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 that preventsthe Regulatory Authority from accepting or approving a Drug Application ( whether new or abbreviated ), submitted by aparty other than [COMPANY] ( or any of its Affiliates or Third Party sublicensees ), for a generic or competing version of apharmaceutical product comprising a compound that is a Bioequivalent to the Active Substance in the LicensedProduct, such as through new molecular entity or orphan drug exclusivity granted by the FDA, or an exclusive right tosell pursuant to the data exclusivity provisions under EC Directives 2004/27 / EC and 2001/83 / EC and Regulation726/2004 / EC, or marketing exclusivity granted in respect of pediatric studies under Regulation 1901/2006, orSection 505A(a ) of the FDC Act ; or ( b ) data protection for regulatory data submitted by [COMPANY] relating to theLicensed Product against unfair commercial use or public release consistent with, or no less stringent than, TRIPsArticle 39.3