RESEARCH USE ONLY
Customer is hereby put on notice that AGENA BIOSCIENCE (“AGENA”) products, including the MassARRAY System, and all other MassARRAY System-related hardware, software, and consumables (except the MassARRAY Dx System, and all other MassARRAY Dx System-related hardware, software, and consumables) are Research Use Only and have not been subjected to regulatory review or cleared or approved by the United States Food and Drug Administration, by any other United States governmental agency or entity, or by any equivalent or similar governmental agency or entity outside the United States, and are not CLIA (or the regional equivalent thereof) registered or licensed or otherwise registered, licensed, or approved under any statute, rule, law, or regulation, for any purpose, whether commercial, diagnostic, medical, or otherwise. Customer bears sole responsibility and liability for validating all products purchased by Customer for Customer’s intended use. Customer assumes the entire risk as to the results and performance of AGENA’s products for Customer’s specific applications and use. “CLIA” means the Clinical Laboratory Improvement Amendments, 1988. Customer assumes full responsibility for the results and use of the results obtained from the use of AGENA’s products and related documentation. AGENA’s products, including the MassARRAY System, and all other MassARRAY System-related hardware, software, and consumables, (except the MassARRAY Dx System, and all other MassARRAY Dx System-related hardware, software, and consumables), are for research use only and are not to be used for diagnostic or medical purposes.
Warranty. This limited warranty extends only to Customer as original purchaser unless otherwise agreed upon in writing by AGENA. AGENA warrants that the MassARRAY System (meaning hardware and installed software but excluding consumables such as kits, chips, and reagents) will be free from defects in materials and workmanship and will conform to AGENA’s specifications in effect as of the date of delivery, and perform accordingly, until the earlier of (i) one (1) year from the date of installation; or (ii) sixteen (16) months from the date of shipment, (the “Warranty Period”) and only so long as the MassARRAY System remains unchanged and in the original condition supplied by AGENA. AGENA warrants that MassARRAY consumables (including but not limited to kits, chips, and reagents) will be free from defects in materials and workmanship and will conform to AGENA’s specifications in effect as of the date of delivery, and perform accordingly from the date of delivery up to the expiration date specified on the product packaging (the “Warranty Period”), provided that such consumables have been stored, handled, and used according to AGENA specifications, and otherwise remain unchanged and in the original condition supplied by AGENA.
Warranty Exclusions. The foregoing warranty does not include, and Customer is responsible for (i) periodic maintenance or calibration recommended for certain products; (ii) except for lasers, the replacement of hardware components such as but not limited to, dispense pins, liquid handler tips, and clean resin tools; (iii) maintaining a procedure to back-up any and all data generated by the MassARRAY System and reconstructing any lost or altered files, data, or programs; (iv) maintaining all computer networking as it relates to the integration of any components of the MassARRAY System outside of the System and within Customer’s networks; (v) proper disposal of waste products (e.g., oil, filter elements) that result from service work performed under the warranty. Further, the foregoing warranty shall not apply to an AGENA product that (i) has been subjected to improper or inadequate maintenance or calibration by Customer; (ii) has been used with third party hardware, software, interfacing, or other products or components provided by parties other than AGENA and not approved in writing by AGENA; (iii) has been used to process samples loaded on re-used and/or refurbished AGENA chip products (including SpectroCHIP® Arrays); (iv) has been repaired, modified, altered, assembled or disassembled, or moved from its original installation location, by persons other than AGENA or an AGENA authorized service provider; (v) has not been maintained, calibrated, operated or installed in accordance with AGENA’s written specifications including operator failure to perform standard operating procedures and routine maintenance as prescribed in the user guides; (vi) has been subjected to abuse, misuse, negligence, neglect, accident, or improper storage, installation, operation, or handling contrary to AGENA’s written specifications or any instructions provided by AGENA; (vii) has failed or been damaged due to environmental conditions at the site of installation including exposure to Bio- Safety Level 3 or 4 (as defined by the United States Occupational Health and Safety Administration) agents; exposure to radioactivity; or the use of or invasion by malicious software programs such as viruses; or (viii) has failed or been damaged due to causes beyond its reasonable control, including, but not limited to, acts of civil or military authority, riots, wars, terrorism, fires, floods, earthquakes, lightning, storms, and other acts of God.
Remedy. If during the Warranty Period AGENA is provided with prompt written notice by Customer of any product failure along with a detailed written description of the failure, then upon AGENA’s inspection and testing as may be necessary to confirm the failure and upon its determination that none of the warranty exclusions above are applicable, AGENA shall at its sole discretion and option, as Customer’s sole remedy and AGENA’s sole obligation under the foregoing warranty: (1) replace the products in whole or components thereof; or (2) repair (and recalibrate as necessitated by repair) the products. Replacement and repaired products and components may include functionally equivalent, reconditioned, refurbished, or new parts. For consumables, provided that AGENA has confirmed the failure and determined that none of the warranty exclusions above are applicable, AGENA reserves the right at its sole discretion to either replace the consumables or to provide Customer with credit for the purchase price paid only, prorated for the unusable portion of the consumables, to be used to offset future purchases. No refunds will be made. Depending upon the type of failure as determined by AGENA, if AGENA needs access to Customer’s facility, Customer shall provide AGENA with access to its facility and information deemed necessary to facilitate a repair, or if directed by AGENA, Customer shall return the products, in whole or in part, at AGENA’s expense per AGENA’s specific instructions provided at the time, or if no specific instructions are provided at the time, in accordance with AGENA’s then current written return procedures (which may be amended from time to time). Prior to any service visit, Customer must notify AGENA in writing of any decontamination of the MassARRAY System or any product that has been exposed to toxic or dangerous substances. No products or components may be returned to AGENA under any circumstances without AGENA’s prior authorization. During service performed at Customer’s facility, Customer must have a Customer representative on-site at all times. Any product or component that has been repaired or replaced under the warranty shall have warranty coverage for the remainder of the original Warranty Period.
EXCEPT FOR THE EXPRESS LIMITED WARRANTY SET FORTH HEREIN, AGENA MAKES NO OTHER WARRANTIES, ORAL OR WRITTEN, EXPRESS, IMPLIED, OR BY STATUTE, WITH RESPECT TO THE MASSARRAY SYSTEM, OR ANY HARDWARE, SOFTWARE, CONSUMABLES, COMPONENTS, AND DOCUMENTATION REGARDING ANY OF THE FOREGOING, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT OF PATENT RIGHTS OR VIOLATION OF INTELLECTUAL PROPERTY RIGHTS OF ANY KIND, OR ARISING FROM COURSE OF DEALING, PERFORMANCE, USAGE OR TRADE. FOR THE AVOIDANCE OF DOUBT, AGENA DOES NOT WARRANT, GUARANTEE, OR MAKE ANY REPRESENTATIONS REGARDING THE USE OR THE RESULTS OF THE USE, OF THE MASSARRAY SYSTEM OR ANY HARDWARE, SOFTWARE, CONSUMABLES, COMPONENTS, AND DOCUMENTATION IN TERMS OF CORRECTNESS, ACCURACY, RELIABILITY, OR OTHERWISE.
IN NO EVENT SHALL AGENA OR ITS SUPPLIERS BE LIABLE TO CUSTOMER OR ANY THIRD PARTY FOR LOST PROFITS, DATA OR BUSINESS, THE COSTS OF PROCUREMENT OF SUBSTITUTE PRODUCTS OR SERVICES, OR FOR ANY INDIRECT, SPECIAL, INCIDENTAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES OF ANY KIND ARISING OUT OF OR IN CONNECTION WITH USE OF THE MASSARRAY SYSTEM AND ANY HARDWARE, SOFTWARE, CONSUMABLES, COMPONENTS, AND DOCUMENTATION PROVIDED TO CUSTOMER BY AGENA, HOWEVER CAUSED AND REGARDLESS OF THE THEORY OF LIABILITY (WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY OR OTHERWISE). AGENA’s TOTAL AND CUMULATIVE LIABILITY ARISING UNDER OR IN CONNECTION WITH CUSTOMER’S USE OF THE MASSARRAY SYSTEM AND ANY HARDWARE, SOFTWARE, CONSUMABLES, COMPONENTS, AND DOCUMENTATION, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY OR OTHERWISE, SHALL BE LIMITED AND SHALL NOT EXCEED THE AMOUNT RECEIVED BY AGENA FROM CUSTOMER PURSUANT TO PURCHASE ORDER AND INVOICE OR WRITTEN CONTRACT WITH CUSTOMER. THE LIMITATIONS SET FORTH IN THIS SECTION SHALL APPLY REGARDLESS OF FORESEEABILITY AND EVEN IF AGENA OR ITS SUPPLIERS HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSSES, COSTS, OR DAMAGES. THE FOREGOING SHALL APPLY REGARDLESS OF ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.