Developmental Milestones Clause Samples
The Developmental Milestones clause establishes specific benchmarks or stages that must be achieved during the course of a project or agreement. Typically, it outlines key deliverables, deadlines, or performance criteria that signal progress, such as completing a prototype, passing a test phase, or reaching a certain level of functionality. By clearly defining these milestones, the clause helps track progress, ensures accountability, and provides a basis for evaluating whether the project is on schedule, thereby reducing ambiguity and managing expectations between the parties involved.
Developmental Milestones. Borrower shall ensure that:
(a) Not later than September 30, 2016, at least one patient shall have enrolled in a Phase 3 clinical trial for KD019-101 for the treatment of autosomal dominant polycystic kidney disease.
(b) Not later than December 31, 2016, at least one patient shall have enrolled in a Phase 2b clinical trial for KD025-205 for the treatment of psoriasis.
(c) Not later than December 31, 2016, the FDA shall have accepted an NDA for a 505(b)(2) for trientine for the treatment of ▇▇▇▇▇▇’▇ Disease.
Developmental Milestones. Developmental Milestones by COMPANY for a LICENSED PRODUCT in accord with Paragraph 5.3 are as follows: Complete IND enabling study 2020 Initiate animal toxicology study last half 2020 File IND first half 2021 Complete PHASE I CLINICAL TRIAL first half of 2022 Commence PHASE II CLINICAL TRIAL 2024 Commence PHASE III CLINICAL TRIAL 2026 Regulatory approval, US or foreign equivalent 2026
Developmental Milestones. Novartis will notify ▇▇▇▇▇ of the first achievement of any of the Milestone Events set forth below within [***] after their achievement. In addition to (and not in lieu of) royalty payments due under this Agreement, Novartis shall pay to ▇▇▇▇▇ the following one-time, non-refundable, non-recoupable, non- creditable milestone payments no later than [***] after receipt of an invoice for the same, which will be issued following receipt of Novartis’ notice, via wire transfer in immediately available funds to the account specified in writing by ▇▇▇▇▇: [***] $ [*** ] [***] $ [*** ] [***] $ [*** ] Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Developmental Milestones. Within thirty (30) days after the first achievement of each of the milestone events set forth in the table below by Virpax or any Related Party in relation to a Product, Virpax shall provide MedPharm with written notice of such achievement and shall pay to MedPharm the corresponding one-time milestone payment set forth below (each a “Developmental Milestone”):
Developmental Milestones. As partial satisfaction of the requirements or the developmental program above and subject to the subsequent paragraph, Assignee shall achieve the following developmental milestones by the dates set forth below:
(i) File an IND application for at least one Product within two years of Closing of this Agreement;
(ii) Initiate clinical studies for at least one Product within three years of Closing of this Agreement;
(iii) Commercialize at least one Product within five years of Closing this Agreement;
(iv) Other diligence provisions as agreed on by the Parties in writing;
Developmental Milestones. (a) Borrower shall have received approval from the FDA to market a generic trientine hydrochloride formulation (based upon the development program currently known as KD034) by December 31, 2019.
(b) Borrower shall have fully enrolled its KD025-213 clinical study of 126 total patients for KD025 for the treatment of Chronic Graft-Versus-Host Disease (cGVHD) by December 31, 2019.
Developmental Milestones. With respect to each Royalty Bearing Product, Licensee shall make the following non-creditable, non-refundable developmental milestone payments to DFCI within [***] days of the occurrence of the following events, whether Licensee, an Affiliate, Sublicensee, a permitted assignee, or a successor achieves the events. For the avoidance of doubt, all development milestone payments are payable [***]. [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***] $[***] [***] $[***]
Developmental Milestones. (a) Not later than December 31, 2017, at least one patient shall have enrolled in a Phase 3 clinical trial for KD019-101 for the treatment of autosomal dominant polycystic kidney disease.
(b) Not later than December 31, 2016, at least one patient shall have enrolled in a Phase 2b clinical trial for KD025-205 for the treatment of psoriasis.
(c) Not later than December 31, 2016, the Borrower shall have submitted to FDA for acceptance an NDA for a 505(b)(2) or an abbreviated new drug application for trientine for the treatment of ▇▇▇▇▇▇’▇ Disease.
(d) Not later than June 30, 2017, the Borrower shall have, for the purposes of advancing IND #069215 towards FDA approval, initiated a new clinical trial for KD019 (separate and distinct from the clinical trial referred to in clause (a) above) for the treatment of non-small cell lung cancer (NSCLC) with activating EGFR mutations and brain metastases or leptomeningeal disease.”
(d) Section 10 of the Existing Credit Agreement is hereby amended by adding new Section 10.03 to read as follows:
Developmental Milestones. Within 30 business days of the achievement of each of the milestone events set forth in the table below (each a “Developmental Milestone”) by Virpax or any Related Party, Virpax shall provide Lipocure with written notice of such achievement and shall pay to Lipocure the corresponding one-time milestone payment set forth next to the applicable milestone in the table below:
Developmental Milestones. Subject to Section 4.2(c) below, within ninety (90) days of the first achievement of each of the milestone events set forth in the table below by Provention or any Related Party, Provention shall provide Vactech with written notice of such achievement and shall pay to Vactech the corresponding one-time milestone payment set forth below (each a “Developmental Milestone”):