definiens: means, in a country, the first arm's - length comme rcial sale by Novo Nordisk, its Affiliate or a Sublicensee of a Licensed Product to a Third Party following receipt of marketing appro val to sell such Licensed Product in such country . The followin g shall not constitute a First Commercial Sale : ( i ) any transfer and/or sale for clinical studies, compassi onate use, named patient programs, sales under a tr eatment IND, any non - registrational studies, or any similar instance where the Licensed Product is sold at cos t or supplied without charge such as clinical supplies, free samples ( promotional or otherwise ) or as donat ions ( for example to non - profit institutions or governmental authorities for a non - commercial purpose ) ; or ( ii ) any sale from Novo Nordisk to its Affiliates or Sublicensee, provided that such sale would be deemed a First Co mmercial Sale if the Licensed Product is resold in the marke t for end - user use