- Regulatory documentation
You must agree with customer duties
Medical Device Software
PLEASE READ THIS AGREEMENT CAREFULLY. THIS MEDICAL DEVICE SOFTWARE DOWNLOAD AGREEMENT (“AGREEMENT”) IS A LEGAL AGREEMENT BETWEEN YOU, EITHER AS AN INDIVIDUAL OR A SINGLE LEGAL ENTITY (“YOU”), AND FRESENIUIS KABI AG (“FK”), GOVERNING YOUR USE OF FK’S PROPRIETARY COMPUTER SOFTWARE APPLICATION AND ITS ASSOCIATED USER DOCUMENTATION (“DOCUMENTATION”) (SUCH SOFTWARE AND DOCUMENTATION IS COLLECTIVELY REFERRED TO HEREIN AS THE “SOFTWARE”). THIS AGREEMENT IS ENFORCEABLE AGAINST YOU AND ANY LEGAL ENTITY THAT OBTAINED THE SOFTWARE AND ON WHOSE BEHALF IT IS USED, E.G., YOUR EMPLOYER IF YOU ARE AN INDIVIDUAL. IF YOU ARE AN INDIVIDUAL ACTING ON BEHALF OF AN ENTITY, E.G., YOUR EMPLOYER, YOU REPRESENT AND WARRANT THAT YOU HAVE BEEN AUTHORIZED AND HAVE AUTHORITY TO ENTER INTO THIS AGREEMENT ON BEHALF OF SUCH ENTITY. BY DOWNLOADING, INSTALLING, ACTIVATING, COPYING, OR USING ANY PORTION OF THE SOFTWARE, YOU ACCEPT THIS AGREEMENT IN ITS ENTIRETY. IF YOU DO NOT AGREE TO ALL OF THE TERMS OF THIS AGREEMENT WITHOUT MODIFICATION, DO NOT DOWLOAD, INSTALL, ACTIVATE, COPY OR USE THE SOFTWARE.
For good and valuable consideration, the receipt of which is hereby acknowledged, You and FK agree as follows:
1.1 License Key. Use of the Software may require that You enter a product activation code (“License Key”) into the Software. License Keys may not be copied, modified, distributed, published, transferred or disclosed outside Licensee, nor may any License Key be used on any copy of the Software or on any other machine other than the copy or machine for which it has been supplied by FK. License Keys shall be deemed part of the Software for all purposes of this Agreement.
2. SCOPE OF LICENSE; RESTRICTIONS.
2.1 License. Subject to Your compliance with the terms of this Agreement, and for so long as this Agreement remains in effect, FK hereby grants to You (and not to any third party) a limited non-exclusive, non-transferable (except as set forth herein), license to install and use the Software solely for its intended purpose as described in the Documentation, in accordance with the Usage Parameters specified in the applicable Order, and in conjunction with Your use of FK’s software. You may make a single copy of the Software solely for backup and archival purposes.
2.2 Restrictions. You acknowledge and agree that You will not: (a) rent, lease, lend, sublicense, sell, encumber or provide commercial services based upon use of the Software; (b) modify, distribute, publish, adapt, translate, prepare derivative works from, decompile, reverse engineer, disassemble or otherwise attempt to derive source code from the Software, except to the extent expressly permitted by applicable law notwithstanding this limitation; (c) attempt to circumvent or disable any security or usage limitation features of the Software by any means or in any manner; (d) remove, obscure, or alter any copyright, trademark or other proprietary rights notices or legends affixed to or contained within the Software; or (g) use the Software in any manner in violation of applicable law. You may not transfer or assign this Agreement, any license rights granted herein, nor the Software or any component thereof, except as expressly permitted herein. The Software may be licensed as a single product. You may not separate its component parts for distribution or any other use.
3. OWNERSHIP. The Software is protected by copyright and other intellectual property laws and treaties. FK and/or its authorized representatives own all rights, title, and interest in the Software, including all copyrights, trade secrets, trademarks, patent rights, ideas, concepts, know-how, techniques, inventions, discoveries, improvements and other intellectual property and proprietary rights therein. Except for the limited license rights granted hereunder, You have no rights in or to the Software or Documentation or any copies thereof, except to possess and use them in accordance with this Agreement. To the extent You are permitted to make copies hereunder, You shall include FK’s copyright, trademark or other proprietary rights notices or legends on any complete or partial copies of the Software in the same form and location as the notice appears on the original work. FK reserves all rights not expressly granted to You in this Agreement and You agree not to take any action that interferes, in any manner, with FK’s or its authorized representatives’ rights with respect to the Software.
4. CONFIDENTIALITY. The Software contains and constitutes valuable confidential and trade secret information of FK, including without limitation, data processing algorithms, innovations and concepts (“Confidential Information”). You agree not to disclose nor permit access to the Software (including, for the avoidance of doubt, the Documentation) to any third parties not under an obligation of confidentiality to You to protect the confidentiality of information You disclose to them, including the Software, nor to utilize for Your own benefit any such Confidential Information except in connection with Your permitted use thereof. This obligation shall survive the termination of this Agreement.
5. UPDATES. FK may, at its option, periodically make available updates, corrections, patches or fixes addressing operational or other issues related to the Software (collectively, “Updates”). Updates shall be deemed part of the Software. Such Updates will be defined in the service agreement that accompanies purchase of the infusion system to which the Software relates. As a medical device, according to European Union regulation, the software may need mandatory withdraw or updates according to post market vigilance regulations. For such cases, your responsibility may be engaged if you do not apply FK requirements in case of medical devices legal violation.
6. LIMITED WARRANTIES.
6.1 Contractual Warranty. FK warrants, for Your benefit alone, that for a period of thirty (30) days from delivery of the Software initially supplied to You the Software’s performance will substantially conform to descriptions thereof contained in FK’s Documentation.
6.2 Warranty Limitations. OTHER THAN AS EXPRESSLY SET FORTH IN SECTION 6.1, ABOVE, NEITHER FK NOR ITS AFFILIATES OR THEIR RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES, SUBSIDIARIES, CONTRACTORS, SUBCONTRACTORS, SUPPLIERS, LICENSORS, AGENTS, PARTNERS, RESELLERS OR DISTRIBUTORS, MAKE ANY EXPRESS OR IMPLIED WARRANTIES OR REPRESENTATIONS TO YOU, ANY OF YOUR AFFILIATES, OR TO ANY OTHER PARTY WITH RESPECT TO THE SOFTWARE, THE DOCUMENTATION, OR OTHERWISE REGARDING THIS AGREEMENT, WHETHER ORAL OR WRITTEN, EXPRESS, IMPLIED, OR STATUTORY. WITHOUT LIMITING THE FOREGOING, ANY IMPLIED WARRANTY OR CONDITION OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IS EXPRESSLY EXCLUDED AND DISCLAIMED. FK DOES NOT WARRANT THAT THE SOFTWARE WILL MEET YOUR REQUIREMENTS, THAT THE SOFTWARE IS WITHOUT DEFECT OR ERROR OR THAT THE SOFTWARE WILL OPERATE WITH ANY HARDWARE OR SOFTWARE NOT SPECIFIED IN THE DOCUMENTATION.
7. TERM AND TERMINATION. This Agreement shall remain in effect until the first to occur of the expiration of any finite term specified in an applicable Order, or until terminated by either party upon notice to the other of a material breach of this Agreement which is incapable of cure; provided, however, if a material breach is capable of cure, the breaching party shall have thirty (30) days from receipt of such notice to cure such breach. If the breach remained uncured after the thirty (30) days notice, the Agreement will be terminated except mutual agreement of the Parties. Upon any termination, You shall immediately cease use of and, within thirty (30) days, return to FK all copies of the Software in Your possession or control or, at FK’s election, destroy all such copies. Termination or expiration of this Agreement shall not relieve You of any unmet payment obligations hereunder, which shall survive.
8. INDEMNIFICATION. You agree to hold harmless, defend, and indemnify FK, its affiliates and their respective officers, directors, employees, subsidiaries, contractors, subcontractors, suppliers, licensors, agents, partners, successors and assigns from all liabilities, claims, demands and expenses, including attorneys’ fees, to the extent due to or arising from Your breach of this Agreement, Your use or misuse of the Software, Your infringement or violation of any intellectual property rights or any other right of any third party, Your negligent or intentional acts and/or Your violation of applicable law. FK may assume exclusive control of any defense of any matter subject to indemnification by You, and You agree to cooperate with us in such event.
9. PEACEFUL POSSESSION GUARANTEE. You acknowledge and agree that FK makes no representation or warranty that any use by You of the Software will not infringe the intellectual property rights of any third party and accordingly any use by the licensee of any of the same shall be entirely at the licensee's risk but shall in any case be subject to all other provisions of this Contract.
10. LIMITATION OF LIABILITY; DISCLAIMER OF DAMAGES.
10.1 Limitation. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, THE TOTAL AGGREGATE LIABILITY OF FK AND ITS AFFILIATES AND THEIR RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES, SUBSIDIARIES, CONTRACTORS, SUBCONTRACTORS, SUPPLIERS, LICENSORS, AGENTS, PARTNERS, RESELLERS, DISTRIBUTORS, SUCCESSORS AND ASSIGNS UNDER ANY PROVISION OF THIS AGREEMENT OR OTHERWISE RELATED TO THIS AGREEMENT SHALL, FOR ANY AND ALL CLAIMS, BASED ON ANY THEORY OF LIABILITY, WHETHER CONTRACT, TORT, STRICT LIABILITY, NEGLIGENCE, OR OTHERWISE, WHETHER RELATING TO THE SOFTWARE, DOCUMENTATION, ANY SERVICES, OR OTHERWISE, SHALL NOT EXCEED THE TOTAL AMOUNT OF ANY DAMAGES THAT YOU MIGHT INCUR FOR ANY REASON WHATSOEVER, UP TO THE AMOUNT ACTUALLY PAID BY YOU FOR THE SOFTWARE.
10.2 Disclaimer. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW AND REGARDLESS OF THEORY OF LIABILITY, WHETHER CONTRACT, TORT, STRICT LIABILITY, NEGLIGENCE, OR OTHERWISE, IN NO EVENT SHALL FK OR ITS AFFILIATES OR THEIR RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES, SUBSIDIARIES, CONTRACTORS, SUBCONTRACTORS, SUPPLIERS, LICENSORS, AGENTS, PARTNERS, RESELLERS, DISTRIBUTORS, SUCCESSORS AND ASSIGNS BE LIABLE FOR ANY SPECIAL, INCIDENTAL, PUNITIVE, INDIRECT, OR CONSEQUENTIAL DAMAGES WHATSOEVER (INCLUDING, BUT NOT LIMITED TO, DAMAGES FOR LOSS OF PROFITS OR LOSS OR DAMAGE TO CONFIDENTIAL OR OTHER INFORMATION OR DATA, FOR BUSINESS INTERRUPTION, FOR PERSONAL OR BODILY INJURY, FOR LOSS OF PRIVACY, FOR FAILURE TO MEET ANY DUTY INCLUDING OF GOOD FAITH OR OF REASONABLE CARE, FOR NEGLIGENCE, NOR 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, THE PROVISION OF OR FAILURE TO PROVIDE SUPPORT OR OTHER SERVICES, OR OTHERWISE ARISING OUT OF THE USE OF THE SOFTWARE OR IN CONNECTION WITH ANY PROVISION OF THIS AGREEMENT OR OTHERWISE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
10.3 Basis of Agreement. THE FOREGOING LIMITATIONS, EXCLUSIONS AND DISCLAIMERS SHALL APPLY TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, EVEN IF A STATED REMEDY FAILS ITS ESSENTIAL PURPOSE, AND CONSTITUTE A FUNDAMENTAL ELEMENT OF THE BASIS OF THE BARGAIN OF THE PARTIES AND, BUT FOR SUCH LIMITATIONS, EXCLUSIONS AND DISCLAIMERS, FK WOULD NOT BE WILLING TO ENTER INTO THIS AGREEMENT.
11. FOREIGN EXPORT. You are not allowed to export the Software, directly or indirectly, into any country in violation of any applicable laws or regulations of your country and the targeted country. I.
12. DATA. You authorize FK to access and collect data for You consisting of such information as may be be stored in the data files of the Software or created using the Software, including data related to use of FK’s devices and softwares (collectively, “Data”). You authorize FK, and FK agrees, to de-identify all Data so accessed and collected by it, and otherwise constituting Protected Health Information (as that term is defined in your local regulation). FK may use and distribute in any manner not prohibited by law any documents, reports, analyses and/or other materials containing Data and/or information derived from Data and otherwise prepared and/or created by FK or the Software which either does not constitute Protected Health Information or which has first been de-identified in accordance with the procedures set forth in your local regulation. Under any circumstances, You are solely responsible for creating, validating and loading into the Software the specific Data You intend to use with the Software. You agree that You will use best practices and protocols in the creation of such Data and will provide to Your personnel reasonable and proper supervision, control and management of the use of the Software and Data. You agree to implement commercially reasonable data security, disaster recovery, data backup and related procedures and practices for the protection of Protected Health Information and other information consistent with best practices and protocols applicable to the management of information technology and data in a healthcare environment.
13. GENERAL PROVISIONS.
13.1 Assignment. You may not assign, sublicense, or otherwise transfer this Agreement or the license rights granted to You herein, or any of Your rights or obligations under this Agreement, to any party without the prior written consent of FK; provided, however, that You may assign this Agreement without FK’s consent in the event of a sale of all or substantially all of Your assets or in the event of a merger, corporate reorganization or business consolidation of Your entity (but excluding any assignment by You to a competitor of FK). This Agreement shall be binding upon and inure to the benefits of the parties, their legal representatives and permitted transferees, successors and assigns as permitted by this Agreement.
13.2 Instruction for use and accompanying documents
MEDICAL DEVICE SOFTWARE IFUs and/or accompanying are provided on the same screen of the device. Before INSTALLING, ACTIVATING, COPYING, OR USING ANY PORTION OF THE SOFTWARE, you have to DOWNLOAD and READ carefully the related documentation provided.
13.3 Software Installation Compliance. To ensure that Your installation and deployment of the Software is consistent with the MEDICAL DEVICE SOFTWARE DOWNLOAD rights granted hereunder and complies with the terms of this Agreement, FK or its representatives may conduct an audit of Your Software installation/deployment not more than once per year on thirty (30) days prior written notice. Such audit will require You to provide an unedited accurate report of all Software installed by You and all valid purchase documentation for all Software within thirty (30) days of request. If the audit findings demonstrate non-compliance with the MEDICAL DEVICE SOFTWARE DOWNLOAD rights granted hereunder, You shall purchase the necessary computering system within fifteen (15) days of being so notified. This section shall survive termination or expiration of the Agreement for a period of two (2) years. The foregoing shall not in any way be construed to limit any other rights and/or remedies that FK may have under law or equity.
13.4 No Waiver. No delay or failure in exercising any right hereunder and no partial or single exercise thereof shall be deemed to constitute a waiver of such right or any other rights hereunder. No consent to a breach of any express or implied term of this Agreement shall constitute a consent to any prior or subsequent breach.
13.5 Notices. With the exception of routine administrative communications between the parties which may be sent via e-mail, all notices under this Agreement shall be in writing to each party at their respective addresses set forth in the Order, to the attention of any individuals identified therein, with a copy to each party’s respective “Legal Department.” Notices shall be given personally or sent by traceable postal service mail, e.g., certified or registered mail, or private overnight courier (e.g., FedEx, UPS or DHL) and shall be deemed given upon delivery, if given personally, or when deposited with the overnight courier or national postal service with the proper postage affixed, if sent by mail, in accordance with this provision. Facsimile (faxed) notices are not effective unless the originals are sent (in the manner stated above) within one (1) business day after the facsimile transmission or they are acknowledged in writing by an authorized representative of the receiving party. The parties may change the address for notice by compliance with this Section.
13.6 Survival. The following provisions shall survive any termination or expiration of this Agreement: 2.2, 3, 4, 7, 8, 9, 10, 11, 12.
13.7 Severability. If any provision hereof is declared invalid by a court of competent jurisdiction, such provision shall be ineffective only to the extent of such invalidity, so that the remainder of that provision and all remaining provisions of this Agreement shall be valid and enforceable to the fullest extent permitted by applicable law.
13.9 Force Majeure. Notwithstanding anything in this Agreement to the contrary, neither party will be liable for any delay or failure with respect to any obligation hereunder, nor for any damages or loss of any kind, resulting from causes beyond its reasonable control, including without limitation, acts of God, earthquake, storms or other elements of nature, labor disputes, blockages, embargoes, riots or other industrial disturbances, electrical, telecommunications, Internet or other third party supplier delay or failure, acts or orders of government, criminal acts, war or terrorism, including cyberattack or other malicious intrusion into or breach of computer systems.
13.10 Governing Law. This Agreement shall be governed and interpreted in accordance with the European laws without regard to its conflicts of laws principles.
13.11 Complete Agreement. This Agreement, including all applicable Orders referencing and incorporating this Agreement, supersedes in full all prior discussions and agreements, oral and written, between the parties relating to the subject matter hereof, and constitutes the entire understanding and agreement of the parties. No additional terms and conditions proposed by You, whether electronically or otherwise or associated with any purchase order or otherwise, shall be applicable to this Agreement or any FK products or services at present or in the future, absent the express manual written consent thereto by FK.
13.12 Amendment or Modification. No amendment or modification of this Agreement shall be valid or binding upon the parties unless it is in writing and signed by the duly authorized officers of the parties.
13.13 No Third Party Benefit. The provisions of this Agreement are for the sole benefit of the parties hereto. Except as expressly provided herein, this Agreement neither confers any rights, benefits, or claims upon any person or entity not a party hereto nor precludes any actions against, or rights of recovery from, any persons or entities not parties hereto.
13.14 Conflicts. In the event of any conflict between the terms and conditions in the body of this Agreement and any inconsistent terms contained in an exhibit or attachment expressly agreed to by the parties to be made part of this Agreement, including an Order, the terms and conditions in the body of this Agreement shall prevail and control over the terms and conditions in such exhibit, attachment or Order.
13.15 Execution. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original but which together shall constitute the same instrument. As this Agreement is executed in electronic form, you agree to be bound by downloading the software on FK website.
13.16 Terms Generally. The defined terms in this Agreement shall apply equally to both the singular and the plural forms of the terms defined. The term “person” includes individuals, corporations, partnerships, trusts, other legal entities, organizations and associations, and any government or governmental agency or authority. The words “include,” “includes” and “including” shall be deemed to be followed by the phrase “without limitation.” The words “approval,” “consent” and “notice” shall be deemed to be preceded by the word “written.” References to this Agreement or the “terms” of this Agreement in the context of any requirement of either party to perform in accordance with this Agreement shall be interpreted to refer to all terms and conditions of this document, and all other terms and conditions as may be contained in an agreed upon Order, exhibit or attachment.
Without in any way diminishing the intent or effect of the first paragraph of this Agreement, if this Agreement is provided to You in electronic form, the parties hereby execute this Agreement by their respective, duly authorized officers or representatives.
Medical Device Accompanying Documents
PLEASE READ THIS AGREEMENT CAREFULLY. THIS MEDICAL DEVICE ACCOMPANYING DOCUMENT DOWNLOAD AGREEMENT (“AGREEMENT”) IS A LEGAL AGREEMENT BETWEEN YOU, EITHER AS AN INDIVIDUAL OR A SINGLE LEGAL ENTITY (“YOU”), AND FRESENIUIS KABI AG (“FK”), GOVERNING YOUR USE OF FK’S PROPRIETARY USER DOCUMENTATION (“DOCUMENTATION”). THIS AGREEMENT IS ENFORCEABLE AGAINST YOU AND ANY LEGAL ENTITY THAT OBTAINED THE DOCUMENTATION, E.G., YOUR EMPLOYER IF YOU ARE AN INDIVIDUAL. IF YOU ARE AN INDIVIDUAL ACTING ON BEHALF OF AN ENTITY, E.G., YOUR EMPLOYER, YOU REPRESENT AND WARRANT THAT YOU HAVE BEEN AUTHORIZED AND HAVE AUTHORITY TO ENTER INTO THIS AGREEMENT ON BEHALF OF SUCH ENTITY. BY DOWNLOADING, COPYING, OR USING ANY PORTION OF THE DOCUMENTATION, YOU ACCEPT THIS AGREEMENT IN ITS ENTIRETY. IF YOU DO NOT AGREE TO ALL OF THE TERMS OF THIS AGREEMENT WITHOUT MODIFICATION, DO NOT DOWLOAD, COPY OR USE THE DOCUMENTATION.
This documentation is regulated under European commission regulation (EU) No 207/2012
of 9 March 2012 on electronic instructions for use of medical devices or equivalent local requirements on medical device.
In any case, for reasons of safety and efficiency, you have the possibility to obtain those instructions for use in paper form on request at no additional cost, within the time period of 7 calendar days at the latest. For such request, please contact your local FK representative.
Before downloading / reading any documentation, you shall check that the document version matches with your device version and language. In case of non availability of document related to your device or in your language, you shall not download any other version and contact your local FK representative to request the appropriated document.
The Regulatory Affairs Platform includes different types of regulatory documents such as Declaration of Conformity, EC certificates, Instructions for Use and other documents related to each medical device.
All these documents are categorized following the below items.