Establishment; Responsibilities. Promptly after the Effective Date, the Parties agree to establish and convene a Joint Review Committee (or “JRC”) to provide a forum for discussing Licensee’s ongoing Development and Commercialization activities with respect to the TAK-385 Licensed Compound and TAK-385 Licensed Products pursuant to this Agreement and the coordination of such Licensee activities with Takeda’s Development and Commercialization of the TAK-385 Licensed Compound and TAK-385 Licensed Products in the Takeda Territory (where applicable). The JRC will consist of representatives and operate by the procedures in accordance with this Section 2.2 (Joint Review Committee). Except as otherwise provided herein, the role of the JRC will be:
Establishment; Responsibilities. 9.1 ESTABLISHMENT shall provide all requested relevant Project information to CFZ in a timely manner, including the Scope Manual and Final Layout.
Establishment; Responsibilities. Within sixty (60) days following the execution of this Agreement, the Parties will establish a Joint Steering Committee (the “JSC”). The responsibilities of the JSC shall consist of decisions regarding execution and management of the Research Program, as follows: (a) ensuring open exchange of information between the Parties regarding the performance of the Work Plan, (b) overseeing and reviewing the status of the Work Plan, and (c) approving material updates to the Work Plan. Licensor will control the day to day activities concerning the implementation of the Work Plan subject to their compliance with this Agreement and the Work Plan. The JSC shall dissolve upon the acceptance of the first IND filing for the first Licensed Product unless otherwise mutually agreed upon by the Parties.
Establishment; Responsibilities. Within 30 days after the Effective Date, the Parties will establish a joint, co-chaired joint management committee (“Management Committee”) that will be responsible for the overall strategic alignment and direction with respect to the Collaboration, including the following:
Establishment; Responsibilities. Within […***…] after the Effective Date, the Parties shall establish a joint steering committee (the “JSC”) as more fully described in this Section 2.1. The JSC will be a forum for discussion, review and coordination regarding the Development, Manufacture and Commercialization of, and the conduct of Medical Affairs Activities with respect to, Licensed Compounds and Licensed Products in the Novartis Territory and the BeiGene Territory and in connection therewith, each Party agrees to keep the JSC reasonably informed, on a summary level, of its progress and activities with respect thereto.
Establishment; Responsibilities. Within [******] after the Effective Date, the Parties shall establish a joint steering committee (the “JSC”) as more fully described in this Section 3.1. The JSC shall serve as a forum to facilitate communications between the Parties and, to the extent provided in this Section 3.1, shall have review and decision-making responsibilities, as well as general oversight of the relevant activities, with respect to: (a) Development (and Manufacture, or having Manufactured, for the purposes thereof) of the Licensed Antibodies and the Licensed Products prior to the Option Effective Date; and (b) the Development and Commercialization of the Profit-Share Product during the Profit-Share Term. In particular, the JSC shall: (i) review and discuss potential amendments to the Agenus Development Plan in accordance with Section 2.2.1; (ii) request, receive, and review information and access to records with respect to the Licensed Antibodies and the Licensed Products prior to the Option Effective Date in accordance with Section 2.2.3; (iii) review, discuss, and approve any amendment to the Gilead Development Plan, including the Gilead Development Budget, in accordance with Section 4.2; and (iv) adopt and approve the Commercialization Plan (including the Commercialization Budget), including any amendments thereto, in accordance with Section 6.1. Representatives . The JSC shall be comprised of [******] (or such other number of representatives as the Parties may mutually agree; provided, that Gilead and Agenus shall at all times have an equal number of representatives on the JSC) from each of Gilead and Agenus. Each representative of a Party shall have sufficient seniority and expertise to participate on the JSC as determined in such Party’s reasonable judgment. Gilead shall have the right to designate the chairperson of the JSC from among its [******] - 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. [******] JSC representatives. Each Party may replace any or all of its representatives on the JSC at any time upon written notice to the other Party in accordance with Section 16.2. Each Party may, upon receiving the other Party’s prior written consent (not to be unreasonably withheld, conditioned, or delayed), invite non-JSC representatives of such Party and any Third Party to attend meetings of the JSC; provided, that an...
Establishment; Responsibilities. The Parties have established, under the License Agreement, a joint manufacturing working group (the “Joint Manufacturing Working Group” or “JMWG”), which shall have, with respect to this Agreement, the responsibilities set forth in this Section 2.3. For clarity, Section 4.1 of the License Agreement and the “Transition Plan” described therein shall remain in full force and effect for Licensed Compounds including the Drug Substance under this Agreement; provided, however, that the disclaimers set forth in Section 4.2.2 (Takeda Materials Disclaimer) of the License Agreement will not negate any express warranties made by Takeda in this Agreement. The JMWG shall be responsible for overseeing, reviewing and coordinating activities related to the supply of Drug Substance under this Agreement and operational decisions with respect thereto, including as follows:
Establishment; Responsibilities. As soon as possible after the Effective Date, the Parties shall form a joint committee (the “Joint Steering Committee” or “JSC”), consisting of [***] representatives of each of Orano Med and Molecular Partners, which shall have the following responsibility for coordinating all activities under, and pursuant to, this Agreement:
Establishment; Responsibilities. The Parties have established, under the License Agreement, a joint manufacturing working group (the “Joint Manufacturing Working Group” or “JMWG”), which shall have, with respect to this Agreement, the responsibilities set forth in this Section 2.3. For clarity, Section 4.1 of the License Agreement and [***] = 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. the “Transition Plan” described therein shall remain in full force and effect for Licensed Compounds including the Drug Substance under this Agreement; provided, however, that the disclaimers set forth in Section 4.2.2 (Takeda Materials Disclaimer) of the License Agreement will not negate any express warranties made by Takeda in this Agreement. The JMWG shall be responsible for overseeing, reviewing and coordinating activities related to the supply of Drug Substance under this Agreement and operational decisions with respect thereto, including as follows:
Establishment; Responsibilities. Within [******] after the Effective Date, the Parties shall establish a joint steering committee (the “JSC”) as more fully described in this Section 3.1. The JSC shall serve as a forum to facilitate communications between the Parties and, to the extent provided in this Section 3.1, shall have review and decision-making responsibilities, as well as general oversight of the relevant activities, with respect to: (a) Development (and Manufacture, or having Manufactured, for the purposes thereof) of the Licensed Antibodies and the Licensed Products prior to the Option Effective Date; and (b) the Development and Commercialization of the Profit-Share Product during the Profit-Share Term. In particular, the JSC shall: (i) review and discuss potential amendments to the Agenus Development Plan in accordance with Section 2.2.1; (ii) request, receive, and review information and access to records with respect to the Licensed Antibodies and the Licensed Products prior to the Option Effective Date in accordance with Section 2.2.3; (iii) review, discuss, and approve any amendment to the Gilead Development Plan, including the Gilead Development Budget, in accordance with Section 4.2; (iv) adopt and approve the Commercialization Plan (including the Commercialization Budget), including any amendments thereto, in accordance with Section 6.1; and (v) review and discuss, from time to time, [******].
