definiens: means, with respect to a Licensed Product in a co untry, any data exclusivity rights, market exclusivity rights, or o ther exclusive right, other than a Patent, granted, conferred or afforded by any Regulatory Authority in such countr y or otherwise under Applicable Law with respect to such Licensed Product in such country, which either conf ers exclusive marketing rights with respect to a pr oduct or prevents another party from using or otherwise rely ing on the data supporting the approval of the Mark eting Approval for a product without the prior written au thorization of the Marketing Approval holder, as ap plicable, such as new chemical entity exclusivity, exclusivit y associated with new Clinical Trials necessary to approval of a change ( e.g., new indication or use ), orphan drug exclusivity, non - patent - related pediatric exclusivity, or any other applicable marketing or data exclusivity, inc luding any such periods under national implementati ons in the EU of Article 10 of Directive 2001/83 / EC, Article 1 4(11 ) of Parliament and Council Regulation ( EC ) No 726/2004, Parliament and Council Regulation ( EC ) No 141/2000 on orphan medicines, Parliament and Counc il Regulation ( EC ) No 1901/2006 on medicinal products for pediatric use and all international equivalents