First Phase III Study definition

First Phase III Study means the Phase III Study for the Product completed prior to the Effective Date, namely #2▇▇-▇▇-▇▇▇.
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First Phase III Study means the Phase III Study entitled "A Phase III Prospective, Randomized, Double-Blind, Placebo-Controlled Dose Ranging, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients with Atrial Fibrillation" and "A Phase II/III Prospective, Randomized, Double-Blind, Placebo-Controlled Dose Ranging, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients with Atrial Flutter" with the protocol # 1235-0703 and protocol # 1235-0703B, respectively. (ll) "FTE" or full time equivalent, means a notional scientific, regulatory or clinical person employed by a Party and assigned to work on the Development with such time and effort to constitute the equivalent of one (1) person working on the Development on a full time basis consistent with normal business and scientific practice (e.g., at least thirty-seven and one half (37.5) hours per week of dedicated effort for at least forty eight (48) weeks per year). (mm) "FTE Costs" means REDACTED (nn) "Fujisawa Japan" means Fujisawa Pharmaceutical Co., Ltd. 4-7, ▇▇▇▇▇▇▇▇▇▇ ▇-▇▇▇▇▇, ▇▇▇▇-▇▇, ▇▇▇▇▇ ▇▇▇-▇▇▇▇ ▇▇▇▇▇. (oo) "Fujisawa Japan Know How" means REDACTED (pp) "Fujisawa Japan Patent Rights" or "Fujisawa Japan Patent" means REDACTED (qq) "Fujisawa Japan Technology" means the Fujisawa Japan Patent Rights and the Fujisawa Japan Know-How. (rr) "Fujisawa Know How" means the FHI Know How and the Fujisawa Japan Know-How. (ss) "Fujisawa Marks" means any and all trademarks selected by Fujisawa for the Product in the Field in the Territory and marked on the packaging or labelling of the Product and on no other product of Fujisawa, alone or accompanied by any logo or design, service marks, trade names and any foreign language equivalents in sound or meaning, whether registered or not, associated therewith. (tt) "Fujisawa Patent Rights" means the FHI Patent Rights and the Fujisawa Japan Patent Rights. (uu) "Fujisawa Technology" means the FHI Technology and the Fujisawa Japan Technology. (vv) "GAAP" means United States generally accepted accounting principles, as consistently applied in the Territory.
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First Phase III Study means the Phase III Study entitled “A Phase III Prospective, Randomized, Double-Blind, Placebo-Controlled Dose Ranging, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients with Atrial Fibrillation” and “A Phase II/III Prospective, Randomized, Double-Blind, Placebo-Controlled Dose Ranging, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients with Atrial Flutter” with the protocol # 1235-0703 and protocol # 1235-0703B, respectively.
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Related to First Phase III Study

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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.

  • 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. [***]