IND Clearance definition

IND Clearance means filing and clearance by FDA without rejection or being placed on clinical hold;

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IND Clearance means, with respect to an IND, the earlier of: (a) receipt by a Party, its Affiliate or a Sublicensee of written confirmation from a Regulatory Authority or other applicable Person that Clinical Trials may proceed under such IND; or (b) expiration of the applicable waiting period after which Clinical Trials may proceed under such IND.

IND Clearance means, with respect to an IND, the earlier to occur of: (a) receipt by or on behalf of Jazz or any of its Affiliates or Sublicensees, of written confirmation from a Regulatory Authority that Clinical Trials may commence or be conducted under such IND; or (b) expiration of the applicable waiting period after which Clinical Trials may commence or be conducted under such IND.

Examples of IND Clearance in a sentence

• Eleven will promptly disclose to Roche, to the extent not already provided, the results of all preclinical testing of any Licensed Product in Eleven’s possession and Control as exists on the later of the Effective Date or the date of IND Clearance.

• If the FDA requires IND Clearance Activities, Eleven shall be responsible for Eleven IND Clearance Activities at Eleven’s cost as necessary to achieve IND Clearance, and Roche shall be responsible at Roche’s cost for Roche IND Clearance Activities as necessary to achieve IND Clearance.

• 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.

• Eleven shall maintain responsibility for payment under Third Party CMO agreements for Eleven IND Clearance Activities.

• As necessary for Roche to continue development of EBI-031, Eleven shall, for three (3) months after the later of the Effective Date and IND Clearance (except as otherwise specifically set forth in this Agreement), cooperate with Roche and disclose and make available to Roche all data and information in Eleven’s possession and Control regarding EBI-031.

More Definitions of IND Clearance

IND Clearance means the first IND for any Licensed Product going into effect in accordance with 21 C.F.R. 312.40(b).

IND Clearance means on a Licensed Product-by-Licensed Product basis the date on which [*], unless otherwise agreed by the Parties.

IND Clearance means on a Licensed Product-by-Licensed Product basis the date on which the IND-enabling studies for such Licensed Product under the applicable Completed Research Program have been completed, Licensee has filed the IND with a Regulatory Authority, and such Regulatory Authority has cleared such IND as safe to proceed.

IND Clearance means, with respect to an IND and the FDA, the earlier of (a) the date the FDA has notified the applicant for such IND that one or more clinical studies may commence under such IND and (b) the date that one or more clinical studies may commence under such IND in the absence of the notice described in clause (a). By way of example, the conditions of clause (b) would be fulfilled if the FDA (i) does not impose a clinical hold within [**] after filing of an applicable IND and (ii) does not provide the notice described in clause (a).

IND Clearance means, with respect to a Novavax Adjuvant Product, the earlier of (a) in the U.S., the date that is thirty (30) days following the filing of the first IND for such Novavax Adjuvant Product, if Novavax has not received any notice of a clinical hold or any other administrative delay from the FDA during such thirty (30) day period, and if Novavax or its Affiliates or Sublicensee does receive a notice of a clinical hold or there is such other administrative delay, then the date of “IND Clearance” for the Novavax Adjuvant 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 Novavax Adjuvant Product to be administered to a human as described in such IND and (b) in other regulatory jurisdictions outside the U.S., the date on which such Novavax Adjuvant Product is first permitted by the applicable Regulatory Authority of such jurisdiction to be administered to a human pursuant to an IND filing in accordance with Applicable Laws (or, to the extent no IND filing is required under Applicable Law in such regulatory jurisdiction, the date of initiation of the first Clinical Trial in such jurisdiction using such Novavax Adjuvant Product).

IND Clearance means acceptance of an IND by the FDA to conduct clinical testing of the applicable pharmaceutical product.

IND Clearance means, with respect to an Antibody Product, (a) in the U.S., the date that is 30 days following the filing of the first IND for an Antibody Product, if Takeda has not received any notice of a clinical hold or any other administrative delay from the FDA during such 30 day period, and if Takeda or its Affiliates or Sublicensee does receive a notice of a clinical hold or there is such other administrative delay, then the date of “IND Clearance” for the Antibody 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 Antibody Product to be administered to a human as described in such IND or (b) in other regulatory jurisdictions outside the U.S., the date on which the first Antibody 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 in such jurisdiction.