RELIANT Audit Right Regarding Manufacturing Facilities Sample Clauses

RELIANT Audit Right Regarding Manufacturing Facilities. Upon prior notice to ETHYPHARM and upon a minimum of one (1) month prior notice of the anticipated audit date, ETHYPHARM will permit (and will cause any owner and operator of any Additional Manufacturing Facility to permit) RELIANT to conduct an inspection and audit, of ETHYPHARM’s or such third party’s manufacturing facilities and operations used in the manufacturing, receiving, sampling, analyzing, storing, handling, packaging and shipping of Product, including, but not limited to, the receipt, storage and issuance of raw materials, labeling and packaging components and ingredients thereof (including, without limitation, all documentation related thereto) for the purpose of quality control and to assure compliance with cGMP, Applicable Laws, Applicable Permits and the terms of this Agreement. RELIANT may not conduct an audit hereunder more frequently than once during any six (6) month period prior to the Approval Date, or more frequently than once during any twelve (12) month period following the Approval Date; provided, however, that RELIANT may conduct an additional audit(s) in the event there is a quality or compliance issue concerning the Product or its manufacture that RELIANT deems in good faith to be material hereunder. RELIANT may conduct such audit using its own personnel or a third party auditor/inspector and shall conduct such audit, or cause such audit to be conducted, during regular business hours and in such a manner so as to minimize interference with ETHYPHARM’s or any third party’s operations. ETHYPHARM will provide, and shall cause any applicable third party to provide, RELIANT with access to relevant personnel during the audit and ETHYPHARM will provide a written response to any written audit observations provided by RELIANT within thirty (30) days of ETHYPHARM’s receipt thereof.
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Related to RELIANT Audit Right Regarding Manufacturing Facilities

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