Marketing Application definition

Marketing Application means an application for marketing authorization which has not yet been approved by the FDA or other Regulatory Authority, including without limitation, FDA New Drug Application, FDA Abbreviated New Drug Application, and other similar marketing applications promulgated by Regulatory Authorities.

Marketing Application means an application, submitted to a Regulatory Authority in any jurisdiction, for Regulatory Approval required in order to Commercialize a product as a drug, including a BLA.

Marketing Application means the application or submission for marketing authorization of a Licensed Product filed with the United Sates Food and Administrations, or equivalent regulatory agency if filed in a country other than the United States.

Examples of Marketing Application in a sentence

• The Company plans to expand upon FlowWorks' proven marketing strategy to attract new customers by implementing innovative marketing automation technologies, which include the use of the Company’s Extend-to-Social Referral Marketing Application.

• All of Vetsource’s proprietary software, business processes and expertise provided with the Services, including but not limited to Vetsource Application, Vetsource website, Vetsource eCommerce Home Delivery Shopping Site and Catalog, Email Marketing Application, and any others specified in appendices.

• Genzyme warrants that the Aldurazyme sold pursuant to Article 4 hereof will be marketed and sold in all material respects in accordance with the conditions of any applicable Marketing Application Approvals, Regulatory Approvals, any applicable labeling claims and any applicable requirements of the Regulatory Scheme regarding the promotion, sale and marketing of Aldurazyme (except to the extent any of the foregoing is the responsibility of BioMarin as the holder of the BLA).

• Genzyme shall be responsible, in its sole discretion and at its sole expense, for filing Marketing Applications for Aldurazyme in each country, other than as expressly provided in Sections 3.10, 3.11, 3.12 and 5.1.2, in which Aldurazyme is licensed, marketed or sold, up to and including Marketing Application Approval, and for thereafter maintaining such Marketing Application Approvals.

• Nothing in this Article 5 shall be deemed to require Genzyme to file Marketing Applications and obtain Marketing Application Approvals in each country in the Territory; Genzyme shall determine in good faith where and when to file and maintain such applications and approvals in a manner consistent with its obligation to use its commercially reasonable and diligent efforts to commercialize Aldurazyme.

More Definitions of Marketing Application

Marketing Application means an application for:

Marketing Application means a New Drug Application (NDA), Worldwide Marketing Authorization (WMA), or Marketing Application Authorization (MAA) or similar application or submission for marketing authorization of a Product filed with a Regulatory Authority including without limitation the FDA.

Marketing Application means a marketing authorization application filed by or under authority of Genzyme with the requisite health regulatory authority of any country requesting approval for commercialization of Aldurazyme for a particular indication in such country, including as applicable, the MAA.

Marketing Application means a BLA, supplemental BLA, NDA, MAA or similar application for Regulatory Approval that is filed with the applicable Regulatory Authority(ies) in a particular country or jurisdiction.

Marketing Application means a New Drug Application (NDA), Worldwide Marketing Authorization (WMA), or Marketing Application

Marketing Application means an NDA (or its equivalent) submitted to the FDA in the United States, an MAA (or its equivalent) submitted to the EMEA in the European Union, or a corresponding application that has been submitted to a Regulatory Authority in any other jurisdiction.

Marketing Application means an ap- plication for approval of a new drug filed under section 505(b) of the act or an application for a biologics license submitted under section 351 of the Pub- lic Health Service Act (42 U.S.C. 262).