definiens: means, with r espect to a Licensed Product, any data or market exclusivity periods, including ( a ) the marketing or data exclusivity afforded approved drug products pursuan t to ( i ) Sections 505(c ), 505(j ), and 505A of the FD&C Act, and the regulatio ns promulgated thereunder, as amended from time to time, or its equivalent in a c ountry other than the United States, or ( ii ) the orphan drug exclusivity afforde d approved drugs designated for rare diseases or conditions under Sections 526 and 527 of the FD&C Act, and the regulations promulgated thereunder, as amended from time to time, or its equivalent in a country other than the United State s, and/or ( iii ) any other period of data or market exclusivity listed in FDA ' s Orange Book or a foreign equivalent for a Licensed Product, and/or ( b ) the c overage of such Licensed Product by a Law which precludes the Regulatory Aut hority in a country from granting Regulatory Approval or accepting an applic ation for Regulatory Approval for another product because the application for the other product ( i ) references a Licensed Product, ( ii ) seeks approval of a produc t containing the same Active Ingredient as that which is contained in the applic able Licensed Product and/or ( iii ) seeks approval of a product for a use for whi ch the applicable Licensed Product is approved