definiens: means the specifications for manufacturing the Pr oduct . Prior to the initiation of the first cGMP manufacturing run an A ppendix C-1 signed by both parties setting forth th e initial Manufacturing Specifications shall be appended to t his Agreement and shall contain at a minimum a coll ection of documents containing certain specifications, pro cedures, assay methods ( QC Release Tests ), personne l contacts and any other information as may be needed and agreed by the parties relating to the manufact ure of Product by [COMPANY] for SGI . This Appendix C-1 shall al so contain a statement to be agreed and acknowledge d by [COMPANY] and SGI that SGI adopts the initial Manufactur ing Specifications as its own specification in conf ormance with Clause 6.7 herein . Any changes or additions to the Manufacturing Specifications shall be made wit h the written approval of SGI