API. A. Client shall supply to Catalent for Processing, at Client’s sole cost, the API and applicable reference standards in quantities sufficient to meet Client’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Catalent for Processing, Client shall provide to Catalent a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Client shall supply the API, reference standards, and certificate of analysis […***…] the Facility no later than […***…] before (but not earlier than […***…] before) the scheduled Processing Date upon which such API will be used by Catalent for Processing. Client shall be responsible at its expense for securing any necessary DEA, export, or import clearances or permits required in respect of supply to Catalent of such items. Upon receipt of the API, Catalent shall conduct release testing of the API as per the Specifications. Catalent shall use the API solely and exclusively for Processing under this Agreement.
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Samples: And Packaging Agreement, Manufacturing and Packaging Agreement (Insys Therapeutics, Inc.), Manufacturing and Packaging Agreement (Insys Therapeutics, Inc.)
