CSA-1-September-2024
CSADPASLA

Cloud Subscription Agreement

Version: September 1st, 2024

Extra Horizon (as defined hereafter) is a software company specialized in software development of medical device software according to the required standards. Furthermore, Extra Horizon is EN ISO 13485:2016-certified with a quality management system for medical devices; ISO 27001:2017 certified for its information security management system and ISO 27701:2019 certified for its privacy information management system. Extra Horizon offers a cloud infrastructure that enables faster development of medical grade software applications, which software is licensed in accordance with the current cloud subscription agreement (the “Cloud Subscription Agreement”) to the Client (as defined hereafter).

This Cloud Subscription Agreement shall apply to all contracts and Work Orders (as defined hereafter) relating to the use of the Extra Horizon Software (as defined hereafter) and/or any Services (as defined hereafter) between Extra Horizon and the Client, except when special agreements between Extra Horizon and the Client expressly stipulate otherwise.

The Cloud Subscription Agreement is deemed accepted by the Client, even when they are conflicting with the Client’s general or special purchasing agreements. The fact that Extra Horizon did not explicitly reject any agreement the Client referred to in any contract or Work Order cannot be interpreted by the Client as an acceptance by Extra Horizon of such agreement. In the event of any conflict between this Cloud Subscription Agreement and any document submitted by the Client, this Cloud Subscription Agreement shall prevail, and such conflicting terms in the Client’s documents are hereby rejected by Extra Horizon.

The designated person, officer, director, employee, or any other person who represents or acts on behalf of the Client, is deemed to have the necessary mandate to legally bind the Client.

By agreeing to an Order Form that references this Cloud Subscription Agreement (this “Agreement”), you agree to this Agreement. If you represent an organization, you represent and warrant that you are authorized to agree to this Agreement on behalf of your organization.

This Agreement supersedes any of the previously signed agreements with relation to the Extra Horizon Software or Professional Services.

1. Definitions

The following definitions (and additional definitions provided below) will apply to these Cloud Subscription Agreement:

“Acceptance Criteria” means the acceptance criteria included in a Work Order as set out in article 3.4;

“Agreement” means this Cloud Subscription Agreement together with any Work Orders between Extra Horizon and the Client;

“Business Days” means Monday to Friday, excluding Belgian public holidays as listed on https://www.belgium.be/nl/werk/verlof_en_loopbaanonderbrekingen/feestdagen;

“Business Hours” means 9:00 A.M. to 6:00 P.M. (CET or, as the case may be CEST, as applicable on any given time in Brussels, Belgium) on Business Days;

“Beta Services” means features, technologies and services made available by Extra Horizon that are not yet generally available, including any products, services or features labeled “beta”, “preview”, “pre-release” or “experimental”;

“Client” means every legal entity that concludes an agreement with Extra Horizon with regards to the Extra Horizon Software and Services through a Work Order;

“Client Data” means the data (including Personal Data) and meta-data of the Client processed or stored through the Extra Horizon Software;

“Confidential Information” of a Party means the information of such Party, whether in written, oral, electronic or other form, which (i) is explicitly marked as confidential or proprietary, or (ii) should reasonably be considered confidential given its nature or the circumstances surrounding its disclosure, regardless of whether or not it is expressly marked as confidential, including (without being limitative) information and facts concerning a Party’s and its affiliates’ business plans, clients, prospects, personnel, suppliers, licensors, licensees, partners, investors, affiliates or others, training methods and materials, financial information, marketing plans, sales prospects, client lists, inventions, program devices, discoveries, ideas, concepts, know-how, techniques, formulas, blueprints, software (in object and source code form), documentation, designs, prototypes, methods, processes, procedures, codes, and any technical data or trade secrets, including all copies of any of the foregoing and any analyses, studies or reports that contain, are based on, or reflect any of the foregoing. Confidential Information shall not include information which can be proven by written records to fall under any of the following information: (i) information which was already in the receiving Party’s lawful possession prior to its receipt from the disclosing Party, without any confidentiality restrictions attached to it, (ii) information which is or becomes generally available to the public through no wrongful act of the receiving Party, (iii) information which is rightfully received by the receiving Party from a third party that is not subject to an obligation of confidentiality owed to the disclosing Party, (iv) information which is independently developed by the receiving Party without reference to or use of the disclosing Party’s Confidential Information, or (v) disclosure of information which is approved by written authorization of the disclosing Party. The Confidential Information of Extra Horizon shall include, without being limitative, the Extra Horizon Software and the Documentation;

“Data Processing Agreement” means the data processing agreement as attached to these Cloud Subscription Agreement as Exhibit 1;

“Deliverables” means deliverables developed by Extra Horizon in the scope of the Professional Services;

“Delivery Date” has the meaning set forth in article 3.4.1 of these Cloud Subscription Agreement;

“Documentation” means the operating manual, including a description of the functions performed by the Extra Horizon Software, user instructions, technical literature and all other related materials, which may be supplied to the Client by Extra Horizon to facilitate the use of the Extra Horizon Software;

“Effective Date” means the date on which the Client has countersigned the initial Work Order;

“Exhibit” means an exhibit to this Cloud Subscription Agreement;

“Extra Horizon” means Extra Horizon, a limited liability company (“naamloze vennootschap” or “NV”) incorporated, organized and existing under the laws of Belgium, with registered seat at Kempische Steenweg 303 box 27, B-3500 Hasselt, Belgium, and registered with the Crossroads Bank for Enterprises (“Kruispuntbank van Ondernemingen” or “KBO”) under enterprise number 0790.640.367 (LER Antwerp, section Hasselt);

“Extra Horizon Software” means Extra Horizon’s cloud infrastructure that enables faster development of medical grade software applications, licensed to the Client by Extra Horizon in accordance with the terms and conditions of the Agreement, and provided through a SaaS-model;

“Fees” shall mean the License Fees, Hosting Fees, and the Professional Service Fees, as the case may be, taken together;

“Force Majeure Event” has the meaning set forth in article 12.5.1 of these Cloud Subscription Agreement;

“GDPR” means the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation);

“Implementation Services” means the implementation services to be delivered by Extra Horizon, pursuant to article 3.1 of this Cloud Subscription Agreement;

“Initial Term” has the meaning set forth in article 9.1.1 of this Cloud Subscription Agreement;

“Intellectual Property Rights” shall mean any and all intellectual property rights, such as, without limitation, all of the following: (a) all inventions (whether patentable or unpatentable and whether or not reduced to practice), all improvements thereto, and all patents, patent applications, and patent disclosures, together with all reissuances, continuations, continuations-in-part, revisions, extensions and re-examinations thereof, (b) all trademarks, service marks, trade dress, logos, trade names, and corporate names, together with all translations, adaptations, derivations, and combinations thereof and including all goodwill associated therewith, and all applications, registrations and renewals in connection therewith, (c) all copyrightable works, all copyrights, and all applications, registrations and renewals in connection therewith, (d) all mask works and all applications, registrations and renewals in connection therewith, (e) all trade secrets and confidential business information and all research and development, know-how, techniques, technical data, technology, and systems, (f) all computer software, including Object Code, Source Code, data and related documentation, (g) all internet web sites, including domain name registrations and content and software included therein, (h) all other proprietary rights, (i) all rights to recover for past infringements of any of the foregoing, and (j) all copies and tangible embodiments thereof (in whatever form or medium);

“License Fees” means the recurring fees payable by the Client in respect of the user rights in respect of the Licensed Products granted hereunder and as set forth in article 2 of this Cloud Subscription Agreement, and in respect of the Support Services provided in accordance with the Service Level Agreement;

“Licensed Products” means the Extra Horizon Software and the relevant Documentation;

“Notified Body” means an entity, established in the European Union and authorized under applicable law to assess and certify the conformity of a medical device with the requirements of the Council Directive 93/42/EEC concerning medical devices, as amended from time to time, or any subsequent or superseding law, statute or regulation, including Regulation (EU) 2017/745 on medical devices;

“Object Code” (or Bytecode) means software assembled or compiled in magnetic or electronic binary form on software media that is readable and usable by machines but not generally readable by humans without reverse assembly, reverse compiling or reverse engineering;

“Party” or “Parties” means Extra Horizon and/or the Client;

“Personal Data” means any information relating to an identified or identifiable natural person; an identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as (but not limited to) a name, an identification number, location data, an online identifier or to one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person;

“Professional Services” means the professional services to be delivered by Extra Horizon, upon Client’s request, pursuant to article 3.3 of this Cloud Subscription Agreement and detailed in the applicable Work Order;

“Regulatory Authority” means any law, rule, or regulation-making or enforcing entity having jurisdiction over Extra Horizon, Client, or any other person, property, activity, or other matter related to this Cloud Subscription Agreement.

“Renewal Term” has the meaning set forth in article 9.1.2 of this Cloud Subscription Agreement;

“Representatives” has the meaning set forth in article 6.1.2 of this Cloud Subscription Agreement;

“Service Fees” means the fees payable by the Client in respect of Services (that are not included in the License Fees);

“Services” means the Support Services, Implementation Services, Professional Services and/or any other services provided by Extra Horizon to the Client under this Cloud Subscription Agreement;

“SLA” means the service level agreement as attached to this Cloud Subscription Agreement as Exhibit 2;

“Source Code” means with respect to any software, such software written in programming languages including all comments and procedural code such as job control language statements, in a form intelligible to programmers trained in and knowledgeable of such software, and capable of being translated into the Object Code form of such software for operation on computer equipment through assembly or compiling;

“Source Code Repository” has the meaning set forth in article 9.6.4 of this Cloud Subscription Agreement;

“Service Credits” has the meaning set forth in article 8 of the Service Level Agreement;

“Support Services” means the maintenance and support services to be delivered by Extra Horizon pursuant to article 3.2 of this Cloud Subscription Agreement and in accordance with the Service Level Agreement;

“Term” has the meaning set forth in article 9.1.2 of this Cloud Subscription Agreement;

“Transition Period” has the meaning set forth in article 9.5.1 of this Cloud Subscription Agreement;

“Transition Plan” has the meaning set forth in article 9.5.1 of this Cloud Subscription Agreement;

“Triggering Event” has the meaning set forth in article 9.6.2 of this Cloud Subscription Agreement;

“Virus” means a virus, cancelbot, worm, logic bomb, Trojan horse or other harmful component of software or data; and

“Order Form” means an ordering document for Subscriptions signed by both parties that refers and incorporates by reference the terms of this Cloud Subscription Agreement.

“Work Order” means a work order document, setting out, at a minimum, the scope, assumptions and Service Fees of Professional Services to be delivered by Extra Horizon to the Client pursuant to this Cloud Subscription Agreement, and which incorporates by reference the terms of this Cloud Subscription Agreement.

2. License

2.1 Subject to this Cloud Subscription Agreement and timely payment of the License Fees, Extra Horizon hereby grants to the Client a personal, restricted, non-exclusive, non-transferable, non-assignable license, without the right to sublicense (except to Client’s contractors and agents for which the use of this license is essential in the course of their services for Client) , for the duration of the Term as defined in the Order Form, to use the Licensed Products in accordance with the purposes set out in the Cloud Subscription Agreement, the Documentation.

2.2 To the extent applicable, the Client may order additional licenses or increase the committed volumes during the Term at the applicable rates at the time of such order. Such order will be effectuated (and only binding) provided such order is confirmed by Extra Horizon in writing in the form of an Order Form.

2.3 The Client shall use commercially reasonable efforts to prevent unauthorized access to, or use of, the Extra Horizon Software, and notify Extra Horizon promptly of any such unauthorized use that becomes known to the Client.

2.4 The Client decides which Client Data will be stored on the Extra Horizon Software. Extra Horizon has no control on the Client Data which the Client stores, but specific employees have access for maintenance purposes.

2.5 From time to time, Extra Horizon may make Beta Services available in the Extra Horizon Software at no charge. Beta Services are made available “as is” and “as available”, and the Support Services shall not apply with respect to Beta Services, and Extra Horizon shall have no liability for any harm or damage arising out of or arising out of or in connection with the Beta Services. The Client may choose to try such Beta Services at its sole discretion, yet only in non-production environments. If the Client elects to use Beta Services for purposes other than internal evaluation, or in production environments, or with any Personal Data, then the Client assumes all of the risks of doing so. The Client must treat the Beta Service as Confidential Information. Extra Horizon may discontinue the Beta Services at any time in its sole discretion and may never make them generally available.

3. Services

3.1 Managed Services.

3.1.1 Extra Horizon agrees to provide the required Extra Horizon Platform Services in one or more specific virtual private clusters as detailed in the Order Form.

3.2 Support Services.

3.2.1 During the Term, Extra Horizon shall provide the Client with Support Services in respect of the Licensed Products in accordance with the Service Level Agreement. For the avoidance of doubt, it is specified that such Support Services are included in the License Fees, unless otherwise specified in the Service Level Agreement.

3.2.2 During the Term, Extra Horizon may, in its sole discretion, provide updates to the Extra Horizon Software. Unless otherwise decided by Extra Horizon, updates (if any) will be deemed to be part of the Extra Horizon Software under the Agreement and as such Client will have access to such updates in accordance with the Service Level Agreement.

3.3 Professional Services.

3.3.1 Extra Horizon may be requested by Client to provide Professional Services. In such an event, the Parties shall prepare and agree upon a Work Order. Each Work Order shall set forth the specific Professional Services to be provided by Extra Horizon, the applicable assumptions and Client dependencies, the applicable Fees and expenses to be paid to Extra Horizon, the applicable acceptance testing and criteria (if any), and such additional terms and conditions as the Parties may mutually agree.

3.3.2 For the avoidance of doubt, it is specified that in no event Extra Horizon shall be obliged to carry out any Professional Services unless agreed in a Work Order duly executed by both Parties.

3.3.3 For the avoidance of doubt, it is specified that the Support Services do not apply to any Deliverable, unless explicitly otherwise agreed in writing between the Parties, in a Work Order or in a separate support and maintenance agreement.

3.3.4 Acceptance.

3.3.4.1 If no Acceptance Criteria are specified in the Work Order, acceptance of the delivered Software will be subject to Client’s written notice of acceptance of the delivered Software. If no such written notice of acceptance or non-acceptance is provided within ten (10) days as of the Delivery Date, as defined below, the Software will be deemed accepted. If the Software is not accepted by the Client, the Client will deliver to Extra Horizon a written notice listing all deficiencies in reasonable detail after which the Parties will mutually agree on a solution. The Business Day following the delivery date of the Software (by delivery of user IDs or otherwise) will be defined as the “Delivery Date”.

3.4.4.2 The following provisions will apply in the event specific Acceptance Criteria are specified in the applicable Work Order for the Software.

  • (i) The Client shall perform acceptance testing in respect of the Software against the Acceptance Criteria, provided that any such acceptance testing must be completed within 30 days after the Delivery Date. The Client will be deemed to have accepted the Software without reservation if

    • (i) the Client uses the Software in a production environment,

    • (ii) the Software performs in accordance with the Acceptance Criteria during the acceptance testing,

    • (iii) the Client notifies Extra Horizon that it accepts the Software,

    • (iv) the Client has not completed acceptance testing of the Software within 30 days from the Delivery Date, or

    • (v) the Client has failed to issue a notice of acceptance or non-acceptance within three (3) Business Days from the end of the acceptance testing.

  • (ii) If the Software fails to perform in accordance with the Acceptance Criteria during the acceptance testing, the Client shall promptly (and in any event within fifteen (15) Business Days of the end of such acceptance testing) deliver to Extra Horizon a written notice listing all deficiencies in reasonable detail. Extra Horizon will then, at its own expense, modify the Extra Horizon Software until Extra Horizon determines that the Extra Horizon Software meets the Acceptance Criteria. Extra Horizon will then deliver to the Client notice of its determination that the modified Extra Horizon Software meets the Acceptance Criteria. Following its receipt of such notice, the Client will as promptly as practicable (and in any event within such period as may be agreed between the Parties) recommence acceptance testing of the Software. The Client will be deemed to have accepted the modified Software without reservation if

    • (i) during the acceptance testing the Client completes a successful registration,

    • (ii) the Client uses the Software in a production environment,

    • (iii) the Extra Horizon Software performs in accordance with the Acceptance Criteria during the acceptance testing,

    • (iv) the Client notifies Extra Horizon that it accepts the Extra Horizon Software,

    • (v) the Client has not completed acceptance testing of the Extra Horizon Software within reasonable period (but in any event within a period of thirty (30) days), after the date of receipt of the notice from Extra Horizon or

    • (vi) the Client has failed to issue a notice of acceptance or non-acceptance within a reasonable period after the date of receipt of the notice from Extra Horizon.

4. Fees

4.1 License Fees.

4.1.1 As consideration for the use rights granted pursuant to article 2 of this Cloud Subscription Agreement the Client agrees to pay to Extra Horizon the License Fees as set out in this article 4 and in the relevant Order Form.

4.1.2 The License Fees will be invoiced on a monthly basis, according to the pricing schedule as described in the Order Form.

4.2 Professional Service Fees.

4.1.1 As consideration for the use rights granted pursuant to article 2 of this Cloud Subscription Agreement and/or the Services the Client agrees to pay to Extra Horizon the Fees as set out in this article 4 and in the relevant Order Form or Work Orders.

4.1.2 The License Fees will be invoiced on a monthly basis, according to the pricing schedule as described in the Order Form.

4.2.1 Any Professional Service Fees will be invoiced on a monthly basis on a “time & materials” basis, at the daily rates set forth in a relevant Work Order.

4.3 Annual Fee adaptation.

4.2.2 The License or Professional service fees may be subject to an annual adaptation on 1 January of every year (starting as of the first 1 January after the first anniversary of the Effective Date) according to following formula using the Agoria “refertelonen landsgemiddelde” index (available at www.agoria.be) or if the Agoria index is no longer published, the index replacing it or failing such index by another index reflecting the increases of labor cost:

(New Amount) = (Old Amount) X (0.20 + 0.80 x (New Index/Starting Index)), whereby the starting index is set at the month of the Effective Date.

A negative index shall have no impact on the Fees. Extra Horizon has no obligation to inform the Client in advance of this adaptation.

4.4 Taxes.

4.4.1 The Fees exclude value added tax, sales tax, use tax, service tax, all other duties and/or taxes or other similar charges imposed on Extra Horizon or the Client by any tax authority (other than taxes imposed on Extra Horizon’s income) which shall be charged separately by Extra Horizon and paid by the Client, to the extent applicable. All such charges, duties and/or taxes shall be identified in the invoice as a separate item.

4.5 Invoices – Payment terms.

4.5.1 Invoices are payable within thirty (30) calendar days from the invoice date. All payments made by the Client to Extra Horizon under the Agreement shall be final and non-refundable. All Fees payable to Extra Horizon under the Agreement shall be paid without the right to set off. If the Client fails to pay any undisputed sums when due, Extra Horizon shall be entitled to interest on the amount due compounded monthly at the rate of eight percent (8%) per month or the maximum permitted by applicable law, calculated from date due and shall also be entitled to recover all costs including reasonable expenses, legal fees and cost of collection. In case of non-payment of the License Fees, with the exception of validly disputed License Fees, Extra Horizon may suspend access to the Licensed Products for License Fees that are not paid within ninety (90) calendar days from the invoice date until all invoices in relation to such License Fees are correctly paid. The Client will receive a fifteen (15) calendar day notice of such action.

4.6 Dispute of Invoice.

4.6.1 In the event the Client disputes any portion of an invoice, the Client shall notify Extra Horizon of such disputed amount and the basis for the Client’s dispute within ten (10) Business Days from the invoice date, together with any appropriate information supporting the Client’s position, and the undisputed portion shall be paid as provided herein, failure of which shall result in the invoice being deemed accepted by the Client.

5. Intellectual property rights

5.1 Licensed Products.

5.1.1 The Licensed Products, including any rights, title and interest (including Intellectual Property Rights) therein, including any and all Intellectual Property Rights created, acquired or developed after the Effective Date and/or pursuant to the Agreement as a modification, improvement, enhancement or extension of the Licensed Products, any and all updates and new versions and any and all copies thereof, irrespective of whether such modification, improvement, enhancement or extension is based on feedback or instructions of the Client, in the broadest sense, shall at all times remain the sole and exclusive property of, and/or shall, as from the moment of their creation, immediately and exclusively vest in Extra Horizon, and the Client shall obtain no rights, title or interest (including without limitation Intellectual Property Rights) in the Licensed Products pursuant to the Agreement except the rights expressly granted hereunder.

5.1.2 The Client agrees that it will not itself, or through any parent, subsidiary, affiliate, agent, (sub)contractor or other third party (i) use the Licensed Products other than as expressly authorized in these Cloud Subscription Agreement, (ii) reverse engineer, disassemble or decompile any binary code used in connection with the Licensed Products, (iii) modify the Licensed Products or develop any derivative works based on the Licensed Products or any Confidential Information of Extra Horizon, (iv) take any action related to the Licensed Products that interferes with, damages, or accesses or uses in any unauthorized manner the hardware, software, networks, technologies or other properties or services of Extra Horizon, (v) remove, suppress or modify in any way any proprietary marking, including any trademark or copyright notice, on or in the Licensed Products, or visible during its operation, or on media or on any Documentation, or (vi) sell, lease, commercialize, rent, display, license, sublicense, transfer, provide, disclose, or otherwise make available to, or permit the use of or access to, the Licensed Products, in whole or in part, to any third party, except as expressly permitted under the Agreement.

5.2 Client Data.

5.2.1 Any pre-existing Intellectual Property Rights in Client Data shall at all times remain unchanged. The Client grants to Extra Horizon a non-exclusive, worldwide, royalty-free and fully paid license to use the Client Data as necessary for the performance of its obligations under the Agreement. The Client Data hosted by Extra Horizon as part of the Extra Horizon Software, and all worldwide Intellectual Property Rights in it, are the exclusive property of the Client. All rights in and to the Client Data not expressly granted to Extra Horizon in the Agreement are reserved by the Client.

5.3 Deliverables.

5.3.1 Parties acknowledge and agree that, except if explicitly stated otherwise in a relevant Work Order, any Deliverables shall, as from the moment of payment of the corresponding Service Fees for the relevant Professional Services, immediately and exclusively vest in the Client without granting any other rights to a Party other than as set out in the Agreement. Extra Horizon shall ensure that it takes all actions reasonably required, including ensuring all individuals who develop such Deliverables waive their moral rights therein, to assign all Intellectual Property Rights in relation to such Deliverables to the broadest extent possible to Client.

5.3.2 The Client grants to Extra Horizon and its affiliates a fully-paid up, perpetual, non-exclusive, non-transferable, non-assignable, without the right to sublicense (except to affiliates of Extra Horizon), worldwide, irrevocable right and license to use the Deliverables (excluding, for the avoidance of doubt, any service marks, trademarks, logos and trade names owned or used by the Client included therein) without limitation in scope, in any event without any use of any Confidential Information of the Client.

5.3.3 The Client acknowledges that Extra Horizon provides professional services for other parties and agrees that nothing herein will be deemed or construed to prevent Extra Horizon from carrying on such services. Extra Horizon will have the right to use techniques, methodologies, processes, tools, ideas, concepts and other know-how gained during the performance of the Professional Services in the furtherance of its own business and to perfect all other Intellectual Property Rights related thereto.

6. Confidentiality

6.1.1 Each Party agrees, during the Term and for a period of five (5) years thereafter, to hold in strictest confidence, and not to use, except for the benefit of the other Party, or to disclose to any person, firm, or corporation without the prior written authorization of the other Party, any Confidential Information of other Party.

6.1.2 Each Party may disclose the Confidential Information only to its and its affiliates’ advisors, consultants, representatives, employees and (sub)contractors (the “Representatives”), provided that they have a legitimate need to know such Confidential Information in light of the purposes of the Agreement and provided such Representatives are bound by adequate (in light of the confidentiality undertakings set forth in this Cloud Subscription Agreement) written confidentiality undertakings prior to being provided access to such Confidential Information. Each Party shall be responsible and liable towards the other Party for any breach of the Agreement by its Representatives.

6.1.3 Notwithstanding the above, should either Party be compelled or required to disclose Confidential Information of the other Party by law, or an order, demand or request of a court or a governmental agency, such Party may disclose the Confidential Information to the extent so compelled or required, provided however, that such Party shall give the other Party reasonable prior written notice of any disclosure, comply with any reasonable instructions of the other Party as to such disclosure, and use its best efforts to obtain confidential treatment or a protective order.

6.1.4 The Parties’ confidentiality obligations as set forth herein shall survive termination of the Agreement. Upon termination of the Agreement or a disclosing Party’s earlier written request, the receiving Party shall promptly return to the disclosing Party all Confidential Information of the disclosing Party in its possession or under its control.

7. Data Privacy

7.1 To the extent any Personal Data is processed by Extra Horizon pursuant to the Agreement, such processing shall be done in accordance with the applicable data protection legislation, such as amongst others, the GDPR, and the provisions of the Data Processing Agreement.

7.2 The parties will comply with Extra Horizon's Data Processing Agreement (DPA) available at https://docs.extrahorizon.com/data-processing-agreement, which is incorporated into this Agreement.

8. Compliance with law and policies

8.1 In all developments related to medical devices, unless otherwise communicated, Extra Horizon shall comply with the following international standards: ISO13485, ISO27001, HIPAA, MDR.

8.2 It is the Client’s responsibility to immediately notify Extra Horizon of all reportable events that could possibly originate from a nonconformity of the provided service or one of the Extra Horizon Software.

8.3 Extra Horizon will at all times fully cooperate with requests of the Notified Body, Regulatory Authority, or the Client or other competent authorities and will be available for audits. Assistance in case of such audit or any other type of regulatory consultancy will be charged at the daily rates set forth in the Work Order, except if the audit reveals a breach or serious assumptions of non-conformity of the Services by Extra Horizon pursuant to the Agreement.

9. Term and Termination

9.1 Term.

9.1.1 The term of this Agreement commences when you agree to an Order Form and will remain in effect until terminated in accordance with this Agreement. Either party may terminate this Agreement for convenience immediately upon notice if all Order Forms under this Agreement have expired or been terminated. Neither party may terminate an Order Form for convenience.

9.1.3 Each Work Order for the execution of professional services may provide for the ability for either or both of the Parties to terminate such Work Order and such termination provisions shall only be applicable to each such respective Work Order. Termination of a Work Order will not affect this Cloud Subscription Agreement. If no specific termination for convenience is provided for in the Work Order, such Work Order has an identical Term as the Order From governing this Cloud Subscription Agreement and cannot be terminated for convenience during the Term.

9.2 Material breach.

9.2.1 Without prejudice to any other rights or remedies which either Party may have against the other for a breach or non-performance of any of the terms of the Agreement, the Agreement may be terminated by either Party by written notice to the other Party with immediate effect:

  • (i) if the other Party commits a material breach of this Cloud Subscription Agreement which either cannot be remedied or is not remedied within thirty (30) calendar days after written notice requiring that it be remedied, or

  • (ii) if the other Party commits any act of fraud, dishonesty, serious misconduct or serious negligence.

9.3 Insolvency.

9.3.1 Each Party shall have the right to immediately terminate the Agreement by written notice to the other Party with immediate effect in the event the other Party ceases to do business as a going concern, makes an assignment for the benefit of creditors, enters into liquidation, receivership, bankruptcy or other insolvency procedure, whether compulsorily or voluntarily, or is unable to pay its debts within the meaning of the applicable laws of the jurisdiction other than for the purposes of reconstruction or amalgamation.

9.4 Obligations upon termination.

9.4.1 Upon expiration or termination of the Agreement for any reason:

  • (i) the Client shall promptly pay to Extra Horizon all Fees and other amounts payable under the Agreement, including all Service Fees for Services rendered before the effective date of expiration or termination. For the avoidance of doubt, disputed fees will not be payable unless (and to the extent) it is finally agreed or determined that Extra Horizon is entitled to obtain the initially disputed fees and, interest will accrue thereon accordingly as set forth in this Cloud Subscription Agreement;

  • (ii) except if otherwise provided in the Agreement, all use rights granted to Client in the Agreement will immediately cease to exist;

  • (iii) each Party (as receiving Party) shall immediately return to the other Party (as disclosing Party) all Confidential Information (of the disclosing Party) it has in its possession or under its control or certify in writing to the disclosing Party that all such Confidential Information has been destroyed; and

  • (iv) any provision of the Agreement that expressly or by implication is intended to come into or continue in force on or after termination or expiry of the Agreement shall remain in full force and effect.

9.5 Transition Services.

9.5.1 Upon expiration or termination of the Agreement, and in order to ensure a smooth transition, Extra Horizon agrees to cooperate with the transition and migration of all Client Data from the Extra Horizon Software to one or more alternate providers identified by the Client and to facilitate an orderly wind-down of the usage of the Extra Horizon Software, in accordance with a mutually acceptable transition plan, to be agreed upon as soon as reasonably possible following a notice of termination, and in any event within ninety (90) calendar days following the notice of termination (the “Transition Plan”), for a transition period up to twelve (12) months (such period to be determined by the Client at its sole discretion) (the “Transition Period”). During such Transition Period, Extra Horizon will

  • (i) continue to provide the Licensed Products and the Support Services against the License Fees agreed upon in the Agreement,

  • (ii) manage all functions necessary to successfully allow a transition of all the Client’s Data in accordance with the Transition Plan, and provide the Client with any relevant tools to create an export of its data in a timely manner promptly upon request thereof by the Client, and

  • (iii) provide any other Services as agreed in the Transition Plan at the agreed upon rates. The Transition Plan will also include an agreed upon acceptance testing procedure, which Parties will use to determine whether or not the transition has been successfully completed. If no Transition Plan has been agreed upon between the Parties, Extra Horizon agrees to return the Client Data to Client within thirty (30) calendar days as of the expiration or termination of the Agreement.

9.5.2 The terms and conditions of the Agreement, including the Client’s obligation to pay the License Fees, shall govern until the earlier of the completion of the transition as set forth in the Transition Plan or the expiry of the Transition Period. If the Cloud Subscription Agreement is terminated by the Client in accordance with Article 9.2.1, Extra Horizon will provide the Services under the Transition Plan (excluding the Licensed Products) at no charge to the Client.

9.6 Continuity license.

9.6.1 Upon expiration or termination of the Agreement pursuant to a Triggering Event, the Client is automatically granted a fully paid-up, royalty-free, worldwide, non-exclusive, non-transferable, non-assignable license, without the right to sublicense (except to affiliates), for the duration of the underlying rights, to use the Licensed Products in accordance with the Documentation for the further commercialization, maintenance and support of the Client’s solution and with due observance of the provisions of Article 6 (which will continue to apply for such period).

9.6.2 For purposes of this Cloud Subscription Agreement, a “Triggering Event” means any of the following:

  • (i) Extra Horizon ceases to do business as a going concern, makes an assignment for the benefit of creditors, enters into liquidation, receivership, bankruptcy or other insolvency procedure, whether compulsorily or voluntarily, or is unable to pay its debts within the meaning of the applicable laws of the jurisdiction other than for the purposes of reconstruction or amalgamation;

  • (ii) Extra Horizon ceases its ongoing business operations relating to the provision of the Extra Horizon Software;

  • (iii) Extra Horizon commits a material breach of the Agreement which either cannot be remedied or is not remedied within thirty (30) calendar days after written notice requiring that it be remedied;

  • (iv) Extra Horizon commits any act of fraud, dishonesty, serious misconduct or serious negligence; and

  • (v) Termination by Extra Horizon pursuant to Article 9.1.2 of this Cloud Subscription Agreement.

9.6.3 Upon expiration or termination of the Agreement pursuant to a Triggering Event, and subject to the license set forth in article 9.6.1, upon its first request, the Client will be granted access to the then current source code of the Licensed Products, together with the relevant Documentation in respect thereof, which will be released to the Client.

9.6.4 For the sole purpose of the access to the source code as provided for under art. 9.6.3, Extra Horizon will deposit the access credentials to the source code repository (the “Source Code Repository”) at a Belgian notary public, or any other independent third party acceptable to both Parties. Extra Horizon guarantees that the Source Code Repository contains the then current version of the Licensed Products, its source code and all relevant documentation.

10. Representations and warranties

10.1 Representations and warranties of Extra Horizon.

10.1.1 Extra Horizon represents and warrants to the Client that:

  • (i) Extra Horizon is a corporation duly organized, validly existing and in good standing under the laws of its incorporation and has all requisite power and authority to execute and deliver the Agreement, to perform its obligations hereunder and to engage in the transactions contemplated thereby. The execution, delivery and performance of the Agreement have been duly authorized by all requisite action on the part of Extra Horizon and the Agreement constitutes the legal, valid and binding obligation on Extra Horizon, enforceable in accordance with its terms.

  • (ii) the Licensed Products or Deliverables do not, upon delivery to the Client, contain any publicly known Virus, and Extra Horizon shall not program into any of the Licensed Products or Deliverables any publicly known Virus or other software routine designed to permit unauthorized access to any Client computer system or to disable, erase or otherwise cause damage to software, hardware or data; and

  • (iii) the Services shall be carried out in a proper and professional manner by properly qualified personnel, using professional diligence and skill in accordance with good industry practice.

  • (iv) the Services will be carried out in accordance with the standards as set forth in article 8.1 of this Cloud Subscription Agreement, as may be amended from time to time;

  • (v) the Extra Horizon Software performs in accordance with the description in the Documentation and completed Work Orders in all material respects;

  • (vi) the Licensed Products or Deliverables do not infringe (i) the Intellectual Property Rights of third parties or (ii) the laws applicable under the Agreement.

10.1.2 Save as expressly set forth in this article 10.1, the Licensed Products are provided “as is” and all other conditions, warranties, terms, undertakings and representations of any kind whatsoever, express or implied, whether by statute, common law or otherwise, in respect of the Services are hereby excluded by the Parties to the fullest extent permitted by law and the Parties shall have no other obligation, duty or liability whatsoever in contract, tort, statute or otherwise to the other Party.

10.2 Representations and warranties of the Client.

10.2.1 The Client represents and warrants to Extra Horizon that the Client is a corporation duly organized, validly existing and in good standing under the laws of its incorporation and has all requisite power and authority to execute and deliver the Agreement, to perform its obligations hereunder and to engage in the transactions contemplated thereby. The execution, delivery and performance of the Agreement have been duly authorized by all requisite action on the part of the Client and the Agreement constitute the legal, valid and binding obligation on the Client, enforceable in accordance with its terms.

11. Indemnification and limitations on liability

11.1 Indemnification.

11.1.1 Extra Horizon shall defend and indemnify the Client as specified herein against any founded and well-substantiated claims brought by third parties to the extent such claim is based on an infringement of the Intellectual Property Rights of such third party by the Licensed Products and excluding any claims resulting from

  • (i) the Client’s unauthorized use of the Licensed Products,

  • (ii) the Client’s or any third party’s (other than Extra Horizon’) modification which is not specified or authorized under the Agreement, of any of the Licensed Products,

  • (iii) the Client’s failure to use the most recent version of the Licensed Products, made available to the Client, or the Client’s failure to integrate or install any corrections to such Licensed Products issued by Extra Horizon, if Extra Horizon indicated that such update or correction was required to prevent a potential infringement,

  • (iv) Client’s use of the Licensed Products in combination with any non-Extra Horizon products or services, if such Claim would not have arisen but for such use of the Licensed Products in combination with any non-Extra Horizon products or services.

11.1.2 Such indemnity obligation shall be conditional upon the following:

  • (i) Extra Horizon is given prompt written notice of any such claim;

  • (ii) Extra Horizon is granted sole control of the defense and settlement of such a claim;

  • (iii) upon Extra Horizon’s request, the Client fully cooperates with Extra Horizon in the defense and settlement of such a claim, at Extra Horizon’s expense; and

  • (iv) the Client makes no admission as to Extra Horizon’s liability in respect of such a claim, nor does the Client agree to any settlement in respect of such a claim without Extra Horizon’s prior written consent. Provided these conditions are met, Extra Horizon shall indemnify the Client for the damages and costs incurred by the Client as a result of such a claim, as awarded by a competent court of final instance, or as agreed to by Extra Horizon pursuant to a settlement agreement.

11.1.3 In the event the Licensed Products, in Extra Horizon’s reasonable opinion, are likely to or become the subject of a third-party infringement claim (as per article 11.1.1 of this Cloud Subscription Agreement), Extra Horizon shall have the right, at its sole option and expense, to:

  • (i) modify the ((allegedly) infringing part of the Licensed Products so that they become non-infringing while preserving equivalent functionality;

  • (ii) obtain for the Client a license to continue using the Licensed Products in accordance with the Agreement; or

  • (iii) terminate the relevant license and pay to the Client an amount equal to a pro rata portion of the License Fee paid to Extra Horizon hereunder for that portion of the Licensed Products which is the subject of such infringement.

11.1.4 The foregoing states the entire liability and obligation of Extra Horizon and the sole remedy of the Client with respect to any infringement or alleged infringement of any Intellectual Property Rights caused by the Licensed Products or any part thereof.

11.2 Limitations on liability.

11.2.1 To the maximum extent permitted by applicable law, the Client agrees that Extra Horizon, its board members, officers, employees and agents shall only be liable for any direct damages resulting from the Agreement and shall never be liable (whether in contract, warranty, tort (including as a result of negligence, product liability or other theory) or otherwise to the Client for cost of cover, recovery or recoupment of any investment made by the Client or its affiliates in connection with the Agreement, and for any other indirect, consequential or other similar damages (including but not limited to damages for loss of profit, revenue, business, contracts or clients, loss of or corruption of data, loss of goodwill, damages to equipment and reputational damages, opportunity loss, loss of anticipated savings, and costs of procuring replacement goods or services), even if Extra Horizon has been advised or notified of the possibility of such costs or damages.

11.2.2 Without prejudice to and without limiting article 11.2.1 of this Cloud Subscription Agreement, Extra Horizon’s liability arising out of or in connection with the Agreement or the transactions contemplated hereby, whether in contract, warranty, tort (including negligence, product liability or other theory), or otherwise, shall not exceed an amount equal to the aggregate Fees payable by the Client to Extra Horizon in the twelve (12)-month period preceding the event causing the liability.

11.2.3 The Client agrees that Extra Horizon can only be held liable as per the terms of this article 11 to the extent damages suffered by the Client are directly and solely attributable to Extra Horizon. Each Party shall have a duty to mitigate damages for which the other Party is responsible. Extra Horizon shall be solely liable for the (sub)contractors it engages for the execution of the Agreement.

11.2.4 Nothing in the Agreement shall operate to exclude or limit either Party’s liability for (i) fraud or willful misconduct, (ii) death or personal injuries caused by its negligence, (iii) any damages relating to the confidentiality obligations as set out in article 6, indemnification of third party claims as set out in article 11.1.1 of this Cloud Subscription Agreement or the applicable data protection laws, including but not limited to the GDPR.[Cambrian14]

12. Miscellaneous

12.1 Independent contractor.

12.1.1 Extra Horizon agrees to perform the Services hereunder solely as an independent contractor. The Parties agree that nothing in the Agreement shall be construed as creating a joint venture, partnership, franchise, agency, employer/employee, or similar relationship between the Parties, or as authorizing either Party to act as the agent of the other. Extra Horizon is and will remain an independent contractor in its relationship to the Client. Extra Horizon shall have no claim against the Client hereunder or otherwise for vacation pay, sick leave, retirement benefits, social security, worker’s compensation, health or disability benefits, unemployment insurance benefits, or employee benefits of any kind. Nothing in the Agreement shall create any obligation between either Party and a third party.

12.2 Entire Agreement.

12.2.1 This Cloud Subscription Agreement (together with all relevant Order Forms and Work Orders, which form an integral part thereof), constitute the final, complete, and exclusive statement of the agreement of the Parties with respect to the subject matter hereof, and supersedes any and all other prior and contemporaneous agreements and understandings, both written and oral, between the Parties.

12.3 Headings.

12.3.1 Headings used in this Cloud Subscription Agreement are provided for convenience only and shall not be used to construe meaning or intent.

12.4 Assignments; Successors and assigns.

12.4.1 No Party may assign any rights or obligations under the Agreement without the prior written consent of the other Party, such consent not to be unreasonably withheld or delayed.

12.4.2 All references in the Agreement to the Parties shall be deemed to include, as applicable, a reference to their respective successors and assigns. The provisions of the Agreement shall be binding on and shall inure to the benefit of the successors and assigns of the Parties.

12.5 Force Majeure Event.

12.5.1 A Party shall be not be considered in breach of or in default under the Agreement on account of, and shall not be liable to the other Party for, any delay or failure to perform its obligations hereunder by reason of fire, earthquake, flood, explosion, strike, riot, war, terrorism, or similar event beyond that Party’s reasonable control (each a “Force Majeure Event”); provided, however, if a Force Majeure Event occurs, the affected Party shall, as soon as practicable, (a) notify the other Party of the Force Majeure Event and its impact on performance under the Agreement, and (b) use reasonable efforts to resolve any issues resulting from the Force Majeure Event and perform its obligations hereunder.

12.6 No Implied Waiver.

12.6.1 The failure of either Party to insist on strict performance of any covenant or obligation under the Agreement, regardless of the length of time for which such failure continues, shall not be deemed a waiver of such Party's right to demand strict compliance in the future. No consent or waiver, express or implied, to or of any breach or default in the performance of any obligation under the Agreement shall constitute a consent or waiver to or of any other breach or default in the performance of any other obligation.

12.7 Severability; Amendments.

12.7.1 Whenever possible, each provision of the Agreement will be interpreted in such manner as to be effective and valid under applicable law, but if any provision of the Agreement is held to be invalid, illegal, or unenforceable in any respect under any applicable law or rule in any jurisdiction, such invalidity, illegality, or unenforceability will not affect any other provision or any other jurisdiction, but this Cloud Subscription Agreement will be reformed, construed, and enforced in such jurisdiction as if such invalid, illegal, or unenforceable provisions had never been contained herein.

12.7.2 No amendment, change, or modification of the Agreement shall be valid unless in writing and signed by both Parties. If there is a conflict between the terms of the body of this Cloud Subscription Agreement and any Work Order, the following order of precedence shall apply (except as expressly stipulated otherwise in this Cloud Subscription Agreement): (1) the applicable Work Order (but solely with respect to the subject matter of such Work Order); and (2) the body of this Cloud Subscription Agreement.

12.7.3 Extra Horizon reserves the right to amend this Cloud Subscription Agreement in its sole discretion from time-to-time to the extent that such amendments concern minor modifications. If Extra Horizon wishes to implement major modifications that are crucial to the Extra Horizon Software, the Services and/or to this Cloud Subscription Agreement, Extra Horizon will notify the Client at the latest fifteen (15) calendar days before the implementation of such major modification. If the Client does not object to such modification within these fifteen (15) calendar days, the modification will be deemed accepted by the Client. If the Client objects to such major modification, Parties will mutually discuss this amendment. If no agreement can be found on this amendment, the Client has the right to terminate the Agreement, taking into account the notice period as set forth in article 9.1.2. of this Agreement.

12.8 Notices.

12.8.1 Any notice or other communication provided for herein or given hereunder to a Party hereto shall be in writing and shall be given in person, by overnight courier, by mail (registered or certified mail, postage prepaid, return-receipt requested) to the address of respective Party as set forth on the Work Order, or by electronic mail with (automatic or explicit) confirmation of receipt. In case of delivery by overnight courier or mail, the parties shall endeavor to provide each other with simultaneous electronic “.pdf” copies of any notice sent hereunder via electronic mail.

12.9 Governing Law.

12.9.1 The Agreement shall be exclusively governed by and construed in accordance with the laws of Belgium without regard to its conflict of law principles. Any dispute arising hereunder which cannot be amicably settled between the Parties within a reasonable period from the dispute arising, shall be submitted to the exclusive jurisdiction of Antwerp.

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