Clinical Development Milestones. RevitaLid shall perform all actions necessary to obtain FDA approval of a Licensed Product, including but not limited to the development of formulations, the conduct of pre-clinical studies and the preparation of filings with the FDA. Without limiting the generality of the foregoing, within twelve (12) months after reaching the Initial Fundraising Target (the “Clinical Development Deadline”), RevitaLid shall have filed an Investigational New Drug Application with the FDA. Licensor may in its sole discretion consent, in writing, to extend the Clinical Development Deadline. If Licensor indicates, in writing, that such consent is withheld, then this Agreement shall terminate in accordance with Section 4.2.2, and all licenses granted hereunder shall revert to Licensor.
Clinical Development Milestones. After the first achievement of each of the following milestone events with respect to a Licensed Product (each, a “Clinical Development Milestone Event”), Licensee shall pay to Mirati the corresponding non-refundable, non-creditable and not subject to set-off, milestone payments set forth in the table below. [***] US $[***] [***] US $[***]
Clinical Development Milestones. BeiGene shall pay to Mirati the following non-refundable, non-creditable milestone payments set forth in the table below. 27 *** Confidential Treatment Requested […***…] US $[…***…] […***…] US $[…***…]
Clinical Development Milestones. Initiation of the first Phase Ib Clinical Trial of a Licensed Product in the Field $[***] Initiation of the first Phase II Clinical Trial of a Licensed Product in the Field $[***] Initiation of the first Phase III Clinical Trial of a Licensed Product in the Field $[***] FDA accepting for filing of an NDA for a Licensed Product in the Field $[***] EMEA accepting for filing of a Marketing Authorization Application for a Licensed Product in the Field $[***] A Regulatory Authority in Asia accepting for filing of an NDA for a Licensed Product in the Field $[***] FDA approving an NDA for a Licensed Product in the Field $[***] EMEA approving Marketing Authorization Application for a Licensed Product in the Field $[***] A Regulatory Authority in Asia approving an Regulatory Approval Application for a Licensed Product in the Field $[***] Cumulative worldwide Gross Sales equals or exceeds $[***] $[***] upon achievement Cumulative worldwide Gross Sales equals or exceeds $[***] $[***] upon achievement, but no sooner than 1st day of a new fiscal year after payment of 1st sales performance milestone Cumulative worldwide Gross Sales equals or exceeds $[***] $[***] upon achievement, but no sooner than 1st day of a new fiscal year after payment of 2nd sales performance milestone Cumulative worldwide Gross Sales equals or exceeds $[***] $[***] upon achievement, but no sooner than 1st day of a new fiscal year after payment of 3rd sales performance milestone
Clinical Development Milestones. Milestone Event (per Collaboration Target) Payment for BI Collaboration Projects Payment for Forma Collaboration Projects [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] If at the time any milestone payment is due for a Collaboration Target, the payment for any preceding milestone has not yet been paid, then all such preceding milestone payments shall be due at the time the most recent milestone event achieved is due. SoExtProf-Criteria are deemed achieved pursuant to Section 3.4(a) or Section 3.5, but in any event shall be deemed to have been met upon commencement of GLP Tox. The phrase “GLP Tox” means a toxicology study of at least [***] that is conducted in compliance with the then-current good laboratory practice standards promulgated or endorsed by the FDA, as defined in U.S. 21 C.F.R. Part 58 (or such other comparable regulatory standards in jurisdictions outside the U.S. to the extent applicable to the relevant toxicology study, as they may be updated from time to time) and is required to meet the requirements for filing an IND.
Clinical Development Milestones. IgA Nephropathy
Clinical Development Milestones. Additional Indications (if any)
Clinical Development Milestones. For clarity, the following milestone payments shall each be due from Xxxxxxx to Achillion one time only, upon the first achievement of the specified milestone event for a combination Licensed Product containing an Achillion Single API and at least one additional Single Agent (and not any other type of Licensed Product) in connection with a Multi-DAA Study. If for any reason milestone event (a) is not achieved before milestone event (b) is achieved, then the milestone (a) shall be deemed achieved concurrently with the achievement of milestone (b). If neither of the milestone events (a) and (b) are achieved before a milestone in Section 8.3.2 is achieved, then the milestone events (a) and (b) shall be deemed achieved concurrently with the achievement of the milestone event under Section 8.3.2. Clinical Milestone Event Milestone Payment (US dollars)
(a) [**] [** ] (b) [**] [** ]
Clinical Development Milestones. HenKan shall make the payments set forth below for the Product on reaching the milestone events described below, either by itself or through any sublicensee, ("Milestone Events") in accordance with this Section. Payments for Clinical Development Milestones shall be payable upon the occurrence of a Milestone Event for each formulation of a Product that requires a separate IND or a separate regulatory approval, except that additional payments of Clinical Development Milestones are not required for an IND or a regulatory approval for a different dose of an already approved formulation of a Product for which such milestones have been previously paid, so that, for example, if the milestones below have been paid with respect to a Product as an intravenous formulation for a particular cancer indication, no such additional milestones shall be due for a different dosage of the same product for the same indication. HenKan shall promptly notify CombinatoRx of the occurrence of any such Milestone Event.
(i) dosing by HenKan of first patient in the Phase III of the $ 750,000 Product or (ii) submission by HenKan of first application for Regulatory Approval in the event that Phase II data is sufficient for submission for regulatory approval Submission by HenKan of first application for Regulatory Approval $ 750,000 Receipt by HenKan of first Regulatory Approval $ 750,000
Clinical Development Milestones. Upon the achievement of the First Milestone and the Second Milestone, La Jolla shall issue additional shares of Series E Preferred Stock to GliaMed as follows (the “Milestone Shares” and, together with the Pre-Clinical Shares, the “Shares”):
