Manufacturing Responsibilities definition

Manufacturing Responsibilities means all the manufacturing, production, quality control, quality assurance, stability testing, packaging, storage, GMP Facility design, construction and validation and related steps, processes, or actions required for Revance to produce Product, in conformance with the Specifications and Regulatory Standards, as contemplated by this Agreement.
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Manufacturing Responsibilities means all the manufacturing, production, quality control, quality assurance, stability testing, packaging, storage, GMP Facility design, construction and validation and related steps, processes, or actions required for
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Manufacturing Responsibilities has the meaning specified in Section 2.2;
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Examples of Manufacturing Responsibilities in a sentence

  • Except for the Client’s right to terminate this Agreement in accordance with the applicable provisions of Section 8 hereof and the indemnity provided in Section 10.3 and subject to the limitations set forth in Sections 10.1 and 10.2, the remedies described in this Article 6 shall be the Client’s sole remedy for any failure by Patheon to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities.

  • Unless it is determined that the cause of any customer complaint resulted from a failure by Patheon to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities, all costs incurred in respect of this Section 6.4 shall be borne by the Client.

  • In the event the Client rejects Drug Product in accordance with this Section 6.1 and the deviation is determined to arise from Patheon’s failure to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities, Patheon will credit the Client’s account for Patheon’s invoice price to the Client for such defective Drug Product.

  • Except to the extent that Patheon has failed to provide the Manufacturing Services in accordance with the Patheon Manufacturing Responsibilities and as set forth in section 6.2 hereof, Patheon shall not be liable nor have any responsibility for any deficiencies in, or other liabilities associated with, any Drug Product manufactured by it, including, without limitation, the costs and expenses of any Recall (collectively, “Drug Product Claims”).

  • The expenses of such testing shall be borne by Patheon if the non-conformity with the Patheon Manufacturing Responsibilities is confirmed, and otherwise by Santarus.

  • The agreements shall include supply agreements, Quality Agreements and Manufacturing Responsibilities Document (“MRD”) appropriate for the Manufacture of the Product(s).

  • Patheon shall provide the Client with reasonable access at mutually agreeable times to any of its facilities in which the Products are manufactured, stored, handled or shipped in order to permit the Client's verification of Patheon's compliance with the Patheon Manufacturing Responsibilities and with all applicable laws and regulations.

  • Upon any transfer of Manufacturing Responsibilities to Takeda pursuant to Section 4.2 of this Agreement, Orexigen shall have similar audit rights with respect to supply of Product for Clinical Trials by Takeda.

  • Patheon shall provide the Client with reasonable access at mutually agreeable times to its Manufacturing Site in which the Product is manufactured, stored, handled or shipped in order to permit the Client's verification of Patheon's compliance with the Patheon Manufacturing Responsibilities and with all applicable Laws.

  • Santarus has the right to reject any portion of any shipment of Finished Products that deviates from the Manufacturer Manufacturing Responsibilities, without invalidating any remainder of such shipment.

Related to Manufacturing Responsibilities

  • Customer Responsibilities means the responsibilities of the Customer set out in the Contract Order Form or agreed in writing between the Parties from time to time in connection with this Contract ;

  • Extended producer responsibility ’ (EPR) means responsibility of any producer of packaging products such as plastic, tin, glass, wrappers and corrugated boxes, etc., for environmentally sound management, till end-of-life of the packaging products ;

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • 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;

  • Responsibilities means the responsibilities delegated to BNY under the Rule as a Foreign Custody Manager with respect to each Specified Country and each Eligible Foreign Custodian selected by BNY, as such responsibilities are more fully described in Article III of this Agreement.