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.OVERVIEW.
1.1License
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.
2.1License.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.
2.2Restrictions.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, patentrights,
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
Agreementand
You agree not
to take any action that interferes, in any manner, with FK’sor 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.
6.1Contractual
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.
6.2Warranty
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.
10.1Limitation.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.
10.2Disclaimer.
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.
10.3Basis
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.
13.1Assignment.
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.
13.2Instruction
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.
13.3Software
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.
13.4No
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.
13.5Notices.
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.
13.6Survival.
The
following provisions shall survive any termination or expiration of
this Agreement: 2.2, 3, 4, 7, 8, 9, 10, 11, 12.
13.7Severability.
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.
13.8Third
Party Software. Third
party materials, e.g., software, and services included in or accessed
through the Software may be subject to other terms and conditions
typically found in a separate license agreement, terms of use or read
me file located within or near such materials and services or
included within the Software.
13.9Force
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.
13.10Governing
Law. This
Agreement shall be governed and interpreted in accordance with the
European laws without regard to its conflicts of laws principles.
13.11Complete
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.
13.12Amendment
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.
13.13No
ThirdParty
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.
13.14Conflicts.
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.
13.15Execution.
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.
13.16Terms
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 theirrespective, duly
authorized officers or representatives.
eIFU download customer agreement
FRESENIUS KABI
Medical Device Accompanying
Documents
Download Agreement
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.
These
documentation will be available in electronic form, on request, for a
period of 15 years after the release date of the concerned device
version.
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.