Clinical Supply Quality Agreement definition

Clinical Supply Quality Agreement means a clinical quality agreement entered into by the Parties for a particular Study in accordance with Section 9.11.
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Clinical Supply Quality Agreement shall have the meaning set forth in Section 2.1(a)(ii).
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Clinical Supply Quality Agreement has the meaning assigned to such term in Section 4.12(b).
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Examples of Clinical Supply Quality Agreement in a sentence

  • Subject to the applicable Clinical Supply Quality Agreement, either Party may, without consulting the other Party, subcontract Manufacturing with regards to either the Sponsor Product or the Regeneron Product, as applicable, to be provided for such Study.

  • The Parties (or their Affiliates) shall enter into a Clinical Supply Quality Agreement for each Study with respect to the quality assurance of the Regeneron Product supplied by Regeneron hereunder for such Study.

  • Each Party shall implement and perform operating procedures and controls for sampling, stability and other testing of its Product, and for validation, documentation and release of its Product and such other quality assurance and quality control procedures as are required by cGMPs and the applicable Clinical Supply Quality Agreement.

  • Sponsor shall not reverse engineer, reverse compile, disassemble or otherwise attempt to derive the composition or underlying information, structure or ideas of the Regeneron Product, and in particular shall not analyze the Regeneron Product by physical, chemical or biochemical means except as necessary to perform its obligations under the applicable Clinical Supply Quality Agreement.

  • The Parties will execute the Clinical Supply Quality Agreement for the initial Study as soon as reasonably practicable following the Effective Date, but in any event, prior to the initiation of the shipment of Regeneron Product for a Study.

  • For all other Studies, the Parties will execute the Clinical Supply Quality Agreement as soon as reasonably practicable following the execution of the Study Plan for such Study, but in any event, prior to the initiation of the shipment of Regeneron Product for such Study.

  • Sponsor shall be solely responsible for taking all steps necessary to determine that Regeneron Product or Sponsor Product, as applicable, is suitable for release before making such Regeneron Product or Sponsor Product, as applicable, available for human use, consistent with the Clinical Supply Quality Agreement.

  • Regeneron shall provide the Regeneron Product to Sponsor in the form of unlabeled vials, and Sponsor shall be responsible for labeling, packaging and leafleting such Regeneron Product in accordance with the terms and conditions of the applicable Clinical Supply Quality Agreement and otherwise in accordance with all Applicable Law, including applicable cGMP, GCP, and health, safety and environmental protections.

  • Sponsor shall, upon receipt of Regeneron Product and within the time defined in the applicable Clinical Supply Quality Agreement, perform the acceptance (including testing, if any) procedures allocated to it under such Clinical Supply Quality Agreement.

  • Audit and inspection rights, recalls, rejection and non-conformances, in each case, with respect to the Regeneron Product and Sponsor Product, are governed by the terms of the applicable Clinical Supply Quality Agreement.


More Definitions of Clinical Supply Quality Agreement

Clinical Supply Quality Agreement in accordance with Section 5.1.1 of the Agreement. -A detailed program of Manufacture with a rolling Calendar Quarter forecast and order and delivery mechanisms will be outlined in the Clinical Supply Agreement. -Biogen to supply Tecfidera® [**]. -Alkermes shall have no liability as a result of any failure or delay in Manufacturing Clinical Supplies. -Alkermes will Manufacture the Products in accordance with Applicable Law and cGMPs, the specifications for the Products and the terms and conditions of the Clinical Supply Agreement and the Clinical Supply Quality Agreement. -Alkermes will perform and document those tests and checks required to assure the quality of the Product that are established by the Clinical Supply Quality Agreement. -The Clinical Supply Agreement will contain terms establishing standards for the release, acceptance and rejection of the Products and will establish a minimum shelf life for the Products. -In accordance with the terms of the Clinical Supply Agreement and the Clinical Supply Quality Agreement, Biogen will be entitled to inspect or have inspected those portions of the facilities that are used by Alkermes in the Manufacture of the Products as well as the relevant Manufacturing records. -Validation batches will be treated as Clinical Supplies until such time as they are utilized in the Commercialization of Product, at which time Biogen will pay Alkermes the difference between the clinical and commercial supply prices. [**] EXHIBIT E Commercial Supply Agreement Terms
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Related to Clinical Supply Quality Agreement

  • Clinical Supply Agreement has the meaning set forth in Section 4.2.

  • Manufacturing and Supply Agreement means the Manufacturing and Supply Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit C.

  • Commercial Supply Agreement has the meaning set forth in Section 5.2.

  • Manufacturing Agreement has the meaning set forth in Section 4.3.

  • Supply Agreement has the meaning set forth in Section 7.1.

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Supply Agreements has the meaning set forth in Section 7.1.

  • Collaborative pharmacy practice agreement means a written and signed

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

  • Pharmacovigilance Agreement has the meaning set forth in Section 5.1.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Development Agreement has the meaning set forth in the Recitals.

  • Development Agreements means all development, utility or similar agreements included in the Permitted Encumbrances.

  • Marketing Agreement means an agreement entered into, with the director, by producers, distributors, processors, or handlers pursuant to this act and binding only on those signing the agreement.

  • General air quality operating permit or "general permit" means an air quality operating permit that meets the requirements of ARM 17.8.1222, covers multiple sources in a source category, and is issued in lieu of individual permits being issued to each source.

  • Red Hat Products means Software, Services, Subscriptions and other Red Hat branded offerings made available by Red Hat.

  • service delivery and budget implementation plan means a detailed plan approved by the mayor of a municipality in terms of section 53(1) (c) (ii) for implementing the municipality’s delivery of municipal services and its annual budget.

  • Technical Services Agreement means the Technical Services Agreement between Sabine Pass Liquefaction, LLC and Contractor, dated May 3, 2013 and any amendments thereto.

  • Collaboration Agreement has the meaning set forth in the Recitals.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Technical Agreement means any technical or quality agreements signed by You (or Your Affiliate) and RB (or RB’s Affiliates) specifying technical and quality responsibilities in respect of the Output entered into prior to the date of the Order.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Supply Plan has the meaning set forth in the CAISO Tariff.

  • Development Plan has the meaning set forth in Section 3.2.

  • Joint Development Agreement has the meaning provided in Section 5.3.

  • Gas supply service means the provision to customers of the