Pivotal Study. The term “
Pivotal Study. Entasis shall use Commercially Reasonable Efforts (either itself or through a Third Party contract research organization), at its expense, to conduct those activities associated with the global pivotal Phase III Clinical Trial for the Lead Product, as allocated to Entasis under and described in the Initial Development Plan (the “Pivotal Study”). The Initial Development Plan shall specify the responsible Party or contract research organization for all such activities. Pursuant to Section 5.6, Zai shall use Commercially Reasonable Efforts to conduct those activities for the Pivotal Study that take place in the Territory in accordance with the Development Plan. Zai shall be responsible for (i) [*] of Patient-Related Costs in the PRC for the Pivotal Study and (ii) [*] of Out-of-Pocket Costs incurred in connection with the Pivotal Study.
Pivotal Study. 8 Section 1.57 Product.............................................................. 8 Section 1.58 Product.............................................................. 8 Section 1.59 Product Development Program.......................................... 8 Section 1.60 Product Development Term............................................. 8 Section 1.61 Regulatory Approval.................................................. 9 Section 1.62 Regulatory Authority................................................. 9 Section 1.63 Royalty Term......................................................... 9 Section 1.64 siRNA................................................................ 9 Section 1.65 siRNA-Attributable Portion........................................... 9 Section 1.66 siRNA Cost of Goods.................................................. 9 Section 1.67
Pivotal Study. If after review of the Pilot Study Report the JSC determines that the results of the Pilot Study as described in the Pilot Study Report meet the success criteria described in the Pilot Study Plan or success criteria otherwise determined by the JSC, and only if the JSC so determines, TALi will submit to the JSC for review and approval a plan for the Pivotal Study (“Pivotal Study Plan,” together with the Pilot Study Plan, the “Study Plans”). The JSC will use all reasonable endeavors to approve the Pivotal Study Plan within [***] ([***]) days of its submission to the JSC, including holding additional meetings of the JSC for this purpose. Prior to accepting the Pivotal Study Plan, the JSC may propose specific amendments to the Pivotal Study Plan that TALi will use all reasonable endeavors to incorporate into any revised Pivotal Study Plan that it may submit to the JSC in substitution for the previous Pivotal Study Plan. Upon JSC approval of the Pivotal Study Plan, TALi will conduct those activities assigned to it under the Pivotal Study Plan in accordance with the timelines therein. Xxxxx will reimburse [***] percent ([***]%) of the direct out-of-pocket costs incurred by TALi for conducting the Pivotal Study, excluding TALi internal costs, provided that such costs were incurred in accordance with the budget set forth in the Pivotal Study Plan, and subject to the maximum Xxxxx reimbursement amount set forth in Section 4.4.
Pivotal Study. “Pivotal Study” shall mean a human clinical trial the results of which could be used as pivotal to establish safety and efficacy of a product as a basis for a marketing approval application submitted to the FDA or the appropriate regulatory authority of such other country, as further defined in 21 CFR §312.21(c), or any successor regulation thereto or foreign equivalents. For clarity, a phase II/III study satisfying the requirements of both a Phase II Study and a Pivotal Study or a Phase II Study satisfying the requirements for regulatory approval, will, for purposes of this Agreement, be deemed both a Phase II Study and a Pivotal Study.
