definiens: means the current Good Manufacturing Practices as promulgated under e ach of the following as in effect on the date of this Agreement and as amended or revised after the date of this Agreement and in effect at the time of the performance of the Services : ( a ) the U.S. Food, Dr ug & Cosmetics Act ( 21 U.S.C. § 301 et seq . ) and related U.S. regulations, including 21 Code of F ederal Regulations ( Chapters 210 and 211 ) and ( b ) t he ICH guide Q7 as app lied to investigational drugs ( Section 19 ) . Client shall have responsibility for determining regulatory strategy and for all regulatory decision s except for those matters that KBI Biopharma, in its reasonable discretion deems contr ary to regulatory requirements or commitments made by KBI Biopharma to regulatory aut horities, of which matters KBI Bi opharma shall promptly notify Client in writing