IND Acceptance definition

IND Acceptance means, with respect to an IND, the earlier of (a) receipt by Kite, its Affiliate or a Sublicensee of written confirmation from a Regulatory Authority or other applicable Person that human clinical studies may proceed under such IND, and (b) expiration of the applicable waiting period after which human clinical studies may proceed under such IND.

IND Acceptance means (a) with respect to an IND for a Product filed with the FDA, either (i) a “may proceed” letter from the FDA in writing in response to a dossier submitted to the FDA; or (ii) expiration of the thirty (30) day period following the date of submission of an IND without receipt of notice from the FDA within such time period that the IND is subject to a clinical hold, whichever event ((i) or (ii)) occurs first, or (b) equivalent authorization to proceed with respect to an IND filed with or submitted to any Regulatory Authority outside the United States.

IND Acceptance means the acceptance by a Regulatory Authority in a Major Market Country of an IND.

Examples of IND Acceptance in a sentence

• The Parties’ objective under each Product R&D Program is to discover, research, conduct preclinical development (including manufacturing process development and certain other manufacturing activities), and obtain IND Acceptance for Regeneron Products that are Directed to the applicable Regeneron Target to enable further development and commercialization by Regeneron.

• Without limiting the first sentence of Section 4.4(a), subject to JSC input on the overall regulatory strategy for the initial IND filing for a given Regeneron Product under a Product R&D Program, Regeneron shall have primary responsibility with respect to submitting, and shall use Commercially Reasonable Efforts to submit, Regulatory Filings necessary to achieve initial IND Acceptance for a Regeneron Product.

• Surface hereby grants Novartis the right, but not the obligation, to exercise up to a total of three (3) Options with respect to any three (3) Option Targets for which (a) Novartis has purchased an Option in accordance with Section 4.1, and (b) Surface has received IND Acceptance with respect to such Option Target.

• For each of the Options, promptly after the first IND Acceptance with respect to an Option Target, Surface will (a) provide to Novartis the Option IND Package with respect to the applicable Option Target, and (b) afford reasonable access during normal business hours to Surface’s personnel by Novartis and its representatives as Novartis may reasonably request to assist Novartis in deciding whether to exercise the Option for such Option Target.

• Notwithstanding the foregoing, such right will terminate with respect to any Licensed Product if RayzeBio enters into a Sublicense with respect to such Licensed Product prior to the first IND Acceptance for such Licensed Product.

More Definitions of IND Acceptance

IND Acceptance means, with respect to a Licensed Product, the earliest of (a) acceptance by the FDA or the EMA of the filing of an IND for such Licensed Product, (b) the passage of any period of time determined by Law by the end of which the FDA or EMA is supposed to comment on such filing, extended if any such comments were made by the period of time necessary to address such comments to the reasonable satisfaction of the FDA or EMA, (c) the first date on which a Party may commence the first clinical trial of such Licensed Product in the U.S. or E.U., or (d) the first dose of such Licensed Product in a human clinical trial in the U.S. or E.U.

IND Acceptance means, with respect to a particular Regeneron Product, that the particular IND for such Regeneron Product was accepted by the FDA (or other applicable Regulatory Authority outside the United States if the IND was submitted to such Regulatory Authority outside the United States), as evidenced by no objection by the FDA (or such other applicable Regulatory Authority outside the United States) within [***]) days after the date of the IND submission (or any amended submission if such amendment restarted the applicable [***]-day period).

IND Acceptance means the expiration of thirty (30) days following receipt by GENENTECH of a notice from the FDA to GENENTECH (or its Sublicensee) that the FDA has received an IND for a Licensed Product filed by GENENTECH (or its Sublicensee) for the purpose of obtaining approval or authority to commence human clinical trials in the United States with such Licensed Product; PROVIDED, HOWEVER, that if the FDA puts a clinical hold on the IND during such thirty (30) day period, the term "IND Acceptance" shall mean that date during the term of this Agreement when GENENTECH (or its Sublicensee) receives written confirmation from the FDA that the clinical hold has been removed and that GENENTECH (or its Sublicensee) has the approval or authority to commence human clinical trials of such Licensed Product under such IND in the United States. Notwithstanding anything set forth herein, "IND Acceptance" shall not be deemed to have occurred in any circumstances where GENENTECH (or its Sublicensee) withdraws any IND filed with the FDA for a Licensed Product at any time prior to the commencement of human clinical trials with such Licensed Product in the United States.

IND Acceptance means, with respect to a Clinical Trial, written approval from the FDA, TGA or EMA that approves the IND and the commencement of such Clinical Trial in the applicable jurisdiction, provided that such written approval will be deemed to have been granted if (a) thirty-five (35) days have elapsed following confirmation by the FDA of its receipt of such IND (as confirmed either via a letter or fax) without (i) imposition of a clinical hold by the FDA or (ii) any other notification by the FDA that the applicable Clinical Trial cannot so proceed as contemplated by such IND or (b) notification by FDA, TGA or EMA that the applicable Clinical Trial can so proceed as contemplated by such IND, in each case (a) and (b), as a consequence of such events, the Clinical Trial may lawfully proceed as described in the applicable IND.

IND Acceptance means that either by issuing no comment during the 30-day IND review period or by providing some affirmative communication, the FDA has assented to the performance of the clinical trial proposed in the IND application.

IND Acceptance means non-refusal of an IND by the FDA, or the equivalent notice from a governmental authority other than the FDA.

IND Acceptance means the earlier of (a) the day following the last day on which the applicable Regulatory Authority may object to an IND submission, provided that no clinical hold is then in place, or (b) the day on which the applicable Regulatory Authority affirmatively accepts an IND submission and notifies the applicable Party it may proceed with Clinical Trials pursuant to such IND. For example, in the United States, in the event that the FDA does not make any objection within 30 calendar days from the IND submission, then IND Acceptance of such IND would occur 31 calendar days from the date of the IND submission. For the avoidance of doubt, if the FDA objects to an IND submission within such 30 day period, then IND Acceptance of such IND shall occur only after such objection is overcome.