Certificate of Analysis; Product Release. The quality control(s) and the release(s) of API (including documentation) shall be done by Hovione in accordance with the Quality Agreement. Hovione shall provide certificates of analysis (“COAs”) to OptiNose for each batch of API delivered under this Agreement. Hovione shall make Batch Records and other documents pertaining to shipments made to OptiNose readily available to OptiNose on site. Any API that does not conform to the Product Specifications or requirements of the Agreement shall not be shipped to OptiNose. API shall have at least [***] of retest period remaining on the date of delivery. Hovione shall be solely responsible for releasing the API to the agreed API Product Specification in Exhibit A.
Appears in 2 contracts
Sources: Supply Agreement (OptiNose, Inc.), Supply Agreement (OptiNose, Inc.)