definiens: means, on a country - by - country basis ( a ) the first commercial sale of aLicensed Treatment by [COMPANY], its Sublicensees or their respective Affiliates to a person or entity who is not [COMPANY], itsSublicensees or their respective Affiliates in such country after grant of Regulatory Approval in the applicable countryor jurisdiction, provided that where such a first commercial sale has occurred in a country for which pricing approval isnecessary for widespread sale, then such sale shall not be deemed a First Commercial Sale until such pricingapproval has been obtained ; or ( b ) any compassionate use or named patient basis sale in such country, following thedate upon which cumulative Net Sales ( across all countries in the Territory ) received from any compassionate use ornamed patient program by [COMPANY], its Affiliate or Sublicensees equals [ … * * * … ], provided the Licensed TreatmentAdministration Sales and Licensed Treatment Monitoring Sales with respect to the Licensed GT Productsadministered pursuant to such programs is greater than the fully loaded costs of such Licensed GT Products