Common use of API Clause in Contracts

API. A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast. B. All API provided by Reliant shall meet applicable Specifications that apply thereto, and shall be produced in accordance with all applicable federal, state and local laws and regulations, including, without limitation, cGMPs. C. Cardinal Health shall inspect API as received to verify its identity and shall give Reliant oral and written notice of any nonconformity with Specifications within thirty (30) calendar days of receipt of API by Cardinal Health. Reliant shall provide a Certificate of Analysis with each delivery of API and such certificate shall be the basis for drug potency. D. Reliant shall retain title to API at all times and shall bear the risk of loss thereof; provided, however, subject to Section 15.1, from the time API is received at Cardinal Health’s Facility to the time API is returned (or Product is delivered) to Reliant’s designated carrier at Cardinal Health’s loading dock, Cardinal Health shall bear the risk of loss of API arising from Cardinal Health’s negligence or failure to comply with cGMPs or failure to comply with all Specifications.