IND Filing Clause Samples
The IND Filing clause establishes the requirements and procedures for submitting an Investigational New Drug (IND) application to regulatory authorities, typically as part of a clinical research or pharmaceutical development agreement. It outlines which party is responsible for preparing and filing the IND, the timelines for submission, and any obligations to share information or obtain consent from the other party before filing. This clause ensures that regulatory filings are handled efficiently and in compliance with legal requirements, thereby facilitating the timely initiation of clinical trials and clarifying responsibilities between the parties.
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IND Filing. [*]the filing of the first Investigational New Drug application ("IND") with the United States Food and Drug
IND Filing. Subject to Section 2.6, Prothena shall provide to Celgene (i) at least [***] ([***]) days prior to the expected filing of an IND for a particular Lead Candidate, [***], and a copy of the proposed draft IND, and Prothena shall consider in good faith any comments of Celgene with respect thereto, (ii) a final copy of the IND within [***] ([***]) days after filing the IND, and (iii) any communications to and from any Regulatory Authority with respect to such IND promptly following receipt or submission of such communications, as applicable. Prothena shall not (and Prothena shall ensure that its Affiliates do not) file any INDs with respect to any Collaboration Candidates under any Program other than Lead Candidates.
IND Filing. Licensor shall allow Licensee to access Licensor's IND relating to murine CBL-1 by providing Licensee with a letter of access to such IND, at the request and at the discretion of Licensee. Licensor shall execute and deliver such other documents as may be reasonably requested by Licensee to access such IND.
IND Filing. [***] U.S. Dollars ($[***]) upon the filing in the U.S. of an IND with the FDA for the first Licensed Product.
IND Filing. Upon filing of the IND for the first Clinical Trial to be carried out under the Pre-POC Development Plan, GNE shall pay to Immunocore a one-time non-refundable irrevocable Event Payment of Fifty Million US Dollars ($50,000,000). GNE shall pay Immunocore the Event Payment within [***] of receipt of an invoice from Immunocore with respect thereto.]
IND Filing. In the event GCOR or its sublicensee files an IND at any time during the Collaboration Term or the Diligence Period on [...***...] or more Licensed Product(s), the Investment Commitment will be reduced by [...***...] for each IND filed. Accordingly the Investment Commitment will be reduced by [...***...] upon filing of the first IND, [...***...] upon filing of a second IND and [...***...] upon filing of a thIRD IND filed by GCOR or its sublicensee.
IND Filing. [*]after the filing of the first Investigative New Drug application ("IND") the United States Food and Drug Administration ("FDA") or foreign equivalent with respect to each Antisense Product.
IND Filing. Upon filing of the first IND with FDA that relates to a SansRosa Product, CollaGenex shall purchase, and the Shareholders shall deliver to CollaGenex, 10% of the Shares at a price per share that results in the aggregate consideration payable at such time being $[**];
IND Filing. The Parties shall, in accordance with the applicable Research Plan, commence the preparation of an IND application for a Licensed Product for the applicable Licensed Collaboration Candidate. If, at the time of the Exercise Effective Date for the Licensed Collaboration Candidate, there are IND Enabling Studies being conducted for other Pre-IND Collaboration Candidates that were included in the same DC Data Package as the Licensed Collaboration Candidate, ▇▇▇▇▇▇▇ may elect [***] ▇▇▇▇▇▇▇ will decide whether to exercise the Commercial Option for any of such other Pre-IND Collaboration Candidate in accordance with Section 4.3 and for which of such candidates IND applications should be prepared. ▇▇▇▇▇▇▇ shall make the IND application decision no later than [***] days after the IND Data Package Delivery Date for [***]. Fate shall be primarily responsible for the preparation of the IND application for such Licensed Product, except that ▇▇▇▇▇▇▇ shall prepare the clinical trial protocol. Fate shall provide the IND application to ▇▇▇▇▇▇▇ for review and comment, and to the JRC for review and approval (and to the JMC for review and approval of the CMC portions of such application), prior to submitting such application to the FDA. Following JRC and JMC approval, Fate shall promptly submit such IND application to the FDA for such Licensed Product. If ▇▇▇▇▇▇▇ notifies Fate that it intends to conduct the first Clinical Trial in a country outside the U.S., the Parties will discuss and agree upon responsibility for preparation and submission of the CTA to the applicable Regulatory Authority in such country.
IND Filing. After completion of the activities set forth in the [***] , the JDPT will propose the Regulatory Filing of INDs for Products to the JSC for review and confirmation (subject, in any case, to each Party’s internal processes regarding the approval of such Regulatory Filings). The JSC (subject to [***] right under Section [***] ) will recommend to [***] an IND for a Product to be filed in a Major Market. [***] shall decide upon the IND filing in accordance with [***] , however no later than sixty (60) days after the JSC confirmation. If the JSC does not recommend such a Regulatory Filing for an IND to [***] , then within thirty (30) days of such determination, the JSC shall specify additional pre-clinical activities for the generation of such regulatory package, in which case the Parties will amend the Development Plan to reflect any such activities. If [***] does not approve the Regulatory Filing recommended by the JSC, then either (i) [***] will, within sixty (60) days, specify additional pre-clinical activities for the generation of such regulatory package, in which case the Parties will amend the Development Plan to reflect any such activities, or (ii) [***] will have the right to terminate this Agreement pursuant to Section 12.4. *** Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.