definiens: means a right or protection, granted by a Regulatory Authority in ajurisdiction, providing with respect to a Licensed Product in such jurisdiction : ( a ) marketing exclusivity or dataexclusivity that prevents the Regulatory Authority from accepting or approving a Drug Application ( whether new orabbreviated ), submitted by a Person other than [COMPANY] ( or any of its Affiliates or Third Party sublicensees ), for ageneric or Page 22 of 87competing version of a pharmaceutical product comprising a compound that is a Bioequivalent to any [COMPANY] SingleAPI in the Licensed Product, such as through new molecular entity or orphan drug exclusivity granted by the FDA, oran exclusive right to sell pursuant to the data exclusivity provisions under EC Directives 2004/27 / EC and 2001/83 / ECand Regulation 726/2004 / EC, or marketing exclusivity granted in respect of pediatric studies under Regulation1901/2006, or Section 505A(a ) of the FDC Act ; or ( b ) data protection for regulatory data submitted by or on behalf of aParty or its Affiliates relating to the Licensed Product against unfair commercial use or public release consistent with, or no less stringent than, TRIPs Article 39.3