Common use of Changes by Regulatory Authorities Clause in Contracts

Changes by Regulatory Authorities. DPT agrees that any changes required by regulatory authority, shall be incorporated into the Product as evidenced by the written approval of COMPANY via a PCR prior to such incorporation. At the time of such incorporation, such changes shall become part of the Specifications and such revised Specifications ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. must be approved in writing by COMPANY before they are implemented. If, as a result of such change, DPT is required by a regulatory authority to perform validation studies for purposes of validating new manufacturing process or cleaning procedures or new raw material and finished Product assay procedures with respect to Product in order to continue to engage in the manufacture of said Product for COMPANY, such studies shall be conducted in accordance with paragraph 5.3 herein. Due to said changes the parties shall mutually agree upon an adjustment to the price of Product, if necessary, and Schedule A shall be amended accordingly.