Inspection by Customer. Customer and its Affiliates shall have the right to visit and inspect any facilities at which Supplier Manufactures API (including facilities at which Supplier tests and stores API) during normal business hours and with reasonable advance notice. Such inspections shall not be conducted more than once per calendar year except in connection with (a) inspections under extraordinary circumstances referred to below and (b) reasonable follow-up inspections in respect of correction of issues identified in an annual inspection. Notwithstanding the foregoing, Customer, its Affiliates and their representative may at any time conduct such an inspection during business hours in connection with any of the following: investigation of any Third Party complaint or injury related to the API; non-compliance of API with Agreed Quality that is either alleged by a Regulatory Authority or has been established; or an inspection by a Regulatory Authority results in findings that are adverse or negative with respect to the API.
Appears in 2 contracts
Sources: Api Supply Agreement (Baudax Bio, Inc.), Api Supply Agreement (Recro Pharma, Inc.)