Responsibilities of the JDC. The JDC shall have the responsibility and authority to:
Responsibilities of the JDC. The Joint Development Committee shall be responsible for the following activities:
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 with respect to Phase I Plans for Phase I Completed Original Products and the clinical development of C4T Co-Dev Products to:
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 be responsible for performing the following functions:
Responsibilities of the JDC. The JDC will oversee the Parties’ efforts for development and will oversee and coordinate the Parties’ efforts with respect to Development. The JDC will review and comment on the Development Plans and Development Budgets and make non-binding recommendations as may be requested by either OXIS or Alteon with respect to adjustment of Development, budget and timetables and the assessment of whether a Licensed Product shall proceed to the next stage of Development. OXIS will update the JDC periodically, but at least ***, of all Development activities. The JDC will review and approve, with respect to Development, the addition of new indications, provided, however, that it is understood that the JDC shall act in a separate advisory capacity only and shall not at any time be deemed to be a committee or subcommittee of the Board of Directors or scientific advisory board of either OXIS or Alteon. The JDC shall not at any time be authorized to enter into agreements for itself or on behalf of either OXIS or Alteon.
Responsibilities of the JDC. The JDC shall perform the following functions for the Development Program:
Responsibilities of the JDC. The purposes of the JDC shall be to monitor and comment upon the Full Development of Clinical Candidates through the initiation of Phase III Clinical Trials. As part of its responsibilities, the JDC shall review and recommend clinical development plans and progress on Phase I and Phase II studies, through initiation of Phase III studies. The party hosting each meeting of the JDC promptly shall prepare, and deliver to the other party within thirty (30) days after the date of such meeting, minutes of such meeting setting forth all recommendations of the JDC relating to the Full Development of each Clinical Candidate in form and content reasonably acceptable to the other party.
Responsibilities of the JDC. The JDC shall prepare and approve (i) the annual implementation of the Development Plan (which includes the Regulatory Plan) for each Product, together with the related Development Budget; (ii) any update or proposed changes to the Development Plan and Budget; and (iii) the Drug Substance Specifications for any pharmaceutical active ingredient to be combined with LAS 34273 (for the avoidance of doubt, the Parties agree that ALMIRALL shall prepare and propose the initial Drug Substance Specifications for LAS 34273), and (iv) the Product Specifications. The preparation and execution of the Development Plan will be performed through the JDC. The JDC shall be responsible, directly or indirectly through working groups established by the JDC for this purpose, for the day-to-day overview of the implementation of the approved Development Plan. The JDC shall review the Development Plan and Development Budget as needed, but at least twice yearly. Any changes to the approved Development Plan that would require a material change in the approved Development Budget must be reviewed and approved by the JDC. The Development Budget shall set forth the estimated Development Costs that are likely to be incurred in the applicable calendar year. The Development Plan shall include time lines, key decision points and priorities for the various Development activities and associated costs. In addition to the detailed Development Plan and Development Budget for a given calendar year, each such plan and budget shall include an outline of the projected plan and estimated budget for the next calendar year. In addition, the JDC shall:
