Instruments:

“Instrument” means a questionnaire used by a patient to collect patient reported outcomes, without interpretation of the response by a clinician or anyone else.

• Instrument Localization Services: Medidata will provide the following, based upon paper Instruments (including any translated versions, as applicable) and specifications provided by Client: (i) coordination for migration of paper Instruments to electronic Instruments in ePRO/eCOA, (ii) Instrument configuration in accordance with Client specification, (iii) facilitation of any required Instrument author review, (iv) language updates based on any Instrument author feedback, (v) on-device review of electronic Instrument, and (vi) associated reports.
• Validated Instrument License Management Service: Medidata will facilitate the acquisition of license(s) for copyrighted validated Instrument(s) by identifying author(s) and version(s) of license(s) to secure. Unless otherwise explicitly set forth in the Sales Order, Validated Instrument License Management Service does not include fees associated with acquisition of the Instrument license(s).
• Validated Instrument License Management Service (for Instruments owned by EORTC): Medidata will facilitate the acquisition of license(s) for copyrighted validated Instrument(s) by identifying author(s) and version(s) of license(s) to secure. Client is fully responsible for any fees associated with acquisition of the Instrument license(s) (for the avoidance of doubt, this does not include the electronic implementation fee, which is included in this Sales Order).
• Instrument Services – License Procurement: Medidata will facilitate the payment of Instrument(s) license fees to the license holder. To support appropriate payment, Client is responsible for: (i) ensuring Medidata is listed as the “invoice recipient” on license agreement(s); (ii) verifying the license royalty fee with Medidata prior to execution of license agreement(s); and (iii) ensuring a fully executed copy of the license agreement(s) is provided to Medidata.

Patient Cloud Applications (ePRO/eCOA, eConsent, myMedidata eCOA, myMedidata eConsent, Sensor Cloud and Circuit Clinical):

Unless specifically included in a Medidata Service reflected on the applicable Sales Order, Client is responsible for: (i) providing Client’s study protocol to Medidata; (ii) obtaining all necessary licenses, authorizations or consents from owner/authors of Instruments, including the right for Medidata to use the applicable Instruments on behalf of Client in its performance of the Services; (iii) any required cognitive debriefing usability testing or full linguistic validation of Instruments, as determined by Client; and (iv) determining device provisioning requirements for the study, including for a ‘bring your own device’ strategy where patients will use their own personal devices, with consideration of (a) Medidata proposed percentage of provisioned hardware based on location, patient population access to compatible hardware and preference for utilization of patient personal devices, and (b) any potential impact on patient eligibility criteria.

For the avoidance of doubt, Medidata shall not be obligated to enter into any license or other agreement directly with any Instrument owner/author.

SensorCloud Services:

“De-identified Raw Data” means de-identified data received from sensor devices.

“De-identified Processed Data” means data which results from De-identified Raw Data that has been algorithmically processed and stored by Medidata during the Sales Order term specifically for Client hereunder.

De-identified Raw Data and De-identified Process Data are Client Data under the Agreement.

Device Services:

“Device Services” means mobile device provisioning to Client for use in conjunction with Application Services, including (i) Device Provisioning and/or (ii) Patient Cloud Helpdesk Support.

“Device Provisioning” means Medidata’s provisioning of mobile technology device to Client solely for Authorized Users’ input of Client Data for the applicable study during the Sales Order term in conjunction with Application Services, including: (i) device configuration setup, limited to pre-installed applications; (ii) Shipment to/from the Client specified destination; (iii) EMM Services; and (iv) five UAT devices per device type (phone, tablet) at no additional charge.

“Device Data and Enterprise Mobility Management (“EMM”) means (i) the monthly mobile device data plan; and/or (ii) the management and tracking of mobile devices, including, as applicable, automated software updates on, and control and security of, devices provisioned by Medidata.

“Patient Cloud Helpdesk Support” means managed service call center support for site, patient, or monitor Authorized Users of Medidata applications and/or Device Provisioning. Patient Cloud Helpdesk Support is available during the hours set forth below:

“Shipped” or “Shipment” means Medidata has sent the device pursuant to Device Provisioning to the location designated by Client and the device is out of Medidata’s possession. The Device Provisioning fee excludes customs clearing fees, including any applicable import license fees, which are the responsibility of Client.

• In the event that Client declines to perform UAT of devices prior to deployment, the configuration of the devices shall be deemed accepted by Client upon deployment and Client shall assume any risk associated with such deployment.
• Utilization of Medidata’s ePRO/eCOA or myMedidata application on a smartphone for patient (personal) mode has the following minimum device requirements:
  

• Devices are provisioned to Client by Medidata on a rental basis during the term of the Sales Order. Client shall return all rented devices on or before conclusion of the Sales Order term (or in the event of an early study termination rented devices must be returned within thirty (30) days from the termination date); in the event the device is not returned by such time, or a returned device is not operable, Client shall be invoiced for the fair market value of the device.
• Device Provisioning fees may vary based upon country specific requirements.
• Device Provisioning Warranty: Medidata warrants to Client that during the term of the Sales Order, devices provisioned to Client thereunder shall operate or perform substantially in conformance with the device manufacturer’s specifications. In the event of any such non-conformity, Medidata shall repair or replace the applicable device. Medidata shall not be liable for any provisioned devices that are abused, altered or misused by Client or any of its Authorized Users, or that become defective or non-conforming through the action or inaction of Client or any of its Authorized Users.

Device Services and Other Subscription Services Adjustment:

• Client may request a one-time adjustment to the study Parameters (number of sites, patients, Instruments, devices, countries, or translations) for Device Services and/or other Subscription Services, on or before ninety (90) days from the transaction date (the Sales Order Effective Date or the Change Order Effective Date, as applicable, the (“Transaction Effective Date”)¹; upon such request Medidata shall provide revised pricing for the requested adjustment to the Parameters. Any resulting reduction in fees shall not exceed twenty-five (25%) percent of the total fees for such Services.
• After ninety (90) days from the Transaction Effective Date, Client may request an additional one-time adjustment to other Subscription Services for Instrument localization and/or Instrument translation, on or before one-hundred eighty (180) days from the Transaction Effective Date; any resulting reduction in fees shall not exceed ten (10%) percent of the total fees for such Services. Any and all adjustments as a result of the aforementioned shall be documented in a change order executed by both parties.
• In the event of any early termination of the study, Client shall be responsible for payment of fees as follows: (i) Device Provisioning fees (see “Device Provisioning Termination” below); and (ii) one hundred (100%) percent of the other Subscription Services fees; and (iii) fees for Services other than as identified in (i) and (ii), through the effective date of termination.

Device Provisioning Termination Process:

If the Sales Order termination is effective within one hundred and eighty (180) days of the Transaction Effective Date, and Client has paid the Device Provisioning fees set forth in the initial transaction (the Sales Order or Change Order as applicable) for the Device Provisioning Services, Client will be eligible for Device Provisioning credits and deployment of unused Devices, as follows:

Device Provisioning Credits

Medidata shall invoice, and Client shall pay, Device Provisioning fees as set forth in the Sales Order and any non-cancellable third-party fees accrued by Medidata in the provision of the Device Provisioning prior to the effective date of termination. Notwithstanding the foregoing, provided Client has paid the total Device Provisioning fees by the Transaction Effective Date, Client will be eligible to receive a Device Provisioning credit for shipping, preparation and recall Device Provisioning fees as set forth in Table A below (the “Device Provisioning Credit”)² which credit may be applied to future Device Provisioning Services.

Unused Device Plan

Client will be eligible to deploy unused device hardware on studies for which a new Sales Order is executed within one year of the termination date of the original Sales Order (“Unused Device Plan”) with payment of a per device transfer fee (see Table A below).

Table A: Device Provisioning Credit and Transfer Fee Schedule

¹For any Sales Order where Device Services and/or other Subscription Services are initially reflected under a Change Order to the Sales Order, the timeframe for permitted adjustment to the study Parameters or eligibility for Device Provisioning Credit shall be determined from the Change Order Effective Date.

²Device Provisioning Credits only apply to Sales Orders with one thousand (1,000) or fewer devices.

³These numbers reflect Medidata’s current rates, which are subject to change and not guaranteed for future studies.