Common use of Manufacturing Facility Clause in Contracts

Manufacturing Facility. (a) At all times during the Term, Capricorn shall maintain the Manufacturing Facility, equipment and processes used in producing the Product in strict compliance with all Applicable Laws and cGMP. (b) Primus and its representatives shall have the right from time to time during normal business hours, and upon reasonable notice, to enter, inspect and evaluate the Manufacturing. Such inspection visits shall be scheduled and organized in such a manner as to comply with cGMP and to minimize to the extent reasonably practicable any disruption to plant and warehouse operations. (c) Capricorn shall notify Primus within ten (10) Business Days following receipt of any notice of inspection by the FDA or other Regulatory Authority related to any aspect of the Manufacturing Facility and shall provide Primus with a copy of the results of any such inspection promptly after receipt. In the event that the inspection report identifies any deficiencies with respect to the Manufacturing Facility or with any processes or procedures, Capricorn shall promptly furnish to Primus a written statement setting forth the remediation measures that Capricorn intends to implement, the anticipated deadline for the completion of such measures, and the effect, if any, upon Capricorn’s ability to comply with its obligations under this Agreement.

Appears in 3 contracts

Sources: License & Manufacturing Agreement, License & Manufacturing Agreement (Primus Therapeutics Inc.), License & Manufacturing Agreement (Primus Therapeutics Inc.)