ORAVIZIO TERMS AND CONDITIONS

VERSION 1.0

Oravizio (“the Service” or “Oravizio” or “Oravizio service”) is a CE marked regulated medical device software service, manufactured by Solita Oy (“we” or “us” or “Solita”). You may contact us at support@oraviz.ioor by mail at Solita Oy, Åkerlundinkatu 11, 33100 Tampere, Finland.

Oravizio is available at https://tool.oraviz.io.

SHORT SUMMARY

To help you understand this agreement we have prepared the below summary of some of the most important things from this agreement. However, please note that this summary does not represent the whole agreement, and in case of any discrepancy, the Terms and Conditions below prevail over this summary.

  1. Oravizio is a CE marked medical software service, manufactured by Solita Oy. Our clinical partner is Coxa Oy.
  2. If you need any support, you can contact us at support@oraviz.io.
  3. Please read carefully the chapter “Service Description”, as it explains what the service is all about, for whom it is, and when it should NOT be used.
  4. Your account with Oravizio is personal, and you should not share it with others.
  5. Oravizio is a commercial service, and its pricing may vary depending on your location.
  6. You or your organization might have been invited to try Oravizio for free for a limited time (pilot period). After that pilot period is over, the service will be available based on the service fee. If you do not wish to continue after the pilot period, your account might be suspended.
  7. There are two types of users of Oravizio: an “Admin user” and a “User”.
  8. An Admin user is in charge of managing the Customer organization’s Users and license to use Oravizio.
  9. As a User you should use Oravizio with your own patients only.
  10. You own all rights to the data you submit to the service.
  11. Only the necessary information is saved and used in order to provide the service.
  12. The service or its contents do not constitute a legal or medical opinion or advice of any kind.
  13. Solita can use your company name and logo as a reference for marketing or promotional purposes of the service.

SERVICE DESCRIPTION

Intended use

Oravizio is a software tool that provides data-driven information about the patient-level risks and outcomes, aiming to help the surgeon, in collaboration with the patient, to make better informed decisions about the treatment when hip or knee joint replacement surgery is considered. It aims to improve the process of shared-decision making in clinical practice that is recognized to be a vital part of modern medicine.

Contraindications

To use Oravizio, the patient must be fit enough for major joint replacement surgery. In practice, this means that if there are absolute contraindications for such surgery, the tool should NOT be used for risk assessment.

Absolute contraindications for using Oravizio:

  • Active sepsis
  • Active bacterial infection of the knee or hip joint
  • Any acute or chronic illness that significantly increases the risk of perioperative death, e.g.
    • Instable coronary arterial disease
    • Recent (< 6 months) coronary artery stenting and clopidogrel medication
    • Acute exacerbation of chronic obstructive pulmonary disease (COPD)
    • Diabetes mellitus (DM) with poor glycemic control (B-HbA1C > 9% (75 mmol/l)
    • Acute kidney disease
    • Severe cirrhosis of the liver
    • Amyotrophic lateral sclerosis
  • Current or recent history of intravenous drug use
  • Alcoholism with recent history of continuous drinking
  • Any other disease or condition that increases the patient’s risk of complication to unacceptable high level, and therefore prevents surgery.

The consideration about the effect of contraindications and the final decision about patient treatment must always be done by a healthcare professional.

Description of the Service

Oravizio shall be used only by or under direct supervision of board-certified orthopaedic surgeons at outpatient clinics. It is used in addition to routine clinical examination of patients, whose eligibility for knee or hip joint replacement surgery is being assessed.

Every patient is examined to evaluate, whether the patient would benefit from such surgery and whether the patient is fit enough to undergo hip or knee replacement surgery. For every patient, Oravizio presents both the patient-specific risks and expected outcomes in joint replacement surgery in an understandable way. The risk calculation algorithm combines patient-specific data, that is manually submitted to Oravizio by the healthcare professionals, with comprehensive patient history data.

Oravizio also helps orthopaedic surgeons to communicate the risk and expected outcomes of joint replacement surgery to the patient.

Oravizio is to be used before surgery. In practice, two conditions must be fulfilled before it is used: 1) The surgeon has evaluated that the patient would benefit from joint replacement surgery in terms of pain relief, improved functional outcome and improved quality of life, and 2) the surgeon has also concluded that there are no absolute contraindications for such surgery. The tool can then be used as an additional utility to further assess the actual risk levels of that specific patient and the short- and long-term outcome of joint replacement, and to aid the surgeon in shared decision making.

Clinical benefit

The information that Oravizio provides to the surgeon is based on a large amount of patient history data. This amount is so vast that it is impossible for a single human being to process such data without technology. Oravizio provides this patient-specific information that enables better informed shared-decision making.

Users

Oravizio is used in aiding shared-decision making only by board-certified orthopaedic surgeons or orthopaedic trainees under direct supervision of senior orthopaedic surgeons. All interpretations based on the tool outcome must always be made by board-certified orthopaedic surgeons.

Use environment

Oravizio is meant to be used at orthopaedic outpatient clinics that are used for clinical examination of patients, or in other similar environments with a comparable setting, privacy and security.

TERMS AND CONDITIONS

These Terms and Conditions (“Terms”) apply to the use of the Service. You accept these Terms by clicking “I agree”, or by ordering or using the Service. By accessing or using the Service you acknowledge that you have read, understood and agree to be bound by these Terms. 

These Terms (or, if applicable, your written agreement with us) and the applicable Order together form a binding agreement between you and us with respect to the Service (“Agreement”).

If you are accessing or using the Service on behalf of a business or third party, you represent and warrant that you have the authority to do so and to bind that business or third party to these Terms. We may hold you responsible for violations of these Terms by that business or third party, and “you,” “your” and “party” will also refer and apply to that business or third party.

If you do not agree to these Terms, do not access or otherwise use the Service.

Your use of the Service is also subject to our Privacy Policy, which sets out how we collect, use, share, and store your personal data.

Admin User” refers to an individual employee of Customer who is responsible for managing their organizations individual users’ ability to use Oravizio.

Customer” or “you” refer to the entity or person having ordered or signed up to the Service.

Order” refers to an order form entered into between the Customer and us (or a distributor appointed by us) to access the Service. In the case of pilot testing of the Service, the Order may also refer to an agreement on limited, free of charge right to use the Service.

Subscription Period” refers to the prepaid fixed term defined in the Order during which the Customer is entitled to use and access the Service.

User” refers to an individual employee of Customer who is allowed to use the Service under the Agreement. The amount of permitted Users is defined in Customer’s Order for the Service.

1         User Accounts

Each User agrees to these Terms to activate their User account as applicable. Customer ensures that its Users comply with the Agreement.

To be able to use the Service, the Users must have a User account. Individual Users are invited to the Service by email by the Admin User. Admin User controls Customer’s user rights and may assign rights to use the Service only to personnel within the Customer organization.

When creating a User account, you must submit to us accurate, current and complete registration details, as requested by us. You agree to keep your information up-to-date at the Service.

The Users’ accounts and passwords are personal. Individual Users’ accounts and passwords may not be shared nor distributed.

Do not disclose your password to third parties and do not let third parties use your account. 

The Customer is liable for any use of the Service with the user names and/or passwords of the Customer (and Users).

We have the right to deny the access to the Service at any time, for example in case we deem that you have breached the Agreement, provided false information or caused harm to us or the other users of the Service.

2         Availability of Service

Oravizio is available via supported web-browsers at https://tool.oraviz.io. You can find an up-to-date list of all supported browsers at the Service. You acknowledge that if you are trying to use Oravizio with an unsupported browser, the Service might not work as expected.

You are responsible for acquiring and maintaining equipment, connections and systems necessary to use the Service.

We aim to maintain the Service available 24/7 excluding planned downtime but we do not guarantee that Service is available without interruption.

Customer understands that the Service may be inaccessible, unavailable or inoperable because of maintenance or for any similar reasons. We have the right to temporarily suspend the provision of the Service based on any reason caused by third parties.

Please note that we are constantly developing the Service and we may change or remove different parts of the Service in part or in whole and cease to provide the Service.

The Service may contain links to websites operated by third parties. We are in no way liable for the content or accuracy of any such websites and therefore, you access such websites at your own risk.

3         Rights and Limitations to use of the Service

All Intellectual Property Rights in or related to the Service and its contents and any related documentation and all parts and copies thereof shall remain the sole and exclusive property of Solita. Intellectual Property Rights means copyrights and related rights (including database and catalogue rights and photography rights), patents, utility models, design rights, trademarks, tradenames, trade secrets, know-how and any other form of registered or unregistered intellectual property rights.

You only have a non-transferable, non-exclusive, limited right to use the Service in a manner and form offered to you from time to time and only for the purposes of the Agreement. Except as expressly stated in these Terms, we do not grant you any Intellectual Property Rights in the Service and all rights not expressly granted hereunder are reserved by us.

If you send us any feedback or suggestions regarding the Services, you grant us (for yourself and all of your Users) an unlimited, irrevocable, perpetual, sublicensable, transferable, royalty-free license to use any such feedback or suggestions for any purpose without any obligation or compensation to Customer, any User or other personnel.

Any reproduction, redistribution, reverse engineering or decompilation of the Service are prohibited (unless allowed by mandatory laws).

Unless otherwise specified, the Service may be used for the Customer’s internal use only and solely for Customer’s own patients. The Customer may not modify, copy, distribute, display, perform, publish, license or create derivative works from, transfer, retransmit or sell the Service or any information, software, materials or documents obtained from or included in the Service except provide the information of the risks and outcomes to a single patient e.g. by printing the risk assessment and/or saving it as a PDF file. The Customer’s rights with respect to the Customer Data are specified in Clause 4 below.

The Service may only be used for lawful purposes and in accordance with applicable laws. Customer is responsible that its use of the Service is in compliance with the applicable laws and regulations.

Prohibited uses of the Service:

  • uploading or installing a virus or other malicious software and attempt to do so;
  • disturbing the operations of Service; and
  • hacking, password mining or obtaining unauthorized access to the Service.

The Customer must comply with any export restrictions that may be applied to the use of the Service.

You may only use and access Oravizio through the interfaces we provide you.

The information and guidance in the Services are there for informational purposes only and as a healthcare professional you are responsible for any decision based on the information and guidance provided by the Service.  You agree that you are solely responsible for acquiring the consent of the patient to use the Service.

4         Customer Data

You own all rights to the data you submit to the Service (“Customer Data”).

Customer will (a) inform Users of all Customer policies and practices that are relevant to their use of the Services and of any settings that may impact the processing of Customer Data; and (b) ensure the transfer and processing of Customer Data under the Contract is lawful.

We and our subcontractors may use Customer Data during the term of the Agreement for the purposes of providing, updating, and maintaining the Service, addressing support or technical issues, and managing the customer relationship between us and Customer as well as analyzing the use of the Service. We may also use Customer Data as required by law or as permitted by our Privacy Policy.

Unless otherwise agreed, we have the right to generate anonymous data and materials based on the Customer Data, such as process and aggregated data. We own all rights to such anonymous data generated by us and may analyze, modify, transfer, share, publish and use the anonymous data for any purpose. Customer or any legal or natural person cannot be identified from such data. The anonymous data does not contain any details specific to a Customer.

The Service shall not be used as a storage service. Customer is solely responsible for storing and creating backup copies of the Customer Data, unless otherwise agreed.

The Customer is responsible for its Customer Data and for ensuring that Customer Data does not infringe any third-party rights or violate applicable legislation.

5         Personal Data

We act as data controller in relation to any personal data we might collect and process in relation to Customer’s use of the Service, such as contact details, payment information, and identification data on the Customer and the Users. We process such personal data in accordance with our Privacy Policy in force from time to time.

To the extent the Customer Data contains personal data Customer acts as data controller under applicable data protection laws and we process such personal data on behalf of Customer as data processor. The personal data we process in such cases may include  Customer’s patient related data, that is manually submitted to the Service by healthcare professionals. The purpose of such processing is to deliver the Service to the Customer and we only process personal data as long as is necessary for the purposes of the Service.

The parties agree to comply with their respective obligations under applicable data protection and privacy laws.

In case we process personal data on behalf of Customer (“Controller”) as data processor (“Processor”):

  • the Controller acknowledges and agrees that the personal data may be transferred or stored outside the EEA or the country where the Customer and the Users are located in order to provide the Service and perform the Parties obligations under the Agreement, unless otherwise instructed by Controller. All international transfers of personal data shall comply with requirements set out in applicable laws;
  • unless otherwise agreed, the Controller authorizes Processor to use subprocessors as they are listed in the Processor’s Privacy Policy for the processing of the personal data for the provision and use of the Service. The processor shall inform the Controller of any intended changes concerning the addition or replacement of subprocessors. In case the Controller objects such change, either party may terminate the Agreement with sixty (60) days’ notice. The Processor shall take appropriate measures to ensure that the used subprocessors comply with the data protection obligations specified in this Agreement, including security and confidentiality requirements. The Processor is responsible for the performance of its subprocessors as it is responsible for the performance of its own obligations;
  • Processor shall ensure that the Processor employees or other persons authorised to process the personal data have committed themselves to confidentiality or are under an appropriate statutory obligation of confidentiality;
  • Processor assists the Controller by appropriate technical and organisational measures, insofar as this is possible, for the fulfilment of the Controller’s obligation to respond to requests for exercising the data subject’s rights under applicable law;
  • Processor assists the Controller by appropriate technical and organisational measures, insofar as this is possible, in ensuring compliance with the Controller’s obligations set out in applicable data protection legislation, relating to data security, personal data breaches, data protection impact assessments and prior consulting obligations;
  • Processor makes available to Controller all information necessary to demonstrate compliance with applicable data protection laws and allows for and contributes to audits, including inspections, conducted by the Controller or another auditor mandated by the Controller;
  • Processor shall process the personal data only in accordance with the terms of the Agreement and any lawful and documented instructions reasonably given by the Controller from time to time;
  • each party shall take appropriate technical and organisational measures against unauthorised or unlawful processing of the personal data or its accidental loss, destruction or damage to ensure the level of security required under applicable laws and the rights of the data subjects; and
  • all personal data processed by Processor shall be anonymized or deleted upon the expiry or termination of the Agreement, or returned to the Controller if the Controller so requires, unless otherwise required by applicable law.

6         Service fees

For Customers that purchase the Service, the fees are specified in the Order. To use the Service, the Customer specified in the Order must pay the fees in accordance with our price list in force from time to time. Prices may vary depending on your location.

Depending on your location and payment method, your transaction with us may be subject to foreign exchange fees. We are entitled to determine the payment methods and currencies available for paying the service fees.

All prices are exclusive of VAT and any other applicable taxes or fees/payment charges imposed by public authorities or financial institutions. Such taxes and fees shall be added to the prices and be borne by the Customer.

Payment for each Subscription Period shall be made in advance upon registration to or renewal of the Service.

All payments of service fees are non-refundable. In the event of early termination during a Subscription Period, the Customer shall not be entitled to a refund of any prepaid fees.

The Customer may upgrade its version of the Service at any time during a Subscription Period. Downgrades of the Service be valid after the expiry of the Subscription Period during which the downgrade was made.

Notices relating to invoices hereunder shall be given in writing within 14 days from the date of receipt of the relevant invoice.

Interest on overdue payments shall be payable according to the Finnish Interest Act. The Customer shall be responsible for the reasonable costs incurred by us when collecting overdue fees.

We may temporarily disable the Customer’s and the Users’ access to the Service in the event the Customer has overdue payments exceeding 30 days.

We are entitled to adjust the fees and charges of the Service at any time by 30 days’ prior notice. The change shall not affect the fees and charges for Subscription Periods commenced before the effective date of the change. You may decide not to continue using Oravizio after such change affects your fees.

7         Confidentiality

A party shall keep confidential and not disclose to third parties any material or information received from the other party and marked as confidential or which should be understood to be confidential, and shall not use such material or information for any other purposes than those stated in this Agreement.

The confidentiality obligation shall, however, not be applied to material and information, (a) which is generally available or otherwise public; or (b) which the party has received from a third party without any obligation of confidentiality as verified by the written records of such party; or (c) which a party has independently developed without using material or information received from the other party as verified by the written records of such party; (d) which a party is obligated to disclose due to applicable mandatory laws, public authority regulations or court orders. In case of disclosure due to (d), the party much promptly inform the other party of such disclosure.

The rights and responsibilities under this Section 7 shall survive the expiry or termination of this Agreement. 

8         Term and termination

This Agreement enters into force as of the acceptance of this Agreement or upon using the Service. The Agreement shall remain in force for the term of the acquired Subscription Period, whereupon the Agreement shall automatically renew for an additional equally long Subscription Period at the list price in effect at the time of renewal, unless the Customer has given us a notice of nonrenewal at least thirty (30) days prior to the expiry of the ongoing Subscription Period, upon which the cancellation will take effect the day after the last day of the current Subscription Period.

We may terminate the Agreement without cause at any moment, with a sixty (60) days’ prior notice.Customer may terminate its free subscriptions immediately without cause.

The parties may terminate the Agreement with immediate effect if the other party substantially breaches the provisions of the Agreement. Customer is responsible for its Users, including for any breaches of the Agreement caused by its Users. We may terminate the Agreement immediately on notice to Customer if we reasonably believe that the Services are being used by Customer or its Users in violation of applicable law.

The provisions of the Agreement which by their nature reasonably should survive the termination or expiration of the Agreement shall survive any expiration or termination of this Agreement. In no event will any termination relieve Customer of the obligation to pay any fees payable to us for the period prior to the effective date of termination.

If you want to terminate the Service, please contact us at support@oraviz.io.

9         No Warranty and Limitation of Liability

Solita warrants that (subject to the other provisions of these Terms) during your Subscription Period, the Service will substantially conform to its service description and is fit for its intended use (as defined in the Service Description above) when properly used on the hardware and/or software designated by Solita. Solita shall not be liable for a breach of any of the warranties in these Terms if Customer uses the Service for other uses than its intended use.

If the Service is defective Solita will repair or replace the Service free of charge. If Solita cannot repair or replace defective Service, Solita will refund the monthly amount shown on the invoice for the Service for the duration of the defect. This is your only remedy for breach of this limited warranty.

The warranties in this clause 9 are exclusive and in lieu of any other warranty of any kind, either express or implied or statutory, including but not limited to the implied warranties of merchantability and fitness for a particular purpose, or that the Service will meet specific requirements, or that the Service will be uninterrupted, completely secure, free of software errors or defects. All such implied or statutory warranties or conditions are hereby excluded to the greatest extent permitted by law.

The Service or its contents (including contracts, documentation and other materials generated by the Service) do not constitute a legal or medical opinion or advice of any kind. We are not liable for any deficiencies or inaccuracies in any of the data generated by the Service or the use of such data. The Customer is responsible for the use and utilization of the contents of the Service in the Customer’s operations.

We are not liable to Customer for any lost profits nor revenues, or for other indirect or consequential damages. Our total aggregate liability under the Agreement shall be limited to the average monthly fees paid by the Customer for the Service multiplied by three (3) or ten thousand euros (EUR 10.000), whichever is higher. The exclusions set forth above shall apply to the greatest extent permitted by law.

10     Other terms

Changing the Agreement:We may amend these Terms by providing the Customer with at least 30 days’ prior notice. If the Customer does not accept the change made by us to these Terms, the Customer has the right to terminate the Agreement by written notice to us prior to the effective date of such change.

Force Majeure:Neither party will be liable by reason of any failure or delay in the performance of its obligations on account of events beyond the reasonable control of a party, which may include denial-of-service attacks, a failure by a third party hosting provider or utility provider, strikes, shortages, riots, fires, acts of God, war, terrorism, and governmental action.

Publicity: Customer grants us the right to use Customer’s company name and logo as a reference for marketing or promotional purposes on our website and in other public or private communications with our existing or potential customers, subject to Customer’s standard trademark usage guidelines as provided to us from time-to-time.

Communications:We may communicate with you through the Service or through other means including email, mobile number, telephone or mail. Please notify us in case your contact details change.

No waiver:Our failure to act with respect to a breach of the Agreement by you does not waive our right to act with respect to that breach or other breaches.

Subcontractors:We are entitled to use subcontractors, including third-party software suppliers, for the provision of the Service.

Entire agreement:The Agreement supersedes all prior agreements, arrangements, and understandings between the parties relating to the subject matter hereof, and constitutes the entire agreement between the parties relating to the subject matter hereof.

Assignments:We are entitled to assign all or any of our rights or obligations hereunder in whole or part to an affiliate or successor or to a purchaser or acquirer of our business assets relating to the Service without the Customer’s prior consent. The Customer is not entitled to assign any of its rights or obligations hereunder in whole or part without our prior written consent.

Governing law and dispute resolution:The Agreement shall be governed by and construed in accordance with the laws of Finland, except for its provisions on choice of law and CISG. Any dispute, controversy or claim arising out of or relating to the Agreement, or the breach, termination or validity thereof, shall be finally settled by arbitration in accordance with the Arbitration Rules of the Finland Chamber of Commerce. The number of arbitrators shall be one. The seat of arbitration shall be Helsinki, Finland.

Effective on June 4th, 2019.