Terms and conditions for Japan Specified Clinical Research (“JSCR”) projects

Purpose

The terms and conditions contained herein defines the applicable terms between Medidata and Customer or Partner, as applicable (herein, collectively referred to as “Client”) with respect to certain Medidata Services available to Client for its JSCR project(s), and are intended to be incorporated into each individual Sales Order for Client’s JSCR project.

Any capitalized terms not defined in this document shall have the same meaning set forth in the Agreement and/or the applicable Sales Order. Except as expressly amended and supplemented in this document, all terms and conditions of the Agreement and/or the applicable Sales Order shall remain in full force and effect. In the event of any conflict between this document and the Agreement and/or the Sales Order, the provisions of this document shall prevail.

The scope of Medidata Services for Client’s JSCR projects shall only be applicable to a Client(s) in Japan which provides Medidata with the right to combine Client’s Data with other data, to be included in Medidata’s benchmarking and analytics services as specified in the Agreement. Medidata has the sole discretion to determine and/or revise the scope and pricing of Medidata Services that are available to JSCR projects, provided that a written Change Order is required to be executed regarding any amendments to an executed Sales Order.

Specific terms and conditions

Japan Specified Clinical Research (JSCR) projects refer to clinical research projects governed by Japan Clinical Research Act which went into effect as of April 2018. JSCR projects under the Japan Clinical Research Act shall exclude clinical trials related to the approval of new medical products that are defined and conducted in accordance with the provisions of the Pharmaceuticals and Medical Devices Act.

Client and its Authorized Users shall access the Application Services solely through Medidata’s hosted portal applications and via a common URL designated and managed by Medidata supporting JSCR projects across Medidata customers. The setup and configuration of the common URL shall be solely managed by Medidata and Medidata retains the right to change the configuration at its own discretion.

Client shall not use the Application Services for any studies or trials that are not JSCR projects, and shall be solely responsible and assume all liability for ensuring full compliance with the Japan Clinical Research Act and any other applicable laws and regulations relating to JSCR projects. In the event the Application Services are used by Client for non-JSCR projects, Client shall be deemed to be in material breach and Medidata shall have the right to terminate the applicable Sales Order(s) by delivering notice thereof to Client with immediate effect.

Individual Sales Orders are required to be executed by Client with Medidata for each and every JSCR project; for the avoidance of doubt, a Sales Order shall not cover multiple JSCR projects. A JSCR single study Sales Order shall not be eligible to consume against any executed multi-study Sales Order(s) between Client and Medidata. The Medidata Study Postponement and Suspension Policy shall apply to JSCR single study Sales Orders by reference.

For the avoidance of doubt, as JSCR projects are not subject to good clinical practice (GCP), the Regulatory and External Client Audit Policies for Medidata Services Policies and the right to audit as contained therein do not apply to JSCR Sales Orders.