Common use of Changes by Regulatory Authorities Clause in Contracts

Changes by Regulatory Authorities. If BLP is required by a regulatory authority to perform validation studies for purposes of validating new manufacturing procedures, new Raw Material or finished Product assay procedures with respect to a Product, in each case which are unique to the manufacture of the Product, in order to continue to engage in the manufacture of the Product for ISTA, BLP shall promptly provide ISTA with notice that such validation studies are required, such notice to include an estimate of all related validation study expenses. ISTA shall notify BLP whether it desires BLP to continue manufacturing the Product, and all direct expenses borne by BLP and pre-approved by ISTA in writing in the conduct of any such validation study shall be reimbursed to BLP by ISTA as incurred.