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.
Sample 1

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.

  • Sorrento Additional Anti-PD-1 Products.8.6.2.(a) Development and Regulatory Milestones.

  • Servier Additional Anti-PD-1 Products.8.6.1.(a) Development and Regulatory 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.

  • 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).

  • Notwithstanding anything to the contrary in this Section 5, until the Change of Control Redemption Price (together with any interest thereon) is paid in full, the Conversion Amount submitted for redemption under this Section 5(b) (together with any interest thereon) may be converted, in whole or in part, by the Holder into shares of Common Stock pursuant to Section 3.

  • Nothing in this Section 6.2.1 (Development and Regulatory Milestones) shall be construed as to limit or otherwise cap any payments owed to Sanofi Kymab under any other provision of this Agreement, including without limitation Section 6.5 (Sublicense Income; Transfer Income).

  • For clarity, the Development and Regulatory Milestones (and payments related thereto) set forth in Section 7.2(a) of the Agreement, and as may otherwise be added for other Licensed Products in an Additional​​Field as addressed by Section 2.4 of the Agreement, shall remain in place for uses of the Licensed Product in the Field and Additional Fields which are not in the COVID-19 Field.

Related to Development and Regulatory Milestones

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

  • 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, 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.

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

  • 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.

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

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

  • Development Work means the conduct of preclinical and clinical trials, the compilation of the regulatory dossier concerning Licensed Products and the conduct of other work necessary or useful for obtaining Regulatory Approval of Licensed Products.

  • 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 3.3 (Milestone Payments).

  • 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:

  • 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.