Common use of DATA MANAGEMENT PLAN Clause in Contracts

DATA MANAGEMENT PLAN. (a) OPKO will comply with the data management plan to be agreed upon by the Parties within *** Business Days following approval by the JDC of the Development Plan (the “Data Management Plan”). For clarity, the Data Management Plan will provide Pfizer the right to review the Development Plan, and OPKO will agree to make modifications requested by Pfizer if they are considered by Pfizer to affect any of the timelines set forth in the Development Plan or may have a material impact on the success of any BLA submissions hereunder by Pfizer. The Data Management Plan will be agreed upon by the Parties prior to recruitment of Subjects for any future Trial. (b) During the Term, with respect to any data collected in connection with any Trial, OPKO will ensure that such data is held in one or more appropriate facilities with information security protections (including in accordance with all Applicable Laws) including: (i) unique accounts for all operators; (ii) cancellation of an account when an employee or other personnel terminates employment; (iii) deactivation of an account when an employee or other personnel ceases working on the Trial; (iv) required password changes at frequent intervals; and (v) regular backups of electronic data.