Phase 2a Study definition

Phase 2a Study means a clinical study of an investigational product in patients that has the primary objective of establishing the safety and initial efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase 2b Study. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents and a Phase 2a Study shall be deemed commenced when Initiated.

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Phase 2a Study means, for the purposes of this Agreement, that certain upcoming clinical study of the Licensed Product conducted by Pieris in the European Union, where the Licensed Product is administered repeatedly to hemodialysis patients with chronic kidney disease. ASKA acknowledges that the final protocol for the Phase 2a Study is still under discussion and subject to further changes before the Phase 2a Study will be initiated.

Phase 2a Study means a Phase 2 Study that is not a Phase 2(b) Study.

Examples of Phase 2a Study in a sentence

• Pieris shall use Commercially Reasonable Efforts to complete the Phase 2a Study for the Licensed Product and shall submit to ASKA in writing the final results of its Phase 2a Study of the Licensed Product when such results are available.

• The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents and a Phase 2a Study shall be deemed commenced when Initiated.

• Notwithstanding the foregoing, if the final results of the Phase 2a Study meet the Success Criteria, but ASKA fails to provide a Satisfaction Notice, then ASKA shall pay Pieris [***] Dollars ($[***] USD) (the “Breakup Fee”) within [***] of the end of the Evaluation Period.

• Within ** after its completion of each Phase 1 and each Phase 2a Study for a Licensed Product, Adolor shall submit to the JDC a report of the results of such Phase 1 or Phase 2a Study, as the case may be, together with all supporting data.

• Based on the results obtained from each such Phase 1 and Phase 2a Study, the JDC shall review and may amend the Development Plan for the Licensed Product.

• Pfizer may, at any time commencing with database lock for the first Phase 2a Study included in the Development Plan for a Licensed Product, but shall in no event later than the enrolment by Pfizer of the first patient in a Phase 2b Study, provide Adolor with a written request for Adolor to transfer the IND for the Named Compound included in such Licensed Product.

More Definitions of Phase 2a Study

Phase 2a Study means that certain Phase 2a clinical trial being conducted by XOMA or its Affiliates as of the Effective Date and referred to as X052118, with respect to the Product in Type 2 diabetes.

Phase 2a Study means a Phase 2 Study of a Product conducted by Licensee that is designed to demonstrate clinical “proof of concept” in a particular Indication.

Phase 2a Study means a Phase 2 Study identified as a Phase 2a Study in the applicable Development Plan.