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:
(i) To review and comment on the MITSUBISHI Development Plan as set forth in Section 3.2.1 below;
(ii) To review and comment on the Core Development Plan and the VERTEX Development Plan as set forth in Sections 3.2.2 and 3.2.3 below;
(iii) To receive and review reports by MITSUBISHI, which shall be prepared and submitted to VERTEX and the JDC no less than [***] days before each semi-annual face-to-face meeting,setting forth in reasonable detail, with supporting data, the results of work performed during the preceding [***] under the MITSUBISHI Development Plan;
(iv) To receive and review reports by VERTEX, which shall be prepared and submitted to MITSUBISHI and the JDC no less than [***] days before each semi-annual face-to-face meeting,setting forth in reasonable detail, with supporting data, the results of work performed during the preceding [***] under the Core Development Plan and the VERTEX Development Plan;
(v) To assist in coordinating scientific interactions and resolving disagreements between VERTEX and MITSUBISHI with respect to the development of Compounds;
(vi) To discuss matters relating to Patents claiming Bulk Drug Substance, the...
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 Original Agreement 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 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:
(i) To review and comment on the MITSUBISHI Development Plan as set forth in Section 3.2.1 below;
(ii) To review and comment on the Core Development Plan and the VERTEX Development Plan as set forth in Sections 3.2.2 and 3.2.3 below;
(iii) To receive and review reports by MITSUBISHI, which shall be prepared and submitted to VERTEX and the JDC no less than [***] days before each semi-annual face-to-face meeting, setting forth in reasonable detail, with supporting data, the results of work performed during the preceding six months under the MITSUBISHI Development Plan;
(iv) To receive and review reports by VERTEX, which shall be prepared and submitted to MITSUBISHI and the JDC no less than [***] days before each semi-annual face-to-face meeting, setting forth in reasonable detail, with supporting data, the results of work performed during the preceding six months under the Core Development Plan and the VERTEX Development Plan;
(v) To assist in coordinating scientific interactions and resolving disagreements between VERTEX and MITSUBISHI with respect to the development of Compounds;
(vi) To discuss matters relating to Patents claiming Bulk Drug Su...
Formation and Responsibilities. As soon as practicable after the execution of this Agreement, HMR and VERTEX will establish a Joint Development Committee (the "JDC") comprised of eight (8) representatives, four of whom shall be designated by each party. Additional JDCs may be established from time to time as the parties deem necessary to handle development of additional Indications as defined in Section 6.2(e). Unless otherwise indicated by the context in which it is used, the term "JDC" as referenced herein shall also include the members of the JDC and any subcommittees which may be established from time to time by the JDC.
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. As of the Effective Date, the Parties have established an executive steering committee (the “Executive Steering Committee” or “ESC”), which shall have the following responsibilities with respect to Licensed Products:
(a) [***] the work of the JPT, and [***] reports and other information submitted by the JPT;
(b) [***] disputes referred to the ESC by the JPT; and
(c) making such other decisions as may be delegated to the ESC pursuant to this Agreement or by written agreement of the Parties.
Formation and Responsibilities. As of the Effective Date, the Parties have established a joint project team (the “Joint Project Team” or “JPT”), which (i) shall [***] the development of the Licensed Products [***] and the submission of applications for Health Registration Approvals and other regulatory submissions for Licensed Products [***] and shall facilitate the flow of information with respect to development activities being conducted for the Licensed Products and clinical studies in support of Health Registration Approvals for the Licensed Products [***]; and (ii) shall serve as a forum for facilitating the flow of information with respect to commercialization of Licensed Products [***], shall [***], in each case for Licensed Products [***], and shall [***]. Specifically, the JPT shall have the following responsibilities:
(a) [***] a strategy for the development and obtaining of Health Registration Approvals for Licensed Products [***];
(b) [***] activities under, and compliance with, the Initial Development Plan and Initial Development Budget, and adopting any amendments thereto, including [***];
(c) [***] the Development Plan and any Development Budget, and [***] any amendments thereto as circumstances may require; CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
(d) [***] the preparation and submission of all Regulatory Documentation [***] with respect to [***] Licensed Product, including Drug Approval Applications;
(e) [***] and submission [***] of all further Regulatory Documentation [***] with respect to Licensed Products [***] and all Regulatory Documentation [***] with respect to [***] Licensed Products, including, in each case, Drug Approval Applications;
(f) [***] communications with the FDA in connection with registration efforts with respect to Licensed Products;
(g) [***] data, reports or other information submitted by either Party with respect to development activities conducted by or on behalf of such Party pursuant to Section 4.10 or otherwise;
(h) facilitating the exchange of information and data with respect to the development of Licensed Products [***] between the Parties;
(i) when so requested by the ESC, preparing a progress report on development and associated regulatory activities with respect to Licensed Products in the Territory, and providing to the ESC such additional information with respect there...
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 CONFIDENTIAL TREATMENT REQUESTED 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.
