definiens: means, with respect to a Product, an agreement between the parties which describes the quality and regulatory responsibilities relating to the Manufacture and release for sale of such Product to [COMPANY] . Where practicable, the Quality Agreement will be compiled and agreed upon by the parties prior to initiation of the process validation batches . The Quality Agreement will be subject to and not inconsistent with the terms of this Agreement, the related Project Agreement and the Specifications, and in the event of conflict between terms of this Agreement, the Project Agreement and/or the Specifications, as applicable, on one hand, and the Quality Agreement on the other, this Agreement, the Project Agreement or the Specifications, as applicable, will govern . The Quality Agreement may be modified from time to time through the issuance of a revised document signed on behalf of each of the parties by an authorized representative(s ) incorporating the modification(s ) and stating the reason for revisions, effective date and revision number of the document . A reference to in this Agreement will mean the MRD and/or the Quality Agreement, as the context requires