Clinical Milestone Clause Samples
A Clinical Milestone clause defines specific, measurable achievements or events that must be reached during the course of a clinical development project. These milestones often include stages such as the completion of patient enrollment, the initiation or completion of clinical trials, or the achievement of regulatory submissions. The clause typically outlines the criteria for each milestone and may tie them to payments, obligations, or the progression of the agreement. Its core practical function is to provide clear benchmarks for progress, ensuring accountability and facilitating the management of timelines and resources in clinical collaborations.
Clinical Milestone. Within thirty (30) days of the achievement of the Phase II Milestone Event (as defined in the Equity Agreement), Ampliphi will pay to Intrexon, according to the timelines and procedures set forth in the Equity Agreement, one of the following: (i) [*****] in cash, or (ii) the Phase II Milestone Shares (as defined in the Equity Agreement).
Clinical Milestone. Borrower shall not have observed any materially adverse data from Borrower’s LIQ861 Phase 3 study as of December 31, 2018.
Clinical Milestone. With respect to at least one internally developed product, Borrower shall achieve final, positive Phase 1 data by May 15, 2017.
2) Section 6.13 of the Agreement is hereby amended and restated, as follows:
Clinical Milestone. Within 90 days following successful completion of the first Phase 2 clinical trial of the Product that favorably meets all primary endpoints, Purchaser shall pay to Seller or its designee(s) one hundred and fifty thousand dollars ($150,000); and
Clinical Milestone. With respect to at least one internally developed product, Borrower shall achieve final, positive Phase 1 data by April 30, 2017.
Clinical Milestone. With respect to at least one internally developed product, Borrower shall file, on or before December 31, 2016, an IND with the FDA or an application for a new clinical trial authorization (CTA) with the Danish Medicines Agency.
Clinical Milestone. Within 90 days following successful completion of two Phase 3 clinical trials of the Product that favorably meet all primary endpoints, Purchaser shall pay to Seller or its designee(s) five hundred thousand dollars ($500,000); provided, however, if the Food and Drug Administration allows Purchaser to submit a New Drug Application upon successful completion of only one Phase 3 clinical trial of the Product, then this payment shall be due within 90 days following successful completion of such one Phase 3 clinical trial of the Product that favorably meets all primary endpoints.
Clinical Milestone. Borrower shall receive FDA approval for Borrower’s LIQ865 IND by August 31, 2017.
Clinical Milestone. The level of achievement of the “Clinical Milestone” objective will be determined based on the Company’s achievement of the Clinical Milestones (as defined below) during the Clinical Milestone Performance Period (as defined below). The level of achievement of the Clinical Milestone objective shall be as follows: The Clinical Milestone objective will be achieved if, at any point during the Clinical Milestone Performance Period, a Clinical Milestone is achieved (as determined by the Compensation Committee based on its sole discretion). Upon the determination by the Compensation Committee of the first achievement of a Clinical Milestone during the Clinical Milestone Performance Period, a number of RSUs equal to the percentage of Aggregate Target RSUs that vests at “Threshold” achievement of the Clinical Milestone objective shall immediately vest. If a second or third Clinical Milestone is achieved during the Clinical Milestone Performance Period, only the additional incremental percentage of the Aggregate Target RSUs shall vest upon determination by the Compensation Committee of the achievement of such Clinical Milestone. For example, if a second Clinical Milestone is achieved, the number of additional RSUs that shall vest shall be equal to the percentage of Aggregate Target RSUs that vests at a “Target” achievement of the Clinical Milestone objective reduced by the number of RSUs that vested upon achievement of the first Clinical Milestone. Each Clinical Milestone may only be achieved once. Notwithstanding the foregoing, none of the RSUs with respect to the Clinical Milestone objective shall vest prior to the first anniversary of the grant date of the RSUs. If any of the Clinical Milestones are achieved (as determined by the Compensation Committee) prior to the first anniversary of the grant date of the RSUs, the number of RSUs that would otherwise have vested upon achievement of such Clinical Milestone (determined as set forth above) shall vest upon such first anniversary, provided that the Participant continues to perform services for the Company on such anniversary date. For the avoidance of doubt, if none of the Clinical Milestones are achieved prior to the end of the Clinical Milestone Performance Period, then the Clinical Milestone objective shall not be achieved.