definiens: shall mean, with respect to a Licensed Product or a PTC Product, as the case may be, that the Licensed Product or PTC Product has been granted marketing exclusivity afforded approved drug products pursuant to ( a ) Sections 505 ( c ), 505(1 ), and 505A 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 States, or ( b ) the orphan drug exclusivity afforded 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 States, and/or ( c ) the Licensed Product or PTC Product is covered by a Law which precludes the Regulatory Authority in a country from granting Regulatory Approval for another product that contains the same active ingredient as that which is contained in the applicable Licensed Product or PTC Product