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. 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. 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. ABL shall use its commercially reasonable best efforts to file the IND by no later than January 31, 2004, to obtain clearance of the IND by the FDA, to commence the Phase I Trial within 30 days following FDA clearance of the IND and to complete the Phase I Trial within 18 months from the commencement of the trial. ABL shall notify UMass and CytRx in writing within two business days following the IND filing and the commencement of the Phase I Trial and shall promptly provide UMass and CytRx with all material correspondence received from or delivered to the FDA or the institution at which the Phase I Trial will be conducted relating to the IND or Phase I Trial.
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, Xxxxxxx may elect [***] Xxxxxxx 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. Xxxxxxx 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 Xxxxxxx shall prepare the clinical trial protocol. Fate shall provide the IND application to Xxxxxxx 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 Xxxxxxx 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.
