Compliance with cGMP Clause Samples
The 'Compliance with cGMP' clause requires that all products or processes covered by the agreement adhere to current Good Manufacturing Practices (cGMP) as defined by relevant regulatory authorities. In practice, this means that manufacturing, testing, and quality control activities must follow established standards to ensure product safety, quality, and consistency. This clause is essential for ensuring that products meet regulatory requirements and helps prevent issues related to product recalls, regulatory sanctions, or compromised consumer safety.
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Compliance with cGMP. BPI hereby represents, warrants and covenants that all Product supplied by BPI hereunder shall be manufactured, tested and handled by BPI or its Affiliates or a Third Party Manufacturer, as applicable, in compliance with all applicable cGMPs, in each case solely to the extent such Product is manufactured, tested and handled by BPI or its Affiliates or a Third Party Manufacturer.
Compliance with cGMP. Subject to the New Components supplied to Aventis complying with all relevant Specifications, Aventis warrants that all Product has been and will be manufactured in conformity with cGMP and with the Specifications as defined and approved in the NDA (and any modifications thereto agreed upon in writing by the Parties).
Compliance with cGMP. ELITE warrants that any Product supplied by it hereunder shall be manufactured in accordance with cGMP.
Compliance with cGMP. Aventis, acting in its own name and on behalf of its Affiliates, represents warrants and covenants that all Product will be manufactured, tested and handled in compliance with Product Approvals and cGMP.
Compliance with cGMP. BioVectra shall use its best efforts to produce the Product under cGMP conditions. Provided however that BioVectra shall be obligated to ensure that the third Batch of Product is produced under cGMP conditions. BioVectra shall monitor and maintain reasonable records respecting its compliance with cGMP, including those referenced in the Quality Assurance Agreement, or as Helix may otherwise reasonably request from time to time. BioVectra further agrees to comply with any and all corrective actions mutually agreed to by the Parties pursuant to any audit performed pursuant to section 5.1. Actual and Reasonable Costs and Expenses incurred by BioVectra with regards to any mutually agreeable implemented corrective actions, except in the event and to the extent that such costs are directly attributable to BioVectra’s breach of the warranties set forth in Sections 11.1 and 11.2 shall be borne by Helix.
Compliance with cGMP. CPL shall monitor and maintain reasonable records respecting its compliance with cGMP, including those referenced in the Quality Assurance Agreement, or as Helix may otherwise reasonably request from time to time. CPL further agrees to comply with any and all corrective actions mutually agreed to by the Parties pursuant to any audit performed pursuant to section 5.1.
Compliance with cGMP. Solvay warrants that any API supplied by it hereunder shall be manufactured in accordance with cGMP.
Compliance with cGMP. It will Manufacture all Intermediate Product in compliance with cGMP; provided, that if the [ * ] of the [ * ] and [ * ] the parties will [ * ] and [ * ]
Compliance with cGMP. Supplier warrants that all Products will be manufactured in conformity with the regulations of the FDA and any comparable state agency applicable thereto.
Compliance with cGMP. Inyx warrants that all Product will be manufactured in conformity with cGMP.