Active Pharmaceutical Ingredients. For the Product, Insys make certain that the Third Party Manufacturer uses Commercially Reasonable Efforts to maintain a rotating inventory of the required active pharmaceutical ingredients (“API”) and inactive pharmaceutical ingredients (“IPI”) in sufficient quantities to satisfy binding purchase orders provided by Mylan to Insys (the “API and IPI Rotating Inventory”). Insys will also make certain that the Third Party Manufacturer manages the API and IPI Rotating Inventory on a “First-In First-Out” (FIFO) basis, in accordance with cGMPs. Insys, as the API supplier, shall perform an audit of its facility supplying the API, and shall certify the results to Mylan, and shall supply Mylan with a copy of the certified audit report within five (5) calendar days of its completion. Insys shall be responsible for the performance of the Third Party Manufacturer under this Section 4.6, and shall provide reports regarding the regular and successful completion of all of these obligations regarding API to Mylan on a timely basis.
Appears in 2 contracts
Samples: Supply and Distribution Agreement, Supply and Distribution Agreement (Insys Therapeutics, Inc.)
Active Pharmaceutical Ingredients. For the Product, Insys make certain that the Third Party Manufacturer uses Commercially Reasonable Efforts to maintain a rotating inventory of the required active pharmaceutical ingredients (“API”) and inactive pharmaceutical ingredients (“IPI”) in sufficient quantities to satisfy binding purchase orders provided by Mylan to Insys (the “API and IPI Rotating Inventory”). Insys will also make certain that the Third Party Manufacturer manages the API and IPI Rotating Inventory on a “First-In First-Out” (FIFO) ***Confidential Treatment Requested 7 basis, in accordance with cGMPs. Insys, as the API supplier, shall perform an audit of its facility supplying the API, and shall certify the results to Mylan, and shall supply Mylan with a copy of the certified audit report within five (5) calendar days of its completion. Insys shall be responsible for the performance of the Third Party Manufacturer under this Section 4.6, and shall provide reports regarding the regular and successful completion of all of these obligations regarding API to Mylan on a timely basis.
Appears in 2 contracts
Samples: Supply and Distribution Agreement (Insys Therapeutics, Inc.), Supply and Distribution Agreement (Insys Therapeutics, Inc.)