CRO External User Access Agreement and License (CROEUAA)
This External User Access Agreement and License Addendum provides the terms under which You (customer) may grant access to Sure’s Platform and Apps of SureClinical, Inc. (“Sure”) to individual users who are not Your employee or contingent staff (an “External User”) and are part of an organization other than You or Your subsidiary or parent (an “External Organization”).
Assent to Be Bound: In order to grant access to External Users with External Organizations, BY CLICKING THE “ACCEPT” BOX, OR THE “AGREE” BOX, OR “OK”, YOU AGREE TO THE TERMS OF THIS AGREEMENT. IF YOU DO NOT AGREE WITH THESE TERMS AND CONDITIONS, YOU MUST NOT ACCEPT THIS AGREEMENT AND MAY NOT GRANT ACCESS TO ANY SURE PRODUCTS OR APPLICATIONS TO EXTERNAL USERS.
You agree to the following (general terms):
Section 1: External User Access Agreement License and Requirements
1.1 Business Relationship with External User: Sure’s Platform and Apps may be licensed to External Users with External Organizations who have a business relationship with You, such as sponsors, CROs, sites, suppliers, and partners and other ‘user types’ who may need full or limited system access to Your data.
1.2 Named User Licensing; External User Personal Identification Information Required: All Platform application products and services are licensed to Named Users, each of whom must be identifiable by Person Name, Organization, Country, and by a unique organization email address. The Platform doesn’t support use of email addresses provided by consumer email services or telecommunications providers to identify users. As part of Sure’s new user account invitation process, or for existing external users, You agree to capture, provide and maintain personally identifiable information for each External User, including at a minimum: First/Last Name, Title, Organization Name, Organization unique email (used for licensing Sure’s products to the External Users), User Type (Sponsor, CRO, Site, Supplier, Partner). In order to ensure government compliance with sanctioned or blocked countries, IP addresses are captured for all users. Sharing of Named User accounts is prohibited and Sure reserves the right to shut down any Named User accounts that have been used by someone other than the Named User.
1.3 External User Organization Identification: As part of Sure’s security and fraud detection policies, You are required to verify the External User’s organization name, email domain address and country. For security and trust verification, all organizations will be added to Sure’s master TrustList™ which contains the trusted organization’s name, user type, description (optional), Country, and email domain address. organizations from sanctioned states or countries, organizations who are from Sure’s competitors, or organizations who Sure deems to have a perceived business or security risk may be placed on a licensing BlockList™. If an organization is on Sure’s BlockList, you may be blocked from granting an invitation to External Users from that organization.
1.4 Advance Payment of External User Fee for Each External User: Payment in advance is required for all User License fees, including a fee for each External User to access Sure’s Platform, Apps and other services and products. Unless otherwise agreed to in writing, notification of payments due for User Licenses will be sent to You at least seven days before payment is due, and again seven days after payment is due. Sure reserves the right to deactivate User Licenses which remain unpaid after our seven-day payment notification period.
1.5 End User Subscription Agreement (EUSA) Clickable Agreement: Upon initial login to the system, each External User will be required to review and agree to Sure’s click-to-agree EUSA user agreement, a copy of which is available at: www.sureclinical.com/eusa.
1.6 Training, Support, and License Fee Payment for External Users: You will be fully responsible for all actions by the External Users, and You will be responsible for insuring that any External Users You’ve added have received sufficient application and system training certification through either Sure’s training or through your own Sure authorized equivalent training. You are required to provide all of Your Users, including External Users, with Tier 1 Support. You agree to be responsible for the payment of External User license fees.
1.7 External User Contact by Sure: As a condition of granting an license to a person with an External Organization, You agree that Sure may contact External Users for any legitimate business purpose including but not limited to support, training, licensing, to provide product information or for other legitimate business purposes.
1.8 No Sure Product Resale: Unless otherwise agreed to in a reseller or redistribution agreement, You are responsible for ensuring that Sure’s Products are not resold, distributed or shared with others for payment or compensation of any kind, whether provided separately or bundled with services for which payment is made. This is especially applicable to CROs who offer outsourced business services to Sponsors. Please see the section below on license restrictions for outsourced business services offered with Sure Products.
1.9 Outsourced Business Services: Sure’s products may not be offered for Internal User access nor for External User access for the provision of outsourced business services. For example, a CRO may use Sure’s products for the CRO’s sole business operations, but the CRO may not offer outsourced business services such as project management, site management or other services with any Sure Internal or External User licenses. However, as Internal Users, your employees, agents and contractors may use Your Sure Instance to manage clinical trials for Your clients or customers, as long as these clients and customers are not provided Power User access (full user) to the Sure Instance – in this case, such usage is not considered an outsourced business service.
1.10 License Restrictions for CRO Instances: Unless otherwise agreed to in a separate CRO External User Access Agreement, Reseller or Distribution agreement, for reasons related to project security, compliance and license restrictions, CROs are prohibited from granting Power User access (full user) to External Users such as Sponsors or their partners on the CRO’s Sure Instance. Acceptable alternatives to granting Sponsors Application Power User access as either an External or Internal User Sponsors is outlined below:
1.10.1 Separate Sponsor Instances with CRO Power User access: CROs can request that a separate sponsor instance be setup, whereby the CRO will be the initial system administrator and will invite the Sponsor to join as instance owner / instance administrator. Sponsor will click-to-agree to Sure’s EUSA agreement. CRO will have full Power User access until such time that the Sponsor terminates the CROs user account. A separate Platform licensing fee may apply for initial setup. All users require Platform and App license fees.
1.10.2 Sponsor access to Team Hubs: CROs can grant access to Sponsor project data that resides on the CROs instance through a project or study Team Hub. Hub App user fees apply.
1.10.3 Sponsor Report Subscriptions and Notifications: CROs can enroll their Sponsor clients in application report subscriptions and notifications. When a project update occurs meeting a specific interest area, the Sponsor can receive a notification and an optional report through the report subscription service.
Additional licensing information and requirements for CROs are available through Your sales representative. Sure reserves the right to conduct a license use audit of all CRO instances. When Sure detects and confirms a breach of the CRO restrictions for security, FDA compliance, unauthorized user account license sharing, unauthorized resale of Sure’s products, then the CRO’s instance will be subject to a thirty-day notice of service cancellation and / or service suspension for cause.
1.11 Peak Platform Requirement: External User licenses are only available on our Peak Platform which You agree to license with this agreement through a no-fee upgrade from your existing Platform license, when available and in production. See the Peak Platform data sheet for more information.
1.12 Platform Renewals: The terms and conditions set forth herein are subject to change by Sure upon Your renewal of Your Platform subscription.
Section 2: License Information
2.1 Application Licenses. Platform Apps can be licensed to External Users with two application license types: Power User (full use) or Hub User (limited use). In order to access any Application (such as ETMF, ISF, CTMS, QMS or other applications available in SureStore), all Users must have a Platform User License, as well as an Application User License for the corresponding application that will be accessed by the User. For flexibility and wider license availability, all Applications are provided with two application license types: 1) an Application Power User license, and 2) an Application Hub User license, Both license types are available to Internal and External Users, for all user types: Sponsor, CRO, Site, Supplier, Partner.
2.2 Hub User License for External Users: External Users typically access “Team” Hubs as Hub Users. Hub Users have access to a focused role specific feature set. Hub Users have limited access to data in your instance, typically restricted to a project or process.
2.3 Minimum Quantity of Qualifying Licenses: To activate a User License subscription, You must buy a minimum quantity of qualifying licenses for some products. For more information about minimum license purchase requirements, please see the Product Data Sheet, Order Forms, or Sure’s SaaS Products and Services charge metrics.
2.4 Types of Users and User Licenses: Based on the capabilities that You wish to access in Sure’s Platform, there are several user types which define product and service use for a user license The Saas Products and Services description (online at sureclinical.com/saas) explains these user types. available license types, and charge metrics.
Section 3. Confidential Information
3.1 Confidential Information. “Confidential Information” means and refers to the Platform or Sure applications and all other materials or information furnished by the Disclosing Party to the Receiving Party that is expressly identified or marked by the Disclosing Party as “confidential” at the time of delivery or which by its nature is normally and reasonably considered confidential, such as information related to past, present or future research, development or business affairs, any proprietary products, materials or methodologies, or any other information which provides the disclosing party with a competitive advantage. Information shall not be Confidential Information where it can be established by clear and convincing evidence that: (i) the information is generally publicly available; (ii) through no wrongdoing of the Receiving Party, the information was rightfully in the Receiving Party’s possession prior to this Agreement; (iii) the information was rightfully acquired by the Receiving Party from a third party entitled to disclose the information; (iv) the information was independently developed by the Receiving Party; or (v) the Disclosing Party authorized the disclosure in a signed writing.
3.2 Duty of Care. The Party receiving (“Receiving Party”) Confidential Information of the other Party (“Disclosing Party”) will maintain adequate security measures to safeguard the Disclosing Party’s Confidential Information from unauthorized disclosure, access, use and misappropriation, using at least the same degree of care that the Receiving Party exercises to protect its own Confidential Information. If the Receiving Party becomes aware of any threatened or actual unauthorized access to, use or disclosure of, or any inability to account for, the Disclosing Party’s Confidential Information, the Receiving Party will promptly notify the Disclosing Party thereof and will assist the Disclosing Party with its efforts to terminate such access, to curtail such threatened or actual unauthorized use or disclosure, or to recover such information or materials. The Receiving Party will be liable to the Disclosing Party for any non-compliance by its agents or contractors to the same extent it would be liable for non-compliance by its employees.
3.3 Legally Required Disclosures. The obligations of confidentiality assumed under this Agreement shall not apply to the extent that the Receiving Party is legally required to disclose the Disclosing Party’s Confidential Information, provided that the Receiving Party: (i) promptly notifies the Disclosing Party of the order to allow the Disclosing Party an opportunity to seek a protective order; (ii) provides the Disclosing Party with reasonable cooperation in its efforts to resist the disclosure, at the Disclosing Party’s expense; and; (iii) disclose only the portion of the Disclosing Party’s Confidential Information that is legally required to be disclosed.
3.4 Accounting for Confidential Information. Any data or other materials, including copies thereof, furnished to or obtained by Receiving Party pursuant to this Agreement shall be promptly returned or destroyed upon request by Disclosing Party. The Receiving Party will certify in writing that it has fully complied with its obligations under this Section within seven (7) days after its receipt of a request by the Disclosing Party for such a certification. This Section shall not be construed to limit either Party’s right to seek relief from damages that are caused by the other Party’s default.
Section 4. IP Rights
4.1 Reservation of Rights. Subject to the limited rights expressly granted hereunder, Sure, its affiliates, its licensors and content providers reserve all of their right, title and interest in and to the Platform, Applications, applicable services and content, including all of their related intellectual property rights. No rights are granted to You hereunder other than as expressly set forth herein.
Section 5. Miscellaneous
5.1 Independent Contractors. The Parties are independent contractors. Nothing contained in this Agreement will be construed or implied to create an agency, partnership or joint venture between the parties.
5.2 Force Majeure. Neither Party will have any liability for delays or failures in the performance of this Agreement to the extent that such delay or failure is caused by any cause not within such Party’s direct control, such as fire, flood, acts of God, natural disaster, war, terrorism, Internet outages, power outages and the like, other than financial inability.
5.3 Governing Law. The laws of the State of Nevada, United States of America shall govern the interpretation and enforcement of this Agreement and any dispute arising out of or related to this Agreement, without giving effect to any conflict of laws principles that may cause the law of any other jurisdiction to apply. The parties consent to jurisdiction of the state and federal courts in Nevada for any action arising under this Agreement. Venue in any action brought to interpret or enforce this Agreement shall lie in Washoe County, Nevada.
5.4 Attorneys’ Fees. In the event that any suit or action is instituted under or in relation to this Agreement, including without limitation to enforce any provision in this Agreement, the prevailing party in such dispute shall be entitled to recover from the losing party all fees, costs and expenses of enforcing any right of such prevailing party under or with respect to this Agreement, including without limitation, such reasonable fees and expenses of attorneys, which shall include, without limitation, all fees, costs and expenses of appeals.
5.5 Entire Agreement. This Agreement is the entire agreement between Sure and You regarding External User Licensing of Platform, applications and content and supersedes all prior and contemporaneous agreements, proposals or representations, written or oral, concerning its subject matter. In the event of any conflict or inconsistency among the following documents, the order of precedence shall be: (1) this Agreement, (2) the Master Subscription Agreement and (3) the Documentation. Titles and headings of sections of this Agreement are for convenience only and shall not affect the construction of any provision of this Agreement.
5.6 Assignment. You may not assign or otherwise transfer this Agreement without the prior written consent of Sure, which consent will not be unreasonably withheld or denied, and any attempt to assign this Agreement without such consent shall be null and void.
5.7 Amendment to the Agreement; Waiver. Except as this Agreement otherwise provides, no amendment to this Agreement shall be binding unless agreed to in a writing executed by Sure and You, and no approval, consent, or waiver shall be enforceable unless signed by the granting Party.
5.8 Severability and Reformation. If any provision of this Agreement is held to be invalid or unenforceable by arbitration or a court of competent jurisdiction, then the invalid or unenforceable provision will be severed, and the remaining provisions of this Agreement will be automatically revised to best reflect the Parties’ original intent.
5.9 Anti-Corruption. Neither Party has received or been offered any illegal or improper bribe, kickback, payment, gift, or thing of value from an employee or agent of the other party in connection with this Agreement. Reasonable gifts and entertainment provided in the ordinary course of business do not violate the above restriction.
5.10 Compliance with Laws. You are responsible for all activity occurring under Your instance, and You will abide by all applicable local, state, national and foreign laws, treaties and regulations in connection with Your use of the Platform, applications, content, other Sure technology. This Agreement and Your right to use the Platform, applications, content, other Sure technology are specifically made subject to all laws, regulations, orders or other restrictions on the export from the United States of America of computer software and related technology and know-how that may be imposed from time to time by the federal government of the United States of America.
5.11 Marketing and Promotional Activities. To the extent indicated in the SureClinical joint marketing agreement ( https://sterlingbio.com/jma/ ), You grant Sure the right to add Your name and logo to Sure’s list of customers and on Sure’s website during the term of this Agreement. Sure’s use of Your name and logo will be in accordance with the SureClinical joint marketing agreement, at https://sterlingbio.com/jma/. Upon Your written request, Sure will promptly remove Your name or any Your marks from Sure’s website, and to the extent feasible, Sure’s marketing materials
Last updated: 11 August 2022