definiens: means, in any country, all app rovals, licenses, registrations or authorizations, ( including, in Europe and Canada only, governmental pricing approvals and governmental formulary acceptance based on pricing approval ( but excluding formulary acceptance of private parties ) ), of any federal regulatory agency, department, bureau or ot her governmental entity, necessary for the sale of the Product . Marketing Approval in a country shall be deemed to occur upon first receipt of notice from the FDA, EMEA or similar agency in such countr y that sale of a Product in such country has been approved, including governmental pricing appro val and governmental formulary acceptance based on pricing approval in Europe and Canada . Mar keting Approval in Europe shall include the approval of any Central Marketing Authorization tha t is filed through the centralized procedure for the EU and approved by the European Commission . If a Central Marketing Authorization is filed through the centralized procedure for the EU and ap proved by the European Commission, Marketing Approval for the EU shall be deemed to have occurre d when pricing approval is received in at least one country in the EU . In the countries of Europe a nd in Canada, shall not be deemed to occur until pricing or formulary approval is obtained . Marketing Approval shall be deemed to have occurred in such country where gover nment approval of pricing has not been obtained if, at any time, Jazz Pharmaceuticals, its Affiliates or sublicensees makes the First Commercial Sale of Product in the country without o btai ning pricing approval, with the date of MAA approval deemed to have occurred on the date of the First Commercial Sale of the Product in the country