Generic Application definition

Generic Application means an abbreviated new drug application, ANDA, 505(b)(2) application under the United States Federal Food, Drug and Cosmetic Act and/or any similar abbreviated approval process for biologics or biosimilars filed with the FDA in the United States or with a Regulatory Agency in any other jurisdiction.
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Generic Application shall have the meaning given such term in Section 9.4.5.
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Examples of Generic Application in a sentence

  • CTA methods can be used to uncover and describe the key patterns, variations, opportunities for improvement, and leverage points in the knowledge work—not just the physical work—of primary care staff and clinicians.

  • Generic Application Factory (GFac)[11], Opal toolkit [13], etc provide tools to wrap legacy scientific application codes as web services.

  • The Generic Application will then form the basis for the Specific Applications for the different vehicles types.

  • Based on the Generic Application, a solution for each vehicle type has to be designed, installed, tested and approved (Specific Application).GAGeneric ApplicationA generic system version that fulfils the Bane NOR requirements and can be adapted to different vehicle types.

  • M4Cloud - Generic Application Level Monitoring for Resource-shared Cloud Environments.

  • Application Environment Profiles are divided into the following class and subclasses: P - Application Environment ProfilesEWOS/TA/93/121 EWOS/EG-OSE/93/051PC - Component Profiles PS - System Profiles In the context of the scope of OSE as outlined in clause 1, this classification covers the domain of "Generic Application Environment Profiles".

  • Bane NOR and the Supplier will enter into a) an overall «Coordination Contract» regulating terms and conditions for the total scope and b) a contract on the Generic Application of the onboard system.

  • POZZEBON, Marlei & VAN HECK, Eric (2006) “Local Adaptations of Generic Application Systems: The Case of Veiling Holambra in Brazil”.

  • Bane NOR will take responsibility for developing, testing and approving a Generic Application of the onboard system.

  • These Generic Application Terms of Use and any supplemental terms under which you are provided the Application may change from time to time.

Related to Generic Application

  • Licensed Application means an Application that (a) meets and complies with all of the Documentation and Program Requirements, and (b) has been selected and digitally signed by Apple for distribution, and includes any additional permitted functionality, content or services provided by You from within an Application using the In-App Purchase API.

  • L/C Application means an application and agreement for the issuance or amendment of a Letter of Credit in the form from time to time in use by the L/C Issuer.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Client Application means an application developed by Licensee that a) utilizes the Runtime Product, b) is installed fully on an end user’s machine, with all report processing local to that machine, and c) adds significant and primary functionality to the Runtime Product.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • Practical application means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is being utilized and that its benefits are, to the extent permitted by law or government regulations, available to the public on reasonable terms.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Commercial applicator means any person, unless exempted in I(4) hereunder, whether or not the person is a private applicator with respect to some uses, who:

  • international application means an application filed under this Treaty;

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Renewal Application means a document used to collect pertinent data for renewal of permits

  • Server Application means an application developed by Licensee that a) utilizes the Runtime Product, b) allows more than one user to Use the Runtime Product through any middle tier application(s), and c) adds significant and primary functionality to the Runtime Product. A Client Application installed in a Windows terminal server environment (e.g. Citrix or Microsoft Remote Desktop Platform) is a Server Application.

  • SAP Application(s) means all Packages (i.e. all Software and Third Party Software) licensed under the Agreement and/or SAP cloud services for which Customer has a valid subscription, excluding User Interfaces for ERP, SAP Technology Solutions and all database Packages.

  • Application Process means the online application process under which the Applicant applies for Hospitality Packages on the Webshop.

  • Mobile Application means a specialized software program downloaded onto a wireless communication device.

  • Account Application or “Application” shall mean the application, as may be amended from time to time, by which this Agreement is established between the Depositor (or following the death of the Depositor, the Beneficiary) and the Custodian. The statements contained therein shall be incorporated into this Agreement.

  • Commercial Product means any such product as defined in FAR 2.101.

  • Electrostatic application means the application to a substrate of charged atomized paint droplets that are deposited by electrostatic attraction.

  • Third Party Applications means online, Web-based applications and offline software products that are provided by third parties and are identified as third-party applications, including but not limited to those listed on the AppExchange and the Reseller Application.

  • FCC Applications means those applications and requests for waivers required to be filed with the FCC to obtain the approvals and waivers of the FCC pursuant to the Communications Act and FCC Rules necessary to consummate the transactions contemplated by this Agreement.

  • Planning Application means the application for [outline/full] planning permission dated [ ] bearing the Council’s reference number [ ];

  • Initial application means the Application first provided to MFA on or before an Application Deadline to request an allocation of Tax Credits.

  • ANDA means an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.

  • Patent Application means an application for patent protection for a CRADA Subject Invention with the United States Patent and Trademark Office (“U.S.P.T.O.”) or the corresponding patent-issuing authority of another nation.

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.