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

Examples of Marketing Authorizations in a sentence

• Re-registrations / changes Updated Authorizations for the use of 86 medicinal products.Documentation for the renewal of the Marketing Authorizations for 76 medicinal products submitted to agencies.1107 changes have been made for medicinal products to agencies.

• For the avoidance of doubt, Novartis does not warrant and shall not be responsible and shall have no liability in this regard for the successful maintenance or renewal of the Marketing Authorizations after the Closing Date and/or whether or not a variation is successful, except if the Regulatory Authority cancels a Marketing Authorization or refuses its renewal as a result of Novartis’ gross negligence or wilful misconduct.

• Marketing Authorizations and When Authorizations are NOT Necessary.

• MorphoSys (and its Affiliates and Sublicensees) shall have the right to file in its own name, and to own, all new INDs, Marketing Authorization Applications and Marketing Authorizations for Licensed Products in the MorphoSys Territory for the Field and may delegate and/or assign these rights to Affiliates and Sublicensees.

• After the Product receives Marketing Authorization in a country in the Territory, Celltech shall be solely responsible for all final release testing in such country(ies) and for ensuring in such country(ies) that the Product labeling and packaging complies with the Marketing Authorizations and all other applicable laws of each such country in the Territory.

More Definitions of Marketing Authorizations

Marketing Authorizations means the United States new drug application or abbreviated new drug application, as applicable, for the Product(s).

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 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 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 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 regulatory authorizations, excluding pricing, reimbursement, formulary and similar approvals, required to sell the Product in the Territory on a country basis.