definiens: means with respect to any country in the Partner Territory, a period of exclusivity ( other than Patentexclusivity ), granted by Applicable Laws or by a Regulatory Authority in respect of such country, which either confers exclusive marketing rights withrespect to a product or prevents another party from using or otherwise relying on the data supporting the approval of the Regulatory Approval for aproduct without the prior written authorization of the Regulatory Approval - holder, as applicable, such as new chemical entity exclusivity, new use orindication exclusivity, new formulation exclusivity, orphan drug exclusivity, non - patent - related pediatric exclusivity, or any other applicable marketing ordata exclusivity, including any such periods under national implementations in the EU of Article 8 of Directive 2001/83 / EC, Article 14(11 ) of Parliamentand Council Regulation ( EC ) No 726/2004, Parliament and Council Regulation ( EC ) No 141/2000 on orphan medicines, Parliament and CouncilRegulation ( EC ) No 1901/2006 on medicinal products for pediatric use and all international equivalents