definiens: means the premarket notifications or premarket ap provals issued by the FDA, European Union Conformity Marking ( CE m arks ) issued by a European Union Notified Body, and all other technical, medical, scientific, Labeling and similar licenses, registrations, authorizations, permits, certifications, franchises, variances, exemptions, orders, approvals, amendments and renewals of the P roducts ( including marketing authorizations and Labeling ap provals ) issued by the Regulatory Authorities of an y country and held or pending ( including any applications ) as of the Closing Date by Sellers or any of their Con trolled Affiliates or third party distributors ( under right s of reservation of such Seller ) that are required for the manufacture, commercialization, Labeling, distribut ion, use, storage, import, export, transport, marke ting or sale of the Products within any country