NDA Filing Date definition

NDA Filing Date shall have the meaning assigned to such term in Section 4.1(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);