END USER LICENSE AGREEMENT
By acceptance of this End User License Agreement (this ” EULA“), a legally binding contract and agreement, which sets forth the license and use rights for the Software (as defined in Section 13 of this EULA), is created between Orthofix Srl, a corporation with an establishment in Milano, Italy(“Orthofix“) and Licensee. The term “Licensee” means the following: (i) the individual acting in its professional capacity as a physician or other professional health care provider (“HCP“) who uses this Software and accepts this EULA and the Approved Device (as defined in Section 4 of this EULA) if such individual does not use this Software and the Approved Device in the course of, or within the scope of, any employment with any other person or entity; or (ii) the person or entity that is the employer of the User (as defined in Section 2 of this EULA) if the User does use this Software, or the Approved Device, in the course of, or within the scope of, any employment with such person or entity.
1. IMPORTANT: BINDING AGREEMENT
a. LICENSEE AGREES THAT, EVERY TIME THAT LICENSEE OR ANY USER ACCESSES OR USES THE SOFTWARE, OR LOGS INTO THE SOFTWARE, LICENSEE REAFFIRMS ACCEPTANCE OF, AND LICENSEE’S AGREEMENT TO, THIS EULA. IF LICENSEE DOES NOT AGREE TO THIS EULA, NEITHER LICENSEE NOR ANY USER MAY ACCESS OR USE THE SOFTWARE.
b. THIS EULA IMPOSES OBLIGATIONS AND LIABILITY ON LICENSEE (INCLUDING, WITHOUT LIMITATION, IN SECTIONS 4 – 9 AND 33 OF THIS EULA), ON EACH USER (SEE SECTION 12 OF THIS EULA), AND THE ACCEPTING INDIVIDUAL (SEE SECTION 11 OF THIS EULA), AND THIS EULA ESTABLISHES LIMITATIONS AND EXCLUSIONS OF LIABILITY AND DISCLAIMERS OF WARRANTIES AND OBLIGATIONS FOR ORTHOFIX AND ANY OF ITS AFFILIATES (INCLUDING, WITHOUT LIMITATION, IN SECTIONS 26 – 32 OF THIS EULA).BY ACCEPTING THIS EULA, LICENSEE CONFIRMS THAT LICENSEE AND ANY USER HAVE SPECIFICALLY TAKEN NOTE OF ALL SUCH OBLIGATIONS AND LIABILITY AND LIMITATIONS, EXCLUSIONS, AND DISCLAIMERS.
c. LICENSEE AGREES THAT NEITHER LICENSEE NOR ANY USER WILL ENTER INFORMATION INTO OR THROUGH USE OF THE SOFTWARE THAT ALLOWS THE IDENTIFICATION OF THIRD PARTIES, IN PARTICULAR, WITHOUT LIMITATION, NAMES OR OTHER IDENTIFIERS RELATING TO PATIENTS. LICENSEE UNDERSTANDS THAT LICENSEE MAY OTHERWISE BE LIABLE UNDER APPLICABLE DATA PRIVACY LAW FOR UNAUTHORIZED DISCLOSURE OF PERSONAL DATA RELATING TO THIRD PARTIES.
2. ACCEPTING INDIVIDUAL; USER
By acceptance of this EULA, the individual who accepts this EULA (the “Accepting Individual”): (i) enters into this EULA for Licensee and binds Licensee to this EULA, (ii) makes the binding warranties, representations, and covenants set forth in Section 11 of this EULA, and (iii) makes, as agent of each individual who will use the Software (each, a “User,” collectively, the “Users”), the binding warranties, representations, and covenants set forth in Section 12 of this EULA.
Licensee shall ensure that each User complies with all obligations of Licensee under this EULA and accesses and uses the Software solely if and to the extent that Licensee is permitted to use the Software under this EULA.
3. ORTHOFIX AFFILIATES; ORTHOFIX PERSONNEL
a. This EULA includes provisions referencing Orthofix Affiliates.The term “Orthofix Affiliate“means any person or entity that is, directly or indirectly, a subsidiary, parent, or other person or entity controlled by, controlling, or under common control with Orthofix.The term “Orthofix Affiliate” shall include, without limitation, Orthofix S.r.l.
b. This EULA also includes provisions referencing Orthofix Personnel. The term “Orthofix Personnel” means any officer, director, manager, employee, contractor, distributor, representative, or agent of Orthofix and/or any Orthofix Affiliate.
4. WARNING: USE WITH APPROVED DEVICE ONLY
The Software is intended solely for use with the TL-Hex hardware, a medical device manufactured by or for Orthofix S.r.l., the manufacturer of record of such medical device, and sold by Orthofix S.r.l. to Licensee directly or through authorized distributors (the “Approved Device“). The Software may not be used with, or for the purpose of, or in support of, any device, equipment, system, process, or product other than the Approved Device. Any use with, or for the purpose of, or in support of, any device, system, process, or product other than the Approved Device is a breach of this EULA and an infringement of the rights in the Software.
5. WARNING: USE FOR APPROVED USE ONLY
The Software and the Approved Device are intended solely for the purpose of treating medical conditions identified in the instructions for use of the Approved Device, and for doing so solely in accordance with generally accepted medical principles and applicable law use at the Practice Jurisdiction (defined in Section 6 of this EULA) (the ” Approved Use“).
6. WARNING: USE BY QUALIFIED HCP ONLY
The Software is intended solely for use by a User who is a Qualified HCP.The term “Qualified HCP” means solely a User who is: (i) an HCP lawfully licensed and admitted to practice medicine in the country or jurisdiction where Licensee is located (the ” Practice Jurisdiction“), (ii) lawfully licensed and admitted in the Practice Jurisdiction to practice medicine of the type including the Approved Use, and (iii) has received all training and instructions necessary for, and has all necessary knowledge for, using the Approved Device and the Software with the Approved Device for the Approved Use or a similar hexapod device.
7. WARNING: WARRANTIES AND REPRESENTATIONS OF LICENSEE
Licensee and each User are solely responsible for the use, application, and implementation, and all decisions related to the use, application, and implementation, of the Software and the Approved Device. Licensee warrants, represents, and covenants Licensee and each User will:
(i) be and remain throughout the access and use of the Software and use of the Approved Device a Qualified HCP;
(ii) use, apply, and implement the Software and the Approved Device solely for the Approved Use;
(iii)follow all generally accepted medical principles and Legal Requirements (as defined in Section 18 of this EULA) in connection with any use, application, or implementation of the Software and/or the Approved Device;
(iv) use greatest care and caution to ensure in diagnosing each patient to be treated using the Software and the Approved Device and in the use, application, and implementation of the Software and the Approved Device for such patient (including, without limitation, that all data and parameters inserted in the process of using the Software are accurate (subject to Section 8 of this EULA regarding Patient Information (as defined in Section 8 of this EULA)); and
(v) accept full responsibility and be fully liable for all results, consequences, injuries, death, damages, and harm, including, without limitation, any injury, death, and other harm to a patient, caused by Licensee’s or any User’s use, application, or implementation of the Software or the Approved Device, or any violation of the foregoing provisions of this EULA, including, without limitation, the foregoing provisions of this Section 7.
8. NO DISCLOSURE OF PATIENT INFORMATION
NO PATIENT INFORMATION MAY BE DISCLOSED TO ORTHOFIX OR ANY ORTHOFIX AFFILIATE OR ANY ORTHOFIX PERSONNEL. Licensee agrees, and shall cause each User, not to disclose any Patient Information to Orthofix or any Orthofix Affiliate or any Orthofix Personnel.The Software permits Licensee or a User to enter information and data, and use the Software for, specific cases and patients. The term ” Patient Information” means any data or information that is personally identifiable data of any patient or other individual treated by Licensee or any User or any individual connected to such patient or other individual, other than Licensee or any User, in particular patient’s name, address, email address, telephone number or other information that, in connection with other information provided, allow the identification of the patient. LICENSEE AND EACH USER SHALL NOT IDENTIFY ANY CASE OR PATIENT THROUGH PATIENT INFORMATION BUT ONLY THROUGH ANONYMIZED OR DE-IDENTIFIED DATA THAT DO NOT PERMIT ORTHOFIX OR ANY ORTHOFIX AFFILIATE OR ANY ORTHOFIX PERSONNEL TO KNOW OR DISCOVER THE IDENTITY OF A PATIENT OR CASE.
Licensee agrees that for Patient Information it will act as data controller under the meaning of applicable privacy law, while Orthofix S.r.l. with registered offices in Via Vittor Pisani no.16, 20124 Milan, Italy and secondary office in Via delle Nazioni no.9, 37012 Bussolengo (Verona), Italy will act as its data processor according to the data processing agreement that will be executed between Licensee and Orthofix S.r.l.
9. WARNING: NO MEDICAL ADVICE OR RECOMMENDATIONS
The Software and/or the Approved Device may be provided by Orthofix and/or Orthofix S.r.l., or an agent, distributor or reseller authorized by Orthofix and/or Orthofix S.r.l., with documentation, guides, or manuals, or documentation, guides, or manuals may be made available by Orthofix and/or Orthofix S.r.l. for the Software and/or the Approved Device (collectively, “Documentation“).Licensee and each User shall comply with all terms and directions of or in the Documentation except if and to the extent such compliance would violate or contradict generally accepted medical principles and applicable law, and provided further that no Documentation or other instructions by Orthofix, Orthofix S.r.l., any other Orthofix Affiliate, or any Orthofix Personnel is or shall be deemed or understood to be any medical advice or instruction of any kind. Nothing in any Documentation or any instructions, statements, or recommendations by Orthofix or any Orthofix Affiliate constitutes or shall be deemed to constitute any medical advice, directions, or recommendations. Licensee and each User are solely and exclusively responsible for assessing the use, application, and implementation of the Software and the Approved Device, and their efficacy and appropriateness for any patient or treatment, under all medical considerations, regardless of any information in any Documentation or any such other instruction.
10. ALERT: MODIFICATIONS
Orthofix may modify, amend, change, and alter this EULA or any provision herein at any time.Licensee agrees that Licensee’s acceptance of each such modification, amendment, change, and alteration shall be a condition precedent for Licensee’s continued license to, and Licensee’s and each User’s access to and use of, the Software or any part thereof, and that this EULA and the license and rights of Licensee, and each User’s access to and use of the Software, hereunder or related to the Software shall automatically terminate, without need for any notice, if Licensee fails to accept such modification, amendment, change, or alteration when requested.
11. REPRESENTATIONS, WARRANTIES, AND COVENANTS BY THE ACCEPTING INDIVIDUAL
By accepting this EULA, the Accepting Individual, individually and personally, warrants, represents, and covenants that:
(i) if the Accepting Individual is not Licensee (e.g., an employee of Licensee), the Accepting Individual has the prior authorization, permission, and agency to enter into this EULA on behalf of Licensee and to legally bind Licensee to this EULA, and
(ii) if the Accepting Individual is not the sole User and the sole User is not Licensee, the Accepting Individual has the prior authorization, permission, and agency to agree to, and to bind each User to, the terms of Section 12 of this EULA, and the Accepting Individual has provided each User with a copy of this EULA.
If any of the foregoing warranties, representations, and covenants is untrue, inaccurate, or breached, the Accepting Individual, jointly and severally with Licensee, will be directly and personally liable to Orthofix under this EULA to the same extent as Licensee.
12. REPRESENTATIONS, WARRANTIES, AND COVENANTS BY EACH USER
If Licensee is not the sole User, each User, by using the Software, individually and personally, warrants, represents, and covenants to:
(i) access and use the Software, and exercises any rights of Licensee, solely for and on behalf of Licensee in accordance with all terms and conditions of this EULA and in compliance with all obligations of Licensee, and
(ii) comply with all obligations of Licensee regarding the use of the Software to the same extent as Licensee in or under this EULA.
If any of the foregoing warranties, representations, and covenants is untrue, inaccurate, or breached by a User, such User, jointly and severally with Licensee, will be directly and personally liable to Orthofix under this EULA to the same extent as Licensee.
The term “Software” means solely the copy of the TL-Hex Software Application for which this EULA is provided by Orthofix to Licensee (in object code version only as made accessible by Orthofix to Licensee remotely on a software as a service (“SaaS“) basis), and any Modification (as defined in Section 15 of this EULA) that is installed in or made available by Orthofix to Licensee.
14. ACCESS TO SOFTWARE
Access to and use of the Software is limited to access and use via the Designated Domain through Licensee Computers at the Licensee Location. The term “Designated Domain” means solely such web address that Orthofix identifies to Licensee, as Orthofix may change from time to time in its sole discretion.The term “Licensee Computer” means solely a computer or the computers in the possession and control of Licensee at all times when the Software is accessed or used from such computer(s).The term “Licensee Location” means solely such physical office or practice location or locations that Licensee identified to Orthofix prior to accepting this EULA and Orthofix has not refused to accept such location or locations as a Licensee Location or Licensee Locations; any other or additional location shall be a Licensee Location only after Licensee has notified Orthofix thereof in advance in writing and Orthofix has not refused to accept such location as a Licensee Location.
Orthofix may (if, as, and when it decides to do so in its sole discretion) install or make available to Licensee, without any obligation by Orthofix, in object code only, any update to the Software that is made available to Licensee by Orthofix, including, without limitation, modification, error correction, update, upgrade, alteration, enhancement, or change of or to the software application defined in this EULA as the “Software” or any Documentation (“Modification“). Orthofix has the right to make any Modification at any time, without obligation by Orthofix to provide any notice or obtain any consent or agreement from Licensee or any third party, and without any right by Licensee or any third party to receive any notice or provide any consent or agreement thereto.
16. LIMITED LICENSE
Orthofix grants Licensee a non-transferable, non-sublicenseable, non-assignable, terminable, limited, and nonexclusive license to access and use the Software solely remotely on a SaaS basis solely at the Designated Domain from a Licensee Computer from a Licensee Location and solely for use and application with the Approved Device, solely in accordance with the terms and conditions of this EULA and the other agreements and policies of Orthofix accepted or agreed to by Licensee and such other applicable Orthofix policies as may be in place from time to time.Orthofix does not make the Software or any part thereof available for downloading or installation, and Licensee does not have any right or license to download or install the Software or any part thereof.
17. LIMITATIONS AND RESTRICTIONS
Licensee (and its employees, if any) do not have any right or license to, and will not, directly or indirectly, in any manner whatsoever: (i) attempt to download or install, or download or install, or use any downloaded or installed version or copy of, the Software or any part thereof; (ii) access or use the Software or any part thereof from any device or equipment other than a Licensee Computer and/or any location other than a Licensee Location; (iii) use the Software or any part thereof for or with any product or hardware other than the Approved Device or for any purpose for which, or in any manner, it is not intended by Orthofix; (iv) copy or reproduce the Software or any part thereof for any purpose (except solely any copying that is necessarily incidental to any permitted access or use of the Software under this EULA or any copying made in exercise of a right granted pursuant to applicable law that cannot be waived in advance); (v) modify, change, or create improvements, derivative works, or derivations from or based on the Software or any part thereof; (vi) sub-license, rent, lease, loan, or distribute the Software, or any part thereof, whether or not for profit or consideration; (vii) access the Software other than through use of the Log-In Information (as defined in Section 19 of this EULA); (viii) permit any third party to access or use the Software or any part thereof; (ix) use or operate the Software or any part thereof for the benefit of any third party in any type of service outsourcing, application service, provider service or service bureau capacity; (x) reverse engineer, decompile, or disassemble the Software or any part thereof, or otherwise reduce it to a human perceivable form, or attempt to do so (subject to any statutory right of Licensee to do so, which cannot be waived by Licensee); (xi) assign, transfer, sell, or encumber the Software, any part thereof, or any right or obligation hereunder or regarding the Software or any part thereof; (xii) use or utilize the Software, or any part thereof, for any purpose or in any manner that is illegal or in violation of any applicable law or rights of any third party; (xiii) remove, modify, change, alter, obscure, or cover any copyright, trademark, patent, or other proprietary notice or marking in or on the Software or any part thereof; or (xiv) export or transfer or make available the Software or any part thereof outside the country in which the Licensee Location is located without Orthofix’s express prior written discretionary approval. ANY ACCESS, EXECUTION, OR USE OF THE SOFTWARE OR ANY PART THEREOF OTHER THAN AS EXPRESSLY PERMITTED UNDER SECTION 16 OF THIS EULA OR IN VIOLATION OF THIS SECTION 17 OR ANY OTHER PROVISION OF THIS EULA, OR FOR ANY PURPOSE OR REASON NOT IN ACCORDANCE WITH A PURPOSE OR REASON PERMITTED UNDER THIS EULA OR BY ORTHOFIX, SHALL BE DEEMED TO BE AN INFRINGEMENT OF ORTHOFIX’S INTELLECTUAL PROPERTY RIGHTS IN THE SOFTWARE AND SUBJECT TO ALL RIGHTS AND REMEDIES OF ORTHOFIX ARISING FROM OR IN CONNECTION WITH SUCH AN INFRINGEMENT.
18. LEGAL REQUIREMENTS
Licensee agrees to use the Software in accordance with any and all law, statutes, regulations, rules, ordinances, directives, and court and governmental orders applicable to Licensee, including, without limitation, all law, statutes, regulations, rules, ordinances, directives, and court and governmental orders related to data privacy, data security, and confidentiality of data and information regarding any data collected, received, shared, or accessed by Licensee in connection with the use of the Software (“Legal Requirements“). Licensee shall ensure at all times that Licensee has all rights and/or licenses to any technology, software, hardware, work, material, data, and/or information that Licensee uses in connection with the Software.Licensee is solely responsible for lawfully procuring any and all such rights and/or licenses at Licensee’s sole cost.
19. LOG-IN INFORMATION
Licensee will receive a unique login identity or username and password for accessing the Software through the internet at the Designated Domain (collectively, “Log-In Information“).Logging in at the Designated Domain using the Log-In Information is a condition precedent for Licensee’s access to and use of the Software or any part thereof.If Licensee is permitted or required by Orthofix, or prompted by the Software, to change the Log-In Information, Licensee shall do so until new identity or username and/or password is accepted by Orthofix at the Designated Domain, and the prior identity or username and/or password shall cease being, and the new identity or username and/or password shall constitute, the Log-In Information. Licensee may access and use the Software solely with the Log-In Information. Licensee agrees not to share any of the Log-In Information with any other person or permit any other person to access, know and/or use any of the Log-In Information, except solely for any employee of Licensee, if any, who is authorized by Licensee to access and use the Software in accordance with this EULA, provided, however, that Licensee shall require each such employee to comply fully with the confidentiality and secrecy obligation and use restrictions that Licensee has with regard to the Log-In Information.Once a person ceases to be an employee or an employee authorized to access and use the Software, Licensee shall ensure that such employee has no further access to the Software, if necessary, by changing the Log-In Information. All Log-In Information shall be deemed to be property of Orthofix.
Licensee is solely responsible, throughout the duration of this EULA and Licensee’s access and use of the Software at the Designated Domain, for obtaining, providing, establishing and maintaining, at Licensee’s sole cost, all software (including, without limitation, any and all licenses or other rights necessary for using such software), hardware, communication, internet access and connection (whether through telephone, cable, DSL, T1, ISDN, or any other form or type of access, connection or connectivity), electricity, and any other prerequisites that are or may be necessary for the access to and use of the Software (collectively, ” Access Requirements“), and neither Orthofix nor any Affiliate or any distributor, agent or reseller of Orthofix or an Affiliate shall be liable for any Access Requirements, or the provision thereof, or any costs, charges, fees, taxes, rates, or other payments incurred or made in connection therewith.
21. SUPPORT; DOWNTIME
a. Neither Orthofix nor any Orthofix Affiliate is obligated or required to provide or make available any support, maintenance, or other services to Licensee, any User, or any other person or entity.
b. Orthofix S.r.l. may, in its sole discretion, directly or indirectly make available, but is not obligated to make available or provide, telephone, email or other support for the Software (” Customer Support“).Orthofix S.r.l. may at any time discontinue, reduce and limit access to, or charge any fee for any Customer Support at any time if and as it decides in its sole discretion, with or without notice to Licensee or any User, except if and to the extent Orthofix S.r.l. has entered into a written contract specifically and nominally with Licensee for any Customer Support, in which case discontinuance of Customer Support shall be governed by such written contract.
c. Orthofix may, from time to time, take down or shut down access to the Software, or parts thereof, for maintenance, repair, or service as Orthofix may deem necessary in its sole discretion (” Downtime“).Licensee acknowledges that, during any Downtime, Licensee may not be able to access and use some or all parts of the Software. Orthofix may, but shall have no obligation to, make commercially reasonable efforts to notify Licensee, or have Licensee notified, in advance of such Downtime, for example by displaying a notice during access of the Software or by posting a notice on the website of the Designated Domain. Orthofix will make commercially reasonable efforts to keep the Downtime to a minimum, but in no event shall Orthofix or any Affiliate or any distributor or reseller of Orthofix or any Affiliate be liable to Licensee or any third party in connection with any Downtime. Orthofix does not offer, and does not agree to, any service level agreement, service levels, credit, uptime, minimum uptime, or other similar features.
Orthofix and/or its licensor(s), if any, own and shall retain all rights, title and interest in and to: (i) the Software and any and all parts thereof (including, without limitation, all Modifications and Documentation), (ii) any and all marks and names of Orthofix or any of its affiliates (including, without limitation, any mark, name, and domain name consisting of or including “Orthofix” and those identified in Section 23 of this EULA and any name or title of the Software), (iii) any technology, invention, concept, system, method, process, and other element of the Software and/or the Approved Device, (iv) any Modification, and any copy, reproduction, update, upgrade, modification, derivation, improvement, and derivative work thereof, thereto, and/or therefrom, by whomever created, and (v) any and all copyrights, patents, trade secret rights, trademark rights, service mark rights, and other intellectual property rights, industrial property rights, and other proprietary rights of any kind, existing anywhere or under any law, in or to any of the foregoing (collectively and individually, “Orthofix Property“). All Software is licensed to Licensee, not sold.Nothing in this EULA or any performance of this EULA constitutes, or shall be interpreted or construed to constitute, any assignment, transfer or conveyance of any right, title or interest, or (except solely for the license expressly granted to Licensee in Section 16 of this EULA) any license or use right, or any right to grant any license or use right whatsoever, in or to any Orthofix Property.Licensee agrees that Licensee will not acquire, by use or otherwise, and will not claim, any ownership, license, or other rights (other than the limited express license granted in Section 16 of this EULA during the term of this EULA) in, or take any action that in any way may jeopardize or jeopardize Orthofix’s ownership or rights in or to, any Orthofix Property.
“ORTHOFIX”, “TRUE/LOK”, “TRUELOK”, “TRUE/LOK HEX”, “TRUELOK HEX”, “TL-HEX”, and all associated designs, styles, and logos are marks of Orthofix and/or its Affiliates, or a licensor of Orthofix and/or its Affiliates, and shall constitute Orthofix Property. Licensee may not use any of such marks except solely in accordance with an express prior written license agreement with Orthofix. Other marks are or may be the property of their respective owners. Licensee may not use any of these marks without the consent of their respective owners.
25. DATA ENTRY; NO ARCHIVE
a. Licensee expressly assumes all risks of error, corruption, loss or damage to any data or information entered by Licensee in connection with the access or use of the Software (“Licensee Data“).
b. Licensee may delete or modify any Licensee Data. Orthofix has no obligation to archive any Licensee Data.Licensee recognizes and acknowledges that any deleted Licensee Data or any Licensee Data prior to any modification will be erased from the database and will not be available or recoverable thereafter, and that any erasure may be delayed until the next generally scheduled database update, which may be conducted within days, weeks, longer or shorter time from each other.
26. NO WARRANTY
Orthofix makes no warranty or representation with regard to the Software or any part thereof, including, without limitation, any Modification or Documentation.
27. WARRANTY DISCLAIMER
THE SOFTWARE, AND ANY PART THEREOF (INCLUDING, WITHOUT LIMITATION, ANY MODIFICATION AND DOCUMENTATION), IS LICENSED, DELIVERED, AND PROVIDED, AND ANY SUPPORT, MAINTENANCE, AND OTHER SERVICES, IF ANY, IS PROVIDED, “AS IS” AND “WHERE IS,” AND ORTHOFIX MAKES NO REPRESENTATION, WARRANTY, COVENANT, OR CONDITION OF ANY KIND TO LICENSEE, ANY END USER, ANY PATIENT, OR ANY OTHER THIRD PARTY, WHETHER VERBAL, WRITTEN, EXPRESSLY, OR IMPLICITLY, AND ORTHOFIX HEREBY DISCLAIMS ALL REPRESENTATIONS, WARRANTIES AND CONDITIONS, EXPRESS, IMPLIED, AND STATUTORY, OF ANY KIND FOR OR RELATED TO OR REGARDING THE SOFTWARE, ANY PART THEREOF (INCLUDING, WITHOUT LIMITATION, ANY MODIFICATION AND DOCUMENTATION), ANY SUPPORT, MAINTENANCE, AND OTHER SERVICES, IF ANY, THE APPROVED DEVICE, AND OTHERWISE UNDER OR IN CONNECTION WITH THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY, NON-INFRINGEMENT, TITLE, WORKMANSHIP, ACCURACY, RELIABILITY, INTEROPERABILITY WITH OTHER SOFTWARE OR ANY HARDWARE, SECURITY, OR QUIET ENJOYMENT OR THAT THE USE OF THE SOFTWARE WILL BE UNINTERRUPTED OR VIRUS- OR ERROR-FREE, OR MEET LICENSEE’S SPECIFIC REQUIREMENTS, FUNCTIONS, OR RESULTS, AND HEREBY DISCLAIMS AND EXCLUDES ALL REPRESENTATIONS, WARRANTIES AND CONDITIONS ARISING AS A RESULT OF CUSTOM, USAGE OR TRADE AND THOSE ARISING UNDER STATUTE, COMMON LAW OR OTHERWISE.
28. LEGAL RESTRICTIONS
Some countries and jurisdictions do not allow the conditions, limitations, disclaimer, or exclusion of implied warranties, representations, or conditions, so some of the disclaimers and exclusions in Sections 26 and/or 27 of this EULA may not apply to Licensee. In such case: (i) the conditions, limitations, disclaimer, or exclusion of implied warranties, representations, or conditions shall not be invalidated or nullified but be revised and remain valid and enforceable such that they are effective to the greatest extent as permitted under applicable law, and (ii) if any implied warranties or conditions would then otherwise arise, such implied warranties and conditions will be limited in duration to ninety (90) days, or if applicable law requires a longer time period, the shortest legally required time period, from the date of the delivery of the Software. The warranties given herein give Licensee specific legal rights and Licensee may have other rights, which may vary from jurisdiction to jurisdiction.
29. LIMITATION OF LIABILITY
IN NO EVENT WILL ORTHOFIX, ANY THIRD PARTY LICENSOR OF ORTHOFIX, ANY ORTHOFIX AFFILIATE, OR ANY ORTHOFIX PERSONNEL BE LIABLE TO LICENSEE, ANY END USER, ANY PATIENT, OR ANY OTHER THIRD PARTY FOR ANY INCIDENTAL INDIRECT OR CONSEQUENTIAL LOSS OR DAMAGE, OR SPECIAL, PUNITIVE, LIQUIDATED OR EXEMPLARY DAMAGES; OR ANY LOST PROFITS, BUSINESS INTERRUPTION, DISCLOSURE OR LOSS OF INFORMATION, DISCLOSURE OR LOSS OF DATA, LOSS OF INCOME, LOSS OF REVENUE, LOSS OF GOODWILL, DAMAGE TO REPUTATION OR LOSS OF ANTICIPATED SAVINGS, WHETHER DIRECT OR INDIRECT, WHETHER IN ANY CASE ARISING FROM OR RELATED TO THIS EULA OR OTHERWISE AND REGARDLESS OF THE TYPE OF CLAIM, THE CAUSE OF SUCH LOSS OR DAMAGE AND WHETHER ORTHOFIX HAS BEEN INFORMED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGE (INCLUDING, WITHOUT LIMITATION, FOR OR RELATED TO OR REGARDING THE SOFTWARE, ANY PART THEREOF, ANY MODIFICATION AND DOCUMENTATION, ANY SUPPORT, MAINTENANCE, AND OTHER SERVICES, IF ANY, THE APPROVED DEVICE, AND OTHERWISE UNDER OR IN CONNECTION WITH THIS AGREEMENT). FURTHER, IN NO EVENT WILL ORTHOFIX TOTAL CUMULATIVE LIABILITY NOT EXCLUDED HEREUNDER, FROM ALL CAUSES OF ACTION OF ANY KIND, EXCEED THE TOTAL AMOUNT OF THE LICENSE FEE OR LICENSE FEES PAID BY LICENSEE TO ORTHOFIX IN CONSIDERATION FOR THE LICENSE TO THE SOFTWARE. THIS LIMITATION APPLIES IRRESPECTIVE OF THE CAUSE OF ACTION, INCLUDING, BUT NOT LIMITED TO, BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, BREACH OF WARRANTY, MISREPRESENTATION (OTHER THAN FRAUDULENT MISREPRESENTATION) OR ANY OTHER LEGAL THEORY AND WILL SURVIVE A FUNDAMENTAL BREACH.
IN THE EVENT THAT ENGLISH LAW IS APPLIED TO THIS EULA, NOTHING IN THIS EULASHALL LIMIT OR EXCLUDE A PARTY’S (OR ANY OF ITS AFFILIATES’) LIABILITY FOR (I) DEATH OR BODILY INJURY CAUSED BY THAT PARTY’S NEGLIGENCE OR, AS THE CASE MAY BE, THE NEGLIGENCE OF ITS AFFILIATE; OR (II) FRAUD OF THAT PARTY (OR ANY OF ITS AFFILIATES); OR (III) BREACH OF TERMS REGARDING TITLE IMPLIED BY SECTION 12 SALE OF GOODS ACT 1979 AND/OR SECTION 2 SUPPLY OF GOODS AND SERVICES ACT 1982 TO THE EXTENT THE SAME CANNOT BE EXCLUDED OR LIMITED BY LAW; OR (IV) ANY LIABILITY TO THE EXTENT THE SAME CANNOT BE EXCLUDED OR LIMITED BY APPLICABLE LAW.
30. LEGAL RESTRICTIONS
Some countries and jurisdictions do not allow for the limitation or exclusion of liability, so the above limitation or exclusion may not apply to Licensee and Licensee may also have other legal rights, which may vary from jurisdiction to jurisdiction. In such case the limitation or exclusion shall not be invalidated or nullified but be revised and remain valid and enforceable such that they are effective to the greatest extent as permitted under applicable law.
31. CHANGE TO WARRANTY AND LIABILITY EXCLUSIONS AND LIMITATIONS
No employee, distributor, reseller, or agent of Orthofix or any Orthofix Affiliate is authorized to change, modify, extend or amend the warranty provided or to waive, restrict, change, or modify the limitation or disclaimer of warranty provisions or exclusions or limitations of liability in this EULA. All such changes will only be effective if pursuant to a separate agreement signed by senior officers of Orthofix and Licensee.
32. BLUE PENCIL
In the event and to the extent that any part or provision of this EULA is invalid or unenforceable in any particular country, state, or jurisdiction, such part or provision shall be interpreted both to be valid and enforceable and to conform to the greatest extent possible to the intent and purpose of such part or provision as set forth in this EULA.
Licensee hereby agrees to defend, indemnify, and hold harmless Orthofix, all Orthofix Affiliates, all Orthofix Personnel, and all resellers, distributors, agents, and contractors of Orthofix or any Orthofix Affiliate (collectively, the “Indemnitees,” each, an ” Indemnitee“) from and against any claim, action, suit, litigation, demand, allegation, arbitration, proceeding, judgment, order, damages, loss, liability, injury, costs, expenses (including, without limitation, reasonable attorneys’ fees and witness and other defense costs), settlement, and other payment obligation of any Indemnitee arising from or in connection with or related to: (i) any breach of this EULA by Licensee, User or any employee or agent of Licensee or User, (ii) any use or application of the Software and/or the Approved Device, or any other equipment or product used by Licensee or User, or any information or results derived from any use or application of the Software or any part thereof, or any reliance on any such information or results or the Software by Licensee, User or any patient or customer (including, without limitation, any personal injury, death, or property damage resulting therefrom), (iii) any violation of any obligation regarding data privacy or protection of personally identifiable or other data (including, without limitation, those of Licensee, User or any patient of Licensee or User), (iv) any negligence or willful misconduct of Licensee, User or any employee or agent of Licensee or User (regardless of any contributory or comparative negligence of any Indemnitee), (v) any loss or misappropriation of any Log-In Information in the possession or under the control of Licensee or User, and/or (vi) any violation of any Legal Requirements or right or property of any third party by Licensee, User or any employee or agent of Licensee or User.
34. BASIS OF BARGAIN
Licensee agrees and acknowledges that Orthofix has set its prices and the parties have entered into this EULA in reliance on the limited warranties, warranty disclaimers, limitations and exclusions of liability, and indemnity set forth herein, that the same reflect an agreed-to allocation of risk between the parties (including the risk that a remedy may fail of its essential purpose and cause consequential loss), and that the same forms an essential basis of the bargain between the parties. Licensee agrees and acknowledges that Orthofix would not have been able to license the Software at the amount charged on an economic basis without such limitations.
If use of the Software may be enjoined due to a claim of infringement by a third party then, at its sole discretion and expense, Orthofix may do one of the following: (a) negotiate a license or other agreement so that the Software is no longer subject to such a potential claim, (b) modify the Software so that it becomes non-infringing, provided such modification can be accomplished without materially affecting the performance and functionality of the Software, (c) replace the Software with non-infringing software, or (d) terminate this license and Licensee shall stop using the Software. The foregoing sets out the entire liability of Orthofix and the sole obligations of Orthofix to Licensee in respect of any claim that the Software or its use infringes any third party rights.
Each of Licensee and Orthofix may terminate this EULA at any time without cause and without any liability by Orthofix or to Licensee or any of Licensee’s employees or contractors in connection therewith. This EULA and the license and rights hereunder shall automatically terminate, without need for any notice, upon the termination, expiration or cancellation of any right or license necessary for Orthofix to grant to Licensee any of the license or rights under this EULA. Orthofix may terminate this EULA on thirty (30) days prior written notice if Licensee fails to materially comply with or materially breaches any provision of this EULA, which termination shall be effective at the end of such thirty (30)-day period unless Licensee can fully cure, and fully cures, such default or breach to Orthofix’s satisfaction within the thirty (30) days. Any such termination by a party shall be in addition to and without prejudice to such rights and remedies as may be available, including injunction and other equitable remedies.
37. EFFECT OF TERMINATION
Upon expiration or termination of this EULA, Licensee shall immediately (a) cease using the Software and any part thereof; and (b) return to Orthofix (or destroy and provide a certificate (if Licensee is an entity, by a senior officer of it) attesting to such destruction) the Software, all parts thereof, and all related material and any written, magnetic, optical or other media provided to Licensee; and (c) irretrievably delete any copy of the Software or any part thereof, whether installed, downloaded or copied. Any use of the Software or any part thereof after termination or expiration of this EULA shall be deemed to be an infringement of the intellectual property rights in and to the Software. The provisions in Sections 22, 23, 26-34, 38, 39, 41-49 of this EULA, and this Section 37, shall survive any expiration or termination of this EULA.
38. EXPORT RESTRICTIONS
Licensee acknowledges that the Software, or any part thereof, may be subject to the jurisdiction of the U.S. Export Administration Regulations (Title 15 of the U.S. Code of Federal Regulations Part 730 et seq. ), U.S. trade embargo regulations (Title 31 of the U.S. Code of Federal Regulations Part 500 et seq.), other regulations of the U.S. Departments of Commerce, State, and Treasury (collectively, ” Export Control Law“).Accordingly, Licensee agrees that Licensee will comply with all Export Control Law and that the Software, or any part thereof, or any part or information thereof, or any access or use thereof, will not be: (i) reexported, sold, or otherwise transferred to countries outside of the United States of America in violation of Export Control Law or any other U.S. Law; or (ii) made available to any person or country outside, or any person that Licensee knows or has reason to suspect will cause the Software, or any part or information thereof, or any access or use thereof, to be made available outside, the United States of America in violation of Export Control Law or any other U.S. Law; or (iii) reexported, sold, or otherwise transferred to or made available to persons or countries within the United States if such a reexportation, sale, transfer or making available would violate the Export Control Law or any U.S. Law.Licensee specifically agrees to make best efforts to cause all Users, including, without limitation, all of its employees, if any, to comply with any and all provisions, terms and conditions set forth in this Section 38 to the same extent as Licensee has such obligation of compliance. In the event of any violation or breach of any of the provisions of this Section 38, Orthofix may immediately terminate this EULA by providing written notice.Licensee is solely responsible for determining its obligations under Export Control Law.
39. U.S. GOVERNMENT RESTRICTED RIGHTS
If and to the extent applicable, Licensee agrees that the Software qualifies as limited rights data and/or restricted computer software under Federal Acquisition Regulations (“FAR“) and is provided to the U.S. Government only with restricted rights and limited rights. Use, reproduction, or disclosure by the U.S. Government is subject to the restrictions herein and as set forth in FAR Sections 52.227-14 and 52.227-19 and the applicable provisions of Part 227 of the Defense FAR Supplement, as amended.
40. PRODUCT COMPONENTS
The Software may contain third party components or elements. The license under this EULA extends to any third party components only if and to the extent, and for as long as, Orthofix has the right to grant the sublicense necessary for such license. Those third party components may be subject to additional terms and conditions. Licensee is required to agree to those terms and conditions in order to use the Software.
41. FORCE MAJEURE EVENT
Neither party will have the right to claim damages as a result of the other’s inability to perform or any delay in performance due to unforeseeable circumstances beyond its reasonable control, such as labor disputes, strikes, lockouts, war, riot, insurrection, epidemic, Internet virus attack, Internet failure, supplier failure, act of God, or governmental action not the fault of the nonperforming party.
42. INJUNCTIVE RELIEF
Licensee agrees that damages alone may be an insufficient remedy for violations of the terms of Sections 4, 5, 6, 8, 16, 17, 18, 22, 23, 37, 38, and 39 of this EULA, and that Orthofix or a licensor of Orthofix, if any, may suffer irreparable damage as a result of such a violation. Accordingly, Orthofix, or any such licensor with regard to property of such licensor, shall be entitled, in the event of a breach or threatened breach of Sections 4, 5, 6, 8, 16, 17, 18, 22, 23, 37, 38, and 39 of this EULA, to seek injunctive relief (or equivalent relief available under the law of the jurisdiction where Orthofix seeks such relief) to enforce the provisions of Sections 4, 5, 6, 8, 16, 17, 18, 22, 23, 37, 38, and 39 of this EULA without posting a bond. Injunctive (or such equivalent) relief shall be in addition to any and all other rights or remedies available to Orthofix or such licensor, including, but not limited to, damages or other relief or remedies for such violation.Assertion or the failure to assert injunctive (or such equivalent) relief shall not constitute a waiver of any such other rights or remedies. In the event it is necessary for Orthofix to institute legal proceedings to enforce Sections 4, 5, 6, 8, 16, 17, 18, 22, 23, 37, 38, and 39 of this EULA, Orthofix or such licensor will be entitled to recover attorneys’ fees and costs incurred by Orthofix in such proceedings if it prevails in such proceedings.
This EULA and the rights and obligations hereunder shall not be assigned or delegated by Licensee without the express prior written consent of Orthofix.Orthofix may, at any time, assign this EULA, or assign any of its rights and/or delegate any of its obligations hereunder, with or without notice to Licensee.Subject to the foregoing, this EULA shall be binding upon and inure to the benefit of the parties hereto and their successors and assigns. A permitted assignment under this Section 43 shall not constitute an amendment of this EULA if the assignment does not change any terms, conditions or provisions of this EULA other than replacing the assigning party with the assignee.
44. FORUM FOR DISPUTES
The parties hereto agree that the courts located in Milano, Italy, will have exclusive jurisdiction to resolve any disputes between Licensee and Orthofix concerning this EULA.The parties hereby irrevocably consent and submit to, and waive any objection to, personal jurisdiction of such courts. Notwithstanding the foregoing, either party may apply to any court of competent jurisdiction for injunctive relief, and Orthofix may enforce Sections 4, 5, 6, 8, 16, 17, 18, 22, 23, 37, 38, and 39 of this EULA in any court of competent jurisdiction.
45. APPLICABLE LAW
This EULA and all contractual and non-contractual obligations arising from it shall be governed by applicable United States federal law and the laws of the State of Texas, United States of America, exclusive of any of its conflicts of law or international privatelaw rules or principles that would result in the application of the law of any other jurisdiction.
The United Nations Convention on Contracts for the International Sale of Goods will not apply to this EULA or any transaction hereunder.
47. NO THIRD PARTY BENEFICIARIES
The parties hereto do not intend any third party to be a third party beneficiary under this EULA, and nothing in this EULA shall be construed for any third party to be a third party beneficiary or to confer any third party beneficiary rights or status on any third party.
This is the entire agreement between Licensee and Orthofix relating to the Software, and Licensee’s use of the same, and supersedes all prior, collateral or contemporaneous oral or written representations, warranties or agreements regarding the same. Any and all terms and conditions set out in any correspondence between the parties hereto or set out in a purchase order, which are different from or in addition to the terms and conditions set forth herein shall have no application and no written notice of same shall be required. In the event that one or more of the provisions of this EULA is found to be illegal or unenforceable, this EULA shall not be rendered inoperative but the remaining provisions shall continue in full force and effect, and such provision shall be validly reformed so as to approximate the intent of the parties hereto as nearly as possible as set forth in this EULA.Any waiver of a right under this EULA or a breach of this EULA must be express and written.The waiver of any breach of any provision of this EULA shall not be construed to be a waiver of any succeeding breach of such provision or a waiver of the provision itself.Selection of a specific remedy does not constitute, and shall not be interpreted to constitute, a waiver of any other remedy, and failure to select a specific remedy does not constitute, and shall not be interpreted to constitute, a waiver of such remedy.