Examples of IND Filing in a sentence
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 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.
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.
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.