IND Filing definition

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

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 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.

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.

• Miksche62Johanna Miksche had no living relatives save an 87-year-old sister (Ursula Lill) and nephews who lived in Germany (Heinz, Johann, and Hannes).

• Licensee also agrees that it will immediately pay all of the deferred royalties due the NIH plus an additional royalty upon obtaining third party financing prior to the IND Filing date, upon termination or expiration of the CRADA, or termination of the Agreement prior to the IND Filing date.

• A determination of whether a given commercial act is contrary to honest practices will have to be reviewed in relation to national laws for the protection against unfair competition.

More Definitions of IND Filing

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 with the FDA or the EMA for a Program Compound.

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

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

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 .

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