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 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.

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

Examples of IND Clearance in a sentence

In addition, within 15 days following the IND Clearance Date, Cypress shall pay ▇▇▇▇▇▇ ▇▇▇▇▇ $750,000 (▇▇▇▇▇▇ ▇▇▇▇▇ acknowledges that is has received such payment).
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.
Each Party shall notify the other Party of the results of any IND Clearance Activity it conducts promptly after its completion, which, in the case of Roche IND Clearance Activities, such notification shall consist of a status update to Eleven regarding Roche’s assessment of the progress towards 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.
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.

More Definitions of IND Clearance

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 a Product, that (a) with respect to the US Territory, a particular IND for the Product has been allowed to go into effect by the FDA, as evidenced by the passage of a thirty (30) calendar day period after the date of the IND submission (or any amended submission if such amendment restarted the applicable thirty (30)-day period) without the FDA placing the IND on clinical hold, (b) with respect to the European Union, that a Member State to which an application for clinical trial authorization has been submitted (Member States concerned) has either: (i) notified the sponsor through the EU portal (the Clinical Trials Information System) that the Clinical Trial is authorized (including an authorization subject to conditions) in accordance with Article 8(1) of Regulation (EU) No. 536/2014, or (ii) not notified the sponsor that the clinical trial is authorized within the relevant periods referred to in Article 8(1) of Regulation (EU) No. 536/2014, with the result that the clinical trial is deemed to be authorized in accordance with Article 8(6) of Regulation (EU) No. 536/2014, and (c) with respect to the United Kingdom, the Medicines and Healthcare Products Regulatory Agency has confirmed its acceptance of an application for clinical trial authorization (including an acceptance subject to conditions) pursuant to the Medicines for Human Use (Clinical Trials) Regulations 2004.

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, 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 and (b) expiration of the applicable waiting period under Applicable Laws and Regulations 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 Pharming, any of its Affiliates, or any Sublicensee of written confirmation from a Regulatory Authority that Clinical Studies may commence or be conducted under such

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.