Regulatory Committee Sample Clauses

Regulatory Committee. Conor and Phytogen shall establish a committee (the “Regulatory Committee”), which will consist of [*] representatives, [*] of which shall be appointed by Conor, and [*] of which shall be appointed by Phytogen. The representatives of each party may be changed from time to time at the discretion of the party making such change. The Regulatory Committee shall meet in person or by teleconference from time to time during the term of the Agreement provided that at least [*] representatives are present. The Regulatory Committee shall be responsible for overseeing and reviewing regulatory and clinical plans for the Product and Conor Devices incorporating Product. The Regulatory Committee may provide guidance and/or make recommendations for such plans. All decisions of the Regulatory Committee shall be made by a majority of the representatives of the Regulatory Committee provided such majority includes at least one appointee of each party; provided, however, that if the Regulatory Committee is unable to reach a majority decision with respect to regulatory recalls of the Conor Device only, then Conor shall make the final decision as to such matter, subject to the provisions of Section 6.4 hereof.
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Regulatory Committee. The Regulatory Committee shall be responsible for (i) implementing the decisions made by the License Steering Committee, (ii) the optimal regulatory filing strategies for the Products, (iii) developing and implementing the regulatory plan for the Products, (iv) liaison activities with regulatory authorities during the development and initial file review through approval or registration in each country for the Products, (v) regulatory activities relating to the development, approval and registration of New Indications and Line Extensions for the Products and (vi) coordinating activities related to post-approval safety and surveillance of the Products. Within the Regulatory Committee, Sanofi shall have the * CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION 11 Lead for Clopidogrel Products and BMS shall have the Lead for Irbesartan Products; provided, however, that, notwithstanding the above, all recommendations and decisions made by the Regulatory Committee shall be jointly made pursuant to Section 6.6(b) hereof. The Regulatory Committee shall report and make its recommendations to the License Steering Committee.
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Regulatory Committee. (a) The RC shall consist of regulatory, research and development, safety and marketing medical managers and such other relevant personnel (as needed) from each of Neurocrine and Pfizer, each of which shall confirm to the other its designees and which shall be responsible for the regulatory compliance of the Development Program in the US Territory. The specific responsibilities of the RC are set forth in Section 4.2.
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Regulatory Committee. The RC will operate within the framework of the governance structure set forth in Article 3. The responsibilities of the RC include, but are not limited to, the following:
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Regulatory Committee. The Regulatory Committee shall be responsible for (i) implementing the decisions made by the License Steering Committee, (ii) the optimal regulatory filing strategies for the Products, (iii) developing and implementing the regulatory plan for the Products, (iv) liaison activities with regulatory authorities during the development and initial file review through approval or registration in each country for the Products, (v) regulatory activities relating to the development, approval and registration of New Indications and Line Extensions for the Products and (vi) coordinating activities related to post-approval safety and surveillance of the Products. Within the Regulatory Committee, Sanofi shall have the Lead for Clopidogrel Products and BMS shall have the Lead for Irbesartan Products; provided, however, that, notwithstanding the above, all recommendations and decisions made by the Regulatory Committee shall be jointly made pursuant to Section 6.6(b) hereof. The Regulatory Committee shall report and make its recommendations to the License Steering Committee.
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Related to Regulatory Committee

  • Advisory Committee The Settling State shall designate an Opioid Settlement Remediation Advisory Committee (the “Advisory Committee”) to provide input and recommendations regarding remediation spending from that Settling State’s Abatement Accounts Fund. A Settling State may elect to use an existing advisory committee or similar entity (created outside of a State-Subdivision Agreement or Allocation Statute); provided, however, the Advisory Committee or similar entity shall meet the following requirements:

  • Development Committee As soon as practicable, the Parties will establish a joint development committee, comprised of at least one (1) and up to two (2) representatives of Omega and at least one (1) and up to two (2) representatives of Acuitas (the “JDC”). One such representative from each Party will be such Party’s Workplan Leader. Each Party may replace its Workplan Leader and other JDC representatives at any time upon written notice to the other Party, provided, however, that each Party shall use reasonable efforts to ensure continuity on the JDC. With the consent of the other Party (which will not be unreasonably withheld, conditioned or delayed), each Party may invite non-voting employees and consultants to attend JDC meetings as necessary, subject to consultant’s agreement to be bound to the same extent as a permitted subcontractor under Section 3.1(i).

  • Joint Commercialization Committee As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:

  • Research Committee 2.2.1 Establishment and Functions of RC. ---------------------------------

  • Joint Patent Committee (a) The Parties will establish a “

  • Steering Committee The Project Manager shall set up a Steering Committee for the Project, consisting of representatives from the Department, the Contractor, and any other key organisations whom the project will impact on, to be agreed between the parties. The function of the Steering Committee shall be to review the scope and direction of the Project against its aims and objectives, monitor progress and efficiency, and assess, manage and review expected impact and use of the findings from the Project. The Committee shall meet at times and dates agreed by the parties, or in the absence of agreement, specified by the Department. The Contractor’s representatives on the Steering Committee shall report their views on the progress of the Project to the Steering Committee in writing if requested by the Department. The Contractor’s representatives on the Steering Committee shall attend all meetings of the Steering Committee unless otherwise agreed by the Department.

  • Audit Committee (A) The Audit Committee shall be composed of five members who shall be selected by the Board of Directors from its own members, none of whom shall be an officer of the Company, and shall hold office at the pleasure of the Board.

  • Transition Committee 8.1.0 A transition committee comprised of the employee representatives and the employer representatives, including the Crown, will be established by January 31, 2016 to address all matters that may arise in the creation of the Trust.

  • Joint Steering Committee [***] following the Effective Date [***], a joint steering committee (the “JSC”) will be established by the Parties to provide oversight and to facilitate information sharing between the Parties with respect to the activities under this Agreement.

  • Compliance Committee (1) Within thirty (30) days of the date of this Agreement, the Board shall appoint a Compliance Committee of at least three (3) directors, of which no more than one (1) shall be an employee or controlling shareholder of the Bank or any of its affiliates (as the term “affiliate” is defined in 12 U.S.C. § 371c(b)(1)), or a family member of any such person. Upon appointment, the names of the members of the Compliance Committee and, in the event of a change of the membership, the name of any new member shall be submitted in writing to the Assistant Deputy Comptroller. The Compliance Committee shall be responsible for monitoring and coordinating the Bank's adherence to the provisions of this Agreement.

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