CONTROLLED DOCUMENTS. 9.1 AMGEN shall make readily available to AKERO, upon request, only documents related to lots of the Product supplied to AKERO which shall include release documentation, summaries of change controls, complaint investigations, deviation/ nonconformances summaries, and stability summary data, as agreed between the Parties. 9.2 AMGEN shall retain controlled documents related to manufacturing and analytical data per AMGEN’s established procedures and cGMP requirements.
Appears in 3 contracts
Sources: Exclusive License Agreement (Akero Therapeutics, Inc.), Exclusive License Agreement (Akero Therapeutics, Inc.), Exclusive License Agreement (Akero Therapeutics, Inc.)