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

IND Acceptance means (a) with respect to an IND for a Licensed 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.

Examples of IND Acceptance in a sentence

• Proforma income statements 2004USD’000Net profit for the year Per consolidated financial statements of the Group2,101Add: acquisition of shares from minority shareholders pursuant to the restructuring exercise (note 3c(i),(ii) & (v)) 198Per proforma financial statements of the Group2,299 There are no proforma adjustments on the income statements for the financial years ended 31 December 2002 and 2003.

• 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.

• Prior to any public announcement or disclosure by Neurocrine, and in any event, within [ † ] days after IND Acceptance, Neurocrine shall notify Xenon in writing if a XEN901 Product achieves IND Acceptance in either SCN8A-EE or a Major Indication, whichever occurs first.

• After the receipt of such notice from Neurocrine, Xenon shall submit to Neurocrine an invoice for a payment of (i) if the IND Acceptance is for SCN8A-EE, eleven million two hundred fifty thousand Dollars ($11,250,000) or (ii) if the IND Acceptance is for a Major Indication, four million five hundred thousand Dollars ($4,500,000).

• Following [***] provided that there has been IND Acceptance for a Regeneron Product Directed to such Regeneron Target, Regeneron shall use Commercially Reasonable Efforts to develop (including submitting for Marketing Approval for) at least one (1) Regeneron Product Directed to the applicable Regeneron Target and, following receipt of Marketing Approval [***], to commercialize such Regeneron Product.

More Definitions of IND Acceptance

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, 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 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 expiration of thirty (30) days following receipt by ABX of a notice from the FDA to ABX that the FDA has received an IND for a Licensed Product filed by ABX 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 ABX receives written confirmation from the FDA that the clinical hold has been removed and that ABX 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 have occurred in any circumstances where ABX 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.