BAX® System X5 User Guide
59
BAX® SYSTEM X5 LIMITATION OF WARRANTY AND LIABILITY
NOTICE: READ THIS LIMITATION OF WARRANTY AND LIABILITY BEFORE USING THE BAX® SYSTEM EQUIPMENT, ASSAYS, AND/OR MEDIA
(“BAX® SYSTEM”).
If the terms are not acceptable, notify Hygiena immediately and arrangements will be made for return of the unused Equipment,
assays, and/or media to Hygiena and for the refund of the purchase price, less shipping costs. USE OF BAX® SYSTEM EQUIPMENT, ASSAYS AND/OR
MEDIA CONSTITUTES AN ACCEPTANCE OF ALL TERMS AND CONDITIONS OF THIS LIMITATION OF WARRANTY AND LIABILITY. Any additional
or different terms in Buyer’s purchase form(s) are material alterations and hereby rejected.
1. BAX® System X5 Equipment should only be used with BAX® System X5 assays.
2. When used with BAX® System X5 PCR assays, BAX® System X5 Equipment is warranted be free of defects in materials, workmanship and design
that may appear under normal and proper use within twelve (12) months from the installation date to the first end user. BAX® System X5 PCR assays
are warranted to conform to the assay description under the conditions of use specified in the user documentation to the expiration date stamped on the
label. BAX® System media is warranted to meet standard specifications in effect on the date of shipment. Hygiena MAKES NO OTHER WARRANTY,
EITHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY AGAINST INFRINGEMENT, ANY WARRANTY OF
MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR THOSE ARISING BY LAW, STATUTE, USAGE OF TRADE, OR COURSE
OF DEALING. User assumes all risk and liability resulting from use of the BAX® System X5 Equipment, PCR assays and media, whether used singly or
in combination with other products.
3. BAX® System software: Hygiena warrants that for a period of 60 days from the date of first date of use by the Customer/end user, BAX® System
software media will be free from defect in materials and workmanship and that the BAX® System software will substantially perform in accordance with
the accompanying BAX® System software documentation. EXCEPT FOR THE EXPRESS WARRANTY ABOVE, HYGIENA MAKES NO OTHER
WARRANTY, EITHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY AGAINST INFRINGEMENT, ANY
WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR THOSE ARISING BY LAW, STATUTE, USAGE OF
TRADE, OR COURSE OF DEALING. User assumes all risk and liability resulting from use of the BAX® System software, whether used singly or in
combination with other products.
4. The accuracy of the BAX® System can be affected by factors over which Hygiena has no control, including, without limitation, the use of the Equipment,
assays and/or media in a manner that is contrary to the conditions of use, the procedures or the instructions specified by Hygiena. Because of the large
number of factors over which Hygiena has no control, Hygiena makes no promise or guarantee of the accuracy of or results obtained from the use of the
BAX® System. In particular, Hygiena disclaims any warranty or liability and assumes no responsibility whatever for the failure of the BAX® System due,
in whole or in part, to user’s failure to: (a) properly maintain Equipment, (b) maintain specified operating or storage conditions, (c) follow the specified
instructions, or (d) use the proper microbiological techniques consistent with the standard of care accepted in the industry for the proper collection,
storage, handling and preparation of the sample.
5. Externally caused failures, such as improper sample preparation, improper storage or loading of reagents, electrical outages, or out-of-specification
environmental conditions are not covered under this warranty. Equipment failures caused by spills, abuse, misuse, negligence, or improper operation
are not covered by this warranty. Modifications, service or repairs by parties other than Hygiena-authorized providers are not covered by this warranty
and, in fact, void this warranty. Circumstances beyond the reasonable control of Hygiena, including fire, explosions, accidents, flood, labor trouble or
shortage, war, act of or authorized by any government, inability to obtain suitable material, Equipment, fuel, power or transportation, or acts of God are
not covered under this warranty.
6. The BAX® System is designed to test only for the presence of the target organisms specified in the particular assay. The BAX® System has been
tested against many, but not all, strains of the target within the sample types specified in the user documentation. Hygiena, therefore, cannot and does
not make any representation or warranty that the BAX® System is capable of detecting every organism in the target genus, serotype, or species in any
sample source. Accordingly, the BAX® System should not be used as the sole test for the release of user’s products, nor should it be used as the sole
basis for determining the safety of user’s products.
7. CUSTOMER/USER ASSUMES ALL RISKS IN USING THE BAX® SYSTEM AND HYGIENA OR ITS AFFILIATES, DISTRIBUTORS, ITS LICENSORS
OR REPRESENTATIVES SHALL HAVE NO LIABILITY TO CUSTOMER/USER OR TO ANY OTHER PERSON OR ENTITY FOR ANY INDIRECT,
INCIDENTAL, SPECIAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES WHATSOEVER, INCLUDING, BUT NOT LIMITED TO, LOSS
OF REVENUE OR PROFIT, LOST OR DAMAGED DATA OR OTHER COMMERCIAL OR ECONOMIC LOSS EVEN IF CAUSED BY THE NEGLIGENCE
OF HYGIENA OR ITS REPRESENTATIVES AND/OR IF HYGIENA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, AND/OR IF
THEY ARE FORESEEABLE.
8. THE SOLE AND EXCLUSIVE REMEDY OF CUSTOMER/USER, AND THE SOLE AND EXCLUSIVE LIABILITY OF HYGIENA, ITS AFFILIATES,
DISTRIBUTORS, LICENSORS OR REPRESENTATIVES FOR ANY AND ALL CLAIMS, INCLUDING BREACH OF WARRANTY, TORT, CONTRACT,
STRICT LIABILITY, NEGLIGENCE OR OTHERWISE SHALL BE LIMITED TO THE FOLLOWING: (a) Should Equipment fail to conform with the
Paragraph 2 warranty, Hygiena shall, at its option: repair or replace the non-conforming Equipment with new or refurbished (repaired or rebuilt) functionally
equivalent Equipment or refund the purchase price; (b) Should BAX® System software fail to conform with the Paragraph 3 warranty, Hygiena will replace
it free of charge; (c) For all other claims, Hygiena may, at its option, refund the purchase price or replace the Equipment, assays or media; (d) In all
cases, user is responsible for the repackaging and return of non-conforming Equipment, along with the reinstallation of new or refurbished Equipment;
and (e) Equipment, assays or media shall not be returned without prior written permission from Hygiena, and then only in the manner prescribed by
Hygiena. The maximum liability of Hygiena, its affiliates, distributors and licensors, and whether or not based on negligence, shall not exceed in the
aggregate the amount equal to: (a) the purchase price of the BAX® System X5 Equipment, PCR assays or media for which damages are claimed, or (b)
in the case of BAX® System software, the amount paid for the software (if licensed separately) or two thousand dollars ($2,000.00USD). Customer/user
shall notify Hygiena of any claim within thirty (30) days thereof and shall commence any action against Hygiena within one (1) year of the cause of action
or otherwise be barred from any remedy. Hygiena shall not be responsible for cost, loss or liabilities that arise
from customer/user’s operation of its
business, and customer/user agrees to indemnify, defend and hold Hygiena and its representatives harmless from such cost, loss or liability.
0615
