Open Label Extension Study definition
Examples of Open Label Extension Study in a sentence
AZ shall be solely responsible for the development of the Products in the Field in the Territory, and shall assume responsibility to fund the On-Going Clinical Trials following the Effective Date and to conduct the On-Going Clinical Trials as soon as practicable following the Effective Date, except that Rigel shall continue to conduct [ * ] the Open Label Extension Study until the Open Label Extension Study Transfer Date as set forth in Section 3.7 below.
The Parties agree that Rigel shall continue to conduct such Open Label Extension Study on behalf of AZ [ * ] following the Effective Date and for a period of [ * ] following such date (the end of such [ * ] period, the “Open Label Extension Study Transfer Date”), notwithstanding the date of transfer to AZ.
Rigel shall conduct such Open Label Extension Study in a good scientific manner, in compliance in all material respects with all Applicable Laws and all applicable portions of the Transition Plan.
Following the Open Label Extension Study Transfer Date, AZ shall be solely responsible for the conduct of such Open Label Extension Study, at its sole cost and expense.
For the avoidance of doubt, AZ shall be responsible for [ * ] the Open Label Extension Study [ * ] following the Effective Date.
Prior to the Open Label Extension Study Transfer Date, the Parties shall in good faith agree on a process to transfer to AZ the responsibility for the conduct of such Open Label Extension Study, and shall cooperate to ensure that such transfer be complete by the Open Label Extension Transfer Date.
The Parties acknowledge that, as of the Execution Date, Rigel is conducting the Open Label Extension Study.
Licensor's internal costs incurred in connection with the Open Label Extension Study shall be charged at the full time equivalent rates as follows: one full time equivalent equal to [REDACTED] hours worked per year at an hourly rate of [REDACTED] for 2009, [REDACTED] for 2010 and [REDACTED] for 2011.
For the avoidance of doubt all such intellectual property shall be deemed Rigel Technology and shall form part of the license granted to AZ as set forth in Section 7.1. Except with the prior approval of AZ, Rigel shall not engage subcontractors and consultants for the performance of the Open Label Extension Study other than those with which it is working as of the Execution Date.
In the event that either Party requests the other Party to perform any development activities relating to the Open Label Extension Study which are not specific to transition activities and which are not otherwise covered in the Transition Plan during such [ * ] period, the requesting Party shall reimburse the other Party for all costs and expenses reasonably incurred by such other Party (including internal costs and Out-of-Pocket Expenses) in connection with such activities, at the FTE Rate.