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

  • With regard to the Commercial Milestone Events in section 9.2.1(c), [*****].

  • A portion of the payments described in Table 2 below (each, a “Commercial Milestone Payment” and together with the Development Milestone Payments the “Milestone Payments”) shall be payable to Seller following first instance of its achievement of the corresponding event with respect to the Product (each a “Commercial Milestone Event” and together with the Commercial Milestone Events the “Milestone Events”) described in the row to the left of such payment in Table 2.

  • Upon receipt of this report, Precision will provide an invoice for the applicable royalty payments and Milestone Payments corresponding to Commercial Milestone Events, and Novartis will pay Precision the foregoing royalties and Milestone Payments corresponding to Commercial Milestone Events in accordance with Section 9.7.

  • 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.

  • Notwithstanding anything herein to the contrary, for purposes of the Commercial Milestone Events, on a Collaboration Target-by-Collaboration Target basis, “Annual Net Sales” means [***].

  • Newsoara shall (and shall ensure that its Affiliates and Sublicensees will) maintain complete and accurate records in accordance with Accounting Standard and in sufficient detail to permit Genelux to confirm the accuracy of Net Sales reported by Newsoara, the achievement of Commercial Milestone Events, and amounts payable under this Agreement.

  • Each Party shall keep complete, true and accurate books and records in accordance with its Accounting Standards in relation to this Agreement in sufficient detail to permit the other Party to confirm the accuracy of the amount of Collaboration Costs subject to sharing or reimbursement, royalty payments, and achievement of Commercial Milestone Events.

  • If in a given Calendar Year more than one Commercial Milestone Events are achieved, Licensee shall pay to AstraZeneca a separate Commercial Milestone Payment with respect to each Commercial Milestone Event achieved.

  • If Gilead or its Affiliates or Sublicensees achieve all of the Commercial Milestone Events (regardless of the number of times such events occur), then the Commercial Milestone Payments payable by Gilead under this Section 10.3 (Commercial Milestone Payments) will not exceed [***].

  • 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).

Related to Commercial Milestone Events

  • Milestone Events has the meaning set forth in Section 3.3 (Milestone Payments).

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

  • Milestone Event has the meaning set forth in Section 8.4.

  • 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 has the meaning set forth in Section 8.3.1.

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

  • Milestone Payment means a payment identified in the Implementation Plan to be made following the issue of a Satisfaction Certificate in respect of Achievement of the relevant Milestone;

  • 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, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • 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 pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • 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 large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • 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 of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.