definiens: means the specifications for manufacturing the Product . Prior to the initiation of the first cGMP manufacturing run, an Appendix C-1 signed by both p arties setting forth the initial Manufacturing Specifications shall be appen ded to this Agreement and shall contain at a minimum a collection of document s containing certain specifications, procedures, assay methods ( QC Relea se Tests ), personnel contacts and any other information as may be needed and agre ed by the parties relating to the manufacture of Product by [COMPANY] for SGI . This Ap pendix C-1 shall also contain a statement to be agreed and acknowledged by [COMPANY] a nd SGI that SGI adopts the initial Manufacturing Specifications as its own spe cification in conformance with Clause 6.7 herein . Any changes or additions to the Manufacturing Specifications shall be made by the written agreeme nt of [COMPANY] and SGI