definiens: shall mean, on a country - by - country and DISCOVERED PRODUCT - by - DISCOVERED PRODUCT basis, a therapeutic product that ( i ) in the instance of a small molecule chemical drug, hasthe same composition of matter as and is bioequivalent to an approved DISCOVERED PRODUCT, or ( ii ) in theinstance of a biological drug, is a biosimilar of and interchangeable with an approved DISCOVERED PRODUCT, andin each instance is intended for the same indication as an approved DISCOVERED PRODUCT, and which has beenapproved for marketing and/or sale under an Abbreviated New Drug Application ( or equivalent, including withoutlimitation for biosimilar biological products ) as a generic or follow - on biologic product by the regulatory authorities, andwhich could not have been sold or with respect to which a license would have been required to be obtained fromCOMPANY, if patent or other exclusivity rights ( for example, data exclusivity ) covering the approved DISCOVEREDPRODUCT would have been in full force and effect