Clinical Supply Quality Agreement definition

Clinical Supply Quality Agreement means a clinical supply 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 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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Examples of Clinical Supply Quality Agreement in a sentence

  • Each Party may make changes from time to time to its Compound or the Manufacturing Site, provided that such changes shall be in accordance with the Clinical Supply Quality Agreement.

  • Collaborator shall conduct the acceptance procedures under the Clinical Supply Quality Agreement within the time frames set forth therein.

  • MSD shall investigate any Non-Conformance of the MSD Compound in accordance with the Clinical Supply Quality Agreement.

  • After Manufacturer’s Release of the MSD Compound and concurrently with Delivery of the Compound to Collaborator, MSD shall provide Collaborator with the documentation described in the Clinical Supply Quality Agreement.

  • The Parties will execute the Clinical Supply Quality Agreement prior to any supply of MSD Compound hereunder, and no later than [***] days after the Effective Date.

  • Notification related to MSD Compound shall be in accordance with the Clinical Supply Quality Agreement.

  • Each Party shall implement and perform operating procedures and controls for sampling, stability and other testing of its Compound, and for validation, documentation and release of its Compound and such other quality-assurance and quality-control procedures as are required by the Specifications, cGMPs and (with respect only to the MSD Compound) the Clinical Supply Quality Agreement.

  • Collaborator shall be responsible for storage and maintenance of the MSD Compound until it is tested and released, which storage and maintenance shall be in compliance with: (i) the Specifications for the MSD Compound, (ii) the Clinical Supply Quality Agreement, (iii) Applicable Law, and (iv) any specific storage and maintenance requirements as may be provided by MSD from time to time.

  • Quality matters and the Manufacture of the MSD Compound shall be governed by the terms of the Clinical Supply Quality Agreement in addition to the relevant quality provisions of this Agreement.

  • MSD hereby represents and warrants to Collaborator that: (i) MSD has the full right, power and authority to grant all of the licenses granted to Collaborator under this Agreement; (ii) MSD Controls the MSD Compound; and (iii) at the time of Delivery of the MSD Compound, such MSD Compound shall have been Manufactured and supplied in compliance with its Specifications, the Clinical Supply Quality Agreement, and all Applicable Law.


More Definitions of Clinical Supply Quality Agreement

Clinical Supply Quality Agreement in accordance with Section 5.1.1 of the Agreement. Program of Manufacturing, Forecasts and Delivery of Products -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. Quality Assurance -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. Supply Price for Clinical Supplies of Products [**] EXHIBIT E Commercial Supply Agreement Terms Clinical Supply Agreement and Quality Agreement
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Clinical Supply Quality Agreement has the meaning assigned to such term in Section 4.12(b).
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Related to Clinical Supply Quality Agreement

  • 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.

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

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

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

  • 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.

  • 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.

  • Clinical peer means a physician or other health care professional who holds a non-restricted license in a state of the United States and in the same or similar specialty as typically manages the medical condition, procedure or treatment under review.

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