Continuing Clinical Trials definition
Examples of Continuing Clinical Trials in a sentence
Except for materials transferred under Section 3.3.2, Rain will be solely responsible at its expense for manufacturing of all of the Licensed Compound and Product that are necessary for further development and commercialization of such Licensed Compound and Product after the Effective Date (except for the Transferred Clinical Trials until transferred and Continuing Clinical Trials until completion).
Rain shall be responsible for preparing and submitting 2022 DSUR and thereafter for the Transferred Clinical Trials and Continuing Clinical Trials.
Upon a written request from Rain, Daiichi Sankyo will transfer interim trial data and audit/compliance-related documents from the Transferred Clinical Trials and Continuing Clinical Trials to Rain.
Daiichi Sankyo shall provide Rain with the draft of itemized [***] invoice for customary and reasonable Third Party costs and expenses incurred for CRO services, data management and biostatistics after the Effective Date to continue the Continuing Clinical Trials, the cumulative total amount of which shall not exceed [***].
Subject to Section 3.1.4, Daiichi Sankyo shall continue to conduct the Continuing Clinical Trials until all subjects complete the study treatment, the clinical drug supplies in Daiichi Sankyo’s possession as of the Effective Date are depleted or the expiration date of such clinical drug supplies has passed, whichever is the earliest.
The cost to prepare the final report for the Continuing Clinical Trials has been included in the cost to be reimbursed by Rain, as provided in Section 3.1.6.
Daiichi Sankyo shall be responsible for preparing the final report for the Continuing Clinical Trials after such Clinical Trials are completed.
Daiichi Sankyo and/or its Affiliates will timely prepare and submit 2021 development safety update reports (“DSUR”) for the Transferred Clinical Trials and Continuing Clinical Trials.