definiens: means, with respect to any Licensed Product in th e United States, any product that is eligible for submission and approved for marketing by the FDA as a therape utic biologic product under Section 351(k ) of the Public Health S ervice Act ( and not eligible for submission for mar keting approval to the FDA under Section 505(b)(2 ) or Sect ion 505(j ) of the Federal Food, Drug and Cosmetic A ct ), including an expression construct used in the manuf acture of the therapeutic biologic product, where s uch product is highly similar to the reference product notwiths tanding minor differences in clinically inactive co mponents and for which there are no clinically meaningful differ ences between the biological product and the refere nce product in terms of the safety, purity, and potency of the product . With respect to Licensed Product in any co untry in the Territory other than the United States, a means any biologic product t hat is eligible for submission for approval under a law of a foreig n jurisdiction, which is either similar to or a cou nterpart of the Public Health Service Act ( and not eligible for sub mission for approval under a law of a foreign juris diction, which is either similar to or a counterpart of the Federa l Food, Drug and Cosmetic Act ), including an expres sion construct used in the manufacture of the therapeutic biologic product, requiring the biologic product to be simi lar to the reference medicine and not having any meaningful di fferences from the reference medicine in terms of q uality, safety or efficacy