Marketing Authorizations definition
Marketing Authorizations means any approved application for Product marketing authorization, including, without limitation, FDA New Drug Application, FDA Biologics License Application, and other similar marketing authorizations promulgated by international regulatory authorities.
Marketing Authorizations means the United States new drug application or abbreviated new drug application, as applicable, for the Product(s).
Marketing Authorizations or “MAs” means the marketing authorizations (drug identification number) listed in Annex 3 for the Products in the Territory.
More Definitions of Marketing Authorizations
Marketing Authorizations means the approval of each NDA issued by the FDA or relevant Health Authority.
Marketing Authorizations means marketing authorizations issued, or applications for marketing authorizations, with respect to any products and all supplements, amendments and revisions thereto.
Marketing Authorizations means all approvals necessary from the relevant Regulatory Authority to permit a Party or its sublicense(s) to market and sell a Licensed Product in a particular country, including an NDA and BLA.
Marketing Authorizations means any approved application for marketing authorization, including without limitation, FDA New Drug Application, FDA Abbreviated New Drug Application, and other similar marketing authorizations promulgated by Regulatory Authorities.
Marketing Authorizations means any regulatory approvals or authorizations required by the FDA, Competent Authority or other regulatory bodies to comply with the laws and regulations of any country or other jurisdiction for sale, marketing and distribution of the Licensed Products.
Marketing Authorizations means all authorizations, licenses, approvals, and registrations to import, market and distribute the Products in the Territory pursuant to the terms of this Agreement, as may be required by an appropriate governmental agency, except any CE M▇▇▇, which such m▇▇▇ shall be obtained and maintained by Micrus.
Marketing Authorizations means all approvals necessary from the relevant Regulatory Authority to permit a Party or its sublicense(s) to market and sell a Compound or Product in a particular country, including approval of an NDA or BLA.