SureClinical MSA Addendum – Effective Dec 31, 2019 – SterlingBio Smart CRO Services and Solutions

SureClinical MSA Addendum - Effective December 31 2019


Notice of ADDENDUM to SureClinical’s Master Subscription Agreement

By using this software You agree to abide by the MASTER SUBSCRIPTION AGREEMENT (“Agreement”) or “MSA,” by and between SureClinical, Inc., a corporation organized under the laws of the State of Nevada, with a place of business at 5566 Longley Lane, Reno, NV 89511 (“SureClinical”), and the company represented by the individual accepting this Agreement on the company’s behalf (“Company”, “You” or “Your”) (each, a “Party” and, collectively, the “Parties”). This Notice of Addendum to the existing MSA between You and SureClinical covers new policies for both You and for external Organizations who may access Your SureClinical System Instance. These policies are effective as of December 31 2019 (the “Effective Date”). If you have questions, please contact SureClinical Inc at:

SureClinical provides customers access to a proprietary, health sciences, software-as-a-service known as the Services, via the Internet on a subscription service basis.  The Services, among other things, enable You to acquire, classify, manage and archive your clinical trial regulatory documents via the SureClinical’s proprietary technology.  The Services consist of the services and products described in this Agreement along with the other services and products described on SureClinical’s website or described in a subscription order or invoice between You and SureClinical.  Any such products and services utilized shall be deemed to be Services and subject to the terms of this Agreement. SureClinical provides these Services (and any updates or improvements to the Services) to You subject to the terms and conditions of this Agreement. 

  1. 1.            SureClinical Digital Signing.  SureClinical makes available for users of the Services a digital signing service that utilizes Adobe Digital Certificates through its identity partners, DigiCert and Entrust, Inc. SureClinical is not a party to any digital signing transaction by You or any user or other person or entity utilizing the digital signing service, which shall be governed by any agreements between you or such user and DigiCert or such other digital identity provider.  SureClinical shall not be responsible for any loss that may result from your use of the digital signing service unless caused by SureClinical’s breach of this Agreement.

  1. 1.1.        Digital Signing Account Types.  For customers who license SureClinical’s Applications and Platform, SureClinical offers two types of digital signing accounts:  Internal Signing and External Signing.  Internal Signing Accounts allow digital signing by and between named users within the customer’s system instance; External Signing Accounts allow digital signing between a named signing initiator (‘Initiator’) and any signing recipient (Recipient), for Internal Signers or External Signers.  With either signing account type, Initiators start a signing workflow process and Recipients participate in the signing process. 

  1. 1.2.        Unlimited Plan Option.  Both Internal and External Signing Account types have an option for an Unlimited Plan license.  With this Plan, Initiators can invite multiple, unlimited numbers of Recipients to participate in a signing workflow process without paying any additional signing fees.  Under the unlimited plan option, 200 signing workflow processes per year can be started by an Initiator for either account type. However, SureClinical may allow customers to exceed the number of signing workflow processes included in their service plan under SureClinical’s reasonable use policy: SureClinical reserves the right to prevent or stop any use of SureClinical services that appears to be abusive or is unduly burdensome.

  1. 1.3.        Transaction Plan Option.   External Signing Account types have an option for a Signing Transaction Plan.  With this Plan, every signature event constitutes a single digital signing transaction. For example, if an Initiator invites a Recipient to participate in a signing workflow where both the initiator and the recipient sign a document, then two digital signing transaction events have occurred, and the Initiator’s account will be charged two digital signing transactions.  Under the Signing Transaction Plan, Initiators will be required to purchase digital signing transaction credits sufficient to cover all signing events in a signing transaction workflow process.  SureClinical will provide dashboards and reports of signing transaction account balances and signing transaction credit usage to users so that they can track their signing usage. SureClinical may elect to extend digital signing transaction credits, however, payment for digital signing transaction credits will be subject to SureClinical’s terms and conditions of sale. 

  1. 1.4.        SureEsign – End User License Agreement.   SureEsign will be made available to ‘External Persons’ who are not Staff Persons for Your Organization.  External End Users of SureEsign services will be required to agree to a click-through End User License agreement.  A copy of the SureEsign End User License Agreement is included by reference to this addendum.

  1. 2.           SureClinical Health Science Professional Network or SureNetwork.  In connection with the Services, SureClinical shall provide a public network, SureNetwork, where healthcare and life science professionals can share their contact information, credentials, areas of expertise, and background within an open online community.  Registered SureNetwork community users may share and digitally sign documents (provided they have signed up for digital certificate services), share information, and professional network details.    In addition, any user that applies for the SureClinical Digital Signing Service can opt in for enrollment in SureNetwork.   Any user that is enrolled in the SureNetwork will have a basic profile created for such user consisting of the user’s name, title, credential, business or organization name, country, city, and if applicable, state.  The user may add and share such additional profile information at the user’s discretion.  Users of SureNetwork are responsible for the accuracy of any profile information and any communications made by them or information shared by them on SureNetwork. SureClinical will not review or verify any profile information provided by a SureNetwork user, applicant, government or external database, organization or person, and will not monitor any communications made by any users of SureNetwork.  SureClinical shall not be liable for any damages or claims resulting from a user’s use of the SureNetwork.  All SureNetwork services may be provided as a subscription agreement and may require execution of a separate Order Form.

  1. 2.1.       SureNetwork – Clinical Study Profile. SureClinical provides registered users of SureNetwork with publicly viewable summary clinical study profile data containing information that can be found on such as: Study ID, NCT Study Identifier, EU Registry ID, Study Title, Brief Summary, Therapeutic Area, Indication, SureNetwork Start Date, SureNetwork End Date, Countries, Study Phase, Enrollment status (enrolling, not enrolling).   Additional optional information such as Sponsor Name, Study Website Address and Study Contact Name may be entered.  Users of SureNetwork are responsible for the accuracy of any clinical profile information and any communications made by them or information shared by them on the SureClinical Health Science Professional Network.

  1. 2.2.        SureClinical Health Science Professional Profiles. SureNetwork users may add and share such additional Health Science Professional Profiles and Clinical Study Profile information at the user’s discretion.  Users of SureNetwork are responsible for the accuracy of any SureClinical Health Science Professional, Clinical Study Profile information and any communications made by them or information shared by them on the Network. SureClinical will not review any Health Science Professional profile, Organization Profile or Clinical Study Profile information provided by a user or applicant.  Although SureNetwork utilizes published government databases, organizations and persons to document, timestamp and record certain credential attributes of some SureNetwork Health Science Professional profiles, such as medical licenses, clinical study experience and other Health Science Professional Profile attributes, such credential attributes are not individually verified by SureClinical.

  1. 2.3.        SureClinical Health Science Organization Profiles – Organization Logos and Marks. SureNetwork users may add and share the name of the organization that they are employed by or affiliated with including the Organization Name, Address, Industry Area, primary contact person for their Parent Organization and Organization logo.    While SureClinical will make reasonable efforts to verify that a SureNetwork user is affiliated with their designated Parent Organization and that an Organization Profile was created by a user affiliated with the Parent Organization, SureClinical will not verify the identity of Organizations in SureNetwork, and will not verify if a SureNetwork User has the authority to add a logo or trademark to the Organization’s profile. All logos and trademarks remain the property of their respective owners.

  1. 2.4.        SureNetwork – Staff Profiles.   For SureNetwork users who are employees or consultants for Your Organization, you may wish to create ‘Staff Profiles’ for these Staff Persons.  SureNetwork will not publish or share Staff Profiles with other Persons, Organizations or entities outside of your Organization.  Use of SureNetwork Staff Profiles is provided under beta license terms and until such time as the feature becomes available in full production release, is provided at no charge to Your Organization for testing and evaluation.  After full production release, SureNetwork Staff Profiles is included at no charge with your SureCTMS or SureQMS application license.

  1. 2.5.        SureNetwork – End User License Agreement.   SureNetwork will be made available to ‘External Persons’ who are not Staff Persons for Your Organization.  External End Users of SureNetwork will be required to agree to a click-through End User License agreement.  A copy of the SureNetwork End User License Agreement is included by reference to this addendum.

  1. 3.            SureClinical Compliance Service.  As part of the Service, SureClinical will make available its auditor’s summary compliance opinion and release and summary test result certificate for the purpose of proof of compliance.  SureClinical does not have any other obligation to provide additional proof of compliance in the form of professional services or audits.  SureClinical provides an optional Compliance Service which includes a separate QA test environment, ongoing Compliance Portal access, and two hours of consultation services for additional prospective validation purposes, for an annual fee at the current published list price.  In addition, SureClinical will provide customized audit services pursuant to a separate order form. 

  2. FINANCIAL TERMS.              

Fees and Payment.  Upon execution of the order SureClinical will invoice You for the annual fees for the first year of the subscription term specified in the initial order and for the non-recurring fees, each as set forth in the initial order between the Parties. For any multiyear subscription term, and for any renewal of the subscription term, SureClinical will be entitled to invoice You for the then applicable annual fees at least 30 days in advance of the anniversary of the Effective Date.  All SureClinical applications require that You license at least one edition of SureClinical’s Platform with your initial order.  After your initial order subscription term for all SureClinical Applications or Platform, SureClinical reserves the right to autorenew your subscription at the then current list prices, unless a new order form is executed.   For any order after the initial order, SureClinical will invoice You for the fees set forth in that order upon execution by both parties of that order or as otherwise provided in that order. If Your use of the subscription products or a module exceeds the usage capacity including: licensed user count, licensed study count, licensed site count, licensed SureDrive count, licensed SureEsign transaction count, licensed storage allocation or licensed bandwidth use for the subscription products or that module, SureClinical will invoice You the then applicable fees for that usage capacity as prorated over the remaining annual period of the subscription term from the date such use exceeded that usage capacity.  Prices do not include, and You shall promptly pay, all applicable taxes in connection with the Services, except for taxes levied on SureClinical’s net income.  Payments must be made annually in advance. All payment obligations are non-cancelableand all amounts paid are non-refundable.  You must provide SureClinical with Your valid credit card or approved purchase order information as a condition to signing up for the Services.  If, during the term, You purchase access to additional Studies and/or Sites, such Studies and/or Sites will be coterminous with the preexisting term and partial months will not be pro-rated.  All pricing terms are confidential, and may not be disclosed to any third party without explicit written authorization from SureClinical Inc.