SureClinical Master Subscription Agreement (MSA)

THIS SURECLINICAL MASTER SUBSCRIPTION AGREEMENT (“Agreement”) between SureClinical Inc (“SureClinical”) and you, either as the individual entering into this Agreement or the company or business on whose behalf the individual is entering into this Agreement (“Company”, “You” or “Your”) (each, a “Party” and, collectively, the “Parties”).  In either case, You represent that You have the authority to enter into this Agreement.

Assent to Be Bound.  By clicking the “I accept the terms…” or the “Accept” box, “OK” or “Approve” checkbox for new user online service enrollment, by executing a written copy of this Agreement, or by accessing or otherwise using the Services, by enrolling in any SureClinical online subscription, or by using any SureClinical online service, User agrees to be bound by the terms of this Agreement. If User does not agree with any term or condition, do not access, order, open, or use the Services.

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

If You are registering for a free trial, the applicable provisions of this Agreement govern the free trial or free services.

BY CLICKING THE “ACCEPT” BOX, EXECUTING AN ORDER FORM FOR SERVICES (“ORDER FORM”) OR USING FREE SERVICES, 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 USE THE SERVICES.

USE BY SC’s DIRECT COMPETITORS:   SC’s direct competitors are prohibited from accessing the Services, except with SC’s prior written consent.

This Agreement was last updated on August 16, 2022. It is effective between You and SC as of the date of Your accepting this Agreement through a free trial, by clicking the “I accept the terms…” or the “Accept” box, “OK” or “Approve” checkbox for new user online service enrollment, by accepting the terms of the End User Subscription Agreement (EUSA), by executing an order form, or by executing this MSA via signature via electronic, hard copy or other forms of assent.

1.0 USE OF THE SERVICES.

1.1     Services and Content.  SC shall provide the Services and accompanying information (“Content”) to You on a subscription basis.  SC shall provide You with a non-exclusive subscription to use the Services and Content in accordance with the terms of this Agreement and the Order Form for the term specified in the Order Form or in the applicable online purchasing portal.  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, for unauthorized and unreported license use, for unreasonable resource overuse, and for any agreed upon annual cost adjustments to our Pricing.  Pricing will be prorated for the portion of that subscription term remaining at the time the subscriptions are added, and any added subscriptions will terminate on the same date as the underlying subscriptions. You agree that Your purchases are not contingent on the delivery of any future functionality or features, or dependent on any oral or written public comments made by SC regarding future functionality or features.

1.2     Additional Obligations of SC. In addition, SC shall (a) provide applicable SC standard support for the Services to You at no additional charge, and/or upgraded support if purchased, (b) use commercially reasonable efforts to make the online Services available 24 hours a day, 7 days a week, except for: (i) planned downtime (of which SC shall either publish as part of its scheduled maintenance window in its SLA documentation, or give advance electronic notice), and (ii) any unavailability caused by circumstances beyond SC’s reasonable control, including, for example, an act of God, act of government, flood, fire, earthquake, civil unrest, act of terror, strike or other labor problem (other than one involving SC employees), Internet service provider failure or delay, Non-SC Application failure or malfunction, or denial of service attack, (c) provide the Services in accordance with applicable laws and government regulations, and (d) be responsible for the performance of its personnel (including its employees and contractors) and their compliance with SC’s obligations under this Agreement, except as otherwise specified in this Agreement.

1.3     Security. SC will maintain appropriate administrative, physical, and technical safeguards for protection of the security, confidentiality and integrity of the data and information submitted by You to the Services, other than Content or non-SC applications (“Customer Data”), as described in the following documentation (“Documentation”):  Service Level Agreement (SLA) at https://www.sureclinical.com/sla/ , End User Subscription Agreement (EUSA), and Products and Services Description (SPSD) and related customer accessible subscription management tools and reports, Product Data Sheets (PDS), Data Processing and Security Addendum to this Agreement, SC’s GDPR Policy, and related compliance documentation.  Those safeguards will include, but will not be limited to, measures designed to prevent unauthorized access to or disclosure of Customer Data (other than by Customer or Users). Except with respect to a free trial, the terms of the GDPR Policy at (“GDPR”) at https://sureclinical.com/gdpr/  are hereby incorporated by reference and shall apply to the extent Customer Data includes Personal Data, as defined in the GDPR. To the extent Personal Data from the European  Economic Area (EEA), the United Kingdom and Switzerland are processed by SC, its Processor Binding Corporate Rules, the EU-UdS and/or Swiss-US Privacy Shield, and/or the Standard Contractual Clauses shall apply as further set forth in the GDPR. For the purposes of the Standard Contractual Clauses, Customer and its applicable Affiliates are each the data exporter, and Customer’s acceptance of this Agreement, and an applicable Affiliate’s execution of an Order Form, shall be treated as its execution of the Standard Contractual Clauses and Appendices. Upon request by Customer made within 30 days after the effective date of termination or expiration of this Agreement, SC will make Customer Data available to Customer for export or download as provided in the Documentation.  All exports requested by Customer are subject to an export services fee.  Service fees may apply to After such 30-day period, SC will have no obligation to maintain or provide any Customer Data, and as provided in the Documentation will thereafter delete or destroy all copies of Customer Data in its systems or otherwise in its possession or control, unless legally prohibited.

1.4     Usage Limits. SC Services and Content are subject to usage limits specified in Order Forms and Documentation.  In the event that Your usage of the Services or Content are in excess of usage limits, SC shall invoice You for such excess usage at SC’s current rates.  In addition, SC may require you to execute a new Order Form for additional quantities of the Services.  Your refusal to execute a new order form and pay for excess usage after thirty (30) days written notice shall constitute a breach of this Agreement.  Upon such breach, SC may in its discretion suspend, limit or terminate Your use of the Services.

1.5     Your Use of the Services. Unless otherwise authorized in a resale or in a third party End User Subscription click-through agreement (“EUSA”), Customer agrees that all Services are licensed to a single Licensed Business (“Licensed Business”).  Customer agrees that the Services may only be accessed by users (“Users”) who are employees and contingent staff of Customer’s Licensed Business.  Unless authorized by a resale or a EUSA agreement, Licensed Business will only allow users (“Users”)  of the Services who are employees and contingent staff of Customer’s Licensed Business.  Unless otherwise authorized in writing by SureClinical, Customer shall utilize a single email domain address for all users of the Licensed Business.    Customer may access and use up to the number of unique individual authorized users, studies and sites specified on the Order Form or in Your online subscription.  You agree that You shall (a) use the Services and Content within the usage limits specified in Your Order Form and Documentation; (b) be responsible for the Users’ compliance with this Agreement, Documentation and Order Forms, including not allowing other persons to utilize or share another User’s Services subscription (c) be responsible for the accuracy, quality and legality of Customer Data, how such Customer Data was acquired and how it is used with the Services and the interoperation of any non-SC applications with which You use the Services or Content, (d) use commercially reasonable efforts to prevent unauthorized access to or use of Services and Content, and notify SC promptly of any such unauthorized access or use, (e) do not allow persons who are not Users to utilize the Services, even if such persons are Your employees, consultants or affiliates, (f) not resell, sell, distribute or offer user accounts or licenses for the Services and Content to third parties, including Your customers and clients, without SC’s prior written consent, or by entering into a reseller, consulting services partner agreement, third party licensing agreement or EUSA with a third party licensing addendum, (g) use the Services and Content only in accordance with this Agreement, including the Products and Services Description, Documentation, the Acceptable Use Policy at https://sureclinical.com/terms/, Order Forms, Data Processing and Security Addendum to this Agreement, and applicable laws and government regulations, (h) comply with terms of service of any Non-SC Applications with which Customer uses the Services or Content. SC may limit, suspend or terminate the SERVICES in its discretion if You breach any of the above requirements, provided that to the extent possible, SC will use commercially reasonable efforts to provide You with notice and an opportunity to cure such violation or threat prior to any such limitation, suspension or termination.  You agree to promptly comply with any notice from SC to remove, modify or disable Content or a Non-SC Application to avoid violating applicable law, third-party rights, or the Acceptable Use Policy.  SC may disable the applicable SERVICE, Content, Platform, App and/or non-SC Application, if You do not take required action in accordance with the above, or if in SC’s judgment continued violation is likely to reoccur.  You shall confirm such deletion and discontinuance of use in writing, if requested by SC, and SC may provide a copy of such confirmation to any such third-party claimant or governmental authority, as applicable.  In addition, if SC is required by any third-party rights holder to remove Content or receives information that Content provided to You may violate applicable law or third-party rights, SC may discontinue Your access to Content through the Services.

1.6   External Users. You may only grant access to the Services to Your employees and contingent staff. Any other users besides Your employees and contingent staff are “External Users” that are part of any organization other than Your organization or Your subsidiary or parent (“External Organization”).  In order to grant access to an External User with an External Organization, You must enter into a separate External User Access click through agreement available at www.sureclinical.com/euaa (sponsors and non-CROs), or for CROs at www.sureclinical.com/croeuaa. 

1.7    Restrictions. You may not personally, or allow a third party to (a) modify, distribute, prepare derivative works of, reverse engineer, or decompile the Services, any object code generated by the Services or any part thereof, or otherwise attempt to discover any source code, or use unauthorized or modified versions of the Services for any purpose; (b) access the Services for purposes of monitoring its availability, performance or functionality, or for any other benchmarking or competitive purposes; (c) make any Service or Content available to anyone other than You or Your Users, or use any Service or Content for the benefit of anyone other than You, unless expressly stated otherwise in an Order Form or the Documentation; (d) make any Service or Content available to an External User unless You have entered into a separate External User Access click through agreement available at www.sureclinical.com/euaa (sponsors and non-CROs), or for CROs at www.sureclinical.com/croeuaa (e) use a Service or Non-SC Application to store or transmit infringing, libelous, or otherwise unlawful or tortious material, or to store or transmit material in violation of third-party privacy rights, or to store or transmit Malicious Code, (f) interfere with or disrupt the integrity or performance of any Service or third-party data contained therein, (g) attempt to gain unauthorized access to any Service or Content or its related systems or networks, (h) permit direct or indirect access to or use of any Services or Content in a way that circumvents a contractual usage limit, or use any Services to access or use any of SC intellectual property except as permitted under this Agreement, an Order Form, or the Documentation, (i) resell or distribute the Services, or create application full-use users (‘Power Users’) for any third party, including Your customers or other third party organizations , without Your acceptance of  into a third party End User Subscription license agreement, (j) copy Content except as permitted herein or in an Order Form or the Documentation, (k) frame or mirror any part of any Service or Content, other than framing on Customer’s own intranets or otherwise for its own internal business purposes or as permitted in the Documentation.  You are being granted no rights in the Services except as specifically provided in this Agreement, and any rights not expressly granted in this Agreement are expressly reserved by SC and its licensors. For adherence to security policies, licensed usage and to protect access by unauthorized third parties,  SC reserves the right to conduct real-time continuous audits of user activity history logs and use of the Services to determine compliance with this Section and Section 1.5.

1.8       Non-SC Products and Services.  SC or third parties may make available third-party products or services, including, for example, Non-SC Applications, Applications for systems integration, and implementation and other consulting services.  Such non-SC Products and Services may be made  available through a “Marketplace” such as an online directory, catalog or marketplace of eClinical applications that interoperate with the Services, including, for example, when available, www.eClinicalOpen.com or at www.eClinicalMarketplace.com,  Google Cloud Marketplace, or other online marketplaces where SureClinical may offer its Services or where other Non-SC Applications may be made available, or in some other manner.  Any acquisition by You of such products or services, and any exchange of data between You and any non-SC provider, product or service is solely between You and the applicable non-SC provider. SC does not warrant or support non-SC applications or other non-SC products or services, whether or not they are designated by SC as “certified” or otherwise, unless expressly provided otherwise in an Order Form. SC is not responsible for any disclosure, modification or deletion of Customer Data resulting from access by such Non-SC Application or its provider.

1.9       New Releases.  SC will from time-to-time issue major product releases updating and improving the Services.  SC is committed to product quality, security, and maintaining continuous operational excellence for the major product releases.  In accordance with global quality best practices, SC maintains and adheres to a published set of standard operating procedures (SOPs) for product quality in major and minor releases. SC’s compliance portal contains copies of SC’s SOPs and release testing, acceptance and validation procedures.  As a cloud-based service provider, SC seeks to provide opportunities for You to validate, test and evaluate new releases. To maintain the highest level of continuous uptime and product quality, SC’s policy is to support the most current production release.  With respect to previous releases that have been superseded by a current production release, SC will not provide warranty and technical Support for previous releases, except as may be agreed to in a mutually signed non-production support agreement between SC and You with respect to the support of previous releases.  Except as specifically set forth in the previous sentence, You are required to accept the current production release to qualify for product warranty and support.  In the event that SC allows You to continue to use a prior release in production, SC reserves the right to require an immediate transition to the current production release, if SC determines in its sole discretion the existence of extenuating circumstances related to security, compliance, product performance, operational considerations or warranty issues that require an immediate transition to the current production release.  In such an event, SC shall have the right to transition You to the current release at any time, in its sole discretion, subject to 1) Notification to You of the planned transition to the current release along with the reason, 2) Notification of the completion and status of the transition, 3) A report or validation certificate providing details of the production system validation tests and reports.

1.10       Customer Training.  You are required to have at least one administrator who has completed current product training in the applicable product training category for the products purchased.  Per government compliance guidance, all users of the Services should receive product training in systems that have government compliance policies.

2. TERMS APPLICABLE TO FREE TRIALS AND FREE SERVICES.

2.1     Free Trials. If You have registered for a free trial, either on SC’s website, or on a Non-SC provider, or on a Partner website such as Google Cloud Platform, Microsoft Azure, or other SC authorized sites, SC will make the applicable Service(s) available to You on a trial basis free of charge until the earlier of (a) the end of the free trial period for which You registered, or (b) the start date of any non-free Service subscriptions ordered by You for such Service(s), or (c) termination by SC in its sole discretion. Additional trial terms and conditions may appear on the trial registration web page and are incorporated herein by reference.

2.1.1   UNLESS YOU PURCHASE A SUBSCRIPTION TO THE SAME SERVICES AS THOSE COVERED BY THE TRIAL OR APPLICABLE UPGRADED SERVICES, ANY DATA ENTERED INTO THE SERVICES, AND ANY CUSTOMIZATIONS MADE TO THE SERVICES DURING YOUR FREE TRIAL WILL BE PERMANENTLY LOST UNLESS YOU SAVE YOUR DATA OR CONVERT YOUR TRIAL TO A PAID PRODUCTION LICENSE.  YOU CANNOT TRANSFER DATA ENTERED OR CUSTOMIZATIONS MADE DURING THE FREE TRIAL TO A SERVICE THAT WOULD BE A DOWNGRADE FROM THAT COVERED BY THE TRIAL.  IF YOU PURCHASE A SERVICE THAT WOULD BE A DOWNGRADE FROM THAT COVERED BY THE TRIAL, YOU MUST SAVE ANY CUSTOMER DATA BEFORE THE END OF THE TRIAL PERIOD OR CUSTOMER DATA WILL BE PERMANENTLY LOST.

2.1.2   NOTWITHSTANDING THE REPRESENTATIONS AND WARRANTIES CONTAINED HEREIN AND INDEMNIFICATION OBLIGATIONS, DURING THE FREE TRIAL THE SERVICES ARE PROVIDED “AS-IS” WITHOUT ANY WARRANTY AND SC SHALL HAVE NO INDEMNIFICATION OBLIGATIONS NOR LIABILITY OF ANY TYPE WITH RESPECT TO THE SERVICES FOR THE FREE TRIAL PERIOD UNLESS SUCH EXCLUSION OF LIABILITY IS NOT ENFORCEABLE UNDER APPLICABLE LAW IN WHICH CASE SC’S LIABILITY WITH RESPECT TO THE SERVICES PROVIDED DURING THE FREE TRIAL SHALL NOT EXCEED $1,000.00 USD.  WITHOUT LIMITING THE FOREGOING, SC AND ITS AFFILIATES AND ITS LICENSORS DO NOT REPRESENT OR WARRANT TO YOU THAT: (A) YOUR USE OF THE SERVICES DURING THE FREE TRIAL PERIOD WILL MEET YOUR REQUIREMENTS, (B) YOUR USE OF THE SERVICES DURING THE FREE TRIAL PERIOD WILL BE UNINTERRUPTED, TIMELY, SECURE OR FREE FROM ERROR, AND (C) DATA PROVIDED DURING THE FREE TRIAL PERIOD WILL BE ACCURATE.  NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THE “LIMITATION OF LIABILITY” SECTION BELOW, YOU SHALL BE FULLY LIABLE UNDER THIS AGREEMENT TO SC AND ITS AFFILIATES FOR ANY DAMAGES ARISING OUT OF YOU USE OF THE SERVICES DURING THE FREE TRIAL PERIOD, ANY BREACH BY YOU OF THIS AGREEMENT AND ANY OF YOUR INDEMNIFICATION OBLIGATIONS HEREUNDER.

2.2       Free Services.  SC may from time to time certain Services available to You for free (“Free Services”).  Your use of Free Services is subject to this Agreement and this section, which will control in the event of a conflict.  Free Services are subject to certain limits as described in the Documentation. Usage over these limits requires Your purchase of additional resources or services.  SC, in its sole discretion and for any or no reason, may terminate Your access to the Free Services in whole or in part. SC may terminate Your access to the Free Services without prior notice, and SC will not be liable to You or any third party for such termination. You are solely responsible for exporting Customer Data from the Free Services prior to termination of Your access to the Free Services for any reason, provided that if SC terminates Your account, except as required by law SC will provide You a reasonable opportunity to retrieve Your Customer Data.

2.2.1    NOTWITHSTANDING THE REPRESENTATIONS AND WARRANTIES CONTAINED HEREIN AND INDEMNIFICATION OBLIGATIONS, THE FREE SERVICES ARE PROVIDED “AS-IS” WITHOUT ANY WARRANTY AND SC SHALL HAVE NO INDEMNIFICATION OBLIGATIONS NOR LIABILITY OF ANY TYPE WITH RESPECT TO THE FREE SERVICES UNLESS SUCH EXCLUSION OF LIABILITY IS NOT ENFORCEABLE UNDER APPLICABLE LAW IN WHICH CASE SC’S LIABILITY WITH RESPECT TO THE FREE SERVICES SHALL NOT EXCEED $1,000.00 USD. WITHOUT LIMITING THE FOREGOING, SC AND ITS AFFILIATES AND ITS LICENSORS DO NOT REPRESENT OR WARRANT TO YOU THAT: (A) YOUR USE OF THE FREE SERVICES WILL MEET YOUR REQUIREMENTS, (B) YOUR USE OF THE FREE SERVICES WILL BE UNINTERRUPTED, TIMELY, SECURE OR FREE FROM ERROR, AND (C) DATA PROVIDED THROUGH THE FREE SERVICES WILL BE ACCURATE. NOTWITHSTANDING ANYTHING TO THE CONTRARY.  IN THE “LIMITATION OF LIABILITY” SECTION BELOW, YOU SHALL BE FULLY LIABLE UNDER THIS AGREEMENT TO SC AND ITS AFFILIATES FOR ANY DAMAGES ARISING OUT OF YOUR USE OF THE FREE SERVICES, ANY BREACH BY YOU OF THIS AGREEMENT AND ANY OF YOUR INDEMNIFICATION OBLIGATIONS HEREUNDER.

3. TERM AND TERMINATION.

3.1   Term. This Agreement commences on the date You first accept it and continues until all subscriptions hereunder have expired or have been terminated.

3.2   Subscription Term. The term of each subscription shall be as specified in the applicable Order Form.  Specific details of renewal terms for Services are provided on the Order Form. Except as expressly provided in the applicable Order Form, renewal of promotional priced, introductory priced,  or one-time priced subscriptions will be at SC’s applicable list price in effect at the time of the applicable renewal. Notwithstanding anything to the contrary, any renewal in which subscription volume or subscription length for any Services has decreased from the prior term will result in re-pricing at renewal without regard to the prior term’s per-unit pricing.

3.3     Termination for Cause. Either Party may terminate this Agreement for cause (i) upon 30 days written notice to the other party of a material breach if such breach remains uncured at the expiration of such period, or (ii) if the other party becomes the subject of a petition in bankruptcy or any other proceeding relating to insolvency, receivership, liquidation or assignment for the benefit of creditors.

3.4     Effect of Termination. The provisions of the Agreement regarding Effect of Termination, Customer Data, Warranties and Warranty Disclaimers, Remedy for Claims of Intellectual Property Infringement, Limitation of Liability, Indemnification, Confidential Information and Miscellaneous shall survive any expiration or termination of this Agreement.

3.5     Payment Obligations. If this Agreement is terminated by You in accordance with the “Termination” section above, SC will refund You any prepaid fees covering the remainder of the term of all Order Forms after the effective date of termination. If this Agreement is terminated by SC in accordance with the “Termination” section above, You will pay any unpaid fees covering the remainder of the term of all Order Forms to the extent permitted by applicable law. In no event will termination relieve You of Your obligation to pay any fees payable to SC for the period prior to the effective date of termination.

4. FINANCIAL TERMS.

4.1     Fees and Payment. You will pay all fees specified in Order Forms. Except as otherwise specified herein or in an Order Form, (i) fees are based on Services and Content subscriptions purchased and not actual usage, (ii) payment obligations are non- cancelable and fees paid are non-refundable, and (iii) quantities purchased cannot be decreased during the relevant subscription term.

4.2     Invoicing. You will provide SC with valid and updated invoicing information such as credit card information (if credit card payment is permitted on the Order Form, a valid purchase order or alternative document reasonably acceptable to SC.  If the Order Form specified payment by credit card, You authorize SC to charge Your provided credit card for all Purchased Services listed in the Order Form for the initial subscription term and any renewal subscription term(s) as set forth in the “Term and Termination” section. Such charges shall be made in advance, either annually or in accordance with any different billing frequency stated in the applicable Order Form. If the Order Form specifies that payment will be by a method other than a credit card, SC will invoice You in advance and otherwise in accordance with the relevant Order Form. Unless otherwise stated in the Order Form, invoiced fees are due on the subscription start date for the Services.  You are responsible for providing complete and accurate billing and contact information to SC and notifying SC of any changes to such information.  If any invoiced amount is not received by SC by the due date, then without limiting SC’s rights or remedies, (a) those charges may accrue late interest at the rate of 1.5% of the outstanding balance per month, or the maximum rate permitted by law, whichever is lower, and/or (b) SC may condition future subscription renewals and Order Forms on payment terms shorter than those specified above.

4.3       Service Suspension and Fee Acceleration.  SC may, without limiting its other rights and remedies, accelerate Your unpaid fee obligations so that all such obligations become immediately due and payable, and suspend Services until such amounts are paid in full, if any payment is 10 days or more overdue, SC will give You at least 10 days’ prior notice that Your account is overdue, in accordance with the “Manner of Giving Notice” section below for billing notices, before suspending services to You, however, no such notice will be provided if You are paying by credit card or direct debit and your payment has been declined.  SC will not exercise the above rights  if You are disputing the applicable charges reasonably and in good faith and are cooperating diligently to resolve the dispute.

4.3.1     Service Termination and True-Up Invoice.  If you are terminating your services as set forth in the “Term and Termination” section, SC will review your account for all license use, overuse, and unpaid fees for your account.  Upon acceptance of your formal notice of termination, SureClinical will provide you with a True-Up (“True-Up”) Order Form and invoice that reconciles all amounts owed for licenses, services and fees.  All amounts in the True-Up Order form and invoice are due upon receipt, unless otherwise agreed to in writing by SC.  Non-payment of a True-Up invoice may result in suspension of the service within 10 days after the True-Up Order Form and Invoice are provided to You.

4.4       Credits for Cancelled/Suspended Studies.  Upon Your providing thirty (30) days written notice of cancellation or suspension of a study, SC will prorate remaining contract fees as specified in whole months in the form of a credit.  The credit may be used toward purchase of future studies or additional SC software services within eighteen (18) months of cancellation or suspension of the study. The credit will expire after eighteen (18) months.

4.5       On-Hold Studies.  You may elect at any time to put a study on hold for up to twelve (12) months, by providing SC with thirty (30) days written notice and completion of a separate order form authorizing a $6,000 study hold fee, and a $6,000 re-connection fee and the anticipated resumption date. During the hold period, months of service shall accrue and will be applied to remaining contract months upon resumption of service. You may export study data at any time prior to placing the study on hold. During the hold period, SC will maintain Your environment in a suspended state and You will not have access to Your study data. You may resume service at any time with ten (10) days written notification and the re-connection fee will become payable to SC.  On-hold Studies will expire after 18 months unless otherwise agreed to in writing by SC.

4.6       Taxes.  SC’s fees do not include any taxes, levies, duties or similar governmental assessments of any nature, including, for example, value-added, sales, use or withholding taxes, assessable by any jurisdiction whatsoever (collectively, “Taxes”). You are responsible for paying all Taxes associated with its purchases hereunder. If SC has the legal obligation to pay  or collect Taxes for which You are responsible under this section, SC will invoice You and You will pay that amount unless You provide SC with a valid tax exemption certificate authorized by the appropriate taxing authority. For purposes of clarifying that the SC Services are not subject to any VAT or other taxes imposed by foreign jurisdictions with respect to granting licenses or royalty rights, SC is not licensing software to You, but as set forth herein, makes available its Services by subscription, and does not give rights to You to reproduce, distribute, edit, copy or resell the Services. Access to the Services is given to You for the purpose of its intended use, and SC does not give extensive usage rights to You for further commercial utilization of the Services.  For additional clarity, SC is solely responsible for taxes assessable against it based on its income only in foreign jurisdictions where SC is domiciled and has a presence.  Presence is defined as where SC has offices, employees, or property in your local jurisdiction. If under the applicable tax legislation the Services are subject to local Income Tax in Your jurisdiction where SC has no Presence, then SC reserves the right to invoice You for taxes levied upon SC for your purchase. In this case, You will pay that amount to the appropriate taxing authority.

5. WARRANTIES AND WARRANTY DISCLAIMERS.

5.1     Warranties of SC. SC warrants to You that during an applicable subscription term (a) this Agreement, the Order Forms and the Documentation will accurately describe the applicable administrative, physical, and technical safeguards for protection of the security, confidentiality and integrity of Customer Data, (b) SC will not materially decrease the overall security of the Services, (c) the Services will perform materially in accordance with the applicable Documentation, and (d) subject to the provision in Section 1.7 regarding integration with non-SC Applications, SC will not materially decrease the overall functionality of the Services. For any breach of a warranty above, Your exclusive remedies are those described in the “Termination” and “Refund or Payment upon Termination” sections below.

5.2     Your Warranties. You warrant that (i) Your access to and use of the Services shall comply in all respects with this Agreement, and (ii) You are not a direct competitor of SC; (iii) You are authorized to enter into this Agreement.

5.3     Disclaimers. EXCEPT AS SPECIFICALLY CONTAINED IN SECTION 5.1, NEITHER PARTY MAKES ANY WARRANTY OF ANY KIND, WHETHER EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT, TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW. CONTENT AND PREVIEW SERVICES ARE PROVIDED “AS IS,” AND AS AVAILABLE  EXCLUSIVE OF ANY WARRANTY WHATSOEVER.

6. IP RIGHTS

6.1     Reservation of Rights. Subject to the limited rights expressly granted hereunder, SC, its affiliates, its licensors and Content providers reserve all of their right, title and interest in and to the 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.

6.2     Content. You have the right to access and use applicable Content subject to the terms of applicable Order Forms, this Agreement and the Documentation.

6.3     Licenses to SC. You hereby grant SC, its affiliates and applicable contractors a worldwide, limited-term license to host, copy, use, transmit, and display any non-SC applications and program code created by or for You using a Service or for use by You with the Services, and Customer Data, each as appropriate for SC to provide and ensure proper operation of the Services and associated systems in accordance with this Agreement. If You choose to use a non-SC application with a Service, You grant SC permission to allow the non-SC application and its provider to access Customer Data and information about Your usage of the non-SC application as appropriate for the interoperation of that non-SC application with the Service. Subject to the limited licenses granted herein, SC acquires no right, title or interest from You or Your licensors under this Agreement in or to any Customer Data, non-SC Application or such program code.  In addition to the above grant, You hereby grant to SC and its affiliates a worldwide, perpetual, irrevocable, royalty-free license to use and incorporate into its Services any suggestion, enhancement request, recommendation, correction or other feedback provided by You or Your Users relating to the operation of SC’s or its affiliates’ Services.

7. LIMITATION OF LIABILITY.

7.1       No Indirect Damages.  NEITHER PARTY OR ITS AFFILIATES SHALL BE LIABLE TO THE OTHER PARTY OR ANY THIRD PARTY FOR ANY LOST PROFITS OR LOST REVENUE, OR FOR ANY INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT, REGARDLESS OF THE FORM OF ACTION AND WHETHER OR NOT THE PARTY OR ITS AFFILIATES HAVE BEEN INFORMED OF, OR OTHERWISE MIGHT HAVE ANTICIPATED, THE POSSIBILITY OF SUCH DAMAGES OR IF A PARTY’S OR ITS AFFILIATES’ REMEDY OTHERWISE FAILS OF ITS ESSENTIAL PURPOSE. THE FOREGOING DISCLAIMER WILL NOT APPLY TO THE EXTENT PROHIBITED BY LAW.

7.2       Exclusive Remedies.  THE PARTIES HAVE RELIED UPON THE LIMITATIONS SET FORTH HEREIN IN DETERMINING WHETHER TO ENTER INTO THIS AGREEMENT. THE REMEDIES PROVIDED TO YOU IN THIS AGREEMENT ARE EXCLUSIVE.

7.3      Limitation of Liability.  EXCEPT FOR THE PARTIES’ RESPECTIVE INDEMNIFICATION OBLIGATIONS PURSUANT TO SECTION 9 OR A BREACH OF A PARTY’S CONFIDENTIALITY OBLIGATIONS UNDER SECTION 10, IN NO EVENT WILL EITHER PARTY’S LIABILITY FOR DAMAGES OR ALLEGED DAMAGES UNDER THIS AGREEMENT, WHETHER IN CONTRACT, TORT OR ANY OTHER LEGAL THEORY, EXCEED THE AMOUNT OF FEES PAID BY YOU TO SC IN THE LAST TWELVE (12) MONTHS.  THE FOREGOING SHALL NOT LIMIT YOUR AND YOUR AFFILIATES’  PAYMENT OBLIGATIONS UNDER THE “FEES AND PAYMENT” SECTION ABOVE.

8.1     SC’s Indemnification of You. SC will indemnify, defend and hold You harmless against any claim, demand, suit or proceeding made or brought against You by a third party alleging that any subscribed Service infringes or misappropriates such third party’s intellectual property rights (a “Claim”), provided You (a) give SC prompt written notice of the Claim, (b) give SC sole control of the defense and settlement of the Claim (however, SC may not settle any Claim Against You that does provide You with an unconditional release of all liability), and (c) give SC all reasonable assistance, at SC’s expense. If SC receives information about an infringement or misappropriation claim related to a Service, SC may in its discretion and at no cost to You (i) modify the Services so that they are no longer claimed to infringe or misappropriate, without breaching SC’s warranties under “SC Warranties” above, (ii) obtain a license for Your continued use of that Service in accordance with this Agreement, or (iii) terminate Your subscriptions for that Service upon 30 days’ written notice and refund You any prepaid fees covering the remainder of the term of the terminated subscriptions. The above defense and indemnification obligations do not apply if the Claim (1) does not state with specificity that the Services are the basis of the Claim Against You; (2) arises from the use or combination of the Services or any part thereof with software, hardware, data, or processes not provided by SC, if the Services or use thereof would not infringe without such combination; (3) arises from Services under an Order Form for which there is no charge; or (4) arises from Content, a non-SC application or Your breach of this Agreement, the Documentation or applicable Order Forms.

8.2     Your Indemnification of SC. You will indemnify, defend and hold SC and its affiliates harmless against any claim, demand, suit or proceeding made or brought against SC by a third party alleging infringement  or misappropriation such third party’s intellectual property rights based upon (a) any Customer Data or Your use of Customer Data with the Services, (b) a non-SC Application provided by You, (c) the combination of a non-SC Application provided by You and used with the Services, or (d) Your use of the Services or Content in an unlawful manner or in violation of the Agreement, the Documentation, or Order Form (each a “Claim”), provided SC (a) promptly gives You written notice of the Claim, (b) gives You sole control of the defense and settlement of the Claim (however, You may not settle any Claim that does provide SC with an unconditional release of all liability), and (c) gives You all reasonable assistance, at Your expense. The above defense and indemnification obligations do not apply if a Claim arises from SC’s breach of this Agreement, the Documentation or applicable Order Forms.

8.3       Exclusive Remedy.  This “Mutual Indemnification” section states the indemnifying party’s sole liability to, and the indemnified party’s exclusive remedy against, the other party for any third-party claim described in this section.

9. CONFIDENTIAL INFORMATION.

9.1     Confidential Information. “Confidential Information” means and refers to the Services 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.

9.2     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.

9.3       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.

9.4       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.

10.1     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.

10.2     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.

10.3     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. The local law requirements for France, Germany, Italy and Spain are attached hereto as Appendix 1.

10.4     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.

10.5     Entire Agreement.  This Agreement is the entire agreement between SC and You regarding Your use of Services and Content and supersedes all prior and contemporaneous agreements, proposals or representations, written or oral, concerning its subject matter. The parties agree that any term or condition stated in Your purchase order or in any other order documentation (excluding Order Forms) is void. In the event of any conflict or inconsistency among the following documents, the order of precedence shall be: (1) the applicable Order Form, (2) this 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.

10.6     Assignment.  You may not assign or otherwise transfer this Agreement without the prior written consent of SC, which consent will not be unreasonably withheld or denied, and any attempt to assign this Agreement without such consent shall be null and void.  Prior written consent shall not be required if a Party is assigning this Agreement in connection with a merger, acquisition, corporate reorganization, or sale of all or substantially all of its assets.  Notwithstanding the foregoing, if a party is acquired by, sells substantially all of its assets to, or undergoes a change of control in favor of, a direct competitor of the other party, then such other party may terminate this Agreement upon written notice. In the event of such a termination, SC will refund You any prepaid fees covering the remainder of the term of all subscriptions for the period after the effective date of such termination. Subject to the foregoing, this Agreement will bind and inure to the benefit of the parties, their respective successors and permitted assigns.

10.7     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 SC and You, and no approval, consent, or waiver shall be enforceable unless signed by the granting Party.

10.8     Audit Rights.  You agree to keep, maintain and preserve full and accurate accounts and records of all use of the Services, examination of which would enable SureClinical to confirm Your compliance with Sections 1.4 (Usage Limits), 1.5 (Your Use of the Services), 1.6 (External Users) and 1.7 (Restrictions) of this Agreement during the Term.  At any time while a subscription is in effect and for two years after termination of the subscription, SureClinical shall have the right to audit Your records to confirm Your compliance with Sections 1.4 (Usage Limits), 1.5 (Your Use of the Services), 1.6 (External Users) and 1.7 (Restrictions) of this Agreement.  SureClinical shall initiate such audit by notifying You in writing of its intention to conduct an audit of Subscriber’s records (“Audit Notice”), and You shall make the requested records available for inspection as soon as reasonably practicable, which in no event shall exceed ten (10) business days from the date of SureClinical’s Audit Notice. Audits may be performed not more than once each year during Your regular business hours and the auditors shall complete such inspection as expeditiously as possible. You shall provide to the auditors such supplementary information and explanation reasonably necessary to explain fully the information contained in Your books, records and accounts. The cost of the audits shall be paid by SureClinical unless the audits findings indicate material non-compliance by You with respect to Sections 1.4 (Usage Limits), 1.5 (Your Use of the Services), 1.6 (External Users) or 1.7 (Restrictions), in which case You shall pay all of the fees and costs associated with the audits.

10.8     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.

10.9     Contract for Services. The parties intend this Agreement to be a contract for the provision of the Services and not a contract for the sale of goods.  To the fullest extent permitted by law, the provisions of the Uniform Commercial Code (UCC), the Uniform Computer Information Transaction Act (UCITA), or any substantially similar legislation as may be enacted, shall not apply to this Agreement.  If You are located outside of the territory of the United States, the parties agree that the United Nations Convention on Contracts for the International Sale of Goods shall not govern this Agreement or the rights and obligations of the parties under this Agreement.

10.10   Export Control.  The Services, Content, other SC technology, and derivatives thereof may be subject to export laws and regulations of the United States and other jurisdictions. SC and Customer each represents that it is not named on any U.S. government denied-party list. Customer will not permit any User to access or use any Service or Content in a U.S.-embargoed country or region (currently Cuba, Iran, North Korea, Sudan, Syria or Crimea) or in violation of any U.S. export law or regulation.  SC Services are not authorized for subscription by the following countries, groups or individuals:  U.S. sanctioned countries as defined by the current State Department list of sanctioned countries; countries identified by the U.S. State Department as State Sponsors of Terrorism, U.S. State Department defined Foreign Terrorist Organizations (FTOs); US Treasury Department OFAC list of blocked individuals, groups, and entities, who are designated as terrorists, narcotics traffickers or who conduct criminal activities. For business reasons, SC Services may not be sold into the following additional countries or organizations:  Countries or organizations controlled by the Chinese Communist Party (CCP); India, Libya, Nigeria, Russia or organizations controlled by Russia; Somalia, Qatar, Venezuela, Yemen. In order to enforce US and international export control and blocked country use restrictions, SureClinical collects information on a user’s location, such as IP address.  User’s location information is not shared or released to any other entity, unless by court order or by demand from a government agency in connection with illegal, illicit or suspected terrorist activities.  Your use of the Service conveys your acceptance of our use of our limited location and IP address monitoring as defined above.

10.11 Client Services Agreement.  In the event that Customer requests services from SureClinical’s Client Services Team such as administrative support, software development, additional training or other SureClinical Client Services, SureClinical will perform only those services that are described in an Order Form(s) or Client Services Agreement and Statement of Work (“CSA”) or additional Order Forms that may be executed from time to time by Company and will constitute amendments to this Agreement.  Unless otherwise provided in this Agreement, an Order Form, or CSA, (a) All Services performed hereunder will be performed solely by SureClinical, (b) SureClinical will furnish, at SureClinical’s own expense, all materials, equipment, tools and supplies necessary to perform the Services, and (c) SureClinical will own all right, title and interest in and to the designs, programs, algorithms, procedures, products, inventions, improvements, developments  or modifications resulting from the performance of services under the CSA (“Designs and Materials”), except to the extent Company’s intellectual property was incorporated into the Design and Materials in which case, SureClinical shall have a perpetual, royalty free license to utilize such intellectual property in the Designs and Materials.  Company hereby irrevocably transfers and assigns any and all of its right, title, and interest in and to Designs and Materials, including but not limited to all copyrights, patent rights, trade secrets and trademarks, to SureClinical. Other than as agreed to in an executed Order Form, Company has no obligation to purchase a specific amount of Services from SureClinical.  Subject to the terms and conditions of this Agreement, SureClinical shall make the Services available to You on a subscription basis during the Term (as defined in the initial or any subsequent Order Form).  Your subscription shall be a non-exclusive subscription to use during the term of the subscription the Services subject to such restrictions and limitations set forth below and elsewhere in this Agreement and as may be specifically set forth on the Order Form.  In the event of any conflict or inconsistency among the following documents, the order of precedence shall be: (1) the applicable Order Form, (2) this Agreement, and (3) the CSA.

10.11     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.

10.12.     Compliance with Laws.  You are responsible for all activity occurring under Your Account Information, and You will abide by all applicable local, state, national and foreign laws, treaties and regulations in connection with Your use of the Services.  This Agreement and Your right to use the Services 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.

10.13.     Marketing and Promotional Activities.  To the extent indicated in the SureClinical joint marketing agreement ( https://sureclinical.com/jma/ ), Customers grant SC the right to add Customer name and logo to SC’s list of customers and on SC’s website during the term of this Agreement. SC’s use of Customer’s name and logo will be in accordance with the SureClinical joint marketing agreement, at https://sureclinical.com/jma/.  Upon Customer’s written request, SC will promptly remove Customer’s name or any Customer marks from SC’s website, and to the extent feasible, SC’s marketing materials.

 

APPENDIX 1

1.0

Local Law Requirements: France. With respect to Customers domiciled in France, in the event of any conflict between any statutory law in France applicable to Customer, and the terms and conditions of this Agreement, the applicable statutory law shall prevail.

Local Law Requirements: Germany. With respect to Customers domiciled in Germany, Section “REPRESENTATIONS, WARRANTIES, EXCLUSIVE REMEDIES AND DISCLAIMERS”, Section “Exclusive Remedy”, and Section “LIMITATION OF LIABILITY” of this Agreement are replaced with the following sections respectively:

2.1  WARRANTIES FOR CUSTOMERS DOMICILED IN GERMANY

2.1.1 Agreed Quality of the Services. SC warrants that during an applicable subscription term (a) this Agreement, the Order Forms and the Documentation will accurately describe the applicable administrative, physical, and technical safeguards for protection of the security, confidentiality and integrity of Customer Data, (b) SC will not materially decrease the overall security of the Services, (c) the Services will perform materially in accordance with the applicable Documentation, and (d) subject to the “Integration with Non-SC Applications” section above, SC will not materially decrease the overall functionality of the Services.

2.1.2 Content. SC is not designating or adopting Content as its own and assumes no warranty or liability for Content. The parties agree that the “Reporting of Defects”, “Remedies resulting from Defects” and “Exclusions” section shall apply accordingly to SC’s responsibility in the event SC is deemed responsible for Content by a court of competent jurisdiction.

2.1.3 Reporting of Defects. Customer shall report any deviation of the Services from the “Agreed Quality of the Services” section (“Defect”) to SC in writing without undue delay and shall submit a detailed description of the Defect or, if not possible, of the symptoms of the Defect. Customer shall forward to SC any useful information available to Customer for rectification of the Defect.

2.1.4 Remedies resulting from Defects. SC shall rectify any Defect within a reasonable period of time. If such rectification fails, Customer may terminate the respective Order Form provided that SC had enough time for curing the Defect. The “Refund or Payment upon Termination” section, sentence and 1 and sentence 3 shall apply accordingly. If SC is responsible for the Defect or if SC is in default with the rectification, Customer may assert claims for the damage caused in the scope specified in the “Limitation of Liability” section below.

2.1.5 Defects in Title. Defects in title of the Services shall be handled in accordance with the provisions of Clause 9 “Mutual Indemnification”.

2.1.6 Exclusions. Customer shall have no claims under this Clause 8 “Warranty” if a Defect was caused by the Services not being used by Customer in accordance with the provisions of this Agreement, the Documentation and the applicable Order Forms.

2.1.7 Liability resulting from Indemnification for Customers domiciled in Germany. The below “Limitation of Liability” section shall apply to any claims resulting from this “Mutual Indemnification” section.

2.2  LIMITATION OF LIABILITY FOR CUSTOMERS DOMICILED IN GERMANY

2.2.1 Unlimited Liability. The Parties shall be mutually liable without limitation

1. in the event of willful misconduct or gross negligence,
2. within the scope of a guarantee taken over by the respective party,
3. in the event that a defect is maliciously concealed,
4. in case of an injury to life, body or health,
5. according to the German Product Liability Law.

2.2.2 Liability for Breach of Cardinal Duties. If cardinal duties are infringed due to slight negligence and if, as a consequence, the achievement of the objective of this Agreement including any applicable Order Form is endangered, or in the case of a slightly negligent failure to comply with duties, the very discharge of which is an essential prerequisite for the proper performance of this Agreement (including any applicable Order Form), the parties’ liability shall be limited to foreseeable damage typical for the contract. In all other respects, any liability for damage caused by slight negligence shall be excluded.

2.2.3  Liability Cap. Unless the parties are liable in accordance with “Unlimited Liability” section above, in no event shall the aggregate liability of each party together with all of its Affiliates arising out of or related to this Agreement exceed the total amount paid by Customer and its Affiliates hereunder for the Services giving rise to the liability in the 12 months preceding the first incident out of which the liability arose. The foregoing limitation will not limit Customer’s and its Affiliates’ payment obligations under the “Fees and Payment” section above.

With the exception of liability in accordance with the “Unlimited Liability” section, the above limitations of liability shall apply to all claims for damages, irrespective of the legal basis including claims for tort damages. The above limitations of liability also apply in the case of claims for a party’s damages against the respective other party’s employees, agents or bodies.

3. Local Law Requirements: Italy. With respect to Customers domiciled in Italy, Section “Invoicing and Payment”, Section “Overdue Charges”, Section “Suspension of Service and Acceleration”, and Section “Anti-Corruption” of this Agreement are replaced with the following sections respectively:

3.1   Invoicing and Payment

3.1.1 Invoicing and Payment. Fees will be invoiced in advance and otherwise in accordance with the relevant Order Form. Unless otherwise stated in the Order Form, fees are due net 30 days from the invoice date. The parties acknowledge that invoices are also be submitted electronically by SC in accordance with the “Electronic Invoicing” section below through the Agenzia delle Entrate’s Exchange System (SDI – Sistema di Interscambio) and any delay due to the SDI shall not affect the foregoing payment term. Customer shall be responsible for providing complete and accurate billing and contact information to SC and shall notify SC of any changes to such information.

3.1.2 Electronic Invoicing. The invoice will be issued in electronic format as defined in article 1, paragraph 916, of Law no. 205 of December 27, 2017, which introduced the obligation of electronic invoicing, starting from January 1, 2019, for the sale of goods and services performed between residents, established or identified in the territory of the Italian State. To facilitate such electronic invoicing, Customer shall provide to SC at least the following information in writing: Customer full registered company name, registered office address, VAT number, tax/fiscal code and any additional code and/or relevant information required under applicable law. In any event, the parties shall cooperate diligently to enable such electronic invoicing process. Any error due to the provision by Customer of incorrect or insufficient invoicing information preventing (a) SC to successfully submit the electronic invoice to the SDI or (b) the SDI to duly and effectively process such invoice or (c) which, in any event, requires SC to issue an invoice again, shall not result in an extension of the payment term set out in the “Invoicing and Payment” section above, and such term shall still be calculated from the date of the original invoice. SC reserves the right to provide any invoice copy in electronic form via email in addition to the electronic invoicing described herein.

3.1.3 Split Payment. If subject to the “split payment” regime, Customer shall be exclusively responsible for payment of any VAT amount due, provided that Customer shall confirm to SC the applicability of such regime and, if applicable, Customer shall provide proof of such VAT payment to SC and, if applicable, Customer shall provide proof of such VAT payment to SC.

3.2  Overdue Charges. Subject to the “Payment Disputes” section below, if any invoiced amount is not received by SC by the due date, then without limiting SC’s rights or remedies, those charges, without the need for notice of default, may accrue late interest at the rate of 1.5% of the outstanding balance per month, or the maximum rate permitted by law (Legislative Decree no. 231/2002), whichever is lower and/or (b) SC may condition future subscription renewals and Order Forms on payment terms shorter than those specified in the “Invoicing and Payment” section above.

3.3  Suspension of Service. Subject to the “Payment Disputes” section below, if any charge owing by Customer under this or any other agreement for services is 10 days or more overdue, SC may, without limiting its other rights and remedies, suspend Services until such amounts are paid in full, provided that, other than for customers paying by credit card or direct debit whose payment has been declined, SC will give Customer at least 10 days’ prior notice that its account is overdue, in accordance with the “Manner of Giving Notice” section below for billing notices, before suspending services to Customer.

3.4  Anti-Corruption.

3.4.1 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.

3.4.2 Code of Conduct and Organization, Management and Control Model. Customer acknowledges that SC has adopted an Organization, Management and Control Model pursuant to Legislative Decree 231/2001 to prevent crimes provided for therein and commits to comply with the principles contained in the above Legislative Decree 231/2001 and in the SC Code of Conduct, which is provided to SureClinical’s employees and consultants. Customer also acknowledges and agrees that the violation of the principles and the provisions contained in Legislative Decree 231/2001 and in the SC Code of Conduct by Customer may entitle SC, based on the severity of the violation, to terminate this Agreement for cause as set out above.

4. Local Law Requirements: Spain. 

With respect to Customers domiciled in Spain, in the event of any conflict between any statutory law in Spain applicable to Customer, and the terms and conditions of this Agreement, the applicable statutory law shall prevail.

Last updated:  16 April 2022