Development and Regulatory Milestone Payment definition

Development and Regulatory Milestone Payment has the meaning set forth in Section 6.2.1.
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.

  • Each Development and Regulatory Milestone Payment shall be payable only once for each Licensed Product that achieves such corresponding Development and Regulatory Milestone Event.

  • 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 [***].

  • 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.

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  • In the event that Development and regulatory Milestone Event 2, 3, 4,or 5 above is achieved before Development and regulatory Milestone Event 1, 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, 4 or 5, as the case may be.

  • Between 1980 and 1983, 4853 S&Ls, which were holding portfolios consisting primarily of traditional fixed-rate mortgages, failed after the short-term interest rates paid to depositors rose to historic levels.82 Regulation Q interest rate ceilings, which stemmed from the Banking Acts of 1933 and 1935, imposed interest rate ceilings on time and savings deposits.

  • Upon receipt of a notice of achievement of such Development and Regulatory Milestone, [*] with respect to the corresponding Development and Regulatory Milestone Payment.

Related to Development and Regulatory Milestone Payment

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

  • Development Milestone Event has the meaning set forth in Section 7.1.

  • 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, if applicable, must be completed by the relevant Milestone Date;

  • Sales Milestone Payment is defined in Section 5.3.

  • 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 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 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 human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

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

  • Development Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

  • 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 out-of-pocket costs and expenses incurred by Adapt or its Affiliates directly attributable to, or reasonably allocable to, the Commercialization of a Product. Commercialization Costs for a Product shall include, preparation of promotional, advertising, communication, medical, and educational materials relating to the Product and other Product literature and selling materials, activities directed to marketing of the Product, including purchase of market data, development and conduct of market research, advertising, public relations, public affairs and other communications with Third Parties regarding the Product; development and conduct of sales force training (including materials, programs and travel to and attendance at training programs) for medical representatives responsible for promoting the Product; and development and maintenance of sales bulletins, call reporting and other monitoring/tracking, sales force targeting, validation and alignment programs and documentation.

  • 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 clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • 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.