Encapsulation by RELIANT Clause Samples
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.
Encapsulation by RELIANT. Notwithstanding any provision herein to the contrary, RELIANT shall not have any obligation to purchase the Product in Finished Dosage Form. RELIANT shall have the option to purchase Product in Bulk Product Form so that RELIANT may encapsulate and package the Product, either directly at its own facilitates or using the services of one or more third-parties. In the event that RELIANT elects not to have ETHYPHARM encapsulate and package the Product, ETHYPHARM agrees to provide to RELIANT, at cost, such assistance as may reasonably be requested by RELIANT to facilitate the transfer of the relevant Confidential Information and Intellectual Property of ETHYPHARM to RELIANT or such third party for the purposes of RELIANT’s or such third party’s encapsulation and packaging of the Product, which assistance shall be provided for a limited period of time to be reasonably agreed upon between the parties. In the event that RELIANT elects to have a third party encapsulate and package the Product using ETHYPHARM Confidential Information and Intellectual Property, RELIANT agrees that it shall obtain an agreement from such third party to keep such Confidential Information and Intellectual Property confidential in accordance with the terms of this Agreement.