definiens: . Marketing Exclusivity means, with respect to a Royalty - Bearing Product, that suchRoyalty - Bearing Product has been granted marketing exclusivity afforded approved drug products pursuant to ( a ) Sections505(c ), 505(j ), and 505A of the Act, and the regulations promulgated thereunder, as amended from time to time, or itsequivalent in a country other than the United States, or ( b ) the orphan drug exclusivity afforded approved drugs designatedfor rare diseases or conditions under Sections 526 and 527 of the Act, and the regulations promulgated thereunder, asamended from time to time, or its equivalent in a country other than the United States, or ( c ) applicable Law covering theRoyalty - Bearing Product which precludes the Regulatory Authority in a country from granting Regulatory Approval foranother product that contains the same active ingredient as that which is contained in the applicable Royalty - Bearing Product