definiens: means the right or protection, granted by a RegulatoryAuthority in a jurisdiction, providing with respect to a drug product in such jurisdiction : ( i ) marketing exclusivity thatprevents the Regulatory Authority from accepting or approving an application for Marketing Authorisation such as a anNDA(whether new or abbreviated ), a Biologics License Application or an application relating to a biosimilar productsubmitted by a party other than the Parties ( or their Affiliates, or licensees or sublicensees as applicable ), for apharmaceutical product ( 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 new molecular entityor biological product or orphan drug or paediatric exclusivity designation by the applicable Regulatory Authority, or anexclusive right to sell pursuant to the data exclusivity provisions such as those under EC Directives 2004/27 / EC and2001/83 / EC and Regulation 726/2004 / EC ; or ( ii ) data protection for regulatory data relating to the drug product againstunfair commercial use or public release consistent with, or no less stringent than, Article 39.3 of the TRIPSAgreement