Notice to RELIANT Sample Clauses

Notice to RELIANT. In the event PRONOVA, the API or any facility at which the API or any component thereof is manufactured, packaged, tested or stored are inspected by any Regulatory Authority, PRONOVA shall promptly notify RELIANT, to the extent that such inspection affects or could reasonably be expected to affect the API, the Product, any Additional Product or the manufacture thereof under this Agreement, of (i) any such inspection with reasonable advance notice, and (ii) any alleged written violations or deficiencies relating to the manufacturing facility at which API is manufactured, packaged, tested or stored, and (iii) the corrective action to be taken, and shall promptly contest such alleged violations or deficiencies in good faith or take the required corrective action, each at PRONOVA’s sole expense. If, based on a specific observation made by any Regulatory Authority following an audit or inspection, either Party reasonably determines that the API was manufactured or stored under conditions that materially deviated from cGMPs, Regulatory Requirements or any applicable law, rule, regulation, guideline or procedure, including the Act, the Parties shall agree upon the appropriate action to be taken in conformance with the FDA 483 or the action letter received from FDA by PRONOVA relating to the API.
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