Formation and Responsibilities. As soon as practicable after the commencement by Vertex of a Development Program with respect to a Drug Product Candidate, VERTEX will establish a Joint Development Committee (“JDC”) which shall include a representative designated by CFFT. Additional JDC’s, which shall also include one CFFT representative, may be established from time to time in connection with the development of additional Drug Product Candidates. The JDC (or its successor organization, as designated by Vertex) will be the principal organization through which the development of a Drug Product Candidate is planned, administered, evaluated and completed, subject to appropriate review and approval at senior management levels as required by VERTEX from time to time. In addition to the CFFT member, the JDC will typically have members from the various functional groups (e.g., research, preclinical safety, clinical, regulatory, marketing) which are or will be expected to be involved in development and launch of the Drug Product Candidate. VERTEX will appoint the JDC Chair. The JDC will typically meet at least quarterly, depending on the level of current development activity, and will be responsible for preparation and implementation of the Development Plan described in Section 3.2.2 below with respect to each Drug Product Candidate.
Formation and Responsibilities. As soon as practicable after the Effective Date, VERTEX and MITSUBISHI will establish a Joint Development Committee (the “JDC”) made up of equal numbers of VERTEX and MITSUBISHI personnel to be designated from time to time by each Party. Each of VERTEX and MITSUBISHI shall have one vote on the JDC. The objective of the JDC shall be to reach agreement by consensus on all matters falling within its authority hereunder within the scope of this Agreement. The Chairperson of the JDC shall be designated by MITSUBISHI. Meetings of the JDC other than regularly scheduled quarterly meetings may be held only if a quorum of [***] representatives of each Party participates; except that lack of a quorum shall not prevent the scheduling and conduct of a meeting by either Party after that Party has made good faith but unsuccessful attempts for more than ninety (90) days to schedule and convene the meeting. Semi-annually, the JDC shall meet face-to-face, alternating between the offices of the Parties, unless otherwise agreed. There shall be a telephonic or video conference meeting of the JDC in each calendar quarter in which a face-to-face meeting is not held. The JDC shall meet as described above, or with such other frequency, and at such time and location, as may be established by the JDC, for the following purposes, among others:
Formation and Responsibilities. Within thirty (30) days after the Effective Date, the Parties shall establish a joint development committee (the “JDC”) for the overall coordination and oversight of the Development of the Product until the Transfer Date. The JDC shall have review, discussion or comment responsibilities for certain matters as specified in Section 3.1(b). The JDC has only the powers expressly assigned to it in Section 3.1(b) and elsewhere in this Agreement. Notwithstanding anything to the contrary set forth in this Agreement, the JDC has no power to interpret, amend, modify, or waive compliance with this Agreement.
Formation and Responsibilities. Within sixty (60) days after the Effective Date, the Parties shall establish a joint steering committee (the “JSC”) for the overall coordination and oversight of the Parties’ activities under this Agreement. The JSC shall have review, discussion or comment responsibilities for certain matters, and decision-making authority for certain matters, as specified in Sections 4.1(b) and 4.1(c), respectively. The JSC has only the powers expressly assigned to it in Sections 4.1(b) and 4.1(c) and elsewhere in this Agreement. Notwithstanding anything to the contrary set forth in this Agreement, the JSC has no power to interpret, amend, modify or waive compliance with this Agreement.
Formation and Responsibilities. As soon as practicable following the Effective Date, Avalon will establish a Product Development Committee (“PDC”), which shall, at Vertex’s option, include representatives designated by Vertex (up to that number of representatives on the PDC designated by Avalon), * the PDC will be the principal organization through which the development of the Compound is planned, administered, evaluated and completed. In addition to the Vertex representatives, the PDC will consist of representatives of Avalon from the various functional groups (e.g., CMC, preclinical safety, clinical, regulatory, marketing) that are or will be expected to be involved in development and launch of the Compound and Drug Product. The initial Avalon and Vertex representatives on the PDC shall be the individuals set forth on Schedule 3.2.1 to this Agreement, and thereafter, each Party may at any time * The asterisk denotes the confidential portions of this document that have been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. substitute other individuals to serve on the PDC. Avalon will appoint the PDC Chair. *
Formation and Responsibilities. Upon the execution of this Agreement, VERTEX and SCHERING will establish a Development Committee made up of equal numbers of VERTEX and SCHERING personnel. The Development Committee will be responsible for the preparation and overall implementation of the Development Plan with respect to each Drug Product Candidate, and may act directly or through such sub-committees as it may deem appropriate to establish. If the Development Committee chooses to designate a Committee Chair, the Chair will be elected from among the members of the Committee by a majority vote of the Committee, and may be removed in the same manner. The Development Committee shall meet formally at least quarterly, or with such other frequency, and at such time and location, as may be established by the Committee, for the following purposes, among others:
Formation and Responsibilities. Within thirty (30) days after the Execution Date, the Parties shall establish a Manufacturing transition team (the “Manufacturing Transition Team”), which shall have the following responsibilities: (i) overseeing forecasting, ordering and order fulfilment under the Praluent Supply Agreements and serving as a forum for the Parties to discuss matters with respect thereto; (ii) overseeing the performance of the Tech Transfer Plans; and (iii) serving as a forum for the Parties to discuss other Manufacturing-related topics, such as and not limited to manufacturing changes or new product launches for Praluent Products.
Formation and Responsibilities. Within [*] after the Effective Date, the Parties shall establish one (1) joint steering committee (the “JSC”) in accordance with clause 3.5, comprised of senior executives, to provide high-level strategic oversight and decision-making regarding the activities of the Parties under this Agreement with respect to all of the Licensed Products.
Formation and Responsibilities. Within thirty (30) days of the Effective Date, VERTEX and SERONO will establish a Joint Development Committee (the "JDC") made up of equal numbers of VERTEX and SERONO personnel to be designated from time to time by each party. Each of VERTEX and SERONO shall have one vote on the JDC. The JDC will be responsible for the preparation and overall implementation of the Development Program with respect to the Drug Product Candidate, and may act directly or through such sub-committees as it may deem appropriate to establish. Meetings of the JDC other than regularly scheduled quarterly meetings may be held only if a quorum of at least two (2) representatives of each party participates; except that lack of a quorum shall not prevent the scheduling and conduct of a meeting by either party after that party has made good faith but unsuccessful attempts for more than ninety (90) days to schedule and convene the meeting. The JDC shall meet formally at least quarterly, or with such other frequency, and at such time and location, as may be established by the JDC, for the following purposes, among others:
Formation and Responsibilities. As soon as practicable after the exercise by NOVARTIS of its Development Election with respect to a Drug Product Candidate, NOVARTIS will establish an International Project Team ("IPT") which shall include one representative designated by VERTEX from time to time; provided, however, an IPT shall no longer include a representative designated by VERTEX in case of a Change of Control of VERTEX. Additional IPT's, which shall also include one VERTEX representative, may be established from time to time in connection with the development of additional Drug Product Candidates. The IPT (or its successor organization, as designated by NOVARTIS) will be the principal organization through which the development of a Drug Product Candidate is planned, administered, evaluated and completed, subject to appropriate review and approval at senior management levels as required by NOVARTIS from time to time. In addition to the VERTEX member, the IPT will typically have members from the various functional groups (e.g., research, preclinical safety, clinical, regulatory, marketing) which are or will be expected to be involved in development and launch of the Drug Product Candidate and Drug Product. NOVARTIS will appoint the IPT Chair. The IPT will typically meet every four to six weeks, depending on the level of current development activity, and will be responsible for preparation and implementation of the Development Plan described in Section 3.2.2 below with respect to each Drug Product Candidate.
