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:
(a) to coordinate the transfer of all Assigned Regulatory Materials to be assigned to Licensee pursuant to Section 4.3.1 (Licensed Product INDs) and Section 4.3.2 (Other Assigned Regulatory Materials);
(b) to review, discuss, and solely with respect to any Development activities in the Takeda Territory set forth therein, approve, any proposed material amendments or revisions to the TAK-385 Development Plan;
(c) to review and discuss the initial TAK-385 Commercialization Plan, and any proposed material amendments or revisions to such Commercialization Plan;
(d) to review and discuss Licensee’s activities and progress under the TAK-385 Development Plan, including to review and discuss the Development reports described in Section 5.4 (Development Reporting);
(e) to review and discuss Takeda’s activities and progress with respect to the Development of the TAK-385 Licensed Compound and TAK-385 Licensed Products in the Men’s Health Field and the Women’s Health Field in the Takeda Territory;
(f) to review and discuss Licensee’s activities and progress against the Commercialization Plan, including to review and discuss the Commercialization reports described in Section 7.4 (Commercialization Reporting);
(g) to review and discuss Takeda’s activities in the Men’s Health Field and its progress against the Takeda Commercialization Plan with respect to activities in the Men’s Health Field, including to review and discuss the Commercialization reports described in Section 7.4 (Commercialization Reporting);
(h) to discuss and coordinate Licensee’s Development activities with Takeda’s Development and Commercialization of the TAK-385 Licensed Compound and TAK-385 Licensed Products in the Takeda Territory (where appropriate);
(i) to discuss the selection of the Product T...
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.
9.2 ESTABLISHMENT shall provide full information regarding requirements for the Project, including a program which shall set forth ESTABLISHMENT objectives, schedule, constraints and criteria, including space requirements and relationships, flexibility, expandability, special equipment, systems, and site requirements.
9.3 All communications with the Subcontractors go through CFZ. However, if it becomes necessary for ESTABLISHMENT to communicate directly with a Subcontractor, ESTABLISHMENT shall notify CFZ in writing of the content of such communication.
9.4 ESTABLISHMENT shall promptly furnish all requested review and approval or other appropriate action with respect to all submittals by CFZ including, without limitation, any samples, estimates, schedules, budgets, shop drawings, construction Subcontracts, bid awards, Change Orders, purchase orders contracts and other items submitted and/or proposed by CFZ. Failure by ESTABLISHMENT may result in an adjustment to the Master Schedule and Contract Sum; provided, however, any such extensions or adjustments are only applicable if documented pursuant to a Change Order as provided herein.
9.5 Payment to CFZ in accordance to all Payment Schedules required for the Project subject to CFZ’s satisfaction of the Payment Application provisions set forth herein. CFZ reserves its right to cover ESTABLISHMENT unpaid invoices with the Bank Guarantee as per this Contract.
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:
(a) The implementation of activities under the Drug Substance Transition Plan (as defined below);
(b) The creation of the Gain-sharing Report and implementation of changes described therein, as set forth in Section 7.3 (Continuous Improvement) hereof. For clarity, the JMWG shall have no authority to amend or waive compliance with any provision of this Agreement.
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:
(a) creating and approving the Development Plan for each Developed Product and each Commercialization Project;
(b) coordinating and facilitating the performance of each Development Plan;
(c) facilitating the identification, protection and management of Intellectual Property created pursuant to the Collaboration;
(d) administering and managing the Collaboration in accordance with the Collaboration Budget;
(e) performing such other responsibilities as may be required of the Management Committee pursuant to this Agreement; and
(f) performing such other responsibilities as may be agreed upon by the Parties.
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 […***…] 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. 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:
i. The JSC shall coordinate and facilitate the exchange of information between the Parties in compliance with this Agreement in order to ensure that significant regulatory, technical scientific or safety issues concerning the Collaboration are addressed consistently and in a timely manner.
ii. The JSC shall discuss and agree upon an R&D Plan and a R&D Budget for each Collaboration Product and any updates thereto pursuant to Section 4.3(c).
iii. The JSC shall discuss and decide on the substitution of DLL3 as the target for the First Product and any Additional Candidates pursuant to Section 4.2.
iv. The JSC shall (without prejudicing any pre-agreed timelines and subject to Section 4.3(d)) review, comment on and approve all regulatory filings and communications for the Collaboration Products and shall discuss and decide on matters concerning Clinical Trials performed under a R&D Plan.
v. The JSC shall discuss and agree upon estimated Collaboration Costs, any updates thereto and, if applicable, cost overruns pursuant to Section 5.4.
vi. The JSC shall facilitate the Parties’ joint efforts to achieve an Out-Licensing on and subject to Section 7.2.
vii. The JSC may discuss issues relating to any proposed publication, communication or other disclosure regarding a Collaboration Product or this Collaboration.
viii. The JSC will establish the Launch Preparedness Plan and, at the request of either Party upon exercise of the Option by the other, it will review and discuss evidence relating to the achievement of the requirements thereunder.
ix. The JSC shall discuss and, as applicable, try to resolve any disputed financial aspects arising from Collaboration Costs overruns, Quarterly Reports or related supporting documentation and more generally, the JSC shall try to resolve any dispute or claim arising out of, relating to or in connection with any provision of this Agreement.
x. The JSC may agree to establish one or more subcommittees operating under its authority to address technical, financial, intellectual property and operational issues arising from the Collaboration and establish the operating rules and delegated competencies thereof.
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: [***] = 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.
(a) The implementation of activities under the Drug Substance Transition Plan (as defined below);
(b) The creation of the Gain-sharing Report and implementation of changes described therein, as set forth in Section 7.3 (Continuous Improvement) hereof. For clarity, the JMWG shall have no authority to amend or waive compliance with any provision of this Agreement.
Establishment; Responsibilities. Within sixty (60) days following the execution of this Agreement, the Parties will establish a Joint Research Committee (the “JRC”). The responsibilities of the Joint Research Committee shall consist of (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 updates to the Work Plan. Except for the foregoing sub-clause (c), the JRC shall not have any decision-making authority. The JRC shall dissolve upon the acceptance of the first IND filing for a Licensed Compound unless otherwise decided by Company.
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. . 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 any such non-JSC r...
