definiens: means, with respect to either a member state of the European Union or a countryoutside the European Union, and in each case subject to the requirements of Applicable Law, thelater of ( i ) receipt by [COMPANY] of the Cinryze Marketing Approval ; ( ii ) the setting of pricing forthe [COMPANY] Product pursuant to Section 6.3 in such member state or non - European country;(iii ) confirmation by Sanquin that no Third Party is entitled to market Cetor or Cebitor or theViroPharma Product, or to prevent the sale and marketing of the [COMPANY] Product by ViroPharmaor Sanquin, as the case may be, in such member state or non - European country ; and ( iv ) ViroPharmaand Sanquin reasonably agreeing that the [COMPANY] Product is commercially available in suchcountry