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.

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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

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 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.
Each of the Company and its subsidiaries has fulfilled its obligations, if any, under the minimum funding standards of Section 302 of the United States Employee Retirement Income Security Act of 1974 (“ERISA”) and the regulations and published interpretations thereunder with respect to each “plan” (as defined in Section 3(3) of ERISA and such regulations and published interpretations) in which employees of the Company and its subsidiaries are eligible to participate.
The following descriptions are hereby added to Exhibit “C-8” of the Service Agreement (the Item Number Descriptions): 3343 2Way-Connect Services — Set-Up Fee (All Applications Using the FDVS Platform) The charge per 2Way-Connect application (such as, but not limited to, the Fraud Application, the Collections Application or the Marketing Application, each being an “Application”) utilized by RCSI and serviced from the FDVS Platform.

More Definitions of Marketing Application

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

Marketing Application means, with respect to a Licensed Product, (i) in the United States, a New Drug Application filed with the FDA pursuant to 21 U.S.C. Section 357 and 21 C.F.R. Section 314 (or any successor application thereto for Regulatory Approval) (an “NDA”), and (ii) in any country other than the United States, an application or set of applications for Regulatory Approval comparable to an NDA and necessary to make, promote and sell Licensed Product commercially in such country.

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 application for a new drug submitted under section 505(b) of the Act, a request to provide for certification of an antibiotic submitted under section 507 of the Act, or a product license application for a biological product submitted under the Public Health Service Act. 23 EXHIBIT 3.5 INVESTMENT REPRESENTATION LETTER This Investment Representation Letter is delivered in connection with the License Agreement dated May 22, 1996 (the "License Agreement") between Southern Research Institute ("SRI"), University of Alabama at Birmingham Research Foundation and Corixa Corporation ("Corixa"), which, among other things, provides for the sale and issuance to SRI of Fifty Thousand (50,000) shares of Corixa's common stock (the "Shares"). The undersigned, in connection with the purchase of the Shares, hereby represents and warrants to Corixa as follows:

Marketing Application means any application for Regulatory Approval in the Territory or equivalent filings with any Governmental Authority in the Territory, including any updates or supporting Regulatory Filings made with respect thereto.