Common use of First Phase Clause in Contracts

First Phase. LICENSOR has initiated a Phase II clinical trial to demonstrate proof of concept of VACCINE and shall complete such trial at LICENSOR's cost and expense. The parties shall agree on acceptable end points concerning immunogenicity, safety and efficacy for proof of concept which end points shall be attached hereto as Appendix C and the meeting of such end points shall establish proof of concept. In parallel with said Phase II trial, LICENSEE shall at its expense perform feasibility studies to produce VACCINE with a commercial cell line. The feasibility studies will have the purpose of (i) demonstrating that a commercially viable yield is obtainable from the chosen cell line(s), (as defined in Appendix D attached hereto) and (ii) subject to prior successful completion of (i), optimizing the manufacturing process, and, if necessary and feasible, producing GMP commercial products for use in a Phase III clinical study and in Phase II/III bridging studies.