General terms and conditions

Version: February 2022

 

This agreement is entered into by and between L2F S.A. (CHE‑300.132.471), with registered office in Rue du Centre 9, 1025, St- Sulpice, Switzerland (“L2F”, “we” “us” or “our”), and any user of the proprietary cloud platform of L2F named Giotto Compliance Platform (the “Giotto Compliance Platform”), whether an individual or a legal entity (“Customer”, “you” or “your”), and governs the provision of any services by L2F to the Customer through the Giotto Compliance Platform, its modules and features (the “Services”). It consists of the general terms and conditions below (“GTC”) and the work order entered into by L2F and the Customer (“Order”), as applicable from time to time (together, the “Giotto Compliance Agreement”). The GTC shall also apply to any additional services, add-on and any and all the updates and developments of the Services offered through the Giotto Compliance Platform, unless otherwise provided. 

In the event of any conflict between the GTC and any Order, the Order shall prevail. The GTC are made effective the earlier of (i) the date you complete the setting up of an account to access the Giotto Compliance Platform or (ii) the date the Order is entered into (the “Effective Date”). You represent that you are lawfully entitled to enter into this Giotto Compliance Agreement. If you are entering into the GTC or the Giotto Compliance Agreement on behalf of an entity, such as the organization you work for, you represent and warrant that you have legal authority to bind that entity and you are authorized to do so.  

L2F and the Customer are referred to, individually, as a “Party” and, collectively, as the “Parties”. 

 

  1. Access and use of the Services. 

    1. Right to access and use. During the Initial Term and any Renewed Term (as defined in Section 7 below) we grant you a revocable, non-exclusive and non-transferable right to access and use the Giotto Compliance Platform, solely for your business or academic operations.  

    2. Scope of the Services. You acknowledge and accept that the Services are offered on a Software-As-A -Service basis. Except for the right to access and use as set forth in Section 1.1, we will not transfer the ownership, nor grant any intellectual property right on any of the contents displayed on the Giotto Compliance Platform. We reserve all and any other rights concerning the Giotto Compliance Platform. The terms of this Giotto Platform Agreement shall also apply in case you request additional services or add-on to the Services already purchased by you.  

    3. Acceptable use. You will be entitled to access and use the Giotto Compliance Platform only in strict accordance with the Giotto Compliance Agreement and for the purposes of performing clinical evaluation activities; each workspace element on the Giotto Compliance Platform where it is possible to use all the features necessary to conduct traceable clinical evaluation activities in a compliance context, that is characterized by a unique research strategy and protocol framework, is defined as a “Project”. The use of the Services does not replace any evaluation on the compliance of medical devices, in vitro diagnostics, pharmaceutical products and/or devices with the applicable legislation and/or regulation and you will always be required to manually validate the results suggested by the Giotto Compliance Platform or accept them without validation under your sole responsibility. You shall not alter, copy, modify, reverse engineer, decompile, disassemble, republish, or redistribute, as a whole or in part, the Giotto Compliance Platform nor work around technical limitations in the Giotto Compliance Platform. You shall not insert any malicious software into the Giotto Compliance Platform, nor disable, tamper with, or otherwise attempt to circumvent any billing mechanism that meters your use of the Services. 

    4. Spreadsheet. As part of the Services, you may export part of the data generated throughout your use of the Giotto Compliance Platform as an electronic document containing a spreadsheet, which will belong to you, and we will not claim any intellectual nor industrial property right on it.  

    5. Sole beneficiary. You will be the sole beneficiary of the Services provided to you in accordance with the Giotto Compliance Agreement. You shall not be authorized to rent, lease, resell, transfer, sublicence, or use in any form, the right to access to the Giotto Compliance Platform – or any portion thereof – for the benefit of any third-party unless you received our prior written consent to do so. 

    6. Changes to the Giotto Compliance Platform. Due to our continuous activities of improving, upgrading and refining the Giotto Compliance Platform and the Services, we may update, change or discontinue, in whole or in part, the Giotto Compliance Platform from time to time. Should we discontinue material functionality of the Giotto Compliance Platform affecting a Service that you are using, or materially alter an application programming interface (API) resulting in a backwards-incompatible change, we will inform you in advance, where technically feasible. 

     

  2. Account.  

    1. Account. To access the Giotto Compliance Platform, we will set up your personal account associated with a valid email address (“Account”). You represent that you have the authority to use the domain of such email address in your capacity as a member of the organization duly entitled to use such domain, if applicable.  

    2. Responsibility for your Account. You are fully responsible for the use of your Account and for maintaining the confidentiality of your authentication credentials. You must promptly inform us about any possible misuse of your Account or of authentication credentials (including any accidental disclosure or loss) or any relevant security incident that might result in such misuse. Once any of such event occurs, we will immediately deactivate your credentials and replace them with new credentials that you will be able to change in any moment.  

     

  3. Trial, Annual Subscription and Subscription Upgrade. 

    1. Free Trial. Your initial use of the Giotto Compliance Platform, before the execution of the Order, and for the period of time agreed by the Parties to carry out a trial that is free of charge and will allow you to activate the number of Projects and/or use the Services agreed by the Parties (“Trial”).  

    2. Annual Subscription. Except for your use of the Giotto Compliance Platform during the Trial or under any other specific offer made by us to you, your use of the Giotto Compliance Platform will be in accordance with the annual subscription option that is referred to in the relevant Order and you will be required to pay all the relevant fees according to Section 5 (“Annual Subscription”). Notwithstanding what is provided in Section 3.3 below, you can activate only the Projects and use the Services that are included in your Annual Subscription.  

    3. Subscription Upgrade. You can at any time request to upgrade your Annual Subscription in order to extend it to cover new Projects and/or Services and we will propose a dedicated Order upgrade, including the terms and economic conditions that will govern such upgrade (“Subscription Upgrade”).  

    4. Customer Materials. You will be entitled to upload at your sole discretion any publications, papers or contents that you intend to use on the Giotto Compliance Platform for one or more Projects under your full responsibility (the “Customer Materials”). You acknowledge that such Customer Materials will be used for the provision of the Services and for labelling, classifying and storing such Customer Materials into the Giotto Compliance Platform. Except for the above we will not use, disclose, share or distribute anyhow any of the Customer Materials. Upon termination of the Giotto Compliance Agreement for whatsoever reason, within the following 30 (thirty) days we will permanently delete any of the Customer Materials you uploaded, and you will be the sole responsible for any back-up of such Customer Materials.  

     

  4. Availability of the Giotto Compliance Platform, maintenance activities and support. 

    1. Obligation of means. You acknowledge and agree that we use any reasonable endeavors to maintain the availability of the Giotto Compliance Platform and we will supply the Services in accordance with industry standard practice, with the care and diligence required from a supplier of similar services. 

    2. Maintenance activities. As part of the Services, we carry out (where possible, during not working days) ordinary maintenance activities aimed at preventing technical problems that might affect the proper functioning and availability of the Giotto Compliance Platform, including rectification of faults and errors to restore and/or maintain functionality of the Giotto Compliance Platform. For the sake of clarity, the Parties acknowledge that the maintenance activities do not cover any development, customization, adaptation or improvement of the Giotto Compliance Platform.  

    3. Support. As part of the Services, we provide you with any technical support you reasonably require by (i) sending emails to the mailbox [email protected], (ii) using the chat box on the Giotto Compliance Platform, when available, and (iii) directly contacting the appointed account manager of L2F. We will not intervene on your IT systems and we provide our support with industry standard care and diligence. 

     

  5. Fees and payment. 

    1. Payment of the Fees. Once your Annual Subscription will be effective, you must pay all the annual fees agreed in the applicable Order, whether or not you have activated all the Projects and/or used all the Services included in your Annual Subscription (“Fees”). All amounts payable by you under the Giotto Compliance Agreement will be paid to us without setoff or counterclaim, and without any deduction or withholding.  

    2. Invoicing. Payment of the Fees shall be in euro (EUR), unless otherwise agreed by the Parties. We will issue the relevant invoice within10 (ten) calendar days after each Order (including those governing a Subscription Upgrade) is executed. Each invoice shall be due for payment 30 (thirty) calendar days from the date of the invoice. In case an invoice is not paid by its due date (“Overdue Invoice”), after 30 (thirty) calendar days from the original due date, we will be entitled to suspend the access and use of the Services until the outstanding amounts of the Overdue Invoice are effectively paid.  

    3. Taxes. Each Party will be responsible, as required under any applicable law, for identifying and paying all taxes and other governmental fees and charges (and any penalties, interests, and other additions thereto) that are imposed on that Party upon or with respect to the transactions and payments under this Agreement. All fees payable by you are exclusive of all taxes, except where applicable law requires otherwise. 

     

  6. Obligations of the Customer. 

    1. Information. You will provide us with all information necessary to enable us to properly and fully perform our obligations under the Giotto Compliance Agreement, as well as immediately notify us of any related changes.  

    2. Autonomous activities. You acknowledge and accept to (i) autonomously equip yourself with necessary hardware and software, as well as with an adequate connectivity service in order to be able to access the Giotto Compliance Platform and benefit from the Services; (ii) autonomously adapt the characteristics of your IT systems and connectivity services, where necessary. 

    3. Compliance with the Law. You must strictly comply with any provision of law or regulation relating to the use of the Services and any measure or order of any competent judicial authority or any other competent authority in the performance of the Giotto Compliance Agreement. 

    4. Warranty on Customer Materials. You represent and warrant that (i) you have all the rights, authorizations and consents that might be required for processing and uploading the Customers Materials on the Giotto Compliance Platform, (ii) all Customer Materials do not infringe any law or regulation, the Giotto Compliance Agreement or any rights of third-parties. 

    5. Cooperation. In the event that you become aware that any third party has improperly used, is improperly using, or is about to improperly use, the Giotto Compliance Platform, you shall immediately notify us of the facts of which you are aware in connection with such actual or potential unauthorized use of the Giotto Compliance Platform and shall provide us with any relevant documents in your possession. The Parties shall cooperate, at their own expense, to the fullest extent possible and agree to take all actions necessary to eliminate such third-party unauthorized use as promptly as possible. 

     

  7. Term, suspension and termination. 

    1. Term. The Giotto Compliance Agreement shall be in full force and effect from the Effective Date until the expiration of your Annual Subscription. Your Annual Subscription will be valid for a period of 1 (one) year starting from the execution of the relevant Order (the “Initial Term”).  

    2. Renewal of the Annual Subscription. At the end of the Initial Term, your Annual Subscription shall be deemed automatically renewed for additional periods of 1 (one) year each (“Renewed Term”), unless terminated by either Party giving a prior written notice to the other Party at least 30 days before the expiry of the Initial Term or the relevant Renewed Term, or in accordance with the different terms set out in the Order, it being understood that we will notify the upcoming expiry of any Renewed Term. 

    3. Extension of the Initial Term and Renewed Term. In case of any Subscription Upgrade the expiry of the Initial Term or any relevant Renewed Term will be extended to 1 (one) year after the relevant proposal for the Subscription Upgrade is entered into by the Parties, unless otherwise provided in the relevant Order. 

    4. Suspension. We will be entitled to suspend your use of the Services if: (i) it is reasonably needed to prevent any unauthorized use of the Giotto Compliance Platform or to resolve any serious technical problem that renders the provision of the Services impossible; (ii) the Fees due under the Giotto Compliance Agreement have not been paid; (iii) you are in breach of any terms of the Giotto Compliance Agreement, without prejudice to our right to terminate the Giotto Compliance Agreement and any other remedy available by law.  

    5. Termination by L2F. We may terminate the Giotto Compliance Agreement (i) in case a material breach of your obligations under the Giotto Compliance Agreement occurs and such material breach remains uncured for a period of 15 days from receipt of our prior written notice to cure such breach to our entire satisfaction; (ii) immediately in case of any infringement of third-party rights or risk of infringement of such rights arising from your use of the Giotto Compliance Platform. In addition, we shall be entitled to terminate the Giotto Compliance Agreement at any time for any reason by providing you at least 90 days’ prior written notice. Upon expiry of the notice period, the Giotto Compliance Agreement will be automatically terminated, and your Projects deactivated, and you will pay the Fees due in relation to such period. 

    6. Effects of termination. In any case the Giotto Compliance Agreement is terminated according to this Section 7, without prejudice to the any other remedy available, (i) we will cease to provide, and you must immediately stop using, the Giotto Compliance Platform and any Service; (ii) your right to use and access the Giotto Compliance Platform under Section 1.1 will cease and your Projects and Account will be deactivated, (iii) if applicable, you must permanently delete any part of the Giotto Compliance Platform that you may have stored or installed, (iv) you must pay any outstanding Fee due to us, except in case of termination as a result of a material breach of the GTC by us. 

     

  8. Data protection.  

    1. Data protection. Each Party agrees that it shall comply with its respective obligations under the applicable data protection or data privacy laws and regulations (the “Data Protection Legislation”). 

    2. Personal data processing. We may process your personal data for the purposes of fulfilling our obligations under the Giotto Compliance Agreement. We do not retain and we do not process any personal data in relation to your use of the Giotto Compliance Platform except for (i) personal data that might be included in the Customers Material and that you ensure that have been transferred to us in strict compliance with the Data Protection Legislation and that we may process as data processor exclusively for the purposes agreed in the Giotto Compliance Agreement in accordance with the instructions provided by you as data controller, (ii) data on your use of the Services as referred to in Section 13.2, that we may process as sole data controller and only to allow the Giotto Compliance Platform to improve over time by learning from the feedbacks you provide during your use of the Services. You accept that personal data referred to in this Section might be transferred to and processed on servers located outside of your jurisdiction, including jurisdictions which may not have Data Protection Legislation equivalent to the one applicable in your jurisdiction. 

    3. Privacy policy and specific agreements. We will process any personal data made available to us in the performance of the Giotto Compliance Agreement in accordance with our privacy policy as applicable from time to time. Our privacy policy is available at our website. The Parties might also agree to be bound by separate agreements on the processing of personal data during the execution of the Giotto Compliance Agreement. In such case, the provisions of any such separate agreement shall prevail on this Section 8. 

     

  9. Confidentiality. 

    1. The Parties will keep confidential any information that is designed as “private” or “confidential” or can be reasonably considered of confidential nature (included financial and/or trading information) obtained under the Giotto Compliance Agreement and will not disclose such information to any person other that their employees or professional advisors, consultants or subcontractors, which have to be bound by an equal confidentiality obligation. The obligation of confidentiality shall equally apply to the existence and the content of the Giotto Compliance Agreement and any and all of the Giotto Compliance Platform, the Services and the Customer Materials. The duty to treat data and information in compliance with this confidentially clause shall not apply to data and information: (i) independently developed by a Party or its affiliated companies or lawfully received free of restriction from another source having the right to disclose such information or data; (ii) known to the Party prior to the Party’s disclosure under the Giotto Compliance Agreement; (iii) information which a Party is requested to disclose by law or any competent regulatory authority and/or governmental body, to the extent required under any applicable laws or regulations; (iv) in public domain. The confidentiality obligations in the Giotto Compliance Agreement remain in force for a period of 3 years following the expiry or termination of the Giotto Compliance Agreement. If the receiving Party or anyone to whom it has transmitted the confidential information becomes legally compelled to disclose any of this information, the receiving Party shall provide the other Party with prompt written notice so that the other Party may seek a protective order or any other appropriate remedy. If such protective order or other remedy is not obtained, the Party compelled to disclose information shall provide only that portion of the confidential information which it is legally required to disclose and shall exercise its best efforts to obtain reliable assurance that confidential treatment will be accorded to the confidential information. Received confidential information, including all copies thereof, shall be returned to the disclosing Party or destroyed after the receiving Party’s need for it has expired or upon termination of the Giotto Compliance Agreement and upon reasonable request of the disclosing Party unless such Party is obliged to keep a copy thereof pursuant any applicable law. 

     

  10. Warranties. 

    1. As is/as available. The access to the Giotto Compliance Platform and the Services are provided to you “as is” and “as available”. To the maximum extent permitted by applicable law, we provide no warranties with respect to the Giotto Compliance Platform or the Services, whether express, implied or statutory, including any warranties of merchantability, fitness for a particular purpose, quiet enjoyment and non-infringement of third-party rights.  

    2. Exclusions. You acknowledge that the Giotto Compliance Platform or the Services might not meet your specific expectations or requirements, that the operation of the Giotto Compliance Platform or Services might not remain uninterrupted, error-free and always compatible with third-party products and that certain options for accessing the Giotto Compliance Platform or using the Services available at a given moment might not remain available after the execution of the relevant Order. The use of the Giotto Compliance Platform and the Services shall remain at your own risk, and we disclaim any warranties regarding the contents and clinical evaluation results available on the Giotto Compliance Platform and your use thereof and/or any decisions taken by you based on the insights gained from the use of the Giotto Compliance Platform or the Services. 

     

  11. Liabilities. 

    1. Limitation of liability. Under no circumstances shall either Party be liable for any consequential, incidental, indirect, special, exemplary or punitive damages, losses, or expenses (including but not limited to business interruption, lost business, lost profits, or lost savings) and notwithstanding the failure of essential purpose of any remedy. Our liability under the Giotto Compliance Agreement is excluded to the maximum extent permitted under any applicable law. We will not be liable for any damages resulting from potential updates and developments of the Giotto Compliance Platform, unless such damages result from our willful misconduct or gross negligence.  

    2. No liability for sources of third-party. Even when embedded into the Giotto Compliance Platform, the sources of contents are autonomous third parties and we give no warranty and accept no responsibility or liability for the accuracy, or the completeness of the information and materials contained therein and made available on the Giotto Compliance Platform. We also give no warranty and accept no responsibility or liability for the accuracy, or the completeness of the Customer Materials. 

    3. Aggregate liability. The aggregate liability of each Party under the Giotto Compliance Agreement for any and all claims is limited to direct damages up to the amount paid for the Services during the 12 months before the cause of action arose. The limits of liability in Section 11.1 apply to the fullest extent permitted by applicable law, but do not apply to: (i) the Parties’ obligations under Section 6.3 and 6.4; or (ii) your use of the Giotto Compliance Platform not in compliance with the Giotto Compliance Agreement, (iii) violation of the other Party’s intellectual property rights. 

     

  12. Indemnification. 

    1. Indemnification. Each Party undertakes to indemnify and hold harmless the other Party, from any and all actions, claims, procedures, direct losses, direct costs and direct expenses – also related to the other Parties’ employees – they might have incurred in as a result of fault, errors or negligence of the other Party in the performance of Giotto Compliance Agreement and/or fulfilment of its obligations pursuant any applicable laws and regulations. 

     

  13. Intellectual property.  

    1. Giotto Compliance Platform. We are and remain the sole owner of all rights, titles and interests, under any applicable law, in copyright, databases, trademark, domain names, designs and patents of invention, know-how, confidentiality and/or business secrets, and any and all other intellectual and industrial property or similar rights in, and to, the Giotto Compliance Platform and to the AI models employed by the Giotto Compliance Platform with the only exception of (i) the rights on software components embedded into the Giotto Compliance Platform which may be used by virtue of appropriate licenses, (ii) the spreadsheet with the data you are entitled to export in accordance with Section 1.4, (iii) the Customer Materials as defined in Section 3.4. 

    2. Data on your use of the Services. We will be entitled to use for any purpose (including without limitation for data mining, benchmarking and analytics purposes, or for developing and marketing new services also for third parties), any data or information (i) collected, processed, developed, produced or obtained from cookies or other tracking and analytics technology present on the Giotto Compliance Platform (including any tracking data related to user traffic), (ii) relating to your access to and use of the Giotto Compliance Platform and, (iii) provided that any such use will exploit data or information that shall not be attributable to you.  

    3. Intellectual property rights infringements. You will immediately inform us of any infringement or imminent risk of any infringements of the intellectual property rights referred to in this Section 13 as soon as you become aware of any such infringement or imminent risk of infringement, providing all useful information and, at your own costs, all the assistance we may reasonably require to you. You expressly acknowledge that any infringement of our intellectual property rights will cause irreparable harm to us, for which monetary damages alone would be inadequate, and that we may thus seek injunctive relief or any other remedy available at law in any jurisdiction, in case of such infringement. 

     

  14. Force Majeure. 

    1. Neither Party will be liable for any delay or failure to perform its obligations under the Giotto Compliance Agreement due to causes beyond its reasonable control, such as natural catastrophes, earthquake, storms or other elements of nature, blockages, embargoes, riots, strikes, acts or orders of government, acts of terrorism, war, black-outs, Internet failure, electrical or power outages, utilities or other electronic communications failures (“Force Majeure Event”). Any such excuse for delay in the execution of the Giotto Compliance Agreement will last only as long as the Force Majeure Event remains beyond the reasonable control of the delayed Party. However, the delayed Party must use its best efforts to mitigate the effect of an event of any Force Majeure Event. This Section 14.1 does not excuse either Party’s obligation to take reasonable steps to follow its normal disaster recovery procedures or your obligation to pay for the Services. The delayed Party must notify the other Party promptly upon the occurrence of any such event or performance by the delayed Party will not be considered excused pursuant to this Section 14.1. 

     

  15. Waiver. 

    1. Waiver. Any tolerance by one Party of conduct by the other Party that violates the provisions of the Giotto Compliance Agreement or of the documents executed in execution of the latter shall not amount to a waiver of the rights deriving from the breached provisions, nor of the right to demand full performance of all the related terms and conditions provided for in the Giotto Compliance Agreement. 

     

  16. Amendments. 

    1. Amendments to the GTC. Provided that the GTC applicable to you are the ones resulting from the last version of the GTC that is published on our website at the time of execution of the last Order that is valid between the Parties. Notwithstanding your right to deactivate your Annual Subscription in accordance with Section 7.2, we reserve the right to amend these GTC at any time; we will notify you with reasonable advance any amendment via e-mail, or notification on the Giotto Compliance Platform. 

    2. Amendments to the Order. Any amendment to a relevant Order (including those governing a Subscription Upgrade) shall be agreed by means of a separate written agreement between the Parties.  

     

  17. Assignments, successors, and independent contractors. 

    1. Assignment. Neither Party has the right to assign or otherwise transfer the Giotto Compliance Agreement or any or all of its rights and obligations under the Giotto Compliance Agreement, without the other Party’s prior written consent. Notwithstanding the foregoing, we may assign without your consent the Giotto Compliance Agreement and/or our rights and/or obligations hereunder (i) to any of our subsidiaries or (ii) to any third party in connection with extraordinary transactions including but not limited to merger, acquisition or sale of all or substantially all of the Giotto Compliance Platform or the Services and/or our assets.  

    2. Successors. Reference to one Party implies a reference to that Party’s lawful successors or assigns. 

    3. Independent contractors. The Parties acknowledge and agree that they are independent contractors, and the Giotto Compliance Agreement is not intended, and does not constitute, nor can it be deemed to constitute a partnership, agency, joint venture, or employment relationship between the Parties. Each of the Parties remains, at all times, an independent contractor fully responsible for its own acts or defaults, including those of its employees or agents as well as those of related third parties.  

     

  18. Entire agreement and severability 

    1. Entire agreement. These GTC, together with any applicable Order (collectively, the Giotto Compliance Agreement) reflect the intentions of the Parties in their entirety and cancel and/or replace any other prior understanding or agreement as to the subject matter hereof.  

    2. Severability. Should any provision or clause in the Giotto Compliance Agreement or any part of any such clause or provision be invalid or ineffective, all the other provisions shall not be rendered invalid or ineffective and will remain in full force. The Parties hereby agree to negotiate in order to replace any such invalid clause and/or provision with another valid and effective clause and/or provision that achieves, insofar as possible, the intentions pursued by the Parties in the invalid or ineffective clause and/or provision. 

     

  19. Notices and communications 

    1. Notices and communications. All notices and/or communications required under the Giotto Compliance Agreement to be given by each Party to the other Party shall be in English, unless otherwise provided by the Parties, and shall include communications via email, the Giotto Compliance Platform, or other electronic forms. 

    2. Receipt. All notices shall be deemed to have been received by a Party when: (a) delivered by registered mail, or courier, on the day shown on the receipt signed by the receiving Party; (b) delivered by hand, on the day of delivery; (c) delivered via certified email, on the day of transmission if supported by a confirmation that the message has been properly transmitted by the certified email provider; (d) if delivered via email, upon confirmation by the receiving Party. 

     

  20. Governing law and jurisdiction. 

    1. Governing law. The Giotto Compliance Agreement, including the jurisdiction clause, shall be governed by, interpreted and construed in accordance with, the substantive laws of Switzerland excluding the United Nations Convention on Contracts for the International Sales of Goods of 11 April 1980 (CISG). 

    2. Jurisdiction. Any and all disputes between the Parties in any way arising from, or connected to the Giotto Compliance Agreement, including but not limited to disputes relating to its validity, interpretation, execution and termination, will be referred to the exclusive jurisdiction of the competent ordinary courts at the place of the registered office of L2F.