definiens: means an exclusive right, other than through the issuance or grant of a Patent, lawfullygranted or conferred by a Governmental Authority or Regulatory Authority or Applicable Law, to market or sell a Product inthat country, including any exclusive right that effectively prevents approval, sale, or marketing of any Competing Productscontaining the same Compound(s ) as such Product or other generic equivalents of such Product in that country for therelevant time period, and which may, for example, provide : ( i ) marketing exclusivity that prevents a Regulatory Authorityfrom accepting an application for Regulatory Approval submitted by a party other than BDSI, an Affiliate thereof, or aSublicensee, for a generic, biosimilar, or bioequivalent version of a pharmaceutical product, including but not limited toexclusivity achieved through new molecular entity, orphan drug, or pediatric drug exclusivity designation by any RegulatoryAuthority or Governmental Authority ; or ( ii ) data protection for regulatory data submitted by BDSI, an Affiliate thereof, or aSublicensee concerning the Product, including but not limited to protection against unfair commercial use or public releaseconsistent with, or no less stringent than, TRIPS Article 39.3