definiens: means, with respect to the Product and a country in the Partner Territory, the ﬁrst sale, transfer or dispositionfor value by or on behalf of Partner or any of its Affiliates to a Third Party in such country after Regulatory Approval for such Product has been obtained insuch country, or, as applicable and permitted in such country before such Regulatory Approval has been obtained, pursuant [ * * * ] . A First CommercialSale excludes any transfer or other distribution of the Product as promotional sample to physicians or hospitals in amounts consistent with industrypractice and consistent with prevailing industry standards, or of a Product transferred or disposed at no charge for research, preclinical, clinical, orregulatory purposes or in connection with patient assistance, compassionate use, use, indigent programs or other charitable purposes ( ineach case except to the extent reimbursed by a third - party payor ) or of a Product for investigator - initiated trials or on a named patient basis