IND Filing definition

IND Filing means the filing of an IND for a Licensed Product with the relevant Regulatory Authority.

IND Filing means an Investigational New Drug Application (as more fully defined in Title 21 CFR 312.22 and 312.23) and all amendments and supplements thereto filed with the FDA.

IND Filing means the acceptance by the FDA of the filing of an IND for the applicable Compound in the U.S.

Examples of IND Filing in a sentence

• Licensee may pay to Kineta a one-time payment in the amount of [***] (which shall be non-creditable and non-refundable) to extend the Option Period from three (3) months after Licensee’s receipt of an IND Filing Package for a Licensed Product to four (4) months after Licensee’s receipt of the Phase I Data Package for such Licensed Product (the “Option Extension Payment”).

• In the event that Santen does not file such IND by the IND Filing Date, Santen can extend the date provided that Santen can show reasonable progress toward meeting the IND Filing Date.

• During the Term of this Agreement, (a) ZAI will use, and will cause each of its Affiliates and any Sublicensees to use, Commercially Reasonable Efforts to Develop, Manufacture, seek Regulatory Approval or Marketing Authorization for, and following Regulatory Approval or Marketing Authorization to Commercialize at least one (1) Licensed Product in the U.S. and E.U. and (b) ZAI covenants and agrees to use its best efforts to file within [*] (the “Initial IND Filing Date”) an IND filing.

• The Research Plan attached hereto as Schedule 1.132 outlines the research activities to be conducted with respect to the initial Licensed Product and directed to the achievement of IND Filing Readiness and manufacture of such initial Licensed Product for a Phase I Clinical Trial.

• Licensee agrees that if it desires to continue further commercial development after completion of the IND Filing, Licensee shall pay all of the deferred royalties due the NIH plus additional royalties as stipulated in Paragraph 9.8 of the Agreement.

More Definitions of IND Filing

IND Filing means the filing of an IND for a Drug Product with the relevant Regulatory Authority.

IND Filing means the filing with the United States Food and Drug Administration (FDA) of an Investigational New Drug (IND) Application in a form suitable for review and processing by the FDA.

IND Filing means the filing of an Investigational New Drug Application (as defined in 21 C.F.R. 312 or any successor regulation) with the FDA or the equivalent application or filing filed with any equivalent agency or governmental authority in the European Union necessary to commence human clinical trials in such jurisdiction.

IND Filing means the filing of an IND based upon which human clinical testing commences in [CONFIDENTIAL TREATMENT REQUESTED].

IND Filing means the filing of an IND for a Candidate in the Territory.

IND Filing means, on a Program-by-Program basis, the filing of an IND by or on behalf of Exicure for a Licensed SNA or Licensed Product in such Program under the Second R&D Term Plan for such Program, at the sole discretion of Exicure (unless Ipsen exercises its rights under Section 3.7).

IND Filing. [*]the first Investigational New Drug application ("IND") with the United States Food and Drug Administration ("FDA") or foreign equivalent with respect to each Therapeutic Protein Product .