Second Phase III Study definition
Second Phase III Study means a Phase III Study to support a Marketing Authorization for a LCSI, and if reasonably prudent to pursue same, for CRBSI.
Second Phase III Study means the Phase III Study, summarized in Exhibit 1.1(bb), entitled “A Phase III Prospective, Randomized, Double-blind, Placebo-controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Post-Cardiac Surgery Patients with Atrial Arrhythmia.”
Second Phase III Study means the Phase III Study, summarized in Exhibit 1.1(bb), entitled "A Phase III Prospective, Randomized, Double-blind, Placebo-controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Post-Cardiac Surgery Patients with Atrial Arrhythmia." (ffff) "Subcontractors" means Third Parties engaged to perform obligations or assist in the enjoyment of the rights of the Parties as permitted by this Agreement. (gggg) "Sublicense" means a sublicense granted by Fujisawa pursuant to Section 3.7(b) to promote, market, distribute, offer for sale, or sell Products in Mexico. (hhhh) "Sublicensee" means a Third Party to whom Fujisawa or its Affiliates has granted a Sublicense. (iiii) "Sublicense Revenue" means the all amounts received by Fujisawa or its Affiliates from a Sublicensee under a Sublicense, including all amounts received for sales of Product to the Sublicensee. (jjjj) "Successful Completion", as used in Section 4.2(a), means the JDMC's decision to continue Development of the Product in the United States within ninety (90) days of receiving the Executive Summary of the First Phase III Study. (kkkk) "Term" has the meaning set out in Section 13.1. (llll) "Territory" means the United States of America and its territories and possessions, Canada and Mexico. (mmmm) "Third Party" means any entity, other than Cardiome or Fujisawa or Affiliate of Cardiome or Fujisawa. (nnnn) "Third Phase III Study" means the Phase III Study, summarized in Exhibit 1.1(bb), entitled "Evaluation of the safety and efficacy of RSD1235 IV against placebo and/or standard drug therapies to convert patients with atrial fibrillation or atrial flutter to normal sinus rhythm." (oooo) "U.S. PTO" means the Unites States Patent and Trademark Office or any successor entity thereto.