New Trials Sample Clauses
New Trials. Subject to the terms hereof, OPKO shall conduct all Trials initiated following the Effective Date (such trials “New Trials”) in accordance with the protocols, standard operating procedures and other development plans specified by the JDC and set forth in the Development Plan or as otherwise approved by the JDC.
New Trials. For any new trial not described in the Trial Master Schedule this insurance applies only if: • Insured give us written notice describing the trial for which coverage is requested; with the trial, in accordance with the terms, conditions and additional premiums determined by us; and • Insured accept such terms and conditions. In the event of loss, the Insured and the Company are both entitled to give notice terminating the insurance to take effect 30 days after the notice of termination, whereupon the unused portion of the premium shall be repaid. However, such part of the premium as corresponds with the Company’s costs for losses during the insurance period shall be considered used.
New Trials a. Scynexis is seeking to initiate (i) a dose ranging trial identified as SCY-078-302 and entitled “A Multicenter, Randomized, Double-blind Phase II-III Study Comparing SCY-078 [Intravenous followed by Oral] to Standard-of-Care [Intravenous followed by Oral] for Candidemia and Invasive Candidiasis Using an Adaptive Design Approach” (the “IC Phase 2/3 Trial”) and (ii) a trial identified as SCY-078-301 and entitled “Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 in Patients with Invasive Fungal Infections that are Refractory to or Intolerant of Standard Antifungal Treatment (FURII)” (the “rIFI Trial”).
b. The IC Phase 2/3 Trial is an adaptive design trial that is intended to commence as a Phase II Clinical Trial that can convert to a Phase III Clinical Trial.
c. The rIFI Trial, depending on results and data obtained, may, with the agreement of the FDA to accept the data, satisfy the requirements of a registration trial.