Certificate of Analysis. Orion shall deliver with each shipment of Product a certificate of analysis, accompanied by a statement that the batch was manufactured according to the Quality Assurance Agreement, together with any other batch related records specified in the Quality Assurance Agreement. Without limitation, the certificate of analysis shall set forth the items tested, specifications and test results for each lot delivered, all in a manner which complies with the NDA, the Act and other applicable laws and regulatory requirements. Batch records for that shipment (including all deviation reports and investigations) will, within seven (7) working days after release of the Product, be shipped to USL’s Quality Assurance Unit for review.
Appears in 4 contracts
Samples: License, Supply, Marketing, Distribution and Collaboration Agreement (Osmotica Pharmaceuticals PLC), License, Supply, Marketing, Distribution and Collaboration Agreement (Osmotica Pharmaceuticals LTD), License, Supply, Marketing, Distribution and Collaboration Agreement (Osmotica Pharmaceuticals LTD)
