Manufacturing and Supply Committee Sample Clauses

Manufacturing and Supply Committee. The Process Science/Clinical Manufacture Agreement shall include a Manufacturing and Supply Committee consisting of an equal number of representatives from each Party, with the responsibility to oversee the manufacturing and supply process during each Process Development Program and to assist the Development Management Committee to (a) establish criteria and timelines for implementation of process development, manufacturing and supply of Candidate Drugs and Licensed Products; (b) oversee the planning and resourcing for an approved manufacturing program; (c) decide on the use of the AZ ABL facility in the manufacturing and supply of Candidate Drugs and Licensed Products; (d) recommend Third Party support, as appropriate; and (e) take such other actions as are set forth in this Article 7 or in the Process Science/Clinical Manufacture Agreement or the Manufacturing and Supply Agreement. The Development Management Committee shall have oversight over the Manufacturing and Supply Committee and each Process Development Program. Any disputes or disagreements arising in the Manufacturing and Supply Committee that cannot be resolved by the members of the Manufacturing and Supply Committee shall be referred to the Chief Executive Officer of ABX and the Executive Vice President of Operations of AZ (or one of his or her direct reports) for resolution. If any such dispute (other than disputes relating to a Party’s interpretation of, or any allegation of breach of, this Agreement, the Process Science/Clinical Manufacture Agreement or the Manufacturing and Supply Agreement) is unable to be resolved, then AZ shall have the final deciding vote; provided, however, that, subject to the relevant provisions of this Article 7, (x) neither Party shall be obligated to perform any activities under a Process Development Program that are not set forth in the applicable Process Development and Manufacturing Plan and any changes to a Process Development and Manufacturing Plan that result in changes to the applicable Program Budget shall require that ABX submit a revised Program Budget proposal pursuant to Section 7.13, and (y) certain technical disputes under the Process Science/Clinical Manufacture Agreement or the Manufacturing and Supply Agreement, such as whether a particular Candidate Drug or Licensed Product conforms to the applicable specifications, shall be referred to an independent testing laboratory for resolution. The Parties acknowledge and agree that, subject to the provi...
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Manufacturing and Supply Committee. Within [**] after the Effective Date, the Parties shall establish a joint manufacturing and supply committee (the “Manufacturing and Supply Committee” or “MSC”), which shall include appropriate representation of each Party (which such representation need not be equal), and each representative shall possess the requisite experience and seniority to enable such person to make decisions on behalf of the applicable Party with respect to the issues falling within the jurisdiction of the MSC. From time to time, each Party may substitute one or more of its representatives to the MSC on written notice to the other Party. Sanofi shall select from its representatives the chairperson for the MSC, which chairperson may be changed from time to time, on written notice to Lexicon. On the MSC, Lexicon shall have an advisory role only, and for clarity, any Dispute arising within the MSC shall not be resolved through the dispute resolution procedures in Section 13.5.2, but instead shall be decided by Sanofi’s MSC representatives. The MSC shall:
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Manufacturing and Supply Committee. Within thirty (30) days after the Effective Date, Auxilium and Asahi agree to establish the Manufacturing and Supply Committee (the “MSC”) as a Committee. The MSC shall consist of up to ten (10) members (or such other number as may be agreed by the Parties in writing), up to five (5) of whom shall be representatives designated by Asahi, and up to five (5) of whom shall be representatives designated by Auxilium. Such representatives shall include individuals who have experience in the manufacturing of pharmaceutical products. The MSC shall be co-chaired by a representative of each of Asahi and Auxilium. One member of the MSC shall serve as secretary of the MSC at each MSC meeting, and the secretary shall alternate from meeting to meeting between an Asahi MSC member and an Auxilium MSC member. The MSC shall advise the JSC with respect to all discussions related to the Manufacture and supply chain for the Product. Meetings of the MSC shall commence at a time to be mutually agreed upon by the Parties and the MSC shall meet at least once every three (3) months, and in any case more or less frequently as Asahi and Auxilium deem appropriate or as reasonably requested by either such Party, on such dates and at such places and times as the Parties shall agree. The MSC may meet either (i) in person alternating between the offices of Asahi and Auxilium, or such other place as the Parties may agree or (ii) by audio or video teleconference. The members of the MSC also may convene or be consulted from time to time by means of telecommunications, video conferences, electronic mail or correspondence, as deemed necessary or appropriate. The MSC shall be a joint forum for the Parties to meet and discuss, with Asahi providing Auxilium reasonable input (which Auxilium shall in good faith consider incorporating into its Manufacturing and supply related decisions), but the MSC shall not be a decision-making body but shall provide regular updates to the JSC on those matters under this Section 3.9 no less frequently than once each calendar quarter after the Effective Date. Additionally, the MSC shall:
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Manufacturing and Supply Committee. (i) The MSC shall consist of members from each of Organon and Pfizer, each of which shall confirm to the other its designees. Consistent with the Production Agreements, the MSC shall be responsible for:
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Related to Manufacturing and Supply Committee

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • Joint Manufacturing Committee A joint manufacturing committee (the “Joint Manufacturing Committee” or “JMC”) will be established pursuant to the Supply Agreement. The roles and responsibilities of the JMC shall be as specified in the Supply Agreement.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • 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:

  • Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.

  • Development Plan As defined in Section 3.2(a).

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

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