definiens: shall meanany Patented Product for which orphan designation is approved by the United States FDA and shall mean a Patented Product which is not an Orphan Product . means any Product(i ) the selling of which would, in the absence of this Agreement, infringe a valid claim of an issued, unexpiredpatent within the Licensed Patent Rights in the country in which such Product is sold by [COMPANY] or its affiliate orsublicensee, ( ii ) with respect to which a market exclusivity period has been granted by a governmental body orregulatory authority and is in effect in the country in which such Product is sold by [COMPANY] or its affiliate orsublicensee, or ( iii ) with respect to which data exclusivity has been granted by a governmental body or regulatoryauthority and is in effect in the country in which such Product is sold by [COMPANY] or its affiliate or sublicensee