definiens: means, in a country, the first arm’s - length commercial sale by NovoNordisk, its Affiliate or a Sublicensee of a Licensed Product to a Third Party following receipt of marketingapproval to sell such Licensed Product in such country . The following shall not constitute a FirstCommercial Sale : ( i ) any transfer and/or sale for clinical studies, compassionate use, named patientprograms, sales under a treatment IND, any non - registrational studies, or any similar instance where theLicensed Product is sold at cost or supplied without charge such as clinical supplies, free samples(promotional or otherwise ) or as donations ( for example to non - profit institutions or governmental authoritiesfor a non - commercial purpose ) ; or ( ii ) any sale from Novo Nordisk to its Affiliates or Sublicensee, providedthat such sale would be deemed a First Commercial Sale if the Licensed Product is resold in the market forend - user use