IND Filing definition

IND Filing means the filing with a Regulatory Authority in a Major Market Country of an IND.

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

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

Examples of IND Filing in a sentence

In addition, upon written request of the IND Beneficiary, the IND Filing Party shall take all actions necessary to permit the IND Beneficiary to cross-reference such IND/IMPD (in its entirety) in its own Regulatory Materials (including any IND) for a product (including any Collaboration Product) that includes the same Building Block as the Reference Product.
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.
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 the Parties agree that NBIX should respond to the relevant Agency within a period shorter than […***…] but are unable to agree the time period for BIAL’s review, NBIX shall, as a minimum, provide BIAL with a draft of such IND Filing by BIAL at the same time as such IND Filing is first circulated for review within NBIX, and BIAL shall have the same amount of time as NBIX personnel to review and comment on such IND Filing.
Lilly shall use [***] to notify Sigilon in writing of Lilly’s proposed modifications to such IND Filing Package, or its approval thereof, within [***] days of Lilly’s receipt thereof, but in no event later than [***] days of Lilly’s receipt thereof.

More Definitions of IND Filing

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 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. f. The following Paragraph 2.19 shall be added to the Agreement:

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 an application made to a Competent Authority to:

IND Filing means the preparation and filing of a “Notice of Claimed Investigational Exemption for a New Drug” with the U.S. Food and Drug Administration (FDA), or any comparable filing in a foreign jurisdiction.

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