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. BeiGene shall pay to Mirati the following non-refundable, non-creditable milestone payments set forth in the table below. 27 *** Confidential Treatment Requested Execution Milestone Event Milestone Payment (USD) […***…] US $[…***…] […***…] US $[…***…]
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. Clinical Development Milestone Event Milestone Payment (USD) [***] US $[***] [***] US $[***]
Clinical Development Milestones. With respect to each Type I Product and each Type II Product in the Fields, Merck shall pay to Idera the following milestone payments upon the achievement of such milestones subject to the terms and conditions of this Agreement.
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.
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”):
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. For clarity, the provisions of only one of the milestone clauses (a) or (b) of this Section 8.2.1 will apply for any Phase 3 clinical study of a Licensed Product under the Global Development Plan, depending on whether or not Geron has exercised its US Opt-In Rights pursuant to Section 2.2.2 as further provided below. In the event that a combined Phase 2/3 clinical study is conducted in respect of a Licensed Product (irrespective of whether that study is initially established as a combined study or transitions into a combined study once it is under way), where the Phase 2 part of that study satisfies the definition of a “Phase 2” clinical study and the Phase 3 part of that trial satisfies the definition of a “Phase 3” clinical study hereunder, the milestone payment set forth in Section 8.2.1(a) or (b), as applicable, shall be payable upon the first dosing of a Licensed Product in the [*] human subject in the Phase 3 part of such clinical study.
Clinical Development Milestones. ➢ $100,000 upon dosing of the first human subject in a Phase I clinical trial of a Licensed Product; ➢ $250,000 upon dosing of a first human subject in a Phase II clinical trial of a Licensed Product; ➢ $500,000 upon dosing of a first human subject in a Phase III clinical trial of a Licensed Product; ➢ $500,000 upon filing of an BLA with FDA (or EMEA or an equivalent authority in) in any jurisdiction, for a Licensed Product; ➢ $1,000,000 following the first commercial sale of a Licensed Product; ➢ $500,000 for the second commercial sale of a Licensed Product. ➢ $250,000 for the first commercial sale of a Licensed Product for any non-human use.
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)
