Audit Right; Facility Access. From and after the commencement of supply hereunder directly or through an independent auditor reasonably acceptable to VIVUS, Purchaser shall have the right, upon reasonable advance notice and during regular business hours, to make an annual inspection and audit of the facilities being used by VIVUS or a VIVUS Affiliate for the production, storage, or testing of Product to assure compliance by or on behalf of VIVUS with cGMPs, the Specifications, and Applicable Law. At Purchaser’s reasonable request, VIVUS agrees to use Commercially Reasonable Efforts to facilitate a similar inspection and audit of the facilities being used by Sanofi and/or any other Third Party manufacturer, such as, solely by way of example, by exercising VIVUS’ audit right in its agreement with such manufacturer, at Purchaser’s cost, and permitting Purchaser or its designee to attend such audit (subject to approval by the Third Party manufacturer to allow such attendance, which VIVUS shall use Commercially Reasonable Efforts to obtain) and in any event sharing the results of such audit with Purchaser.
Appears in 3 contracts
Samples: Commercial Supply Agreement (Petros Pharmaceuticals, Inc.), Commercial Supply Agreement (Vivus Inc), License and Commercialization Agreement (Vivus Inc)
Audit Right; Facility Access. From and after the commencement of supply hereunder directly or through an independent auditor reasonably acceptable to VIVUS, Purchaser shall have the right, upon reasonable advance notice and during regular business hours, to make an annual inspection and audit of the facilities being used by VIVUS or a VIVUS Affiliate for the production, storage, or testing of Product to assure compliance by or on behalf of VIVUS with cGMPs, the Specifications, and Applicable Law. At Purchaser’s reasonable request, VIVUS agrees to use Commercially Reasonable Efforts commercially reasonable efforts to facilitate a similar inspection and audit of the facilities being used by Sanofi MTPC and/or any other Third Party manufacturer, such as, solely by way of example, by exercising VIVUS’ ’s audit right in its agreement with such manufacturer, at Purchaser’s cost, and permitting Purchaser or its designee to attend such audit (subject to approval by the Third Party manufacturer to allow such attendance, which VIVUS shall use Commercially Reasonable Efforts commercially reasonable efforts to obtain) and in any event sharing the results of such audit with Purchaser.
Appears in 2 contracts
Samples: Commercial Supply Agreement (Auxilium Pharmaceuticals Inc), Commercial Supply Agreement (Vivus Inc)