definiens: shall mean, on a Product - by- Product and country - by - country basis, the ﬁrst sale of a Product by or on behalf of GSKor its Aﬃliates or Sublicensees, such as but not limited to, sales to a Third Party wholesaler, pharmacy, outpatient clinic, inpatient clinic, hospital, dispensing physician or government agency in a given country after necessary Regulatory Approval has been granted with respect to suchProduct in such country, provided, however, that in the event of a sale of a Product prior to Regulatory Approval which is substantiallycomparable to a commercial sale eﬀected only after Regulatory Approval is obtained, then the ﬁrst sale in any such arrangement shall alsoconstitute 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 EUR [ * * * * * ] . Foravoidance of doubt, any sale of a Product by [COMPANY] to an Affiliate or Sublicensee or subcontractor is not a First Commercial Sale