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).
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Clinical Milestone. Borrower shall not have observed any materially adverse data from Borrower’s LIQ861 Phase 3 study as of December 31, 2018.
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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:
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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
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Clinical Milestone. With respect to at least one internally developed product, Borrower shall achieve final, positive Phase 1 data by April 30, 2017.
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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.
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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.
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Clinical Milestone. Borrower shall receive FDA approval for Borrower’s LIQ865 IND by August 31, 2017.
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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.
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Related to Clinical Milestone

  • Development Milestones In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving (either itself or through the acts of a SUBLICENSEE) the following development milestones in its diligence activities under this AGREEMENT: (a) (b).

  • Commercial Milestones (a) Within [*****] calendar days after the end of the first Calendar Year in which aggregate annual Net Sales for that Calendar Year for the Licensed Product in the Territory reach any threshold indicated in the Commercial Milestone Events listed below, EverInsight shall notify VistaGen of the achievement of such Commercial Milestone Event and VistaGen shall invoice EverInsight for the corresponding non-refundable, non-creditable Milestone Payment set forth below and EverInsight shall remit payment to VistaGen within [*****] Business Days after the receipt of the invoice, as described in Section 8.6 (Currency; Exchange Rate; Payments). Annual Net Sales Milestones for Licensed Product Milestone Payments (in Dollars) (each a “Commercial Milestone Event”): (1). [*****] (2). [*****] (3). [*****] (4). [*****] (5). [*****] (b) For the purposes of determining whether a Net Sales Milestone Event has been achieved, Net Sales of Licensed Product(s) in the Territory shall be aggregated. For clarity, the annual Net Sales Milestone Payments set forth in this Section 8.3 (Commercial Milestones) shall be payable only once, upon the first achievement of the applicable Commercial Milestone Event, regardless of how many times such Commercial Milestone Event is achieved. (c) If a Commercial Milestone Event in Section 8.3 (Commercial Milestones) is achieved and payment with respect to any previous Commercial Milestone Event in Section 8.3 has not been made, then such previous Commercial Milestone Event shall be deemed achieved and EverInsight shall notify VistaGen within fifteen (15) calendar days of such achievement. VistaGen shall then invoice EverInsight for such unpaid previous Commercial Milestone Event(s) and EverInsight shall pay VistaGen such unpaid previous milestone payment(s) within thirty (30) Business Days of receipt of such invoice. (d) In the event that, VistaGen believes any Commercial Milestone Event under Section 8.3(a) has occurred but EverInsight has not given VistaGen the notice of the achievement of such Commercial Milestone Event, it shall so notify EverInsight in writing and shall provide to EverInsight data, documentation or other information that supports its belief. Any dispute under this Section 8.3(d) (Commercial Milestones - subsection (d)) that relates to whether or not a Commercial Milestone Event has occurred shall be referred to the JSC to be resolved in accordance with ARTICLE 3 (Governance) and shall be subject to resolution in accordance with Section 14.10 (Dispute Resolution). The Milestone Payments made for each Commercial Milestone Event shall be non-creditable and non-refundable.

  • Development Milestone Payments TriSalus shall pay (or cause to be paid) to Dynavax, in accordance with and subject to the terms of this Section 2.3, Section 2.4 and Section 6.4 (each such milestone, a “Development Milestone”, and each payment in respect thereof, a “Development Milestone Payment”): (i) Upon the successful completion by a Milestone Obligor after the Closing of a [**] study with respect to a Product using PEDD, a payment of [**] US Dollars ($[**]), with such Development Milestone Payment being payable only once (for purposes of the foregoing, successful completion means completion of such study in accordance with the plan for such study); (ii) For the first patient Dosed by a Milestone Obligor in each Phase 1 Clinical Trial for a Product for each Indication, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (iii) For the first patient Dosed by a Milestone Obligor in each Phase 2 Clinical Trial for a Product for each Indication, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (iv) For each Phase 2 Clinical Trial for a Product for each Indication conducted by or on behalf of a Milestone Obligor meeting the primary endpoint for such Phase 2 Clinical Trial based on full tables, figures and listings or continued development of such Product for the same Indication as such Phase 2 Clinical Trial, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (v) For each Phase 3 Clinical Trial for a Product for each Indication conducted by or on behalf of a Milestone Obligor meeting the primary endpoint for such Phase 3 Clinical Trial based on full tables, figures and listings or continued development of such Product for the same Indication as such Phase 3 Clinical Trial, a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products are in development by Milestone Obligor; (vi) Upon receipt by a Milestone Obligor of each Regulatory Approval for any Product for any Indication in the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval; (vii) Upon receipt by a Milestone Obligor for each Regulatory Approval of any Product for any Indication in any country or region outside the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments, regardless of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval; (viii) Upon receipt by a Milestone Obligor for each Regulatory Approval for a Product with Orphan Drug Exclusivity for each Indication of a Product in the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments (which, for clarity, shall be payable in addition to the Development Milestone payable under Section 2.3(a)(vi) for receipt of such Regulatory Approval), regardless of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval; and (ix) Upon receipt by a Milestone Obligor for each Regulatory Approval for a Product with Orphan Drug Exclusivity for each Indication of a Product in any country or region outside the U.S., a payment of [**] US Dollars ($[**]), up to a maximum of [**] such payments (which, for clarity, shall be payable in addition to the Development Milestone payable under Section 2.3(a)(vii) for receipt of such Regulatory Approval), regardless ​ of how many Indications are pursued for a Product or how many Products achieve Regulatory Approval.

  • Milestone Event Milestone Payment [***] [***]

  • Milestone A principal event specified in the Contract Documents including the Material Completion and Occupancy Date and other events relating to an intermediate completion date or time.