Common use of Encapsulation by RELIANT Clause in Contracts

Encapsulation by RELIANT. RELIANT, or its designated partner, shall encapsulate, package, label, test, and otherwise use API supplied in accordance with this Agreement to manufacture, hold and distribute the Product and Additional Product in accordance with the Act, cGMPs, Regulatory Approvals and all other applicable Regulatory Requirements. In the event RELIANT, the Product (or any Additional Products) or any facility at which the Product (or any Additional Products) is encapsulated, packaged, paper labeled, tested or otherwise manufactured or stored are inspected by any Regulatory authority, RELIANT shall promptly notify PRONOVA, to the extent that such inspection affects or could reasonably be expected to affect the Product (or 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 encapsulated, packaged, paper labeled, tested or otherwise manufactured 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 RELIANT’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 Product (or any Additional Product) was manufactured or the API was 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 RELIANT relating to the API, or Product or the Additional Product.