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 Certain confidential information contained in this document, marked by [***], has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential. 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 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. ***Text Omitted and Filed Separately Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4), and 240.24b-2 Execution Copy
IND Filing. For all Products Developed and Commercialized under Section 4.2 or Section 4.3, [* * *], Novo shall be responsible for the preparation and submission of the IND filing and for seeking IND Approval and shall have control over all interactions with the applicable Regulatory Authority. [* * *], the Parties shall be jointly responsible for the preparation and submission of the IND filing, including responses to any questions from the Regulatory Authorities during review, at Novo’s expense, but Novo will otherwise be responsible for seeking IND Approval and shall have control over all interactions with the applicable Regulatory Authority. Novo shall own all Regulatory Approvals and be responsible for all decisions in connection therewith for Regulatory Approvals of Products in the Field; provided, that Dicerna shall reasonably cooperate in these efforts as reasonably requested by Novo at Novo’s expense.
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 filing of the first Investigational New Drug application ("IND") with the United States Food and Drug
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.
