Quality and Compliance Standards definition

Quality and Compliance Standards means the quality and compliance standards approved by the JAC (but ultimately subject to Amgen final approval if there are any disagreements) from time to time, including manufacturing standards, such as international Good Clinical Practices (GCP), international Good Manufacturing Practices (GMP), quality standards, supply chain standards, such as NMPA, international Good Supply Practice (GSP), distribution standards, such as WHO Good Distribution Practice (GDP), safety and healthcare compliance standards and generally accepted national and international pharmaceutical industry codes of practice (including guidelines under the International Conference on Harmonization (ICH)).
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Quality and Compliance Standards means the quality and compliance standards approved by the JSC from time to time, including manufacturing standards, such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), quality standards, supply chain standards, such as NMPA, international Good Supply Practice (GSP), distribution standards, such as Good Distribution Practice (GDP), safety and healthcare compliance standards and generally accepted national and international pharmaceutical industry codes of practice (including guidelines under the ICH).
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Quality and Compliance Standards means all Good Manufacturing Practices and Good Automated Manufacturing Practice and other standards set out the URS.
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Examples of Quality and Compliance Standards in a sentence

  • The Parties will have the right to require that any personnel that materially violates Applicable Law or the Quality and Compliance Standards cease to perform activities under this Agreement.

  • Within a reasonable time prior to the expected First Commercial Sale in the Collaboration Territory, Amgen will perform an audit of BeiGene on its management of product distribution in compliance with the Quality and Compliance Standards, including NMPA Good Supply Practice (GSP).

  • The School District shall contribute Seventeen Thousand Three Hundred ($17,300.00) Dollars annually to a Tax Deferred Annuity of the Superintendent's choice.

  • The Parties will mutually agree on the Quality and Compliance Standards from time to time and the Parties’ compliance therewith, provided that in the event of any disagreement related to such Quality and Compliance Standards, such matter shall be escalated to the JSC and Amgen shall, after consultation with the JSC, have the tie-breaking vote on such matter.

  • The Distribution shall comply with the Quality and Compliance Standards and the requirements set forth in the Quality Agreement.

  • The Parties will provide each other with all reasonably requested cooperation to enable each of them to comply with Proper Conduct Practices, Applicable Law and the Quality and Compliance Standards, including permitting each Party to reasonably monitor activities conducted by a Party in connection with this Agreement in order to verify the other Party’s compliance therewith with respect to the Collaboration Scope and market environment of the Collaboration Territory.

  • BeiGene shall promptly notify Amgen of any significant discrepancies or concerns related to BeiGene’s, an Affiliate’s or any Third Party’s (including sub-distributors, wholesalers and pharmacies) ability to perform any of its obligations related to the Distribution of Products in the Collaboration Territory or to comply with the Quality and Compliance Standards or, if applicable, the Proper Conduct Practices.

  • The distribution shall comply with the Quality and Compliance Standards and the requirements set forth in the Quality Agreement.

  • Each Party will conduct, and ensure that each of its Affiliates and Third Parties engaged by such Party conducts, all of its and their activities with respect to the development, registration, manufacture, distribution, promotion and Commercialization of the Product in accordance with this Agreement, the Initial Global Development Plan, the Global Development Plan, the Global Pricing Policy, the Quality and Compliance Standards, Proper Conduct Practices, and all Applicable Law.

  • Amgen shall have the right to audit BeiGene with respect to such Distribution activities, upon reasonable notice (at least [*]) and at a reasonable frequency (no more than once per year absent reasonable evidence of a concern), and BeiGene shall ensure that Amgen has the right to audit any such Affiliates or Third Parties involved in such Distribution, with respect to their respective compliance with the Quality and Compliance Standards or, if applicable, the Proper Conduct Practices.