For Optioned Programs Clause Samples
The 'For Optioned Programs' clause defines the terms and conditions that apply specifically to programs or projects for which an option has been granted, but not yet fully exercised. In practice, this clause outlines the rights and obligations of the parties during the option period, such as development responsibilities, payment structures, or timelines for exercising the option. Its core function is to provide a clear framework for managing the relationship and expectations between parties while the option is pending, thereby reducing uncertainty and potential disputes.
For Optioned Programs. Without limitation to the foregoing, subject to Section 4.7(c)(vi), the JDC shall have the following responsibilities with respect to each Optioned Program:
(A) subject to Section 3.5(c), monitor and provide strategic oversight of the Development activities of the Parties with respect to Optioned Molecules and Optioned Products included in such Optioned Program (including the conduct of the R&D Plan and Budget) and facilitate communications between the Parties with respect to such Development activities, including with respect to any discussions with, and commitments to or agreements with, Regulatory Authorities with respect to any such Optioned Product (including regarding (1) any Phase 4 Clinical Trials in each case included in the R&D Plan and Budget and (2) any Optioned Combinations, Arcus Combinations or Excluded Combinations);
(B) prepare the R&D Plan and Budget for such Optioned Program, in each case, for review and approval by the JSC;
(C) review, at least annually, the R&D Plan and Budget for such Optioned Program, and, in each case, suggest any applicable amendments thereto for review and approval by the JSC;
(D) review and approve the design of all Clinical Trials and Nonclinical Studies conducted under the R&D Plan and Budget for such Optioned Program;
(E) review the conduct and the results of Clinical Trials and Nonclinical Studies and based on such results, determine whether and when to initiate or discontinue any Clinical Trial or Nonclinical Study under the R&D Plan and Budget for such Optioned Program; provided that nothing herein is intended to limit a Party’s ability to comply with Applicable Law or manage subject safety;
(F) pursuant to Section 5.2(a), establish a global strategy for obtaining Regulatory Approval for Optioned Molecules and Optioned Products included in such Optioned Program, and oversee any material matters in connection therewith;
(G) pursuant to Section 4.8(b)(ii), review and discuss any Arcus Independent Activities Plan and Budget with respect to such Optioned Program, and present any such Arcus Independent Activities Plan and Budget and any comments with respect thereto to the JSC for its further review and approval, if any;
(H) review the progress of any Arcus Independent Activities with respect to such Optioned Program;
(I) pursuant to Section 3.5(c)(i)(B), [***]; and
(J) coordinate communications with the medical community regarding such Optioned Program, including determining what information will be disclosed r...
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.
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.
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;