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 an [COMPANY] Single APIcomponent of the Licensed Product or the Licensed Product itself is / are in force in such country : ( a ) at least one ValidClaim of the [COMPANY] Background Patent Rights or Development Program Patent Rights in such country Covers either(i ) any [COMPANY] Single API contained in the Licensed Product, or the combination of Single Agents in the LicensedProduct, as a composition of matter, or ( ii ) a method of using an [COMPANY] Single API or the Licensed Productcorresponding to any indication for the Licensed Product approved by the Regulatory Authority in such country ; and / or(b ) Regulatory Exclusivity Rights protect the Licensed Product, an [COMPANY] Single API of the Licensed Product ( e.g.,as a new chemical entity, data exclusivity, pediatric exclusivity, or the like ), or any indication ( e.g., if an orphan drugindication ) approved for the Licensed Product by the Regulatory Authority in such country