FDA Inspection. DPT shall advise COMPANY if an authorized agent of the FDA or other governmental agency visits DPT’s manufacturing facility and requests or requires information or changes which specifically pertain to the Products. FDA audit time specific to Products will be billed to COMPANY from DPT at the then-prevailing QA hourly rate.
Appears in 4 contracts
Samples: Manufacturing Agreement (Insys Therapeutics, Inc.), Manufacturing Agreement (Insys Therapeutics, Inc.), Manufacturing Agreement (Insys Therapeutics, Inc.)
FDA Inspection. DPT shall advise COMPANY Connetics if an authorized agent of the FDA or other governmental agency visits DPT’s 's manufacturing facility and requests or requires information or changes which specifically directly pertain to the Products. FDA audit time specific to Products will be billed to COMPANY Connetics from DPT at the then-prevailing QA hourly rate. DPT agrees to provide Connetics with copies of any written observations made in connection with such inspections, and any written responses to those observations.
Appears in 3 contracts
Samples: Manufacturing and Supply Agreement (Connetics Corp), Manufacturing and Supply Agreement (Connetics Corp), Manufacturing and Supply Agreement (Connetics Corp)
FDA Inspection. DPT shall advise COMPANY within one (1) business day if an authorized agent of the FDA or other governmental agency visits DPT’s manufacturing facility and requests or requires information or changes which specifically directly pertain to the Products. FDA audit time specific to Products will be billed to COMPANY from DPT at the then-prevailing QA hourly rate.
Appears in 2 contracts
Samples: Agreement (Auxilium Pharmaceuticals Inc), Manufacturing Agreement (Auxilium Pharmaceuticals Inc)
