IND Filing Sample Clauses

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. 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. [***] U.S. Dollars ($[***]) upon the filing in the U.S. of an IND with the FDA for the first Licensed Product.

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. 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. 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. 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.