Inspection notification. ENDOCEUTICS shall permit inspections of the Manufacturing Facilities by Governmental Authorities. ENDOCEUTICS agrees to promptly notify AMAG of any inspection of the Manufacturing Facilities by any Governmental Authority relating to the PRODUCT. ENDOCEUTICS shall keep AMAG informed of the status of the matter with the relevant Governmental Authority. AMAG shall have the right to review and comment on any correspondence by ENDOCEUTICS to such Governmental Authority for the Territory relating to critical observations raised during the inspection and related to the PRODUCT before such correspondence is sent, and ENDOCEUTICS shall consider any such comments in good faith. For clarity, the foregoing right of review and comment will not apply to correspondence between any CMO and a Governmental Authority. [***].
Appears in 2 contracts
Sources: Manufacturing and Supply Agreement, Manufacturing and Supply Agreement (Amag Pharmaceuticals Inc.)