Regulatory Milestones definition

Regulatory Milestones means those milestones listed in Section 7.10(c).
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Regulatory Milestones shall have the meaning given to it in Schedule 2;
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Regulatory Milestones shall have the meaning set forth in Section 1.11(d).
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Examples of 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.

  • All payments owed to Selecta under Sections 6.4 (Development Milestones), 6.5 (Regulatory Milestones), 6.6 (Commercial Milestones) and 6.9 (Royalties) are, and shall otherwise be deemed to be, for purposes of the Bankruptcy Laws, “royalties” as defined under the Bankruptcy Laws.

  • For the avoidance of doubt, after giving Selecta notice of its intent to terminate this Agreement pursuant to this Section 9.2(a), Spark shall not be required to make any payments to Selecta for achievement within the Notice Period of any milestone set forth in Section 6.4 (Development Milestones), 6.5 (Regulatory Milestones) or 6.6 (Commercial 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).

  • Within [***] of achievement, Spark shall promptly notify Selecta of the achievement of any milestone event for a Licensed Product in the Field achieved in accordance with Sections 6.4 (Development Milestones), 6.5 (Regulatory Milestones) and 6.6 (Commercial Milestones).

  • Client shall pay OXB the Regulatory Milestone Payments on a Target-by-Target basis as set out in Schedule 2 following the first achievement of the Regulatory Milestones with respect to Licensed Product directed to such Target and subject to the further terms in Schedule 2.

  • 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.

  • COMPANY shall pay to the LICENSOR the following one- time milestone payments: Regulatory Milestones Positive phase 3: * Dollars ($*) US FDA Approval: * Dollars ($*) A study is considered approved when the FDA issues a license.


More Definitions of Regulatory Milestones

Regulatory Milestones means Milestone Events (ii) and (iii) of Section 2.08(a).
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Regulatory Milestones has the meaning set forth in Section 4.2.1.
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Related to 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).

  • 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.

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

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

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

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

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

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

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

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

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

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

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

  • 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 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.

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

  • 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).

  • 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.

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

  • Monitoring Indicator means a measure of HSP performance that may be monitored against provincial results or provincial targets, but for which no Performance Target is set;

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • 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.

  • 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;