IIT Study definition

IIT Study means a human clinical study initiated, sponsored and conducted by an investigator at a research institution for which a Party or its Affiliate provides drug supplies; provided that such Party or Affiliate has no right or ability to direct or control such human clinical study; it being understood and agreed that “IIT Study” excludes (a) any human clinical study that could reasonably be expected, in and of itself, to be used to obtain a regulatory approval and (b) any human clinical study that includes a head-to-head comparison of a Research Product, either alone or in combination with any other pharmaceutical compound, with such Research Product, either alone or in combination with any other pharmaceutical compound.
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Related to IIT Study

  • Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.