Study Postponement and Suspension Policy

Study Postponement and Suspension Policy

Purpose

This policy defines the procedure for postponing or suspending the services provided for a single study subject to an executed single study sales order (“Single Study SO”) between Medidata and Customer or Partner, as applicable (herein, collectively referred to as “Client”).

Scope

  • Postponement: A Client may postpone the services provided for a single study prior to the Single Study SO Effective Date, by providing prompt written notice prior to the Single Study SO Effective Date, to avoid applicable services suspension fees (as set forth below).  If Client notifies Medidata after the Single Study SO Effective Date, the services suspension fees and process set forth below will apply.
  • Suspension: A Client may suspend the services for a single study, as set forth in a Single Study SO, for a fixed services suspension fee (as set forth below) and as outlined in the suspension process below.
Currency Fixed Services Suspension Fee Per Suspension Request (3-6 months) – Global Phase II or III Studies Fixed Services Suspension Fee Per Suspension Request (3-6 months) – Emerging Market, Medical Device, Not for Profit, and Phase I and IV Studies
USD – $ 5,000 1,500
EUR – € 4,375 1,313
GBP – £ 4,025 1,208
CNY – ¥ 33,333 10,000
SGD – $ 7,500 2,250
AUD – $ 7,500 2,250
CAD – $ 6,136 1,841
JPY – ¥ 675,000 202,500

 

  • In the event a Client requests an extension of the suspension period or a subsequent suspension period for the same Single Study SO, Client will pay an additional services suspension fee for each additional suspension period, in accordance with the schedule set forth above.
  • In the event multiple Single Study SOs are aggregated in a single contract document, this policy will apply to each Single Study SO independently.
  • This policy does not apply to studies deployed under multi-study enterprise subscription sales orders.

Suspension Process

In the event that a Client reasonably determines that a study must be suspended, then Client may suspend the services pursuant to the applicable Single Study SO.  During the suspension period, the study will be inactive and will not be accessible to Client.  In the event of a study suspension, the following applies: 

  • Client will complete the on-line Study Suspension Request Form posted at Study Suspension Request Form in advance of the effective date of the study suspension;
  • Medidata will suspend services for the applicable study for a minimum period of three (3) months and a maximum period of six (6) months. Suspension periods will be in whole month increments.
  • The suspension period will begin on a Single Study SO Anniversary Day after the Study Suspension Request Form is properly submitted. “Anniversary Day” means either: (i) the the day following the day of the month of the Single Study SO end date, where the end date is other than 28th – 31st of the month; or (ii) the first day of month, where the Single Study SO end date is 28th- 31st of the month. Examples below:
    • If the Single Study SO end date is on the 19th day of the month, the suspension period will begin on the 20th day of a month after the Study Suspension Request Form is submitted
    • If the Single Study SO end date is on the 29th day of the month, the suspension period will begin on the 1st day of a month after the Study Suspension Request Form is submitted
  • Upon the effective date of the study suspension, Client will be charged a services suspension fee in accordance with the schedule set forth above;
  • Medidata will not charge a services suspension fee for a study suspension initiated prior to production use availability/production ready; 
  • Client and Medidata will document the study suspension period and applicable fee(s) in a change order to the applicable Single Study SO. For the avoidance of doubt, the suspension will not be effective until such change order is fully executed by Client and Medidata.
  • In the event Client elects to re-start the suspended study prior to the end of the suspension period, Client will notify Medidata via the Study Suspension Restart Notification Form posted at Study Suspension Restart Notification Form.