Clinical Development Milestones Clause Samples
The Clinical Development Milestones clause defines specific objectives or achievements that must be reached during the clinical development phase of a project, such as the completion of certain clinical trials or regulatory submissions. These milestones typically serve as benchmarks for progress and may trigger payments, reporting obligations, or other contractual actions when achieved. By clearly outlining these key development targets, the clause ensures both parties have a shared understanding of expectations and timelines, thereby facilitating project management and reducing the risk of disputes over performance or deliverables.
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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. 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. 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. 28 *** Confidential Treatment Requested […***…] US $[…***…] […***…] US $[…***…]
Clinical Development Milestones. IgA Nephropathy
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. ➢ $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. 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. Additional Indications (if any)
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.
(a) Geron Opt-Out. If, and only if, Geron has not notified ▇▇▇▇▇▇▇ of ▇▇▇▇▇’▇ exercise of US Opt-In Rights prior to the expiration of the Geron Election Period, each of the following milestone payments shall be due from ▇▇▇▇▇▇▇ to ▇▇▇▇▇ one time only, upon the first achievement of the specified milestone event for a Licensed Product:
(i) [*] [*] ($[*])
(ii) [*] [*] ($[*])
(iii) [*] [*] ($[*])