Filing of an NDA definition

Filing of an NDA means the date of acceptance for review by the competent registration body in a given country of an NDA.
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Examples of Filing of an NDA in a sentence

  • TMC shall be responsible for any costs associated with preparation, submission and prosecution of all such Filing of an NDA and NDA Approvals required.

  • Filing of an NDA with the FDA and equivalent in foreign regulatory jurisdictions Within 60 days of filing an NDA or equivalent, Licensee, or its Patent Counsel will provide written notification to the University explaining its plans for Patent Term Extension or submission of Supplementary Certificates or equivalent by identifying which patent(s), Licensee’s Patent Counsel shall seek extensions for, when the NDA or equivalent is approved.

  • Filing of an NDA with the FDA (or foreign equivalent) for a clinical indication covered by a Valid Claim.

  • Filing of an NDA with EMEA for such Milestone Compound: $ 4,000,000 $ 3,000,000 6.

  • Filing of an NDA in Japan for such Licensed Product: $ 2,000,000 $ 1,500,000 6.

  • Filing of an NDA with EMEA for such Licensed Product: $ 4,000,000 $ 3,000,000 5.

  • Filing of an NDA in the U.S. for such Licensed Product: $ 5,000,000 $ 3,750,000 4.

  • Filing of an NDA with the FDA (or $ * foreign equivalent) for a clinical indication covered by a Valid Claim.

  • In the case of a skipped Milestone Event (e.g., acceptance for Filing of an NDA, etc.), any Milestone Payment that would have preceded the skipped Milestone Event will be due concurrently with the payment of the achieved Milestone Event, subject, however, to Section 6.2(c) above.

Related to Filing of an NDA

  • Filing office means an office designated in section 400.9-501 as the place to file a financing statement;

  • Filing means any registration, petition, statement, application, schedule, form, declaration, notice, notification, report, submission or other filing.

  • Registration Filing Date means the date that is sixty (60) calendar days after the Effective Date.

  • HSR Filing means filings with the United States Federal Trade Commission and the Antitrust Division of the United States Department of Justice of a Notification and Report Form for Certain Mergers and Acquisitions (as that term is defined in the HSR Act) with respect to the subject matter of this Agreement, together with all required documentary attachments thereto.

  • Registration Form means a book voter registration form and a by-mail voter

  • Date of filing means the date an applicant submits a noti- fication of intent or the date an applicant files an application, whichever is earlier.

  • Applicable IP Office means the United States Patent and Trademark Office, the United States Copyright Office or any similar office or agency within or outside the United States.

  • Registration Application means an application for registration of this Agreement as a planning agreement on the title of the Land pursuant to Section 7.6 of the Act in a form approved by the Registrar General;

  • Filing officer means the office that is designated by section

  • Filing Party has the meaning set forth in Section 6.12(b).

  • USPTO means the United States Patent and Trademark Office.

  • Filing Statement means all UCC financing statements or other similar financing statements and UCC (Form UCC-3) termination statements required pursuant to the Loan Documents.

  • Filing Date means, with respect to the Initial Registration Statement required hereunder, the 30th calendar day following the date hereof and, with respect to any additional Registration Statements which may be required pursuant to Section 2(c) or Section 3(c), the earliest practical date on which the Company is permitted by SEC Guidance to file such additional Registration Statement related to the Registrable Securities.

  • LCT Election has the meaning assigned to such term in Section 1.06.

  • filing system means any structured set of personal data which are accessible according to specific criteria, whether centralised, decentralised or dispersed on a functional or geographical basis;

  • 10) Election has the meaning set forth in Section 6.05(a).

  • Deferral Election means the Participant’s election under Section 3.1 to defer all or a portion of his or her Compensation.

  • Initial Effectiveness Deadline means the date which is (i) in the event that the Initial Registration Statement is not subject to a full review by the SEC, sixty (60) calendar days after the Closing Date or (ii) in the event that the Initial Registration Statement is subject to a full review by the SEC, ninety (90) calendar days after the Closing Date.

  • Deferral Election Form means the form established from time to time by the Plan Administrator that the Director completes, signs and returns to the Plan Administrator to designate the amount of the Deferrals.

  • Shelf Effectiveness Deadline As defined in Section 4(a) hereof.

  • Payment Election means an election pursuant to Section 5.1.

  • Additional Effectiveness Deadline means the date which is the earlier of (x) (i) in the event that the Additional Registration Statement is not subject to a full review by the SEC, thirty (30) calendar days after the earlier of the Additional Filing Date and the Additional Filing Deadline or (ii) in the event that the Additional Registration Statement is subject to a full review by the SEC, fifty (50) calendar days after the earlier of the Additional Filing Date and the Additional Filing Deadline and (y) the fifth (5th) Business Day after the date the Company is notified (orally or in writing, whichever is earlier) by the SEC that such Additional Registration Statement will not be reviewed or will not be subject to further review; provided, however, that if the Additional Effectiveness Deadline falls on a Saturday, Sunday or other day that the SEC is closed for business, the Additional Effectiveness Deadline shall be extended to the next Business Day on which the SEC is open for business.

  • Proxy Form means the proxy form attached to the Notice;