Development and Regulatory Milestone Event definition

Development and Regulatory Milestone Event has the meaning set forth in Section 8.4.
Sample 1
Development and Regulatory Milestone Event is defined in Section 13.7 (Development and Regulatory Milestones).
Sample 1Sample 2
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

  • 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.

  • 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.

  • 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.

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

  • No later than [***] after the occurrence of a Development and Regulatory Milestone Event, Purchaser shall (i) provide written notice (a “Development and Regulatory Milestone Statement”) to Seller and/or, if after dissolution of Seller, the Seller Representative, of the occurrence of such Development and Regulatory Milestone Event and (ii) subject to Section 7.03(b), pay the corresponding Milestone Payment.

  • RAJESH KUMARPARTNER Director DirectorM No. 506726 DIN 03321016 DIN 03319765Place: New Delhi Date : 25/09/2019 For R N K A & Co.Chartered Accountants For SBC EXPORTS LIMITED CA.

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

  • 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.

  • In the event that Licensee, its Affiliates or its Sublicensees under this Agreement achieves a Development and Regulatory Milestone Event, it will notify Licensor thereof within [***] Business Days of such achievement.

  • The venue seeks to cater for a variety of different style of functions that will range from small to medium sized events, both casual and formal.

Related to Development and Regulatory Milestone Event

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

  • 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 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.

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

  • 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 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.

  • 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 large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • 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 study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • 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 any clinical studies of a Licensed Product conducted on humans.

  • 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 or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.