Anumana Appoints Kevin Ballinger and Jean-Luc Butel to Board of Directors

SaMD T&C

Anumana Standard License Terms and Conditions

  1. SOFTWARE LICENSE. Anumana grants Customer for the duration of the Term a non-exclusive, non-transferable, non-sublicensable, revocable (upon a termination of this Agreement), royalty-free, limited license to access (via an Anumana-provided Docker container), install, and execute one copy of the ECG-AI™ LEF SaMD, and the right for Customer and its authorized employees, consultants, subcontractors, or other Customer-designated representatives (collectively, “End-Users” and each an “End-User”) to use (a) the ECG-AI LEF™ SaMD solely in compiled binary or “object code” form, for internal business purposes and subject to the terms of this Agreement and the Documentation.
  2. LICENSE RESTRICTIONS. The rights granted to Customer pursuant to the Order Form (“Order Form”) and Standard License Terms and Conditions (“Standard Terms”) (together the Order Form and Standard Terms are the “Agreement”) are subject to the following restrictions. Customer shall not (a) reproduce, license, sublicense, sell, resell, rent, lease, transfer, assign (except as permitted in Section 22), distribute, disclose or otherwise commercially exploit the Licensed Software, or make the Licensed Software available to any third party other than End-Users; (b) make the Licensed Software available to any third party for purposes of testing the Licensed Software and disclosing publicly the results of the tests; (c) interfere with, disrupt, modify, make derivative works of, disassemble, reverse compile, or reverse engineer any part of the Licensed Software; (d) access the Licensed Software for research and development or competitive assessment purposes, or to build a similar or competitive product or service or extend term of the license granted hereunder; (e) either publicly or privately, republish, download, display, post or transmit in any form or by any means the Licensed Software or any component of either of them; or (f) remove any copyright or other proprietary rights notices appearing in or on the Licensed Software.
  3. LICENSE FROM CUSTOMER. Customer hereby grants to Anumana a non-exclusive, royalty-free, fully paid up, non-sublicensable (except to contractors and service providers providing services on behalf of Anumana), non-transferable (except as set forth in Section 22) right and license, during the Term, to use information that Customer provides to Anumana in connection with Customer’s use of the Licensed Software, to enable Anumana to perform Anumana’s obligations under this Agreement. Additionally, and subject to Anumana’s confidentiality obligations to Customer pursuant to Section 11, Customer hereby grants to Anumana a non-exclusive, royalty-free, fully paid up, non-sublicensable (except to contractors and service providers providing services on behalf of Anumana), non-transferable, perpetual, and irrevocable right and license during and after the Term to collect, analyze and use data and other information relating to Customer’s use of the Licensed Software, including, without limitation, data derived from such use (collectively, “Use Information”) to improve and enhance the Licensed Software and for other development, diagnostic and corrective purposes in connection with the Licensed Software and System and other Anumana offerings, provided that (a) if any Use Information pertains to individuals, such data will be de-identified to ensure the identity of such individuals cannot be ascertained, including through combination with other data sets; and (b) any such Use Information  is not disclosed to third parties in a way that identifies or is traceable to Customer. Anumana will maintain reasonable and appropriate physical, organizational, administrative, and technical safeguards, compliant with applicable laws, rules and regulations designed to protect Use Information from loss, misuse, unauthorized access, disclosure, alteration, and destruction.
  4. CUSTOMER OBLIGATIONS.
    4.1 Deployment, Interoperability, & Integration.

    1. Prior to, on, or shortly after the Effective Date, Anumana will provide Customer a Customer Deployment Solution Design Document (“Deployment Plan”) describing the technical requirements, resources, key integration milestones, and steps necessary to implement and enable Customer’s use of the Licensed Software. Per Customer’s requirements, the Licensed Software may be deployed via on-premises hardware or allocation of computer resources on a virtual private cloud that Customer owns and maintains. The Deployment Plan will include the Customer requirements necessary for deployment of the Licensed Software according to one of the foregoing methods.
    2. Without limiting the other requirements set forth in this Agreement, the Deployment Plan, and the Documentation, Customer agrees to obtain prior to deployment, and maintain throughout the Term, all required technical hardware, software, 3rd Party Vendor Agreements, and resources necessary to support the deployment, integration, and continued run-time of the Licensed Software according to the technical requirements set forth in the Documentation, including the minimum requirements set forth in the Order Form.

    4.2 Use. Customer agrees to take all reasonable steps to safeguard the Licensed Software to ensure that no unauthorized person has access to it. Each party acknowledges and agrees that the Licensed Software contains valuable, confidential information and trade secrets and that the unauthorized use and/or copying of the same would be harmful to Anumana. Customer represents and warrants that it will comply with all laws, rules and regulations that apply to its use of the Licensed Software or Use Information and any other activities in connection with this Agreement. Further, Customer (a) agrees to cause all its End-Users, in connection with their access to and/or use of the Licensed Software, to comply with the obligations and restrictions in this Agreement pertaining to the access and use of the Licensed Software, and (b) shall be liable for such End-Users’ use of the Licensed Software. All clinical and medical treatment, diagnostic, and/or billing decisions are Customer’s responsibility.

  5. TECHNICAL SUPPORT. During the Term, Anumana will provide remote/online, and email support during its regular business hours for the following: (a) implementation of the Licensed Software; (b) implementation of upgrades, updates and fixes to the Licensed Software; (c) training, as needed, regarding the use of the Licensed Software, and (d) troubleshooting technical issues/problem diagnosis and resolution concerning the use or performance of the Licensed Software.
  6. UPDATES. Anumana will make available to Customer at no additional charge all maintenance releases, including upgrades, updates, patches, and fixes, to the Licensed Software (collectively, “Updates”) that Anumana makes generally available to its Customers. New software features and functionality offered in major new releases of the Licensed Software, if priced separately, are not included in the Updates. Any Updates or additions to the functionality of the Licensed Software shall be subject to the terms of this Agreement.
  7. RECORDS AND AUDIT. Customer agrees to maintain complete and accurate records in accordance with generally accepted accounting principles during the Term and for a period of five (5) years after the termination or expiration of this Agreement with respect to matters necessary for accurately determining amounts due hereunder. Anumana may, at its own expense, on reasonable prior notice, periodically inspect and audit Customer’s records with respect to matters covered by this Agreement, provided that if such inspection and audit reveals that Customer has underpaid Anumana with respect to any amounts due and payable during the Term, Customer shall promptly pay the amounts necessary to rectify such underpayment, together with interest. Customer shall pay for all amounts the audit determines to be owed pursuant to this Agreement, including the relevant Order Form(s). Such inspection and auditing rights will extend throughout the Term of this Agreement and continue for a period of five (5) years after the termination or expiration of this Agreement.
  8. INTELLECTUAL PROPERTY.
    8.1  Ownership. All right, title, and interest, including all copyrights, trademarks, trade secrets, patents, patent applications, moral rights, contract rights and other proprietary and/or intellectual property rights (collectively, “Intellectual Property Rights”) in and to the Licensed Software and Documentation shall be owned and retained by Anumana and its licensors. Any rights not expressly granted by Anumana in the Agreement are reserved. Customer acknowledges that it acquires no ownership interest in the Licensed Software. Anumana acknowledges and agrees that Customer is the sole and exclusive owner of all Use Information. Any third-party software included in the Licensed Software may only be used in conjunction with the Licensed Software and is not licensed for use independent from such product or service.

    8.2  Feedback. Customer may from time-to-time provide Anumana with suggestions, comments, or other feedback (collectively, “Feedback”) with respect to the Licensed Software. Feedback is voluntary and provided AS IS in all respects. Anumana is not obligated to hold Feedback in confidence. Anumana may use Feedback for any purpose without obligation of any kind. Customer grants Anumana and its affiliates an irrevocable, non-exclusive, perpetual, royalty-free, transferable, sublicensable (through one or more tiers) license to use the Feedback.
  9. PUBLICITY; CUSTOMER MARKS. Anumana may identify Customer as an Anumana Customer and include Customer’s name and logo on Anumana’s website and in other marketing material, provided that Anumana may not and shall not disclose any information regarding Customer in breach of Anumana’s confidentiality obligations to Customer per Section 11. Customer retains all title and rights to Customer’s name and logo. Customer may withdraw its approval of any Anumana use of Customer’s name or logo at any time in its sole discretion upon written notice to Anumana, which withdrawal shall be effective promptly but in no case more than thirty (30) days from the date of Customer’s notice, provided that no such withdrawal will require the recall of any previously published or distributed materials. Following execution of this Agreement, the parties may agree to issue a separate or joint press release(s) regarding this Agreement and the wording of each press release shall be mutually agreed in writing, in advance.
  10. OPEN SOURCE SOFTWARE. Certain items of software provided to Customer with the Licensed Software are subject to “open source” or “free software” licenses (“Open Source Software”). Some of the Open Source Software is owned by third parties. The Open Source Software is not subject to the terms and conditions of Section 2. Instead, each item of Open Source Software is licensed under the terms of the license that accompanies such Open Source Software. Nothing in this Agreement limits Customer’s rights under, or grants Customer rights that supersede, the terms and conditions of any applicable license for the Open Source Software.
  11. CONFIDENTIAL INFORMATION.
    11.1.  Confidential Information. For purposes of this Agreement, “Confidential Information” means all proprietary or confidential information disclosed by one party to the other party, whether orally or in writing, that is designated as confidential or that reasonably should be understood to be confidential given the nature of the information or the circumstances of disclosure, including, without limitation: (a) proprietary product, software or services information, or related technology, ideas and algorithms; (b) trade secrets; (c) either party’s technical, business or financial information and plans; (d) the pricing and other terms reflected on Anumana quotes, Order Forms, and/or purchase orders that Customer provides Anumana pursuant to this Agreement; (e) any personal data; and (f) Use Information. Confidential Information shall not include information that the receiving party can show (i) is or becomes generally known or publicly available through no fault of the receiving party; (ii) is known by, or is in the possession of, the receiving party prior to its disclosure, as evidenced by business records, and is not subject to restriction; (iii) was independently developed by the receiving party without the use of or reference to the Confidential Information of the disclosing party; or (iv) is lawfully obtained without restriction from a third party who has the right to make such disclosure.

    11.2.  Protection of Confidential Information. Each party shall protect the other party’s Confidential Information from unauthorized dissemination, and the receiving party shall use, and shall ensure that its employees and agents use, the same degree of care that it uses to protect its own like information, at all times employing at least a reasonable standard of care. The receiving party shall not disclose to third parties the disclosing party’s Confidential Information without the prior written consent of the disclosing party. The receiving party shall use the disclosing party’s Confidential Information solely as necessary to directly fulfill the receiving party’s obligations or exercise its rights under this Agreement.

    11.3.  Disposition Upon Termination. Upon the termination of this Agreement for any reason whatsoever, or if the disclosing party reasonably determines that the receiving party no longer requires access to the Confidential Information to perform its obligations, the receiving party shall destroy copies of all Confidential Information in the receiving party’s possession. Notwithstanding the foregoing, the receiving party’s confidentiality obligations under this Section 11 shall survive for three years after termination of this Agreement.

    11.4.  Permitted Disclosure. Notwithstanding any provision in this Agreement to the contrary, the receiving party may disclose portions of disclosing party’s Confidential Information (a) to its lawyers and accountants who have a need to know such information and who are under the same protection and use obligations as in Section 11.2, above, (b) to its employees and contractors who have a need to know and are subject to written agreements that contain confidentiality restrictions no less protective than those set forth herein, and (c) pursuant to an order of a governmental agency or court of competent jurisdiction compelling disclosure, provided that the receiving party shall provide the disclosing party reasonable advance notice of such intended disclosure.

    11.5.  Remedies. The receiving party acknowledges that its breach of this Agreement may cause irreparable damage to the disclosing party, and hereby agrees that the disclosing party is entitled to seek, in addition to any other remedies available to it, injunctive and other relief as may be granted by a court of competent jurisdiction, associated with the receiving party’s breach.

  12. LIMITED WARRANTY. The Licensed Software is warranted to conform substantially to the Documentation for a period of ninety (90) days from Customer’s receipt of the Licensed Software (“Documentation Warranty”). Anumana’s sole liability, and Customer’s sole and exclusive remedy, for any breach of the Documentation Warranty is that Anumana shall, at its option, repair or replace the Licensed Software so that it conforms to the Documentation Warranty or, if repair or replacement is not commercially feasible, then Customer may terminate the Order and the license granted hereunder. Anumana will have no obligation hereunder (or to provide any technical support) if the alleged defect is due to (a) any use of the Licensed Software other than in accordance with its published specifications; (b) installation, maintenance or modification of the Licensed Software by anyone other than Anumana; (c) software, hardware, data or other materials provided by Customer or a third party; or (d) any condition resulting, in whole or in part, from Customer’s or a third party’s negligence or abuse, accident, natural disaster, or any other causes not within Anumana’s control.

    12.1.  DISCLAIMER OF WARRANTIES    . EXCEPT FOR THE FOREGOING DOCUMENTATION WARRANTY, ANUMANA MAKES NO WARRANTIES, EXPRESS, IMPLIED OR STATUTORY, AS TO THE LICENSED SOFTWARE, THE LICENSED SOFTWARE OR ANY SERVICES THAT ANUMANA PROVIDES TO CUSTOMER UNDER THIS AGREEMENT, AND ALL OTHER WARRANTIES AS TO QUALITY, CONDITION, ACCURACY OR COMPLETENESS OF RESPONSES, RESULTS, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NONINFRINGEMENT ARE EXPRESSLY DISCLAIMED. THE LICENSED SOFTWARE AND LICENSED SOFTWARE ARE NOT WARRANTED TO BE UNINTERRUPTED OR ERROR FREE. CUSTOMER WILL HAVE SOLE RESPONSIBILITY FOR THE ADEQUATE PROTECTION AND BACKUP OF CUSTOMER DATA AND/OR EQUIPMENT USED WITH THE LICENSED SOFTWARE.
  13. TERM AND TERMINATION. Term. This Agreement is effective as of the Effective Date and except where noted otherwise, shall continue in effect until the termination of the Initial Term (the “Initial Term”) or any Renewal Term (each, a “Term”). Unless otherwise specified in the Order Form, upon the expiration of the Initial term in the Order Form, the Term shall automatically renew for successive twelve (12) month periods (each such period is a “Renewal Term”) unless Customer provides 60 days’ notice prior to the end of the current Term.  Standard, Customer, and Service Fees are subject to change upon renewal of the Initial Term.

    13.1.  Termination.     Either party may terminate an Order Form as set forth in the Master Agreement.   Additionally, either party may terminate an Order Form for convenience upon sixty (60) days’ prior written notice to the other party.

    13.2.  Effect of Termination. If Anumana terminates an Order due to Customer’s material breach, then all amounts set forth in the Order Form shall become immediately due and payable (including amounts not yet paid for the remainder of the Initial Term or applicable Renewal Term set forth in the Order Form) and Customer shall not be entitled to any refunds for any pre-paid amounts. In such case, Customer will promptly pay all such amounts to Anumana upon receipt of the termination notice. If Customer terminates an Order Form due to Anumana’s material breach, or Anumana terminates an Order Form for convenience, then Anumana shall provide Customer a pro rata refund for any amounts pre-paid for the remainder of the initial Term or applicable Renewal Term. Upon termination, the license granted hereunder shall terminate and Customer shall immediately cease all use of the Licensed Software and destroy any copies of the Licensed Software. Notwithstanding any termination of any Order, those sections of this Agreement that, by their terms, are intended to survive the termination of this Agreement, will remain in effect.
  14. DISPUTE RESOLUTION. Excluding any claims arising from or related to the infringement or misappropriation of the Licensed Software, the parties will attempt to resolve any claim, dispute or controversy between the parties (whether in contract, tort or otherwise) (a “Dispute”) through face-to-face negotiation between authorized representatives of each party or through mediation using a mutually agreeable mediator. If the parties are unable to resolve the Dispute through negotiation or mediation within a reasonable period after a party has notified the other of the Dispute’s existence, the Dispute will be settled by binding arbitration, held in the Commonwealth of Massachusetts according to the then current CPR Rules for Non-Administered Arbitration (“Arbitration”). Each party agrees that such arbitration shall be conducted on an individual basis and not in a class, consolidated or representative action. Notwithstanding any provision in this Agreement to the contrary, if the class-action waiver in the prior sentence is deemed invalid or unenforceable, neither party is entitled to arbitration. This arbitration agreement is subject to the Federal Arbitration Act. The arbitrator’s award may be entered in any court of competent jurisdiction. The existence or results of any negotiation, mediation or arbitration will be treated as confidential. If the arbitration provision in this Agreement is found unenforceable or not to apply for a given dispute, then the proceeding must be brought exclusively in a court of competent jurisdiction in the Commonwealth of Massachusetts.
  15. EXPORT. The Licensed Software and Use Information may be subject export requirements, including licenses, under United States or foreign laws. Each party shall comply with all applicable relevant laws, whether United States or foreign, governing the exports of the Licensed Software and/or Use Information.
  16. DATA SECURITY

    16.1.  PRIVACY AND PROCESSING. The parties acknowledge that Anumana does not have access to protected health information through the Licensed Software in its current deployment as of the Effective Date. To the extent Use Information is made available to Anumana by Customer, Customer shall de-identify the Use Information unless the parties mutually agree in writing otherwise. If Anumana must access protected health information (“PHI”) for any reason under this Agreement that is not a permitted use under the Health Insurance Portability and Accountability Act (“HIPAA”) Privacy Rule, including but not limited to exercising an audit right, the parties agree to execute a business associate agreement.

    16.2.  Personal Data. Customer shall provide to individuals all notices required under applicable laws for Anumana’s lawful processing of Personal Data under this Agreement. Anumana is prohibited from (a) “selling” or “sharing” (as such terms are specifically defined in certain applicable laws) Personal Data; (b) retaining, using, or disclosing Personal Data for any purpose other than providing services under this Agreement; and (c) processing Personal Data outside of the direct business relationship between Anumana and Customer. Except as otherwise expressly provided in this Agreement, Anumana is not processing Personal Data as consideration for any services provided to Customer. Customer may take reasonable and appropriate steps to ensure that Anumana uses Personal Data in a manner consistent with Anumana’s obligations. Anumana shall notify Customer if Anumana determines that it can no longer meet its obligations under the applicable data protection laws that require such a notification. Customer may, upon written notice to Anumana, take reasonable and appropriate steps to stop and remediate unauthorized use of Personal Data. Anumana shall (1) ensure that each Anumana representative processing Personal Data is subject to a duty of confidentiality regarding such information; (2) at Customer’s election, return to Customer or destroy Personal Data after the end of the services under this Agreement, subject to certain exceptions as permitted or required by applicable laws; (3) require any subcontractor with access to Personal Data (“Subprocessor”) to agree to obligations substantially similar to those in this section and provide Customer an opportunity to object to Anumana’s use of a subcontractor; and (4) upon Customer’s written request, make available to Customer all documentation reasonably necessary to demonstrate Anumana’s compliance with applicable laws, including (to the extent available), a report of any audits conducted on Anumana related to Anumana’s policies and technical and organizational measures in support of its compliance with applicable laws.

    16.3.  Subprocessors. Customer may, on reasonable and objective grounds, object to Anumana’s use of a new Subprocessor by providing Anumana with written notice within ten (10) days with documentary evidence that reasonably shows that the Subprocessor does not or cannot comply with the requirements in this Agreement or the requirements of this section (“Objection”). If an Objection arises, Customer and Anumana will confer in good faith regarding a mutually acceptable resolution to address such Objection, including but not limited to reviewing and implementing additional documentation supporting the Subprocessor’s compliance with this Agreement or applicable laws.

    16.4.  Security.  Anumana is not responsible for: (i) securing Customer’s network; (ii) preventing unauthorized access to Customer’s network or the Product; (iii) backup management; (iv) data integrity; (v) recovery of lost, corrupted, or damaged data, images, software, or equipment; or (vi) providing or validating antivirus or related IT safeguards unless sold to Customer by Anumana. NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY FOR DAMAGES CAUSED BY PRODUCT REGARDLESS OF A PARTY’S COMPLIANT SECURITY MEASURES.
  17. GOVERNING LAW. The Order and this Agreement are governed by the laws of the Commonwealth of Massachusetts without regard to conflict of law principles.
  18. FORCE MAJEURE. Neither party will be liable to the other for failure to fulfill obligations hereunder if such failure is due to causes beyond its control, including, without limitation, acts of God, earthquake, fire, flood, embargo, catastrophe, sabotage, utility or transmission failures, governmental prohibitions or regulations, national emergencies, insurrections, riots or wars, acts of terrorism, Internet or power outages, or viruses which did not result from the acts or omissions of such party (“Force Majeure Event”). The time for any performance required hereunder will be extended by the delay incurred as a result of such Force Majeure Event.
  19. WAIVER. Anumana’s failure to enforce at any time, or for any period, any term of this Agreement shall not be construed as a waiver of Anumana’s rights thereafter to enforce such term. Anumana’s waiver of a Customer default will not be deemed a continuing waiver but will apply solely to the instance to which the waiver is directed.
  20. CONFLICTS; AMENDMENT. This Agreement, including the Order Form set forth the entire agreement and understanding between Anumana and Customer regarding the subject matter hereof and supersedes any previous or contemporaneous communications, representations, proposals, commitments, understandings, negotiations, discussions, understandings or agreements (including non-disclosure or confidentiality agreements), whether oral or written, regarding the same subject matter. This Agreement and Order Form expressly supersedes and replaces in their entirety any pre-printed terms on a Customer purchase order or similar document. In the event of a conflict between the terms of an executed Order Form and the terms of this Agreement, the terms of the executed Order Form shall govern. Any Amendment to the Standard Terms or Order Form requires the written agreement of both parties.
  21. SEVERABILITY. If any term or condition of this Agreement is deemed unenforceable, it shall be severed, and every other provision of this Agreement shall be enforced as if the unenforceable term or condition had never been a part hereof.
  22. ASSIGNMENT. Neither party may assign the Order Form without the other party’s prior written consent, provided that either party may assign an Order Form without the other party’s consent in connection with a merger, acquisition, or sale of all or substantially all of its assets or business to which the Order Form and Standard Terms relate. Party that assigns an Order as permitted in this Section 22 shall provide the other party with prompt notice of such assignment. Subject to the foregoing, the Order Form and Standard Terms will be binding upon and inure to the benefit of the parties and their permitted successors and assigns.
  23. INDEPENDENT PARTIES. The parties to this Agreement are independent contractors, and this Agreement does not create any partnership, joint venture or agency relationship between Anumana and Customer.
  24. NOTICES. Any notice delivered by Anumana to Customer under this Agreement will be delivered by email to the email address set forth in the Order Form or such other email address that Customer provides to Anumana. Customer will direct legal notices or other correspondence under this Agreement to Anumana at One Main Street, Suite 400, East Arcade, Cambridge, MA 02142, Attn: General Counsel, with a copy via email to: generalcounsel@Anumana.net
  25. COMPLIANCE WITH MEDICARE ANTI-KICKBACK, SELF-REFERRAL AND ANTI-REBATE LAWS. Each party represents, warrants, and covenants that neither it nor any of its personnel will engage in any activity prohibited by 42 USC §1395nn (42 Code of Federal Regulations, Part 411, (411.1 to 411.361)), 42 USC §1320a-7a and 42 USC §1320a-7b (42 Code of Federal Regulations, Part 1001 (1001.952(a) to 1001.1001)) or any other laws relating to the referral of patients, including anti-rebating and self-referral prohibitions and limitations, as those regulations now exist or as subsequently amended, renumbered or revised, nor will the party or its personnel associate or engage in similar activities with respect to any third-party payors, including soliciting or receiving, directly or indirectly, any compensation, in cash or in kind or offering to pay any compensation to a third person in exchange for referring an individual to a person for the furnishing of any item or service for which payment may be made in whole or in part by Medicare or Medicaid or any other state or federally funded health care program.
  26. NOT EXCLUDED. Each party represents that (i) it is not currently excluded, debarred or suspended from participation in any federal health care programs and is not under investigation or by any state or federal governmental agency that may lead to such an exclusion, debarment or suspension; and (ii) to the best of its reasonable knowledge, none of its employees, officers, directors and any health care providers contracted to provide services to patients (“Staff”) is currently excluded, debarred or suspended from participation in any federal health care programs and is not under investigation or by any state or federal governmental agency that may lead to such an exclusion, debarment or suspension. If any of the representations and warranties set forth in this Section ceases to be true for a party, such party will promptly remove, or cause to be removed, the excluded, debarred, or suspended individual from providing services hereunder and notify the other party within one (1) business day of confirming the exclusion, debarment or suspension.