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Ellume COVID-19 Home Test Terms and Conditions

These Terms and Conditions are a legally binding contract between You (defined below) and Ellume, LLC (“Ellume,” “we,” or “us”) regarding use of the COVID-19 Home Test (defined below).

PLEASE READ THE FOLLOWING TERMS CAREFULLY.

BY CLICKING “I ACCEPT,” OR BY DOWNLOADING OR INSTALLING THE APP (DEFINED BELOW), OR OTHERWISE ACCESSING OR USING THE COVID-19 HOME TEST,YOU AGREE THAT YOU HAVE READ AND UNDERSTOOD, AND, AS A CONDITION TO USE OF THE COVID-19 HOME TEST (INCLUDING ON ANY SUBJECT (AS DEFINED BELOW)), YOU AGREE TO BE BOUND BY, THE FOLLOWING TERMS AND CONDITIONS, TOGETHER WITH THE COVID-19 HOME TEST PRIVACY POLICY (TOGETHER, THESE “TERMS”). IF YOU ARE NOT ELIGIBLE UNDER SECTION 2 BELOW, OR DO NOT AGREE TO THESE TERMS, THEN USE OF THE COVID-19 HOME TEST IS NOT PERMITTED. USE OF THE COVID-19 HOME TEST, AND ELLUME’S PROVISION OF THE COVID-19 HOME TEST, CONSTITUTES AN AGREEMENT BY ELLUME AND BY YOU TO BE BOUND BY THESE TERMS.

ARBITRATION NOTICE. Except for certain kinds of disputes described in Section 15, You agree that disputes arising under these Terms will be resolved by binding, individual arbitration, and BY ENTERING TO THESE TERMS, YOU AND ELLUME ARE EACH WAIVING THE RIGHT TO A TRIAL BY JURY OR TO PARTICIPATE IN ANY CLASS ACTION OR REPRESENTATIVE PROCEEDING. YOU AGREE TO GIVE UP YOUR RIGHT TO GO TO COURT to assert or defend Your rights under this contract (except for matters that may be taken to small claims court). Your rights will be determined by a NEUTRAL ARBITRATOR and NOT a judge or jury. (See Section 15.)

INDICATION FOR THE COVID-19 HOME TEST. The COVID-19 Home Test is authorized for non-prescription home use, and is intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens from mid-turbinate nasal swabs that are self-collected by an individual age 16 years or older, or are collected by a person aged 18 years or older from an individual age 2 years and older. This test is intended for use in individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection. Utilizing the App, users follow step-by-step instructions found in the App to perform the test, and results are transmitted to the user’s smartphone and displayed via the App. As stated in the Instructions (defined below), You should not use this test on anyone under 2 years of age, if You or a Subject is prone to nose bleeds, or if You or a Subject had a facial or head injury/surgery in the last 6 months.

As used in this document, the following terms have the following meanings:

“Affiliate” means, with respect to Ellume, any entity that currently or in the future directly or indirectly controls, is controlled by, or is under common control with Ellume, where “control” means the power to direct or cause the direction of the management of Ellume, whether through the ownership of voting securities, by contract, or otherwise.

“Analyzer” means the single-use hardware device developed by or on behalf of Ellume as identified in the Product Information Leaflet.

“App” means the mobile software application developed by or on behalf of Ellume as identified in the Product Information Leaflet.

“COVID-19 Home Test” means the “Ellume COVID-19 Home Test,” as referenced and authorized in the EUA, which is manufactured by or on behalf of Ellume Limited.

“EUA” means the Emergency Use Authorization issued by the FDA found at https://www.fda.gov/media/144457/download.

“FDA” means the U.S. Food and Drug Administration.

“Instructions” means all printed and digital materials, labeling, and links developed by or on behalf of Ellume and included in or distributed with the COVID-19 Home Test, such as the Product Information Leaflet, Quick Start Guide, Frequently Asked Questions, instructions in the App, and outer package instructions, in each case as updated by Ellume from time to time.

“Nasal Swab” means the mid-turbinate nasal swab developed by or on behalf of Ellume as identified in the Product Information Leaflet.

“Software” means the App and all software embedded within the Analyzer.

“Subject” means any individual other than You whose Nasal Swab sample is collected by You.

“You” means you, an individual who is bound to these Terms.

LEGAL DISCLAIMERS: WITHOUT LIMITING ANY OTHER TERMS SET FORTH IN THESE TERMS, THE FOLLOWING DISCLAIMERS APPLY:

THE COVID-19 HOME TEST IS AUTHORIZED BY THE FDA UNDER AN EUA BUT IS NOT OTHERWISE FDA CLEARED OR APPROVED. THIS PRODUCT HAS BEEN AUTHORIZED ONLY FOR THE DETECTION OF PROTEINS FROM SARS-COV-2 BASED ON WHAT WE KNOW ABOUT SARS-COV-2 AT THE TIME FDA ISSUED THE EUA AND IS NOT AUTHORIZED FOR DETECTING ANY OTHER VIRUSES OR PATHOGENS. THIS PRODUCT IS ONLY AUTHORIZED FOR THE DURATION OF THE DECLARATION BY THE FDA THAT CIRCUMSTANCES EXIST JUSTIFYING THE AUTHORIZATION OF EMERGENCY USE OF IN VITRO DIAGNOSTICS FOR DETECTION AND/OR DIAGNOSIS OF COVID-19 UNDER SECTION 564(B)(1) OF THE FEDERAL FOOD, DRUG AND COSMETIC ACT, 21 U.S.C. § 360BBB-3(B)(1), UNLESS THE DECLARATION IS TERMINATED OR AUTHORIZATION IS REVOKED SOONER.

THE COVID-19 HOME TEST IS NOT INTENDED TO REPLACE CARE PROVIDED BY A DOCTOR OR ANY HEALTHCARE PROFESSIONAL. THE COVID-19 HOME TEST DOES NOT GENERATE OR PROVIDE ANY MEDICAL ADVICE OR OPINIONS, NOR DOES THE USE OF THE COVID-19 HOME TEST ESTABLISH A DOCTOR-PATIENT RELATIONSHIP BETWEEN ANY PERSON AND ELLUME. USE OF THE COVID-19 HOME TEST IS FOR INFORMATIONAL PURPOSES ONLY AND DOES NOT SERVE AS A SUBSTITUTE FOR THE ADVICE OF A MEDICAL PROFESSIONAL. ELLUME IS NOT RESPONSIBLE FOR VERIFYING, AND DOES NOT VERIFY, THE ACCURACY OF THE INFORMATION THAT IS INPUT INTO, TRANSMITTED TO, OR GENERATED WITH THE SOFTWARE. IF YOU THINK YOU OR A SUBJECT MAY HAVE A MEDICAL EMERGENCY, CALL A DOCTOR OR 911 IMMEDIATELY. THE COVID-19 HOME TEST IS NOT INTENDED FOR EMERGENCY SITUATIONS. NEVER DISREGARD OR DELAY SEEKING PROFESSIONAL ADVICE BASED ON THE USE OF, OR A TEST RESULT FROM, THE COVID-19 HOME TEST. REGARDLESS OF THE TEST RESULT FROM THE COVID-19 HOME TEST, YOU SHOULD NOT DELAY CONTACTING A DOCTOR OR SEEKING PROFESSIONAL MEDICAL CARE IF YOUR OR A SUBJECT’S SYMPTOMS WORSEN OR IF YOU OR A SUBJECT NEEDS MEDICAL ATTENTION.

AS WITH ANY DIAGNOSTIC TEST, YOU UNDERSTAND THAT IT IS POSSIBLE FOR A TEST RESULT TO BE A FALSE NEGATIVE OR FALSE POSITIVE, AND THAT YOU OR A SUBJECT MAY HAVE OR DEVELOP COVID-19 IRRESPECTIVE OF A NEGATIVE TEST RESULT. SEE THE FREQUENTLY ASKED QUESTIONS FOR ADDITIONAL INFORMATION ON FALSE NEGATIVE OR FALSE POSITIVE TEST RESULTS. IF THE SARS-COV-2 MUTATES OR CHANGES FROM WHAT WE CURRENTLY KNOW ABOUT THE VIRUS, THE ACCURACY OF THE COVID-19 HOME TEST MAY BE IMPACTED.

YOU ACKNOWLEDGE THAT THE RESULTS OF THE COVID-19 HOME TEST AND INFORMATION INPUT INTO THE SOFTWARE MAY BE REPORTED TO A PUBLIC HEALTH AUTHORITY OR OTHER ENTITY AS REQUIRED BY LAW. ELLUME IS NOT RESPONSIBLE FOR, AND DOES NOT CONTROL, THE USE OR DISCLOSURE OF SUCH INFORMATION ONCE IT IS REPORTED TO A PUBLIC HEALTH AUTHORITY OR OTHER ENTITY IF REQUIRED BY LAW. REGARDLESS OF THE RESULT FROM THE COVID-19 HOME TEST, YOU WILL BE SOLELY RESPONSIBLE FOR ALL MEDICAL EXPENSES ASSOCIATED WITH ANY MEDICAL TREATMENT AND ANY OTHER HEALTHCARE SERVICES FOR YOU OR A SUBJECT, INCLUDING ANY CONFIRMATORY COVID-19 TESTING. IF YOU OR A SUBJECT TESTS POSITIVE WITH THE COVID-19 HOME TEST, THE AFFECTED PERSON SHOULD SELF-ISOLATE AND SEEK ADDITIONAL CARE OR MEDICAL ADVICE FROM A HEALTHCARE PROFESSIONAL. IF YOU OR A SUBJECT TESTS NEGATIVE BUT EXPERIENCES COVID-LIKE SYMPTOMS, THE AFFECTED PERSON SHOULD OBTAIN MEDICAL ATTENTION FROM A HEALTHCARE PROFESSIONAL BECAUSE A NEGATIVE RESULT DOES NOT PRECLUDE SUCH PERSON FROM HAVING A SARS-COV-2 INFECTION.

U.S. CONSUMERS SHOULD KNOW THAT THE PUBLIC READINESS AND EMERGENCY PREPAREDNESS ACT (“PREP ACT”) PROVIDES, AMONG OTHER THINGS, MANUFACTURERS OF COVID-19 PRODUCTS, SUCH AS THE COVID-19 HOME TEST, IMMUNITY FROM LIABILITY FOR CLAIMS OF LOSS CAUSED, ARISING OUT OF, RELATING TO, OR RESULTING FROM THE ADMINISTRATION OR USE OF SUCH COVID-19 PRODUCTS. HOWEVER, THE U.S. GOVERNMENT HAS ESTABLISHED THE COUNTERMEASURES INJURY COMPENSATION PROGRAM (“CICP”) TO PROVIDE COMPENSATION FOR QUALIFYING PERSONS WHO EXPERIENCE A SERIOUS INJURY RESULTING FROM THE USE OF A COVID-19 PRODUCT TO HELP COVER UNREIMBURSED MEDICAL EXPENSES, AMONG OTHER COMPENSATION. FOR ADDITIONAL INFORMATION ON THE PREP ACT, SEE https://www.phe.gov/preparedness/legal/prepact/pages/default.aspx. IF YOU ARE INTERESTED IN LEARNING MORE ABOUT THE CICP, SEE ADDITIONAL INFORMATION AT HTTPS://WWW.HRSA.GOV/CICP/ABOUT AND https://www.hrsa.gov/sites/default/files/hrsa/cicp/cicpfactsheet.pdf.

  1. Use and Safety. You represent, warrant, and covenant that You have read, understand, agree with, and will comply with, the Instructions (including any warnings and precautions described therein) and these Terms in connection with any access to or use of the COVID-19 Home Test. You may use the COVID-19 Home Test on a Subject or Yourself, in each case in accordance with the Instructions and these Terms. If You have any medical or healthcare questions regarding whether the COVID-19 Home Test is right for You or a Subject, or if You or a Subject need medical attention in connection with any access to or use of the COVID-19 Home Test, You should consult with a healthcare professional. WITHOUT LIMITING ANY OTHER TERMS OR CONDITIONS SET FORTH IN THESE TERMS, YOU ACKNOWLEDGE AND AGREE THAT YOU ARE SOLELY RESPONSIBLE FOR ALL USE OF THE COVID-19 HOME TEST (INCLUDING ON ANY SUBJECTS), AND YOU ARE SOLELY RESPONSIBLE FOR ALL ACTS AND OMISSIONS ARISING FROM OR IN CONNECTION WITH THESE TERMS OR ANY ACCESS TO OR USE OF A COVID-19 HOME TEST.
  2. Eligibility. SEE THE “INDICATION FOR THE COVID-19 HOME TEST” LANGUAGE ABOVE. YOU MUST BE AT LEAST 16 YEARS OLD TO SELF-COLLECT A NASAL SWAB USING THE COVID-19 HOME TEST. YOU MUST BE AT LEAST 18 YEARS OLD TO COLLECT A NASAL SWAB USING THE COVID-19 HOME TEST FROM A SUBJECT WHO IS AT LEAST 2 YEARS OF AGE. IF YOU ARE AT LEAST 18 YEARS OLD YOU ALSO MUST OTHERWISE HAVE THE LEGAL CAPACITY TO ENTER INTO A BINDING CONTRACT IN ORDER TO ACCESS OR USE THE COVID-19 HOME TEST.

    IF YOU ARE AT LEAST 16 YEARS OLD BUT YOUNGER THAN 18 YEARS OF AGE: (A) YOU MUST SHOW THESE TERMS TO YOUR LEGAL GUARDIAN WHO IS AT LEAST 18 YEARS OF AGE (EACH, A “GUARDIAN”) BEFORE ANY USE OF THE COVID-19 HOME TEST; AND (B) THAT GUARDIAN MUST READ, UNDERSTAND, AGREE WITH, AND ACCEPT THESE TERMS ON YOUR BEHALF, IN WHICH CASE THE TERM “YOU” AS USED IN THESE TERMS REFERS TO BOTH THAT GUARDIAN AND YOU. USE OF THE COVID-19 HOME TEST IS NOT PERMITTED UNLESS YOU COMPLY WITH THE PRECEDING SENTENCE.

    NOTICE TO GUARDIANS: IF YOU ARE A GUARDIAN WHO IS REQUIRED TO ACCEPT THESE TERMS ON BEHALF OF ANOTHER PERSON, YOU AGREE THAT YOU ARE BOUND BY THESE TERMS, AND THAT YOU ARE RESPONSIBLE FOR: (I) ENSURING THAT PERSON COMPLIES WITH THESE TERMS; AND (II) ALL CONSEQUENCES ARISING FROM OR IN CONNECTION WITH THAT PERSON’S ACCESS TO OR USE OF THE COVID-19 HOME TEST (INCLUDING ANY USE ON SUBJECTS). ACCORDINGLY, ANY BREACH OF THESE TERMS BY THE PERSON ON WHOSE BEHALF YOU ARE REQUIRED TO ACCEPT THESE TERMS WILL BE DEEMED A BREACH BY YOU.

    By entering to these Terms, You represent, warrant, and covenant to us that: (1) You meet the eligibility criteria for using the COVID-19 Home Test, as described in this Section 2 and in the Instructions; (2) we have not previously suspended or terminated Your access to the App; (3) all access to and use of the COVID-19 Home Test will comply with any and all applicable laws and regulations; and (4) to the extent You are a healthcare professional, You further agree to use the COVID-19 Home Test as described in the Product Overview For Healthcare Professionals and the Fact Sheet for Healthcare Professionals.

  3. Test Registration. Due to the need to respond to the COVID-19 public health emergency, in order to use the COVID-19 Home Test, we need certain information about the person whose Nasal Swab sample will be analyzed by the Analyzer, such as date of birth, zip code, and state of residence as further described in the COVID-19 Home Test Privacy Policy. Test results will only be accessible if such information we require is provided in addition to following the Instructions.
  4. Enterprise Accounts. To access some features of the App, You must register for an account. When You register for an account, You may be required to provide us with some information about Yourself, such as an organization code and test code. You agree that the information You provide to us is accurate and that You will keep it accurate and up-to-date at all times. When You register, You will be asked to provide a password. You are solely responsible for maintaining the confidentiality of Your account and password, and You accept responsibility for all activities that occur under Your account. If You believe that Your account is no longer secure, then You must immediately notify us at support@ellumehealth.com.
  5. Licenses
    1. Limited License. Conditioned on Your complete and ongoing compliance with these Terms, Ellume grants You a personal, non-exclusive, non-transferable, non-sublicensable, and revocable license to: (a) install and use one object code copy of the App obtained from either the Apple App Store or Google Play on a smartphone that You own or control that runs the iOS or Android operating system; and (b) execute and run the object code version of the software incorporated into the Analyzer as and to the extent such software is so incorporated into the Analyzer, in the case of clauses (a) and (b), solely to the extent necessary for You to use the COVID-19 Home Test in accordance with these Terms and the Instructions. The foregoing license is for non-commercial purposes only.
    2. License Restrictions. Except and solely to the extent such a restriction is impermissible under applicable law, You may not, and You may not allow or permit any third party to: (a) reproduce, distribute, publicly display, or publicly perform the Software; (b) make modifications to the Software; or (c) interfere with or circumvent any feature of the Software, including any security or access control mechanism. If You are prohibited under applicable law from using the Software, You may not use it.
    3. Feedback. If You choose to provide feedback, input or suggestions regarding the COVID-19 Home Test (including about problems with, or proposed modifications or improvements to, the COVID-19 Home Test) (“Feedback”), then You hereby grant Ellume a perpetual, irrevocable, non-exclusive, transferable, fully-paid, royalty-free, and worldwide right, with the right to grant and authorize sublicenses, to use, disclose, and exploit the Feedback in any manner and for any purpose, including to improve the COVID-19 Home Test and to create other products and services, without limitation or any credit or fees due to You or any third party. You represent, warrant, and covenant that You have and will have all rights to grant the license set forth in this Section 5.3.
  6. Ownership; Proprietary Rights. The Software is owned and operated by Ellume or its licensors. The visual interfaces, graphics, design, compilation, information, data, computer code (including source code or object code), products, software, services, and all other elements of the Software (“Materials”) provided by Ellume are protected by intellectual property and other laws. All Materials included in the Software are the property of Ellume or its third-party licensors. Ellume reserves all rights to the Materials not granted expressly in these Terms.
  7. Third Party Terms
    1. Linked Websites. The App may contain links to third-party websites, such as informational websites from the Center for Disease Control. Linked websites are not under Ellume’s control, and Ellume is not responsible for their content, functionality, or any problems or issues arising from or in connection with any such websites.
    2. Third Party Software. The Software may include or incorporate third-party software components that are generally available free of charge under licenses granting recipients broad rights to copy, modify, and distribute those components (“Third Party Components”). Although the Software is provided to You subject to these Terms, nothing in these Terms prevents, restricts, or is intended to prevent or restrict You from obtaining Third Party Components under the applicable third party licenses or to limit use of Third Party Components under those third party licenses.
  8. Push Notifications. When You install the App on a mobile device, You agree to receive push notifications, which are messages an app sends to that mobile device when the app is not on. You can turn off notifications by visiting that mobile device’s “settings” page.
  9. Prohibited Conduct. WITHOUT LIMITING ANY OTHER TERMS SET FORTH IN THESE TERMS, AND TO THE FULLEST EXTENT PERMITTED BY LAW, BY USING THE COVID-19 HOME TEST YOU AGREE NOT TO, AND NOT TO ALLOW OR ENABLE ANY THIRD PARTY TO:
    1. use the COVID-19 Home Test in a manner that does not comply with the Instructions, these Terms, or for any illegal purpose or in violation of any local, state, national, or international law;
    2. violate, or encourage others to violate, any right of a third party, including by infringing or misappropriating any third-party intellectual property right or violating any right of privacy;
    3. (i) interfere with security-related features of the Software, including by disabling or circumventing features that prevent or limit use or copying of any content; (ii) reverse engineer, decompile, or disassemble the COVID-19 Home Test, or otherwise attempt to derive any source code, trade secrets, or know-how in or underlying the same; (iii) infringe or misappropriate any intellectual property rights owned or controlled by any of the Ellume Entities (defined in Section 13) in or to the COVID-19 Home Test; or (iv) access the COVID-19 Home Test for the purpose of developing, distributing, or making accessible any products or services that compete with the COVID-19 Home Test;
    4. interfere with the operation of the Software or any user’s enjoyment of the Software, including by: (i) uploading or otherwise disseminating any virus, adware, spyware, worm, or other malicious code to the App; (ii) collecting personal information about another user or third party without consent; or (iii) interfering with or disrupting any network, equipment, or server connected to or used to provide the App;
    5. perform any fraudulent activity, including impersonating any person or entity, claiming a false affiliation, accessing any other person’s account without permission, or falsifying age or date of birth information;
    6. sell or otherwise commercialize or transfer the access granted under these Terms or any Materials or any right or ability to view, access, or use any Materials; or
    7. attempt to do any of the acts described in this Section 9 or assist or permit any person in engaging in any of the acts described in this Section 9.
  10. Modification of these Terms. We reserve the right to change these Terms on a prospective basis at any time upon 7 days’ notice. Please check these Terms periodically for changes. If a change to these Terms materially modifies Your rights or obligations, we may require that You accept the modified Terms in order to continue to use the App. Material modifications are effective upon Your acceptance of the modified Terms. Immaterial modifications are effective upon publication. Except as expressly permitted in this Section 10, these Terms may be amended only by a written agreement signed by authorized representatives of the parties bound to these Terms. Disputes arising under these Terms will be resolved in accordance with the version of these Terms that was in effect at the time the dispute arose.
  11. Term, Termination and Modifications
    1. Term. These Terms take effect on the first to occur of: (a) when You accept these Terms; or (b) when You first download or install the App or otherwise access or use the COVID-19 Home Test, and these Terms will continue until terminated as described in Section 11.2.
    2. Termination. If You violate any provision of these Terms, all authorization to access and use the COVID-19 Home Test (including the App) under these Terms and these Terms themselves automatically will terminate. In addition, Ellume may, at its sole discretion, terminate these Terms or suspend or terminate access to the App, at any time for any reason or no reason, with or without notice. You may terminate Your account and these Terms at any time by contacting customer service at support@ellumehealth.com.
    3. Effect of Termination. Upon termination of these Terms: (a) Your license rights under these Terms will terminate, all use of the App must immediately cease, and You must delete the App from Your smartphone; (b) You must immediately and permanently discard all other components of the COVID-19 Home Test within Your possession or control; and (c) the following portions of these Terms, and all defined terms needed to interpret the same, will survive: (i) all terms and conditions appearing before Section 1 above; and (ii) Sections 1, 2, 5.3, 6, 11.3, 12, 13, 14, 15, and 16.
    4. Modification of the COVID-19 Home Test. Ellume reserves the right to modify, limit access to, or discontinue the COVID-19 Home Test at any time (including by modifying, limiting access to, or discontinuing certain features of the App or other components of the COVID-19 Home Test), temporarily or permanently, without notice. Ellume will have no liability for any such actions, including any suspension or termination of access to or use of the App.
  12. Indemnity. THE FOLLOWING TERMS APPLY TO THE FULLEST EXTENT PERMITTED BY LAW:

    You are solely responsible for Your use of the COVID-19 Home Test (including any use on Subjects), and You will defend and indemnify Ellume and its Affiliates and their respective licensors, suppliers, distributors, officers, directors, employees, consultants, and agents from and against every action, investigation, proceeding, or claim brought by a third party, and any related liability, damage, loss, and expense, including reasonable attorneys’ fees and costs, arising out of or connected with: (a) Your access to or use of the COVID-19 Home Test, including any unauthorized use of, or misuse of, the COVID-19 Home Test; (b) Your violation of any portion of these Terms or any applicable law or regulation; (c) Your violation of any third-party right, including any intellectual property right or publicity, confidentiality, other property, or privacy right; or (d) any dispute or issue between You and any third party, including a Subject. The indemnified party reserves the right, at its own expense, to assume the exclusive defense and control of any matter otherwise subject to indemnification by You (without limiting Your indemnification obligations with respect to that matter), and in that case, You agree to cooperate with our defense of those claims.

  13. Disclaimers; No Warranties. THE FOLLOWING TERMS APPLY TO THE FULLEST EXTENT PERMITTED UNDER APPLICABLE LAW:

    NOTWITHSTANDING ANYTHING IN THESE TERMS TO THE CONTRARY:

    THE COVID-19 HOME TEST AND ALL MATERIALS AND CONTENT AVAILABLE ON OR THROUGH THE APP ARE PROVIDED “AS IS” AND ON AN “AS AVAILABLE” BASIS, AND ELLUME HEREBY DISCLAIMS, ON BEHALF OF THE ELLUME ENTITIES AND THEIR RESPECTIVE SUPPLIERS AND LICENSORS, ALL WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, RELATING TO THE COVID-19 HOME TEST (INCLUDING ALL MATERIALS AND CONTENT AVAILABLE ON OR THROUGH THE APP), INCLUDING: (A) ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, QUIET ENJOYMENT, OR NON-INFRINGEMENT; AND (B) ANY WARRANTY ARISING OUT OF COURSE OF DEALING, USAGE, OR TRADE.

    WITHOUT LIMITING THE FOREGOING IN THIS SECTION 13:

    (I) ELLUME DOES NOT WARRANT THAT THE COVID-19 HOME TEST (INCLUDING ANY MATERIALS, DATA, OR CONTENT OFFERED ON OR THROUGH THE APP), WILL BE UNINTERRUPTED, SECURE, OR OTHERWISE FREE FROM DATA SECURITY ISSUES OR BREACHES, OR FREE OF ERRORS, VIRUSES, OR OTHER HARMFUL COMPONENTS, AND ELLUME DOES NOT WARRANT THAT ANY OF THOSE ISSUES WILL BE CORRECTED SHOULD THEY OCCUR; AND

    (II) NEITHER ELLUME NOR ANY OF ITS AFFILIATES (collectively, the“Ellume Entities”) NOR ANY OF THEIR RESPECTIVE LICENSORS OR SUPPLIERS MAKE ANY WARRANTIES TO YOU IN CONNECTION WITH ANY DATA COLLECTED, TRANSMITTED, AND/OR RECEIVED BY OR THROUGH THE SOFTWARE (collectively,“Covered Data”) OR ANY RESULTS OR OUTPUT DERIVED FROM, BASED UPON, OR OTHERWISE ARISING FROM OR IN CONNECTION WITH ANY ACCESS TO, REVIEW, OR OTHER USE OF THE COVERED DATA (collectively, “Results”).

  14. Limitation of Liability. THE FOLLOWING TERMS APPLY TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW:

    NOTWITHSTANDING ANYTHING IN THESE TERMS TO THE CONTRARY:

    THE ELLUME ENTITIES WILL NOT HAVE ANY LIABILITY TO YOU FOR ANY DISPUTE THAT YOU MAY HAVE WITH ANY THIRD-PARTY PERSON OR ENTITY (INCLUDING ANY SUBJECT) IN CONNECTION WITH THE COVID-19 HOME TEST (INCLUDING ANY COVERED DATA OR RESULTS).

    AS NOTED ABOVE IN THE “LEGAL DISCLAIMERS” SECTION, THE COVID-19 HOME TEST IS COVERED BY THE PREP ACT. ACCORDINGLY, YOU ACKNOWLEDGE AND AGREE THAT THE ELLUME ENTITIES WILL HAVE NO LIABILITY IN CONNECTION WITH THE COVID-19 HOME TEST TO THE FULLEST EXTENT PROVIDED UNDER THE PREP ACT.

    THE FOLLOWING SECTIONS 14(A) AND (B) APPLY WITH RESPECT TO ANY LIABILITY THAT ANY OF THE ELLUME ENTITIES MAY HAVE TO YOU FOR WHICH ANY SUCH ENTITY IS NOT PROTECTED FROM SUCH LIABILITY UNDER THE IMMUNITY GRANTED BY THE PREP ACT:

    1. IN NO EVENT WILL THE ELLUME ENTITIES BE LIABLE TO YOU FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES (INCLUDING DAMAGES FOR LOSS OF PROFITS, GOODWILL, OR ANY OTHER INTANGIBLE LOSS) ARISING OUT OF OR RELATING TO ANY ACCESS TO OR USE OF, OR INABILITY TO ACCESS OR USE, THE COVID-19 HOME TEST OR ANY MATERIALS OR CONTENT ON THE APP (INCLUDING ANY COVERED DATA AND RESULTS), WHETHER BASED ON WARRANTY, CONTRACT, TORT (INCLUDING NEGLIGENCE), STATUTE, OR ANY OTHER LEGAL THEORY, AND WHETHER OR NOT ANY ELLUME ENTITY HAS BEEN INFORMED OF THE POSSIBILITY OF SUCH DAMAGE.
    2. EXCEPT AS PROVIDED IN SECTION 15.5, THE AGGREGATE LIABILITY OF THE ELLUME ENTITIES TO YOU ARISING OUT OF OR RELATING TO THE COVID-19 HOME TEST OR OTHERWISE UNDER OR IN CONNECTION WITH THESE TERMS, WHETHER BASED ON CONTRACT, TORT (INCLUDING NEGLIGENCE), STATUTE, OR ANY OTHER LEGAL THEORY, IS LIMITED TO THE GREATER OF: (I) THE AMOUNT YOU PAID DIRECTLY TO ELLUME FOR THE SPECIFIC COVID-19 HOME TEST ON WHICH ANY DISPUTE WITH YOU IS BASED; AND (II) $30 USD.

    EACH PROVISION OF THESE TERMS THAT PROVIDES FOR A LIMITATION OF LIABILITY, DISCLAIMER OF WARRANTIES, OR EXCLUSION OF DAMAGES IS INTENDED TO AND DOES ALLOCATE THE RISKS BETWEEN THE PARTIES UNDER THESE TERMS. THIS ALLOCATION IS AN ESSENTIAL ELEMENT OF THE BASIS OF THE BARGAIN BETWEEN THE PARTIES. EACH OF THESE PROVISIONS IS SEVERABLE AND INDEPENDENT OF ALL OTHER PROVISIONS OF THESE TERMS. THE LIMITATIONS IN THIS SECTION 14 WILL APPLY EVEN IF ANY LIMITED REMEDY FAILS OF ITS ESSENTIAL PURPOSE.

  15. Dispute Resolution and Arbitration
    1. Generally. In the interest of resolving disputes between You and Ellume in the most expedient and cost effective manner, and except as described in Section 15.2 and 15.3, You and Ellume agree that every dispute arising in connection with these Terms or the COVID-19 Home Test will be resolved by binding arbitration. Arbitration is less formal than a lawsuit in court. Arbitration uses a neutral arbitrator instead of a judge or jury, may allow for more limited discovery than in court, and can be subject to very limited review by courts. Arbitrators can award the same damages and relief that a court can award. This agreement to arbitrate disputes includes all claims arising out of or relating to any aspect of these Terms or the COVID-19 Home Test, whether based in contract, tort, statute, fraud, misrepresentation, or any other legal theory, and regardless of whether a claim arises during or after the termination of these Terms. YOU UNDERSTAND AND AGREE THAT, BY ENTERING INTO THESE TERMS, YOU AND ELLUME ARE EACH WAIVING THE RIGHT TO A TRIAL BY JURY OR TO PARTICIPATE IN A CLASS ACTION.
    2. Exceptions. Despite the provisions of Section 15.1, nothing in these Terms will be deemed to waive, preclude, or otherwise limit the right of either party to: (a) bring an individual action in small claims court; (b) pursue an enforcement action through the applicable federal, state, or local agency if that action is available; (c) seek injunctive relief in a court of law in aid of arbitration; or (d) to file suit in a court of law to address an intellectual property infringement claim.
    3. Opt-Out. If You do not wish to resolve disputes by binding arbitration, You may opt out of the provisions of this Section 15 within 30 days after the date that You agree to these Terms by sending a letter to Ellume, LLC, Attention: Legal Department – Arbitration Opt-Out, 24766 2nd St, Hayward, California, USA 94541 that specifies: Your full legal name, the email address associated with Your registration on the COVID-19 Home Test, and a statement that You wish to opt out of arbitration (“Opt-Out Notice”). Once Ellume receives Your Opt-Out Notice, this Section 15 will be void and any action arising out of these Terms will be resolved as set forth in Section 16.2. The remaining provisions of these Terms will not be affected by Your Opt-Out Notice.
    4. Arbitrator. Any arbitration between You and Ellume will be settled under the Federal Arbitration Act and administered by the Judicial Arbitration & Mediation Services, Inc. (“JAMS”) by a single arbitrator in accordance with the rules of JAMS (“JAMS Rules”), which rules are available at https://www.jamsadr.com/rules-comprehensive-arbitration/. JAMS may be contacted at www.jamsadr.com, or by contacting Ellume. The arbitrator has exclusive authority to resolve any dispute relating to the interpretation, applicability, or enforceability of this binding arbitration agreement.
    5. Notice of Arbitration; Process. A party who intends to seek arbitration must first send a written notice of the dispute to the other party by certified U.S. Mail or by Federal Express (signature required) or, only if that other party has not provided a current physical address, then by electronic mail (“Notice of Arbitration”). Ellume’s address for Notice is: Ellume, LLC, 24766 2nd St, Hayward, California, USA 94541. The Notice of Arbitration must: (a) describe the nature and basis of the claim or dispute; and (b) set forth the specific relief sought (“Demand”). The parties will make good faith efforts to resolve the claim directly, but if the parties do not reach an agreement to do so within 30 days after the Notice of Arbitration is received, You or Ellume may commence an arbitration proceeding. All arbitration proceedings between the parties will be confidential unless otherwise agreed by the parties in writing. During the arbitration, the amount of any settlement offer made by You or Ellume must not be disclosed to the arbitrator until after the arbitrator makes a final decision and award, if any. If the arbitrator awards You an amount higher than the last written settlement amount offered by Ellume in settlement of the dispute prior to the award, Ellume will pay to You the higher of: (i) the amount awarded by the arbitrator; or (ii) $10,000.
    6. Fees. If You commence arbitration in accordance with these Terms, Ellume will reimburse You for Your payment of the filing fee, unless Your claim is for more than $10,000, in which case the payment of any fees will be decided by the JAMS Rules. Any arbitration hearing will take place at a location determined by JAMS but if the claim is for $10,000 or less, You may choose whether the arbitration will be conducted: (a) solely on the basis of documents submitted to the arbitrator; (b) through a non-appearance based telephone hearing; or (c) by an in-person hearing as established by the JAMS Rules in the county (or parish) of Your billing address. If the arbitrator finds that either the substance of Your claim or the relief sought in the Demand is frivolous or brought for an improper purpose (as measured by the standards set forth in Federal Rule of Civil Procedure 11(b)), then the payment of all fees will be governed by the JAMS Rules. In that case, You agree to reimburse Ellume for all monies previously disbursed by it that are otherwise Your obligation to pay under the JAMS Rules. Regardless of the manner in which the arbitration is conducted, the arbitrator must issue a reasoned written decision sufficient to explain the essential findings and conclusions on which the decision and award, if any, are based. The arbitrator may make rulings and resolve disputes as to the payment and reimbursement of fees or expenses at any time during the proceeding and upon request from either party made within 14 days of the arbitrator’s ruling on the merits.
    7. No Class Actions. YOU AND ELLUME AGREE THAT EACH MAY BRING CLAIMS AGAINST THE OTHER ONLY IN YOUR OR ITS INDIVIDUAL CAPACITY AND NOT AS A PLAINTIFF OR CLASS MEMBER IN ANY PURPORTED CLASS OR REPRESENTATIVE PROCEEDING. Further, unless both You and Ellume agree otherwise, the arbitrator may not consolidate more than one person’s claims, and may not otherwise preside over any form of a representative or class proceeding.
    8. Modifications to this Arbitration Provision. If Ellume makes any future change to this arbitration provision, other than a change to Ellume’s address for Notice of Arbitration, You may reject the change by sending us written notice within 30 days of the change to Ellume’s address for Notice of Arbitration, in which case Your account with Ellume will be immediately terminated and this arbitration provision, as in effect immediately prior to the changes You rejected will survive.
    9. Enforceability. If Section 15.7 or the entirety of this Section 15 is found to be unenforceable, or if Ellume receives an Opt-Out Notice from You, then the entirety of this Section 15 will be null and void and, in that case, the exclusive jurisdiction and venue described in Section 16.2 will govern any action arising out of or related to these Terms.
  16. Miscellaneous
    1. General Terms. All of the terms and conditions set forth in this document prior to Section 1 above are incorporated into and made a part of these Terms. These Terms, together with the Instructions and the COVID-19 Home Test Privacy Policy, are the entire and exclusive understanding and agreement between You and Ellume regarding use of the COVID-19 Home Test. If there is any conflict or inconsistency between these Terms and the Instructions, these Terms control to the extent of that conflict or inconsistency. You may not assign or transfer these Terms or Your rights under these Terms, in whole or in part, by operation of law or otherwise, without our prior written consent. We may assign these Terms at any time without notice or consent. These Terms shall bind and inure to the benefit of Your and Ellume’s, heirs, successors, and assigns. The failure to require performance of any provision will not affect our right to require performance at any other time after that, nor will a waiver by us of any breach or default of these Terms be a waiver of any subsequent breach or default. Only waivers that we make expressly in writing that specifically reference the relevant provision and issue being waived have legal effect. Use of section headers in these Terms is for convenience only and will not have any impact on the interpretation of any provision. Throughout these Terms the use of the word “including” means “including but not limited to,” and the use of the word “or” will mean “and/or.” If any part of these Terms is held to be invalid or unenforceable, the unenforceable part will be given effect to the greatest extent possible, and the remaining parts will remain in full force and effect.
    2. Governing Law. These Terms are governed by the laws of the State of California without regard to conflict of law principles. You and Ellume submit to the personal and exclusive jurisdiction of the state courts and federal courts located within Alameda County, California for resolution of any lawsuit or court proceeding permitted under these Terms.
    3. Privacy Policy. Please read the COVID-19 Home Test Privacy Policy carefully for information relating to our collection, use, storage, disclosure of personal information. The COVID-19 Home Test Privacy Policy is incorporated by this reference into, and made a part of, these Terms.
    4. Consent to Electronic Communications. By using the COVID-19 Home Test, You consent to receiving certain electronic communications from us as further described in the COVID-19 Home Test Privacy Policy. Please read the COVID-19 Home Test Privacy Policy to learn more about our electronic communications practices. You agree that any notices, agreements, disclosures, or other communications that we send to You electronically will satisfy any legal communication requirements, including that those communications be in writing.
    5. Contact Information. The COVID-19 Home Test is offered by Ellume, LLC, located at 24766 2nd St, Hayward, California, USA 94541. You may contact us by sending correspondence to that address or by emailing us at support@ellumehealth.com or calling 1-888-885-6121.
    6. Notice to California Residents. If You are a California resident, under California Civil Code Section 1789.3, You may contact the Complaint Assistance Unit of the Division of Consumer COVID-19 Home Tests of the California Department of Consumer Affairs in writing at 1625 N. Market Blvd., Suite S-202, Sacramento, California 95834, or by telephone at (800) 952-5210 in order to resolve a complaint regarding the COVID-19 Home Test or to receive further information regarding use of the COVID-19 Home Test.
    7. No Support or Services. We are under no obligation to provide technical support services or any other services in connection with the COVID-19 Home Test. We will decide whether to offer any such services in our sole discretion. In instances where we may offer any such services, those services, and the terms under which we offer them, will be subject to policies that we will publish.
    8. International Use. The COVID-19 Home Test is intended for individuals located within the United States only. All use from outside the United States is prohibited.
  17. Notice Regarding Apple. This Section 17 only applies to the extent You are using our mobile application on an iOS device. You acknowledge that these Terms are between You and Ellume only, not with Apple Inc. (“Apple”), and Apple is not responsible for the App or the content thereof. Apple has no obligation to furnish any maintenance and support services with respect to the App. If the App fails to conform to any applicable warranty, You may notify Apple and Apple will refund any applicable purchase price for the App to You; and, to the maximum extent permitted by applicable law, Apple has no other warranty obligation with respect to the App. Apple is not responsible for addressing any claims by You or any third party relating to the App or Your possession and/or use of the COVID-19 Home Test, including: (a) product liability claims; (b) any claim that the App fails to conform to any applicable legal or regulatory requirement; or (c) claims arising under consumer protection or similar legislation. Apple is not responsible for the investigation, defense, settlement, and discharge of any third-party claim that the App and/or Your possession and use of the App infringe a third party’s intellectual property rights. You agree to comply with any applicable third-party terms when using the App. Apple and Apple’s subsidiaries are third party beneficiaries of these Terms, and upon Your acceptance of these Terms, Apple will have the right (and will be deemed to have accepted the right) to enforce these Terms against You as a third-party beneficiary of these Terms. You hereby represent and warrant that: (i) You are not located in a country that is subject to a U.S. Government embargo, or that has been designated by the U.S. Government as a “terrorist supporting” country; and (ii) You are not listed on any U.S. Government list of prohibited or restricted parties.

Last Updated: February 1, 2021

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