definiens: means, on a country -by - country basis ( a ) the first commercial sale of a Licensed Treatment by [COMPANY], its Sublicensees or their respective Affiliates to a person or entity who is not [COMPANY], its Sublicensees or their res pective Affiliates in such country after grant of Regulatory Approval in the applicable country or jurisdiction, provided that where such a first commercial sale has occurred in a country for which pricing approval is necessary for widespread sale, then su ch sale shall not be deemed a First Commercial Sale until such pricing approval has been obtained ; or ( b ) any compassionate use or named patient basis sale in such country, following the date upon which cumulative Net Sales ( across all countries in the Ter ritory ) received from any compassionate use or named patient program by [COMPANY], its Affiliate or Sublicensees equals [ * * * ] Dollars ( $ [ * * * ] ), provided the Licensed Treatment Administration Sales and Licensed Treatment Monitoring Sales with respect to the Lic ensed GT Products administered pursuant to such programs is greater than the fully loaded costs of such Licensed GT Products