MTD Achievement definition
MTD Achievement means the determination of the maximum tolerated dose for ARQ 092 or if no maximum tolerated dose for ARQ 092 is determined, the determination of the recommended Phase 2 dose by agreement of the Parties based on clinical or biological activity in the absence of dose limiting toxicity in one or more Phase 1 Clinical Trials as set forth in the Phase 1 Development Plan. In the case that agreement on such recommended Phase 2 dose cannot be reached, DS shall have the right to make the final decision.
Examples of MTD Achievement in a sentence
ARQULE shall provide written notice (the “MTD Achievement Notice”) to DS within * (*) days of MTD Achievement and shall continue the Phase 1 Development Activities until the transition of the responsibility for the Phase 1 Development Activities to DS is completed.
Additional details outlining our approach to each workstream are in the following sections.
Notwithstanding the foregoing, DS shall have the option to assume all responsibility for Phase I Development Activities following MTD Achievement.