NDA Filing Date definition

NDA Filing Date shall have the meaning set forth in Section 3.5(a).
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NDA Filing Date means the date on which LICENSEE (or its sublicensee or collaborative partner) files its first New Drug Application (or its equivalent) with the United States Food and Drug Administration or any comparable foreign regulatory authority for the use of a Licensed Product to treat attention deficit hyperactivity disorder and/or any other neuropsychiatric disease or disorder in any country.
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Examples of NDA Filing Date in a sentence

  • In such event, Company agrees that it will provide an extension of the NDA Filing Date to [*].

  • Therefore, until the Initial Regulatory Filing is made (the "NDA Filing Date"), DURECT shall be primarily responsible for conducting the clinical studies and all other regulatory matters, manufacturing matters and/or pre-clinical studies necessary to support, prepare and file the Initial Regulatory Filing, and DURECT shall use all commercially reasonable efforts necessary to make the Initial Regulatory Filing.

  • Notwithstanding the foregoing, Purchaser will not be considered to have abandoned development if prior to the NDA Filing Date, Purchaser provides to the Company: (i) a notification that it will not be able to file an NDA by the NDA Filing Date, and (ii) [*].

Related to NDA Filing Date

  • Initial Filing Date means the date on which the Initial Registration Statement is filed with the SEC.

  • 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.

  • Additional Filing Date means the date on which the Additional Registration Statement is filed with the SEC.

  • Initial Filing Deadline means the date which is thirty (30) calendar days after the Closing Date.

  • Required Filing Date has the meaning assigned to such term in Section 2.1.1(b);

  • Registration Filing Date means the date that is ninety (90) calendar days after the Effective Date.

  • 10-K Filing Deadline As defined in Section 10.05 of this Agreement.

  • Significant Obligor NOI Quarterly Filing Deadline With respect to each calendar quarter (other than the fourth calendar quarter of any calendar year) and each Significant Obligor, the date that is fifteen (15) days after the Relevant Distribution Date occurring on or immediately following the date by which the related Mortgagor is required to deliver quarterly financial statements to the lender under the related Loan Agreement in connection with such calendar quarter (which date is set forth in Section 10.11(a) for any Significant Obligor with respect to the Trust).

  • Filing Deadline Date has the meaning set forth in Section 2(a) hereof.

  • Additional Filing Deadline means if Cutback Shares are required to be included in any Additional Registration Statement, the later of (i) the date sixty (60) days after the date substantially all of the Registrable Securities registered under the immediately preceding Registration Statement are sold and (ii) the date six (6) months from the Initial Effective Date or the most recent Additional Effective Date, as applicable.

  • Filing Deadline As defined in Sections 3(a) and 4(a) hereof.

  • Significant Obligor NOI Yearly Filing Deadline With respect to each calendar year and each Significant Obligor, the date that is the 90th day after the end of such calendar year.

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

  • Effectiveness Deadline Date has the meaning set forth in Section 2(a) hereof.

  • Effectiveness Deadline As defined in Section 3(a) and 4(a) hereof.

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

  • 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.

  • Required Filing Dates has the meaning specified in Section 10.19.

  • Amendment Effectiveness Deadline Date has the meaning set forth in Section 2(d) hereof.

  • 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.

  • Required Effectiveness Date As defined in Section 2.1.

  • Plan Supplement Filing Date means the date or dates on which the Plan Supplement shall be filed with the Bankruptcy Court. The first Plan Supplement Filing Date shall be at least seven days prior to the Voting Deadline or such later date as may be approved by the Bankruptcy Court without further notice.

  • Effectiveness Target Date As defined in Section 5.

  • Application Approval Date means the date that the Application is approved by the Board of Trustees of the District and as further identified in Section 2.3.B of this Agreement.

  • Target Registration Date shall have the meaning set forth in Section 2(d) hereof.

  • Merger Registration Statement means the registration statement, together with all amendments, filed with the SEC under the Securities Act for the purpose of registering the offer of shares of NBT Common Stock to be offered to holders of CNB Common Stock in connection with the Merger.