definiens: means the regulatory requirements for curre nt good manufa cturing practices, including the United States ’ current Good Manufacturing Practices pursua nt to the FD&C Act ( 21 U.S.C. Sect . 301 et seq . ), and pursuant to relevant regulations found in Title 21 of the U.S. Code of Federal Regulations ( including Parts 11, 210, 211, 600 and 611 ), and the European Union ’s cu rrent Good Manufacturing Practices pursuant to the European Commission in Directive 91/356 / EEC, as ame nded by 2003/94 / EC, the International Conference on Harmonization Guidances for Industry Q7 ( Good Ma nu facturing Practice ) and Q10 ( Quality Systems ), and any comparable Laws of Canada and any other cou ntry designated by the parties by mutual agreement as applicable in a Firm Order, as each may be amend ed from time to time . As of the Effective Date, cGM P inc ludes compliance with European Union, ICH Q7, ICH Q 10, Canadian and United States Laws and regulatory guidance and regulatory and statutory re quirements, directives and guides relating to good manufacturing, formulating, assembling, packaging, storing, han dling, testing and quality control, laboratory, warehousing and distribution practices, adherence t o any applicable product license requirements, and adherence to relevant current U.S., Canadian and E. U. guidance documents