definiens: means collectively all laws, regulations, ordinances, decrees, judicial and administrative orders, policies and other requirements of an y applicable Regulatory Authority that cover or apply to the manufacture, supply, or distribution of API for use in human pharmaceuticals, including the FD&C Act and the regulations administered by the FDA ( including 21 C.F.R. Parts 11, 210 and 211 ), any e quivalent laws, rules, and regulations in the Territory, and the following to the extent not in conflict with any laws or regulations that are issued or enforced by the FDA, MHLW, and other Regulatory Authorities as in effect during the provision of and ap plicable to API Manufacturing and other services provided by FFFC hereunder : ( a ) USP / NF / EP and other applicable compendia standards ; ( b ) guidance documents ( including Guidelines, Points to Consider, Inspection Technical Guides, International Conference on Harmonization documents ) ; and ( c ) cGMP