Responsibilities of the JDC Clause Samples

Responsibilities of the JDC. The JDC shall have the responsibility and authority with respect to Phase I Plans for Phase I Completed Original Products and the clinical development of C4T Co-Dev Products to: (a) Approve each Phase I Plan (if for a Phase I Completed Original Product) and Development Plan (if for a C4T Co-Dev Product); (b) Approve any revisions to the Phase I Plan and Development Plan under (a); (c) Review and oversee the execution of the Phase I Plan and Development Plan under (a) and oversee the progress of activities under such plans; (d) Oversee the Phase I Study of Phase I Completed Original Products; (e) Oversee the Clinical Studies of C4T Co-Dev Products; (f) Establish timelines and criteria for development decision points; (g) Review and discuss filing of the IND for each Phase I Completed Original Product; (h) Determine whether development success criteria have been met (Phase I Data Package); (i) Review the efforts of the Parties and allocate those resources for the Phase I Plan and Clinical Studies; (j) review regular updates to the Shared Development Cost Budget for Development Costs as set forth in Sections 6.2.2 and 6.3.2; (k) identify appropriate resources necessary to conduct the Development Plan; (l) establish and set expectations and mandates for its JOT; (m) create or disband its JOT as deemed appropriate; (n) oversee its JOT, if applicable; (o) align on the drug substance and drug product strategy, including stability program, and its execution for the drug product used for the Phase I Studies of Phase I Completed Original Products; (p) oversee manufacture and release of drug substance and drug product batches to be used for Phase I Studies of Phase I Completed Original Products; (p) depending on the Clinical Studies following Phase I Studies of C4T Co-Dev Products, approve the appropriate CMC strategy for drug substance and drug product to be used in either Phase II Studies or Phase III Studies and oversee its execution; (q) define the drug substance and drug product specifications for the batches used for Phase I Studies of Phase I Completed Original Products and any batches made prior to Roche exercising the Roche Option Right of Phase I Completed Original Products for the subsequent Phase II Studies and/or Phase III Studies after exercise of the Roche Option Right; and (r) Attempt to solve any disputes on an informal basis. The JDC shall have no responsibility and authority other than that expressly set forth in this Section 11.10.

Responsibilities of the JDC. The Joint Development Committee shall be responsible for the following activities: (i) reviewing and approving amendments to the Protocol; (ii) approving Participating Sites and Investigators; (iii) reviewing the progress of the Study and making necessary joint decisions; (iv) establishing the Data Review Committee (as described in Section Article 2) and deciding whether and how address its recommendations; (v) evaluating and determining how to address any safety matters related to the Combination; (vi) reviewing the progress of the Sample Analysis Plan and making necessary joint decisions, including subsequent amendments to the Sample Analysis Plan and determining the timing for Sample Analysis to be performed by a Party and the transfer of results to the other Party; (vii) coordinating the transfer of materials and information between the Parties, including the Study Data, the Final Study Report, the Samples and the Sample Data; (viii) addressing any issues that may arise in the event of a shortage of supply of Corvus Molecule or Genentech Molecule for the Study, subject to Section 4.3; (ix) attempting to resolve any Disputes related to the Study; and (x) performing such other functions as appropriate to further the purposes of the Study, or as otherwise specified in this Agreement.

Responsibilities of the JDC. The Joint Development Committee shall be responsible for performing the following functions: (i) review and approve the final version of the Protocol and any amendments to the Protocol, subject to Section 2.4; (ii) discuss potential Participating Sites and Investigators; (iii) review the progress of the Study and make necessary joint decisions; (iv) establish the Data Review Committee (as described in Section 3.2) and decide how to address its recommendations; (v) coordinate, and be the primary conduit for, the transfer of materials and information between the Parties, including the Study Data, the Final Study Report, the Samples and the Sample Data; and (vi) perform such other functions as appropriate to further the purposes of the Study, or as otherwise specified in this Agreement or agreed to by the Parties.

Responsibilities of the JDC. The JDC shall:

Responsibilities of the JDC. In addition to any responsibilities expressly described elsewhere in this Agreement, the JDC will:

Responsibilities of the JDC. The JDC shall have the responsibility and authority to: (a) Plan, implement, and oversee any further Development of Product with respect to the U.S. Territory; (b) Discuss and monitor the Development of Product with respect to the Transcept Territory; (c) Establish subcommittees pursuant to Section 3.11 on an as-needed basis, oversee the activities of all subcommittees so established, and address disputes or disagreements arising in all such subcommittees; and (d) Perform such other functions as the Parties may agree in writing.

Responsibilities of the JDC. The JDC shall have the responsibility and authority to: (a) discuss, plan, revise and implement the Clinical Development Plan, including manufacturing of Irofulven for the Phase 2 Clinical Trial; (b) discuss, plan, and inform of any further Development of Products in all indications in the Field in the Territory, including manufacturing of Products in support of such activities; (c) use Commercially Reasonable Efforts to align each Party’s strategy for the Development of the Products in the Territory; (d) no less frequently than on a bi-annual basis, review, amend and approve any updates to the Clinical Development Plan, including the activities, budget and timeline for Development (see Section 4.2(b)); (e) review and approve proposed Publications in scientific journals, which will need to be approved unanimously by the JDC members, presentations at conferences, and/or press releases resulting from Development activities;

Responsibilities of the JDC. The responsibilities of the JDC shall include: (a) overseeing, reviewing and coordinating the Parties’ implementation of the Research Plan, including reviewing data provided by Notch to evidence its achievement of the Research Milestones and Development Milestones; (b) making key decisions as designated in the Research Plan, including determining whether or not the Research Milestones (as applicable) have been met, as set forth in Section 3.4; (c) subject to Section 2.1, amending the Research Plan, including following the substitution of an Exclusive Target pursuant to Section 2.5 or the addition of an Exclusive Target pursuant to Section 2.6; (d) undertaking and/or approving such other matters as are specifically provided for the JDC under this Agreement; and (e) serving as an initial forum for resolving any disputes between the Parties.

Responsibilities of the JDC. The JDC shall have the responsibility and authority to: (a) review the Development of the Licensed Product in the Field in the Territory and discuss the overall strategy for Development of the Licensed Product in the Field in the Territory; (b) monitor the progress of all clinical studies that are ongoing as of the Effective Date; (c) oversee the execution of the [*] and [*] with respect to the Licensed Product; [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. (d) review, approve and monitor performance against [*] for Development activities as set forth in the Development Plans; (e) review and monitor performance against [*] for Development activities as set forth in the Development Plans; (f) discuss the [*] as developed by Schering pursuant to Section 5.1; and (g) perform such other functions as the Parties may agree in writing.