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.
View Source
Generic Application shall have the meaning given such term in Section 9.4.5.
View Source

Examples of Generic Application in a sentence

  • If no such terms are provided, the Onshape Generic Application Terms of Use (reprinted below) will be the ▇▇▇▇.

  • Hanmi shall provide Aptose with the unopened Generic Application within three (3) days of receipt.

  • Secondly, it shall be the base of a generic Safety Case Structure similar to the Technical Safety Report of the CENELEC Standards and structured into Generic Parts, Generic Application Parts and Specific Application Parts.

  • Notwithstanding the foregoing provisions of Section 9.4, Aptose control any legal action and any activity taken to resolve a dispute with respect to any infringement of Hanmi Patent Rights with respect to any Generic Application.

  • Generic Application Form - Business Immigration Stream Appendix 5J.

  • For any action with respect to any infringement of Hanmi Patent Rights with respect to any Generic Application, in the event that Aptose is unable to initiate or prosecute such action solely in its own name, Hanmi will join such action voluntarily and will execute and cause its Affiliates to execute all documents necessary for Aptose to initiate, prosecute and maintain such action.

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.

  • Biosimilar Application has the meaning set forth in Section 7.3.3.

  • 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 an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • Client Application means an application developed by Customer 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.