definiens: means exclusive marketing rights or data exclusiv ity rights conferred by a Governmental Authority with r espect to a Licensed Product preventing a product o ther than such Licensed Product from receiving BLA approval b y relying on any data obtained or submitted for suc h Licensed Product, which exclusive marketing rights or data exclusivity rights are granted upon approva l of a Licensed Product in the country in question in the US pursuant to 42 U.S.C. § § 262(k ) ( 7 ) and 262(m)(2)(A ) and in the EMA pursuant to European Directive 2001/83 / E C on the Community Code for medicinal products ( Article 10 ) ( for example, as of the Effective Date, the longest period of Regulatory Exclusivity in t he US is twelve ( 12 ) years ( with an additional six ( 6 ) month s if there is pediatric exclusivity ), eight ( 8) yea rs in Japan, and between eight ( 8) and eleven ( 11 ) years in the EU ) and analogous provisions in countries other than th e US or in EU