Development and Regulatory Milestones definition

Development and Regulatory Milestones shall have the meaning provided in Section 5.2.
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Development and Regulatory Milestones are specified in Schedule 3.
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Examples of Development and Regulatory Milestones in a sentence

  • Payment for each of the Development and Regulatory Milestones shall be made only once regardless of how many times a Product achieves the corresponding Development and Regulatory Milestone, and no payment shall be due for any Development and Regulatory Milestone which is not achieved.

  • Each such report shall include an update regarding Development activities conducted by or on behalf of Buyer (including activities conducted under the Development Plan) and progress towards achieving the Development and Regulatory Milestones.

  • TAIHO shall notify Arcus in writing within [***] days after the Achievement of any Development and Regulatory Milestones.

  • Licensee shall notify AstraZeneca promptly of the achievement of each of the events identified as a milestone in Section 4.2.1 (Milestones; Development and Regulatory Milestones) or Section 4.2.2 (Milestones; Commercial Milestones).

  • The Development and Regulatory Milestones shall be as follows: Development and Regulatory Milestone Payment [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] Buyer shall provide Seller with written notice within thirty (30) days after the achievement of the corresponding Development and Regulatory Milestone.

  • The maximum aggregate amount payable by Vir pursuant to this Section 6.3.1 (Development and Regulatory Milestones) is Three Hundred Twenty-Three Million Dollars ($323,000,000).

  • Below grade piping and trenching will be used to connect wells located in roads/access-ways to the main manifold or branch lines at above grade locations.

  • In the event that Vir has not provided Sanofi notice of achievement of a particular Milestone Event as provided in Section 6.3.1 (Development and Regulatory Milestones) or Section 6.3.2 (Sales Milestones), Sanofi believes that any such Milestone Event has been achieved by Vir or its Affiliates or its or their Sublicensee with respect to a Licensed Product, then it shall so notify Vir in writing and the Parties shall promptly meet and discuss in good faith whether such Milestone Event has been achieved.

  • Each milestone payment in this Section 6.2.1 (Development and Regulatory Milestones) shall be payable only once, upon the first achievement of such milestone by the first Licensed Product for such Indication, and no milestone payment in this Section 6.2.1 (Development and Regulatory Milestones) will be payable for subsequent or repeated achievements of milestone events with respect to one or more of the same or different Licensed Products for the same Indication.

  • Midatech shall (i) use all reasonable efforts to (a) research, Develop, and obtain and maintain Regulatory Approvals for, Licensed Products in accordance with the Development Plan and the timelines set forth therein and (b) achieve the Development and Regulatory Milestones, and (ii) administer the first dosing of the first human subject in a Clinical Trial of a Licensed Product on or before [***].

Related to Development and Regulatory Milestones

  • Development Milestone is defined in Section 5.3.

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

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

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

  • Development Plan has the meaning set forth in Section 3.2.

  • 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.

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

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Development Program means the implementation of the development plan.

  • Commercialization Plan has the meaning set forth in Section 6.2.

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

  • 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).

  • Development Schedule shall have the meaning set forth in Section 1.1.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Development Phase means the period before a vehicle type is type approved.

  • Development Work means any work carried out in relation to the physical construction of a mine;

  • 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 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 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 Events has the meaning set forth in Section 7.2.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

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

  • 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.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following: