For Optioned Programs Sample Clauses

For Optioned Programs. Without limitation to the foregoing, subject to Sections 4.7(c)(vi), 6.3(c) and 6.6, the JEC shall have the following responsibilities with respect to each Optioned Program: (A) monitor and provide strategic oversight of such Optioned Program and facilitate communications between the Parties with respect to the Development, Manufacture and Commercialization of Optioned Molecules and Optioned Products included in such Optioned Program; (B) pursuant to Section 4.1 and subject to Section 3.5(c), review and approve the initial R&D Plan and Budget for each new Optioned Program or an expansion of such R&D Plan and Budget to include a new Clinical Trial; and, in each case, any amendments (other than such an expansion) to any R&D Plan and Budget proposed by the JDC (except for amendments that do not escalate to the JEC), including (1) with respect to any commercially-available prescription drug products to be included in any Clinical Trials for such Optioned Program and (2) notwithstanding Section 2.5(a)(ii), matters related to any new Clinical Trial (excluding Clinical Trials involving any Arcus Combination or Excluded Combination) or other activities to be included in an existing R&D Plan & Budget of an Optioned Program that [***] but excluding [***] (z) any amendment to the R&D Plan and Budget that is within the final decision-making authority of [***] at the JDC pursuant to Section 2.2(d) [***]; (C) pursuant to Section 6.2(b), review and approve the initial Commercialization Plan and Budget for such Optioned Program or an expansion of such Commercialization Plan and Budget to include a new Optioned Product or indication and any amendments (other than such an expansion) thereto proposed by the JCC, but excluding any such amendment to the Commercialization Plan and Budget that is [***] at the JCC pursuant to Section 2.3(d); (D) pursuant to Section 7.2(a), review and approve the initial Global Manufacturing Plan and Budget for such Optioned Program or an expansion of such Manufacturing Plan and Budget to include a new Optioned Product or formulation and any amendments (other than such an expansion) thereto proposed by the JMC, but excluding any such amendment to the Global Manufacturing Plan and Budget that is [***] at the JMC pursuant to Section 2.4(d); (E) pursuant to Section 4.8(b)(iv), approve any Arcus Independent Activities Plan and Budget with respect to such Optioned Program and any amendments thereto proposed by the JDC, provided that the JEC’s approval ...
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For Optioned Programs. Without limitation to the foregoing, the JSC shall have the following responsibilities with respect to each Optioned Program: (A) monitor and provide strategic oversight of such Optioned Program and facilitate communications between the Parties with respect to the Development, Manufacture and Commercialization of Optioned Molecules and Optioned Products included in such Optioned Program;
Sample 1
For Optioned Programs. Without limitation to the foregoing, the JSC shall have the following responsibilities with respect to each Optioned Program: (A) monitor and provide strategic oversight of such Optioned Program and facilitate communications between the Parties with respect to the Development, Manufacture and Commercialization of Optioned Molecules and Optioned Products included in such Optioned Program; (B) review and approve the R&D Plan and Budget, Global Manufacturing Plan and Budget and Global Commercialization Plan and Budget for such Optioned Program and, in each case, any amendments thereto proposed by the applicable Committee, provided that the final initial draft R&D Plan and Budget for the Autotaxin Program agreed by the Parties prior to the Effective Date shall be deemed approved by the JSC; (C) review and approve the design of each Phase 2 Clinical Trial and Phase 3 Clinical Trial and any Phase 4 Clinical Trials in each case included in the R&D Plan and Budget and Mutual Post-Approval Commitments that are Initiated with respect to such Optioned Program after the Initial Option Closing for such Optioned Program; (D) discuss strategies regarding intellectual property and new indications for such Optioned Program; (E) in accordance with Section 7.2(d), review and discuss any Independent Activities Plan with respect to such Optioned Program; and (F) allocate responsibility between the Parties with respect to any Mutual Post-Approval Commitments; which, unless mutually agreed, shall provide for Galapagos conduct of activities in the Galapagos Territory and Gilead conduct of activities in the Gilead Territory.
Sample 1
For Optioned Programs. Without limitation to the foregoing, subject to Sections 4.7(c)(vi), 6.3(c) and 6.6, the JSC shall have the following responsibilities with respect to each Optioned Program: (A) monitor and provide strategic oversight of such Optioned Program and facilitate communications between the Parties with respect to the Development, Manufacture and Commercialization of Optioned Molecules and Optioned Products included in such Optioned Program; (B) pursuant to Section 4.1 and subject to Section 3.5(c), review and approve the R&D Plan and Budget for such Optioned Program and, in each case, any amendments thereto proposed by the JDC, including with respect to any commercially-available prescription drug products to be included in any Clinical Trials for such Optioned Program; (C) pursuant to Section 6.2(b), review and approve the Commercialization Plan and Budget for such Optioned Program and any amendments thereto proposed by the JCC; (D) pursuant to Section 7.2(a), review and approve the Global Manufacturing Plan and Budget for such Optioned Program and, in each case, any amendments thereto proposed by the JMC; and (E) pursuant to Section 4.8(b)(iv), approve (subject to Arcus’s final decision-making authority pursuant to Section 2.5(b)(ii)(B)(3)) any Arcus Independent Activities Plan and Budget with respect to such Optioned Program.
Sample 1

Related to For Optioned Programs

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