definiens: means, with respect to a particular country or jurisdiction, all approvals, licenses, registrations orauthorizations by any Regulatory Authority necessary to market a Company Product in such country or jurisdiction, butexcludes agencies or authorities regulating Environmental Laws . For clarity, for the purposes of Sections 9.1(a)(i)-(iii ), ( i ) thereceipt of a subpart H approval under 21 CFR 314.510 in the United States shall be deemed in theUnited States, ( ii ) the receipt of the conditional marketing authorization for medicinal products for human use falling withinthe scope of regulation ( EC ) No . 726/2004 in the European Union shall be deemed in the EuropeanUnion, ( iii ) receipt of approval of an NDA / MAA submitted to the FDA shall be deemed receipt of inthe United States, and ( iv ) receipt of centralized approval of an NDA / MAA submitted to the EMA shall be deemed receipt of in the European Union