Immunization Study Sample Clauses

Immunization Study. ZARS shall have the right, in its discretion, to elect to conduct a well controlled clinical trial in pediatric patients selected from a mutually agreed age group studying the efficacy of the Licensed Product in producing topical local anesthesia for immunizations (the “Immunization Study”), and, if it shall so elect, it shall use all commercially reasonable efforts to promptly conduct such study as follows: (i) ZARS shall be responsible for the design of the Immunization Study, for site enrollment, direct fees to be paid to the site(s) for the conduct of such clinical trial, monitoring, data management and statistical analysis, all at ZARS’ expense, provided that TALISKER shall have the right to advise on the selection of some of the participating sites and investigators and shall have the right to approve the prospectively identified primary efficacy endpoint. For purposes of clarity, TALISKER shall have no obligations with respect to: (A) the conduct of the Immunization Study including, without limitation any obligation under Section 5.1(a)(ii); (B) the making of any regulatory filings in the Territory including, without limitation, any Registration Application(s); or (C) the milestone payment set forth in Section 3.1(b); unless it has approved the design of the Immunization Study and the primary endpoint of such study, which approval shall not be unreasonably withheld. (ii) TALISKER shall be responsible for making any and all regulatory filings within the Territory required after the Effective Date to allow for the conduct of the Immunization Study and shall provide ZARS with adequate study drug (active and placebo) to conduct such clinical trial(s). TALISKER shall be responsible for all third party, direct, costs relating to the Immunization Study up to a maximum of [ * ]. All amounts in excess of [ * ] shall be reimbursed to TALISKER by ZARS. For the avoidance of doubt, ZARS shall not be charged for any internal TALISKER overheads or other such indirect costs in connection with TALISKER’s activities pursuant to this Section 5.1(a)(ii). (iii) TALISKER shall be responsible for any regulatory filing within the Territory to seek approval for any expanded indication related to the results of the Immunization Study and shall use commercially reasonable efforts to obtain such approval.