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 means marketing authorizations issued, or applications for marketing authorizations, with respect to any products and all supplements, amendments and revisions thereto.

Examples of Marketing Authorizations in a sentence

• Licensee shall have the responsibility to prepare and file all requested documentation to obtain and maintain approval from the Regulatory Authorities (including Marketing Authorizations) necessary for the Development and Commercialization of the Licensed Products in the Field and the Territory, and otherwise interact with the relevant authorities as appropriate with respect to the Licensed Products.

• Should the Company decide, in its sole discretion, to apply for and obtain a Marketing Authorization in a country or region, then the Company will be responsible for filing and maintaining the Marketing Authorization(s) for the Product and shall bear all related costs.

• The Distributor shall provide all documents to the Company required for the Distributor to apply for and obtain such Marketing Authorization(s).

• The Company shall inform the Distributor on a continuous basis about the status of Marketing Authorizations for the Product in the US, Canada, and Europe (through the EMA).

• CMS shall keep the original copies of the Marketing Authorizations of the Products in the Territory whilst DKSH shall keep the counterpart of the original copies of the Marketing Authorizations in the Territory for the purpose of importation and customs clearance procedures and other occasions as required by competent authorities.

More Definitions of Marketing Authorizations

Marketing Authorizations means the approval of each NDA issued by the FDA or relevant Health Authority.

Marketing Authorizations or “MAs” means the marketing authorizations (drug identification number) listed in Annex 3 for the Products in the Territory.

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 without limitation an NDA and BLA.

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 Mxxx, which such mxxx 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.

Marketing Authorizations mean the authorizations issued by the AGENCY which are necessary for the marketing, use, distribution and sale of the PRODUCT and AG PRODUCT in the TERRITORY.

Marketing Authorizations means the marketing authorizations or any equivalent regulatory approvals listed in Annex 3 for the Product in the Territory.