Development and Regulatory Milestone Event definition

Development and Regulatory Milestone Event has the meaning set forth in Section 6.2(a). 1.42
Sample 1
Development and Regulatory Milestone Event is defined in Section 13.7 (Development and Regulatory Milestones).
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Development and Regulatory Milestone Event has the meaning set forth in Section 10.2.1 (Regulatory Milestones). 1.65 “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 Event in a sentence

  • 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.

  • Licensee shall pay Sanofi the following non-refundable, non-creditable development and regulatory milestone payments described in the tables below for the applicable Development and Regulatory Milestone Events (“Development and Regulatory Milestone Payments”) within [***] after receipt of invoice therefor from Sanofi, which invoice Sanofi shall provide to Licensee following Sanofi’s receipt of notice from Licensee of the achievement of the applicable Development and Regulatory Milestone Event.

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

  • Atreca shall provide Zymeworks with notice of the first achievement (either by Atreca, its Affiliate or Sublicensee) of each Development and Regulatory Milestone Event within the time period specified in Section 5.1.3(a).

  • Then, assume that a different Licensed Product for the same RT Target achieves the first RT Target Development and Regulatory Milestone Event.

  • By way of example and not limitation, assume that a Licensed Product achieves the first RT Target Development and Regulatory Milestone Event for the first (1st) RT Target, and immediately after the Initiation of the Phase II Clinical Trial for such Licensed Product, Moderna decides to discontinue the Development of such Licensed Product Directed Against that RT Target.

  • Notwithstanding the foregoing, Atreca shall have the right to make a public announcement regarding the achievement of any Development and Regulatory Milestone Event or Commercialization Milestone Event under Article 5, provided that Atreca shall provide Zymeworks with no less than [***] (if reasonably possible subject to Applicable Law) in which to review and comment on such announcement, and shall take Zymeworks’ comments into consideration in good faith.

  • Regeneron shall report to CytomX its achievement of each Milestone Event no later than [***] days after the end of the Calendar Quarter of such achievement of such Milestone Event; provided that Regeneron shall use good faith efforts to inform CytomX of any Development and Regulatory Milestone Event within [***] Business Days following achievement of such Milestone Event.

  • Still, these complementarities probably occurred in a context of increased total work time for women, where women who worked for pay continued to provide some amount of nonmarket labor.The gifts of productivity increases and fertility decline that underlie continued growth in the household sector could slow down and even reverse in the near future.

  • Moderna shall provide prompt written notice to Metagenomi upon achievement of a DT Moderna Target Development and Regulatory Milestone Event.

Related to Development and Regulatory Milestone Event

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

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

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

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

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

  • 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 2 means achievement of annual Net Sales of at least $35,000,000 during any Calendar Year ending on or before December 31, 2024.

  • 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).

  • 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 means an event or task described in the Implementation Plan which, if applicable, must be completed by the relevant Milestone Date;

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

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

  • 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 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 III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • 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.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

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

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

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

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.