definiens: means a marketing or data exclusivity right conferred as a result of ( a ) designation as a drugfor rare diseases or conditions under Sections 525 et seq . of the FDC Act, ( b ) an exclusive right to sell under an NDA pursuantto Section 505(j)(5)(F)(ii ), ( iii ) and ( iv ) or 505(c)(3)(E)(ii ), ( iii ) and ( iv ) of the FDC Act or any relevant subsequent legislation, rules or regulations, ( c ) the exclusive right granted by the FDA upon completion of pediatric studies requested by the FDAunder Section 505A of the FDC Act, ( d ) Article 10 of EU Directive 2001/83 / EC and/or Article 3(3 ) of EU Regulation726/2004 / EC or ( e ) EU Regulations 141/2000 / EC and/or 847/2000 / EC, as applicable, or any equivalent or similar rights inthe Territory, successor legislations of any of the foregoing or subsequent legislation that has the effect of extendingmarketing or data exclusivity right to a pharmaceutical product