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. 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. 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. [*]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.
IND Filing. Asahi hereby transfers to CoTherix the IND [***] and shall execute and deliver to the FDA a letter in a form approved by CoTherix transferring ownership to CoTherix of the IND [***], and shall execute any other instrument necessary to accomplish the foregoing. Until such time as FDA officially recognizes the transfer of this IND to CoTherix, Asahi shall continue to maintain such IND in good standing and full force and effect, and in particular (but without limitation) shall continue to perform any required adverse event or safety reporting to FDA until such time as FDA will accept such reporting directly from CoTherix. For the avoidance of doubt, the Parties agree that after the date on which such letter transferring ownership is delivered to the FDA, the IND [***] shall become CoTherix Intellectual Property Rights; provided, however, that even after such transfer of ownership to IND [***], any and all data and information that is already contained in or attached to the IND [***]as of the date on which such letter transferring ownership is delivered to the FDA shall remain Asahi Intellectual Property Rights, notwithstanding anything to the contrary provided for herein. In addition to the IND [***], CoTherix shall be responsible for appropriate filing in the name of CoTherix one or more INDs or IND Equivalents with the appropriate Regulatory Agencies covering Clinical Development of Products in the Territory. Regulatory Documentation required for such transfer or filing as described in this Section 2.4 will be translated in accordance with the provisions of Section 2.8.
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 $[**];
