QA Agreement definition
Examples of QA Agreement in a sentence
Such QA Agreement shall also detail the specifications for the API, procedure for batch release and acceptance.
The Parties shall enter into a separate QA Agreement, in the agreed form attached at Exhibit B to this Agreement, relating to the Parties’ QA responsibilities and in particular addressing the following (but without limitation): documents, records, samples, change management and approval, inspections, complaints, recalls, testing and release.
In the event of any conflict between a substantive provision of this Agreement and a substantive provision of the QA Agreement, the substantive provisions of the QA Agreement will prevail with respect to any issues relating to Product Quality Assurance and the substantive provisions of this Agreement will prevail with respect to any other term.
In the event GW Delivers any Defective Product to NOVARTIS and subject to NOVARTIS’ timely notification (as set forth in the QA Agreement), and subject always to Clause 14.4 below, GW shall replace any such Defective Product or, at NOVARTIS’ sole discretion, any Batch containing such Defective Product, with conforming Product or conforming Batch of Product, as the case may be, at GW’s cost.
This Agreement, together with its Annexes, and the Distribution and License Agreement, the QA Agreement and the Pharmacovigilance Agreement sets forth the entire agreement and understanding of the Parties as to the subject matter hereof and supersedes all proposals, oral or written, and all other prior communications between the Parties with respect to such subject matter.
The exact timelines for audits, including without limitation, the intervals and the number of days for the prior written notice, will be set forth in the QA Agreement.
NOVARTIS hereby consents to subcontractors listed in Annex E to the QA Agreement continuing to provide the Processing related services setout therein following the date of this Agreement.
The Product should also be labelled according to the QA Agreement set forth in Attachment E.
The response shall include confirmation of GW’s ability to supply the quantity of vials of the Product set out in the Firm Order (less any amount required to be retained by Law, the QA Agreement or to complete stability testing) and the date(s) by which GW will be able to Deliver the vials ordered each an “Acknowledgment”).
GW represents and warrants that (i) it shall Process, store and Deliver Product in material compliance with applicable GMPs, applicable Laws, the QA Agreement, and Master Batch Records and/or any other procedures agreed upon by the Parties in writing, and (ii) at the time of Delivery, Product will conform to the Specifications (the “Product Warranties”).