definiens: means, with respect to each Licensed Product in anycountry in the Territory, any period of data, market or other regulatory exclusivity ( other than Patent exclusivity)granted or afforded by Applicable Law or by a Regulatory Authority in such country that confers exclusive marketingrights with respect to such Licensed Product in such country or prevents another party from using or otherwise relyingon any data supporting the approval of the NDA or supporting the MAA for such Licensed Product without the priorwritten consent of the NDA - holder or MAA - holder, as applicable, such as new chemical entity exclusivity, new use orindication exclusivity, new formulation exclusivity, orphan drug exclusivity, non - patent related paediatric exclusivity orany other applicable marketing or data exclusivity, including any such periods listed in the FDA ’s Orange Book or anysuch periods under national implementations in the EU of Article 10 of Directive 2001/83 / ED, Article 14(11 ) ofParliament and Council Regulation ( EC ) No . 726/2004, Parliament and Council Regulation ( ED ) No . 141/2000 onorphan medicines, Parliament and Council Regulation ( ED ) No . 1901/2006 on medicinal products for paediatric useand all international equivalents of any of the foregoing