Clinical Milestone Event definition

Clinical Milestone Event and “Collaboration Product” shall each respectively have the meanings as set forth in the PKU Channel Agreement.
Sample 1
Clinical Milestone Event is defined in Section 11.6.2 (Clinical and Development Milestones).
Sample 1
Clinical Milestone Event means the first dosing of a patient by or on behalf of Synthetic, or an Affiliate or permitted sublicensee of Synthetic, in a “phase I” clinical trial (as such is defined by relevant FDA guidelines) for a given Collaboration Product, irrespective of whether such occurs in the United States of America under the jurisdiction of the FDA or occurs elsewhere (including under the jurisdiction of a foreign regulatory agency).
Sample 1

Examples of Clinical Milestone Event in a sentence

  • For clarity, each milestone set forth below shall be due and payable one time only (regardless of the number of Co-Co Products to achieve any such Clinical Milestone Event).

  • All Milestone Events prior to the second Clinical Milestone Event may only be referenced in public announcements in general terms and without specificity as to the particular milestone.

  • To this end, upon each achievement of any Clinical Milestone Event that triggers a milestone payment being due by Synthetic to Intrexon under Section 5.2(a) above, Synthetic shall notify Intrexon as soon as possible if Synthetic intends to elect to pay the specific milestone payment in equity, such notification being in writing and delivered to Intrexon in no event less than ten (10) business days from the date of achievement of the respective Clinical Milestone Event.

  • The stress response triggers the release of stress hormones and activates the sympathetic nervous system.

  • Other communities may, of course, find other reasoning schemes more important, or they may just need an extension compared to what we pro- vide here.Thus, we build a two-layer approach.

  • For the avoidance of doubt, the Parties agree and acknowledge that [***] shall not constitute a [***] or a Clinical Milestone Event under the CTLA and as a result no Milestone Payment will become payable as a result of such first dosing.

  • The actual proposal will be submitted at a later date for official approval.

  • Any cash amounts paid to Intrexon under this Section 5.2(a) shall be due within thirty (30) days after achievement of the respective Clinical Milestone Event, and any issuance of securities to Intrexon in payment (partial or full) of Synthetic’s obligations under this Section 5.2(a) shall be in accord with the terms and conditions of the Equity Agreement.

  • In the absence of a valid designation by Executive meeting the requirements of this Section 7, or in the event of the death of a Beneficiary for whom no successor Beneficiary has been validly designated, Executive's compensation, or the portion of such compensation then payable to such deceased Beneficiary, shall be paid to the administrator or executor of Executive's estate for the benefit of Executive's estate, who shall in that event be deemed a Beneficiary under this Section 7.

  • The Parties agree that Synthetic’s option to pay any milestone payments that come due for achievement of the Clinical Milestone Event under this Agreement in equity (or partially in equity) shall in no event require Intrexon to accept equity of Synthetic as payment if, upon Intrexon’s reasonable conclusion after consultation with its outside advisors, receipt of such equity payment by Intrexon would cause Intrexon to have to consolidate Synthetic’s financial statements with Intrexon’s financial statements.

Related to Clinical 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.

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

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

  • 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.

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

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

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

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

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

  • Sales Milestone Payment is defined in Section 5.3.

  • 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).

  • 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).

  • 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.

  • 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 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 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 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 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.

  • 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 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.

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

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