definiens: means, with respect to the Company, standards for clinical trials for 53 pharmaceuticals ( including all applicable requireme nts relating to protection of human subjects ), as s et forth in the U.S. Federal Food, Drug and Cosmetic Act of 193 8, as amended ( the ) and applicable regulations promulgated thereunder ( including, for example, 21 C.F.R. Parts 50, 54, and 56 ), as amended from time to time, and such standards of good clinical practice ( inclu ding all applicable requirements relating to protec tion of human subjects ) as are required by Regulatory Autho rity in any other countries, including applicable r egulations or guidelines from the International Conference on Harmonisation of Technical Requirements for Registr ation of Pharmaceuticals for Human Use, in which the Company Products are sold or intended to be sold, to the e xtent such standards are not less stringent than in the U nited States