If the Post-POC Principal Party disapproves the conduct of any proposed Additional Trial outside of the applicable Global Development Plan (or any amendment to the plan therefor) in accordance with this Section 5.5, the Post-POC Other Party may not proceed with the proposed Additional Trial (or amend the plan therefor).
Notwithstanding anything in this ARTICLE III to the contrary (but, for clarity, without limitation to ARTICLE VIII), in no event shall the Post-POC Other Party with respect to an IO Licensed Product be allocated any responsibility for any Development, Manufacturing or regulatory activity with respect to such IO Licensed Product without its prior consent, which may not be unreasonably withheld, conditioned or delayed.
The Post-POC Other Party shall also provide to the Post-POC Principal Party any drug safety data from such additional clinical trials in accordance with Section 7.4. Separate from the determination of whether to include such clinical trial(s) in the relevant Development Plan, the Post-POC Principal Party may disapprove the conduct of an Additional Trial outside the relevant Development Plan, or any such protocols or clinical trial designs, or any amendments thereto, for [***].
The IOSC will establish procedures for the expeditious review of clinical trial protocols for the IO Licensed Products submitted to the IOSC by the Post-POC Other Party pursuant to this Section 5.5, including (a) timelines and deadlines for approving such clinical trial protocols and (b) pre-approval authorizations for Non-Approval Trials.
If the Post-POC Other Party disputes such disapproval, such dispute shall be referred to the Executive Officers for resolution.