definiens: shall mean : ( a ) all relevant federal, state and l ocal laws, statutes, rules, codes of practice, regulations, and ordinances in the United States, Europe and any other countries, as mutuall y agreed upon in advance by the Parties, as well as industry standards and regulatory guidelines applicable to the manufacture and supply of API, including, [ * * * ] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED . ALL SUCH OMITTED MATE RIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED the United States Federal Food, Drug, and Cosmetic Act ; ( b ) cGMPs ; and ( c ) all applicable regulations and guidelines of any Regulatory Authority ; in each cas e, together, with any and all amendments thereto