definiens: shall mean, on a Product -by- Product and country -by - country basis, the first sale of a Product by or on behalf of [COMPANY] or its Affiliates or Sublicensees, such as but not limited to, a Third Party wholesaler, pharmacy, outpatient clinic, inpatient clinic, ho spital, dispensing physician or government agency in a given country after necessary Regulatory Approval has been granted with respect to such Product in such country, provided, however, that in the event of a sale of a Product prior to Regulatory Approval which is substantially comparable to a commercial sale effected only after Regulatory Approval is obtained, then the first sale in any such arrangement shall also constitute a First Commercial Sale . For the avoidance of doubt,, and shall not be construed as a First Commercial Sale if the aggregate, annual Net Sales for all such programs are less than [ * * * * * ] . For avoidance of doubt, any sale of a Product by [COMPANY] to an Affiliate or Sublice nsee or subcontractor is not a First Commercial Sale