definiens: means, with respect to a product in a particular country or jurisdiction, all approvals ( including approvals resulting from any p riority review, breakthrough therapy, accelerated a pproval or fast track designation, application or submission ), licenses, registrations or authorizations necessar y for the Commercialization of such product in such country o r jurisdiction, including, ( a ) with respect to the United States, approval of an Approval Application for suc h product by the FDA and with respect to the Europe an Union, approval of an Approval Application for such product by the European Medicines Agency or the applicable Regulatory Authority in any particular c ountry in the EU, ( b ) where applicable, Price Appro val in such country or jurisdiction, ( c ) where applicable, pre- and post - approval marketing authorizations ( i ncluding any prerequisite Manufacturing approval or authoriz ation related thereto ), and ( d ) where applicable, l abeling approval