OTC Preclinical Development Plan Sample Clauses

OTC Preclinical Development Plan. As of the Effective Date, the Parties have agreed on an initial OTC Preclinical Development Plan, attached to this Agreement as Exhibit 4.4. Either Party may propose amendments to the OTC Preclinical Development Plan from time to time, and such amendments shall become effective upon the approval of the JSC. The OTC Preclinical Development Plan shall set forth: (a) the activities to be conducted by each Party for the preclinical Development of OTC Products, including IND enabling studies; (b) the estimated timelines for such activities; (c) the estimated internal and external costs to be incurred by or on account of each Party in connection with such activities; and (d) the criteria for selecting OTC Development Candidates.