definiens: or means the then -current standards for the manufacture of pharmaceutical products, as applicable pursuant to ( a ) the FD&C Act ( 21 U.S.C. 321 et seq . ) ; ( b ) relevant United States regulations in Title 21 of the United States Code of Federal Regulations ( incl uding Parts 11, 210, and 211 ) ; ( c ) EC Directive 2003/94 EC of October 8, 2003 ; ( d ) the EC Guide to Good Manufacturing Practice for Medicinal Intermediate Products ; ( e ) International Conference on Harmonization ( ICH ) ICH Q7A Good Manufacturing Practice Guid ance for Active Pharmaceutical Ingredients ; ( f ) any Japanese laws, rules, guidelines, or regulations corresponding to the subject matter of the foregoing ; and ( g ) all additional Regulatory Authority documents or regulations that replace, amend, modify, sup plant or complement any of the foregoing means the period commencing with the Effective Date and ending on [ * ]