definiens: means, on a Licensed Product - by - Licensed Product and country - by - country basis, the first sale for monetary value of such Licensed Product by [COMPANY], its Affiliates or its sublicensees to an end user for use, consumption or resale of such Licensed Product in such country fo llowing receipt of Regulatory Approval of such Licensed Pro duct in such country . Sale of a Licensed Product un der this Agreement by [COMPANY] to an Affiliate of [COMPANY] o r a sublicensee of [COMPANY] shall not constitute a First Commercial Sale unless such Affiliate or such subli censee is the end user of such Licensed Product . Fo r the avoidance of doubt, the sale of Licensed Product fo r clinical study purposes, early access programs ( s uch as to provide patients with a Licensed Product prior to R egulatory Approval pursuant to treatment INDs or pr otocols, named patient programs or compassionate use program s ) or any similar uses shall not constitute a First Commercial Sale