Term & Condition

These Terms of Service govern the delivery of Internet based Software as a Service (the “Service”) that Syntactx Technologies LLC (“Syntactx”) provides its users (“Customers”) under the terms of the Software as a Service Agreement (“Agreement”) between Syntactx and its Customers. Unless otherwise noted, these Terms of Service are subject to the terms of the Agreement and capitalized terms contained herein shall have the meanings set forth in the Agreement.

Services

Access

Syntactx provides its Customers access to Services via the Internet in accordance with these Terms of Service which enables secure access to a Customer Data. Syntactx provides robust monitoring and performs monthly measurement of Service delivery.

Support

Syntactx provides Support for Services to its Customers, subject to the terms of Customer’s Agreement, including:

  • Real-time technical and operational assistance to Customer’s designated personnel via telephone, e-mail and web support.
  • Application of upgrades, patches, error corrections and bug fixes during normal scheduled maintenance periods.
  • Updates to SaaS Product documentation.
  • Telephone support services to Customers
  • Access to Customer Data, upon Customer single request per study, on a compact disc (CD) or digital versatile disc (DVD) containing PDFs for all sites and subjects.
Data Management

Syntactx manages all Services in accordance with standard information security policies and applicable standard operating procedures (“SOPs”) and as outlined below:

  • Security (physical, network, and application): Syntactx maintains, monitors and uses reasonable safeguards based on industry accepted security frameworks to protect against the unauthorized, accidental or unlawful destruction, loss, disclosure, alteration or transfer of Customer Data.
  • Retention: Customer shall have access to the Service during the term of Customer’s Agreement, and upon termination or expiration of the Agreement, for retrieving Customer Data in durable formats.
  • Privacy: Syntactx complies with all laws and regulations applicable to the provision of the Service and processing of Customer Data. Syntactx maintains appropriate technical and organization security measures to ensure protection of Customer Data.
  • Disaster Recovery: Syntactx uses cloud-based data centers. Syntactx maintains a disaster recovery facility in a separate, geographically distinct location, in the event Syntactx hosting services at the primary location(s) are unavailable. Syntactx maintains policies and procedures regarding its disaster recovery and avoidance procedures, damage assessment and incident handling.

Service Levels

Availability

Syntactx uses commercially reasonable efforts to make the Services “Available” (as defined below) at least ninety-nine percent (99.0%) of the time as measured over the course of each calendar month excluding unavailability as a result of any of the Exceptions described below (the “Availability Requirement”). “Available” means the Hosted Services are available for access and use by Customer and its Authorized Users over the Internet and operating in material accordance with the Specifications. Availability is calculated as the actual monthly uptime when the Services are available, divided by scheduled monthly uptime and expressed as a percentage.

For purposes of calculating the Availability Requirement, the following are “Exceptions” to the Availability Requirement, and neither the Hosted Services will be considered un-Available nor any Service Level Failure be deemed to occur in connection with any failure to meet the Availability Requirement or impaired ability of Customer or its Authorized Users to access or use the Services that is due, in whole or in part, to any: (a) access to or use of the Services by Customer or any Authorized User, or using Customer’s or an Authorized User’s Access Credentials, that does not strictly comply with this Agreement and the Specifications; (b) Customer Failure; (c) Customer’s or its Authorized User’s Internet connectivity; (d) Force Majeure Event; (e) failure, interruption, outage or other problem with any software, hardware, system, network, facility or other matter not supplied by Provider pursuant to this Agreement; (f) Scheduled Downtime; or (g) disabling, suspension or termination of the Services pursuant to the Agreement.

Response Times

“Service Level Failure” means a material failure of the Services to meet the Availability Requirement Syntactx will respond to any Service Level Failures and Service errors or outages in accordance with the following levels of severity, each as reasonably determined by Syntactx:

* The response times are measured from when Customer notifies Syntactx about a performance problem with the Service and Syntactx’s issuance of a trouble ticket number to Customer.

Severity Level Description Response*
Severity Level 1
Critical Business Impact
Customer’s business processes can no longer continue due to Customer reported errors or deficiencies in the Syntactx Services. Syntactx will respond to the reported error or deficiency within one business day and use all commercially reasonable efforts to resolve the reported issue(s) as soon as practicable.
Severity Level 2
Serious Business Impact
Customer’s business processes can function temporarily or work around the Customer reported error or deficiency in the Syntactx Services, however there is a serious impact on Customer’s productivity and/or the Service Level. Syntactx will respond to the reported error or deficiency within one business day. Syntactx will use commercially reasonable efforts to resolve the reported issue.
Severity Level 3
Minor Business Impact
Customer’s business process can continue or work around the reported issue(s) through proper business procedures with no serious impact on service levels associated with the reported error or deficiency of the Syntactx Services Syntactx will respond to the reported error or deficiency within one (1) business day and use commercially reasonable efforts to resolve the reported issue. Such errors or deficiencies may be corrected in the next release of the Services.
Severity Level 4
Enhancement Request
Customer request for Syntactx to make a change or improvement in the Syntactx Services and/or functionality. Syntactx will evaluate whether to implement the proposed enhancement in the context of Syntactx’s development plans. Implemented enhancements may be included in a future release of the Services.

* The response times are measured from when Customer notifies Syntactx about a performance problem with the Service and Syntactx’s issuance of a trouble ticket number to Customer.

Service Credit

In the event of a Service Level Failure, Syntactx shall issue a credit to Customer in the amount of [NUMBER IN WORDS] percent ([NUMBER] %) of the monthly Fees for the Services due for the Service Period the Service Level Failure occurred (each a “Service Credit”), subject to the following:

  • Syntactx has no obligation to issue any Service Credit unless (i) Customer reports the Service Failure to Syntactx immediately on becoming aware of it; and (ii) requests such Service Credit in writing within [NUMBER] days of the Service Level Failure; and
  • in no event will a Service Level Credit for any Service Period exceed [NUMBER] percent of the total Fees that would be payable for that Service Period if no Service Level Failure had occurred.

Any Service Credit payable to Customer will be issued to Customer in the calendar month following the Service Period in which the Service Level Failure occurred.

Scheduled Downtime.

Syntactx will use commercially reasonable efforts to: (a) schedule downtime for routine maintenance of the Hosted Services between the hours of ([NUMBER]) a.m. and ([NUMBER]) a.m., Eastern Time; and (b) give Customer at least [NUMBER] hours prior notice of all scheduled outages of the Hosted Services (“Scheduled Downtime”).

Exclusive Remedy.

Payment of Service Credits as set forth in Section 2.3 are Syntactx’s sole obligation and liability and Customer’s sole remedy for any Service Level Failure.

Customer Responsibilities

Customer must report Severity Level 1 and 2 issues by telephone. In addition, Customer shall provide Syntactx with documentation of any error or deficiency and provide Syntactx with the necessary instructions and data required to reproduce the error or deficiency reported by Customer and all other reasonable support and assistance requested by Syntactx as necessary to discover the cause or a cure for the reported error or deficiency of the Services.

Regulatory And Audit Policies

These Regulatory and Audit Policies (“Regulatory Policies”) are applicable to Customers who have been given access to those Syntactx Services that are subject to regulatory health authority review pursuant to the terms and conditions contained within the applicable Agreement.

Client Audit Rights And Regulatory Inspections

During the Term, Syntactx agrees to permit Customer representatives to examine or audit the Services performed hereunder at Syntactx’s worldwide corporate headquarters upon at least forty-five (45) days’ notice during regular business hours, to determine whether the Services are being conducted in accordance with the Agreement and all applicable laws, rules and regulations. In each twelve (12) month period, Client shall be entitled to conduct one (1) audit without charge by Syntactx. If such audit would require subsequent audit(s) as may be necessary to verify corrective action(s), such audit(s) shall be at no charge to Client. Any information of Syntactx or its subcontractors obtained or observed during such examination or audit shall be deemed Syntactx’s Confidential Information.

Regulatory Inspections And Inquiries

In the event either party is notified of an inspection or inquiry by a regulator that relates directly to the Customer’s clinical trial for which Syntactx is providing Services, the party so named is encouraged to promptly notify the other party of any such regulatory inspection or inquiry. This notification can be made by either party via email or mail service. When notifying Syntactx, this information shall be sent to the attention of the head of Syntactx’s quality and regulatory affairs function at 4 World Trade Center, 150 Greenwich Street, 44th Floor, New York, New York 10007 USA. For purposes of these Regulatory Policies, “regulator” means a government or regulatory body with binding authority to regulate Syntactx’s or Customer’s healthcare and life sciences-related activities. Syntactx agrees that during any such regulatory inspection or inquiry of the Customer and its contracted sites that relates to the Services provided to Customer, Syntactx shall make available to the regulatory authority via the Customer all records lawfully required. In the event of a regulatory inspection or inquiry of Syntactx, Syntactx shall make available for inspection all records lawfully required in accordance with the Agreement.

Furthermore, Syntactx has a formal, contractual agreement with its infrastructure-as-a-service (IaaS) third-party hosting provider that documents the provider’s commitment to support regulatory investigations (e.g., inspections) of Syntactx, as well as regulatory investigations of Customers employing the Services, including provision of relevant documents, information and records to Syntactx. In the event Syntactx requires further input to satisfy a regulatory investigation, the provider will use commercially reasonable efforts (taking into account potential risks to their systems, services, or intellectual property) to assist Syntactx in responding to the regulatory authority’s questions.

Regulatory Matters

Syntactx will use commercially reasonable efforts to provide the Services in conformance with generally accepted standards of good clinical practice (GCP) and/or good post-marketing study practice (GPSP) and all applicable laws, rules, and regulations relating to the conduct of any clinical trial and/or post-marketing study. In particular, Syntactx complies with GCP and GPSP regulatory requirements related to internal or self-inspection by way of the Develop and Release Software Product standard operating procedure (SOP) (specifically for known product issues) and the Quality Incident Management SOP (for data, security, software, hosting, and other operational incidents), which SOPs describe how issues and incidents (discovered by internal or self-inspection, as well as reported by Customer) are identified, tracked, and managed internally. These known product issues and quality incidents are communicated with Customers and regulatory authorities as required.

Syntactx has established and agrees to maintain a quality management system and educational/training system that is compliant with regulatory expectations. Syntactx has established and agrees to maintain a system of self-inspection, with a record that such inspection has occurred.

Debarred Persons

Syntactx is not using and will not knowingly use the services of any person debarred under any country-specific debarment lists (in particular 21 U.S.C. § 335a of the FDA regulations) in any capacity in connection with the performance of the Services. In addition, Syntactx is not using and will not knowingly use the services of any person or affiliate person/firm for whom convictions subject to debarment have occurred in the past five (5) years in any capacity in connection with the performance of the Services. If, at any time during the Term of the Agreement, Syntactx becomes aware that it or any person employed or engaged by it or an affiliate person/firm in any capacity in connection with the performance of the Services for Customer has been or is in the process of being debarred or is convicted of any offense subjecting it or any person to debarment, subject to applicable law, Syntactx will notify Customer promptly in writing and such person will cease providing the Services.

Updates & Notices

Syntactx may amend its obligations under these Terms of Service. Customer will be notified in advance of any change of material impact to Syntactx’s obligations under these Terms of Service within thirty (30) days of such change.

Last Updated: August 2017