definiens: means the premarket notifications or premarket ap provals issued by the FDA, European Union Conformity Marking ( CE marks ) i ssued by a European Union Notified Body, and all ot her technical, medical, scientific, Labeling and simila r licenses, registrations, authorizations, permits, certifications, franchises, variances, exemptions, orders, approval s, amendments and renewals of the Products ( includi ng marketing authorizations and Labeling approvals ) is sued by the Regulatory Authorities of any country a nd held or pending ( including any applications ) as of the Clos ing Date by Sellers or any of their Controlled Affi liates or third - party distributors ( under rights of reservation of such Seller ) that are required for the manufacture, commercialization, Labeling, distribution, use, sto rage, import, export, transport, marketing or sale of the Products within any country