JDC Responsibilities Sample Clauses
The 'JDC Responsibilities' clause defines the specific duties and obligations assigned to the Joint Development Committee (JDC) within an agreement. Typically, this clause outlines the JDC's role in overseeing collaborative activities, making key decisions regarding project milestones, and resolving disputes between parties. For example, the JDC may be responsible for approving development plans, monitoring progress, and ensuring compliance with agreed timelines. The core function of this clause is to clearly allocate decision-making authority and operational oversight, thereby promoting efficient collaboration and minimizing misunderstandings between the parties involved.
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 JDC shall be responsible for the following items as they relate to its applicable Licensed Molecule and corresponding Licensed Products in the Territory:
(i) coordinating the initial transfer of ASCENTAGE Know-How from ASCENTAGE to INNO;
(ii) creating, reviewing and approving the Development Plan, including all material updates, amendments, modifications, and waivers of provisions thereof by consensus of all of its members;
(iii) reviewing and evaluating the progress of the Development and regulatory strategies and Development Plans for each Development program, including without limitation all health, safety and quality concerns;
(iv) oversight, review and coordination of the Development strategy, Development Plan, regulatory activities and budget for the Development of the applicable Licensed Product, provided that, any proposed budget overage that is more than ten percent (10%) will need to be approved by the JSC, and without such approval such overages will be borne by the Party with operational control over the relevant activities;
(v) monitoring the progress of work being done under the Development Plan;
(vi) performing such other Development functions as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement; and
(vii) creating IIT policy, joint review and approval of the IIT plan and budget.
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. 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 strategy for the Development of Licensed Product including, without limitation the following:
(a) reviewing and recommending to the JSC Global Development Programs and Country Specific Trials for each country, including any changes to Global Development Programs as the JDC considers appropriate in response to Regulatory Authority requirements imposed or directed following preparation of an annual budget for a Global Development Program, and managing and allocating clinical drug supply of Licensed Product to facilitate Global Development Programs, Country Specific Trials and Phase 4 Clinical Trials for post-launch marketing support, or other purposes; [*] 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 and Exchange Act of 1934, as amended.
(b) reviewing and recommending to the JSC a detailed annual budget and a three-year projection for Development Expenses associated with Global Development Programs beginning with the 2007 calendar year, the Parties having approved the budget for Global Development Programs in 2006 prior to the Effective Date, a summary of which is attached hereto as Exhibit E;
(c) establishing and recommending to the JSC forecasts for non-clinical and clinical supply of Licensed Product;
(d) together with the JCC, recommending to the JSC Phase 4 Clinical Trials and target product profiles for Licensed Product, including acute peripheral arterial occlusion, catheter occlusion, stroke, deep vein thrombosis, and other indications for Licensed Product as they are identified as potential indications for which the Parties intend to Develop Licensed Product;
(e) facilitating the exchange of all data, Information, Materials or results relating to Licensed Product; and
(f) performing such other functions as appropriate to further Development of Licensed Product in the Territory.
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. 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.
JDC Responsibilities. The JDC shall have the following responsibilities with respect to the Collaboration:
(1) determining the overall Development strategy for the Collaboration;
(2) reviewing for approval (i) the annual update to the Development Plan and (ii) any modifications to such Development Plan in each case within thirty (30) days of each submission to the JDC;
(3) determining each Party’s responsibilities under the Development Plan consistent with Section 3.1;
(4) facilitating the transfer of Know-How and Confidential Information from SONNET to ALKEM for purposes of conducting the Development Plan;
(5) reviewing any new intellectual property filings and assessing the applicability of such patents to the Development Plan;
(6) regularly assessing the progress of the Parties in their conduct of the Development Plan and against the timelines and budgets contained therein, reviewing relevant data, and considering issues of priority; and
(7) performing such other activities as are contemplated under this Agreement and, subject to any Amendments pursuant to Section 12.10, that the Parties mutually agree shall be the responsibility of the JDC.