Research Milestone Event definition

Research Milestone Event is defined in Section 13.4 (Research Milestones).
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Research Milestone Event has the meaning set forth in Section 11.3(a).
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Research Milestone Event means each of the four (4) events set forth in the table in Section 11.5.1 (as further described in Schedule 1.188).
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Examples of Research Milestone Event in a sentence

  • The Parties shall discuss the timing and contents of a press release to announce the fact of the execution of the this Agreement, achievement of each Research Milestone Event and Development Milestone Event for the progress of Collaborative Research, and make such press release if the Parties mutually agree upon the timing and contents; thereafter, ONO and Receptos may each disclose to any Third Party the information contained the contents in such press release without further approval of the Other Party.

  • Receptos shall provide prompt written notice to ONO of any delays of any nature, and by any person, which are causing, or are likely to cause, Receptos’ inability to achieve a Research Milestone Event, and in which case, the Parties shall cooperate in good faith to remove such delays or otherwise achieve such Research Milestone Event on time.

  • In the event that there is any disagreement or dispute between Receptos and ONO with respect to achievement of the Research Milestone Event, the Parties shall discuss in good faith such disagreement or dispute.

  • It is agreed by Receptos that each Research Milestone Payment in this Section 6.3 shall be payable only once by ONO with respect to Collaboration Target under this Agreement upon the first achievement of the applicable Research Milestone Event, regardless of subsequent or repeated achievement of such milestone event by any ***, Collaboration Compound or ONO Post Collaboration Compound.

  • In the event that ONO fails to materially perform or delays the performance of its obligations under Section 2.3.2 or the Research Plan which are reasonably necessary for Receptos’s efforts towards the achievement of Research Milestone Event Nos.

  • Notwithstanding achievement of Research Milestone Event No. 3 by Receptos, in the event that ONO decides to cause a Cessation of Active Research before expiration of the Research Term with respect to the Collaboration Target, ONO shall provide a Cessation Notice of Active Research to Receptos at any time after eighteen (18) months of the Effective Date.

  • Development Milestone Event Milestone Amount if Condition I is satisfied Milestone Amount if only Condition II is satisfied 1 Selection by ONO, its Affiliates or Licensees of a Preclinical Compound (provided, however, that if this Development Milestone Event is achieved prior to designation of the Lead Compound, then the Research Milestone Payment for Research Milestone Event No. 8 shall be paid at the time of the payment of Development Milestone Payment relating to this Development Milestone Event No. 1.

  • For each Research Program, Denali shall notify Takeda and the JSC if Denali determines in good faith that the Research Milestone Criteria for a particular Research Milestone Event have been satisfied by a Research Biologic within such Research Program (each a “Criteria Achievement Notice”) and shall provide Takeda and the JSC with [***].

  • Further, if a Research Milestone Event is achieved prior to the end of the Wind Down Period, the applicable Research Milestone Payment shall be made by ONO to Receptos.

  • During the Target Exclusivity Period after the Research Term, in the event that ONO identifies and selects Lead Compound from any *** which is not claimed or covered by the Collaboration Compound IP, subject to achievement of Research Milestone Event No. 3, ONO shall pay to Receptos an amount equal to Research Milestone Payment for Research Milestone Event No. 8.


More Definitions of Research Milestone Event

Research Milestone Event is defined Section 9.2 (Research Milestone Payments).
Sample 1

Related to Research 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).

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

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

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

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

  • Sales Milestone Payment is defined in Section 5.3.

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

  • 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;

  • 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 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. [***]

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

  • 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.

  • 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 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 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 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 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.

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

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.