TERMS AND CONDITIONS OF SUPPLY

HEADSAFE US, Inc. - For use in United States

Introduction

HEADSAFE SELLS ITS NUROCHEK HARDWARE AND SOFTWARE TO LICENSED HEALTH CARE PROVIDERS IN THE UNITED STATES. THE NUROCHEK PRO HARDWARE IS ONLY FOR USE IN CONJUNCTION WITH THE SOFTWARE SUPPLIED WITH IT.

ACCEPTING HEADSAFE'S WRITTEN OFFER TO WHICH THESE TERMS AND CONDITIONS ARE DEEMED INCORPORATED WILL CAUSE THE ORGANIZATION ("CLIENT") - TO WHICH HEADSAFE'S WRITTEN OFFER IS ADDRESSED - TO ACCEPT HEADSAFE'S OFFER AND ENTER INTO A BINDING LEGAL AGREEMENT WITH HEADSAFE ("AGREEMENT") CONTAINING THESE TERMS AND CONDITIONS WHICH GOVERN BOTH THE PURCHASE AND THE USE OF THE NUROCHEK PRO HARDWARE AND THE SOFTWARE. THE PERSON ACCEPTING HEADSAFE'S OFFER WARRANTS THAT HE/SHE HAS THE AUTHORITY TO CREATE A LEGALLY BINDING AGREEMENT BETWEEN THAT ORGANIZATION AND HEADSAFE.

NO ADDITIONAL OR DIFFERENT TERMS AND CONDITIONS PROPOSED BY CLIENT (IN WHATEVER OTHER DOCUMENT) WILL APPLY TO THE SUBJECT MATTER OF THE AGREEMENT.

CLIENT'S ENTRY INTO THE AGREEMENT IS NOT CONDITIONED ON THE DELIVERY OF ANY FUTURE FUNCTIONALITY OR FEATURES OF THE HARDWARE AND SOFTWARE, OR ON ANY ORAL OR WRITTEN PUBLIC COMMENTS MADE BY HEADSAFE REGARDING FUTURE FUNCTIONALITY OR FEATURES OF THE HARDWARE AND SOFTWARE.

THE AGREEMENT BECOMES EFFECTIVE AS OF THE DATE OF ACCEPTANCE ("EFFECTIVE DATE").

1. Definitions

1.1. Affiliate means any entity that directly or indirectly controls, is controlled by, or is under common control with the subject entity. "Control," for purposes of this definition, means direct or indirect ownership or control of more than 50% of the voting interests of the subject entity.

1.2. Agreement has the meaning given to it in the Introduction above.

1.3. Authorized User means a person who is either (a) a Licensed Healthcare Practitioner or (b) acting under the supervision of a Licensed Healthcare Practitioner and who is authorized by Client to access and use the Hardware and Software and to whom Client has supplied customary log-in credentials (i.e. a user identification and initial password).

1.4. BAA has the meaning given to it in Section 7.3.

1.5. Business Associate has the meaning given to it in the HIPAA Privacy Rules (45 C.F.R. § 160.103).

1.6. Client has the meaning given to it in the Introduction above.

1.7. Client Equipment means (a) computer hardware, software and network infrastructure used to access the Software; (b) data storage platforms and networks and (c) internet access and (d) any ancillary services needed to connect to, access or otherwise use the Hardware and Software.

1.8. Cloud Infrastructure means cloud computing software, hardware or other infrastructure or services, whether public, private, community-based or otherwise.

1.9. Data Privacy Laws means all data protection and privacy laws applicable to the processing of Personal Information by Headsafe or its Sub-processors.

1.10. Documentation means documentation (a) describing the design, features and functionality of the Hardware and Software and (b) providing including instructions for use of the Hardware and Software, as provided and updated by Headsafe from time to time.

1.11. Effective Date has the meaning given to it in the Introduction above.

1.12. Excusable Event means any one or circumstances beyond Headsafe's reasonable control, including failure of or interruption to the operation of the Cloud Infrastructure, an act of God, act of government, flood, fire, earthquake, civil unrest, act of terror, pandemic, epidemic, quarantine restriction, strike or other labor problem (other than one involving Headsafe personnel), internet service provider failure or delay, failure of third party applications or denial-of-service attack and in the case of hardware, inability to obtain components or other materials used in the manufacture of the Hardware.

1.13. FDA means the United States' Food and Drug Administration.

1.14. Hardware means the Nurochek Pro device comprising SSVEP/EEG headset, sensors, cable and accessories (and includes any replacement parts for such Hardware).

1.15. Headsafe Trademark Guidelines means the quality control guidelines that Headsafe publishes in connection with use of the Headsafe Trade Marks.

1.16. Headsafe Trade Marks means the trade marks and logos (whether or not registered) owned and used by Headsafe in relation to the Nurochek Pro Solution.

1.17. HIPAA means the Health Insurance Portability and Accountability Act of 1996, and the regulations made under that Act (as amended from time to time).

1.18. HIPAA Privacy Rule means the so-named regulation issued under HIPPA.

1.19. License means the license granted by Headsafe to described in Section 3.1.

1.20. License Fee means the fee charged to Client by Headsafe for access and use of the Software, the amount and manner of computation of which is as agreed from time to time between Headsafe and Client.

1.21. Licensed Healthcare Practitioner means a health professional whose scope of practice under applicable United States federal or state law, permits them to use the Hardware and Software and/or to supervise the use of the Hardware and Software by others.

1.22. Malicious Code means code, files, scripts, agents or programs intended to do harm, including, for example, viruses, worms, time bombs, and trojan horses.

1.23. Nurochek Pro Solution means the name used by Headsafe when describing to combination of the Hardware and the Software.

1.24. Patient means an individual, under the care of Client (or a Licensed Healthcare Practitioner engaged by Client) who undergoes a Test administered by an Authorized User.

1.25. Patient Data means biometric, diagnostic output, demographic and other relevant data relating to a Patient and their injury that is collected by Client in respect that Patient at the time of the applicable Test through use of the Hardware and Software. Such data will include date and time of injury and of the Test, EEG data collected through use of the Hardware and the diagnosis of the Licensed Healthcare Practitioner supervising the Test.

1.26. Personal Information means information or an opinion (including information or an opinion forming part of a database), whether true or not, and whether recorded in a material form or not, about an identified individual, or an individual who is reasonably identifiable.

1.27. PHI means Protected Health Information as defined under HIPPA.

1.28. Planned Downtime means times at which the Software is not available as a result of scheduled maintenance being undertaken by Headsafe (of which Headsafe will give advance notice).

1.29. Software means the Nurochek Pro software applications that operate in conjunction with the Hardware comprising:

  • (a) software (installed by Client on a computer under the control of Client and located at the location where Tests are being performed on Patients) which is used to collect the Patient Data (Data Collection Software); and
  • (b) software (hosted on Cloud Infrastructure and provided by Headsafe as a service) which processes Patient Data to generate diagnostic information for use by the Licensed Healthcare Practitioner supervising the Test (Diagnostic Software).

1.30. Technical Support means technical support services for the Software, as provided by Headsafe to Client from time to time and as further described in Schedule 2.

1.31. Sub-processor means a third party engaged to process Personal Information.

1.32. Suspend means the immediate disabling of access to the Software, or components of the Software, as applicable, to prevent further use of the Software.

1.33. Taxes means all taxes, levies, duties or similar governmental assessments of any nature, including value-added, sales, use or withholding taxes, assessable by any jurisdiction whatsoever.

1.34. Test means a single instance of the collection from a patient of Patient Data and the analysis of that Patient's Patient Data using the Hardware and Software.

1.35. Third Party Application means any web-based or offline software application that is used by Client but is not provided by Headsafe.

1.36. Update means any update or upgrade of the Software that Headsafe may make available to users of its Software generally.

2. Interpretation and Application

2.1. Interpretation. In this agreement, unless the context otherwise requires:

  • (a) Gender. words denoting any gender include all genders.
  • (b) Headings. headings are for convenience only and do not affect interpretation.
  • (c) Singular/Plural. the singular includes the plural and vice versa.
  • (d) Currency. the currency of account and payment under the Agreement is the lawful currency of the United States.

2.2. Application. Headsafe may offer to Client, during the currency of the Agreement, (a) spare parts for the Hardware and/or (b) supplementary products and/or services. Such additional offers will be subject to the terms and conditions specified in the additional offer.

3. Software

3.1. Software License. Headsafe grants to Client a non-exclusive, non-transferable license to Client to enable it access to and use of the Data Collection Software and the Diagnostic Software in accordance with the Agreement. The license enables Client to (a) install and use the Data Collection Software on its own devices and (b) access the Diagnostic Software as a cloud-based service.

3.2. Support. Headsafe will provide Technical Support, maintenance and generally available updates to Client in respect of both the Data Collection Software and the Diagnostic Software.

3.3. Upgrades. Headsafe shall provide all Updates to Customer (at no charge to Customer) as they are released by Headsafe to all of its customers.

3.4. Availability. While Headsafe will make every commercial effort for the Software to be available at all times, Client acknowledges and agrees that the Software may not be available due to either an Excusable Event or Planned Downtime.

3.5. Software Changes. Headsafe reserves the right to make changes to the Software at any time and from time to time, provided that Headsafe will not materially decrease the functionality of the Software. Client acknowledges and agrees that such changes may require changes to the Client Equipment to maintain Client's desired level of performance.

3.6. Monitoring. Headsafe reserves the right to manage and track use by Client and Authorized Users of the Hardware and Software for the purpose of gathering data to enable it to optimize the performance of the Hardware and Software.

3.7. License Fee. Access to and use by Client and its Authorized Users of the Software is subject to timely payment of the License Fee by Client to Headsafe.

3.8. Adjustments to License Fee. Headsafe reserves the right to adjust its License Fee or licensing models in the future. Any change to pricing or license model will be notified to Client in advance and will not retroactively affect any License Fees already paid. If Client does not agree to the new License Fee resulting from such adjustment, it may cease using the Software under Section 14.2(c). Continued access to use of the Software after License Fee changes take effect constitutes acceptance of the new License Fee.

3.9. Suspension. If Headsafe becomes aware of an Authorized User's breach of the Agreement, then Headsafe may Suspend that Authorized User's use of the Software until the breach, the cause of the Suspension, has been cured. Headsafe may Suspend use of the Software if an Executable Event occurs to the minimum extent and of the minimum duration required. If Headsafe Suspends use of the Software without prior notice to Client, then Headsafe will provide Client with the reason for the Suspension as soon as is reasonably possible.

4. Hardware

4.1. Sale and Purchase. Headsafe agrees to sell and deliver to Client, and Client agrees to purchase from Headsafe, the Hardware on the terms set out in the Agreement.

4.2. Delivery. Headsafe will procure delivery of the Hardware ordered by Client, delivery will be made F.O.B. Headsafe's shipping point in the US unless otherwise specified in writing to Client. For clarity, FOB means that title to and risk of loss for applicable Hardware passes to Client on Headsafe's delivery of the Hardware to Client's carrier at Headsafe's shipping point in the US.

4.3. Delays. Headsafe will use commercially reasonable efforts to meet estimated delivery times notified to Client in respect of Hardware deliveries. Headsafe is not liable for any delay or failure in performance due to an Excusable Event.

4.4. Acceptance. Client must inspect the Hardware upon delivery. Any claim for visible damage, shortage, or non-conformity must be made in writing to Headsafe within five days after Client's receipt of the Hardware. If Client fails to so notify Headsafe of any defect or non-conformance within that five-day period, the Hardware will be deemed to be accepted and to conform to the Hardware specifications.

4.5. CISG. The United Nations Convention on Contracts for the International Sale of Goods (CISG) do not apply to the sale of the Hardware.

4.6. Technical Support. Headsafe will provide Technical Support, maintenance and generally available updates to Client in respect of the Hardware.

4.7. Maintenance. Client is responsible for maintaining the Hardware in accordance with the Documentation, including cleaning the Hardware.

4.8. PMSI. Client grants Headsafe a 'purchase money security interest' in all Hardware supplied to Client until full payment for the Hardware is received by Headsafe. Client agrees to perform all acts and execute all documents as may be necessary to perfect Headsafe's security interest.

4.9. Returns of Hardware. Hardware shall not be returned to Headsafe without its prior written authorization (in which case return instructions will apply). Unauthorized returns or attempts to return Hardware without permission will not be accepted by Headsafe.

5. Client Equipment

5.1. Supply. Client is responsible, at its cost, for procuring, supplying and properly maintaining any Client Equipment.

5.2. Liability. Client is responsible, and under no circumstances will Headsafe (or any of its licensors or suppliers) be responsible, for any loss, damage or liability attributable to the operation of any Client Equipment or any failure or interruption in the operation of any Client Equipment.

5.3. Security. Client must (a) establish and maintain industry standard information, physical and administrative security protocols for all Client Equipment; (b) establish and maintain backup and disaster recovery plans and (c) prevent unauthorized access to the Software through the Client Equipment.

6. Client Obligations

6.1. Client Responsibilities. Client:

  • (a) Authorized Users. is responsible for Authorized Users' compliance with the Agreement and for all activities that occur through Authorized Users' use of the Hardware and the Software;
  • (b) Informed Consent. must obtain (where practicable) a Patient's informed consent to use of the Hardware and Software (including its purpose and relevant risks or benefits);
  • (c) Patient Data. is responsible for the accuracy, quality and legality of Patient Data, including any obtaining all required consents or rights required to use Patient Data;
  • (d) Unauthorized Access or Use. must prevent unauthorized access to or use of the Hardware and the Software, and notify Headsafe promptly of any such unauthorized access or use; and
  • (e) Hardware. will ensure that the Hardware is maintained in good working order and operated in accordance with the Headsafe's instructions.

6.2. Usage Restrictions. Client must not:

  • (a) Use. permit access to and use of the Hardware and the Software by anyone other than a Licensed Healthcare Practitioner (or by trained staff under a Licensed Healthcare Practitioner's supervision) using Client's Hardware or access and use any Software for the benefit of anyone other than Patients and anywhere other than the United States;
  • (b) Improper use. use the Hardware and the Software (i) for any purpose other than legitimate medical diagnostics on Patients, or (ii) without proper indication or in any manner inconsistent with the Documentation, or (iii) Headsafe's regulatory approval, or (iv) in any unlawful or unethical manner;
  • (c) Resale etc. sell, resell, license, sublicense, distribute, rent or lease the Hardware and/or Software or any part, feature, function or output thereof, or include use of the Hardware and the Software in a service bureau or outsourcing offering;
  • (d) Unlawful Use. use the Hardware and the Software to store or transmit infringing, libelous, or otherwise unlawful or tortious material, or to store or transmit material in violation of third-party privacy rights or in violation of the Agreement, applicable laws or government regulations, or form otherwise fraudulent or malicious purposes;
  • (e) Malicious Code. use the Hardware and the Software to store or transmit Malicious Code;
  • (f) Unauthorized Access or Circumvention. attempt to gain unauthorized access to the Hardware and the Software or related systems or networks or circumvent any contractual usage limits;
  • (g) Removal of Indicia. remove any legal, copyright, trademark or other proprietary rights notices contained in or on the Hardware and the Software or materials Client receives or accesses through use of the Hardware and the Software the;
  • (h) Framing. frame or mirror any part of the Software, other than framing on Client's own intranets or otherwise for its own internal business purposes or as permitted in the Agreement;
  • (i) Competing Product. access the Hardware and the Software in order to build a competitive product or service or use a Service in a way that competes with products or services offered by Headsafe; or
  • (j) No Copying etc. copy, adapt, reformat, reverse-engineer, disassemble, decompile, download, translate or otherwise modify the Hardware and the Software or Headsafe's website, through automated or other means.

6.3. Language. Client acknowledges and agrees that (a) the Software and Documentation and (b) support for the Software will be provided only in the English language.

6.4. Marketing. Client has the right to create and publish promotional materials relating to the Nurochek Pro Solution which may include promotional materials provided by Headsafe to Client. Client, in creating and publishing promotional materials relating to the Nurochek Pro Solution, must comply with all applicable laws and must ensure that the promotional materials are accurate and not misleading. Client will provide Headsafe with a copy of any such promotional materials promptly on Headsafe's request. Client, in exercise of its rights under this Section 6.4. may use Headsafe Trade Marks as approved by Headsafe in writing or in strict accordance with the Headsafe Trademark Guidelines.

7. Healthcare Compliance and Patient Data

7.1. Protection of Patient Data. Headsafe will implement appropriate technical and organizational measures for protection of the security of Patient Data. These measures will include, but will not be limited to, maintaining and testing (at least annually) an incident management program, and measures for preventing inappropriate access, use, modification or disclosure of Patient Data by Headsafe personnel. Headsafe will promptly inform Client following discovery of any breach of security, confidentiality, and/or integrity of the Software or Patient Data affecting Client.

7.2. Medical Judgement. Any output derived from use of the Hardware and Software is an aid to diagnosis of concussion. The output does not provide definitive medical advice or treatment recommendations. Any output from the Software is intended to assist in clinical decision-making, not to replace a Licensed Health Practitioner's own professional judgment and/or an assessment of a Patient. Client acknowledges and agrees that the Licensed Health Practitioner remains solely responsible for all diagnoses, decisions, and treatment plans made for Patients.

7.3. BAA. Headsafe must comply with the terms of the Business Associate Addendum set forth in Schedule 1 (BAA) which is hereby incorporated into the Agreement. In the event of any conflict between the terms of the BAA and the Agreement, the terms of the BAA govern with respect to PHI.

7.4. Minimum Necessary. Client agrees to limit the PHI disclosed to Headsafe to the minimum necessary to accomplish the intended purpose of the disclosure.

7.5. De-identification. Headsafe may de-identify PHI received from Client in accordance with the HIPAA Privacy Rule and use and disclose such de-identified information for any purpose permitted by law.

7.6. State Privacy Laws. Client acknowledges that state-specific healthcare privacy laws may impose additional requirements beyond HIPAA. Client is responsible for ensuring its use of the Hardware and the Software complies with all applicable state laws, including but not limited to: (a) California Confidentiality of Medical Information Act; (b) New York Mental Hygiene Law; (c) Texas Medical Records Privacy Act; and (d) other state-specific health information privacy laws. If Client's use of the Hardware and the Software requires compliance with specific state law requirements beyond those addressed in the Agreement, Client must notify Headsafe in writing prior to submitting any state-regulated data to the Hardware and the Software.

7.7. Data Security. Headsafe (a) maintains a comprehensive written information security program that includes administrative, technical, and physical safeguards appropriate to the size, complexity, and nature of its business operations and the sensitivity of Patient Data; (b) conducts periodic risk assessments of its information security program and adjusts controls based on identified risks; (c) encrypts all Patient Data containing PHI or Personal Information both at rest and in transit using industry-standard encryption methodologies, including TLS 1.2 or higher for data in transit and AES-256 for data at rest; and (d) implements role-based access controls and multi-factor authentication for all systems containing Patient Data.

7.8. Breach Notification. In the event either party discovers any actual or reasonably suspected unauthorized access, use, disclosure, alteration, or destruction of Patient Data containing PHI (Security Incident), that party will: (a) notify the other in writing of the Security Incident within 72 hours of discovery; (b) take reasonable steps to mitigate harm and protect Patient Data from further unauthorized access or disclosure; (c) investigate the Security Incident and provide the other with information necessary for it to meet any notification obligations under applicable law; (d) coordinate with the other on appropriate communications with affected individuals.

7.9. Response Plan. Each party will maintain a written Security Incident response plan that specifies the actions to be taken in the event of a Security Incident.

7.10. Training and Awareness. Headsafe ensures all personnel with access to Patient Data receive appropriate training on: (a) privacy and security policies and procedures; (b) identification and reporting of potential Security Incidents; (c) HIPAA compliance requirements. Headsafe conducts refresher training at least annually, and additional training when there are material changes to policies, procedures, or regulatory requirements.

7.11. Data Retention. Headsafe retains Patient Data for the period specified in the Documentation, or as required by law.

7.12. Data Destruction. On termination of the Agreement or on Client's written request, Headsafe will securely destroy or return Patient Data containing PHI in accordance with the BAA and applicable law. Headsafe employs secure data destruction methods consistent with NIST Special Publication 800-88 Guidelines for Media Sanitization.

7.13. Sub-processors. Headsafe ensures that any Sub-processors, that creates, receives, maintains, or transmits Patient Data containing PHI on behalf of Headsafe, agrees to the same restrictions and conditions that apply to Headsafe with respect to such Patient Data. Headsafe conducts appropriate due diligence on all Sub-processors and maintains a current inventory of such relationships.

7.14. Record Keeping. Headsafe maintains documentation of its privacy and security policies, risk assessments, training records, and Security Incident investigations as required by applicable law. Upon written request and subject to reasonable confidentiality restrictions, Headsafe will make available to Client documentation necessary to demonstrate compliance with its obligations under this Section 7.

8. Fees and Payment

8.1. Non-Payment. Any payments due from Client to Headsafe not made within 30 days of the date of such invoice will accrue interest at the rate of 1.5% of the outstanding balance per month, or the maximum rate permitted by law, whichever is lower.

8.2. Billing Information. Client is responsible for (a) providing complete and accurate billing and contact information to Headsafe and (b) notifying Headsafe of any changes to such information.

8.3. Payment Processors. Headsafe may engage third-party payment processors to process online payments made by Client pursuant to the Agreement, and that such payment processors will be provided Client's payment information in order to help Headsafe process Client's payments.

8.4. Suspension of Service and Acceleration. If any amount owing by Client under the Agreement is 30 or more days overdue, Headsafe may, without limiting other rights and remedies, (a) accelerate Client's payment obligations under the Agreement so that all such obligations become immediately due and payable, and (ii) Suspend use of the Software by Client until such amounts are paid in full. Headsafe will give Client at least ten days' prior written notice, before implementing Suspension under this Section 8.4.

8.5. Taxes. License Fees and Hardware prices do not include any taxes, levies, duties or similar governmental assessments of any nature, including, for example, value-added, sales, use or withholding taxes, assessable by any jurisdiction whatsoever (collectively, Taxes). Client is responsible for paying all Taxes associated with its payment for the right to use the Software pursuant to the Agreement. If Headsafe has the legal obligation to pay or collect Taxes for which Client is responsible under this Section 8.5, Headsafe will invoice Client and Client will pay that amount unless Client provides Headsafe with a valid tax exemption certificate authorized by the appropriate Taxing authority.

8.6. Increases. Headsafe may, after the first anniversary of the Effective Date and on 45 days prior written notice to Customer, increase the License Fees and Hardware prices. If Client does not agree to the increase notified to it, it may cease using the Software under Section 14.2(c).

8.7. Prepayments. Client is not entitled to any refund of any prepayments made by it to Headsafe under the Agreement – except as specifically provided in the Agreement.

9. Proprietary Rights and Licenses

9.1. Reservation of Rights by Headsafe. Subject to the rights and licenses expressly granted under the Agreement, Headsafe reserves all of its right, title, and interest in and to the Hardware and the Software and any other proprietary materials of Headsafe, including all intellectual property rights subsisting therein. Client acquires no rights with respect to the Hardware and the Software and any other proprietary materials, by implication or otherwise.

9.2. Reservation of Rights by Client. Client reserves all of Client's rights, title and interest in Patient Data, provided that Headsafe may use Patient Data as provided in Section 9.3.

9.3. Use of Patient Data. Client grants Headsafe the right to use Patient Data, in compliance with applicable law, in order to: (a) provide the Software pursuant to the Agreement; (b) communicate with any persons provided to Headsafe by Client; (c) prevent or address service or technical problems; (d) as Client expressly permits in writing; or (e) as may be required by law.

Headsafe may also use Patient Data in an aggregated, de-identified and generic manner, in compliance with applicable law, for marketing, survey purposes, setting benchmarks, feature suggestions, product analytics and new product features or services, the Hardware and the Software utilization analyses and related purposes, provided that: (i) it is used only for internal administrative purposes and general usage statistics; (ii) does not identify Client or its Patients, agents, representatives, customers or employees and is not attributable to such persons or entities in any way; and (iii) where Patient Data is used in this manner to create publicly disclosed general usage statistics, such statistics are used to report only the total aggregate use among Headsafe customers.

9.4. Feedback. Client grants to Headsafe a worldwide, perpetual, irrevocable, transferable, royalty-free license to use and incorporate into the Hardware and the Software any suggestion, enhancement request, recommendation, correction or other feedback provided by Client or Authorized Users relating to the operation of the Hardware and the Software, provided that Headsafe will not identify Client as the source of such feedback.

10. Confidentiality

10.1. Definition. Confidential Information means all information and materials disclosed by a party (Disclosing Party) to the other party (Receiving 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 and the circumstances of disclosure. Headsafe Confidential Information includes the Hardware and the Software, any proprietary materials provided through the Hardware and the Software and any preferential pricing terms Headsafe provides to Client. Client Confidential Information includes Patient Data. Confidential Information of a party includes any business and marketing plans, technology and technical information, product plans and designs, and business processes disclosed by such party.

Confidential Information does not include any information that: (a) is or becomes generally known to the public without breach of any obligation owed to the Disclosing Party; (b) was known to the Receiving Party prior to its disclosure by the Disclosing Party without breach of any obligation owed to the Disclosing Party; (c) is received from a third party without breach of any obligation owed to the Disclosing Party; or (d) was independently developed by the Receiving Party as shown by documents and other competent evidence in the Receiving Party's possession.

10.2. Protection of Confidential Information. The Receiving Party will: (a) use the same degree of care that it uses to protect the confidentiality of its own confidential information of like kind (but not less than reasonable care); (b) not use any Confidential Information of the Disclosing Party for any purpose outside the scope of the Agreement; and (c) except as otherwise authorized by the Disclosing Party in writing, disclose Confidential Information of the Disclosing Party only to those of its employees, officers, advisors, contractors, and agents and its Affiliates' employees, officers, advisors, contractors, and agents who need that access for purposes consistent with the Agreement and who are subject to confidentiality obligations consistent with this Section 10. Receiving Party is fully responsible for the compliance of its employees, officers, advisors, contractors, and agents and its Affiliates' employees, officers, advisors, contractors, and agents with the terms of this Section 10.

10.3. Compelled Disclosure. The Receiving Party may disclose Confidential Information of the Disclosing Party to the extent compelled by law or by the order of a court or similar judicial or administrative body to do so, provided the Receiving Party gives the Disclosing Party prior notice of the compelled disclosure (to the extent legally permitted) and reasonable assistance, at the Disclosing Party's cost, if the Disclosing Party wishes to contest the disclosure. If the Receiving Party is compelled by law to disclose the Disclosing Party's Confidential Information as part of a civil proceeding to which the Disclosing Party is a party, and the Disclosing Party is not contesting the disclosure, the Disclosing Party will reimburse the Receiving Party for its reasonable cost of compiling and providing secure access to that Confidential Information.

11. Representations, Warranties, Remedies and Disclaimers

11.1. Headsafe Warranties. Headsafe warrants:

  • (a) Hardware. for 12 months from delivery of the Hardware that (i) the Hardware will be free from defects in materials and workmanship; and (ii) under normal use the Hardware will perform materially in accordance with the specifications for the Hardware as set out in the Documentation;
  • (b) AI. that the Software uses fixed algorithms to provide its diagnostic output; and
  • (c) Software. that (i) the Software will perform materially in accordance with the specifications for the Software set forth in the Documentation; and (ii) Headsafe has used commercially reasonable efforts to detect and prevent the introduction of Malicious Code into the Software.

11.2. Remedy in respect of Hardware Warranty. For any breach of a warranty in Section 11.1(a):

  • (a) Notification. Client will promptly notify Headsafe of any failure of the Hardware to perform materially in accordance with its specifications arising out of the warranties in Section 11.1(a) and return the Hardware as set forth herein at Client's expense.
  • (b) Instructions. Client will follow the cleaning procedures set forth in the Documentation and any other instructions from Headsafe regarding return of the Hardware.
  • (c) Response. Upon receipt of the Hardware, Headsafe will promptly evaluate the Hardware. If Headsafe: (i) confirms that the Hardware is defective and is subject the warranty in Section 11.1(a), Headsafe will promptly replace the defective Hardware with either new or refurbished Hardware. (ii) determines that the Hardware is not defective or is not subject to the warranty in Section 11.1(a), Headsafe will notify Client and Client will have the option of purchasing replacement Hardware.

11.3. Remedy in respect of Software Warranty. For any breach of a warranty in Section 11.1(c):

  • (a) Notification. Client will promptly notify Headsafe of any failure of the Software to perform materially in accordance with its specifications subject arising out of the warranties in Section 11.1(c).
  • (b) Instructions. Client will follow any other instructions from Headsafe in relation the Software.
  • (c) Response. if the Hardware is subject the warranty in Section 11.1(c), Headsafe will promptly use commercially reasonable efforts to correct the failure of the Software so that it operates in accordance with the Documentation.

11.4. Exclusive Remedies. THE REMEDIES IN SECTION 11.3 IS EXCLUSIVE, IS SUBJECT TO THE LIMITATIONS SET FORTH HEREIN AND SHALL BE CLIENT'S SOLE REMEDY WITH RESPECT TO ANY CLAIM OF BREACH OF WARRANTY ARISING OUT OF THE AGREEMENT.

11.5. Exclusions. EXCEPT AS EXPRESSLY PROVIDED HEREIN, HEADSAFE (A) MAKES NO WARRANTY OF ANY KIND, WHETHER EXPRESS, IMPLIED, STATUTORY OR OTHERWISE AND (B) SPECIFICALLY DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW.

11.6. Disclaimers. HEADSAFE DISCLAIMS ALL LIABILITY AND INDEMNIFICATION OBLIGATIONS FOR ANY HARM OR DAMAGES CAUSED BY (A) ANY THIRD-PARTY HOSTING PROVIDERS OR THIRD PARTY APPLICATIONS; (B) ANY SOFTWARE, HARDWARE, EQUIPMENT, ACCESSORIES OR ANY OTHER MATERIALS OR SERVICES NOT PROVIDED OR APPROVED IN WRITING BY HEADSAFE; (C) USE OF THE HARDWARE AND/OR SOFTWARE IN A MANNER OR ENVIRONMENT OR FOR ANY PURPOSE, FOR WHICH HEADSAFE DID NOT LICENSE IT OR IN BREACH OF HEADSAFE'S INSTRUCTIONS FOR USE; (D) USE OUTSIDE THE UNITED STATES; (E) ANY MODIFICATION, MAINTENANCE OR REPAIR OF THE HARDWARE BY ANYONE OTHER THAN HEADSAFE; (F) OR DEFECT OR DEFICIENCY (INCLUDING FAILURE TO CONFORM TO DOCUMENTATION) THAT RESULTS, IN WHOLE OR IN PART, FROM ANY IMPROPER STORAGE OR HANDLING, FAILURE TO MAINTAIN THE DEVICE IN THE MANNER DESCRIBED IN HEADSAFE'S INSTRUCTIONS FOR USE.

12. Mutual Indemnification

12.1. Indemnification by Headsafe. Headsafe will defend Client against any claim, demand, suit or proceeding made or brought against Client by a third party alleging that the use of the Hardware and the Software in accordance with the Agreement infringes or misappropriates such third party's intellectual property rights (an IP Claim against Client), and will indemnify Client from any damages, attorney fees and costs finally awarded against Client as a result of, or for amounts paid by Client under a court-approved settlement of, an IP Claim against Client, provided Client (a) promptly give Headsafe written notice of the IP Claim against Client, (b) give Headsafe sole control of the defense and settlement of the IP Claim against Client (except that Headsafe may not settle any IP Claim against Client unless it unconditionally releases Client of all liability), and (c) give Headsafe all reasonable assistance, at Headsafe's expense.

12.2. Response to IP Claim against Client. If Headsafe receives information about an infringement or misappropriation claim related to the Hardware or the Software, Headsafe may in its discretion and at no cost to Client (a) modify the Hardware and/or the Software so that it no longer infringes or misappropriates, without breaching the warranties under Section 11.1, or (b) obtain a license for Client's continued use of the Hardware and the Software in accordance with the Agreement, and if neither (a) nor (b) is commercially reasonable, (c) terminate Client's use of the Hardware and the Software upon 30 days' written notice.

12.3. Exclusions. The above defense and indemnification obligations do not apply to the extent an IP Claim against Client arises from: (a) a Third Party Application, (b) Client's breach of the Agreement, (c) Client's negligence, recklessness, gross negligence, or willful misconduct (d) any use of the Hardware and/or the Software in combination with other products, equipment, software or data not supplied by Headsafe; (e) any use of the Hardware other than in accordance with its instructions for use contained in the Documentation, or (f) any modification of the Hardware and/or the Software by any person other than Headsafe or its authorized representatives.

12.4. Indemnification by Client. Client will defend Headsafe against any claim, demand, suit or proceeding made or brought against Headsafe by a third party alleging that Patient Data, or Client's use of the Hardware and/or the Software in breach of the Agreement, infringes or misappropriates such third party's intellectual property rights (a IP Claim Against Headsafe), and will indemnify Headsafe from any damages, attorney fees and costs finally awarded against Headsafe as a result of, or for any amounts paid by Headsafe under a court-approved settlement of, an IP Claim Against Headsafe, provided Headsafe (a) promptly gives Client written notice of the IP Claim Against Headsafe, (b) gives Client sole control of the defense and settlement of the IP Claim Against Headsafe (except that Client may not settle any IP Claim Against Headsafe unless it unconditionally releases Headsafe of all liability), and (c) gives Client all reasonable assistance, at Client's expense.

12.5. Exclusive Remedy. This Section 12 states the indemnifying party's sole liability to, and the indemnified party's exclusive remedy against, the other party for any type of claim described in this Section 12.

12.6. Indemnification Procedure. The party having the benefit of the indemnification obligation under this clause 12 (Beneficiary) must (a) give the party having the indemnification obligation (Indemnifier) prompt written notice of any claim that is the subject of the indemnity (Claim); (b) allow the Indemnifier to have sole control over the defense and settlement of the Claim, provided, however, that the Beneficiary shall have the option, at its sole discretion, to participate in the defense of any such claim using attorneys selected by it, the costs and expenses of which shall be the responsibility of Beneficiary; (c) provide all assistance reasonably requested by Indemnifier, at Indemnifier's expense, in the defense and settlement of the claim; and (d) not consent to the entry of any judgment or enter into any settlement with respect to a Claim without the Beneficiary's prior written consent (not to be unreasonably withheld or delayed) unless (i) the judgment or proposed settlement involves only the payment of monetary damages by the Indemnifier, and does not impose injunctive or other equitable relief upon or otherwise adversely affect the Beneficiary; (ii) there are no additional Claims pending against the Beneficiary, and no adverse impact on existing Claims, as a result of the judgment or proposed settlement; and (c) the Beneficiary will have no liability with respect to such judgment or proposed settlement and will not otherwise be materially and adversely affected by the terms of such settlement.

13. Limitation of Liability

13.1. Limitation of Liability. EXCEPT FOR EACH PARTY'S INDEMNIFICATION OBLIGATIONS UNDER SECTION 12 AND CLIENT'S PAYMENT OBLIGATIONS INCLUDING UNDER SECTION 8, NEITHER PARTY'S LIABILITY WITH RESPECT TO ANY SINGLE INCIDENT OR SERIES OF RELATED INCIDENTS ARISING UNDER THE AGREEMENT WILL EXCEED THE AMOUNT PAID BY CLIENT IN THE 12 MONTHS PRECEDING THE INCIDENT OR SERIES OF RELATED INCIDENTS, PROVIDED THAT IN NO EVENT WILL EITHER PARTY'S AGGREGATE LIABILITY ARISING UNDER THE AGREEMENT EXCEED THE TOTAL AMOUNT PAID BY CLIENT UNDER THE AGREEMENT. THE ABOVE LIMITATIONS WILL APPLY WHETHER AN ACTION IS IN CONTRACT OR TORT (INCLUDING NEGLIGENCE), BREACH OF DUTY OR FOUNDED ANY OTHER COMMON LAW AND STATUTORY CLAIM AND REGARDLESS OF THE THEORY OF LIABILITY. THE FOREGOING DISCLAIMER WILL NOT APPLY TO THE EXTENT PROHIBITED BY LAW.

13.2. Exclusion of Consequential and Related Damages. EXCEPT FOR EACH PARTY'S INDEMNIFICATION OBLIGATIONS UNDER SECTION 12, IN NO EVENT WILL EITHER PARTY HAVE ANY LIABILITY TO THE OTHER PARTY FOR ANY LOST PROFITS, REVENUES OR INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL, COVER OR PUNITIVE DAMAGES (INCLUDING, WITHOUT LIMITATION, LOSS OF PROFITS OR GOODWILL), WHETHER AN ACTION IS IN CONTRACT OR TORT AND REGARDLESS OF THE THEORY OF LIABILITY, EVEN IF A PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE FOREGOING DISCLAIMER WILL NOT APPLY TO THE EXTENT PROHIBITED BY LAW.

13.3. No Guarantee. HEADSAFE DOES NOT GUARANTEE THAT THE OUTPUT FROM THE HARDWARE AND SOFTWARE WILL BE 100% ACCURATE OR CONCLUSIVE FOR EVERY INDIVIDUAL TEST. NO MEDICAL HARDWARE OR SOFTWARE IS INFALLIBLE, AND DIAGNOSTIC OUTPUT CAN BE AFFECTED BY FACTORS SUCH AS USER ERROR, PATIENT VARIATION, OR UNFORESEEN TECHNICAL ISSUES. THE SUPERVISING LICENSED HEALTH PRACTITIONER MUST ALWAYS USE CLINICAL JUDGMENT AND CONSIDER CONFIRMATORY TESTS OR ASSESSMENTS AS NECESSARY.

14. Term and Termination

14.1. Term. The Agreement commences on the Effective Date and continues until it is terminated.

14.2. Termination. Either party may terminate the Agreement:

  • (a) Breach. ten days after providing written notice to the other party of a material breach of its obligations under the Agreement if such breach remains uncured at the expiration of such ten-day period;
  • (b) Insolvency. if the other party becomes the subject of a petition in bankruptcy or any other proceeding relating to insolvency, receivership, liquidation or assignment for the benefit of creditors; or
  • (c) Convenience. upon 30 days' written notice to the other party provided that Headsafe is not entitled to give notice, under this Section 14.2(c), prior to the first anniversary of the Effective Date.

14.3. After End of Agreement. After the end of the Agreement:

  • (a) Patient Data. Headsafe has no obligation to maintain or provide Patient Data, and may, in its sole discretion, delete or destroy all copies of Patient Data in Headsafe's systems or otherwise in Headsafe's possession or control, unless legally prohibited. Client must ensure that it maintains a copy of any Test results of a Patient in its record systems for the applicable Patient.
  • (b) Cessation of Rights. all rights of Client under the Agreement automatically and immediately cease and Client must immediately (i) cease all use of the Hardware and Software; (ii) delete the Data Collection Software from its computer systems; (iii) return to Headsafe or destroy (at Headsafe's election) all Documentation and/or Nurochek Pro promotional materials in its possession or control; (iv) cease all use of the Headsafe Trade Marks and the Promotional Materials, including removing the Headsafe Trade Marks from any website or social media site on which they have been published; and (v) certify in writing to Headsafe that it has done the foregoing within ten days of the end of the Agreement.
  • (c) Outstanding Amounts. On the end of the Agreement Client must pay all undisputed sums due to Headsafe.

14.4. Surviving Provisions. The Sections that are intended by their nature to survive termination or expiration will survive any termination or expiration of the Agreement.

15. Regulatory Compliance

15.1. FDA Registration. The Hardware and the Software have received FDA clearance under Section 510(k) clearance number K243426 for their intended use described in the Documentation.

15.2. Use. Client acknowledges that it has received, reviewed, and understood the FDA-cleared indications for use, contraindications, warnings, and limitations associated with the Hardware and the Software. Client must use the Hardware and the Software only for the intended use specified in the FDA clearance and Documentation. Adverse Event Reporting. Client must promptly notify Headsafe of any adverse events, malfunctions, or other incidents associated with the Hardware and the Software that: (a) may have caused or contributed to a death or serious injury; or (b) malfunctioned in a manner that would likely cause or contribute to a death or serious injury if the malfunction were to recur. Such notifications must be made to Headsafe at support@nurochekpro.com (or such other email address notified by Headsafe for this purpose) within 24 hours of Client becoming aware of the event. Client acknowledges that Headsafe has medical device reporting obligations to the FDA and agrees to cooperate with Headsafe's investigation of any reportable events. Headsafe will maintain procedures for receiving, reviewing, and evaluating complaints, and for submission of medical device reports to the FDA in accordance with 21 CFR Part 803 (Medical Device Reporting).

15.3. Post-Market Surveillance. Headsafe maintains a post-market surveillance program to monitor the safety and performance of the Hardware and the Software in accordance with 21 CFR Part 822 (Postmarked Surveillance of Medical Devices) and applicable FDA guidance. Client must cooperate with Headsafe's post-market surveillance activities, including responding to surveys, providing requested information about device use and performance, and allowing Headsafe to access relevant device usage data. Client acknowledges that Headsafe may be required to conduct post-market studies as a condition of FDA clearance and agrees to participate in such studies if requested, subject to appropriate compensation and terms to be mutually agreed upon.

15.4. Quality System Regulations. Headsafe maintains a quality management system in compliance with 21 CFR Part 820 (Quality System Regulation) and ISO 13485:2016. Client must follow all instructions for use, maintenance, and storage of the Hardware provided by Headsafe to ensure continued compliance with quality system requirements. Client must not modify, alter, or otherwise change the Hardware or any labeling, as this may compromise the Hardware's compliance with FDA regulations.

15.5. Field Safety Corrective Actions. In the event Headsafe initiates a field safety corrective action, recall, or other safety communication regarding the Hardware or the Software, Client must: (a) promptly review and acknowledge receipt of such communications; (b) implement any required actions within the timeframe specified by Headsafe; (c) facilitate Headsafe's access to the Hardware for inspection, repair, or replacement as needed; (d) maintain records of all actions taken in response to field safety corrective actions. Headsafe will bear reasonable costs associated with implementation of field safety corrective actions unless such actions were necessitated by Client's misuse or failure to follow instructions for use.

15.6. Software Updates. Headsafe will provide notice of any significant changes to the Software that may affect its safety or effectiveness, or that may necessitate a new or updated FDA submission. Client must promptly install all Software updates provided by Headsafe, as failure to do so may result in non-compliance with FDA requirements or compromise the safety and effectiveness of the Hardware and the Software.

15.7. Prescription Status. The Hardware and Software is a prescription medical device under 21 C.F.R. § 801.109 and may only be used by or upon the order of a licensed healthcare provider in accordance with applicable state laws governing the practice of medicine. Client represents and warrants that all Authorized Users authorized to order or administer tests using the Hardware and the Software are either (a) appropriately licensed healthcare providers or (b) operating under the supervision of such licensed healthcare providers in accordance with applicable law.

15.8. Labeling Requirements. Client must not remove, modify, or obscure any labeling, warnings, or instructions for use provided with the Hardware. Client must ensure all Authorized Users review and understand the labeling, warnings, and instructions for use prior to operating the Hardware. Client acknowledges that the Documentation provided by Headsafe is considered part of the device labeling for regulatory purposes.

15.9. Regulatory Updates. Headsafe will notify Client of material changes in regulatory requirements affecting the Hardware or the Software. If changes in regulatory requirements necessitate modifications to the Hardware or the Software, Headsafe will implement such changes and provide Client with updated Documentation. Client acknowledges that continued compliance with FDA regulations may require Hardware updates, Software updates, or changes to protocols, and agrees to implement such changes as directed by Headsafe.

16. General Provisions

16.1. Giving Notice. All notices, permissions, and approvals under the Agreement must be in writing and will be deemed to have been given upon: (a) personal delivery, (b) the second business day after sending by confirmed facsimile, or (c) the first business day after sending by email (provided email will not be sufficient for notices of an indemnifiable claim). Notices to Headsafe must be addressed to Headsafe as designated by Headsafe. Notices to Client must be addressed to Client as designated by Client.

16.2. Governing Law and Jurisdiction. Each party agrees that the Agreement is governed by and is to be construed in accordance with the laws of the State of Florida –, in all respects, without regard to choice or conflicts of law rules, and that all disputes arising out of or relating to the Agreement are limited to the exclusive jurisdiction and venue of the state and federal courts located within Florida. Each party hereby consents to and waives any objections with respect to such jurisdiction and venue.

16.3. Entire Agreement. The agreement constitutes the entire agreement between Client and Headsafe regarding Client's use of the Hardware and the Software and supersedes all prior and contemporaneous agreements, proposals or representations, written or oral, concerning its subject matter.

16.4. Waiver. No waiver of any provision of the Agreement will be effective unless in writing and signed by the party against whom the waiver is to be asserted.

16.5. Amendment. No modification or amendment of any provision of the Agreement will be effective unless in writing and signed by the party against whom the waiver is to be asserted. The parties agree that any term or condition stated in a Client purchase order or in any other order documentation is void.

16.6. Assignment. Neither party may assign any of its rights or obligations under the Agreement, whether by operation of law or otherwise, without the other party's prior written consent (not to be unreasonably withheld). Either party may assign the Agreement in its entirety, without the other party's consent to its Affiliate or in connection with a merger, acquisition, corporate reorganization, or sale of all or substantially all of its assets or equity securities. Notwithstanding the foregoing, if a party is acquired by, sells substantially all its assets to, or undergoes a change of control in favor of, a direct competitor of the other party, then the other party may terminate the Agreement upon written notice.

16.7. Relationship. The parties are independent contractors. The agreement does not create a partnership, franchise, joint venture, agency, fiduciary, or employment relationship between the parties.

16.8. Third-Party Beneficiaries. The parties do not intend to create any third-party beneficiaries of the Agreement, and nothing in the Agreement is intended, nor is anything in the Agreement to be construed to create any rights, legal or equitable, in any person other than the parties.

16.9. Waiver. No failure or delay by either party in exercising any right under the Agreement will constitute a waiver of that right.

16.10. Severability. If any provision of the Agreement is held by a court of competent jurisdiction to be contrary to law, the provision will be deemed null and void, and the remaining provisions of pursuant to this agreement will remain in effect.

16.11. Headings. Headings used in the agreement and all associated agreements are solely for convenience and is not deemed to affect in any manner the meaning or intent of the applicable agreement or any provision there/hereof.

16.12. Equitable Relief. Nothing in the Agreement will limit either party's ability to seek equitable relief.

16.13. Attorney Fees. If any legal action or proceeding is brought to enforce or interpret the Agreement, the prevailing party in such action will be entitled to recover its reasonable attorneys' fees and costs, in addition to any other relief to which it may be entitled.

16.14. Jury Trial Waiver. EACH PARTY HEREBY WAIVES ITS RIGHTS TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION BASED UPON OR ARISING OUT OF THE SUBJECT MATTER HEREOF. THE SCOPE OF THIS WAIVER IS INTENDED TO BE ALL-ENCOMPASSING OF ANY AND ALL DISPUTES THAT MAY BE FILED IN ANY COURT AND THAT RELATE TO THE SUBJECT MATTER HEREOF, INCLUDING, WITHOUT LIMITATION, CONTRACT CLAIMS, TORT CLAIMS (INCLUDING NEGLIGENCE), BREACH OF DUTY CLAIMS, AND ALL OTHER COMMON LAW AND STATUTORY CLAIMS.

Technical Support

The purpose of Technical Support is to address issues with the Software that prevents it from performing in substantial conformance with the Documentation. A resolution to such an issue may consist of a fix, work around or other relief reasonably determined by Company. Support is only provided to Client.

Subscriber can submit a request for Technical Support (Support Request).

A Support Request is to be submitted by email to: support@nurochekpro.com.

Technical Support will commence within 24 hours of a Support Request being submitted.

When making a Support Request, Client must provide accurate information to assist Headsafe to resolve the request, including:

  • details of the issue;
  • the circumstances in which the issue arose; and
  • further information relating to the issue as may be reasonably required to resolve the Support Request.

and Headsafe will use all reasonable commercial efforts to resolve the issue notified in a Support Request as soon as reasonably practicable starting from commencement of Technical Support.