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.