definiens: shall mean any laws, rules, regulations, guidelin es, or other requirements of any Governmental Authority that may be in effect from time to time a nd that are applicable to a Party and its activitie s performed pursuant to this Agreement in the country where suc h activity is performed, including but not limited to, laws, rules, regulations, guidelines or other requirement s relating to anti - bribery or anticorruption, and : ( i)the Foreign Corrupt Practices Act of 1977, the U K Bribery Act, and the 1997 OECD Convention on Comb ating Bribery of Foreign Public Officials in International Business Transactions ; ( ii)the International Conference on Harmonisation ( ) Guidelines, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients ; and/or ( iii)current good manufacturing practices ( ) as described in the PIC / S GMP guides ; Parts 210 and 211 of Title 21 of the United States Code of Federal Regulations and a ll applicable rules, regulations, orders and guidan ce published thereunder ; European Commission Directives 91/356 / E EC, as amended by Directive 2003/94 / EC, and 91/412 / EEC, and the current Good Manufacturing Prac tices guidance published by the European Commission in the (, IV Volume and the relevant annexes ), as specifie d by the competent authorities ; and any other applicable local regulation ; together with the othe r latest United States Food and Drug Administration ( ) and European Medicines Agency ( ), the corresponding legal framework as applicable in Japan, Australia, Switzerland and Singapore and ICH guidance document s pertaining to manufacturing and quality control p ractice, all as [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH ( I ) N OT MATERIAL AND ( II ) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED