Manufacturing Decision-Making Sample Clauses

Manufacturing Decision-Making. Except as otherwise expressly provided in this Agreement, all strategic matters regarding the Manufacturing and supply of Products shall be decided by consensus by the JMC, subject to the provisions of Section 2.7.
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Manufacturing Decision-Making. After the Opt-In/Our Date, Takeda shall have final decision-making authority for all matters regarding the Manufacturing of Licensed Compounds and Licensed Products. Decisions with respect to a Licensed Product in the U.S. for which Protagonist has not exercised an Opt-Out Right shall be consistent with its Joint Global Development Plan or Joint Commercialization Plan, as applicable.

Related to Manufacturing Decision-Making

  • Decision Making The Joint Development Committee and Joint Commercialization Committee shall each act by unanimous agreement of its members, with each Party having one vote. If the Joint Development Committee or Joint Commercialization Committee, after [* * *] (or such other period as the Parties may otherwise agree) of good faith efforts to reach a unanimous decision on an issue, fails to reach such a unanimous decision, then either Party may refer such issue to the Executive Officers. Such Executive Officers shall meet promptly thereafter and shall negotiate in good faith to resolve the issues. If Executive Officers cannot resolve such issue within [* * *] of referral of such issue to the Executive Officers, the resolution of such issue shall be as follows: (a) if such issue properly originated at the Joint Development Committee, determined by the Developing Party of the relevant Licensed Compound or Licensed Product at issue; provided that, notwithstanding the foregoing: (i) if Acceleron is the Developing Party and such issue relates to (x) the approval of an Additional Development Disease, or (y) matters under Section 5.6.3(d), then such issue shall be determined by [* * *]; (ii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the Joint Development Committee’s decision to go forward with a Phase 3 Clinical Trial of the relevant Licensed Compound or Licensed Product; provided that [* * *] shall continue to determine any issues that relate to the budget for and the conduct of the [* * *]; and (iii) regardless of which Party is the Developing Party, such issue shall be determined by [* * *] following the earliest of: (x) [* * *], and (y) the occurrence of any [* * *]; and (b) if such issue properly originated at the Joint Commercialization Committee, determined by Celgene. Notwithstanding the foregoing, none of Acceleron, Celgene, the Joint Development Committee or the Joint Commercialization Committee may make any decision inconsistent with the express terms of this Agreement without the prior written consent of each Party.

  • Initial Decision Maker The Architect will serve as the Initial Decision Maker pursuant to Article 15 of AIA Document A201–2017, unless the parties appoint below another individual, not a party to this Agreement, to serve as the Initial Decision Maker.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Concession Area, including its abandonment.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • SITE-BASED DECISION MAKING A. The District shall provide the training and staff development to support accountability/site- based decision-making activities. Teachers shall be given release time to attend these programs. B. Participation on the SAC shall not serve as a basis for the evaluation of any teacher. C. A minimum of three (3) to a maximum of five (5) teachers from each school shall serve on their school’s budget advisory committee formed for the purpose of making recommendations on the school’s general fund budget. Teacher members shall be elected by the faculty. Minutes from such meetings may be requested by the faculty and may be posted on the CTA bulletin board at the school by the Association Representative.

  • Office of Inspector General Investigative Findings Expert Review In accordance with Senate Bill 799, Acts 2021, 87th Leg., R.S., if Texas Government Code, Section 531.102(m-1)(2) is applicable to this Contract, Contractor affirms that it possesses the necessary occupational licenses and experience.

  • Claim Decision Upon receipt of such claim, the Plan Administrator shall respond to such claimant within ninety (90) days after receiving the claim. If the Plan Administrator determines that special circumstances require additional time for processing the claim, the Plan Administrator can extend the response period by an additional ninety (90) days for reasonable cause by notifying the claimant in writing, prior to the end of the initial ninety (90) day period, that an additional period is required. The notice of extension must set forth the special circumstances and the date by which the Plan Administrator expects to render its decision. If the claim is denied in whole or in part, the Plan Administrator shall notify the claimant in writing of such denial. The Plan Administrator shall write the notification in a manner calculated to be understood by the claimant. The notification shall set forth: (i) The specific reasons for the denial; (ii) The specific reference to pertinent provisions of the Agreement on which the denial is based; (iii) A description of any additional information or material necessary for the claimant to perfect the claim and an explanation of why such material or information is necessary; (iv) Appropriate information as to the steps to be taken if the claimant wishes to submit the claim for review and the time limits applicable to such procedures; and (v) A statement of the claimant’s right to bring a civil action under ERISA Section 502(a) following an adverse benefit determination on review.

  • Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

  • Program Review The State ECEAP Office will conduct a review of each contractor’s compliance with the ECEAP Contract and ECEAP Performance Standards every four years. The review will involve ECEAP staff and parents. After the Program Review, the State ECEAP Office will provide the contractor with a Program Review report. The contractor must submit an ECEAP Corrective Action Plan for non-compliance with ECEAP Performance Standards. The Plan must be approved by the State ECEAP Office.

  • 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

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