NUROCHEK PRO SOFTWARE LICENSE AGREEMENT

New Zealand

The person signing for the Licensee warrants to Headsafe that they have the authority to create a legally binding agreement between Licensee and Headsafe.

TERMS AND CONDITIONS [New Zealand]

1. Definitions

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.

Authorised User means a person who is either:

  • a Licensed Healthcare Practitioner; or
  • acting under the supervision of a Licensed Healthcare Practitioner and who is authorised by Licensee to access and use the Nurochek Pro Hardware and Nurochek Pro Software and to whom Licensee has supplied customary log-in credentials (ie a user identification and initial password).

Cloud Infrastructure means cloud computing software, Nurochek Pro Hardware or other infrastructure or services, whether public, private, community-based or otherwise.

Documentation means documentation:

  • describing the design, features and functionality of the Nurochek Pro Hardware and Nurochek Pro Software; and
  • providing instructions for use of the Nurochek Pro Hardware and Nurochek Pro Software, as provided and updated by Headsafe from time to time.

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 Nurochek Pro Hardware, inability to obtain components or other materials used in the manufacture of the Nurochek Pro Hardware.

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

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.

Law means:

  • Australian Commonwealth, State, Territory, local government legislation or any law of a foreign jurisdiction, including regulations, by-laws, declarations, ministerial directions and other subordinate legislation;
  • common law as it applies in Australia; and
  • the requirement or authorisation of any Australian or New Zealand regulatory agency (including conditions in respect of any authorisation).

Licence means the license granted by Headsafe to described in clause 3.1.

Licence Fee means the fee charged to Licensee by Headsafe for access and use of the Nurochek Pro Software, the amount and manner of computation of which is published from time to time by Headsafe.

Licensed Healthcare Practitioner means a health professional whose scope of practice, under applicable Law where the Nurochek Pro Hardware and Nurochek Pro Software is used, permits them to use the Nurochek Pro Hardware and Nurochek Pro Software and/or to supervise the use of the Nurochek Pro Hardware and Nurochek Pro Software by others.

Licensee Equipment means:

  • computer Nurochek Pro Hardware, software and network infrastructure used to access the Nurochek Pro Software;
  • data storage platforms and networks;
  • internet access; and
  • any ancillary services needed to connect to, access or otherwise use the Nurochek Pro Hardware and Nurochek Pro Software.

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

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

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

  • software (installed by Licensee on a computer under the control of Licensee and located at the location where Tests are being performed on Patients) which is used to collect the Patient Data (Data Collection Software); and
  • 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).

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

NZ Privacy Act means the New Zealand Privacy Act 2020 and the New Zealand Health Information Privacy Code (enacted under that Act).

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

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

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.

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

Privacy Laws means all privacy laws applicable to the processing of Personal Information by Headsafe or its Sub-processors including the NZ Privacy Act.

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

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

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

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.

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 Nurochek Pro Hardware and Nurochek Pro Software.

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

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

2. Interpretation

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

  • Gender. words denoting any gender include all genders.
  • Headings. headings are for convenience only and do not affect interpretation.
  • Singular/Plural. the singular includes the plural and vice versa.
  • Currency. the currency of account and payment under this agreement is the lawful currency of New Zealand.
  • Effective Date. This agreement becomes effective as of the date on which it has been signed by both Headsafe and Licensee.

3. Nurochek Pro Software

3.1. Nurochek Pro Software Licence. Headsafe grants to Licensee a non-exclusive, non-transferable licence to Licensee to enable it to access and use the Data Collection Nurochek Pro Software and the Diagnostic Nurochek Pro Software in accordance with this agreement.

The licence enables Licensee to:

  • install and use the Data Collection Nurochek Pro Software on its own devices; and
  • access the Diagnostic Nurochek Pro Software as a cloud-based service.

3.2. Support. Headsafe will provide Technical Support, maintenance and generally available updates to Licensee 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 clients.

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

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

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

3.7. Licence Fee. Access to and use by Licensee and its Authorised Users of the Nurochek Pro Software is subject to timely payment of the Licence Fee by Licensee to Headsafe.

3.8. Adjustments to Licence Fee. Headsafe reserves the right to adjust its Licence Fee or licensing models in the future. Any change to pricing or licensing model will be notified to Licensee in advance and will not retroactively affect any Licence Fees already paid. If Licensee does not agree to the new Licence Fee resulting from such adjustment, it may cease using the Nurochek Pro Software under clause 13.2(c). Continued access to use of the Nurochek Pro Software after Licence Fee changes take effect constitutes acceptance of the new Licence Fee.

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

4. Licensee Equipment

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

4.2. Liability. Licensee 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 Licensee Equipment or any failure or interruption in the operation of any Licensee Equipment.

4.3. Security. Licensee must:

  • establish and maintain industry standard information, physical and administrative security protocols for all Licensee Equipment;
  • establish and maintain backup and disaster recovery plans; and
  • prevent unauthorised access to the Nurochek Pro Software through the Licensee Equipment.

5. Client Obligations

5.1. Licensee Responsibilities. Licensee:

  • (a) Authorised Users. is responsible for Authorised Users' compliance with this agreement and for all activities that occur through Authorised Users' use of the Nurochek Pro Hardware and the Nurochek Pro Software;
  • (b) Informed Consent. must obtain (where practicable) a Patient's informed consent to use of the Nurochek Pro Hardware and Nurochek Pro 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) Unauthorised Access or Use. must prevent unauthorised access to or use of the Nurochek Pro Hardware and the Nurochek Pro Software, and notify Headsafe promptly of any such unauthorised access or use; and
  • (e) Nurochek Pro Hardware. will ensure that the Nurochek Pro Hardware is maintained in good working order and operated in accordance with the Headsafe's instructions.

5.2. Usage Restrictions. Licensee must not:

  • (a) Use. permit access to and use of the Nurochek Pro Hardware and the Nurochek Pro Software by anyone other than a Licensed Healthcare Practitioner (or by trained staff under a Licensed Healthcare Practitioner's supervision) using Licensee's Nurochek Pro Hardware or access and use any Nurochek Pro Software for the benefit of anyone other than Patients and anywhere other than Australia and/or New Zealand;
  • (b) Improper use. use the Nurochek Pro Hardware and the Nurochek Pro Software:
    • for any purpose other than legitimate medical diagnostics on Patients;
    • without proper indication or in any manner inconsistent with the Documentation;
    • Headsafe's regulatory approval; or
    • in any unlawful or unethical manner;
  • (c) Resale etc. sell, resell, license, sublicense, distribute, rent or lease the Nurochek Pro Hardware and/or Nurochek Pro Software or any part, feature, function or output thereof, or include use of the Nurochek Pro Hardware and the Nurochek Pro Software in a service bureau or outsourcing offering;
  • (d) Unlawful Use. use the Nurochek Pro Hardware and the Nurochek Pro 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 this agreement, applicable Law or government regulations, or form otherwise fraudulent or malicious purposes;
  • (e) Malicious Code. use the Nurochek Pro Hardware and the Nurochek Pro Software to store or transmit Malicious Code;
  • (f) Unauthorised Access or Circumvention. attempt to gain unauthorised access to the Nurochek Pro Hardware and the Nurochek Pro 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 Nurochek Pro Hardware and the Nurochek Pro Software or materials Licensee receives or accesses through use of the Nurochek Pro Hardware and the Nurochek Pro Software;
  • (h) Framing. frame or mirror any part of the Nurochek Pro Software, other than framing on Licensee's own intranets or otherwise for its own internal business purposes or as permitted in this agreement;
  • (i) Competing Product. access the Nurochek Pro Hardware and the Nurochek Pro 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 Nurochek Pro Hardware and the Nurochek Pro Software or Headsafe's website, through automated or other means.

5.3. Language. Licensee acknowledges and agrees that (a) the Nurochek Pro Software and Documentation and (b) support for the Nurochek Pro Software will be provided only in the English language.

5.4. Marketing. Licensee has the right to create and publish promotional materials relating to the Nurochek Pro Solution which may include promotional materials provided by Headsafe to Licensee. Licensee, in creating and publishing promotional materials relating to the Nurochek Pro Solution, must comply with all applicable Law and must ensure that the promotional materials are accurate and not misleading. Licensee will provide Headsafe with a copy of any such promotional materials promptly on Headsafe's request. Licensee, in exercise of its rights under this clause 5.4, may use Headsafe Trade Marks as approved by Headsafe in writing or in strict accordance with the Headsafe Trademark Guidelines.

6. Healthcare Compliance and Patient Data

6.1. Protection of Patient Data. Licensee acknowledges that Patient Data will not be processed or stored by Headsafe in New Zealand but will be processed and stored by Headsafe in a jurisdiction that provides comparable safeguards to those in the New Zealand Privacy Act.

6.2. Headsafe will implement appropriate technical and organisational 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.

6.3. Headsafe will promptly inform Licensee following discovery of any breach of security, confidentiality and/or integrity of the Nurochek Pro Software or Patient Data affecting Licensee.

6.4. Medical Judgement. Any output derived from use of the Nurochek Pro Software is an aid to diagnosis of concussion. The output does not provide definitive medical advice or treatment recommendations.

6.5. Any output from the Nurochek Pro Software is intended to assist in clinical decision-making, not to replace a Licensed Health Practitioner's own professional judgment and/or assessment of a Patient. Licensee acknowledges and agrees that the Licensed Health Practitioner remains solely responsible for all diagnoses, decisions, and treatment plans made for Patients.

6.6. Minimum Necessary. Licensee agrees to limit the Personal Information disclosed to Headsafe to the minimum necessary to accomplish the intended purpose of the disclosure.

6.7. De-identification. Headsafe may de-identify Personal Information received from Licensee and use and disclose such de-identified information for any purpose permitted by Law.

6.8. Data Security. Headsafe:

  • 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;
  • conducts periodic risk assessments of its information security program and adjusts controls based on identified risks;
  • encrypts all Patient Data containing 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
  • implements role-based access controls and multi-factor authentication for all systems containing Patient Data.

6.9. Breach Notification. In the event either party discovers any actual or reasonably suspected unauthorised access, use, disclosure, alteration, or destruction of Patient Data containing Personal Information (Security Incident), that party will:

  • notify the other in writing of the Security Incident within 72 hours of discovery;
  • take reasonable steps to mitigate harm and protect Patient Data from further unauthorised access or disclosure;
  • investigate the Security Incident and provide the other with information necessary for it to meet any notification obligations under applicable Law; and
  • coordinate with the other on appropriate communications with affected individuals.

6.10. 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.

6.11. Training and Awareness. Headsafe ensures all personnel with access to Patient Data receive appropriate training on:

  • privacy and security policies and procedures;
  • identification and reporting of potential Security Incidents; and
  • privacy compliance requirements.

Headsafe conducts refresher training at least annually, and additional training when there are material changes to policies, procedures, or regulatory requirements.

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

6.13. Data Destruction. On termination of this agreement or on Licensee's written request, Headsafe will securely destroy or return Patient Data containing Personal Information in accordance with the applicable Law. Headsafe employs secure data destruction methods consistent with NIST Special Publication 800-88 Guidelines for Media Sanitization.

6.14. Sub-processors. Headsafe ensures that any Sub-processors, that creates, receives, maintains, or transmits Patient Data containing Personal Information 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.

6.15. 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 Licensee, documentation necessary to demonstrate compliance with its obligations under this clause 6.

7. Fees and Payment

7.1. Non-Payment. Any payments due from Licensee 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.

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

7.3. Payment Processors. Headsafe may engage third-party payment processors to process online payments made by Licensee pursuant to this agreement, and that such payment processors will be provided Licensee's payment information in order to help Headsafe process Licensee's payments.

7.4. Suspension of Service and Acceleration. If any amount owing by Licensee under this agreement is 30 or more days overdue, Headsafe may, without limiting other rights and remedies:

  • accelerate Licensee's payment obligations under this agreement so that all such obligations become immediately due and payable, and
  • Suspend use of the Nurochek Pro Software by Licensee until such amounts are paid in full.

Headsafe will give Licensee at least ten days' prior written notice, before implementing Suspension under this clause 7.4.

7.5. Taxes. Licence Fees and Nurochek Pro 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). Licensee is responsible for paying all Taxes associated with its payment for the right to use the Nurochek Pro Software pursuant to this agreement. If Headsafe has the legal obligation to pay or collect Taxes for which Licensee is responsible under this clause 7.5, Headsafe will invoice Licensee and Licensee will pay that amount unless Licensee provides Headsafe with a valid tax exemption certificate authorised by the appropriate Taxing authority.

7.6. Increases. Headsafe may, by prior written notice to Customer, increase the Licence Fees. If Licensee does not agree to the increase notified to it, it may cease using the Nurochek Pro Software under clause 13.2(c).

7.7. Prepayments. Licensee is not entitled to any refund of any prepayments made by it to Headsafe under this agreement – except as specifically provided in this agreement.

8. Proprietary Rights and Licenses

8.1. Reservation of Rights by Headsafe. Subject to the rights and licences expressly granted under this agreement, Headsafe reserves all of its right, title, and interest in and to the Nurochek Pro Hardware and the Nurochek Pro Software and any other proprietary materials of Headsafe, including all intellectual property rights subsisting therein. Licensee acquires no rights with respect to the Nurochek Pro Hardware and the Nurochek Pro Software and any other proprietary materials, by implication or otherwise.

8.2. Reservation of Rights by Licensee. Licensee reserves all of Licensee's rights, title and interest in Patient Data, provided that Headsafe may use Patient Data as provided in clause 8.3.

8.3. Use of Patient Data. Licensee grants Headsafe the right to use Patient Data in order to:

  • provide the Nurochek Pro Software pursuant to this agreement;
  • communicate with any persons provided to Headsafe by Licensee;
  • prevent or address service or technical problems;
  • as Licensee expressly permits in writing; or
  • as may be required by Law.

8.4. Additional Use of Patient Data. 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 Nurochek Pro Hardware and the Nurochek Pro Software utilization analyses and related purposes, provided that:

  • it is used only for internal administrative purposes and general usage statistics;
  • does not identify Licensee or its Patients, agents, representatives or employees and is not attributable to such persons or entities in any way; and
  • 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 clients.

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

9. Confidentiality

9.1. 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. Further:

  • Headsafe Confidential Information includes the Nurochek Pro Hardware and the Nurochek Pro Software, any proprietary materials provided through the Nurochek Pro Hardware and the Nurochek Pro Software and any preferential pricing terms Headsafe provides to Licensee.
  • Licensee 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.

However, Confidential Information does not include any information that:

  • is or becomes generally known to the public without breach of any obligation owed to the Disclosing Party;
  • was known to the Receiving Party prior to its disclosure by the Disclosing Party without breach of any obligation owed to the Disclosing Party;
  • is received from a third party without breach of any obligation owed to the Disclosing Party; or
  • was independently developed by the Receiving Party as shown by documents and other competent evidence in the Receiving Party's possession.

9.2. Protection of Confidential Information. The Receiving Party will:

  • 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);
  • not use any Confidential Information of the Disclosing Party for any purpose outside the scope of this agreement; and
  • except as otherwise authorised 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 this agreement and who are subject to confidentiality obligations consistent with this clause 9.

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 clause 9.

9.3. 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.

10. Representations, Warranties, Remedies and Disclaimers

10.1. Headsafe Warranties. Headsafe warrants:

  • (a) AI. that the Nurochek Pro Software uses fixed algorithms to provide its diagnostic output; and
  • (b) Nurochek Pro Software. that:
    • the Nurochek Pro Software will perform materially in accordance with the specifications for the Nurochek Pro Software set forth in the Documentation; and
    • Headsafe has used commercially reasonable efforts to detect and prevent the introduction of Malicious Code into the Nurochek Pro Software.

10.2. Remedy in respect of Nurochek Pro Software Warranty. For any breach of a warranty in clause 10.1(c):

  • (a) Notification. Licensee will promptly notify Headsafe of any failure of the Nurochek Pro Software to perform materially in accordance with its specifications subject arising out of the warranties in clause 10.1(c).
  • (b) Instructions. Licensee will follow any other instructions from Headsafe in relation the Nurochek Pro Software.
  • (c) Response. if the Nurochek Pro Hardware is subject the warranty in clause 10.1(c), Headsafe will promptly use commercially reasonable efforts to correct the failure of the Nurochek Pro Software so that it operates in accordance with the Documentation.

10.3. Exclusive Remedies. The remedies in clause 10.3 are exclusive and are subject to the limitations set forth herein and shall be Licensee's sole remedy with respect to any claim of breach of warranty arising out of this agreement.

10.4. Exclusions. Except as expressly provided herein, Headsafe:

  • makes no warranty of any kind, whether express, implied, statutory or otherwise; and
  • specifically disclaims all implied warranties, including any implied warranty of merchantability, fitness for a particular purpose, to the maximum extent permitted by applicable law.

It is also expressly agreed that the New Zealand Consumer Guarantees Act does not apply to this agreement.

10.5. Disclaimers. Headsafe disclaims all liability and indemnification obligations for any harm or damages caused by:

  • any third-party hosting providers or third party applications;
  • any software, Nurochek Pro Hardware, equipment, accessories or any other materials or services not provided or approved in writing by Headsafe;
  • use of the Nurochek Pro 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; or
  • use outside the Australia and/or New Zealand.

11. Mutual Indemnification

11.1. Indemnification by Headsafe. Headsafe will:

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

11.2. Response to IP Claim against Licensee. If Headsafe receives information about an infringement or misappropriation claim related to the Nurochek Pro Hardware or the Nurochek Pro Software, Headsafe may in its discretion and at no cost to Licensee:

  • (a) modify the Nurochek Pro Hardware and/or the Nurochek Pro Software so that it no longer infringes or misappropriates, without breaching the warranties under clause 10.1; or
  • (b) obtain a licence for Licensee's continued use of the Nurochek Pro Hardware and the Nurochek Pro Software in accordance with this agreement, and if neither (a) nor (b) is commercially reasonable; or
  • (c) terminate Licensee's use of the Nurochek Pro Hardware and the Nurochek Pro Software upon 30 days' written notice.

11.3. Exclusions. The above defense and indemnification obligations do not apply to the extent an IP Claim against Licensee arises from:

  • a Third Party Application;
  • Licensee's breach of this agreement;
  • Licensee's negligence, recklessness, gross negligence, or willful misconduct;
  • any use of the Nurochek Pro Hardware and/or the Nurochek Pro Software in combination with other products, equipment, software or data not supplied by Headsafe;
  • any use of the Nurochek Pro Hardware other than in accordance with its instructions for use contained in the Documentation; or
  • any modification of the Nurochek Pro Hardware and/or the Nurochek Pro Software by any person other than Headsafe or its authorised representatives.

11.4. Indemnification by Licensee. Licensee will:

  • defend Headsafe against any claim, demand, suit or proceeding made or brought against Headsafe by a third party alleging that Patient Data, or Licensee's use of the Nurochek Pro Hardware and/or the Nurochek Pro Software in breach of this agreement, infringes or misappropriates such third party's intellectual property rights (an IP Claim Against Headsafe); and
  • 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:
    • promptly gives Licensee written notice of the IP Claim Against Headsafe;
    • gives Licensee sole control of the defense and settlement of the IP Claim Against Headsafe (except that Licensee may not settle any IP Claim Against Headsafe unless it unconditionally releases Headsafe of all liability); and
    • gives Licensee all reasonable assistance, at Licensee's expense.

11.5. Exclusive Remedy. This clause 11 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 clause 11.

11.6. Indemnification Procedure. The party having the benefit of the indemnification obligation under this clause 11 (Beneficiary) must:

  • give the party having the indemnification obligation (Indemnifier) prompt written notice of any claim that is the subject of the indemnity (Claim);
  • 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;
  • provide all assistance reasonably requested by Indemnifier, at Indemnifier's expense, in the defense and settlement of the claim; and
  • 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:
    • 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;
    • 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
    • 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.

12. Limitation of Liability

12.1. Limitation of Liability. Except for each party's indemnification obligations under clause 11 and Licensee's payment obligations including under clause 7, neither party's liability with respect to any single incident or series of related incidents arising under this agreement will exceed the amount paid by Licensee 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 this agreement exceed the total amount paid by Licensee under this agreement. These 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.

12.2. Exclusion of Consequential and Related Damages. Except for each party's indemnification obligations under clause 11, in no event will either party have any liability to the other party for any loss of profits, loss of revenues or loss of goodwill or other indirect, special, incidental, consequential or punitive damages, 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.

12.3. No Guarantee. Headsafe does not guarantee that the output from the Nurochek Pro Hardware and Nurochek Pro 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.

13. Term and Termination

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

13.2. Termination. Either party may terminate this agreement:

  • (a) Breach. ten days after providing written notice to the other party of a material breach of its obligations under this 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 clause 13.2(c), prior to the first anniversary of the Effective Date.

13.3. After End of Agreement. After the end of this 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. Licensee 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 Licensee under this agreement automatically and immediately cease and Licensee must immediately:
    • cease all use of the Nurochek Pro Hardware and Nurochek Pro Software;
    • delete the Data Collection Nurochek Pro Software from its computer systems;
    • return to Headsafe or destroy (at Headsafe's election) all Documentation and/or Nurochek Pro promotional materials in its possession or control;
    • 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
    • certify in writing to Headsafe that it has done the foregoing within ten days of the end of this agreement.

13.4. Outstanding Amounts. On the end of this agreement, Licensee must pay all undisputed sums due to Headsafe.

13.5. Surviving Provisions. The clauses of this agreement, that are intended by their nature to survive termination or expiration, will survive any termination or expiration of this agreement.

14. Regulatory Compliance

14.1. Use. Licensee acknowledges that it has received, reviewed, and understood the indications for use, contraindications, warnings, and limitations associated with the Nurochek Pro Hardware and the Nurochek Pro Software. Licensee must use the Nurochek Pro Hardware and the Nurochek Pro Software only for the intended use specified in the Documentation.

14.2. Adverse Event Reporting. Licensee must promptly notify Headsafe of any adverse events, malfunctions, or other incidents associated with the Nurochek Pro Hardware and the Nurochek Pro Software that:

  • may have caused or contributed to a death or serious injury; or
  • 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@teamheadsafe.com (or such other email address notified by Headsafe for this purpose) within 24 hours of Licensee becoming aware of the event.

Licensee acknowledges that Headsafe has medical device reporting obligations 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 applicable regulator.

14.3. Post-Market Surveillance. Headsafe maintains a post-market surveillance program to monitor the safety and performance of the Nurochek Pro Hardware and the Nurochek Pro Software. Licensee 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. Licensee acknowledges that Headsafe may be required to conduct post-market studies and agrees to participate in such studies if requested, subject to appropriate compensation and terms to be mutually agreed upon.

14.4. Quality System Regulations. Headsafe maintains a quality management system. Licensee must follow all instructions for use, maintenance, and storage of the Nurochek Pro Hardware provided by Headsafe to ensure continued compliance with quality system requirements. Licensee must not modify, alter, or otherwise change the Nurochek Pro Hardware or any labeling, as this may compromise the Nurochek Pro Hardware's compliance with the applicable regulations.

14.5. Field Safety Corrective Actions. In the event Headsafe initiates a field safety corrective action, recall, or other safety communication regarding the Nurochek Pro Hardware or the Nurochek Pro Software, Licensee must:

  • promptly review and acknowledge receipt of such communications;
  • implement any required actions within the timeframe specified by Headsafe;
  • facilitate Headsafe's access to the Nurochek Pro Hardware for inspection, repair, or replacement as needed;
  • 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 Licensee's misuse or failure to follow instructions for use.

14.6. Nurochek Pro Software Updates. Headsafe will provide notice of any significant changes to the Nurochek Pro Software that may affect its safety or effectiveness. Licensee must promptly install all Nurochek Pro Software updates provided by Headsafe, as failure to do so may compromise the safety and effectiveness of the Nurochek Pro Hardware and the Nurochek Pro Software.

14.7. Status. Licensee represents and warrants that all Authorised Users authorised to use the Nurochek Pro Hardware and administer tests using the Nurochek Pro Hardware and the Nurochek Pro Software are either:

  • Licensed Healthcare Providers; or
  • operating under the supervision of such Licensed Healthcare Providers in accordance with applicable Law.

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

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

15. General Provisions

15.1. Giving Notice. All notices, permissions, and approvals under this agreement must be in writing and will be deemed to have been given upon:

  • personal delivery,
  • 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 Licensee must be addressed to Licensee as designated by Licensee.

15.2. Governing Law and Jurisdiction. Each party agrees that:

  • this agreement is governed by and is to be construed in accordance with the laws of the State of New South Wales, Australia, in all respects, without regard to choice or conflicts of law rules; and
  • all disputes arising out of or relating to this agreement are limited to the exclusive jurisdiction and venue of the state and federal courts located within New South Wales, Australia.

Each party hereby consents to and waives any objections with respect to such jurisdiction and venue.

15.3. Entire Agreement. The Agreement constitutes the entire agreement between Licensee and Headsafe regarding Licensee's:

  • use of the Nurochek Pro Hardware; and
  • Acquisition of the right to use, and use of, the Nurochek Pro Software,

and supersedes all prior and contemporaneous agreements, proposals or representations, written or oral, concerning its subject matter.

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

15.5. Amendment. No modification or amendment of any provision of this 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 Licensee purchase order or in any other order documentation is void.

15.6. Assignment. Neither party may assign any of its rights or obligations under this 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 this 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 this agreement upon written notice.

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

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

15.9. Waiver. No failure or delay by either party in exercising any right under this agreement will constitute a waiver of that right.

15.10. Severability. If any provision of this 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.

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

15.12. Equitable Relief. Nothing in this agreement will limit either party's ability to seek equitable relief.

15.13. Legal Costs. If any legal action or proceeding is brought to enforce or interpret this 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.

Schedule 1 - Technical Support

The purpose of Technical Support is to address issues with the Nurochek Pro 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 Licensee.

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

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

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

When making a Support Request, Licensee 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.