THE PORTABLE NEUROMODULATION STIMULATOR (PONS®) DEVICE
TERMS AND CONDITIONS OF SALE IN THE U.S.
  • SCOPE OF AGREEMENT. These Terms and Conditions of Sale, together with any attachments and appendices for the Portable Neuromodulation Stimulator (PoNS®) Device or a PoNS Mouthpiece (individually or collectively the “Product”)(these “Terms and Conditions”), as evidenced by a valid Prescription, the current terms and conditions of the and the current terms and conditions of the physician locator assistance (if any) (collectively, this “Agreement”), constitute the agreement between Customer, as identified on the Prescription and Helius Medical, Inc., a division of Helius Medical Technologies, Inc. (“Helius”) concerning Helius’ (a) sale of the Products under this Agreement and (b) Customer’s purchase and use of such Products under this Agreement. The term “Customer” also includes any persons and/or legal entities for which the Customer has the actual or apparent authority to purchase Products on behalf of and whose acceptance of such Products from Helius shall constitute agreement to be bound by the Agreement.
  • SALE AND USE OF THE PRODUCTS.
    • Sale of Products. Subject to these Terms and Conditions, Helius hereby agrees to sell to Customer, and Customer hereby agrees to purchase from Helius, all Products set forth on the Prescription. Customer may purchase additional Products under this Agreement by submitting a valid Prescription. CUSTOMER EXPRESSLY AGREES THAT HELIUS’ THEN-CURRENT TERMS AND CONDITIONS OF SALE ARE EXPRESSLY INCORPORATED BY REFERENCE INTO THE SALE. IN THE EVENT OF A CONFLICT BETWEEN THE TERMS AND CONDITIONS OF THIS AGREEMENT AND ANY SUBSEQUENT TERMS AND CONDITIONS OF HELIUS, THE SUBSEQUENT TERMS AND CONDITIONS SHALL GOVERN WITH RESPECT TO THE PRODUCTS COVERED BY THE APPLICABLE SALE. Helius maintains its current terms and conditions on ponstherapy.com and a hard copy is available to Customer upon written request therefor. Products provided under this Agreement are new unless otherwise indicated in writing by Helius. Products may, however, contain components that have previously been used and, where previously used components are used, the Helius Products shall meet or exceed Helius’ specifications for newly manufactured products.
    • Supplies. Customer acknowledges that the safe and effective operation of the System requires use of the Software and Supplies, which are specifically engineered and manufactured to meet System compatibility, quality and performance standards, and accordingly Customer agrees to use only the Software and Supplies provided by or expressly authorized by Helius with the System. Customer hereby acknowledges that the System contains software that monitors all procedures performed, and the System will not operate without the use of certain Supplies.
    • Authorized Use. The Products are being sold or licensed (as applicable) to Customer with the understanding that the operation of the System must be undertaken only in a manner that is compliant with the User Manual. The System is for use by a single individual and must not be shared. The System must only be dispensed under Prescription by a health care provider and used under the supervision of a Rehabilitation Therapist utilizing the System pursuant to the laws, rules and regulations of the jurisdiction in which the System is operated (each, a “Provider”). The Rehabilitation Specialist will activate the device at time of first utilization. Only Providers and individuals operating under the supervision of a Provider (each Provider and each such individual, an “Authorized User”) may use the Products. Customer must ensure that all Authorized Users have the requisite training and skill required to use the Products as required by all applicable governmental authorities in the jurisdiction in which the System is operated. Customer and its Authorized Users must at all times be and remain in full compliance with all applicable laws, rules and regulations, including, without limitation, those promulgated by state medical agencies and certification boards, relating to use of the Products. Customer agrees to defend, indemnify and hold Helius harmless from and against all claims, damages and expenses (including reasonable attorneys’ fees) against or incurred by Helius arising out of Customer’s or any Authorized User’s actual or alleged misuse of the Products and/or failure to comply with applicable laws, rules and regulations.

  • PRICING AND PAYMENT TERMS.
    • Price for Products. The prices for such Products shall be Helius’ then-current rates.
    • Taxes, Fees, Expenses, and Charges. Customer shall pay any and all taxes, assessments, levies and/or fees, and any and all other charges, interest and penalties, relating to Customer’s purchase of Products and Services and Customer’s performance of any procedures. Customer shall be solely responsible for any and all sales, use, excise or consumption taxes or duties assessed on the purchase price of Products and Services and not collected by Helius at time of sale. Except for Services covered by the Limited Warranty set forth in Section 8, payment for such Services is due prior to Helius performance thereof and will be charged at Helius then-current rates.
    • Discounts and Rebates. The pricing for the Products may reflect or be subject to discounts, rebates or other price reductions, which Customer may be obligated under applicable laws to report to Medicare, Medicaid or other state, federal or private payers, and to make this information available to these entities for review. It is the Parties’ intent that any discounts, rebates or other price reductions received by Customer under this Agreement comply with the federal Anti-Kickback Statute and other applicable federal and state law and, further, that any discounts provided under this Agreement or any other discount purchase program satisfy the discount safe harbor of the federal Anti-Kickback Statute (as set forth under 42 C.F.R. §1001.952(h)). Customer acknowledges that the Discount Safe Harbor of the federal Anti- Kickback Statute requires that certain discounts, including certain rebates and reductions in price, be reported and/or passed on to federal and state health care programs such as Medicare and Medicaid. As a condition of this Agreement, Customer understands and agrees that, to the extent applicable, it will properly disclose discounts and rebates, and reflect such discounts and rebates in costs claimed or charges made, under federal and state health care programs in accordance with federal and state laws. The reporting requirements for discount programs for medical products reimbursed by federally funded healthcare programs are defined by federal regulations under the federal Anti-Kickback Statute, 21 C.F.R. §1001.952(h). Helius will refrain from doing anything that impedes Customer from meeting its obligations under the federal Anti-Kickback Statute, and its implementing regulations, with respect to discounts received under this Agreement.
    • Payment Terms. Customer shall pay all amounts due to Helius in advance. Payments shall be directed to such address and/or account as Helius may specify in writing from time to time. Helius shall not be responsible for any misdirected payments by Customer as a result of cyber fraud (e.g., phishing), Customer error or otherwise.
  • SHIPMENT, STORAGE, RISK OF LOSS, ACCEPTANCE. Helius will use commercially reasonable efforts to meet shipment schedules. However, all shipments provided by Helius at the time of order acceptance by Helius are estimates only. Helius will have no liability whatsoever because of any delay in the delivery of all or any part of any order of a System for any reason. In the event of a shortage, Helius reserves the right to allocate inventories and production in its sole discretion. Helius shall provide Customer at least five (5) days’ prior notice of the scheduled shipping date and Customer shall accept delivery on such date; provided, however, at Customer’s written request, Helius will store the System for up to thirty (30) days after the System is ready for shipment at no charge. Helius may charge Customer storage fees at its then- prevailing rates for storage of Systems in excess of thirty (30) days. Unless otherwise by Helius, all Systems will be delivered FCA (Incoterms 2020) Helius’ shipping point. All terms implied by FCA are incorporated into this Agreement. Customer is deemed to have accepted the Products without right of return, and risk of loss and title passes to Customer, when the Products are delivered to the shipper at Helius’ shipping point.
  • SOFTWARE AND DOCUMENTATION. The Software and Documentation included or used with the System is not sold but rather is licensed to Customer. Helius hereby grants to Customer a personal, limited, non-exclusive, non-transferable, and non- sublicensable right and license during the Term (as defined in Section 11(a)) for Customer and its Authorized Users to operate and use the Software and the Documentation solely in conjunction with the operation and use of the System as permitted hereunder. Customer and its Authorized Users obtain no right, title or interest in or to the Software, except for the limited license granted hereunder, and Helius and its licensors reserve all rights not expressly granted.
    • Limitations. Customer and its Authorized Users may use the Software only in connection with the use and operation of the System in accordance with the Documentation and Helius’ instructions provided from time to time. Customer may not loan, rent, lease, license or otherwise transfer to any other person, or host on behalf of any other person, the Software, and may not copy, modify, remove, disassemble, decompile, reverse engineer, create derivative works from or tamper with the Software. Any attempted transfer or use of the Software without the prior signed written consent of Helius will void the license and all warranties granted herein in connection with the System.
    • Copies. Customer and its Authorized Users may not copy or otherwise reproduce the Software or Documentation except as expressly permitted by this Agreement and provided that Customer complies with the obligations of confidentiality set forth herein. Except to the extent that this prohibition is not permitted under applicable law, Customer will not decompile, reverse engineer or disassemble the Software in an attempt to derive or use the source code therefrom.
    • Third Party Software. The Software may include Redistributable Code, which is the property of Helius’ licensors, and protected under United States and international copyright, trade secret or other proprietary rights laws, as well as international treaties. Customer is hereby granted a non- exclusive, non-transferable (except to the extent that transfer of the corresponding System is expressly permitted under this Agreement) and non-sublicensable license during the Term for Customer and its Authorized Users to use and display the Redistributable Code solely in connection with the authorized operation of the System and in conformance with the terms and conditions of this Agreement. Except to the extent that this prohibition is not permitted under applicable law, Customer may not reproduce, redistribute, decompile, reverse engineer or disassemble the Redistributable Code, and may not disintegrate the Redistributable Code from the Software.
  • LIMITED COPYRIGHT AND TRADEMARK LICENSE.
    • Limited License. The Software and Documentation are not sold but rather they are licensed to Customer for use by the Customer’s Rehabilitation Therapist. Subject to Customer’s compliance with this Agreement, Helius hereby grants to Customer a personal, non-exclusive, non-transferable (except to the extent that transfer of the corresponding System is expressly permitted under this Agreement), and non-sublicensable license during the Term (as defined in Section 11(a)) for Customer and its Authorized Users to operate and use the Software and the Documentation solely in conjunction with the operation and use of the System as permitted hereunder, in the form provided by Helius, and in accordance with the Documentation. Customer and its Authorized User obtain no right, title or interest in or to the Software, except for the license granted above in this Section 6(a), and Helius and its licensors reserve all rights not expressly granted in this Agreement.
    • License Termination. Notwithstanding the foregoing, Helius may on reasonable prior notice terminate the license granted by Section 5(a) as to one or more or all of the Helius Marks and the Marketing Collateral.
  • LIMITED WARRANTY.
    • Warranty Term. The term of the Limited Warranty in Section 7(b) shall be as follows:
      • For the System and Software (excluding Redistributable Code), one (1) year from Customer’s acceptance of the System in accordance with Section 5.
      • For upgrades to the System and/or Software, ninety (90) days after the installation of such upgrade(s).
      • For other Products, the shorter of: (a) one (1) year from Customer’s acceptance of such Products in accordance with Section 5; and (b) the shelf-life expiration dates listed on the applicable packaging (if any).
    • Limited Warranty. For the duration of the warranty terms set for in Section 7(a), Helius warrants to Customer that:
      • The System will be free from defects in material and workmanship and, when used in accordance with the Documentation by Authorized Users, will perform substantially in accordance with the Specifications.
      • Software, excluding Redistributable Code, as delivered with the System or upgraded by Helius and properly installed and operated on the System it is originally licensed for, will function substantially as described in the User Manual.
      • Helius will pass through to Customer the warrant(ies) that Helius receives on the Redistributable Code (if any). For the avoidance of doubt, pass through of the warranty means that Customer is required to deal directly with the manufacturer of the Redistributable Code, as applicable, in relation to technical support, service, warranty and all other matters related to the Redistributable Code.
      • All other Products will be free from defects in material and workmanship and conform to applicable Specifications.
    • Warranty Remedies. Customer’s sole and exclusive remedy under the Limited Warranty set forth herein is limited, at Helius’ sole discretion, to repair or replacement (which may include replacement with refurbished Products or components) of any Product and/or component that failed to conform to the Limited Warranty. If Software, other than Redistributable Code, fails to so conform during its warranty period, as the sole remedy Helius or Helius’ supplier will at its discretion provide a suitable fix, patch or workaround for the non-conformance which may be included in a past or future version of the Software. Where the Limited Warranty service results in Customer receiving replacement Products and/or components, such replacement Products and/or components shall be subject to the Limited Warranty, including the Warranty Term, applicable to the original Products and/or components. Where refurbished Products or components are provided, such refurbished Products or components shall meet or exceed Helius’ specifications for newly manufactured Products or components.
    • Warranty Limitations. The Limited Warranty provided under this Agreement, may, at Helius’ sole discretion, be voided by any of the following: (i) Customer’s failure to comply with the terms of this Agreement; (ii) Customer’s failure to make any modifications, including without limitation, any Software updates required by Helius; (iii) the abuse, misuse, negligent handling, abnormal use or working conditions, accident, alteration, willful damage, neglect or unauthorized repair or modification of the Products; (iv) use of the Products in a manner inconsistent with the User Manual; (v) use of the Products by anyone other than an Authorized User; (vi) use of expired or refurbished Supplies or with otherwise unauthorized supplies; or (vii) failure to follow Helius’ instructions (whether written or oral). Helius will make the final determination as to whether the existence and cause of any alleged defect satisfies the Limited Warranty.
    • Prohibition on Warranty Transfer. The Limited Warranty set forth herein is not, without Helius’ express written permission, transferable to any third party. Any purported transfer of this Limited Warranty without Helius express written permission is null, void and of no force or effect.
    • NO OTHER WARRANTIES. EXCEPT AS SET FORTH ABOVE IN THIS SECTION 7, THE PRODUCTS ARE PROVIDED “AS IS” AND HELIUS HEREBY DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY OR OTHER, AND HELIUS SPECIFICALLY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT, AND ALL WARRANTIES ARISING FROM COURSE OF DEALING, USAGE OR TRADE PRACTICE. WITHOUT LIMITING THE FOREGOING, HELIUS MAKES NO WARRANTY OF ANY KIND THAT THE PRODUCTS OR RESULTS OF THE USE THEREOF, WILL MEET CUSTOMER’S OR ANY OTHER PERSON’S REQUIREMENTS, OPERATE WITHOUT INTERRUPTION, ACHIEVE ANY INTENDED RESULT, BE COMPATIBLE OR WORK WITH ANY SOFTWARE, SYSTEM OR OTHER SERVICES, OR BE SECURE, AVAILABLE, ACCURATE, COMPLETE, FREE OF HARMFUL CODE OR ERROR FREE. CUSTOMER ACKNOWLEDGES THAT HELIUS DOES NOT CONTROL THE TRANSFER OF DATA OVER THE INTERNET, AND THAT TRAKSTAR CLOUD AND OTHER COMPONENTS OF THE SYSTEM WILL BE SUBJECT TO LIMITATIONS INHERENT IN THE USE OF THE INTERNET. HELIUS IS NOT RESPONSIBLE FOR ANY DELAYS, DELIVERY FAILURES OR OTHER DAMAGE RESULTING FROM SUCH INTERNET PROBLEMS. THE FOREGOING DOES NOT AFFECT ANY WARRANTIES WHICH CANNOT BE EXCLUDED OR LIMITED UNDER APPLICABLE LAW.
  • LIMITATIONS OF LIABILITY.
    • NOTWITHSTANDING ANYTHING TO THE CONTRARY, HELIUS SHALL NOT BE LIABLE FOR INCIDENTAL, CONSEQUENTIAL, INDIRECT OR SPECIAL DAMAGES OF ANY KIND, INCLUDING BUT NOT LIMITED TO DAMAGES FOR LOST REVENUE OR LOST PROFITS, LOSS OF DATA, LITIGATION EXPENSE, DAMAGE TO REPUTATION, LOSS OF BUSINESS OR ANY OTHER FINANCIAL LOSS ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT, INCLUDING IN CONNECTION WITH THE SALE, LICENSE, INSTALLATION, PERFORMANCE, FAILURE, USE OR INTERRUPTED USE OF THE PRODUCTS, AND INCLUDING THE PORTABLE NEUROMODULATION STIMULATOR (PONS™) DEVICE AND ANY COMPONENT THEREOF, OR FROM HELIUS’ NEGLIGENCE OR OTHER FAULT IN CONNECTION THEREWITH. NOTWITHSTANDING ANYTHING TO THE CONTRARY, HELIUS’ LIABILITY FOR ANY LOSS OR DAMAGE ARISING OUT OF OR RESULTING FROM THIS AGREEMENT, ITS PERFORMANCE OR BREACH HEREOF, OR IN CONNECTION WITH THE PRODUCTS, REGARDLESS OF THE FORUM AND REGARDLESS OF WHETHER ANY ACTION OR CLAIM IS BASED ON CONTRACT, TORT, INDEMNIFICATION OR OTHERWISE, SHALL NOT EXCEED THE TOTAL OF ALL SUMS PAID BY CUSTOMER TO HELIUS FOR THE PRODUCT OR SERVICE THAT IS THE SUBJECT OF THE CLAIM.

    • CUSTOMER ACKNOWLEDGES THAT THE LIMITATIONS OF LIABILITY AND DISCLAIMERS OF WARRANTY SET FORTH IN THIS AGREEMENT APPLY REGARDLESS OF WHETHER ANY REMEDY FAILS OF ITS ESSENTIAL PURPOSE. CUSTOMER ACKNOWLEDGES THAT HELIUS HAS SET THE PURCHASE PRICE OF THE PRODUCTS AND OTHER FEES AND CHARGES IN RELIANCE ON THE DISCLAIMERS OF WARRANTY AND LIMITATIONS AND EXCLUSIONS OF LIABILITY SET FORTH IN THIS AGREEMENT AND THAT THE SAME FORM AN ESSENTIAL BASIS OF THE BARGAIN BETWEEN THE PARTIES.
  • APPLICABLE LAW; DISPUTE RESOLUTION; ATTORNEYS’ FEES.
    • Applicable Law. The laws of the Commonwealth of Pennsylvania govern this Agreement, without regard to conflict of laws principles or any other principles that would result in the application of a different body of law.
    • Dispute Resolution. Any case, controversy or claim arising out of or relating to this Agreement, including its breach and/or interpretation, shall be exclusively resolved (i) first by non- binding mediation for at least one day and no more than two (2) days in Bucks County, Pennsylvania before a mutually agreed mediator and (ii) if the case, controversy or claim is not resolved by such mediation, then binding arbitration to occur in Bucks County, Pennsylvania under the auspices of the American Arbitration Association under its the then-current Commercial Arbitration Rules (the “Rules”) before one arbitrator appointed in accordance with such Rules and utilizing such limited and expedited discovery as the Rules may provide for and the arbiter may deem appropriate. It is the intent of the Parties that any disputes subject to this Section 10(b) shall be resolved as promptly, efficiently and expeditiously as possible and the Rules shall be applied to accomplish these objectives. Notwithstanding the foregoing dispute resolution process, neither party shall be precluded, at any time, from seeking injunctive relief in any court of law to compel arbitration or to preserve the status quo. The arbitrator shall issue a written report to the parties, detailing the basis of any arbitration award. Judgment on the award rendered by the arbitrator may be entered in any court having jurisdiction.
    • Attorney Fees. If any dispute resolution or other legal proceeding is initiated with respect to this Agreement, in the event that Helius is the substantially prevailing party in such proceeding, in addition to all other remedies available to Helius, Customer shall reimburse Helius for its reasonable attorneys’ fees, costs and expenses associated with the proceeding, including (i) expenses incurred prior to the initiation of the proceeding in seeking collection or other compliance with rights hereunder and (ii) expenses incurred in responding to unfounded claims.
  • HIPPA BUSINESS ASSOCIATE PROVISIONS.
    • Access to PHI. All capitalized terms in these HIPAA Business Associate Provisions shall have the meaning set forth in their definitions in the: (i) Standards for Privacy of Individually Identifiable Health Information (the “Privacy Standards”) and the Standards for the Security of Electronic Protected Health Information (the “Security Standards”) issued under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), at 45 C.F.R. Parts 160 and 164, as such definitions are currently in effect and as subsequently amended; and (ii) The American Recovery and Reinvestment Act of 2009 and any regulations issued pursuant to such Act (“ARRA”). Any ambiguity in this Agreement shall be resolved to permit the parties to comply with HIPAA. In fulfillment of certain provisions of this Agreement and in the course of its continued relationship with Customer, Helius may have or will require access to Protected Health Information (“PHI”) of Customer. Helius may use and disclose said PHI received from Customer solely as permitted or required by this Agreement or as otherwise required by law. All such uses and disclosures shall be in compliance with each applicable requirement of 45 C.F.R. § 164.504(e).

    • Obligations of Helius Relating to HIPAA. Helius shall not use or disclose PHI received from Customer in any manner that would constitute a violation of the Privacy Standards if used in such manner by Customer. Except as otherwise limited in this Agreement, Helius may disclose PHI for the proper management and administration or to carry out the legal responsibilities of Helius, provided that disclosures are required by law, or Helius obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purpose for which it was disclosed to the person, and the person notifies Helius of any instances of which it is aware in which the confidentiality of the information has been breached. Except as otherwise limited in this Agreement, Helius may use PHI to provide data aggregation services to Customer as permitted by 45 C.F.R. § 164.504(e)(2)(i)(B). Helius may de-identify PHI, provided that the de-identification processes conform to the requirements of the Privacy Standards. Once the data is de- identified, such information shall no longer be considered PHI. Helius may also create a Limited Data Set for purposes of research, public health, or health care operations subject to the Data Use Addendum in APPENDIX B attached hereto. Helius shall not directly or indirectly receive remuneration in exchange for any PHI, unless Helius or Customer has obtained a valid HIPAA- compliant authorization from the patient that specifies whether the PHI can be further exchanged for remuneration by Helius. Helius agrees to use appropriate safeguards to prevent use or disclosure of PHI otherwise than as provided for by this Agreement. Helius agrees to implement administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the Electronic PHI that it creates, maintains, or transmits on behalf of Customer, as required by the Security Standards and the ARRA, including without limitation, 45 C.F.R. §§ 164.308, 164.310 and 164.312. Helius agrees to implement reasonable and appropriate policies and procedures to comply with the Security Standards as required by 45 C.F.R. § 164.316(a) and the ARRA. Helius also agrees to maintain such policies and procedures in written or electronic form and will document and retain such documentation regarding all actions, activities and assessments required under the Security Standards consistent with 45 C.F.R. § 164.316(b) and the ARRA. Helius agrees to mitigate, to the extent practicable, any harmful effect that is known to Helius of an unauthorized use or disclosure of PHI by Helius in violation of the requirements of this Agreement. Helius agrees to report to Customer any use or disclosure of PHI not provided for by this Agreement of which Helius becomes aware. Helius also agrees to report within 15 business days to Customer the discovery by Helius of any Security Breach and any successful Security Incidents. Helius agrees to report to Customer any unsuccessful Security Incidents as requested by Customer. Helius’ reports to Customer regarding Security Breaches shall include the identification of each individual whose unsecured PHI (as defined under ARRA and the HIPAA Standards) has been, or is reasonably believed by Helius to have been, accessed, acquired, or disclosed during such Security Breach. Customer agrees to make any notifications regarding such Breaches required under the HIPAA Standards and the ARRA, and Helius agrees to provide Customer with notification-related information required under the HIPAA Standards and the ARRA.

    • Agents and Subcontractors. Helius agrees to require any agent or subcontractor to whom it provides PHI received from, or created or received by Helius on behalf of Customer, to agree to be bound by the same restrictions and conditions that apply through this Agreement to Helius with respect to such PHI. Helius agrees to disclose to such subcontractors or agents only the minimum PHI necessary (as defined under the HIPAA Standards and the ARRA) to perform or fulfill a specific function required or permitted under the Services Agreement or this Agreement.
    • Designated Record Set. Upon request of Customer, Helius agrees to provide Customer access to PHI in a Designated Record Set so that Customer may meet the requirements under 45 C.F.R. § 164.524 and the ARRA (including access to the information in electronic form). At the request of Customer, Helius agrees to make any amendments to PHI in a Designated Record Set that Customer directs or agrees to pursuant to 45 C.F.R. § 164.526 and the ARRA. Helius agrees to document such disclosures of PHI and information related to such disclosures as would be required for Customer to respond to a request by an individual for an accounting of disclosures of PHI in accordance with 45 C.F.R. § 164.528 and the ARRA. To the extent that Customer provides the individual with a list of business associates and the individual contacts Helius directly, Helius agrees to provide the individual with an accounting of disclosures relating to that individual, as required under the ARRA. Helius agrees to implement a restriction agreed to by Customer on the use and disclosure of an individual’s PHI, providing Customer notifies Helius in writing of the same. Helius understands that Customer must accept a request for a restriction if the disclosure is to a health plan for the purposes of carrying out payment or health care operations (and is not for treatment) and the PHI pertains solely to a healthcare item or services for which Customer involved has been paid out of pocket in full. Helius agrees to provide to Customer information collected as described immediately above to permit Customer to respond to a request by an individual for an accounting of disclosures of PHI in accordance with 45 C.F.R. § 164.528. Helius agrees to make its internal practices, books, and records relating to the use and disclosure of PHI received from, or created or received by Helius on behalf of, Customer, available to the Secretary of the Department of Health and Human Services (“Secretary”) for purposes of determining Customer’s compliance with the Privacy and Security Standards.
    • Post-Termination. Upon termination of this Agreement for any reason, Customer agrees that it shall be infeasible for Helius to return or destroy all PHI received from Customer to the extent that this information will have been revised and incorporated into Helius’ database of related information. Helius agrees to extend the protections of this Agreement to PHI in its possession and limit further uses and disclosures of such PHI to those purposes that make the return or destruction of PHI infeasible, for so long as Helius maintains such PHI. Helius shall require any subcontractors or agents to return or destroy all PHI received from Customer, but only to the extent that such received PHI has not been revised and incorporated into Helius’ database of related information. Upon Customer’s knowledge of a material breach by Helius of this Agreement, Customer shall either (1) provide Helius an opportunity to cure the alleged material breach within 30 days of receipt of written notice of the breach and terminate this Agreement if Helius does not cure the breach within said 30 days; or (2) immediately terminate this Agreement if Helius has breached a material term of these HIPAA Business Associate Provisions and cure is not possible. If neither termination nor cure is feasible, Customer may report the breach to the Secretary. Upon Helius’ knowledge of a pattern of material breaches or violations of this Agreement by Customer, Helius shall work with Customer to take steps to cure the breach or end the violation and if such steps are unsuccessful, Helius shall terminate this Agreement, if feasible. If it is not feasible to terminate this Agreement, Helius may report the problem to the Secretary.
    • Customer Notification. To the extent impacting Helius’ use or disclosure of PHI, Customer shall notify Helius of: (1) any limitation(s) in the notice of privacy practices of Customer; (2) any change in, or revocation of, the permission by an individual relating to that individual’s PHI; and (3) any restriction on the use or disclosure of PHI that Customer has agreed to or is otherwise required by law. Furthermore, Customer shall not request that Helius use or disclose PHI in any manner that would not be permissible under HIPAA if done by Customer.
    • Cooperation. The parties agree to take such action as is necessary to amend this Agreement from time to time as is necessary for Customer and Helius to comply with the HIPAA Standards.
  • TERM, SUSPENSION AND TERMINATION.
    • Term. This Agreement shall commence upon the date the Prescription is delivered to Helius (the “Agreement Effective Date”) and shall continue thereafter until the last obligation of either party hereunder has been performed or waived, unless sooner terminated as a result of any Termination Event described below (the “Term”).
    • Suspension. Helius may suspend and/or decline further sales of Products and Services if Customer is otherwise in breach of this Agreement. Helius may require Customer to pay for Products and Services in cash, wire transfer of immediately available funds or cashier’s check.
    • Termination Events. This Agreement may be terminated by Helius upon written notice to Customer upon the occurrence of any of the following events, unless Customer has cured such event (if curable) to Helius’ satisfaction within thirty (30) days after the date of Helius written notice (or immediately upon written notice if such event is not curable) (collectively, the “Termination Events”): (i) Customer fails to operate any of the Products in accordance with this Agreement; (ii) Customer has tampered with or altered in any way any of the Products; (iii) Customer prohibits, fails to permit or fails to cooperate in the conduct of any inspection of the System requested by Helius; or (iv) Customer breaches any term of this Agreement.
    • Effect of Termination. Upon the effective date of any Termination Event: (i) Customer and all Authorized Users shall immediately cease all use of the Products, including, for the avoidance of doubt, the System and the Software; (ii) Helius may cancel all pending orders for Products and refuse to accept any future orders from Customer for Products; and (iv) Helius may deactivate the Systems purchased under this Agreement. Sections 2(a), 2(c), 3(b), 3(c), 3(d), 5, 7, 8, 9, 10, 11(d), 12, and 13 shall survive the termination of this Agreement for any reason in accordance with their respective terms.
  • DEFINITIONS.
    • “Documentation” means any and all information in written, graphic, electronic or machine-readable form relating to use or operation of the System, including but not limited to, the User Manual, instructions for use and installation, service, repair and warranty information.
    • “Helius Marks” means the trademarks, service marks, trade dress and other indicia of origin controlled by Helius, including all logos, designs and trade dress, that Helius approves from time to time for use by Customer in connection with Customer advertising or marketing its use of the System.
    • “Marketing Collateral” means the brochures, videos, testimonials, social media, customer facing product aids and other materials that Helius makes available to Customer for Customer’s marketing of its use of the System.
    • “Product” means any System, Software or Supplies provided or to be provided under this Agreement.
    • “Redistributable Code” means all third party software that is licensed to Helius and is distributed with the Software.
    • “Prescription” means a valid prescription issued by a licensed medical provider.
    • “Services” means any and all delivery, installation, training, support, maintenance, repair and warranty services provided to Customer by or on behalf of Helius under this Agreement.
    • “Software” means the software programs, tools and data, whether embedded or incorporated in the System or used in conjunction with the operation of the System.
    • “Specifications” means installation, operating, maintenance, services and usage guidelines and requirements for the Products as published by Helius from time to time.
    • “Supplies” means components, controller, mouthpiece, charger, cord, accessories, spare parts and replacement parts sold by Helius for use with the System.
    • “System” means the Portable Neuromodulation Stimulator (PoNS™) Device (including controller, information display, mouthpiece and related electrodes) and accessories thereto. In the event that Customer purchases multiple Systems under this Agreement, each shall be deemed a separate System for purposes of the Agreement. “System” shall include any Helius-approved replacement for the System (if any).

    • “Termination Events” has the meaning assigned to such term in Section 12(c).
    • “User Manual” means the Portable Neuromodulation Stimulator (PoNS™) Device user manual provided by Helius including, if any, new versions, revisions, updates and modifications thereto.
  • MISCELLANEOUS.
    • Proprietary Information. In connection with this Agreement, Customer and its employees and agents may have access to private and confidential information owned or controlled by Helius relating to equipment, apparatus, programs, software, specifications, drawings, business plans, pricing, data and other information, including but not limited to Product pricing and these Terms and Conditions. Similarly, Helius and its employees and agents may have access to private and confidential information owned or controlled by Customer relating to Customer’s practice. All such information shall be and remain its owner’s exclusive property, and the receiving party shall keep and shall obligate its employees and agents to keep any and all such information confidential and shall not copy or disclose it to others without the owner’s prior written approval, and shall return all tangible copies of such information to the owner promptly upon request. Nothing herein shall limit either party’s use or dissemination of information not actually derived from the other party or information that has been or subsequently is made public by the owner or with the owner’s consent. Customer expressly agrees and acknowledges that private and confidential information received from Helius may not be disclosed to other customers or any competitors of Helius, including any employees or agents of such competitors, without the prior written consent of Helius. Customer shall only use the private and confidential information received from Helius, including the Documentation, to use the System in accordance with this Agreement and the applicable Documentation. Helius intends to protect the privacy and security of protected health information received by or disclosed to any Helius representative in accordance with the HIPAA Business Associate Provisions above. Notwithstanding any other term of this Agreement, Helius may access and use, and shall retain all right, title and interest in transactional and performance data related to use of the Software. Helius may use aggregated and anonymized data based upon Customer data, so long as such data does not reveal any personally identifiable information of any particular individual person, of Customer or of any Authorized Users, for product development and improvement and research and analysis purposes. The Products will be considered the private and confidential information of Helius without the need for any specific markings.
    • Binding Effect; Assignments. This Agreement shall be binding upon the parties hereto and all successors and permitted assigns. Except as provided herein, Customer shall have no right to assign or transfer any right or obligation hereunder without Helius’ prior written consent.
    • Entire Agreement, Merger, Amendments and Waivers. This Agreement sets forth the complete and exclusive agreement between the parties regarding Customer’s purchase and use of the Products purchased by Customer under this Agreement. This Agreement merges and supersedes all prior and contemporaneous agreements, representations and understandings of the parties with respect to the subject matter hereof. No amendment, modification or waiver of any provision of this Agreement shall be effective unless mutually agreed in writing, provided that in the event of any conflict between this Agreement and the terms and conditions set forth in an Order Confirmation for Customer’s future purchase of Products, the terms and conditions in the Order Confirmation shall govern. No failure or delay in exercising any right or remedy shall be a waiver thereof.
    • No Third Party Beneficiaries. There are no third party beneficiaries to this Agreement.
    • Severability. The Parties agree that each provision contained in this Agreement shall be treated as a separate and independent clause, and unenforceability of any one clause shall not impair the enforceability of any other clause. Moreover, if one or more provisions contained in this Agreement shall for any reason be held to be overly broad so as to be unenforceable, such provisions shall be construed by the appropriate judicial body by limiting and reducing them, so as to be enforceable to the extent to be compatible with the applicable law.
    APPENDIX B
    DATA USE ADDENDUM
    This Data Use Addendum (this “DUA”), is incorporated by reference into the Portable Neuromodulation Stimulator (PoNS™) Device Terms and Conditions of Sale and applies to all Product purchased by Customer from Helius. This DUA addresses the conditions under which Helius may obtain, use, maintain and disclose a Limited Data Set derived from Customer’s information, in accordance with 45 C.F.R. §164.514.
    • DEFINITIONS. Unless otherwise specified in this DUA or the Terms and Conditions, all capitalized terms used in this DUA shall have the meaning established for purposes of the Health Insurance Portability and Accountability Act (“HIPAA”), codified at Title 45 parts 160 through 164 of the U.S. Code of Federal Regulations, as amended from time to time.
    • PERMITTED USES AND DISCLOSURES OF LIMITED DATA SET. This DUA allows Helius to use Customer’s information to create a Limited Data Set and use and disclose the Limited Data Set for research, public health, or health care operations, including but not limited to inclusion in regulatory filings (e.g., FDA submissions), data analytics supporting research initiatives or healthcare operations, and internally by Helius to perform product evaluation and improvements. Authorized personnel from the following divisions within Helius may use and disclose information from a Limited Data Set:
        • Executive team
        • Legal Department
        • Research & Development
        • Product Development
        • Clinical
        • Operations
        • Customer Services/Sales
        • Marketing
      In addition to Helius, it is expressly authorized that Helius may share the Limited Data set or outputs derived from the Limited Data Set with the following types of third party entities:
        • Regulatory Agencies (e.g., Food and Drug Administration, Department of Defense, the Department of Veterans Affairs)
        • Clinicians
        • Helius Customers
    • USE OF CUSTOMER IDENTITY. Helius agrees to leave Customer’s name and operational locations confidential unless Customer agrees to such disclosure in writing.
    • MINIMUM NECESSARY. Helius shall access only those data fields which are the minimum necessary to accomplish the purposes set forth in this DUA.
    • RESPONSIBILITIES OF HELIUS. Helius agrees to:
        • Treat the Limited Data Set as both confidential information and PHI, subject to the Terms and Conditions and HIPAA;
        • Use or disclose the Limited Data Set only as permitted by this DUA, the Terms and Conditions, or as Required by Law;
        • Use appropriate safeguards as required by HIPAA, including appropriate physical, administrative, and technical safeguards to prevent the use or disclosure of the Limited Data Set other than as permitted by this DUA, the Terms and Conditions, or as Required by Law;
        • Report to Covered Entity any unauthorized use or disclosure of the Limited Data Set that rises to the level of a Breach, in accordance with the requirements of Section 11 of the Terms and Conditions;
        • Not use or further disclose the Limited Data Set in a manner that would violate HIPAA, if done by Customer;
        • Ensure that any agents to whom Helius provides the Limited Data Set agree to at least the same restrictions and conditions that apply to Helius under this DUA;
        • Not use the Limited Data Set to identify or contact the individuals who are the subjects of any Limited Data Set.
    • NO TRANSFER OF RIGHTS, TITLE OR INTEREST. Customer hereby retains its entire right, title, and interest, including all intellectual property rights, in and to all of its data. Any disclosure of such data in a Limited Data Set hereunder shall not be construed as an assignment, grant, option, license or other transfer of any such right, title or interest whatsoever to Helius, its affiliates or its representatives.
    • REMOVAL OF CERTAIN IDENTIFIERS. For avoidance of doubt, the parties acknowledge and agree that a Limited Data Set shall exclude the following direct identifiers of the individual or of relatives, employers, or household members of the individual:

        • Names;
        • Postal address information, other than town or city, State, and zip code;
        • Telephone numbers;
        • Fax numbers;
        • Electronic mail addresses;
        • Social security numbers;
        • Medical record numbers;
        • Health plan beneficiary numbers;
        • Account numbers;
        • Certificate/license numbers;
        • Vehicle identifiers and serial numbers, including license plate numbers;
        • Device identifiers and serial numbers;
        • Web Universal Resource Locators (URLs);
        • Internet Protocol (IP) address numbers;
        • Biometric identifiers, including finger and voice prints; and
        • Full face photographic images and any comparable images.