SimplerQMS A/S Terms and Conditions

These Terms and Conditions were last updated on 14th October, 2024.

1. Introduction

The following terms and conditions (the “Terms”) govern all use of SimplerQMS (the “Software”), services and products available at or through the Software.

The Software is operated by SimplerQMS A/S (“SimplerQMS”).

A person, entity or organization (the “Customer”) must enter into a separate written Main Agreement (an “Agreement”) signed by Customer in order to let the Customer and the Customer’s Users access the Software (as defined below).

Use of the Software, is subject to entering an Agreement, including any related Addendum, and further requires due payment under such an Agreement.

The Software offered is subject to each Customer, Administrator and User’s compliance with (i) all of the terms and conditions contained herein, the specific Agreement any addenda hereto, and in (ii) all operating rules, policies (including, without limitation, SimplerQMS’s Privacy Policy) and procedures (collectively, the “Agreement”).

Please read these Terms carefully before accessing or using the Software. Upon the Customer’s (i) execution of an Agreement and/or (ii) access or use of any part of the Software, the Customer agrees to terms and conditions of these Terms, as amended from time to time. If a Customer or User does not agree to all of these Terms, then such Customer or User may neither access nor use the Software.

If SimplerQMS makes any changes to these Terms, the Customer shall be notified thereof, and such change shall take effect following the first renewal of the Agreement after such change has been notified to the Customer.

2. User Profiles

1. In order to access the Software, an end-user (each, a “User”) will need a SimplerQMS user profile (a “User Profile”), which account may be assigned to a User by an Administrator (as defined below).
2. The Administrator is responsible for creating and maintaining user profiles according to the established user management procedure. SimplerQMS may remove any content, description or keyword that it considers inappropriate or unlawful, or otherwise likely to cause SimplerQMS liability. The Administrator must immediately notify SimplerQMS of any unauthorized uses of User’s User Profile or any other breaches of security especially if the established user management procedure has not been followed or if security in any manner has been compromised.

3. Customer Accounts, Administrators and Customers

1. Customer has ultimate control over the use of such Customer’s account (the “Customer Account”) by authorized Users and Administrators (as defined below) to manage certain quality and regulatory functions using the Software.
2. Each Customer Account will be administered by one or more Users who are appointed by the Customer as administrators (each an “Administrator”). An Administrator will have special rights in relation to those Customer Accounts they administer, including the ability to grant Users with access to the Customer Account and to remove Users from the Customer Account.
3. A Customer will have special rights in relation to such Customer’s Account, including the ability to grant Administrators and Users with access to the Customer Account and to remove Administrators and Users from the Customer Account. The Customer will, at all times, have access to and ownership of the Content (as defined below) and output of a Customer Account.
4. If User is using a User Profile assigned to User by a Customer or Administrator, or if User’s use of a SimplerQMS User Profile is in connection with User’s role as an employee or contractor, User’s use of the User Profile may be subject to the terms of User’s employment or other contractual relationship with Customer. SimplerQMS is not responsible for the monitoring or enforcement of any third party contractual obligations or policies. Customers and Administrators may be able to access or disable User’s account.

4. License to Software.

1. The Software allows a User to access SimplerQMS through any of the available user interfaces.
2. Unless otherwise specified in the individual agreement, SimplerQMS shall give Customer and Customer’s authorized Administrators and Users, access to the Software following Customer’s payment of the subscription fee for the Initial Subscription Term. So long as Customer, and each User and Administrator authorized by Customer, comply with these Terms, the relevant Agreement and any Addendum, SimplerQMS gives Customer, and Customer’s authorized Administrators and Users a limited, nonexclusive, nontransferable license to use the Software, including those components and functionality specified in the applicable Agreement.
3. Customers and Users agree not to reverse engineer or decompile the Software, attempt to do so, or assist anyone in doing so.

5. Responsibility of Users

1. If a User contributes to, comments upon, or otherwise posts any written content, design, process, work of authorship, documentation, formula, data or other material to the Software (together “Content”), that User is entirely responsible for such Content, and any harm resulting from that Content.
   
   By making Content available, a User represents and warrants that:
   • the downloading, copying and use of the Content will not infringe the proprietary rights, including but not limited to the copyright, patent, trademark or trade secret rights, of any third party;
   • if User’s employer has rights to intellectual property User create, User has received permission from User’s employer to post the Content or make the Content available on the Software;
   • User has fully complied with any third-party licenses relating to the Content;
   • the Content does not contain or install any viruses, worms, malware, Trojan horses or other harmful or destructive content;
   • the Content is not spam, is not machine or randomly-generated, and does not contain unethical or unwanted commercial content designed to drive traffic to third-party sites or boost the search engine rankings of third-party sites, or to further unlawful acts (such as phishing) or mislead recipients as to the source of the material;
   • the Content is not pornographic, does not contain threats or incite violence, and does not violate the privacy or publicity rights of any third party; or
   • use the Software to store, transmit or otherwise distribute any content that is unlawful, defamatory, harassing, abusive, fraudulent, obscene, threatening, abusive, hateful, or is otherwise objectionable as reasonably determined by SimplerQMS.
2. Users shall not, and shall not agree to, and shall not authorize, encourage or permit any third party to:
   • use the Software for any fraudulent or inappropriate purpose;
   • use any robot, spider, other automated device, or manual process to monitor or copy any content from the Software other than copying or exporting of the Content as permitted by SimplerQMS policies; or
   • rent, lease, distribute, or resell the Software, or use the Software for developing a competitive solution (or contract with a third party to do so), or remove or alter any of the logos, trademark, patent or copyright notices, confidentiality or proprietary legends or other notices or markings that are on or in the Software or displayed in connection with the Service.
3. Without limiting any of those representations or warranties, SimplerQMS has the right (though not the obligation) to, in SimplerQMS’s sole discretion, refuse or remove any Content that, in SimplerQMS’s reasonable opinion, violates any SimplerQMS policy or is in any way harmful, objectionable, or unlawful. SimplerQMS will have no obligation to provide a refund of any amounts previously paid.
4. The Customer’s responsibilities are defined in the Customer Quality Agreement.

6. No transfer of SimplerQMS Intellectual Property

This Agreement does not transfer from SimplerQMS any SimplerQMS or third party intellectual property. All rights, title and interest in and to such intellectual property, including, without limitation, the Software, will remain (as between the parties) solely with SimplerQMS.

The SimplerQMS trademark and logo, and all other trademarks, service marks, graphics and logos used in connection with the SimplerQMS Software, are trademarks or registered trademarks of SimplerQMS or SimplerQMS’s licensors. Other trademarks, service marks, graphics and logos used in connection with the Software may be the trademarks of other third parties. Use of the Software grants Customer or User no right or license to reproduce or otherwise use any SimplerQMS or third-party trademarks.

7. Content License

1. When Users submit, store, send or receive Content to a particular Customer Account using the Software, Users give SimplerQMS (and those third-party contractors SimplerQMS works with) a license to publish such Content on the Software so as to make it accessible to authorized Users and Administrators with access to the relevant Customer Account, and SimplerQMS may use, host, store, reproduce, modify, create derivative works (such as those resulting from adaptations or other changes SimplerQMS make so that User’s Content works better with our Software, or to create the Software’s output), communicate, publish, display and distribute such Content for this purpose. The rights Customer and Users grant in this license are for the limited purpose of operating and improving the Software. SimplerQMS will not disclose or make available to the public Content which is stored by Users using the Software. This also means that SimplerQMS will not use any content stored by the Customer in the Software for it’s own use or by re-selling such content in any form.
2. SimplerQMS may display User’s profile name and actions User takes using the Software (such as Content that User posts and comments that User posts) within the relevant Customer Account.
3. Except for the licenses set forth in this Section, this Agreement does not transfer from User to SimplerQMS any right, title and interest in and to Content posted by User.

8. No Obligation to Review Content

SimplerQMS has not reviewed, and cannot review, all of the Content stored using the Software, and cannot, therefore, be responsible for that Content. By operating the Software, SimplerQMS does not represent or imply that it endorses the material there posted, or that it believes such material to be accurate, useful or non-harmful. User is responsible for taking precautions as necessary to protect User’s self and User’s computer systems from viruses, worms, Trojan horses, and other harmful or destructive content. The Software may contain Content that is offensive, indecent, or otherwise objectionable, as well as Content containing technical inaccuracies, typographical mistakes, and other errors. The Software may also contain Content that violates the privacy or publicity rights, or infringes the intellectual property and other proprietary rights, of third parties, or the downloading, copying or use of which is subject to additional terms and conditions, stated or unstated. SimplerQMS disclaims any responsibility for any harm resulting from the use by Users of Content on the Software or from any downloading by those Users of Content there posted.

9. Regulatory compliance

SimplerQMS is dedicated to deliver an Electronic Quality Management System to companies working in the life science industry in compliance with the FDA GxP Guidelines and Regulations, FDA 21 CFR Part 820, FDA 21 CFR Part 11, ISO 13485:2016 and Eudralex Vol. 4 Annex 11. Please see the SimplerQMS Customer Quality Agreement for details about outsourced responsibilities.

The SimplerQMS software is configured, validated and under change control for compliance with FDA GxP Guidelines and Regulations, FDA 21 CFR Part 820, FDA 21 CFR Part 11, ISO 13485:2016, Eudralex Vol. 4 Annex 11. SimplerQMS’s own internal quality management system is certified according to ISO 13485:2016.

10. Fees, Term, Termination

1. General Terms
   • In respect of Software, Customer agrees to pay SimplerQMS the subscription fees specified in the applicable Agreement.
   • Subscription fees for the Subscription Term shall be payable upon execution of the Agreement and prior to SimplerQMS granting Customer access to the Software. For subscription fees for each period of the Subscription Term, Customer agrees to pay invoices within thirty (30) days of receipt, unless otherwise specified in the Agreement. Payment shall be made by the currency specified in the Agreement by wire transfer to the account listed on the invoice. Customer agrees to accept electronic invoices.
   • Customer will be responsible for paying any VAT, sales tax, license and use taxes, additional taxes, fees, or assessments levied by any local, state or federal government or governmental agency relating to, resulting from or based on use of the Software pursuant to this Agreement.
   • All rates, prices and charges are automatically increased by 5 % as of January 1st each year.
2. Term
   • The initial term for the use of the Software shall be specified in the relevant Agreement (the “Initial Subscription Term”).
   • Upon the expiration of the Initial Subscription Term, the Software term shall automatically renew for additional and successive one-year (1) periods unless either party notifies the other party in writing of its election not to renew at least ninety (90) days prior to the expiration of the then-current term (the Initial Subscription Term and each successive term, collectively, the “Subscription Term”).
3. Termination
   • In the event of a material breach of this Agreement (including these Terms, the Agreement or any Addendum) by either SimplerQMS or Customer, the other party may terminate the Agreement, and the Software specified therein, by giving the defaulting party fifteen (15) business days’ prior written notice of termination thereof; provided, however, that such termination will not be effective if the defaulting party has cured such material breach prior to the expiration of such fifteen (15) business day notice period. The Customer’s failure to duly pay any subscription fee (initial or for each renewal) shall constitute a material breach.
   • Whenever a subscription is terminated SimplerQMS will export all the Customer content to Excel file(s) with metadata per document and reference to the document. Furthermore, Customer documents and files will be exported as well. The data will be made available on a USB-drive or a secure web folder to which the customer will have access for 15 days after the subscription has been terminated. After that time the customers data are destroyed permanently. It is a condition for such export and making data available that the Customer has made all payments due to SimplerQMS.
4. Late Payments
   • In the event of non-payment or late payment of the Fees by the Customer, SimplerQMS reserves the right to suspend the Customer’s access to the Software, and charge penalty interest up to the maximum rate permitted by law. Both parties shall use best endeavors to resolve any dispute(s), but failing that, the Agreement may be terminated or the Customer’s access to the Software suspended.
   • Unpaid invoices will be sent to collection. If the situation is not resolved within a reasonable time, SimplerQMS reserves the right to terminate the Customer’s right of use to the Software.

11. Data Privacy

1. SimplerQMS reserves the right to use the information that you provide in accordance with the terms and conditions of the SimplerQMS Privacy Policy. Furthermore, the SimplerQMS Data Processing Agreement sets out the rights and obligations that apply to SimplerQMS handling of personal data on behalf of the Customer.
2. SimplerQMS personnel will never request User password information in any manner whatsoever; furthermore, SimplerQMS will never transmit password information via email nor any other written or spoken media. Forgotten or lost user passwords may only be reset using the facilities within the SimplerQMS Software.

12. Backup/Recovery

SimplerQMS is hosted in Microsoft Azure. The Microsoft Azure datacenters are highly secured and designed to automatically survive from hardware and infrastructure failures. The redundant infrastructure offers for instance emergency power support, fire detection and suppression systems, video surveillance, dual internet service providers, and much more.

Files stored in SimplerQMS are automatically geo-replicated utilizing the Microsoft Azure Storage services. Geo-replication maintains six copies of your data. Your data is replicated three times within the primary region and three times within a secondary region hundreds of miles away from the primary region, providing high-level durability. In the event of a failure at the primary region, Azure Storage failovers to the secondary region. Geo-replication ensures that your data is durable in two separate regions.

13. Changes

SimplerQMS reserves the right, in its sole discretion, to add, modify, or delete portions and/or functionality of the Software. SimplerQMS shall provide at least Two (2) months advance notice of anticipated major changes in future versions of the Software that will require Customer to upgrade the Software. SimplerQMS and the Customer shall cooperate on updating the Software at a time which causes the least possible disturbance to the Customers business activities.

Customer shall cooperate with SimplerQMS in respect of implementing or adopting any updates to the Software which are recommended by SimplerQMS to comply with applicable regulations or guidelines relevant to the quality or regulatory processes managed by the Software. To ensure regulatory compliance and a high quality of the Software, SimplerQMS has the right to update the Software, once the advance notice period has passed.

SimplerQMS reserves the right, at its sole discretion, to modify or replace any part of these Terms relating to the Software (but not, for the avoidance of doubt, the specific terms of a Agreement or any Addendum). The revised Terms will be effective immediately upon being emailed to the Customer. Customer’s use of the Software after modifications to these Terms become effective constitutes binding acceptance of such changes by the Customer.

14. Warranties

1. Except for the warranties specifically set forth in Sections 13(b), (c) and (d), SimplerQMS and its suppliers and licensors hereby disclaim all warranties of any kind in respect of the Software, including, without limitation, the warranties of merchantability, fitness for a particular purpose. Neither SimplerQMS nor its suppliers and licensors, makes any warranty that the Software will be error-free. Customer and Users understand that Customer’s and Users’ use of the Software are at Customer’s and Users’ own discretion and risk.
2. Software – Guaranteed Uptime/Availability/Support
   • SimplerQMS aims for high availability rates for the Service and produces statistical information about it. The targeted availability percentage per month is 99.5%.
     In order to provide high-quality service, SimplerQMS must schedule maintenance timeslots, and the Service could be affected by maintenance operations. Please see the “SimplerQMS Service Level Agreement” document for more information.
   • SimplerQMS will provide standard operational support free of charge and will take commercially reasonable measures to resolve all requests submitted by users. Please see the “SimplerQMS Service Level Agreement” document for more information.
3. All communication traffic between the Client Software and Server Software is encrypted. In addition, firewalls protect the communication and continuous development is carried out to block any unauthorized traffic.
4. SimplerQMS utilizes Microsoft Azure (“Azure”) infrastructure. Content stored via the Software, is securely stored in Azure facilities according to industry best practices with respect to computer software Security and Privacy.
5. Access to Content stored in the Software is restricted to only those SimplerQMS personnel who absolutely must have access to said data to perform their job functions.

15. Limitation of Liability

1. The following limitations of liability shall apply in any case of negligence, strict liability or other legal or equitable theory:
   • SimplerQMS, or its suppliers or licensors, disclaim (i) any special, incidental or consequential damages; (ii) punitive and exemplary damages, (iii) Customer cost of procurement for substitute products or services.
   • Any claims for damages, price reduction, indemnity are jointly in the aggregate limited to an amount equal to the fees paid by Customer or User to SimplerQMS, under this Agreement, if any, during the twelve (12) month period prior to the cause of action.
   • SimplerQMS shall have no liability for any failure or delay due to matters beyond their reasonable control.
   • The foregoing shall not apply to the extent prohibited by applicable law.
2. In no event will SimplerQMS, or its suppliers or licensors, be liable for any deficiency or failure in the quality or regulatory functions of any Customer or User, any failure to obtain the approval of any regulatory or governmental agency, or liability arising from the products manufactured or distributed by any Customer or User under any contract, negligence, strict liability or other legal or equitable theory.

16. General Representation and Warranty

Each Customer and User represents and warrants that (i) such Customer or User’s use of the Software will be in strict accordance with these Terms, the applicable Agreement and any Addendum, and with all applicable laws and regulations (including without limitation any local laws or regulations in such Customer or User’s country, state, city, or other governmental area, regarding online conduct and acceptable content, and including all applicable laws regarding the transmission of technical data exported from the country in which such Customer or User resides) and (ii) such Customer or User’s use of the Software will not knowingly infringe or misappropriate the intellectual property rights of any third party.

17. Indemnification

1. Customer agrees to indemnify and hold harmless SimplerQMS, its contractors, and its licensors, and their respective directors, officers, members, managers, employees and agents from and against any and all claims and expenses, including attorneys’ fees, arising out of the negligent or unlawful act or omission or any violation of this Agreement by, Customer or any User authorized to access Customer’s Account.
2. User agrees to indemnify and hold harmless SimplerQMS, its contractors, and its licensors, and their respective directors, officers, employees and agents from and against any and all claims and expenses, including attorneys’ fees, arising out of User’s use of the Software, User’s violation of this Agreement, or User’s negligent or unlawful act or omission.
3. SimplerQMS agrees to indemnify, defend and hold harmless Customer, and Customer’s affiliates, officers, agents, and employees from and against any claims and expenses, incurred as a result of any third-party claim to the extent arising from or connected with an allegation that Customer’s use of the Software in accordance with this Agreement, infringes the intellectual property rights of a third party. Notwithstanding the foregoing, in no event shall SimplerQMS have any obligations or liability arising from: (i) use of the Software in a modified form or in combination with materials or software not furnished by SimplerQMS, or (ii) any Content provided by a User.
4. SimplerQMS agrees to indemnify and hold harmless Customer, Customer’s affiliates, officers, agents, and employees from and against any and all claims and expenses, including attorneys’ fees, arising out of the negligent or unlawful act or omission or any violation of this Agreement by, SimplerQMS or any User authorized to access Customer’s Account.

18. Right to Audit

Customer or a 3^rd party appointed by Customer shall have the right to audit the relevant records of SimplerQMS upon reasonable notice and not more than once annually to verify compliance with the terms of this Agreement. The maximum duration of audits is 3 hours. Additional hours, fees and expenses incurred in connection with such audits will be borne by the auditing party. Any such audit shall occur during regular business hours, and shall not unreasonably interfere with regular business activities.

19. Miscellaneous

These Terms, together with the applicable Agreement and any Addendum, if applicable, constitutes the entire agreement between SimplerQMS and the Customer and Users concerning the subject matter hereof, and supersedes all prior representations, agreements and understandings, written or oral. This Agreement shall me governed and construed in accordance with Danish law. Any disputes relating to this Agreement shall be subject to the exclusive jurisdiction of the courts of Denmark.

The prevailing party in any action or proceeding to enforce this Agreement shall be entitled to costs and attorneys’ fees. If any part of this Agreement is held invalid or unenforceable, that part will be construed to reflect the parties’ original intent, and the remaining portions will remain in full force and effect.

A waiver by either party of any term or condition of this Agreement or any breach thereof, in any one instance, will not waive such term or condition or any subsequent breach thereof. User may not assign User’s rights under this Agreement to any party without prior written consent of SimplerQMS, which will not be unreasonably withheld. SimplerQMS may assign its rights under this Agreement without condition. This Agreement will be binding upon and will inure to the benefit of the parties, their successors and permitted assigns. The parties hereto are acting as independent contractors, and nothing in this Agreement shall be construed as establishing a partnership, joint venture, agency, employment or other similar relationship between the parties hereto. If the performance of this Agreement or of any obligation hereunder, except for the payment of any amounts due hereunder, is prevented, restricted or interfered with by reason of any cause beyond the reasonable control of the affected party, such party, upon prompt written notice to the other party, shall be excused from such performance to the extent of the aforementioned prevention, restriction or interference.