Commercial Milestone Events definition

Commercial Milestone Events has the meaning set forth in Section 3.3.
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Commercial Milestone Events has the meaning set forth in Section 6.2.2 (Commercial Milestones).
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Commercial Milestone Events has the meaning set forth in Section 8.2.2.
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Examples of Commercial Milestone Events in a sentence

  • The same goes for the collateral effects of medication: the pharmaceutical industry is generated by collateral effects, since curing a disease can cause another malfunction of a body.

  • 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.

  • Within [*] following ELUMINEX’s receipt of such invoice, ELUMINEX shall pay such Commercial Milestone Payment to FIBROGEN in accordance with Section 3.6.1. For clarity, each Commercial Milestone Payment shall be payable by ELUMINEX only once, regardless of the number of times each such Commercial Milestone Event is achieved, and Net Sales of any Product outside its Royalty Term shall not count towards the [*] for determining Commercial Milestone Events.

  • The Development/Regulatory Milestone Events and Commercial Milestone Events may be referred to individually or collectively as “Milestone Events,” and Development/Regulatory Milestone Payments and Commercial Milestone Payments may be referred to individually or collectively as “Milestone Payments”.

  • If Gilead or its Affiliates or Sublicensees achieve all of the Commercial Milestone Events with respect to all applicable Financial Products, then the Commercial Milestone Payments payable by Gilead under this Section 9.5 (Commercial Milestone Payments) will not exceed (i) [**] with respect to the COM503 Financial Product, and (ii) [**] with respect to the Second Financial Product.

  • BIMA will pay the milestone payments for PD Commercial Milestone Events and Non-PD Commercial Milestone Events that are achieved in the U.S. when such amounts become due and payable in accordance with Section 7.2.2 (PD Commercial Milestone Payments) and Section 7.3.2 (Non-PD Commercial Milestone Payments).

  • BIMA will pay the milestone payments for PD Commercial Milestone Events and Non-PD Commercial Milestone Events that are achieved in the U.S. when such amounts become due and payable in accordance with Sections 2.1.1 (PD Milestone Payments) and 2.2.1 (Non-PD Milestone Payments).

  • The maximum aggregate amount payable by Takeda pursuant to this Section ‎8.4 is [***] In the event that any of the Commercial Milestone Events set forth in this Section ‎8.4 occurs and any of the preceding Commercial Milestone Events set forth in this Section ‎8.4 have not occurred, then each such skipped Commercial Milestone Payment shall become due and payable concurrently with the Commercial Milestone Payment for the Commercial Milestone Event with respect to which payment is due.

  • The Development Milestone Events and Sales Milestone Events (but not the Commercial Milestone Events) are intended to be sequential, such that satisfaction of any later stage Milestone Event shall be deemed to have satisfied all earlier stage Milestone Events (to the extent not previously satisfied).

  • Contract performance will be measured each month by comparing the number of recorded defects to the number of allowable defects as determined by the AQL.

Related to Commercial Milestone Events

  • Milestone Events has the meaning set forth in Section 7.2.

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

  • Milestone Event has the meaning set forth in Section 8.2.1.

  • Development Milestone is defined in Section 5.3.

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Milestone 2 means achievement of annual Net Sales of at least $35,000,000 during any Calendar Year ending on or before December 31, 2024.

  • Project Milestone means the project milestone set forth in Schedule-J;

  • Milestone 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.

  • Project Milestones means the project milestones set forth in Schedule-G;

  • Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;

  • Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.

  • Milestone Date means the date set against the relevant Milestone in the Implementation Plan;

  • Sales Milestone Payment shall have the meaning set forth in Section 8.4.

  • Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.

  • Milestone Payment has the meaning set forth in Section 4.2.

  • Milestone Failure means a failure by the Grant Recipient fully to achieve any Milestone by the relevant Milestone Date;

  • Milestones means control points in the project that help to chart progress. Milestones may correspond to the completion of a key deliverable, allowing the next phase of the work to begin. They may also be needed at intermediary points so that, if problems have arisen, corrective measures can be taken. A milestone may be a critical decision point in the project where, for example, the consortium must decide which of several technologies to adopt for further development.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.