Standard of Manufacture. EURAND shall supply RELIANT with Product meeting the Specifications. All Product supplied by EURAND to RELIANT hereunder shall be consistent with the DMF and produced in a facility and in a manner compliant with cGMP and all other Applicable Laws and shall not be adulterated or misbranded within the meaning of the Act. Each shipment of Product from EURAND to RELIANT shall be sampled and analyzed by EURAND to determine if the shipment meets the Specifications. EURAND shall deliver to RELIANT with each shipment of the Product a certificate of analysis stating that the Product meets the Specifications. EURAND agrees that it shall make no changes in the production of Product without the specific written prior approval of a duly authorized representative of RELIANT unless expressly required either by cGMP or the Act.
Appears in 4 contracts
Samples: Development, License and Supply Agreement (Reliant Pharmaceuticals, Inc.), Development, License and Supply Agreement (Reliant Pharmaceuticals, Inc.), Development, License and Supply Agreement (Reliant Pharmaceuticals, Inc.)
