Product Quality, Disposition Sample Clauses

Product Quality, Disposition a. BioVectra will manufacture Product according to GMPs, Manufacturing Procedure, Specifications and quality requirements set forth in the Quality Agreement as well as in accordance with all Applicable Law (collectively, all the forgoing the “Manufacturing Requirements”). The Quality Agreement contains and governs all quality related matters and set forth the responsibility of the Parties with respect to certain tasks including change control, deviations, stability, complaints, records, sampling, testing, retaining of samples, release, as well as tasks related to regulatory reporting, investigations, and recalls. Each Batch of Product will be sampled and tested by BioVectra against the Specifications, and the quality assurance department of BioVectra will review the documentation relating to the manufacture of the Batch and will assess if the manufacture has taken place in compliance with the Manufacturing Requirements. b. In addition to any release requirements set forth in the Quality Agreement, BioVectra will release Product against agreed upon Specifications (set out in Appendix 3 and Appendix 4) and provision to Keryx of a Certificate of Conformance, Certificate of Analysis, certificate of origin (including a BSE / TSE statement), and a summary of Batch deviations (collectively “Batch Documentation”) for each Batch of Product will be delivered to Keryx by electronic mail in the form of a PDF. BioVectra will provide to Keryx following release of each Batch, a PDF scan of the executed Batch records. Upon request, and at Keryx’s cost, BioVectra will also deliver to Keryx all Records and Supporting Documentation in the possession or under the control of BioVectra relating to the manufacture of each Batch of Product (or any intermediate or component of Product). Any scope changes to the manufacturing schedule, release requirements or quality requirements and associated impact(s), including impacts to costs, will be reviewed and assessed prior to implementation, and in all cases subject to the prior mutual agreement of both Parties. c. In addition to Section 3.a. above, as required by GMP, at release Product will be absent of any foreign particulate matter. Safety screening will be implemented by BioVectra as part of the Manufacturing Procedure to aid in the identification of foreign particulate matter. [**] of this Agreement shall be [**]. Because Product contacts [**] of the manufacturing surfaces as a condition of production, it is expected and understoo...