CLINICAL DEVELOPMENT COMMITTEE Clause Samples
The Clinical Development Committee clause establishes a designated group responsible for overseeing and guiding the clinical development activities within a project or collaboration. This committee typically consists of representatives from the involved parties and meets regularly to review progress, make key decisions on study design, and address any issues that arise during clinical trials. By centralizing decision-making and ensuring coordinated oversight, the clause helps streamline the clinical development process and resolves potential disputes or miscommunications between parties.
CLINICAL DEVELOPMENT COMMITTEE. (a) The Parties shall form a Clinical Development Committee which shall:
(i) oversee the implementation of (1) the clinical studies as set forth in Exhibit 3.1 and (2) the pursuit of Regulatory Approval in the U.S. Territory including but not limited to the preparation and filing of the U.S. NDA;
(ii) be responsible for developing further clinical strategies for the Product in the U.S. Territory and in the EU; and
(iii) shall act in an advisory capacity to the Parties with respect to (1) potential combination therapies using the Product and one or more other pharmaceutical products; and (2) studies to obtain additional approved indications for the Product.
(b) The Clinical Development Committee shall consist of no more than eight (8) total members, four (4) representatives each from ▇▇▇▇▇▇ and SuperGen, and shall be chaired alternatively on an annual basis by one (1) of the SuperGen representatives and by one (1) of the ▇▇▇▇▇▇ representatives. It shall follow the rules established by Section 4.2(a)(i) through (v) for the U.S. Marketing Board, except that:
(i) final decisions with respect to clinical development and regulatory strategy for the Product in the U.S. Territory (including but not limited to, for example, when and how to close the data base, when and how to file for Regulatory Approval, when and how to conduct interim analyses, and all protocols for clinical studies) and for clinical development in the EU shall be made by the Clinical Development CONFIDENTAIL TREATMENT REQUESTED Committee;
(ii) final decisions with respect to Marketing Studies intended for use solely within the U.S. Territory shall be made by the U.S. Marketing Board, and by ▇▇▇▇▇▇ with respect to Marketing Studies intended for use solely within the International Territory, irrespective of the country or countries in which such Marketing Studies are conducted;
(iii) final decisions with respect to clinical development for the Product in the International Territory outside the EU, and for clinical development and regulatory strategy for the Product in the International Territory, shall be made by ▇▇▇▇▇▇; and
(iv) The Clinical Development Committee shall endeavor to work by consensus. In the event of a deadlock in any vote or on any issue relating to this Section 4.4 on which the Clinical Development Committee is to make a final decision, the Parties shall refer the deadlocked issue to SuperGen's Executive Vice President of Medical Affairs and ▇▇▇▇▇▇'▇ Hospital Products Division Vi...
CLINICAL DEVELOPMENT COMMITTEE. The Parties shall form a Clinical Development Committee which shall
(i) oversee, review and coordinate the implementation of (1) the clinical studies, and (2) the pursuit of Regulatory Approval in the U.S. Territory, including, but not limited to, the preparation and filing of the U.S. NDA;
(ii) be responsible for developing further clinical strategies for the Product in the U.S. Territory.
(iii) determine the Party responsible for managing the Clinical Development and Regulatory Approval activities.
CLINICAL DEVELOPMENT COMMITTEE