definiens: means a marketing or data exclusivity right conferred as a result of ( a ) designation as a drug for rare diseases or conditions under Sections 525 et seq . of the FDC Act, ( b ) an exclusive ri ght to sell under an NDA pursuant to Section 505U ) ( 5)(F)(i i ), ( iii ) and ( iv ) or 505 ( c)(3)(E)(i i ), ( i ii ) and ( i v ) of the FDC Act or any relevant subseq uent legisl ation, rules or regulation s, ( c ) the exclusive right granted by the FDA upon completion of pediatric studies requested by the FDA under Section 505A(a ) of the FDC Act, ( d ) Article I0 of EU Directive 2001183 / EC and/or Article 3(3 ) of EU Regulation 726/2004 / EC or ( e ) EU Regulations 141/2000 / EC and/or 847/2000/ E, as app licable, or any eq u iva lent or similar rights in the Territory or Jurisdiction, su ccessor legislations of any of the foregoing or subsequent legislati on that has the effect of extending marketing or data exclusivit y right to a pharmaceutical product