End User License Agreement
Hygiena PCR INSTRUMENT, SYSTEM and services end user LICENSE agreement
Last modified: December, 2025
This End User License Agreement (“EULA”) is between you (“you” or “your”) and Hygiena LLC (“Hygiena,” “our” or “we”) and applies to your access to and use of the PCR instrument with which this EULA is incorporated (the “Instrument”) and that was supplied by Hygiena to the party that purchased or leased the instrument (“Customer”). The Instrument is part of a “System” that includes (i) the Instrument; (ii) a separate, third-party laptop computer that may be used to operate the Instrument (the “Laptop”); and (iii) software that is embedded in the Instrument, installed on the Laptop and/or hosted in a cloud environment (the “Software”). Through your use of the System, you may establish a user account, access hosted tools and technology developed by Hygiena and generate results from testing samples (the “Services”). The System also includes documentation that describes the use and operation of the Instrument, the Laptop, the Software and the Services (the “Documentation”). We may modify, improve and update the System and the Services from time to time, including by delivering software updates to you (“Updates”), and this EULA applies to the System and Services as modified by us or our authorized representatives, including Updates.
PLEASE READ THIS AGREEMENT CAREFULLY. BY CLICKING ON THE “I AGREE” BUTTON, YOU ACKNOWLEDGE THAT YOU HAVE READ THIS EULA, UNDERSTAND IT AND AGREE TO BE BOUND BY ITS TERMS AND CONDITIONS AND REPRESENT AND WARRANT THAT YOU ARE OF LEGAL AGE TO ENTER INTO A BINDING AGREEMENT AND HAVE BEEN AUTHORIZED BY CUSTOMER TO ACCESS AND USE THE SYSTEM AND THE SERVICES. IF YOU DO NOT AGREE TO BE BOUND BY EACH OF THE FOLLOWING TERMS AND CONDITIONS, YOU WILL NOT GET ACCESS TO THE SYSTEM OR THE SERVICE.
ATTENTION: PLEASE READ OUR PRIVACY POLICY at https://www.hygiena.com/privacy-policy CAREFULLY BEFORE ACCESSING THE SYSTEM AND THE SERVICES. IF YOU DO NOT ACCEPT THE PROCESSING OF PERSONAL INFORMATION AS DESCRIBED PRIVACY POLICY, DO NOT USE OR OTHERWISE ACCESS THE SYSTEM OR THE SERVICES.
ARBITRATION NOTICE: THESE TERMS OF USE CONTAIN AN ARBITRATION CLAUSE IN SECTION 21. EXCEPT FOR CERTAIN TYPES OF DISPUTES DESCRIBED IN SECTION 21, DISPUTES BETWEEN HYGIENA AND YOU WILL BE RESOLVED BY MANDATORY BINDING ARBITRATION.
Customer Agreement
You acknowledge that Customer purchased, leased or otherwise received the right to hold and use the System under a master services or other agreement by and between Hygiena and Customer (the “Customer Agreement”) and that your rights to access and use the System and Software as permitted in this EULA is solely for the purpose of testing samples for the benefit of Customer within the scope of your employment or engagement by Customer. All information that you enter into the System (“Customer Data”) and all results generated by the System and Services from the testing of samples (“Results”) are solely owned by Customer.
License Grant
Subject to the terms and conditions of this EULA, Hygiena grants to you a nonexclusive, nontransferable, limited license during the term, without right of sublicense, (a) to access and use the System and the Services; (b) to copy, distribute and use unmodified versions of Results; and (c) to install and run Updates to the Software when provided by Hygiena or its representatives but only on the Instrument or Laptop to which such Updates apply, in each case solely for the purpose of testing samples and generating Results for your analysis within the scope of your employment or engagement by Customer (the “Permitted Use”).
Third-Party Technology
You acknowledge that (a) the Instrument and the Laptop are manufactured by third parties and are sold, leased or loaned to Customer by Hygiena or an authorized reseller (“Third-Party Hardware”); (b) elements of the Software contain code and other materials licensed from third parties (“Third-Party Software”); and (c) portions of the Services are hosted by third-party vendors and hosting services (“Third-Party Services” and, collectively, “Third-Party Technology”). Third-Party Technology may be subject to additional terms (“Third-Party Terms”), which terms are set forth here: https://www.hygiena.com/eula. In addition, some elements of Third-Party Software may require provision or reproduction of certain notices or license terms upon distribution (collectively, “Third-Party Notices”), which notices are set forth here: https://www.hygiena.com/eula. You and Customer are responsible for regularly reviewing such terms to determine the status of, and for complying with, all such applicable terms and conditions. Your use of the System and Services is contingent on compliance with these additional terms of license (however such rights do not expand the license grants herein or your permitted use). If Hygiena’s rights to provide any Third-Party Technology are terminated, expire, or are otherwise diminished, you understand and agree that Hygiena may cease to include the applicable Third-Party Technology in the System and Services and may terminate the affected functionality in, or of, the System and Services with or without notice to you. HYGIENA WILL HAVE NO LIABILITY WHATSOEVER TO YOU WITH RESPECT TO ANY DIMINISHMENT IN THE FUNCTIONALITY IN THE SYSTEM AND SERVICES.
Restrictions on Use
We reserve all rights not granted to you. Except as expressly permitted under this EULA, you agree not to, and you will not permit others to: (a) license, sublicense, sell, resell, market, rent, lease, assign, transfer, distribute, transmit, host, outsource, display, perform, disclose or otherwise commercially exploit the System and Services or make the System and Services (or any portion thereof) available to any third-party; (b) copy or use the System and Services for any purpose; (c) remove or alter any trademark, logo, copyright or other proprietary notices, legends, symbols or labels in the System and Services; (d) modify, make derivative works of, disassemble, reverse compile or reverse engineer any part of the System and Services (except to the extent applicable laws specifically prohibit such restriction for interoperability purposes, in which case you agree to first contact Hygiena and provide Hygiena an opportunity to create such changes as are needed for interoperability purposes); (e) attempt to access or derive the source code of the Software; (f) share your log-in credentials with any other person or access the System and Services using another person’s log-in credentials, unless approved by Customer; (g) modify or make unauthorized repairs to the Instrument or Laptop; (h) use the Instrument or Laptop in a manner that is not consistent with the Documentation for the Instrument; or (i) use the System and Services except for the Permitted Use.
Supplemental Terms for New Products
From time to time, Hygiena may offer Customer additional products and services that are compatible with or incorporated into the System and Services (“New Products”) and that are subject to additional terms and conditions that are applicable to you (“Supplemental Terms”). If Customer purchases or licenses any New Products, you agree that you will be bound by the applicable Supplemental Terms when you begin use of the New Product(s). Supplemental Terms are in addition to the applicable terms and conditions of this EULA. Unless expressly provided in the Supplemental Terms, all terms and conditions of this EULA will apply to your use of New Products. Supplemental Terms will be made available at https://www.hygiena.com/terms-and-conditions . Hygiena will use reasonable efforts to notify you when Supplemental Terms are posted, which notice may be made within the functionality of the New Products. Supplemental Terms may be amended in accordance with Section 20.
Safety Warning
Hygiena does not manufacture the Third-Party Hardware and does not control its safety features. You must use all Third-Party Hardware in a reasonable manner, using due care, and only for the Permitted Purpose. You must not modify or repair Third-Party Hardware except as expressly authorized by Hygiena or its authorized representatives or as provided in the Documentation for such Third-Party Hardware. To the fullest extent permitted by applicable laws, Hygiena disclaims all liability arising from your use of Third- Party Hardware.
Compliance; Export Controls
You agree to use the System and Services in accordance with all laws, rules and regulations applicable to you and Customer. Software and the transmission of applicable technical data, if any, in connection with the System and Services may be subject to export controls. You agree to comply with all applicable laws regarding software and the transmission of technical data exported from the U.S. or the country in which you reside, and you further agree that you will not export or reexport, directly or indirectly, the System and/or the Services into any country prohibited by the United States Export Administration Act and the regulations thereunder or other applicable U.S. law.
Suspension of Services
Subject to any additional terms under the Customer Agreement, Hygiena reserves the right to suspend or terminate your access to the System and the Services if Hygiena determines, in its sole discretion, that you have violated this EULA or that your continued use of the System and the Services poses a risk to Hygiena, other authorized users or any other third-party, including Hygiena’s affiliates.
Ownership
You acknowledge and agree that (a), as between you and Hygiena, Hygiena is the sole owner of all right, title and interest (including all intellectual property rights) in and to the System and the Services, and all components thereof; and (b) you do not acquire any ownership interest in the System and Services. You will not act in any way which may impair any such rights in and to the System and the Services.
Suggestions
You hereby grant to Hygiena a royalty-free, worldwide, transferable, sublicensable (through multiple tiers), irrevocable, perpetual license to use or incorporate in the System and Services any suggestion, enhancement requests, recommendations of other feedback provided by you relating to the operation, features or functionality of the System and/or the Services.
U.S. Government End Users
The System is a “commercial item,” as that term is defined in 48 C.F.R. 2.101 (Oct. 1995), consisting of “commercial computer software” and “commercial computer software documentation,” as such terms are used in 48 C.F.R. 12.212 (Sept. 1995). Consistent with 48 C.F.R. 12.212 and 48 C.F.R. 227.7202-1 through 227.7202-4 (June 1995), all U.S. Government end users acquire use of the System and Services with only those rights set forth herein.
European End Users
If the System is used within a country of the European Union, nothing in this Agreement shall be construed as restricting any rights available under Directive 2009/24/EC of the European Parliament and of the Council of 23 April 2009 on the legal protection of computer programs.
Confidentiality
“Confidential Information” means the Software, the Documentation and the proprietary and confidential components of the System and the Services and all other confidential or proprietary information disclosed or made accessible to you by Hygiena, except for information which you can demonstrate is available to the public prior to disclosure to you or becomes available to the public by publication or otherwise without your fault. You will not use or disclose any Confidential Information except as expressly authorized by this EULA. You will protect all Confidential Information using the same degree of care which you use to protect your own confidential information, but in no event less than a reasonable degree of care. You will take prompt and appropriate action to prevent unauthorized use or disclosure of Confidential Information. If you are legally compelled to disclose any Confidential Information, you will provide Hygiena prompt written notice of such requirement so that an appropriate protective order or other relief may be sought.
Term and Termination
This EULA is effective as of the date on which you accept this EULA and shall remain in effect until the earliest to occur of the following events: (a) this EULA is terminated by you or by Hygiena in accordance with this Section 14; (b) your employment with or engagement by Customer ends or Customer otherwise terminates your right to access and use the System and Services (which termination will be conclusive if Customer notifies Hygiena of such termination); and (c) the expiration or termination of the Customer Agreement between Hygiena and Customer. Hygiena may terminate this EULA if you fail to comply with any of the terms of this EULA, with written notice to you. You may terminate this EULA at any time with written notice to us or by ceasing use of the System and Services and destroying all copies thereof. Upon termination of this EULA, your license will terminate and you must stop all use of the System and the Services and destroy all copies of any portion of the System and the Services, including Documentation, that is in your possession or control. Termination of this EULA will also terminate your right and license to access and use any New Products that were purchased or acquired during the term of this EULA, unless Hygiena approves in writing otherwise. All defined terms and the following sections will survive termination of this EULA: 1, 3 and 9 through 22.
Disclaimer of Warranties
EXCEPT AS EXPRESSLY SET FORTH IN THE CUSTOMER AGREEMENT, TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE SYSTEM AND SERVICES ARE PROVIDED “AS IS” AND WITH ALL FAULTS AND DEFECTS WITHOUT ANY WARRANTY OF ANY KIND, AND HYGIENA, ON ITS OWN BEHALF AND ON BEHALF OF ITS AFFILIATES AND ITS AND THEIR RESPECTIVE MANUFACTURERS, LICENSORS AND SERVICE PROVIDERS, EXPRESSLY EXCLUDES AND DISCLAIMS ANY WARRANTIES, WHETHER EXPRESS, IMPLIED OR STATUTORY, OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT AND WARRANTIES ARISING FROM COURSE OF DEALING, COURSE OF PERFORMANCE, USAGE OR TRADE PRACTICE. WITHOUT LIMITING THE FOREGOING, HYGIENA DOES NOT WARRANT THAT ACCESS TO, OR OPERATION OF, THE SYSTEM OR THE SERVICES (INCLUDING WITHOUT LIMITATION, THE CUSTOMER DATA AND THE RESULTS) WILL BE UNINTERRUPTED, SECURE, MEET ANY PERFORMANCE OR RELIABILITY STANDARDS, OR BE ERROR-FREE, THAT ALL ERRORS CAN OR WILL BE CORRECTED, OR THAT THE SYSTEM OR THE SERVICES (INCLUDING WITHOUT LIMITATION THE CUSTOMER DATA AND RESULTS) OR ANY COMPONENT THEREOF, OR WILL SATISFY YOUR OR ANY THIRD-PARTY’S REQUIREMENTS. YOU ARE SOLELY RESPONSIBLE FOR REVIEWING, UNDERSTANDING AND INTERPRETING THE RESULTS GENERATED BY THE SYSTEM AND THE SERVICES.
Limitation of Liability
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL (a) HYGIENA OR ITS AFFILIATES, OR ANY OF ITS OR THEIR RESPECTIVE MANUFACTURERS, LICENSORS OR SERVICE PROVIDERS, BE LIABLE UNDER OR AS A RESULT OF THIS EULA TO YOU OR TO ANY THIRD-PARTY FOR ANY INDIRECT, SPECIAL, INCIDENTAL, PUNITIVE, CONSEQUENTIAL OR EXEMPLARY DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF GOODWILL, WORK STOPPAGE, EQUIPMENT FAILURE OR MALFUNCTION, LOST OR CORRUPTED DATA, LOST PROFITS, LOST BUSINESS OR LOST OPPORTUNITY), OR ANY OTHER SIMILAR DAMAGES, UNDER ANY THEORY OF LIABILITY (WHETHER IN CONTRACT, TORT, STRICT LIABILITY OR ANY OTHER THEORY), EVEN IF HYGIENA HAS BEEN INFORMED OF THE POSSIBILITY THEREOF, AND (b) HYGIENA’S TOTAL, CUMULATIVE LIABILITY FOR ANY LOSS, COST, CLAIM, LEGAL ACTION OR DAMAGES OF ANY KIND (WHETHER IN CONTRACT, TORT, STRICT LIABILITY OR ANY OTHER THEORY) ARISING OUT OF OR RELATED TO THIS EULA EXCEED $100. NO CLAIM, REGARDLESS OF FORM, WHICH IN ANY WAY ARISES OUT OF THIS EULA MAY BE MADE OR BROUGHT BY YOU MORE THAN ONE (1) YEAR AFTER THE BASIS FOR THE CLAIM BECOMES KNOWN TO YOU. THE LIMITATIONS OF LIABILITY SET FORTH IN THIS SECTION 16 AND EXCLUSION OF CERTAIN DAMAGES SHALL APPLY REGARDLESS OF THE SUCCESS OR EFFECTIVENESS OF ANY EXCLUSIVE REMEDIES.
Jurisdictional Restrictions
SOME STATES, COUNTRIES OR JURISDICTIONS LIMIT THE SCOPE OF OR PRECLUDE LIMITATIONS OR EXCLUSION OF REMEDIES OR DAMAGES, OR OF LIABILITY, SUCH AS LIABILITY FOR GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, OR DO NOT ALLOW IMPLIED WARRANTIES TO BE EXCLUDED. IN SUCH STATES, COUNTRIES OR JURISDICTIONS, THE LIMITATION OR EXCLUSION OF WARRANTIES, REMEDIES, DAMAGES OR LIABILITY SET FORTH ABOVE MAY NOT APPLY TO YOU. HOWEVER, THE LIMITATION OR EXCLUSION OF WARRANTIES, REMEDIES, DAMAGES OR LIABILITY SET FORTH ABOVE SHALL APPLY TO THE FULLEST EXTENT PERMITTED BY LAW. YOU MAY ALSO HAVE OTHER RIGHTS THAT VARY BY STATE, COUNTRY OR OTHER JURISDICTION.
Indemnification
You will defend, indemnify and hold harmless Hygiena, its Affiliates, and each manufacturer, licensor or service provider that makes available any Third-Party Technology and their respective directors, officers, employees, representatives, members, and agents against all claims, actions and demands, and all reasonable attorney’s fees, expert fees, costs and expenses and all liability, losses and damages incurred or arising in connection therewith, arising out of or relating to: (a) your breach of this EULA; (b) your misuse of the System or Services; and (c) your negligence, gross negligence or willful misconduct.
Intended Third-Party Beneficiaries
YOU ACKNOWLEDGE THAT EACH AFFILIATE OF HYGIENA AND EACH MANUFACTURER, LICENSOR AND SERVICE PROVIDER THAT MAKES AVAILABLE ANY THIRD- PARTY TECHNOLOGY IS AN INTENDED THIRD-PARTY BENEFICIARY OF THE RELEASES, WAIVERS AND COVENANTS GIVEN BY YOU IN THIS EULA. SUBJECT TO THE FOREGOING, NOTHING IN THIS EULA IS INTENDED TO CONFER ANY RIGHT, REMEDY, CAUSE OF ACTION OR LIABILITY ON ANY PERSON OTHER THAN HYGIENA AND ITS SUCCESSORS AND ASSIGNS AND YOU.
Amendment
Without limiting Section 5, Hygiena may amend this EULA and any term or condition set forth herein, including any Supplemental Terms, by delivering notice to you (which notice may be provided through your user account) or by notice to the Customer that has given you access to the System and the Services, and the amendment will be effective thirty (30) days after Hygiena gives such notice. Third-Party Terms and Third-Party Notices may be amended from time to time by updating the applicable webpage at https://www.hygiena.com . The Privacy Policy may be amended from time to time in accordance with its terms. Except as provided in this Section 20, no provision of this EULA may be modified, amended, waived or terminated except by an instrument in writing signed by the parties hereto. No course of dealing between the parties will modify, amend, waive or terminate any provision of this EULA or any rights or obligations of any party under or by reason of this EULA.
Dispute Resolution
- Governing Law. The laws of the State of [Delaware, USA] will govern this EULA, without reference to its conflicts of law principles. The United Nations Convention on Contracts for the Sale of Goods does not apply to this EULA. The Uniform Computer Information Transactions Act will not apply to this EULA, or any business conducted pursuant to it, regardless of when and however adopted, enacted and amended under the laws of any jurisdiction.
- Arbitration. Any controversy or claim arising out of or relating to this Agreement, or the breach thereof, shall be finally determined by arbitration administered by JAMS in accordance with the JAMS Commercial Arbitration Rules (the “Rules”). The place of arbitration shall be [Delaware, USA]. The number of arbitrators shall be one (1). The arbitration shall be conducted in the English language, and the English-language version of this EULA will be controlling. Notwithstanding any contrary provisions in the Rules, each party shall bear its own costs and expenses of the arbitration and one-half (1/2) of the fees and costs for the arbitrator unless the arbitrator determines the fees and costs should be borne by one of the parties. The arbitrator may not award or assess punitive damages against either party.
- Equitable Relief. You recognize and agree that Hygiena would suffer irreparable damage as a result of any breach or threatened breach of Section 4 (Restrictions on Use), Section 6 (Safety Warning) or Section 13 (Confidentiality) or by your misuse or misappropriation of Hygiena’s intellectual property rights. You therefore agree that if you breach or threaten to breach of Section 4, Section 6 or Section 13 or if you misuse or misappropriate Hygiena’s intellectual property rights (or threaten to do so), in addition to any other legal or equitable remedies available, Hygiena shall have the remedy of seeking a restraining order or other appropriate equitable relief in addition to its right to arbitration. Such relief may be brought in the state or federal courts having jurisdiction and sitting in [Los Angeles County, California, USA], and the parties consent to the non-exclusive jurisdiction of such courts
General
This EULA is the entire and exclusive agreement between you and Hygiena with respect to the subject matter hereof. This EULA is intended to be interpreted in a manner consistent with the Customer Agreement, and nothing in this EULA is intended to modify any term in the Customer Agreement or limit either party’s rights or remedies under the Customer Agreement. If any provision of this EULA is held to be unenforceable, that provision will be removed and the remaining provisions will remain in full force. The failure of either party to require performance by the other party of any provision hereof will not affect the full right to require such performance at any time thereafter; nor will the waiver by either party of a breach of any provision hereof be taken or held to be a waiver of the provision itself. You shall not assign or otherwise transfer any of your rights, or delegate or otherwise transfer any of your obligations or performance, under this EULA, in each case whether voluntarily, involuntarily, by operation of law, or otherwise, without Hygiena’s prior written consent; provided that the foregoing restriction does not prohibit the transfer by Customer of the System and Software to a successor-in-interest to Customer if the Customer Agreement is assigned in accordance with the terms and conditions of the Customer Agreement. Any purported assignment, delegation, or transfer in violation of this Section 22 is void. Neither party will be responsible to the other party for failure or delay of performance if caused by: an act of war, hostility, or sabotage; acts of God; droughts, floods, hurricanes and other such weather events; pandemic; electrical, internet, or telecommunication outage that is not caused by the obligated party; government restrictions (including the denial or cancelation of any export, import or other license); or other event outside the reasonable control of the obligated party. This EULA will not be construed as creating a relationship of employment, agency, partnership, joint venture, or any other form of legal association. Neither party has any power to bind the other party or to assume or to create any obligation or responsibility on behalf of the other party. All notices and other communications required or permitted under this EULA will be in writing and will be deemed given (a) if to Hygiena, when delivered to Hygiena LLC, Attn: legal@hygiena.com; or, (b) if to you, when delivered by (i) courier service (including via First Class Mail with the United States Postal Service) to the mailing address on file with Hygiena, (ii) e-mail to the e-mail address on file with Hygiena; (iii) by placing a notice within your user account; (iv) by notifying Customer in accordance with notice provisions in the Customer Agreement; and (v) any other reasonable method.