Development Milestone Events definition

Development Milestone Events has the meaning set forth in Section 3.2.
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Development Milestone Events means those Development milestone events to be achieved by Licensee in connection with the performance of its Development activities with respect to the TAK-385 Licensed Compound and TAK-385 Licensed Products, as set forth in the TAK-385 Development Plan.
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Development Milestone Events has the meaning set forth in Section 10.2.1 (Development Milestone Events and Payments).
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Examples of Development Milestone Events in a sentence

  • If a Development Milestone Event for a Target is skipped (i.e., a later Development Milestone Event for a Target is payable before the achievement of an earlier Development Milestone Event for such Target), then the Development Milestone Payments for such earlier-listed and skipped Development Milestone Events for such Target will be deemed to have been achieved upon the achievement of the subsequent Development Milestone Event; [***].

  • Furthermore, if a Development Milestone Event is achieved for a given Preclinical Compound before a prior Development Milestone Event (“prior” and “subsequent” referring to a lower number in the table above, e.g., Development Milestone Event 2 being “prior” to Development Milestone Event 3), then all such prior Development Milestone Events shall be deemed achieved upon achievement of the subsequent Development Milestone Event.

  • If Xxxxxxx or its Affiliates or Sublicensees achieve all Development Milestone Events with respect to Products that are the subject of a particular Research Program (regardless of the number of times such events occur or the number of Products that trigger such event), then the maximum amount payable by Xxxxxxx with respect to a particular Research Program under this Section 8.5 (Development Milestones) is [***] .

  • Unless earlier terminated in accordance with the provisions set forth herein this Agreement shall remain in effect from the Effective Date until the earlier of the expiration of all Target Exclusivity Periods or completion of all Development Milestone Events (the “Term”), provided, however, that the Term shall expire upon expiration of Wind Down Period, if the Target Exclusivity Periods expire pursuant to Section 3.2.5.

  • As additional consideration for the conduct of the Research Collaboration, for each Genentech Draft Pick Target, Licensee shall owe milestone payments to Constellation for the first Collaboration Compound or Licensed Product directed to such Genentech Draft Pick Target to achieve the Research and Development Milestone Events as set forth in this Section 5.4 (each such payment, a “Research and Development Milestone Payment”).

  • In the event that Receptos concludes that the contents of such Annual Update is insufficient to determine whether or not one or more Research Milestone Events and Development Milestone Events has been achieved by ONO, Receptos shall have the right to request ONO to provide further detailed information relating to the subject matter of such Annual Update in order to make such determination, and ONO shall in good faith respond to Receptos’ request.

  • In the first example, the sublicense development milestone events are the same as the Development Milestone Events in this Agreement.

  • In the second example, the sublicense development milestone events in some cases precede the Development Milestone Events in (his Agreement, and in other cases, follow the Development Milestone Events.

  • ONO shall provide Receptos with an Annual Update set forth in Section 6.5 in sufficient detail to permit Receptos to understand and confirm as to whether each of Research Milestone Events and Development Milestone Events has been achieved by ONO.

  • Xxxxxxx’x obligations under this Section 5.3 (Development Reports) will terminate on a Research Program-by-Research Program basis following achievement and payment of all Development Milestone Events for a Research Program.


More Definitions of Development Milestone Events

Development Milestone Events shall be as set forth in Section 6.4.
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Development Milestone Events. With respect to one Indication for a Licensed Product
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Development Milestone Events means the Phase I Milestone Event, the Phase II Milestone Event, the Pivotal Trial Milestone Event, the U.S. Approval Milestone Event, and the European Approval Milestone Event.
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Development Milestone Events shall have the meaning set forth in Section 7.2.1.
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Development Milestone Events and the development milestone payments set forth in Table 10.2.1 the “Development Milestone Payments”). Table 10.2.1 – LICENSED PRODUCT DEVELOPMENT MILESTONES Development Milestone Events For Licensed Products Development Milestone Event Payment (in U.S. Dollars) [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****]
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Related to Development Milestone Events

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

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

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

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

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

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

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

  • 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.

  • 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;

  • 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.

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

  • Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.

  • 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 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 II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

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

  • Milestone Payment Date has the meaning set forth in Section 2.4(a).

  • 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 I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • 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 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.