definiens: means the right or protection, granted by a Regulatory Authority in a jurisdiction, providing with respect to a drug product : ( i ) marketing exclusivity that prevents the Regulatory Authority fromaccepting or approving an application for Regulatory Approval such as a New Drug Application ( whether new orabbreviated ), a BLA or an application relating to a biosimilar product submitted by a party, for a pharmaceuticalproduct ( including a generic, biosimilar, similar medicinal product or generic or competing version of apharmaceutical product ) that is the same or a bioequivalent of the drug product, such as through newmolecular entity or biological product or orphan drug or pediatric exclusivity designation by the applicableRegulatory Authority, or an exclusive right to sell pursuant to the data exclusivity provisions such as thoseunder EC Directives 2004/27 / EC and 2001/83 / EC and Regulation 726/2004 / EC ; or ( ii ) data protection forregulatory data relating to the drug product against unfair commercial use or public release consistent with, orno less stringent than, Article 39.3 of the TRIPS Agreement