Clinical Event definition

Clinical Event means the occurrence of at least one patient being treated under the Phase II b clinical trial sponsored by the Company pursuant to Protocol VEGF2-CAD-CL-007, entitled “A Multicenter, Randomized, Double-Blind, Dose Ranging Placebo-Controlled Study Evaluating Defined Doses Of Percutaneously Delivered Via Boston Scientific Corporation Stiletto(tm) Endocardial Injection Catheter pVGI.1 (VEGF2) (Placebo, 20, 200, Or 800µG) In Patients With Class III Or IV Angina.
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Clinical Event means any action, or any adverse inspection or audit finding that would reasonably be expected to result in an action, by a governmental authority to place a clinical hold order on, or otherwise terminate, suspend or restrict in any material respect, any ongoing clinical trial conducted by MyoKardia or any of its subsidiaries with respect to any mavacamten, danicamtiv, MYK-224, LUS-1, ACT-1 and the early stage targets covered by MyoKardia’s genetic cardiomyopathy programs (each, a “Product”) which would reasonably be expected to result in a material delay or material impairment in the ability of MyoKardia to obtain any regulatory authorizations from any governmental authority relating to such Product.
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Clinical Event means any action, or any adverse inspection or audit finding that would reasonably be expected to result in an action, by a Governmental Authority to place a clinical hold order on, or otherwise terminate, suspend or restrict in any material respect, any ongoing clinical trial conducted by the Company or any of its Subsidiaries with respect to any Product which would reasonably be expected to result in a material delay or material impairment in the ability of the Company to obtain any Regulatory Authorizations from any Governmental Authority relating to such Product.
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Examples of Clinical Event in a sentence

  • Vertex shall provide CRISPR with reasonably detailed updates, in accordance with the notice procedures set forth in the Pharmacovigilance Agreement, about any such Specified Clinical Event.

  • Signature By Print Name Title Address: Address: 3600 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇ Date Received The Cashless Exercise Program (referenced in the Option Agreement) provides that the Optionee, upon exercise of an Option, will receive cash or Common Stock, or a combination thereof, equal to the difference between the Option exercise price and the Fair Market Value of the Common Stock on the exercise day.

  • Upon the occurrence of the public announcement of the Clinical Event during the Option Period, the Escrow Agent shall release the Escrow Funds to the Company as provided in the Escrow Agreement.

  • Their responsibilities will include protocol and case report form review, oversight for Clinical Event Committee (CEC) and Data Monitoring Committee (DMC) services, consultation to InspireMD and the HCRI Team for trial strategy issues, provision of overall medical support to HCRI Project Teams, and clinical review of report deliverables generated by HCRI.

  • Notwithstanding anything to the contrary in this Agreement or the Pharmacovigilance Agreement, Vertex will promptly notify CRISPR (and, in any event, within [***] Business Day), in accordance with the notice procedures set forth in the Pharmacovigilance Agreement, after Vertex or any Affiliate thereof becomes aware of the occurrence of any Specified Clinical Event (as hereinafter defined), and Vertex will provide CRISPR with reasonably detailed information regarding such Specified Clinical Event.

  • Any remainder after such reimbursement is made shall be retained by the Enforcing Party; provided, however, that any award or settlement received by; (i) Biohaven will be treated as Net Sales and be subject to royalties for the Calendar Quarter in which such amounts are received by Biohaven, and (ii) Highlightll will be treated as Net Sales subject to fees under Section 4.4.2 for the Calendar Quarter in which such amounts are received by Highlightll in the event of a Highlightll Territory Clinical Event.

  • Within [***] following the end of each Calendar Quarter, commencing upon the First Commercial Sale of a first Licensed Product and thereafter, Biohaven and, solely in the event of a Highlightll Territory Clinical Event, Highlightll, shall provide the other Party with detailed written reports of such Commercialization activities it has performed, or caused to be performed, since the preceding report regarding its Territory.

  • Since January 1, 2018 through the date hereof, there has not occurred any Key Clinical Event.

  • Therefore, these events will be collected on the aforementioned specialized Clinical Event eCRFs but not reported in an expedited manner.

Related to Clinical Event

  • Medical event means an improper administration of radiation or radioactive material to a patient or human research subject that requires reporting to the department.

  • 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.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • 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.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.