Development and Regulatory Milestone Payment definition

Development and Regulatory Milestone Payment has the meaning set forth in Section 6.2(a).
Sample 1
Development and Regulatory Milestone Payment is defined in Section 13.7 (Development and Regulatory Milestones).
Sample 1Sample 2
Development and Regulatory Milestone Payment has the meaning set forth in Section 10.2.1 (Regulatory Milestones). 1.66 “Development Data” has the meaning set forth in Section 4.7 (Licensee Data Disclosure and Use). 1.67 “Development Report” has the meaning set forth in Section 4.6 (Development Reports). 1.68 “Disclosing Party” has the meaning set forth in Section 11.1.1 (Duty of Confidence). 1.69 “Dispute” has the meaning set forth in Section 16.1 (Exclusive Dispute Resolution Mechanism). 1.70 “Dollar” means the U.S. dollar, and “$” will be interpreted accordingly. 1.71 “Effective Date” has the meaning set forth in the Preamble. 1.72 “Entity” has the meaning set forth in Section 10.11.5 (No Partnership). 1.73 “Executive Officers” has the meaning set forth in Section 3.4.2 (Decisions of the JSC). 1.74 “Exploit” means to make, have made, use, import, export, offer to sell, sell, Develop, Manufacture, perform Medical Affairs activities for, Commercialize, or otherwise exploit. “Exploitation” will be construed accordingly. 1.75 “FD&C Act” means the United States Federal Food, Drug and Cosmetic Act, as amended from time to time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).
Sample 1

Examples of Development and Regulatory Milestone Payment in a sentence

  • Notwithstanding Sections 5.1-5.3 above, in the event that TAIHO concurrently exercises an Option with respect to Licensed Products from two (2) or more Arcus Programs that are being Developed as a combination therapy (an “Intra-Portfolio Combination”) then each Option Exercise Payment and Development and Regulatory Milestone Payment for such Licensed Products included in such Intra-Portfolio Combination will be reduced by [***] percent ([***]%).

  • In the event that Development and Regulatory Milestone Event 2, 3 or 4 below is achieved before Development and Regulatory Milestone Event 1, then then the Development and Regulatory Milestone Payment for 1 shall become due and payable upon the achievement of Development and Regulatory Milestone Event 2, 3 or 4, as the case may be.

  • 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 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.

  • During the [***] following the delivery of a Development and Regulatory Milestone Dispute Notice, Purchaser and Seller or the Seller Representative shall attempt in good faith to resolve any dispute as to whether any Development and Regulatory Milestone Event has occurred and whether any Development and Regulatory Milestone Payment is payable.

  • Zymeworks shall provide an invoice for the corresponding Development and Regulatory Milestone Payment, and Atreca shall make the corresponding payment in accordance with Section 6.1.1. Atreca shall provide Zymeworks with written notice of the first achievement (either by Atreca, its Affiliate or Sublicensee) of each Commercialization Milestone Event [***] in accordance with Section 6.1.3, and shall make the corresponding milestone payment [***].

  • In addition, at any time Warrant Agent may apply to any officer of Company for instruction, and may consult with legal counsel for Company with respect to any matter arising in connection with the services to be performed by the Warrant Agent under this Agreement.

  • With respect to Development and Regulatory Milestone Events other than those for Market Approval in a country or region, if a latter event is achieved before an earlier event, then the Development and Regulatory Milestone Payment for the earlier Development and Regulatory Milestone Event shall become due and payable upon the achievement of the next Development and Regulatory Milestone.

  • Development and Regulatory Milestone Event Development and Regulatory Milestone Payment 1.

  • For clarity, each Development and Regulatory Milestone Payment shall be made only once, regardless of the number of times the corresponding Development and Milestone Regulatory Event is achieved (and regardless of whether the corresponding Development and Milestone Regulatory Event is achieved for more than one Licensed Product in the Licensed Territory).

Related to Development and Regulatory Milestone Payment

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

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

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

  • Sales Milestone Payment has the meaning set forth in Section 8.3.1.

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

  • 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 Event has the meaning set forth in Section 8.4.

  • 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.

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

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

  • 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 Plan has the meaning set forth in Section 3.2.

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

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

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

  • 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).

  • Development Program means the implementation of the development plan.

  • Commercialization Costs means the sum of the following costs and expenses incurred by the Parties or their respective Affiliates, in Commercializing the Shared Products (and related Manufacturing activities) in the Territory, in each case, to the extent incurred in accordance with the Commercialization Plan and Commercialization Budget:

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

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • 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.