Clinical Efficacy definition
Examples of Clinical Efficacy in a sentence
Following the demonstration of Clinical Efficacy or earlier as determined by the JSC, the Parties will arrange for end-of-phase 2 meetings (as described in 21 CFR 312.47(b) or equivalent foreign regulations) with each of the FDA and EMA (each, an “EOP2 Meeting”).
In consideration for the grant of the Option and the provision by AVEO of the AVEO Materials, Ophthotech shall pay AVEO a one-time milestone payment of six million Dollars ($6,000,000) within [**] days after the Clinical Efficacy Milestone Payment Trigger Date.
The Study shall be conducted in full compliance with the Sponsor's protocol VTX002-201 “A Phase 2, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects with Moderately to Severely Active Ulcerative Colitis” and any amendments thereto (the “Protocol”).
Ophthotech may exercise the Option at any time until the latest to occur of: (i) twelve (12) months after the achievement of the Clinical Efficacy Milestone, (ii) ninety (90) days after the Clinical Efficacy Milestone Payment Trigger Date, and (iii) thirty (30) days after AVEO and Ophthotech agree as to the definitive form of license agreement (the “Option Period”).
Ophthotech shall also notify AVEO of the achievement of the Clinical Efficacy Milestone within such [**] days after such achievement.
Prior to the full payment of the amounts required under Section 2.3, IDEC shall provide Pharmacia biannual progress reports of the development of 9-AC, including summary reports of the clinical studies conducted by NCI under the CRADA and information sufficient to indicate the extent of progress, if any, toward demonstration of Clinical Efficacy and submission and approval of the NDA for 9-AC.
Notwithstanding the foregoing, such payment shall not be payable if Ophthotech gives AVEO a notice of termination pursuant to Section 9.5 on or prior to the date [**] days after the Clinical Efficacy Milestone Payment Trigger Date, whether or not such termination becomes effective prior to the date [**] days after the Clinical Efficacy Milestone Payment Trigger Date.
IDEC shall promptly notify Pharmacia upon the occurrence of Clinical Efficacy.
The Parties will endeavor to conclude its negotiations no later than the later of [**] days after AVEO enters into the KHK Agreement Amendment with KHK or [**] days after the Clinical Efficacy Milestone.
If, at the time Ophthotech exercises the Option, the Clinical Efficacy Milestone Payment Trigger Date has not yet occurred, Ophthotech shall pay the milestone set forth in Section 4.3 after such Option exercise at such time as the Clinical Efficacy Milestone Payment Trigger Date does occur if the License Agreement remains in effect as of such subsequent occurrence.