Common use of Processing Changes Clause in Contracts

Processing Changes. (a) Once a DMF has been lodged with the APVMA Supplier shall not make any regulatory changes to the Manufacturing Process that would impact the APVMA’s acceptance of the quality and purity of the Product, the Master Batch Record or Product Specifications for the manufacture of the Product, without the prior written consent of Customer, such consent shall not be unreasonably delayed or withheld. (b) Customer may request changes to the Manufacturing Process, Master Batch Record, the Product Specifications, storage, testing or analytical methods or any starting materials for the manufacture of the Product, provided that any such changes which impact the cost of manufacturing the Product inclusive of any process development, re-validation, scale-up and/or regulatory filings necessary to support such changes will be reflected in a corresponding increase in the Fees paid by Customer under this Agreement. The notice of any such change by Customer shall comply with the cGMP documentation system and SOPs maintained by Supplier at its production site. (c) In the event of a change to the Manufacturing Process, Master Batch Record or the Product Specifications, the relevant documents and related Exhibits to this Agreement will be revised accordingly. (d) All operational Master Batch Records and SOP’s utilized by Supplier are to be in the English language.