Audit; Contract Manufacturers Sample Clauses

Audit; Contract Manufacturers. Each party shall have the right to inspect all manufacturing facilities utilized by the other party, and to review manufacturing procedures and practices employed, in order to verify their conformance with applicable GMP, GLP and other regulatory requirements. Prior to consummating any Third Party manufacturing arrangement contemplated hereunder, Vertex, Lilly and such Third Party shall promptly consider and mutually agree on reasonable manufacturing audit procedures, appropriate and customary under the circumstances, that may be implemented with respect to the Third Party manufacturing arrangement. Either party may employ reputable contract manufacturers to meet all or a part of their respective manufacturing responsibilities under this Agreement. Any such contract manufacturer shall have a previously demonstrated capacity to manufacture acceptable quality and quantities of drug products for use in pharmaceuticals sold in major industrial markets. Activities referred to a Third Party contract manufacturer shall nevertheless remain the overall responsibility of the referring party who will closely supervise the contract manufacturer and participate with it as appropriate in the particular task referred.
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Related to Audit; Contract Manufacturers

  • PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.

  • Manufacturers Promptly after obtaining actual knowledge thereof, notice of any Manufacturer Event of Default or termination or replacement of a Manufacturer Program;

  • Quality Management System Supplier hereby undertakes, warrants and confirms, and will ensue same for its subcontractors, to remain certified in accordance with ISO 9001 standard or equivalent. At any time during the term of this Agreement, the Supplier shall, if so instructed by ISR, provide evidence of such certifications. In any event, Supplier must notify ISR, in writing, in the event said certification is suspended and/or canceled and/or not continued.

  • Manufacturer A firm that operates or maintains a factory or establishment that produces on the premises, the materials or supplies obtained by the Contractor. Regular Dealer - A firm that owns, operates, or maintains a store, warehouse, or other establishment in which the materials or supplies required for the performance of the contract are bought, kept in stock, and regularly sold to the public in the usual course of business. A regular dealer engages in, as its principal business and in its own name, the purchase and sale or lease of the products in question. A regular dealer in such bulk items as steel, cement, gravel, stone, and petroleum products need not keep such products in stock, if it owns and operates distribution equipment for the products. Brokers and packagers are not regarded as manufacturers or regular dealers within the meaning of this section. United States Department of Transportation (USDOT) - Federal agency responsible for issuing regulations (49 CFR Part 26) and official guidance for the DBE program.

  • Technical Support Services 2.1 The technical support services (the "Services"): Party A agrees to provide to Party B the relevant services requested by Party B, which are specified in Exhibit 1 attached hereto ("Exhibit 1").

  • Support Services Rehabilitation, counselling and EAP’s. Support is strictly non- punitive, and can be accessed at anytime (self-identification of the need for help is strongly encouraged).

  • TRANSPORT SERVICES Upon the conclusion of such multilateral negotiations, the Parties shall conduct a review for the purpose of discussing appropriate amendments to this Agreement so as to incorporate the results of such multilateral negotiations.

  • 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 [***].

  • Subcontracting for Medicaid Services Notwithstanding any permitted subcontracting of services to be performed under this Agreement, Party shall remain responsible for ensuring that this Agreement is fully performed according to its terms, that subcontractor remains in compliance with the terms hereof, and that subcontractor complies with all state and federal laws and regulations relating to the Medicaid program in Vermont. Subcontracts, and any service provider agreements entered into by Party in connection with the performance of this Agreement, must clearly specify in writing the responsibilities of the subcontractor or other service provider and Party must retain the authority to revoke its subcontract or service provider agreement or to impose other sanctions if the performance of the subcontractor or service provider is inadequate or if its performance deviates from any requirement of this Agreement. Party shall make available on request all contracts, subcontracts and service provider agreements between the Party, subcontractors and other service providers to the Agency of Human Services and any of its departments as well as to the Center for Medicare and Medicaid Services.

  • STATEWIDE CONTRACT MANAGEMENT SYSTEM If the maximum amount payable to Contractor under this Contract is $100,000 or greater, either on the Effective Date or at any time thereafter, this section shall apply. Contractor agrees to be governed by and comply with the provisions of §§00-000-000, 00-000-000, 00-000-000, and 00- 000-000, C.R.S. regarding the monitoring of vendor performance and the reporting of contract information in the State’s contract management system (“Contract Management System” or “CMS”). Contractor’s performance shall be subject to evaluation and review in accordance with the terms and conditions of this Contract, Colorado statutes governing CMS, and State Fiscal Rules and State Controller policies.

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