definiens: shall mean : 1 ) distribution through programs providing Licensed Product togovernment agencies or not - for - profit organizations established for charitable, humanitarian, or educational purposes such as organizations classified bythe Internal Revenue Service under 501(c)(3 ) or ( 4),or any national or international equivalent thereof ; and 2 ) distribution through programs providingLicensed Products to individual physicians, pharmacies or patients in countries that are listed, at the time of first sale of any Licensed Product by theWorld Bank, as a low or low middle income country which are listed in attached APPENDIX I. If the actual Net Selling Price of products distributed for aHumanitarian Purpose or under an IND exceeds the Absorbed Costs, the distribution shall be deemed to be a Sale . For these purposes, shall mean the amounts allocated by COMPANY for distribution of a Licensed Product calculated in accordance with reasonable cost accountingmethods consistent with the way COMPANY allocates such costs to other products and which shall be calculated from : ( i ) direct labor used in support ofmanufacturing operations ; ( ii ) materials ; ( iii ) overhead costs including facility and administrative expenses ; and ( iv ) reasonable third party costs