definiens: shall mean applicable Good Manufacturing Practices for drugs pursuant to ( i ) the FDA rules and regulations, 21 CFR Parts 11, 210 - 211, 600 and 601, ( ii ) the U.S. Federal Food, Drug, an d Cosmetic Act, as amended ( 21 USC 301 et seq . ), ( iii ) the Commission Directive 2003/94 / EEC of 08 Octobe r 2003, ( iv ) the EC Guide to Good Manufacturing Pract ice for Medicinal Licensed Products, including resp ective guidance documents, and the relevant current Intern ational Conference on Harmonization ( ICH ) guidance documents, and ( v ) any corresponding good manufactu ring laws, rules or regulations of any agreed upon foreign jurisdiction, as they may be amended from time to t ime, provided that any such foreign jurisdiction good manufacturing requirements have been expressly agre ed to in an SOW or other writing signed by Client a nd Althea