s) for further Development, Manufacture and Commercialization (“Antibody Production Activities”), and (2) perform such other Development and Manufacturing activities with respect to the Project Antibodies as 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”)which other activities, timeline (“Schedule”)for clarity, 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 performed following ▇▇▇▇▇▇’▇ exercise of the Lead PROTAC Dossier (as may be provided under Section 3.2.4) (collectively, the “Deliverables”Option or execution of a License Agreement). It is understood The Parties may amend the Research Plan shall not include IND enabling activities, such as preparation for regulatory filings upon mutual written agreement. Paragon and Paramora will use [***] to conduct and complete the like, except as the Parties may agree on a case-by-case basis and activities set forth 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 timelines set forth in such Research Plan and were attached as Exhibits 2.3(a) and 2.3(b) to in compliance with the Original AgreementBudget.

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.

Research Plan. Within As of the A&R Effective Date, the Parties have agreed to the Research Plan for Research Program #1. No later than [***] after the A&R Effective Date (or, in the case of any Research Program and corresponding Selected Target(s) added after the establishment of each Exclusive Target pursuant to Section 2.10 below (or within such longer period as is mutually agreed upon by A&R Effective Date, no later than [***] after the Parties’ written agreement on such additional Research Program and corresponding Selected Target(s)), Arvinas and Genentechthe Parties will agree on a research plan, through to the JPT, shall prepare and, through the JRC, agree upon extent a research plan consistent (unless otherwise has not been previously 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 Aupon, for such Exclusive Target Research Program #2 and each Research Program added under this Agreement following the A&R Effective Date that will include design, modeling, synthesis, evaluation, and other mutually agreed activities (each, a “Research Plan”). The Research Plan shall also provide for the use of any Paragon In-Licensed IP or Crescent IP and the performance of any CMC Activities that have been agreed by the Parties to be used for a Research Program. For clarity, if at the end of such [***] period (or any extension thereof mutually agreed in writing) (i) the Parties have not agreed on a Research Plan for a Research Program, or (ii) Crescent has not paid Paragon the Research Initiation Fee for a Research Program, Paragon shall have no obligations to Crescent with respect to such Research Program or the corresponding Selected Target(s). Once the Parties agree on the Research Plan and Crescent pays the Research Initiation Fee for a Research Program, Paragon and Parascent shall conduct research under such Research Program during the Research Term in an effort to (1) generate or conjugate Project ADCs for further Development, Manufacture and Commercialization (“ADC Conjugation Activities”), and (2) perform such other Development and Manufacturing activities with respect to the Project ADCs as set forth in reasonable detail the applicable Research Plan (which other activities, including timelines and budgets therefor (including any relevant FTE requirements for Arvinas)clarity, of each may be performed following Crescent’s exercise of the Parties to use Diligent Efforts in order to identify Licensed PROTACs that demonstrate (a) in vitro protein degradation Option or execution of the Exclusive Target (“Stage I”) and (b) certain in vitro[**]and in vivo[**]activity (“Stage II”a License Agreement for such Research Program). For each of Stage I and Stage II of the Research Program, The Parties may amend the Research Plan shall include scope of for a Research Program upon mutual written agreement. Paragon and Parascent will use [***] to conduct and complete the 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 set forth in the Research Plan shall not include IND enabling activities, such as preparation for regulatory filings and each Research Program on the like, except as the Parties may agree on a case-by-case basis and timelines set forth 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 and in compliance with the Parties in writing. The Budget for such 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 AgreementProgram.

Research Plan. Within All activities conducted by the Parties during the Research Term [***] will be conducted pursuant to a comprehensive research plan (the “Research Plan”), which will outline the research activities to be conducted by the Parties, responsibilities of each Party, the number of FTEs conducting such activities and the SoH2L-Criteria, and will contain a proposed budget for such activities. The Research Plan will be designed with the objective of satisfying the SoH2L-Criteria and enabling a determination as to whether such criteria have been met. A generic Research Plan has been agreed to by the Parties and is attached hereto as Exhibit B. The actual Research Plan as described here in Section 2.2 on a Collaboration Target-by-Collaboration Target basis will be agreed by the Parties and amended to Exhibit B. On a quarterly basis, the JSC will adjust the FTE allocations in the Research Plan based on the level of ongoing activities and submit such amended Research Plan to the Parties for approval consistent with the principle of supporting the research of [***] Collaboration Targets in [***] of the establishment of each Exclusive Target pursuant to Section 2.10 below (or within such longer period as is mutually agreed upon by Research Term. In addition, the Parties), Arvinas and Genentech, through JSC will update 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 Outlinefrom time to time during the Research Term (but no less frequently than [***]), including a Budget equal to provide for activities for newly designated Collaboration Targets or to remove activities for terminated Collaboration Targets, and shall submit such updated Research Plan to the general budget set forth under Appendix A, Parties for such Exclusive Target (each, a “Research Plan”)approval. The Each updated 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, will replace the Research Plan shall include scope previously in effect. Each Research Plan will be reviewed as necessary at each meeting of activities (“Work Plan”)the JPC and JSC, timeline (“Schedule”)and at any other time upon the request of either Party, 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 (JPC may suggest modifications to the JSC, which may suggest modifications to the Parties, as may be provided under Section 3.2.4) (collectivelyappropriate, to reflect material scientific or commercial developments. In the “Deliverables”). It is understood event of any inconsistency between 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 terms of this Agreement will prevail and any such inconsistent portion of a Research Plan prepared in accordance with this Section 2.3 is hereby expressly rejected. For clarity, only the Parties, and any revisions not the JPC or JSC, shall have the right to such amend the 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 Agreementincluding its budget).

Research Plan. Within No later than [***] of after the establishment of each Exclusive Target pursuant Effective Date, the Parties will agree on a research plan, 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 extent a research plan consistent (unless otherwise has not been previously 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 Aupon, for such Exclusive Target the Research Program that will include design, modeling, synthesis, evaluation, and other mutually agreed activities (each, a “Research Plan”). The Research Plan shall set forth also provide for the use of any Paragon In-Licensed IP or Crescent IP that has been agreed by the Parties. For clarity, if at the end of such [***] period (or any extension thereof mutually agreed in reasonable detail the activities, including timelines and budgets therefor writing) (including any relevant FTE requirements for Arvinas), of each of i) the Parties have not agreed on the Research Plan, or (ii) Crescent has not paid Paragon the Research Initiation Fee, Paragon shall have no obligations to use Diligent Efforts in order Crescent with respect to identify Licensed PROTACs that demonstrate (a) in vitro protein degradation of the Exclusive Target (“Stage I”) Research Program or the Selected Target. Once the Parties agree on the Research Plan and (b) certain in vitro[**]and in vivo[**]activity (“Stage II”). For each of Stage I and Stage II of Crescent pays the Research Initiation Fee for the Research Program, Paragon and Parascent shall conduct research under the Research Program during the Research Term in an effort to (1) generate or conjugate Project ADCs for further Development, Manufacture and Commercialization (“ADC Conjugation Activities”), and (2) perform such other Development and Manufacturing activities with respect to the Project ADCs as set forth in the Research Plan shall include scope of activities (“Work Plan”)which other activities, timeline (“Schedule”)for clarity, 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 performed following Crescent’s exercise of the Lead PROTAC Dossier (as may be provided under Section 3.2.4) (collectively, the “Deliverables”Option or execution of a License Agreement). It is understood The Parties may amend the Research Plan shall not include IND enabling activities, such as preparation for regulatory filings upon mutual written agreement. Paragon and Parascent will use [***] to conduct and complete 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 set forth in the Research Plan. Notwithstanding Plan on 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 timelines set forth 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 and in accordance compliance 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 writingBudget. The Research Plans for the two [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (2I) Initial Targets were approved by the Parties on the Original Effective Date and were attached as Exhibits 2.3(aIS NOT MATERIAL AND (II) and 2.3(b) to the Original AgreementIS THE TYPE OF INFORMATION THAT THE REGISTRANT BOTH CUSTOMARILY AND ACTUALLY TREATS AS PRIVATE AND CONFIDENTIAL.