definiens: means, with respect to the applicable Licensed Product having RegulatoryApproval in a given country, that either or both of the following protections pertaining to the Active Substance of theLicensed Product is / are in force in such country : ( a ) at least one Valid Claim of the [COMPANY] Product Patent Rights orDevelopment Program Patent Rights in such country Covers either ( i ) the Active Substance contained in the LicensedProduct as a composition of matter, or ( ii ) a method of using the Active Substance or the Licensed Productcorresponding to its First Indication approved by the Regulatory Authority in such country ; and/or ( b ) RegulatoryExclusivity Rights protect the Active Substance of the Licensed Product ( e.g., as a new chemical entity, dataexclusivity, pediatric exclusivity, or the like ) or its First Indication ( e.g., if an orphan drug Indication ) approved for theLicensed Product by the Regulatory Authority in such country