Development Committee Review Clause Samples

Development Committee Review. Notwithstanding Sections 5.1 or 5.2, all protocols for clinical trials to be conducted for Collaboration Products in any territory shall be submitted for review by the Development Committee prior to the initiation of such trials and filing such protocols with any health regulatory agency; and RPRP and Introgen will be bound by the recommendations of the Development Committee with respect to such protocols. In addition, Introgen and RPRP shall submit their product registration plans to the Development Committee for review and comment, and the recommendations of the Development Committee with respect to such plans shall be binding on Introgen and RPRP. It is understood, however, that this Section 5.5 only requires that each party abide by such recommendations as are agreed by the Development Committee, and does not require that the Development Committee approve protocols or registration plans.
Development Committee Review. All protocols for clinical trials to be conducted, and all product registration plans, for Collaboration Products for applications within the Field in the Territory to the extent the same are within the Development Program shall be submitted to the Development Committee for review and comment by the Development Committee prior to filing of such protocols and registrations, respectively, with any health regulatory agency; and subject to Article 2 above, protocols for such trials shall be subject to approval of the Development Committee.
Development Committee Review. 32 7.5 Ownership........................................................................ 32

Related to Development Committee Review

  • Audit Committee Review Prior to the earlier of the consummation of an initial Business Combination and the Liquidation, the Company’s audit committee will review on a quarterly basis all payments made by the Company to the Sponsor, to the Company’s officers or directors, or to the Company’s or any of such other persons’ respective affiliates.

  • Development Committee Arcadia and ▇▇▇▇▇▇ shall establish a development committee (the “Development Committee”) comprised of no more than three (3) representatives of each of Arcadia and ▇▇▇▇▇▇. The Development Committee shall be chaired by a member thereof designated from time to time by Arcadia. The Development Committee shall oversee the Research Plan, Milestones and development and production of plants and microorganisms that produce Transgenic Oil in accordance with the Research Plan. The Development Committee may revise the Research Plan and the Milestones as deemed necessary and appropriate by unanimous written consent of all members. Meetings of the Development Committee shall be at least biannual and at such times and places or in such form (e.g., in person, telephonic or video conference) as the members of the Development Committee shall determine. Representatives of both Parties shall be present at any meeting of the Development Committee. Decisions of the Development Committee shall be made by a written consent signed by all six (6) members thereof. The Development Committee shall keep minutes of its deliberations setting forth, among other matters, all proposed actions and all votes thereon. All records of the Development Committee shall at all times be available to both Parties. The Development Committee by unanimous consent may delegate to one Party or to a specific representative the authority to make certain decisions. The Development Committee may revoke such authority by the written consent of four members. All disagreements within the Development Committee shall be subject to the following: (i) The members of the committee will endeavor in good faith for a period of not more than ninety (90) days to attempt to resolve the disagreement; (ii) If the members of the committee are unable to resolve the disagreement by the end of such period, the committee shall promptly present the disagreement to the President of ▇▇▇▇ Products Division and the President of Arcadia or their respective designees, and the two executives shall endeavor to resolve the disagreement for a period of not more than thirty (30) days; (iii) If the two executives are unable to resolve this disagreement, the disagreement shall be submitted for ADR as provided in Section 12(a).

  • Joint Development Committee (a) The Parties shall establish a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than [**] days after the Effective Date. Each Party may change any one or more of its representatives to the Joint Development Committee at any time upon notice to the other Party. (b) The JDC shall meet at least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder.

  • Technical Advisory Committee (TAC The goal of this subtask is to create an advisory committee for this Agreement. The TAC should be composed of diverse professionals. The composition will vary depending on interest, availability, and need. TAC members will serve at the CAM’s discretion. The purpose of the TAC is to: • Provide guidance in project direction. The guidance may include scope and methodologies, timing, and coordination with other projects. The guidance may be based on: o Technical area expertise; o Knowledge of market applications; or o Linkages between the agreement work and other past, present, or future projects (both public and private sectors) that TAC members are aware of in a particular area. • Review products and provide recommendations for needed product adjustments, refinements, or enhancements. • Evaluate the tangible benefits of the project to the state of California, and provide recommendations as needed to enhance the benefits. • Provide recommendations regarding information dissemination, market pathways, or commercialization strategies relevant to the project products. The TAC may be composed of qualified professionals spanning the following types of disciplines: • Researchers knowledgeable about the project subject matter; • Members of trades that will apply the results of the project (e.g., designers, engineers, architects, contractors, and trade representatives); • Public interest market transformation implementers; • Product developers relevant to the project; • U.S. Department of Energy research managers, or experts from other federal or state agencies relevant to the project; • Public interest environmental groups; • Utility representatives; • Air district staff; and • Members of relevant technical society committees. • Prepare a List of Potential TAC Members that includes the names, companies, physical and electronic addresses, and phone numbers of potential members. The list will be discussed at the Kick-off meeting, and a schedule for recruiting members and holding the first TAC meeting will be developed. • Recruit TAC members. Ensure that each individual understands member obligations and the TAC meeting schedule developed in subtask 1.11. • Prepare a List of TAC Members once all TAC members have committed to serving on the TAC. • Submit Documentation of TAC Member Commitment (such as Letters of Acceptance) from each TAC member. • List of Potential TAC Members • List of TAC Members • Documentation of TAC Member Commitment

  • APPENDIX B – INDEPENDENT ASSESSMENT COMMITTEE CHAIRPERSONS Note: The parties agree to meet to discuss the following Independent Assessment Committee Chairpersons. The parties agree to revise and update the list to ensure that an adequate number of Chairpersons are available. If the parties are unable to reach agreement on the revised list, Arbitrator ▇▇▇▇▇ will remain seized to resolve the dispute.