These terms and conditions apply to all Planmeca Romexis software and its versions purchased on Planmeca's web site (the "Software") or delivered to You together with Planmeca's devices or separately in USB stick format.
As the Software is likely to evolve and change during Your subscription, Planmeca Oy (the "Licensor") may need to revise these terms in connection of update or upgrade and the revised terms shall automatically apply to the corresponding versions of the Software distributed with the revised terms. If any part of these terms is found void and unenforceable, it will not affect the validity of rest of the terms, which shall remain valid and enforceable.
These Software License Terms governs the use of the Software License and is a legally binding agreement between You, as the Licensee, and Planmeca Oy, as the Licensor governing Your right to use the Software. These Software License Terms are hereinafter referred to as the “Software License Terms” and You and the Licensor also as the “Party” or the “Parties”. Your use of the Software is conditional to You agreeing to these Software License Terms and to any modification thereof by pressing “I agree” at the prompt when installing the Software and are enforceable like any written negotiated agreement signed by You. If You do not agree to these Software License Terms, You shall have option to choose “Cancel” but in such case the Software will not operate, and You will need to discontinue the installation and return the Software to the place of purchase or with the consent of the Licensor, destroy the same in verifiable manner.
Software includes (without limitations) any related manuals, user and other documentation, computer programs, and information provided by Licensor, including new updates and or upgrades for the major version of the Software made available to licensees of such Software, if any.
"Updates" means an update package, correction of error(s), file used for updating databases, or configuration information used by the Software. A minor version release ("Upgrade") is indicated by the second number digit of the version number and a major version release ("Major Upgrade") is indicated by the first number digit i.a. 1.x in which number 1 mean product series and "x" the version in question. Upgrade does not include new separately installed modules or significant new features or significant new functions.
During the twelve-month period after the purchase the Licensee shall be entitled to receive Updates and other than Major Upgrades free of charge. In any event the Licensee is solely liable for updating and upgrading the Software to optimize the proper functioning and data security as well as data protection requirements of the Software. As Software may be reliant on updates, neglecting them may lead to Software becoming inoperable.
Licensor hereby grants You a non-exclusive and non-transferable license to use the Software during the term of this Software License, in object code form only and in accordance with the terms of these Software License Terms. You have no right to license or sublicense the Software and You are under the obligation to return or destroy the Software upon the expiration or termination of these Software License Terms.
The Grant of Software License entitles to use each licensed Software only by a single user at a time in Your own internal operations and, if necessary for use on such computer or terminal, to integrate it with another program, all portions of the program continuing to be subject to this Software License in full. Licensor shall not be held liable for any non-performance, interruptions in operation, or damages resulting directly or indirectly from an integration of the Software made by You, even if such integration was approved by Licensor.
You shall be responsible for using the Software only in accordance with these Software License terms and further instructions provided either by the Licensor or any of the manufacturers of such medical device that is connected to or used in the Software.
Should You receive any copy of the Software to upgrade a previous version of such Software such upgraded version of the Software shall be the only version You are entitled to use unless otherwise agreed and, unless expressly otherwise permitted by Licensor in writing in advance, You shall return or destroy or erase all program material and related documentation, including all copies and modifications, relating to the previous Software.
The Software may only be used as a tool to support the using of the connected medical device, for instance to planning and evaluating the treatment or in diagnosis of the patient by the health care professional. In all event, the health care professional is solely liable for the diagnosis, the treatment, and the evaluation of whether each treatment is fit for the specific patient, and for the outcome of any diagnosis and treatment, as well designed medical device (if any). If the Software is used for measuring or planning of a treatment and/or designing and/ or manufacturing any medical device for the patient the health care professional shall be obliged to verify the outcome before any treatment, as well as test and fit any such medical device manufactured with the assistance of the Software, with the specific patient beforehand or otherwise ensure that such treatment and/or medical device is fit for the specific patient. Planmeca, its distributors or the manufacturers shall waive from any and all liabilities relating thereto and You as a licensee shall hold Planmeca, its distributors and manufacturers harmless from damage incurred to either of them.
You are granted no rights hereunder other than those expressly set out hereinabove and, consequently, all other activities related to the Software are prohibited. Such prohibited activities include but are not limited to (i) deleting, adding to, copying, duplicating, reproducing, modifying, integrating, transferring, assigning or conveying the Software or any part thereof, or any copy or merged portion thereof, in whole or in part, except as expressly provided for herein or authorized by Licensor in writing in advance, (ii) distributing, renting or leasing of the Software to another party, and/or (iii) offering management services based on Software to third parties without Licensor's prior written consent. You shall not decompile, reverse assemble, disassemble or reverse engineer the Software or otherwise attempt to derive source code from the Software. When information of the internal structure of the Software is necessary in order to obtain interoperability of the Software with other software programs, You shall immediately contact Licensor.
You hereby expressly acknowledge and accept that Licensor and its software suppliers own throughout the world all right, title and interest in the Software, any copies thereof and all intellectual property rights contained or embodied therein including the ownership to any modifications or translations of the Software and that such ownership or rights shall not be transferred to You.
With respect to any software of third party suppliers contained or to be contained in the Software, You acknowledge and accept the ownership of Licensor's suppliers hereunder and that Licensor's suppliers are direct and intended third party beneficiaries of this Software License with rights solely against You, including (without limitation), on reasonable prior notice to and consent of Licensor, the right to directly enforce and/or terminate Your license to use the Software. Further, You agree that Licensor's suppliers have no liability or obligations towards You or third parties arising out of or in connection with this Software License. You shall execute any such amendments to this Software License as may be required from time to time by the Licensor in order to comply with terms and conditions of any of the Licensor's third party software suppliers. In addition to the above, separate terms of third party software license shall be applied, if such license terms have been separately specified.
The Software shall be delivered subject to all restrictions and protections provided for under the applicable copyright, other laws concerning proprietary rights or otherwise applicable laws. Unless otherwise agreed by Licensor in writing in advance, You have no right to reproduce or otherwise duplicate the Software or any part thereof for any purpose or to allow any third parties to do the same to allow any use of the Software by any third party, including hosting thereof . Notwithstanding the above, You may make one copy of the Software for back-up purposes if it is necessary for the use of the Software but You shall have no other right to copy the Software or allow it to be copied even for private purposes. Such copy and the media thereof shall contain the same copyright, trademark, and other proprietary and confidentiality notices, marks and/or legends etc. as the original and shall be subject to the same conditions as the original. You shall not remove, obliterate or cancel from view any Software identification, copyright notices or other notices, marks or legends or proprietary restrictions etc. from the Software.
You shall comply with all applicable EU, US and other national export control laws and re-export restrictions and regulations thereof regarding export, distribution and/or use of the Software) and have and maintain all permits and licenses required by any governmental unit or agency; and (iii) comply with all applicable laws and regulations, in performing its obligations under these terms and with respect to the Software. You shall not commit any act or omission which will result in a breach of any such export regulation or requirements.
The Software contains proprietary and confidential information of Licensor and its suppliers and is considered by Licensor and its suppliers to constitute valuable trade secrets. You shall not disclose, provide, or otherwise make available such trade secrets or copyright material, and shall hold the Software in confidence and protect the Software with at least the same degree of care with which You protect Your own similar confidential information but in no event less than a reasonable standard of care. You shall ensure that Your officers and employees shall protect the confidentiality of the Software and all confidential and non-public information relating thereto and shall not disclose such information to any third party. This obligation of confidentiality shall survive the termination of the Software License Terms.
You shall be responsible for the use of the Software: (i) in safe environment, and (ii) by implementing appropriate safety measures, procedures and privacy policies applicable in Your operations. You shall also comply with all data protection laws applicable to You.
You shall comply with EU General Data Protection Regulation (EU) 2016/679 (hereinafter "GDPR") if:
I. You are (as a Controller or a Processor) established in the EU, regardless of whether or not the processing takes place within the EU;
II. You are (as a Controller or a Processor) not established in the EU but offering Products or Services within the EU or to EU individuals.
On the basis of GDPR You will be the Controller in the in meaning of the GDPR Article 4 when using the Software for the purpose of collecting and processing the medical data of Your patients. In the role of the Controller You are solely liable for the compliance of the obligations set for the Controller under the GDPR.
In order to increase Your awareness of how to comply with some of the GDPR requirements in relation to the Software and the use thereof, the Licensor may from time-to-time publish instructions for the best practices, for instance configuration guidance of the Software. The recommendations provided by such guidelines complement Your organizational and technical measures and are not intended to create compliance as a sole control mechanism. Furthermore, these best practices require that You have implemented appropriate processes and transparency in Your organization in relation to applicable data privacy rights.
The Licensor shall not take any responsibility of Your use of the Software or non-compliance of Licensor's instructions but You alone shall ensure that all measures arising from the GDPR or from our instructions, as deemed applicable shall be introduced by You when using the Software in the processing of the Personal Data. In the event that You order support or maintenance to the Software from the Licensor's distributor or any other third party support provider You are obliged to enter into a separate data processing agreement with such service provider prior to start of such support or maintenance service in accordance with Article 28 (3) of the GDPR. If no data processing agreement is in place, You may not receive the support or maintenance that You may from time-to-time need for the proper and secure functioning or use of the Software.
In the event that the Licensor shall provide first level support and maintenance to the Software, the Licensor shall provide You the data processing agreement to be signed as a prerequisite for the support and accessing Your system and the Software by the Licensor. The same requirement of the GDPR shall be applicable to Your support request to Licensor.
The Licensor may collect, view or process data from the Software and the use such data to (a) improve the quality and the features Software, or to other similar development purposes as well as to (b) to respond to support requests, (c) fix a bug or an error in the Software or to (d) detect, prevent, or otherwise address fraud, security, unlawful, or technical issues. The collected data may include without limitations, data about Software version, serial number, license number, module access, button clicks, stack traces, connected equipment, current location (country and city). The Licensor shall only use information confidentially and shall not disclose such information to any third-party without Your prior written consent, except that it may give Your local distributor recommendations for version updates or similar bug fixes should the Licensor find it beneficial to Your use of the Software. You may opt-out from data collection by using settings provided in the Software. The Licensor has no access to any Personal Data, including Your users’ or patients’ personal data or to any user activity outside of Planmeca Romexis application.
Separate from above referred use of Your data for the development purposes, the Software may be accessed by Your request by Licensor’s distributor or any other third party support or maintenance provider in order to provide necessary support and maintenance service in relation to the Software. In certain event the Licensor as the manufacturer of the Software may also need to provide You second level support, in which case the Licensor may use the data collected from the Software to support and maintenance purposes. For the support and maintenance purposes also the Personal Data, such as x-ray images, may need to be accessed and analyzed. In such case the support and maintenance service provider shall act as the Processor of Your Personal Data and You as the Controller, and the Licensor as the subprocessor of the Processor in accordance with the GDPR. You shall be required to agree and sign with the Processor a Data Processing Agreement concerning the processing of the Personal Data on Your behalf, and consent to the Licensor acting as the subprocessor to ensure to proper performance of the Software. If the Licensor shall be Your direct support and maintenance service provider in the first level, the Licensor’s performance shall in all event be subject the entering into the Data Processing Agreement.
To the maximum extent permitted by applicable law, Licensor and its suppliers provide the Software and hereby disclaim all warranties and conditions, either express, implied, statutory or arising from a course of dealing, usage or trade practice, including, but not limited to, any (if any) implied warranties or conditions of merchantability, of fitness for a particular purpose, compatibility, of lack of viruses, of accuracy or completeness of responses, of results, or of lack of negligence or lack of workmanlike effort, all with regard to the Software and any part thereof, and the provision of or failure to provide support services, all of which are excluded. The Licensor or its supplier shall give no warranty or condition of correspondence to description, or non-infringement with regard to the Software or any part thereof. Licensor makes no representations concerning the quality of the Software and does not promise that the Software will be error-free or will operate without interruption. You shall bear the entire risk as to the quality or compatibility of or arising out of use or performance of the Software in accordance with these Terms.
To the maximum extent permitted by applicable law, in no event shall Licensor or its suppliers be liable for any actual or special, incidental, direct, indirect, consequential or punitive damages whatsoever (including, but not limited to, damages for loss of profits or confidential or other information, for business interruption, for personal injury, for personal data breach, for failure to meet any duty including of good faith or of reasonable care, for negligence, and for any other pecuniary or other loss whatsoever) arising out of or in any way related to the use of or inability to use the Software by any person, the provision of or failure to provide support services, or otherwise under or in connection with any provision of these Software License Term even in the event of the fault, tort (including negligence), strict liability, breach of contract or breach of warranty of Licensor or any of its suppliers, and even if Licensor or any of its suppliers has been advised of the possibility of such damages. In no event shall the Licensor or its suppliers' liability to You, whether in contract, tort (including negligence), or otherwise exceed the price paid for the Software License during any twelve (12) month period by You.
You shall carry and maintain paid up policies for adequate products liability insurance, with Licensor identified as an additional insured, and You shall provide the Licensor with proof of all such insurance, copies of all such policies, and any renewals thereof at Licensor's request.
Your license to use the Software shall commence upon the acceptance of these Software License Terms (subject to the payment thereof), and shall thereafter remain in effect until terminated, as set forth herein.
If You fail to pay any monies or otherwise comply with these Software License or other connected, applicable Terms due in connection with the Software, or violate any term or condition of these Software License Terms, this Software License shall be terminated and expire without any notice from the Licensor.
Immediately upon termination, You shall destroy all copies of all and any part of the Software in Your possession or under Your control. You shall have no right to keep or use any copy of the Software and related documentation for any purpose after termination of this Software License.
Upon termination by Licensor or its suppliers of this Software License, You shall, within two (2) business days thereafter, certify to Licensor that in accordance with instructions from Licensor or its suppliers, all copies of the Software have been destroyed, whether same is in tangible or intangible form and You shall further certify that all use thereof is and shall remain terminated.
You also may terminate this Software License by giving notice of termination to Licensor and destroying all copies of all and any part of the Software in Your possession or under Your control. You shall be liable to pay any monies due and payable until the date of expiry of the Software License. No payment made by the date of expiry of the Software License shall be returned.
This Software License shall be construed, governed by and interpreted in accordance with the laws of Finland, excluding the UN Convention on Contracts for the International Sale of Goods.
Any dispute, controversy or claim arising out of or relating to these Software License Terms, or the breach, termination or validity thereof shall be finally settled by arbitration in accordance with the Rules of the Arbitration Institute of the Central Chamber of Commerce of Finland by one (1) arbitrator to be agreed upon by the Parties within thirty (30) days of receipt by the other Party of a Party's request for arbitration and appointment of the arbitrator. Failing such agreement by the Parties within the contemplated period of thirty (30) days, the sole arbitrator shall be appointed by the Institute. The arbitration shall take place in Helsinki, Finland, and the procedure shall be conducted in English.
Notwithstanding the foregoing, Licensor and its suppliers shall have the right, but not the obligation, to undertake legal proceedings in a court of Your domicile, principal place of business or other appropriate court to: (i) settle any issue or dispute arising out of or relating to monies due by You to Licensor; (ii) protect or enforce any patent, trademark, copyright or other intellectual property right, confidential information or trade secrets; or (iii) proceed with litigation commenced by a third party.
You may not assign this Software License or any rights under it and may not delegate any duties under this Software License without Licensor's prior written consent. Any attempt to assign or delegate without that consent will be void.
These Software License Terms may be modified by Planmeca from time-to-time.
The failure of Licensor to enforce any provision of these Software License Terms shall not be considered a waiver of any subsequent breach of that provision or as a waiver of any other provision hereof.
If any portion hereof is found to be illegal, invalid, void or unenforceable, the remaining provisions of these Software License Terms shall remain in full force and effect.
Headings used in these Software License Terms are provided for convenience only and shall not be used to construe meaning or intent.