Definition of POC Study
POC Study means, with respect to a Product, a Phase IIa Clinical Study that is appropriately designed (a) to demonstrate efficacy in Esophageal Squamous Cell Carcinoma ("ESCC") through relevant primary and/or secondary efficacy endpoints as described in the POC Development Plan and (b) to support generation of efficacy data that would allow movement of such Product into a Phase IIa Clinical Study or Phase III Clinical Study that would support the regulatory strategy of seeking Regulatory Approval for ESCC in the Territory.
Examples of POC Study in a sentence
- The JSC will then select one (1) Compound from each project for progression to a POC Study (each a Program 4 Primary Compound).
- Notwithstanding the foregoing, if such dispute is with respect to (i) determination which PET Study(ies) (if any) Synosia will perform as described in Section 3.1(b), or (ii) a proposal by Synosia to modify or depart from any of the Minimum Parameters of the POC Study, then the preceding sentence will not apply.
POC Study means the initial proof-of-concept study that Elanco will conduct at its expense as consideration for the rights granted under this Agreement. The criteria for establishing this POC Study are described in Exhibit A of this Agreement. As additional consideration to Lipid Sciences for entering into this Agreement, Elanco will also provide technical advice regarding the detailed design and scope of this POC Study, at no charge to Lipid Sciences.