Common use of Phase I Clinical Trials Clause in Contracts

Phase I Clinical Trials. Licensor shall have the exclusive right, and sole responsibility and decision-making authority, to Develop the Collaboration Compound and Product in the Reserved Territory and in the Company Territory by conducting (either itself or through its Affiliates, agents, subcontractors and/or Sublicensees) the PRC Phase I Dose Escalation Clinical Trial, the PRC Phase I Expansion Cohort Clinical Trial, and the Ex-PRC Phase I Dose Escalation Clinical Trial, at its own cost and expense. With regard to the Ex-PRC Phase I Expansion Cohort Clinical Trial, the Parties shall, through the JAC, use good faith efforts to agree its final study design. Whether or not such agreement has been reached, Company, within [...***...] after consideration in the JAC of the final study design of the Ex-PRC Phase I Expansion Cohort Clinical Trial, shall notify Licensor in writing if it will conduct (either itself or through its Affiliates, agents, subcontractors and/or Sublicensees) one or more Ex-PRC Phase I Expansion Cohort Clinical Trials at its own cost and expense. Unless Company gives such written notice (or if Company gives such written notice but the notice indicates that Company will not conduct all of the Ex-PRC Phase I Expansion Cohort Clinical Trials ), Licensor shall have the right to determine, in its sole discretion, to conduct (either itself or through its Affiliates, agents, subcontractors and/or Sublicensees) one or more Ex-PRC Phase I Expansion Cohort Clinical Trials at its own cost and expense; and, if Licensor makes such determination, Licensor shall have the exclusive right and sole responsibility and decision-making authority with respect to such the Ex-PRC Phase I Expansion Cohort Clinical Trial(s). Notwithstanding Licensor’s responsibilities and decision-making rights set forth with regard to the PRC Phase I Dose Escalation Clinical Trial, the PRC Phase I Expansion Cohort Clinical Trial, and the Ex-PRC Phase I Dose Escalation Clinical Trial, Licensor agrees to consult and review with Company, through the JAC, the design of such planned Phase I Clinical Trials, and allow Company to review and comment on the respective draft protocols.

Appears in 2 contracts

Samples: License Agreement (BeiGene, Ltd.), License Agreement (BeiGene, Ltd.)

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Phase I Clinical Trials. Licensor shall have the exclusive right, and sole responsibility and decision-making authority, to Develop the Collaboration Compound and Product in the Reserved Territory PRC and in the Company Territory by conducting (either itself or through its Affiliates, agents, subcontractors and/or Sublicensees) the PRC Phase I Dose Escalation Clinical Trial, the PRC Phase I Expansion Cohort Clinical Trial, and the Ex-PRC Phase I Dose Escalation Clinical Trial, at its own cost and expense. With regard to the Ex-PRC Phase I Expansion Cohort Clinical Trial, the Parties shall, through the JAC, use good faith efforts to agree its final study design. Whether or not such agreement has been reached, Company, within [...***...] after of consideration in the JAC of the final study design of the Ex-PRC Phase I Expansion Cohort Clinical Trial, shall notify Licensor in writing if it will conduct (either itself or through its Affiliates, agents, subcontractors and/or Sublicensees) one or more of the Ex-PRC Phase I Expansion Cohort Clinical Trials at its own cost and expense. Unless Company gives such written notice (or if Company gives such written notice but the notice indicates that Company will not conduct all of the Ex-PRC Phase I Expansion Cohort Clinical Trials ), Licensor shall have the right to determine, in its sole discretion, to conduct (either itself or through its Affiliates, agents, subcontractors and/or Sublicensees) one or more of the Ex-PRC Phase I Expansion Cohort Clinical Trials Trial at its own cost and expense; and, and if Licensor makes such determination, Licensor shall have the exclusive right right, and sole responsibility and decision-making authority with respect to such the Ex-PRC Phase I Expansion Cohort Clinical Trial(s). Notwithstanding Licensor’s responsibilities and decision-making rights set forth with regard to the PRC Phase I Dose Escalation Clinical Trial, the PRC Phase I Expansion Cohort Clinical Trial, and the Ex-PRC Phase I Dose Escalation Clinical Trial, Licensor agrees to consult and review with Company, through the JAC, the design of such planned Phase I Clinical Trials, and allow Company to review and comment on the respective draft protocols.

Appears in 2 contracts

Samples: License Agreement (BeiGene, Ltd.), License Agreement (BeiGene, Ltd.)

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