临床研究

The details of the clinical protocol will be summarized in a mutually agreeable Statement of Work and will be detailed in a mutually agreeable clinical protocol (“Protocol”).  To the extent any terms or provisions of the Statement of Work or Protocol conflict with the terms and provisions of this Agreement, the terms and provisions of this Agreement shall control, except to the extent that the Statement of Work expressly and specifically states an intent to supersede this Agreement on a specific matter. The Statement of Work will be attached hereto as an Exhibit and incorporated herein by reference.

临床试验方案的细节将在双方约定的《工作说明》中予以总结，并将在相互同意的临床试验方案（“试验方案”）中予以详细说明。若《工作说明》或试验方案所载的任何条款或规定与本协议的条款与规定相冲突的，应以本协议的条款与规定为主，《工作说明》明确且特别声明其在具体事宜上取代本协议的除外。《工作说明》将通过引用并入本协议，并作为其附件。

Conduct of CLINICAL STUDY

临床研究的开展

XXX shall propose to Sponsor (a) one or more site(s) at which to conduct the Clinical Study (“Study Site(s)”), and (b) for each Study Site, the principal investigator who will conduct the Clinical Study at that Study Site (“Site Principal Investigator”).  Sponsor shall make the final selection and approve each individual Study Site and Site Principal Investigator. Sponsor shall make such selection and give such approval at its sole discretion, and may reject any Study Site and/or Site Principal Investigator for any reason.  Upon Sponsor’s rejection of any Study Site and/or Site Principal Investigator, XXX shall promptly propose a new Study Site and/or new Site Principal Investigator.

XXX应向申办者提议（a）开展临床研究的一个或多个临床试验机构（“研究机构”），及（b）对于每个临床试验机构，将在该研究机构开展临床研究的首席研究员（“机构首席研究员”）。申办者应最终选择并批准各研究机构及机构首席研究员。申办者应酌情做出该等选择并批准，并可以任何理由拒绝任何研究机构和/或机构首席研究员。申办者拒绝任何研究机构和/或机构首席研究员之后，XXX应及时提议新的研究机构和/或新的机构首席研究员。

XXX will assure conduct of the Protocol and Statement of Work in accordance with the terms and conditions of this Agreement.

XXX将确保根据本协议的条款与条件执行试验方案与《工作说明》。

XXX shall be responsible for ensuring that the Site Principal Investigators and all other individuals assisting with the study (collectively, “Study Personnel”) use the highest standards of care, skill, and diligence used by persons who are skilled, trained and experienced with respect to the type of services required by the Protocol to conduct the Protocol in accordance with (a) the applicable Statement of Work; and (b) all recognized medical and ethical standards for the conduct of research or clinical investigations.

XXX应负责确保，机构首席研究员和协助研究的所有其他人员（合称“研究人员”）根据（a）相关《工作说明》及（b）所有被认可的开展研究或临床研究的医学及道德标准使用熟练、受训且经验丰富的人员所使用的与试验方案所规定的服务类型相关的最高标准的审慎、技能和勤勉程度执行试验方案。