Common use of For Optioned Programs Clause in Contracts

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 regarding such Optioned Program, and serving as a forum to discuss interactions with key opinion leaders and patient advocacy groups; (K) pursuant to Section 13.4(a)(iv), establish and approve a Publication strategy for such Optioned Program, and amend such Publication strategy from time to time, as appropriate; and (L) allocate responsibilities to each Party for the conduct of Medical Affairs Activities in support of the Development of any Optioned Product in such Optioned Program, pursuant to the R&D Plan and Budget, and oversee the conduct thereof.

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 (including post-approval commitments) with respect to any such Optioned Product Product; (B) monitor and provide strategic oversight of the Manufacturing activities of the Parties with respect to Optioned Molecules and Optioned Products included in such Optioned Program (including regarding the conduct of the Global Manufacturing Plan and Budget and formulation, validation, scale up, and other activities to maintain supply for Development), and facilitate communications between the Parties with respect to such Manufacturing activities; (1C) any Phase 4 Clinical Trials in each case included in prepare the R&D Plan and Budget and (2) any Optioned Combinations, Arcus Combinations or Excluded Combinations); (B) prepare the R&D Global Manufacturing Plan and Budget for such Optioned Program, in each case, for review and approval by the JSC; (CD) review and approve the final substance and form of each Publication covering activities (or the results thereof) in any R&D Plan and Budget or Independent Activities Plan; (E) review, at least annually, the R&D Plan and Budget and Global Manufacturing Plan and Budget for such Optioned Program, and, in each case, suggest any applicable amendments thereto for review and approval by the JSC; (DF) 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 discuss 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; (FG) pursuant to Section 5.2(a), establish a global strategy review the conduct of all Clinical Trials and Nonclinical Studies conducted under the R&D Plan and Budget for obtaining Regulatory Approval for Optioned Molecules and Optioned Products included in such Optioned Program, including any Requested or Required Phase 4 Clinical Trials and oversee any material matters Mutual Post-Approval Commitments, in connection therewitheach case, included in such R&D Plan and Budget; (GH) pursuant to agree upon a Technology Transfer Plan for such Optioned Program; (I) in accordance with Section 4.8(b)(ii7.2(b), 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; discussion; (HJ) 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 regarding such Optioned Program, and serving as a forum to discuss interactions with key opinion leaders and patient advocacy groups; (K) pursuant to Section 13.4(a)(iv), establish and approve a Publication strategy for such Optioned Program, and amend such Publication strategy from time to time, as appropriate; and (L) allocate responsibilities to each Party for the conduct of Medical Affairs Activities in support of the Development of any Optioned Product in such Optioned Program, pursuant to the R&D Plan and Budget, and oversee the conduct thereof.

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 (including post-approval commitments) with respect to any such Optioned Product Product; (B) monitor and provide strategic oversight of the Manufacturing activities of the Parties with respect to Optioned Molecules and Optioned Products included in such Optioned Program (including regarding the conduct of the Global Manufacturing Plan and Budget and formulation, validation, scale up, and other activities to maintain supply for Development), and facilitate communications between the Parties with respect to such Manufacturing activities; (1C) any Phase 4 Clinical Trials in each case included in prepare the R&D Plan and Budget and (2) any Optioned Combinations, Arcus Combinations or Excluded Combinations); (B) prepare the R&D Global Manufacturing Plan and Budget for such Optioned Program, in each case, for review and approval by the JSC; (CD) review and approve the final substance and form of each Publication covering activities (or the results thereof) in any R&D Plan and Budget or Independent Activities Plan; (E) review, at least annually, the R&D Plan and Budget and Global Manufacturing Plan and Budget for such Optioned Program, and, in each case, suggest any applicable amendments thereto for review and approval by the JSC; (DF) 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 discuss 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; (FG) pursuant to Section 5.2(a), establish a global strategy review the conduct of all Clinical Trials and Nonclinical Studies conducted under the R&D Plan and Budget for obtaining Regulatory Approval for Optioned Molecules and Optioned Products included in such Optioned Program, including any Requested or Required Phase 4 Clinical Trials and oversee any material matters Mutual Post-Approval Commitments, in connection therewitheach case, included in such R&D Plan and Budget; (GH) pursuant to agree upon a Technology Transfer Plan for such Optioned Program; (I) in accordance with Section 4.8(b)(ii7.2(b), 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 anydiscussion; (HJ) review the progress of any Arcus Independent Activities with respect to such Optioned Program; (I) pursuant to Section 3.5(c)(i)(B), [***]; and (JK) coordinate communications with the medical community regarding such Optioned Program, including determining what information will be disclosed regarding such Optioned Program, and serving serve as a forum to discuss interactions with key opinion leaders and patient advocacy groups; (K) pursuant to Section 13.4(a)(iv), establish and approve a Publication strategy for such Optioned Program, and amend such Publication strategy from time to time, as appropriate; and (L) allocate responsibilities to each Party for the conduct of Medical Affairs Activities in support of the Development of any Optioned Product in such Optioned Program, pursuant to the R&D Plan and Budget, and oversee the conduct thereof.

For Optioned Programs. Without limitation to the foregoing, subject to Section Sections 4.7(c)(vi), 6.3(c) and 6.6, the JDC JEC 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 activitiesthe Development, including with respect to any discussions with, Manufacture 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 Commercialization 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; (GB) pursuant to Section 4.8(b)(ii4.1 and subject to Section 3.5(c), review and discuss 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 present any such Arcus Independent Activities Plan and Budget Program and any comments with respect amendments thereto proposed by the JDC, provided that the JEC’s approval of such plan and amendments shall in each case be subject to the JSC for its further review and approval, if any;[***] final decision-making authority pursuant to Section 2.5(b)(ii)(B)(3); and (H) review the progress of any Arcus Independent Activities with respect to such Optioned Program; (IF) pursuant to Section 3.5(c)(i)(B)6.6, review and approve the initial Medical Affairs Plan and Budget for such Optioned Program or an expansion of such Medical Affairs 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 Medical Affairs Plan and Budget that is [***]; and (J) coordinate communications with ] at the medical community regarding such Optioned Program, including determining what information will be disclosed regarding such Optioned Program, and serving as a forum to discuss interactions with key opinion leaders and patient advocacy groups; (K) JCC pursuant to Section 13.4(a)(iv2.3(d), establish and approve a Publication strategy for such Optioned Program, and amend such Publication strategy from time to time, as appropriate; and (L) allocate responsibilities to each Party for the conduct of Medical Affairs Activities in support of the Development of any Optioned Product in such Optioned Program, pursuant to the R&D Plan and Budget, and oversee the conduct thereof.