Common use of JDC Responsibilities Clause in Contracts

JDC Responsibilities. The JDC shall have the following responsibilities with respect to the Development of Licensed Product during the License Term: (i) reviewing and approving (A) the Development Plan, (B) each annual update to the Development Plan, (C) any other modifications to the Development Plan, in each case within thirty (30) days after each submission thereof to the JDC (or sooner as circumstances warrant), and (D) guidelines for conduct of Territory-Specific Clinical Trials and Post-Approval Clinical Studies; (ii) monitoring and overseeing Development of Licensed Product in the Field in the Territory, and monitoring the Parties’ respective commitments relating to shared Development Costs; (iii) reviewing updates from AVEO regarding the Development of the Licensed Product in the Territory, and updates from Biogen Idec regarding the conduct of Territory-Specific Clinical Trials and Post Approval Clinical Studies, including, in each case a review of (a) the status of such Development efforts; (b) the results of pre-clinical and clinical studies of Licensed Product in the Field completed since the last update; (c) the design of proposed pre-clinical and clinical studies, and (d) the content of proposed regulatory filings related to Licensed Product in the Field in the Territory; (iv) regularly assessing the progress of conduct of the Development Plan against the timelines and budgets contained therein, and reviewing relevant data, and considering issues of priority; and (v) coordinate on issues related to Manufacture of Licensed Product for the Field in the Territory, subject to Article VII. For purposes of clarity, it is expected that with respect to the sharing of information regarding the Licensed Product, each Party will, through the JDC and through regular communication between each Party’s designated Collaboration Manager, keep the other Party informed at a detailed level about all activities related to the Development and Manufacture of the Licensed Product in the Field under this Agreement, and will provide all information requested by the other Party related to the Development and Manufacture of the Licensed Product in the Field. The JDC shall not have the authority to modify the terms of this Agreement.

JDC Responsibilities. The In addition to its overall responsibility for overseeing, reviewing and managing the Development Plans, the JDC shall have shall, in particular: (a) manage and govern the following responsibilities activities of the Parties with respect to the development, manufacture, and regulatory approval of MAGE-A4 Compounds, Licensed Product(s) and Companion Diagnostics; (b) work with the Project Co-Leaders to coordinate the activities of the Parties hereunder, including review and approval of the allocation of resources and efforts under the Development Plan; (c) review and approve any proposed modification of the Development Plans, including the Development Budgets; (d) analyse the opportunities for development of MAGE-A4 Compound both as a monotherapy and in combination, including by deciding whether to seek new indications, formulations or uses for the Licensed Products in the Territory where appropriate, such as for Licensed Product life cycle management; (e) review and approve the protocols for all Clinical Trials conducted under the Development Plans and any material amendments thereto (including any amendments which would change the primary endpoint of such Clinical Trial, dosage or similar matters), provided that such review and approval shall be conducted within a timeframe that does not extend beyond [***]; (f) review quarterly financial forecasts for development (including timing of expenditures) to ensure actual and anticipated expenditure is within the approved Development Budget for the relevant [***]; (g) discuss and oversee CMC related activities including CMC related regulatory activities and maintenance of regulatory submissions, including INDs, for Licensed Products to ensure regulatory compliance and timely management of responses to any regulatory authority queries pre- and post-approval as was during regulatory review processes; (h) review, discuss, coordinate and approve funding or supply of Licensed Product during for any externally sponsored research in the License Term:Territory and establish a group to review and approve proposals for externally sponsored research involving the Licensed Product(s); (i) reviewing review, discuss, and approving (A) the Development Plan, (B) each annual update approve publication strategy relating to the Development Plan, (C) any other modifications to Licensed Products and the Development Planplan for scientific presentations and publications, in each case within thirty (30) days after each submission thereof accordance with Article 17, save that publication strategy relating to Research Programs shall be reviewed and coordinated by the JDC (or sooner as circumstances warrant), and (D) guidelines for conduct of Territory-Specific Clinical Trials and Post-Approval Clinical StudiesJRC; (iij) monitoring discuss and overseeing Development approve plans for development of biomarkers, Companion Diagnostics and any other diagnostic products for use in connection with a Licensed Product; (k) review, discuss and approve in consultation with the JPT distribution of Licensed Product in the Field in the Territory, and monitoring the Parties’ respective commitments relating to shared Development Costsfor “compassionate use” or as free goods; (iiil) reviewing updates from AVEO regarding work to resolve any disputes, controversy or claim related to the Development matters and authority of the Licensed Product in the TerritoryJDC, including any issues presented to it by, and updates from Biogen Idec regarding disputes within, any Working Group or the conduct of Territory-Specific Clinical Trials and Post Approval Clinical Studies, including, in each case a review of (a) the status of such Development efforts; (b) the results of pre-clinical and clinical studies of Licensed Product in the Field completed since the last update; (c) the design of proposed pre-clinical and clinical studies, and (d) the content of proposed regulatory filings related to Licensed Product in the Field in the Territory; (iv) regularly assessing the progress of conduct of the Development Plan against the timelines and budgets contained therein, and reviewing relevant data, and considering issues of priorityJPT; and (vm) coordinate on issues related perform such other functions as appropriate to Manufacture of Licensed Product for further the Field in the Territory, subject to Article VII. For purposes of clarity, it is expected that with respect to the sharing of information regarding the Licensed Product, each Party will, through the JDC and through regular communication between each Party’s designated Collaboration Manager, keep the other Party informed at a detailed level about all activities related to the Development and Manufacture of the Licensed Product in the Field under this Agreement, and will provide all information requested Agreement as determined by the other Party related to the Development and Manufacture of the Licensed Product in the FieldParties. The JDC shall not have the authority to modify the terms of this Agreementconsider at its first meeting whether any additional matters should fall within its remit.

JDC Responsibilities. The JDC shall develop the strategies for and oversee the Development of the Licensed Products in the Territory, and shall serve as a forum for the coordination of Development activities for the Licensed Products for the Territory. In particular, the JDC shall have the following responsibilities unless Protagonist has exercised the Rusfertide Opt-Out Right or a Partial Opt-Out Right (in which case the limited discontinuation shall apply solely with respect to the Development of applicable Licensed Product during that would be the License Term:subject of such plans and activities): (i) reviewing and approving (A) oversee the Development Plan, (B) each annual update to the Development Plan, (C) any other modifications to the Development Plan, in each case within thirty (30) days after each submission thereof to the JDC (or sooner as circumstances warrant), and (D) guidelines for conduct of Territory-Specific Clinical Trials and Post-Approval Clinical Studies;Development activities under the Joint Global Development Plan for Rusfertide and, as applicable, any Joint Global Development Plans for Licensed Products other than Rusfertide; ​ (ii) monitoring and overseeing serve as a forum for discussing proposed Development of activities conducted under the Joint Global Development Plan for Rusfertide and, as applicable, any Joint Global Development Plans for Licensed Product in the Field in the Territory, and monitoring the Parties’ respective commitments relating to shared Development CostsProducts other than Rusfertide; (iii) reviewing updates from AVEO regarding the Development of serve as a forum for discussing and coordinating strategies for obtaining Regulatory Approvals for the Licensed Product Products in the Territory and progress for Licensed Products in the Territory, and updates from Biogen Idec regarding the conduct of Territory-Specific Clinical Trials and Post Approval Clinical Studies, including, as described in each case a review of (a) the status of such Development efforts; (b) the results of pre-clinical and clinical studies of Licensed Product in the Field completed since the last update; (c) the design of proposed pre-clinical and clinical studies, and (d) the content of proposed regulatory filings related to Licensed Product in the Field in the TerritorySection ‎‎4.7(a); (iv) regularly assessing review, discuss and determine whether to approve for submission to the progress of conduct of JSC for its approval any amendment to (A) the Joint Global Development Plan against for Rusfertide (including, as applicable, the timelines corresponding Shared Development Budget and budgets contained thereinassociated regulatory strategy), including to add any Clinical Trial or Indications as described in Section ‎4.2(b); (v) for any Licensed Product other than Rusfertide, as applicable, review, discuss and determine whether to approve for submission to the JSC for its approval, its applicable Joint Global Development Plan (including the corresponding Shared Development Budget and associated regulatory strategy) for such Licensed Product, and reviewing relevant dataall annual and interim amendments thereto as described in Section ‎4.2(a); (vi) serve as a forum for exchange and discussion with respect to Development reports for the Licensed Products for the U.S., and considering issues as described in Section ‎4.7(a); (vii) approve the engagement of priorityThird Party Development subcontractors as set forth in Section ‎4.8; and (vviii) coordinate on issues related perform such other functions as expressly set forth herein, or as the Parties may mutually agree in writing, to Manufacture of Licensed Product for the Field in the Territory, subject to Article VII. For purposes of clarity, it is expected that with respect be allocated to the sharing of information regarding the Licensed Product, each Party will, through the JDC and through regular communication between each Party’s designated Collaboration Manager, keep the other Party informed at a detailed level about all activities related to the Development and Manufacture of the Licensed Product in the Field under this Agreement, and will provide all information requested by the other Party related to the Development and Manufacture of the Licensed Product in the Field. The JDC shall not have the authority to modify the terms of this AgreementJDC.