definiens: means, on a country - by - country basis, the first i nvoiced sale of a Licensed Product by a [COMPANY] Party to a Third Party after gra nt of a Marketing Authorization in the applicable country or jurisdiction, provided that where such a first invoiced sale has occurred in a country for which Pricing Approval is necessary for widespread sale, then such sale shall not be deemed a First Commercial Sale until such Pricing Approval has bee n obtained . For clarity, a First Commercial Sale shall not be deemed to have occurred when supplying Licensed Product as samples, to patients for compassionate use or named patient use, for Clinica l Trials or pursuant to IIR Agreements, for charitable, promotional, pre - clinical, clinical, ma nufacturing, testing or qualification, regulatory o r governmental purposes, or for other similar purpose s ( in each of the foregoing cases prior to Pricing Approval ) . In the event that, in a given country wi th respect to a Licensed Product, ( a ) [COMPANY] has received all approvals, licenses, registrations or authorizations, other than Pricing Approvals, which are necessary to constitute Regulatory Approval for suc h Licensed Product in such country, and ( b ) despite the lack of Pricing Approval, has initiated a comme rcial launch of such Licensed Product in such country, the first sale of such Licensed Product in such country shall be deemed to be the of such Licensed Product