definiens: means : ( i ) a marketing or data exclusivity right conferred as a result of designation as a drug for rare diseases or conditions under Sections 525 et seq . of the FDC Act, an exclusive right to sell under an NDA pursuant to Section 505(j)(5 ) or 505(c)(3)(D)(ii ) and ( iii ) of the FDC Act or any relevant subsequent legislation, rules or regulations, or the exclusive right granted by the FDA upon completion of pediatric studies requested by the FDA under Section 50SA(a ) of the FDC Act or any successor legislation ; ( ii ) a marketing or data exclusivity right conferred as a result of Article 10 of EU Directive 2001/83 / EC andlor Article 3(3 ) ofEU Regulation 726/2004 / EC or EU Regulations 14112000 / EC and/or 847/20001E, as applicable ; or ( iii ) any equivalent or similar rights in any jurisdiction in the Territory, successor legislations of any of the foregoing or subsequent legislation that has the effect of extending marketing or data exclusivity right to a phannaceuticai product