SureClinical SaaS Products and Services Description (SPSD)

THIS SURECLINICAL SAAS PRODUCTS AND SERVICES DESCRIPTION  (SPSD) (“Agreement”) is incorporated by reference with the Master Subscription Agreement, 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 (“SC”), and either the individual entering into this Agreement or the company on whose behalf the individual is entering into this Agreement (“Company”, “You” or “Your”) (each, a “Party” and, collectively, the “Parties”).  

List of Definitions and Terms for SureClinical’s Software as a Service (SaaS) Offerings

Application(s) – An application is a software program.  SureClinical offers cloud applications.  With cloud applications, both local and cloud-based application components work together.  For example, cloud application components are accessed through a local web browser application with a continuous internet connection.

Application Credits – Customer purchased credits applicable towards the use of the Applications, including Application Named User Credits,  Applications Project Credits, Transaction Credits, or other application credit types.

Charge Metric – measurable metrics of usage or other measurable metrics upon which charges are based.

Named User Feature Permission Set – The set of features that are assigned to a named user type:  Power Users have full feature functionality for products that they are licensed to use, Hub Users have limited feature functionality for a licensed product.  In general, hub users have mostly read-only capabilities and cannot initiate workflows for signing, web meetings or for any other workflow unless otherwise stated in the product datasheet or if explicitly offered in a license agreement or order form.

Projects are Customer projects or clinical studies with a specified project start and project stop date.  For example:  Project XYZ, starts Jan 1 2020, ends Dec 31 2020.  Project duration: 12 months.   Projects are often used to track license usage, resource usage, transaction usage and other charges.

Study Site Months (legacy metric) – Purchased credits applicable towards project / study-based Applications that use Application Credits – such as SureETMF, SureEISF, SureArchive applications.   Study site month Charge Metrics are calculated by multiplying the number of sites by the number of study months = SSM.

Site – (Legacy Metric) Study sites are organizations in a customer project and may be used as a licensing metric.  Sites can be Active, Inactive or Archived:

 Active Sites:  Active Sites are defined as site organizations and persons used in the project. Sites use SureClinical system resources such as cloud storage, workflows, digital signing transactions, web meetings, activities, tasks and reports.  

Inactive Sites:  Inactive Sites are Sites that are not being actively used in the project that don’t use SureClinical system resources.   To qualify as an inactive site, no SureClinical system resources may be associated with the Site Organization or Site Persons.  System resources include, but are not limited to:  Site documents, Site activities, Site meetings, Site workflows or Site digital signing.  For licensing purposes, if you wish to change the site status to ‘Inactive,’ all system resources must be removed, otherwise your site will be considered active.  To retain system resources for the site, change the status to ‘Archived’ as below.  Inactive sites don’t use system resources and will not be charged as an Active Site.

Archived Sites:  Archived Sites are Sites that were Active in the past, but are now Inactive and are being archived in the project, with all prior system resources retained.  To qualify as an Archived site, SureClinical system resources will be charged for cloud storage and maintenance.  New SureClinical resources cannot be allocated for Site documents, Site activities, Site meetings, Site workflows or Site digital signing, unless the site status changes to ‘Active.’  Archived sites use system resources and will be charged as an Active Site.

Site Status Changes:  Site licensing is considered a ‘named license’ for a specific site per project.  Site status changes may be made once per site every six months or by request to SureClinical support. Please contact SureClinical if you have any questions.

Client Instance – a cloud resource that contains a specific configuration of SureClinical’s SaaS Products and Services and holding Your data. 

Master Subscription Agreement or MSA  – the Master Subscription Agreement entered into by You and SureClinical which contains the applicable terms and conditions with respect to your subscriptions of SureClinical products and services, viewable online at https://sureclinical.com/msa/.   MSA’s may only be renewed at the end of each Initial subscription period with the express written consent of an authorized SureClinical representative.   The start date of the MSA coincides with Your Initial Platform Subscription start date; and the the end date of the MSA coincides with Your Initial Platform Subscription end date.   Unless otherwise agreed to by both Parties in writing, all MSAs are subject to termination at the end date of Your Initial Platform Subscription.  An automatic renewal is available as a purchase option with your Initial Order Form.  

Order Form – an executed agreement to purchase SureClinical’s SaaS Products and Services, containing applicable terms and conditions with respect to a single order of SureClinical SaaS Products and Services.

Named User Licenses –  all SureClinical products accessed by any User require a named user license for each individual User.   Named User  licensing is a method of linking a software license to a specified uniquely identified individual.   For added security, Named Users may also be linked to a limited number of hardware devices in use by the Named User individual. 

 For security and compliance reasons, users may not share application credentials, and each user must have an individually-assigned application entitlement referred to as a Named User License. 

Named User Identity Verification is required for all Users.   In order to verify User Identities, SureClinical may request all of the following:  First Name, Last Name, Job Title, Organization, Organization Email Address and optionally a mobile phone for authentication of identities.  In order to issue a standard trust digital signing identity to each individual Named User, we require an Organization email address domain such as “John.Smith@MyOrg.com”, where ‘MyOrg.com’ is used for your Organization’s email address domain.  For trust and security reasons, we don’t allow the use of public email services such as Gmail, Yahoo or other public email services.   All Employees, Consultants, Contingent Staff and persons who are employed by the licensing organization must have the same organization email address domain as the primary licensing organization’s email address domain, unless otherwise approved by SureClinical in writing.   For high trust identity verification of Medical Doctors or others who dispense medications,  a valid government photo ID may need to be submitted by Users.  

Trusted Organization Verification:  In some cases you may wish to provide account access to SureClinical’s Services to a third party organization or third party users who aren’t employed by your organization.  In order to prevent potential security risks posed by third party organizations and users, You may be asked to verify the identity of third party organizations by entering the Organization Name, Organization Type (such ase Sponsor, Site, CRO, Supplier, or Partner), Organization Country and Organization email address domain into an “Organization TrustList.”  We may provide a service that checks the identity of organizations that You add against our Organization BlockList.   Our BlockList contains names of Organizations who:  Have unresolved security issues with their accounts, or have been reported to SureClinical for suspected identity fraud, or who have otherwise demonstrated business practices that are considered harmful to participants in our system and network.  The Organization TrustList and BlockLists may be shared across instances for continuous organization verification, however, these lists won’t be publicly published on the internet.  If you find an Organization that should not be on the BlockList, please report the Organization name and reason(s) why you believe the Organization should not be on the BlockList to our support team so that we can take appropriate action.

 Digital Certificate Issuance:  All Named Users are assigned a uniquely identifiable, non-sharable digital certificate for digital signing, identification and security. Unless otherwise offered, Named users are created once, and whether or not the user has used the products, all fees for the named user shall accrue and be payable under the order form terms. 

Named User Transfer Requests:  Named uses who are Employees, Consultants, Contingent Staff of the licensing organization and have the same email address domain as the licensing organization may transfer their named user license to a different named user upon written request to SureClinical.  Unless otherwise specified, SureClinical will consider named user transfers on the one year product subscription anniversary of the product licensed, or when Employees, Consultants, Contingent Staff in the licensing organization have left the licensing organization.  A named user is issued ONCE a unique person who is given access to SureClinical SaaS Products and Services, and a unit of measure by which the SureClinical SaaS Products and Services may be obtained, and for security and regulatory compliance, named user login credentials may not be shared. 

Transferrable Named User Subscription:  Organizations may wish to provide short term named user licenses of 3-4 months or so to several different employees or third party individuals.  For a small fee, we offer a Transferable Named User Subscription License that allows limited transfer of the Named User License to up to two individuals    The minimum term for Transferrable Named User Licenses is typically 12 months and it contains the following restrictions:  a) The initial Named User license can be reallocated to up to two different Named Users during the license subscription term; b) No individual person may receive a Transferrable Named User license twice during the  subscription license term. 

SaaS Products and Services – SureClinical’s software as a service products and services, including Applications, made available on a subscription basis. 

Subscription Agreement Term or Agreement Term – the term set forth in Your first Order Form and which shall be the term under the Master Subscription Agreement and any extensions of that term, and which shall apply to all subscriptions of SureClinical SaaS Products and Services.   All SureClinical subscription agreements are licensed on an annual basis, unless otherwise specified in the Order Form.

Products and Services Description – this Description of SureClinical’s SaaS Products and Services; additional general terms of use may be found in the Master Subscription Agreement and in the End User Subscription Agreement (click through agreement for all external users; details below).

Transaction – a unit of measure by which a specified SureClinical SaaS Product or Service feature capability is subscribed for a specified Client Instance.  For example, with SureClinical’s SureInterface Application Programming Interface (API) product, You may request that a SureClinical SaaS Product perform an ‘External data transfer’ operation, which would be charged as a Transaction.

You – client subscribing to the SureClinical SaaS Products and Services; also the ‘licensing organization.’

By executing an Order Form and purchasing SaaS Products and Services from SureClinical, You agree to this SaaS Products and Services Description.  In the event of a conflict between this SaaS Products and Services Description, and the Order Form or the Master Subscription Agreement, the documents shall prevail in the following priority:  first, the Order Form, second, the Master Subscription Agreement and third, this SaaS Products and Services Description. If You do not agree with any term or condition, do not access, open, or use the SureClinical SaaS Products or Services.

SureClinical SaaS Products and Services

The following SureClinical SaaS Products and Services offerings are covered by these SaaS Specific Offering Terms.

SureClinical SaaS Products and Services Charge Metrics Table

NOTE: ALL APPLICATIONS REQUIRE A PLATFORM USER LICENSE (FOR INFO VISIT OUR PRICING FAQ PAGE)

Client Invoicing and Charge Metrics for SureClinical SaaS Products and Services

The SureClinical SaaS Products and Services are provided on a subscription basis and invoiced using one or more charges based on Charge Metric(s).   During the Subscription Agreement Term, SureClinical has the right to invoice You for Your use of any of SureClinical Products and Services using the associated Charge Metric(s).  See Your Order Form for the Charge Metric that will be used during the Subscription Agreement Term.

Subscription Agreement Term:  The term in Your Master Subscription Agreement is the then current Agreement Term specified in Your Order Form and shall be the term applying to all of Your subscriptions of SureClinical SaaS Products and Services.  The first Subscription Agreement term is referred to as the ‘Initial Agreement Term’.

Client Instance:  Your data typically resides on a Client Instance in a regional data center whose geography is selected by You at the commencement of the Initial Subscription Agreement Term.  Your requested changes to move the Client Instance from an initial regional data center to a new geography or region are subject to service fees, depending on the amount of data and type of move requested by You.  Data center fees in the new region may be different, and additional data center fees may apply.  

Client Instance Owner Organization:   SureClinical licenses the SaaS software products and services on a Client Instance to a single Organization.  All Employees, Consultants, Contingent Staff of the licensing organization who have the same email address domain as the licensing organization, are considered Internal Users of the Client Instance, and the licensing Organization is referred to by Us as the Instance Owner for Administrative functions.

Named User Metric:  You must obtain separate, dedicated Named User subscription entitlements for each Named User accessing the SureClinical SaaS Products and Services offering in any manner directly or indirectly (for example: via a multiplexing program, device, or application server) through any means during the measurement period specified in the then current Agreement Term specified in the Order Form.   An entitlement for a Named User is made for each SureClinical SaaS Product and Service, and is unique to that Named User and may not be shared, nor may it be reassigned other than for the permanent transfer of the Named User entitlement to another person.    Named User subscriptions are offered by “Named User Subscription Type.”  A Named User subscription can have one Named User Subscription Type.”   A Named User Subscription Type limits the set of permitted SaaS Product and Service Application Features for the Named User Subscription Type.  See the table, Named User Subscription Types and SureClinical SaaS Product and Service Application Feature Permissions.

Transfer of Named User due to staff changes:  In order to accommodate Your organizational changes such as when someone leaves Your organization, You may transfer an existing Named User subscription assignment to a new Named User person. Unless otherwise specified or agreed to by SureClinical in writing, You may request a transfer of an existing Named User person assignment to a new Named User person once every twelve months during the period specified in the then current Agreement Term.

Named User Credits:  For SureClinical SaaS Products and Services that utilize a Named User metric, Clients purchase Named User Credits in advance.  The Named User Credits can be assigned to Persons for access to SureClinical SaaS Products.  See Application Credits below.

Named User Subscription Types and Default Feature Permission Set by SureClinical SaaS Product and Service:

Named User Subscription is used by most SureClinical SaaS Products and Services.  To allow for flexible subscription allocation by Product and Service, “SureClinical SaaS Product and Service Named User Subscriptions” are offered by Named User Subscription Type.   Named User Subscription Types are based on a defined, default set of SureClinical SaaS Product and Service feature permission sets.  The Named User Subscription has two user feature permission sets:     Power User (or ‘Full User’) has access to all application feature permissions for the specified SureClinical SaaS Products and Services.   Client can purchase subscriptions for the Named User Subscription Types as needed for the applicable SureClinical SaaS Products and Services during the Subscription Agreement Term.  SureClinical reserves the right to amend, modify or eliminate these additional Named User Subscription Types after the Subscription Agreement Term.  

The table below, “Named User Subscription Types and Default Feature Permission Set by SureClinical SaaS Product and Service”  provides a summary of all Named User Subscription Types by SureClinical SaaS Product and Service, along with a summary of the SureClinical SaaS Product and Service feature permission limitations.   Application feature permissions may be extended for Full Users.   When assigning the Application Subscription Type to a user, You cannot add application feature permissions unless the permissions are allowed by the selected application subscription type.

Table: Named User Subscription Types and SureClinical SaaS Product and Service Application Feature Permissions*

*Multiple Application Subscription Usage:  A single user assigned to three (3) SureClinical SaaS Applications will use three (3) subscriptions, not one (1).

External Application Users – Client General Obligations

The SureClinical Applications set forth in the table above support ‘External Application Users’.  External Application Users are defined as any user from an Organization or Company that is different than Your  organization and which has no corporate ownership affiliation with Your  organization.  External Application Users must have an email address that is different from Your email domain.  You agree that External Application Users shall be bound to these terms and conditions (some of which are referenced in the MSA under SureEsign users, SureNetwork users):

• End User Subscription Agreement: External Application Users will be required to agree to a ‘click through’ SureClinical end user subscription agreement to access SureClinical SaaS Products and Services, the form of which is attached to the Master Subscription Agreement. 
• Registration: External Application Users may have one account per subscribed user.  You are responsible for managing and administering External Application User Accounts, including but not limited to:  External Application User Account registration, passwords, External Application User account profile editing, management and deletion.   
• Org TrustList/BlockList Checking: For security and compliance, You shall check the Organization Identity of each External Application User Account against our TrustList/BlockList, and You agree to report suspected security or identity breaches by External App Users / Third Parties.
• Unauthorized use of External Application User Accounts: You are responsible for safeguarding the account information and for notifying SureClinical of any unauthorized use or loss of any account information.  SureClinical may suspend or cancel account information on the terms set forth in the Master Subscription Agreement. 
• Private SureNetwork: As part of SureClinical’s SaaS Product application offerings, SureClinical makes a private network available for You to use to capture, manage, access and store profiles for persons, organizations and projects, identified as the Private SureNetwork Product.  SureNetwork is associated with a Client’s Instance.  If You elect to offer SureNetwork access to Your External Application Users under an applicable SureClinical subscription, You have sole responsibility for External Application User data capture, verification, management, access and storage; person and organization profile validity, document validity, license validity, and for any other data in Your private SureNetwork.   
• SureNetwork Profile Documents: SureNetwork person and organization profile documents are not edited or reviewed by SureClinical, and SureClinical makes no claims as to the accuracy, veracity, quality, intellectual property rights or ownership rights of any profile document.  Profile owners are solely responsible for any profile documents uploaded to their account.  If objectionable or harmful material is present in a user’s profile document, or if other users complain about a user’s profile documents, SureClinical reserves the right to request that the Profile owner modify or remove profile documents that don’t meet SureClinical’s standards for professional conduct and truthfulness.
• Opt-In / Opt-Out in SureNetwork: All persons who have created or verified a person profile in SureNetwork, or who have requested information on SureNetwork, explicitly acknowledge that they have opted-in to SureNetwork.  SureNetwork users may be contacted by another SureNetwork user or by a SureNetwork representative.   Any SureNetwork persons and/or users can opt-out of SureNetwork at any time by contacting the Client Instance administrator / owner.
• Data Privacy, External Application Users: SureClinical adheres to published application and GDPR privacy policies at sureclinical.com/privacy and in the event of a conflict between the privacy policy and the Master Subscription Agreement, the Master Subscription Agreement will control.   For clarity, You have sole responsibility to create, manage, administer, edit and delete any External Application User data on External Application User’s behalf.  SureClinical will not access Client’s Instance to modify, edit or delete External Application User’s data.  Per GDPR definitions, SureClinical is a Data Controller and You are a Data Processor.
• User Promises: All users represent and warrant: user is at least 18 years of age; user will enter true and correct information in user’s profile and private network; user will link or enter into user’s profile or private network only information for which user has rights or permission to so use; user will use the Saas Products and Services professionally and as intended and not for any other purpose; user will comply with all applicable laws when using the Saas Products and Services.
• Prohibited Uses: Except as otherwise specifically permitted in this Products and Services Description or the Master Subscription Agreement, External Application Users may not: (a) enter false information into user’s profile or private network; (b) violate the intellectual property rights of others in using the Saas Products and Services; (c) violate the privacy rights of others; (d) disclose confidential information; (e) permit simultaneous use of the Saas Products and Services by more than one user; (f) reverse engineer, decompile, or disassemble or otherwise attempt to derive the source code for any Saas Product and Service (except to the extent applicable laws specifically prohibit such restriction); (g) redistribute, encumber, sell, rent, lease, sublicense, use the Saas Products and Services in a timesharing or service bureau arrangement, or otherwise transfer rights to any Saas Product and Service; (h) publish any results of benchmark tests run on the Saas Products and Services to a third party without SureClinical’s prior written consent; or (i) use the Saas Products and Services on a system with more CPUs than the number subscribed, by more users than have been subscribed, on more computers or computing devices than the number subscribed, or by more developers than the number subscribed, as applicable.

Transaction Metric

Transactions are charged for certain SureClinical SaaS Products and Services such as SureInterface Enterprise Connectors, Application Programming Interface (API) transactions, SureEsign transactions (for signing transactions not covered by the ‘Unlimited Plan’, or other SureClinical SaaS Products and Services as specified in the SureClinical SaaS Products and Services and Charge Metrics table or in the product description on our website.)  Please reference Transaction Unit pricing as provided in the Sales Order.  To utilize Transaction pricing, You must obtain separate, dedicated license entitlements for the applicable products in an Order Form during the Subscription Agreement Term.

Transaction Credits

For SureClinical SaaS Product and Services that utilize a Transaction metric, You purchase Transaction Credits in advance of using the Transaction.  See Application Credits below.

SureClinical Product and Services

Definitions of Subscriptions, Subscription Agreement Term and Application Credits

A subscription to SureClinical SaaS Products and Services is provided with the purchase of an annual subscription.  The SaaS Products and Services that You receive as part of Your subscription depend on which SaaS Products and Services  You subscribed to, such as SureCTMS, SureQMS or other applications.  A summary of the features offered with each Product are available on SureClinical’s website under htttp://sureclinical.com/products as of the date hereof.  Additional product licensing and pricing FAQ are available on our website at https://sureclinical.com/resources/pricing/faq/.  All SC Pricing terms and conditions and licensing are subject to change. 

Platform License Requirement:  SureClinical’s platform provides continuous compliance for all users, and a platform user license is required for all users who accesses our platform, whether or not they use our Applications.  Platform user licenses often include SureEsign FDA Part 11 compliant digital signing services, cloud storage, team hubs and other core digital services.  We also license our platform to each Company as the core subscription product that determines the start and end of each master subscription agreement.

Subscription Agreement Term:  The initial subscription purchase of our platform license specifies the initial Subscription Agreement Term in the Order Form.   Our minimum Subscription Agreement term for new orders is 12 months.  The Subscription Agreement Term has a subscription start date, a subscription end date and duration.  This information is specified in the Order Form. 

Mid-Term Subscription Purchases:  After the Subscription Agreement Term has commenced for initial subscription purchases,  additional subscription purchases may be made during the Subscription Agreement Term.   If a subscription purchase occurs after the initial purchase, it is considered a ‘mid-term subscription purchase.’  Mid-term Subscription purchases for Services may be added during a subscription term, prorated for the portion of that subscription term remaining at the time the subscriptions are added, and any added subscriptions will co-terminate on the same date as the underlying initial Platform subscription end date.  

 The Pricing of any added subscriptions will generally be the same pricing as the underlying subscription pricing, however, we reserve the right to adjust subscription pricing for any applicable volume pricing, and for any agreed upon annual cost adjustments to our Pricing.

All Subscription User pricing is for Named Users on a monthly basis.  For mid-term subscription purchases, we may refer to our subscription unit pricing metric as “Price Per User,” “Application Credit Price”, “Price Per Named User Per Month”, or “Sales Price” as specified on a prior order Form.  If no Sales Price per unit is specified, the then current list price is used for subsequent application subscriptions.  

Application Credits:   Application Credits are a mechanism for Clients to control the assignment, management and usage or SureClinical SaaS Products and Services subscriptions and cloud resources.  Similar to how cell phone minutes are purchased in advance with a subscription, SureClinical Application Credits may be purchased in advance of usage under the initial or then current Subscription Agreement Term.  After Client’s purchase, the Application Credits are assigned to the Client’s Application Credit Account for the associated SureClinical Application.  Client decides how Application Credits are allocated, assigned and used through a Client application subscription settings area.

Application Credit Types:   Based on the SureClinical Application Product or Service that a Client elects to purchase a subscription for, SureClinical Application Credits are available for advance purchase.  Application Credits may be further defined by Application Credit type, such as:  Named User Credits [Named User Type], Project Credits [Project Credit Type], Transaction Credits [Transaction Type].  Named User Credits are based on how many people need to access the specified application – each user requires a subscription linked to the user’s unique identity.   For Your flexibility, there are multiple Named User Types – see the table below for more details. Project Credits are created for subscribing to SureClinical Application for named projects.  Projects often have start and stop dates that don’t fall on an annual period.  Project Credits provide You with a flexible application usage model that can be controlled by You in the application subscription settings area.   Transaction Credits are designed for Application Products that are of a transactional nature, such as Application Data Exchange, Payments or Digital Signing Transaction Plans.

Application Credit Purchases

Orders for Application Credits are placed at either the beginning of an initial Subscription Agreement Term, or during the term (mid-contract) of the Master Subscription Agreement.    In either case, the purchase may be made through:  1) An Order Form through SureClinical’s Client Success Team; 2) Through an In-Application order (when available). 

Order Form Purchases:    Order Form purchases for Application Credits contain:  Your then current Subscription Agreement Term; a description of the type and quantity of the Products and Services being subscribed to, the then current Master Subscription Agreement unit price for the Application Credits; fees payable and any implementation or other terms and conditions applying to their supply. A subscription to a Product or Service is not included in an Order Form unless it has been specifically referenced therein.  Unless otherwise specified in the Order Form, the prices for any subsequent subscription purchases during the Subscription Agreement Term shall be based on the then current list price.  An Order Form shall be effective when signed by Your authorized representative.

In-App Purchases using Application Credits:  At such time when available, SureClinical may provide You with the ability to make In-App purchases.  Upon availability, In-App purchases can be made by You to purchase subscriptions to SureClinical SaaS Products and Services that have an initial sales order which has been authorized and executed by You and SureClinical.  In-App purchases are initiated by an authorized SureClinical Named User who has been assigned SureClinical In-App purchase privileges.  To make an In-App purchase, Your Named User with In-App privileges will click on the ‘Subscription tab’, select an authorized application and make a request to purchase.   If You HAVE an Application Credit balance to cover the In-App Purchase, then the In-App purchase may be completed with no payment required.  Alternatively, if You DO NOT have an Application Credit balance to cover the In-App Purchase, then the In-App purchase may be completed, however an electronic invoice will be sent to You where payment will be required under the last sales order form terms and conditions for the applicable SaaS Product and Service for the then current Subscription Agreement Term.

In-App Purchase Process:  Upon availability, all In-App orders shall provide the following details to Your authorized In-App purchase Named User:   Your then current Subscription Agreement Term with start, stop dates and duration; the SureClinical SaaS subscribed Application name(s); the Purchase Credit Type being purchased for the subscribed Application(s), the number of Application Credits being purchased, the then current Subscription Agreement Term Application Credit unit price;  Total Fees payable for the order, and a summary of the standard terms and conditions applying to the subscription of the Application.   After an In-App purchase is made, You will be sent an email confirming the purchase, along with the purchase details, including SureClinical’s standard sales order terms and conditions for You in the then current Subscription Agreement Term.  Pricing for In-App Purchases is based on the then current volume purchase charge metric pricing specified in the last sales order for the applicable SaaS Product and Service.  If no volume purchase price charge metric is specified for the In-App Purchase, the then current list pricing shall be applied.    A Product subscription is not included in an In-App Purchase unless it has been specifically referenced in the In-App Purchase.  An In-App Purchase shall be effective when confirmed In-App by Your SureClinical SaaS Named User with In-App purchase privileges.

In App Purchase Reporting:  When In App Purchase becomes available, in addition to In-App invoices emailed to You, In-App Purchases will be available for review from within the applicable SureClinical application and shall include, when applicable and available, the following data:

In-App Purchase Details:     The then current Subscription Agreement Term and name, duration in months; Application Credit Type, if applicable (e.g., App Credit, Named User Credit, Transaction Credit, Project Credit); SureClinical Subscription Application Name(s);  SureClinical Credit Units Purchased,  SureClinical Credit Unit Price per credit, Total Fees payable for the purchase, Total Fees paid for invoices that have been paid by You. 

In-App Purchases Using Application Credits:   For convenience, efficiency and enhanced client control, SureClinical will offer You a control panel to view their Application Credit Balance and Your In-App Purchase history. 

In-App Purchase Summary:  A summary of all In-App Purchases for the then current Subscription Agreement Term and name, with each purchase transaction, date, fees paid per purchase transaction, total Agreement Term fees paid for all In-App Purchases for the then current Subscription Agreement Term.

Application Credit Notifications:  SureClinical will make Application Credit balance and usage reports available through subscription notifications for:  Client Application Credit balance usage with projected zero balance date based on current usage;  Subscription Term Expiration date.

Project Application Credit Reporting:  To facilitate Project Application Credit usage, SureClinical may make details of Project Application Credit reporting to Your authorized administrators with In-App Purchasing authorization:

Project Details:  (if a Project is associated with the Purchase):  Project name, Project start, end dates; maximum organizations (sites or orgs licensed); Project pause date, Project restart date (if Project paused); Project end date; Project archive start date.

Project Actions:  Auto-allocate Project App Credits, Transaction Credits, Named User Credits from Client account when Project is at zero balance (default).

Project Notification Subscriptions:  Send Client email notifications for:  Subscription Term expiration date; Credit balance usage with projected zero balance and expiration dates.

Unused Application Credits

You acknowledge and agree that any unused or unprocessed Application Credits (or related services) under the Application Credit limitation set forth in a sales order (“Unused Application Credits”) will automatically expire at the end of the Initial Term or the then-applicable additional term of the Subscription Agreement Term and You shall not be entitled to a refund or credit for any Unused Application Credits nor will You be entitled to rollover any Unused Application Credits into an Additional Term or another or future agreement or arrangement.

Other Products and Services

SureClinical Digital Signing

SureClinical makes available for users of the SaaS Products and 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 Master Subscription Agreement of this Products and Services Description.

Digital Signing Account Types and Plans

For customers who license SureClinical’s Applications and platform, SureClinical offers two types of digital signing accounts:  Initiator Signing and Participant Signing.  ; Initiator Signing Accounts allow digital signing between a named signing initiator (‘Initiator’) and any signing process recipient (Participant).   Participant Signing Accounts allow digital signing of signing processes sent by Initiators.  Participants may not initiate signing processes.  With either signing account type, Initiators start a signing workflow process and Participants participate in the signing process. 

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 Participants to participate in a signing workflow process without paying any additional signing fees.  Under the unlimited plan option, up to 200 signing workflow processes per month 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.

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 Participant to participate in a signing workflow where both the initiator and the participant 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. 

SureEsign – End User Subscription 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 Subscription agreement.  A copy of the SureEsign End User Subscription Agreement is included by reference to this agreement.

SureClinical Health Science Professional Network or SureNetwork.  In connection with the SaaS Products and 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.

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 clinicaltrials.gov such as: Study ID, ClinicalTrials.gov 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.

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.

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.

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.

SureNetwork – End User Subscription 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 Subscription agreement.  A copy of the SureNetwork End User Subscription Agreement is included by reference to this Products and Services Description.

SureClinical Compliance Service.  As part of the SaaS Products and Services, 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. 

Product Support Services

SureClinical offers several product support subscription offerings for its SaaS Products and Services and Applications.

Tier 0 Support – Tier 0 Support is included with Your subscription and You are required to use Tier 0 support to the extent necessary.  Tier 0 consists of online help and online training.

Tier 1 Support – Tier 1 Support is provided by You.  Tier 1 Support consists of common IT helpdesk support services such as:  troubleshooting basic PC issues, web browser or software installations, password, PIN resets and account unlocks, virus and malware scanning and removal, network connectivity issues, email account setup, application setup and navigation assistance, printer and scanner issues, mobile device assistance, user creation, user administration and management, contacting vendor support on users’ behalf, ongoing training.  SureClinical makes available its free SureClinical Helpdesk Connector to assist You with Tier 1 Support.  SureClinical’s In-Application Helpdesk Connector is provided as a resource and tool for Your IT helpdesk.   SureClinical monitors issue trends only, but does not actively monitor or review helpdesk IT reports.  Reports are directly submitted to the email address or system URL specified by You.  SureClinical disclaims any responsibility for the accuracy, security of any email or recipient system.  Helpdesk provides a connection from SureClinical’s applications to your Helpdesk staff or system for basic IT helpdesk support resources and assistance.  The helpdesk connector forwards a summary report to Your helpdesk from SureClinical with details such as: username, user email, device identification, issue summary, optional description and application context where the help request was made.  SureClinical does not monitor the helpdesk requests.   Your Requirement: For each SureClinical Product and Service licensed, You are required to have a minimum of ONE application administrator who has completed SureClinical’s Administrator training within the last three years.  

Tier 1.5  Multilingual Support – not included with subscription, but available for additional fee.   Multi-Language (French, Italian, German, Spanish, English), 24×5, 4hr response time  – Requires Sales Order proposal. Cost varies by Your needs. Minimum of $10,000/month with a one-year subscription term.

Tier 2 Support (Standard Support)  – Tier 2 Support is SureClinical’s standard support level provided to You pursuant to the Master Subscription Agreement, this Products and Services Description, and the SureClinical Service Level Agreement (”SLA”), which is attached to the Master Subscription Agreement, and subject to the terms set forth therein.  Under SureClinical’s Tier 2 Support, You and Your users will be provided access to SureClinical’s free application training videos, free online application help, and 25 support tickets per year.  Additional tickets are charged at $150/incident.  

Tier 2 Standard Product and Service Support Channels, Support Tiers, Language and Time Zone Availability by Product

• Standard support is provided for all SureClinical Products and Services with the following Standard Support Matrix

Tier 2.5 Support (Concierge Services)  –   SureClinical provides tailored Product Concierge services such as:  User creation and administration, Permissions customization, Group creation and management, Product configuration, Product UAT and Validation, Audit Services and more.  Requires Sales Order proposal. Cost varies by Your needs. Minimum of $10,000/month with a one-year subscription term.

Renewal   

A sales order or In-App Purchase (with or without Credits) will expire upon the expiration of the Subscription Agreement Term, and unless otherwise stated in the sales order. 

Fees

You must pay SureClinical the Fees in the manner and amounts set forth in the Master Subscription Agreement and Order Form.    All payments will be nonrefundable, non-cancellable and irrevocable except as otherwise provided in the Master Subscription Agreement or Order Form.    

Datacenter Use Overages

SureClinical provides its products through its authorized global cloud data center providers, including Google Cloud and NTT Dimension Data.  You are provided monthly data center use credits as shown in the data center credit table below.  95% of our clients, including the very largest organizations with 50 or more projects, have not exceeded our standard monthly data center credits allocations.  Non-standard data storage and network data egress (exports) from Client Instances will be subject to data overage fees.

True-Up Invoicing for Overage

Clients who have exceed their standard monthly data center use credit allocation will be billed for data center overages, with a true-up statement delivered quarterly or at the end of your 12 month subscription cycle.  Payment for customer data center use overages are due upon receipt.  SureClinical will notify You of data center overages via application notifications and/or email.  SureClinical will invoice and You must pay for undisputed overages monthly in arrears, net thirty (30) days of SureClinical’s invoice date, and with respect to any disputed overages, the parties agree to act in good faith to resolve any dispute regarding overages within 30 days of receipt of the invoice in question.  Fees for overages will be calculated as the quantity of overages multiplied by 130% of the data center’s published list price rate and will be passed through to You; a commensurate increase in support service fees may be charged to You for data center use overages that cause SureClinical to incur non-standard support, engineering or cloud operation resource utilization expenses.  SureClinical may offer additional data center credits or packages for purchase of additional storage, bandwidth or other resources.  Support service fees will be billed at SureClinical’s then published list price support service rate schedule. 

Service Subscriptions

To support Your ongoing support service needs, SureClinical offers professional services on a recurring service subscription basis.  Service subscriptions are generally:  a 12-month minimum term; paid in advance on a quarterly basis. For example:  eClinical Concierge Services, Professional Services or Tier 1 Support Service Subscriptions.  Terms for Service Subscriptions and optional services are specified in the Sales Order Form and if Professional Services are requested, a Statement of Work detailing the services to be provided is required.  Fees for service subscriptions are defined within a sales order with details of the Services covered in a Services Agreement signed by the parties.

Optional Services

SureClinical offers Optional Services such as Consulting, Integration and Connector Development Services, and for Premium Support Services.  Fees for service subscriptions are defined within a sales order with details of the Services covered in a Services Agreement signed by the parties.

YOUR OBLIGATIONS

General Obligations.  You shall: (a) Implement and deploy SureClinical’s SaaS Products and Services in a manner consistent with all applicable laws and regulations, and obtaining all consents necessary to enable SureClinical to lawfully process any required User Information, (b) implement appropriate information security controls having regards to the sensitivity of the User Information, (c) notify SureClinical as soon as reasonably practical of any suspicious transactions or operations, (d) accurately supply all requested data fields, (e) set reasonable data processing and transmission parameters to minimize the cost of delivering SureClinical’s SaaS Products and Services, (f) implement and maintain appropriate safeguards to identify data and processing errors, (g) maintain Your own computer and telecommunication systems for communication and data exchange with SureClinical, (h) monitor and restrict the use of all passwords, user identification numbers and other security measures subject to their control and in accordance with Your policies, (i) select qualified personnel to operate systems, software and equipment interfacing the SureClinical SaaS Products and Services, (j) train all personnel in the use of the SureClinical’s SaaS Products and Services, (k) ensure that You implement any country-specific compliance requirements in accordance with applicable law. 

Taxes

The amounts due to SureClinical under the Master Subscription Agreement, this Products and Services Description and any applicable sales orders do not include bank fees, transfer fees, taxes, duties or similar fees.  If SureClinical does not receive full payment of the fees or is required to pay (a) sales, use, property, value-added, withholding or other taxes, (b) any customs or other duties, or (c) any import, warehouse or other fees, associated with the importation or delivery based on the subscriptions granted or services performed hereunder or on Your use of the SaaS Products and Services, then such taxes, duties or fees will be billed to and paid by You.  If You are permitted to declare any such taxes, You must declare and pay such taxes and SureClinical will not be required to invoice You.  This paragraph does not apply to and You shall not be required to pay taxes based on SureClinical’s gross receipts, income or payroll. Notwithstanding anything to the contrary herein, You shall be entitled to deduct and withhold from the fees hereunder such amounts as You are required to deduct and withhold with respect to the making of such payment under applicable tax laws. To the extent that amounts are so withheld and paid over to the appropriate tax authority by You, You shall immediately provide SureClinical with proof of such withholding tax payment, and, accordingly, such withheld amounts shall be treated for all purposes of these Terms of Use as having been paid to SureClinical.

Entire Agreement

This SaaS Products and Services Description and the Master Subscription Agreement constitute the complete and exclusive agreement between SureClinical and User with respect to the subject matter hereof and supersedes all prior or contemporaneous oral or written communications, proposals, representations, understandings, or agreements not specifically incorporated herein. This Products and Services Description may not be amended except in a writing duly signed by an authorized representative of SureClinical and You.

Effective date:        Jan 1 2022