Manufacturing Process Events Clause Samples

Manufacturing Process Events. If a manufacturing process event occurs during the manufacture of any Product batch which is likely to materially affect the safety, efficacy or regulatory status of the Product in Canada, CATALYST shall notify KYE as soon as reasonably possible (but in any event within two (2) Business Days of becoming aware of the process event). KYE and CATALYST shall consult with each other as to the disposition of all affected batches of the Product, which disposition shall be at the expense of CATALYST. CATALYST agrees to report to KYE, on a semi-annual basis, any atypical process events, regardless of whether they are or are not likely to materially affect the safety, efficacy, or regulatory status of the Product. No Product may be reworked unless the rework procedure is in conformity with GMP and the Quality Agreement or otherwise agreed in writing between the Parties.

Manufacturing Process Events. Following review by TGC quality assurance personnel of a manufactured batch of Clinical Vaccine, TGC shall report in writing to IAVI’s Quality Assurance Manager any out-of-specification event or significant deviation that occurs during the manufacture or testing of any Clinical Vaccine, which event may affect the safety, efficacy or GMP compliance of such Clinical Vaccine, and when appropriate, disposing of any affected Clinical Vaccine. IAVI shall also have the right to review manufacturing documents as described in Article 2.2.