Responsibility for Manufacturing Sample Clauses

Responsibility for Manufacturing. Subject to the terms and conditions of this Agreement, ArriVent shall be responsible for manufacturing and supplying Licensed Products in the Licensed Territory by itself or through a Third-Party manufacturer for Commercialization of Licensed Product following receipt of Regulatory Approval on a country-by-country basis in the Licensed Territory. ArriVent shall be responsible for supplying Licensed Products for clinical trials and related programs required for Regulatory Approvals in the Licensed Territory. All such supplies shall be manufactured in accordance with current applicable laws, regulations, and good industrial practice in the relevant territory.
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Responsibility for Manufacturing. Except as otherwise set forth in this Section 6.1 (Responsibility for Manufacturing), Amgen will be the “Manufacturing Lead” for the Product for the United States and shall have sole responsibility for the supply and Manufacturing of the Product for the United States. If the Manufacturing Lead elects to cease Manufacturing the Product for the United States, the Manufacturing Lead shall select a Third Party commercial manufacturer to Manufacture the Product for the United States, [***]; provided, however, that [***].
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Responsibility for Manufacturing. Except as otherwise provided in this Agreement, Chiesi shall use commercially reasonable efforts to produce and supply to Cornerstone its entire requirements of the Product for use in the Field of Use for sale in the Territory in response to Purchase Orders (as defined below). Cornerstone will purchase exclusively from Chiesi the Product for use in the Field of Use for sale in the Territory. During the Term, Chiesi, and its contract manufacturer, collectively shall hold and maintain all licenses and permits, for the Term of this Agreement, as are required to fabricate, package, label, test and store the Products in the Territory, and sell the Products to Cornerstone.
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Responsibility for Manufacturing. LIRUM shall be solely responsible for manufacturing, or procuring the manufacture of, all of its requirements of Compound and/or Licensed Products for use and/or sale in the Field in the Territory.
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Responsibility for Manufacturing. Subject to oversight by the Joint Scientific Committee or Joint Manufacturing Committee, as applicable, and subject to this Section 5.1, MTEM will be primarily responsible for Manufacturing activities with respect to SLT-A Fusion Proteins Directed to each Designated Target and Components thereof (“Discovery Material”) during the applicable Program Term and for Manufacturing activities with respect to Licensed Products and Components thereof (“Development Material,” together with Discovery Material, the “Supply”) through completion of the first Phase I Clinical Trial for the applicable Licensed Product, including supplying Antibodies expressed as a single chain protein as requested by Takeda and at Takeda’s cost, unless otherwise agreed to in writing by the Parties. Notwithstanding the foregoing, Takeda will, upon notice to MTEM at any time in Takeda’s sole discretion, have the right to assume, or allow its designee to assume, some or all of such Manufacturing activities.
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Responsibility for Manufacturing. Subject to Section 4.4 (Manufacturing Option), as between the Parties, Selecta shall solely lead, control, and be responsible for the Manufacture of the Xork and Xork Products in the Territory. Selecta shall use Commercially Reasonable Efforts to Manufacture and supply, either itself or through an Affiliate or a contract manufacturing organization (“CMO”), all supplies of Xork and Xork Products for both Parties’ Development and Commercialization activities conducted in the Territory in accordance with the Astellas Development Plan, the Xork Development Plan, the Clinical Supply Agreement, and the Commercial Supply Agreement. At each meeting of the JSC or [***] per Fiscal Quarter during a meeting of the Alliance Managers (if the JSC is no longer in existence), [***]. Schedule 4.1 (Selecta CMOs) sets forth a list of all CMOs used by Selecta in the Manufacture of the Xork Product as of the Effective Date. Selecta shall provide Astellas at least [***] days prior written notice of any new CMO proposed to be used by Selecta and provide an updated Schedule 4.1 (Selecta CMOs).
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Responsibility for Manufacturing. Subject to oversight by the Joint Manufacturing Committee, as applicable, and subject to this Section 5.1, MTEM shall be primarily responsible for Manufacturing activities with respect to Development Material for a Licensed Product and Components thereof through completion of the first Phase I Clinical Trial for such Licensed Product. Notwithstanding the foregoing, Takeda shall, upon notice to MTEM at any time in Takeda’s sole discretion, have the right to assume, or allow its designee to assume, some or all of such Manufacturing activities as provided in Section 5.2 In addition to the support that MTEM shall provide to Takeda with respect to regulatory filings under Section 2.2.1, at any time and upon Takeda’s sole discretion and reasonable request, MTEM shall prepare manufacturing sections of regulatory filings when MTEM was responsible for the manufacturing activities covered by such filings.
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Responsibility for Manufacturing. Except as expressly set forth herein, Company shall be solely responsible ***, for manufacturing, or procuring the manufacture of, all of its requirements of Compound and/or Licensed Products for use and/or sale in the Field in the Territory. Company shall ensure that (i) all quantities of Compound and Licensed Products are manufactured in compliance with applicable specifications and current good manufacturing practices in facilities which have and maintain all necessary approvals from the FDA, the Commission/EMA and/or other relevant Regulatory Authorities in the Territory; and (ii) any use or transfer of the Product Cell Line or Culture Cell Media is subject to, and at all times compliant, with Schedule 9.
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Related to Responsibility for Manufacturing

  • Responsibility for Patent Rights (a) University has primary responsibility at the expense of Company for the preparation, filing, prosecution, and maintenance of all Patent Rights, using patent counsel reasonably acceptable to Company. University shall consult with Company as to the preparation, filing, prosecution, and maintenance of all Patent Rights reasonably prior to any deadline or action with the United States Patent & Trademark Office or any foreign patent office and shall furnish Company with copies of relevant documents reasonably in advance of consultation. University shall consider in good faith any comments of Company on any patent filings for the Patent Rights.

  • Responsibility for Costs The Servicer is responsible for collection from such Borrower of any recording or similar costs or expenses incidental to the granting of relief with respect to a delinquent Mortgage Loan.

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time.

  • Responsibility for Subcustodians Except as provided in the last sentence of this Section 8.6, the Custodian shall be liable to the Fund for any loss or damage to the Fund caused by or resulting from the acts or omissions of any Subcustodian to the extent that such acts or omissions would be deemed to be negligence, gross negligence or willful misconduct in accordance with the terms of the relevant subcustodian agreement under the laws, circumstances and practices prevailing in the place where the act or omission occurred. The liability of the Custodian in respect of the countries and Subcustodians designated by the Custodian, from time to time on the Global Custody Network Listing shall be subject to the additional condition that the Custodian actually recovers such loss or damage from the Subcustodian.

  • Joint Manufacturing Committee In accordance with Section 2.5(c)(iv), the Parties shall promptly establish and convene a joint Manufacturing Committee (the “JMC”) for the overall coordination and oversight of the Manufacturing of clinical and commercial supplies of the Product under this Agreement as provided in the Manufacturing Plan (including the Manufacture of API, Drug Product and Finished Product). The JMC shall consist of representatives of each Party, and shall operate by procedures, as set forth in Section 2.5. The role of the JMC shall be:

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Development Responsibilities Unless the Parties agree in writing upon an alternate allocation of responsibility, the Parties shall have the following rights and obligations with respect to operational responsibilities under each Development Plan:

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • Responsibility for Information Recipients The Asset Representations Reviewer will be responsible for a breach of this Section 4.9 by its Information Recipients.

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