IND Clearance definition
IND Clearance means filing and clearance by FDA without rejection or being placed on clinical hold;
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 a Party 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
From the Closing Date until the later of (i) the date of IND Clearance for the first Product by the FDA or (ii) the date that is [**] following the Closing Date, Seller will make available to Buyer or its designees such personnel of Seller as may reasonably be requested by Buyer to assist Buyer in connection with understanding the content, or implementing or using the content, of the Technology Transfer.
More Definitions of IND Clearance
IND Clearance means on a Licensed Product-by-Licensed Product basis the date on which [*], unless otherwise agreed by the Parties.
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 the IND-enabling studies for such Licensed Product under the applicable Research Program have been completed, Passage has filed the IND with a Regulatory Authority, and such Regulatory Authority has cleared such IND as safe to proceed, unless otherwise agreed in writing by the Parties.
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, 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.
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 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).