Changes Required by Applicable Law. VIVUS will promptly, at its own expense, implement any changes to any procedures, Specifications, methods (including testing methods) or standard operating procedures relating to the manufacture or supply of the Product required by Applicable Law or the NDA (collectively, “Required Manufacturing Changes”); provided that Purchaser shall be responsible for any and all expenses arising from any such changes required by any changes to the NDA submitted to any Regulatory Authority by the Purchaser without VIVUS’ prior written consent.
Appears in 3 contracts
Samples: Commercial Supply Agreement (Petros Pharmaceuticals, Inc.), Commercial Supply Agreement (Vivus Inc), License and Commercialization Agreement (Vivus Inc)
Changes Required by Applicable Law. VIVUS will promptly, at its own expense, implement any changes to any procedures, Specifications, methods (including testing methods) or standard operating procedures relating to the manufacture or supply of the Product required by Applicable Law or the NDA (collectively, “Required Manufacturing Changes”); provided that Purchaser shall be responsible for any and all expenses arising from any such changes required by any changes to the NDA submitted to any Regulatory Authority by the Purchaser without VIVUS’ prior written consent.
Appears in 2 contracts
Samples: Commercial Supply Agreement (Auxilium Pharmaceuticals Inc), Commercial Supply Agreement (Vivus Inc)