definiens: means, with respect to any Licensed Product in the United States, any product that is eligible for submission and approved for marketing by the FDA as a therapeutic biologic productunder Section 351(k ) of the Public Health Service Act ( and not eligible for submission for marketing approval to theFDA under Section 505(b)(2 ) or Section 505(j ) of the Federal Food, Drug and Cosmetic Act ), including an expressionconstruct used in the manufacture of the therapeutic biologic product, where such product is highly similar to thereference product notwithstanding minor differences in clinically inactive components and for which there are noclinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product . With respect to Licensed Product in any country in the Territory other than theUnited States, a means any biologic product that is eligible for submission for approvalunder a law of a foreign jurisdiction, which is either similar to or a counterpart of the Public Health Service Act ( andnot eligible for submission for approval under a law of a foreign jurisdiction, which is either similar to or a counterpartof the Federal Food, Drug and Cosmetic Act ), including an expression construct used in the manufacture of thetherapeutic biologic product, requiring the biologic product to be similar to the reference medicine and not having anymeaningful differences from the reference medicine in terms of quality, safety or efficacy