IND Clearance Date definition

IND Clearance Date means, with respect to any IND, the date on which the sponsor of such IND is permitted to initiate clinical trials following submission of such IND to the applicable Regulatory Authority.
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IND Clearance Date means January 2, 2002.
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IND Clearance Date shall have the meaning set forth in Section 3.1(a).
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Examples of IND Clearance Date in a sentence

  • In the event that the IND Clearance Date has not occurred prior to January 30, 2017, thirteen million two hundred and fifty thousand dollars ($13,250,000) of the upfront fee paid under Section 8.1 shall be creditable towards clinical and sales milestones that are or become due under the Platform Agreement.

  • In addition, within 15 days following the IND Clearance Date, Cypress shall pay ▇▇▇▇▇▇ ▇▇▇▇▇ $750,000 (▇▇▇▇▇▇ ▇▇▇▇▇ acknowledges that is has received such payment).

  • In addition, within 15 days following the IND Clearance Date, Cypress shall pay ▇▇▇▇▇▇ ▇▇▇▇▇ [...***...

  • Notwithstanding the above, CELGENE shall be deemed to have exercised the CELGENE Worldwide Rights Option upon the Second IND Clearance Date, in which case CELGENE shall notify SUTRO promptly after such filing, and shall pay the applicable Option Exercise Fee within five (5) Business Days following filing.

  • I▇ ▇▇▇▇▇▇▇▇, within 15 days following the IND Clearance Date, Cypress shall pay Pierre Fabre $750,000.


More Definitions of IND Clearance Date

IND Clearance Date means the earlier of (a) receipt of an IND clearance letter from the FDA with respect to any IND for a Licensed Product or (b) provided there is no clinical hold in effect, [***] days after the date of submission of any IND for a Licensed Product.
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IND Clearance Date means, with respect to an IND for a Licensed Product that was filed by Licensee, or any Affiliate or Sublicensee of Licensee, (a) in the U.S., the date that is [***] days following the filing of the first IND for such Licensed Product, if Licensee or its Affiliates or Sublicensees has not received any notice of a clinical hold or any other administrative delay from the FDA during such [***] day period; provided that, if Licensee or its Affiliate or Sublicensee does receive a notice of a clinical hold or there is such other administrative delay, then “IND Clearance Date” for such Licensed Product will be the date on which the FDA lifts such clinical hold or such other administrative delay is otherwise resolved and the FDA first allows the Licensed Product to be administered to a human pursuant to such IND, or (b) in other regulatory jurisdictions outside the U.S., the date on which such Licensed Product is first permitted by the applicable Regulatory Authority of such jurisdiction to be administered to a human pursuant to an IND in accordance with Applicable Law.
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