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 JDC, which will have no decision-making authority, will monitor the activities of Company in the Development Program and serve as a forum for reviewing Company’ progress and results of the Development Program.
JDC Responsibilities. The role of each JDC shall be to oversee the development of each Licensed Product for the indications within the scope of such JDC, including to:
(i) Review and approve the applicable Development Plan prepared by Pfizer for the Licensed Product for which it is responsible;
(ii) Review and approve material amendments to the applicable Development Plan;
(iii) Review and approve the overall strategy for clinical studies;
(iv) Monitor the progress of all clinical trials and other studies for the Licensed Product for which it is responsible, including reviewing activities against the applicable Development Plan; and
(v) To the extent practicable, review material activities relating to Regulatory Approval of the Licensed Product in question, including review pre-meeting briefing documents, executive summaries and meeting minutes in connection with meetings with Regulatory Authorities in the United States and the Major EU Countries; and
(vi) Perform such other functions as appropriate to further the purposes of this Agreement. Upon receipt of the Regulatory Approval of a Licensed Product for all of the indications within the scope of a JDC in the United States and the Major EU Countries, such JDC and its subcommittees shall terminate.
JDC Responsibilities. The Joint Development Committee shall have the responsibility and authority for the operational aspect of the Development of the Licensed Product in the Territory, including, without limitation, to (i) provide a forum for exchange of information related to the Development Programs; and (ii) discuss and propose to the Joint Steering Committee any material amendments or updates to the Development Plan.
JDC Responsibilities. In addition to its overall responsibility for managing the Development Program, the JDC shall, in particular:
(a) prepare and approve amendments to the Development Plan;
(b) oversee implementation of the Development Plan in and for the Territory, ensuring that activities thereunder are performed in accordance with the approved timelines and budgets;
(c) request from CG as needed, information or reports regarding CG Territory Activities and discuss such CG Territory Activities as appropriate;
(d) ensure that each Party keeps the JDC informed regarding all material activities performed by such Party under this Agreement that are within the purview of the JDC;
(e) generate and maintain a list of all Products identified under the Development Program;
(f) work to resolve any scientific, clinical, or technical disputes, controversy or claim within its scope of authority;
(g) determine whether Kissei may conduct (or appoint, license, or otherwise authorize or facilitate any Affiliate or Third Party to conduct) activities directed to the development of any Collaboration Compound or Product for another Indication in the Territory as set forth in Section 2.2.3 (Certain Activities);
(h) determine whether to provide Product to support any proposal for an investigator-initiated study of such Product as set forth in Section 2.2.2 (Certain Activities); and
(i) perform such other functions as may be allocated to the JDC under this Agreement or by mutual written agreement of the Parties.
JDC Responsibilities. In addition to its overall responsibility for overseeing the Development Program, the JDC shall, in particular:
(a) work with the Project Co-Leaders to coordinate all material Development activities performed by each Party and monitor progress of the Development activities of the Parties hereunder;
(b) review and approve amendments to the Development Plan as proposed by the JPT;
(c) review and approve the allocation of resources and efforts for the Development Programs;
(d) determine the specific format and timeline for the transfer of any Deliverables in respect of any Development Program, as set forth in Section 7.1;
(e) discuss any potential Permitted Third Party TCR Agreements related to any Development Program under this Agreement, as appropriate, as set forth in Section 8.1;
(f) subject to ARTICLE 13, review and approve the overall Development communication and publication strategy as developed by the JPT;
(g) work to resolve any disputes, controversy or claim related to the matters within the authority of the JDC, including resolving disputes arising within any Working Group of the JDC; and
(h) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties.
JDC Responsibilities. Each JDC will be responsible for the following items as they relate to the Licensed Molecule and the Licensed Product(s) in the Zai Lab Territory:
JDC Responsibilities. The JDC shall be responsible for overseeing and coordinating the Development of the Licensed Compound in the Partner Territory and in the Field, including (i) reviewing and approving changes to the Partner Development Plan, (ii) reviewing the Parties’ Development activities and progress against the Partner Development Plan, (iii) evaluating the Partner Development Plan outcomes against the Stopping Criteria, and (iv) reviewing, discussing and coordinating scientific presentations and publication plans with respect to the Licensed Compound, Licensed Product and any results arising therefrom during the course of the Partner Development Plan. [*] = 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 406 of the Securities Act of 1933, as amended.
JDC Responsibilities. The JDC will be responsible for developing a plan for the overall worldwide Development of each Collaboration Product, including specifically:
(a) Preparing and submitting to the JSC for review, and, in the discretion of the JSC, approval of, on at least an annual basis, the Global Development Plan, including any changes to the Global Development Plan that the JDC considers appropriate in response to interactions with Regulatory Authorities, to manage clinical drug supply of Collaboration Product or for any other reason. In proposing Development activities for inclusion in the Global Development Plan, the JDC shall designate them as either Joint Activities or Territory Specific Activities.
(b) Preparing and submitting to the JSC for approval on at least an annual basis, as part of the Global Development Plan, a detailed annual budget and a [ * ] projection for Development Expenses associated with the Joint Activities (but not Territory Specific Activities) for each Collaboration Product beginning with the calendar year in which the applicable Election is made or Opt-In Notice is given, as the case may be; provided, however, that such responsibility may be delegated to the Parties’ controllers or other individuals within the Parties’ finance groups or to a joint finance committee if established as a subcommittee of the JSC.
(c) Establishing and recommending to the JSC forecasts for non-clinical and clinical supply of Collaboration Product; provided, however, that such responsibility may be delegated to a joint supply or manufacturing committee if established as a subcommittee of the JSC.
JDC Responsibilities. In addition to serving as a forum for the exchange of information and discussion of issues, in each case with respect to the Development of the Collaboration Off-the-Shelf T-Cell Therapies Directed To each Collaboration Target for which an Opt-In is in effect, the JDC will review, exchange and discuss the following information and issues in particular:
(a) GNE will provide to the JDC updates [***];
(b) GNE will provide the JDC with all updates (or draft updates, as available) [***];
(c) GNE will provide the JDC with [***];
(d) Adaptimmune, through the JDC, may provide its comments to GNE regarding the Development (and, eventually, the US launch) of the applicable Collaboration Off-the-Shelf T-Cell Therapies, which [***].
