Supplemental FDA Application definition

Supplemental FDA Application means a “Supplemental New Drug Application” or a “Supplemental Biologics License Application” (as both of such are defined according to relevant FDA guidelines and regulations establishing the mechanisms for the submission of data in support of the FDA granting approval for new, amended, and/or expanded label indications for a prior-approved drug product in the United States of America).
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Supplemental FDA Application means a “Supplemental New Drug Application” or a “Supplemental Biologics License Application” (as both of such are defined according to relevant FDA guidelines and regulations establishing the mechanisms for the submission of data in support of the FDA granting approval for new, amended, and/or expanded label indications for a prior-approved drug product in the United States of America). The event giving rise to a milestone payment under subsections (i) through (iii) of this Section 5.2(b) shall be a “Milestone Event” and together, the “Milestone Events.”
Sample 1
Supplemental FDA Application means a “Supplemental New Drug Application” or a “Supplemental Biologics License Application” (as both of such are defined according to relevant FDA guidelines and regulations establishing the mechanisms for the submission of data in support of the FDA granting approval for new, amended, and/or expanded label indications for a prior-approved drug product in the United States of America). CONFIDENTIAL TREATMENT REQUESTED BY ORAGENICS, INC. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.
Sample 1

Related to Supplemental FDA Application

  • 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.

  • L/C Amendment Application means an application form for amendment of an outstanding standby or commercial documentary letter of credit as shall at any time be in use at the Issuing Lender, as the Issuing Lender shall request.

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

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

  • Project Application means the federal Section 5311 operating assistance project application submitted by the Municipal Corporation to, and as approved by the Commissioner for the Project described in Appendix C of this Agreement, including all project supporting information submitted therewith.

  • New Drug Application means a New Drug Application filed with the FDA in accordance with Applicable Law.

  • Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.

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

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • Creation Application means an application by a Participating Dealer for the creation and issue of Units in an Application Unit size (or whole multiples thereof) in accordance with the Operating Guidelines and the Trust Deed.

  • 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.

  • Country Supplement means a supplement to this Prospectus specifying certain information pertaining to the offer of Shares of the Company or a Fund or Class in a particular jurisdiction or jurisdictions.

  • 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.

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

  • Application Package means the forms, schedules, checklists, exhibits, computer disks and instructions thereto obtained from the Agency, which shall be completed and submitted to the Agency in accordance with all regulations in order to apply for the HTC Program.

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

  • Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

  • 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).

  • 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.

  • Complete application means a document prepared in

  • 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.

  • Access Application means an application for Access Rights as described in section 3.7;

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • 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.

  • Athlete Application means the form set by the NZOC that must be completed by any Athlete applying to be nominated and selected to the Games Team.

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity: