definiens: means any Clinical Study in a single tumor type or enriched for a tumor type that is intended to show safetyand efficacy ( which efficacy may be shown by a biomarker or other assay ) in the target population, at the intended clinicaldose or doses or range of doses, on a sufficient number of subjects and for a sufficient period of time to confirm the optimalmanner of use of the Product prior to initiation of the Phase 3 Trials, and which itself provides sufficient evidence of safetyand efficacy to be included as a supportive study to the Phase 3 Trial in filings with Regulatory Authorities . includes any clinical study designated under a Collaboration Plan as a Phase 2b Trial, ” Phase 2a Study ” or or means a pivotal Clinical Study ( whether or not denominated as a Clinical Study under applicable regulations ) in human patients that is of the size and design intended to establish that aProduct is safe and effective for its intended 105 use ; to define warnings, precautions and adverse reactions that are associated with the Product in the dosage range to beprescribed ; and is intended to support Approval of such Product . or includesany clinical study designated under a Collaboration Plan as a or means in vitro and in vivo studies of one or more Compounds, not in humans, including those studiesconducted in whole animals and other test systems, designed to determine the toxicity, bioavailability, and pharmacokineticsof the Product and whether the Product has a desired effect