definiens: means, with respect to each Royalty Product in any country, a period of exclusivity ( other than Patent exclusivit y ) granted or afforded by Applicable Law or by a Re gulatory Authority in such country that confers exclusive ma rketing rights with respect to such Royalty Product in such country or prevents another party from using or oth erwise relying on any data supporting Regulatory Ap proval of such Royalty Product without the prior written c onsent of the holder of the Drug Approval Applicati on, such as new chemical entity exclusivity, new use or indi cation exclusivity, new formulation exclusivity, or phan drug exclusivity, non - patent related pediatric exclusivi ty, reference product exclusivity or any other appl icable marketing or data exclusivity, including any such p eriods listed in the FDA ’s Orange Book or Purple Bo ok, or any such periods under Article 14(11 ) of Parliament and Council Regulation ( EC ) No . 726/2004, Parliame nt and Council Regulation ( EC ) No . 141/2000 on orphan medi cines, Parliament and Council Regulation ( EC ) No