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SMARTSTEP Standard Trading Terms US Institutions

These Standard Trading Terms govern the supply by SmartStep, Inc. (“SmartStep”) of access to the SmartStep digital platform to the institution identified in the Commercial Terms Sheet (the “Institution”). They are incorporated into, and form part of, the Commercial Terms Sheet signed by the parties. SmartStep and the Institution are each a “party” and together the “parties”. 

1.  DEFINITIONS AND INTERPRETATION 

1.1  In the Agreement, the following definitions apply: 

“Add-On Services” means optional modules, features, integrations, hardware components or additional services made available by SmartStep from time to time, which may be licensed or purchased separately and are specified in a Commercial Terms Sheet. 

“Agreement” means the Commercial Terms Sheet, these Standard Trading Terms, the BAA and the EULA, together with any schedules and any further Commercial Terms Sheet agreed between the parties. 

“Authorised User” means an employee, contractor or clinician of the Institution who is authorised by the Institution to access the Platform and to whom a Licence is allocated, and who meets the requirements set out in the EULA. 

“BAA” means the business associate agreement between the parties meeting the requirements of 45 C.F.R. §§ 164.314(a) and 164.504(e). 

“Business Day” means a day other than a Saturday, Sunday or federal public holiday in the United States. 

“Business Hours” means 9:00 a.m. to 5:00 p.m. Eastern Time on a Business Day. 

“Clinical Administrator” means an Authorised User with elevated administrative permissions, including user management, configuration and oversight of clinical and operational use of the Platform. 

“Commercial Terms Sheet” means the document signed by the parties which sets out the commercial terms for the Institution’s use of the Platform and incorporates these Standard Trading Terms. 

“Contract Year” means each period of twelve (12) months beginning on the Effective Date or an anniversary of it. 

“Core Platform” means the standard SmartStep digital platform functionality made generally available to customers as part of the base subscription. 

“Covered Entity” means has the meaning given at 45 C.F.R. § 160.103. 

“Effective Date” means the date stated in the Commercial Terms Sheet. 

“EULA” means the SmartStep Institution End User License Agreement – USA, as made available through the Platform and updated from time to time. 

“Fees” means the fees payable by the Institution as set out in the Commercial Terms Sheet. 

“HIPAA” means the Health Insurance Portability and Accountability Act of 1996, as amended (including by the HITECH Act), and the regulations promulgated under it. 

“Institution Sites” means the clinic, hospital or other locations of the Institution listed in the Commercial Terms Sheet. 

“Licence” means a named-user licence to access and use the Platform. 

“Patient Terms of Use” means the SmartStep Platform Patient Terms of Use – USA, as updated from time to time. 

“Platform” means the SmartStep digital platform, including the Core Platform and any licensed Add-On Services. 

“PHI” means Protected Health Information as defined at 45 C.F.R. § 160.103, limited to information created or received by SmartStep from or on behalf of the Institution. 

“Privacy Policies” means the SmartStep App Privacy Policy – USA and the SmartStep Consumer Health Data Privacy Policy, each as updated from time to time. 

“Super User” means an Authorised User with advanced clinical or analytical permissions, including access to enhanced reporting, data review and configuration features. 

“Term” means the term of the Agreement determined in accordance with clause 12. 

1.2  In the Agreement: headings are for convenience only; “including” means “including without limitation”; references to a statute include that statute as amended and any successor legislation and regulations made under it; and words in the singular include the plural and vice versa. 

2.  CONTRACT DOCUMENTS AND ORDER OF PRECEDENCE 

2.1  The Agreement comprises the documents listed in the definition of “Agreement”. Each party acknowledges that it has read those documents. 

2.2  If there is any conflict or inconsistency between those documents, they take precedence in the following order: 

(a)  the BAA, in respect of PHI; 

(b)  the Commercial Terms Sheet, in respect of Licence quantities, Fees and commercial terms; 

(c)  these Standard Trading Terms; and 

(d)  the EULA. 

2.3  The Privacy Policies and the Patient Terms of Use govern the relationship between SmartStep and patients and other individual users of the Platform. They are not varied by the Agreement, and nothing in the Agreement confers any right on the Institution under them. 

2.4  SmartStep may update the EULA, the Privacy Policies and the Patient Terms of Use from time to time. SmartStep will give the Institution not less than thirty (30) days’ written notice of any change to the EULA that materially reduces the Institution’s rights or materially increases its obligations. 

3.  PURPOSE AND SCOPE 

3.1  SmartStep shall provide Authorised Users with access to the Platform, together with onboarding, training, support and enablement services reasonably required to support clinical and operational use. 

3.2  The Platform is intended to support clinical and operational workflows by enabling the capture, visualisation, monitoring and reporting of patient activity and gait-related data, in line with the Institution’s internal clinical and operational policies. 

3.3  The Agreement governs the provision of the Platform for use only at Institution Sites and only by Authorised Users. 

3.4  The Platform is intended to support, and not to replace, clinical judgement or decision-making. The Institution retains sole responsibility for all clinical decisions and outcomes and for the care of its patients. 

4.  LICENCE AND PERMITTED USE 

4.1  SmartStep grants the Institution and its Authorised Users a non-exclusive, non-transferable, non-sublicensable, revocable licence to access and use the Platform during the Term, strictly in accordance with the Agreement, the EULA and the applicable Commercial Terms Sheet. 

4.2  Licences are issued on a named-user basis and allocated to individual Authorised Users. Each Licence is allocated to one Authorised User at a time and may be reallocated by the Institution, provided that no Licence is shared by more than one individual concurrently. 

4.3  Authorised Users may access the Platform across multiple Institution Sites, subject to the Licence quantities and usage limits in the Commercial Terms Sheet. 

4.4  The Institution shall not permit access by any person who is not an Authorised User, nor use the Platform outside the agreed clinical or operational purposes, nor at locations that are not Institution Sites. 

4.5  The Institution may purchase Add-On Services in addition to the Core Platform. Add-On Services may be provided on a one-off or recurring basis. Unless otherwise stated in the relevant Commercial Terms Sheet, recurring Add-On Services are coterminous with the Term, and one-off Add-On Services are deemed delivered on completion or enablement and create no ongoing service obligation. 

4.6  The Platform includes Single Sign-On (SSO) capability. Implementation, configuration and activation of SSO are not included unless expressly stated in a Commercial Terms Sheet. Where a further SSO implementation is required as a result of a corporate, ownership or organisational change affecting the Institution, that implementation shall be treated as a separate project subject to separate scoping and commercial agreement. 

4.7  The Platform supports different Authorised User role types, including Clinical Administrators and Super Users. Role assignment determines access levels and permissions. Unless a Commercial Terms Sheet states otherwise, all Authorised Users count toward the applicable Licence quantities and minimum commitments regardless of role, and a change in role assignment does not of itself reduce them. 

5.  SUPPORT AND SERVICE MANAGEMENT 

5.1  SmartStep shall provide support services designed to acknowledge reported issues promptly, communicate clearly on status and next steps, and use all reasonable efforts to resolve issues proportionate to their nature and impact. 

5.2  Acknowledgement and initial response, including triage and proposed next steps, shall be provided within one (1) Business Day during Business Hours following receipt of a support request submitted to [email protected]. Such initial support is included within the Fees. 

5.3  Resolution efforts will take into account issue severity, clinical and operational impact, technical complexity and any third-party dependencies. 

5.4  Any response times, severity classifications or service guidance described in the Agreement or supporting documentation are indicative only and do not constitute binding service levels. 

6.  PLATFORM AVAILABILITY 

6.1  SmartStep shall use reasonable endeavours to make the Platform available on a continuous basis. 

6.2  Availability excludes planned maintenance, emergency maintenance, Platform updates and circumstances beyond SmartStep’s reasonable control. 

6.3  The Platform is provided without guarantee of uninterrupted or error-free operation. 

7.  MAINTENANCE, UPDATES AND PRODUCT EVOLUTION 

7.1  SmartStep may deploy updates, enhancements, bug fixes and performance improvements from time to time. 

7.2  Where reasonably practicable, SmartStep shall give advance notice of planned maintenance or changes that materially affect availability or core functionality. 

7.3  The Institution acknowledges that the Platform is an evolving product. SmartStep may modify, enhance or retire features provided that such changes do not materially reduce the overall value of the Platform during the Term. 

8.  DATA PROTECTION, PRIVACY AND SECURITY 

8.1  Roles. The Institution is a Covered Entity. SmartStep, in creating, receiving, maintaining or transmitting PHI on behalf of the Institution in connection with the Platform, acts as the Institution’s business associate (as defined at 45 C.F.R. § 160.103). 

8.2  Business Associate Agreement. The parties shall enter into, and maintain throughout the Term, the BAA. SmartStep shall create, receive, maintain, transmit, use and disclose PHI only as permitted by the BAA, the Agreement and applicable law. In the event of any conflict between the BAA and any other part of the Agreement in relation to PHI, the BAA prevails. 

8.3  Security. SmartStep shall implement and maintain appropriate administrative, physical and technical safeguards meeting the requirements of the HIPAA Security Rule and proportionate to the nature of the data and the risks presented by the processing. 

8.4  Data captured. The Platform stores gait data, selected physiological and activity measures, structured survey responses and optional video recordings, as described in the Privacy Policies. 

8.5  De-identification and aggregation. SmartStep may create and use de-identified and aggregated data derived from use of the Platform, but only to the extent permitted by the BAA and by 45 C.F.R. §§ 164.502(d) and 164.514. As between the parties, SmartStep owns all right, title and interest in such de-identified and aggregated data. 

8.6  Other privacy laws. Each party shall comply with applicable state consumer privacy and consumer health data laws in connection with its own activities under the Agreement. SmartStep maintains the Privacy Policies in respect of information it processes in its own right. 

8.7  Incidents. Each party shall notify the other promptly on becoming aware of any suspected security incident, breach or misuse affecting the Platform or PHI. Notification and reporting in respect of PHI are governed by the BAA. 

8.8  Intra-group transfers. The transfer and processing of data between SmartStep group entities is governed by SmartStep’s intra-group data transfer arrangements as amended from time to time, and remains subject to the BAA. 

9.  INSTITUTION’S RESPONSIBILITIES 

9.1  The Institution shall: 

(a)  ensure that Authorised Users are appropriately trained and authorised; 

(b)  ensure that use of the Platform complies with applicable law, professional standards and clinical governance requirements; 

(c)  promptly notify SmartStep of any suspected security incident, breach or misuse; 

(d)  maintain its Notice of Privacy Practices and obtain all consents, authorisations and other legal permissions required in connection with the disclosure of PHI to SmartStep; 

(e)  be responsible for the acts and omissions of its Authorised Users as if they were its own; and 

(f)  provide, at its own cost, the equipment, connectivity and system requirements necessary for Authorised Users to access the Platform. 

9.2  The Institution retains responsibility for all clinical decisions and outcomes supported by use of the Platform, and for its patient records. The Institution acknowledges that the Platform is not an electronic medical record and should not be treated as a system of record. 

10.  COLLABORATION AND ESCALATION 

10.1  Support services are collaborative in nature. The parties shall act in good faith to investigate issues, share relevant information and prioritise matters that materially impact patient safety, clinical delivery or operational continuity. 

10.2  Escalation routes and operational contacts may be agreed and updated by the parties from time to time without formal amendment to the Agreement. 

11.  FEES AND PAYMENT 

11.1  Fees are payable in accordance with the Commercial Terms Sheet, in US dollars. 

11.2  Unless the Commercial Terms Sheet states otherwise, Fees are payable monthly in advance by credit card. The Institution shall provide valid credit card details, keep them current throughout the Term, and authorises SmartStep and its payment processor to charge that card for all Fees as they fall due on a recurring basis until the Agreement ends and all Fees have been paid. SmartStep shall use a PCI-DSS compliant payment processor and shall not itself store full card numbers. Where the Effective Date is not the first day of a month, the first payment shall be pro-rated. 

11.3  Fees are exclusive of all sales, use, excise and similar taxes, which are the responsibility of the Institution, excluding taxes based on SmartStep’s net income. All payments shall be made without deduction, withholding or set-off, except as required by law. Where the Institution claims exemption it shall provide a valid exemption certificate issued by the appropriate taxing authority. 

11.4  In the event of conflict between these Standard Trading Terms and a Commercial Terms Sheet, the Commercial Terms Sheet prevails solely in respect of Licence quantities, Fees and commercial terms. 

11.5  Without prejudice to its other rights, SmartStep may suspend access to the Platform, in whole or in part, if any undisputed Fees remain unpaid more than thirty (30) days after written notice of non-payment, or, where Fees are payable by credit card, more than ten (10) Business Days after notice given under clause 11.9. 

11.6  Licence fees may be increased with effect from each anniversary of the Effective Date by the amount stated in the Commercial Terms Sheet. Where Fees are payable by credit card, SmartStep shall give the Institution not less than thirty (30) days’ written notice of the revised Fees before the first charge at the increased rate. 

11.7  Any minimum commitment stated in the Commercial Terms Sheet is payable regardless of the Institution’s actual usage. 

11.8  Where the Institution is unable to pay by credit card and the monthly fee is in excess of $500 per month, the parties may agree, at Smartstep’s sole discretion,  in the Commercial Terms Sheet that Fees are payable in advance by ACH transfer against invoice, payable within the period stated there. 

11.9  If a credit card payment fails, SmartStep may re-present the charge and shall notify the Institution. The Institution shall provide valid replacement card details, or pay the outstanding Fees by ACH transfer, within ten (10) Business Days of that notice. 

11.10  The Institution shall notify SmartStep promptly of any change to its card details, and remains liable for all Fees falling due whether or not a valid card is held on file. 

11.11  SmartStep shall issue the Institution an invoice for each charge, whether Fees are paid by credit card or by ACH transfer. Each invoice shall show the Fees charged, the period to which they relate, the number of Licences charged, and any taxes separately stated. Where Fees are paid by credit card, SmartStep shall issue the invoice at or before the time the card is charged, and that invoice is issued for record-keeping purposes only and does not vary the time for payment under clause 11.2. Each party shall retain invoices for not less than seven (7) years. 

12.  TERM AND TERMINATION 

12.1  The Agreement commences on the Effective Date and continues for the Initial Term stated in the Commercial Terms Sheet, unless terminated earlier in accordance with this clause. Following expiry of the Initial Term, the Agreement continues until terminated under clause 12.3. Where the Commercial Terms Sheet states that there is no Initial Term, clauses 12.2, 12.3 and 12.5 do not apply and the Agreement continues until terminated in accordance with the Commercial Terms Sheet or clause 12.4. 

12.2  Subject to clause 12.1, the Institution may terminate the Agreement for convenience during the Initial Term on not less than ninety (90) days’ prior written notice, provided that it pays SmartStep an early termination charge equal to all unpaid Fees that would have been payable in respect of its minimum Licence commitment for the remainder of the Initial Term. 

12.3  Subject to clause 12.1, following expiry of the Initial Term, either party may terminate the Agreement for convenience on not less than three (3) months’ prior written notice, such notice to expire no earlier than the end of the then-current subscription period. 

12.4  Either party may terminate the Agreement with immediate effect by written notice if the other party commits a material breach which is not cured within thirty (30) days of written notice specifying the breach, or becomes insolvent, ceases to carry on business, or becomes subject to a petition in bankruptcy, receivership or liquidation. 

12.5  Where the Institution terminates the Agreement for convenience during the Initial Term pursuant to clause 12.2, no refund is due in respect of Fees already paid, and all Fees for any subscription period that has commenced remain payable in full. 

12.6  One-off fees, including fees for Add-On Services and hardware, remain payable in full once the relevant services have been delivered or enabled. 

12.7  On expiry or termination, all Licences and Authorised User access terminate. The return or destruction of PHI is governed exclusively by the BAA, and the Institution remains responsible for its patient records. 

12.8  Termination or expiry does not affect any accrued rights, remedies, obligations or liabilities. Clauses 8, 13, 14, 16, 17, 18, 20 and 26, and any other clause which by its nature is intended to survive, survive termination. 

13.  INTELLECTUAL PROPERTY 

13.1  All intellectual property rights in the Platform remain vested in SmartStep or its licensors. 

13.2  SmartStep grants the Institution a non-exclusive, royalty-free licence for Authorised Users to use the Platform at Institution Sites during the Term. 

13.3  Nothing in the Agreement transfers ownership of intellectual property between the parties. 

13.4  SmartStep owns any input, feedback or suggestions provided by the Institution or its Authorised Users, and may exploit the same for any purpose without compensation. 

14.  CONFIDENTIALITY 

14.1  Each party shall keep confidential any non-public information disclosed by the other party in connection with the Agreement and shall not disclose it except as required to perform its obligations or as required by law. 

14.2  This clause survives termination of the Agreement for a period of five (5) years. PHI is governed by the BAA and not by this clause. 

15.  WARRANTIES 

15.1  SmartStep warrants that the Platform will perform materially in accordance with its documentation during the Term, and that the Platform does not infringe the intellectual property rights of any third party. 

15.2  Each party warrants that it is duly organised and validly existing, has the power and authority to enter into the Agreement, and that entering into the Agreement will not breach any obligation binding upon it. 

15.3  Except as expressly stated in the Agreement and to the fullest extent permitted by applicable law, the Platform is provided on an “as is” and “as available” basis and SmartStep disclaims all other warranties, whether express, implied or statutory, including implied warranties of merchantability and fitness for a particular purpose. 

16.  INDEMNITY 

16.1  SmartStep shall indemnify the Institution against all direct costs (including reasonable legal and professional costs) suffered or incurred by the Institution arising out of any third-party claim that the Platform infringes the intellectual property rights of any person. 

16.2  Clause 16.1 does not apply to the extent that the infringement arises from modifications to the Platform made by the Institution, data uploaded to the Platform by the Institution or its Authorised Users, combination of the Platform with products or services not supplied by SmartStep, or the Institution’s non-compliance with the Agreement. 

16.3  The Institution shall indemnify SmartStep against all third-party claims arising out of the Institution’s or its Authorised Users’ use of the Platform, the Institution’s clinical decisions and provision of care, or the Institution’s breach of applicable law. 

16.4  Indemnification is conditional on the indemnified party giving prompt written notice of the claim, allowing the indemnifying party to control the defence and settlement (provided that no settlement imposing liability or obligation on the indemnified party may be made without its prior written consent, not to be unreasonably withheld), and providing reasonable cooperation at the indemnifying party’s expense. 

17.  LIMITATION OF LIABILITY 

17.1  Neither party shall be liable for any indirect, special, exemplary, incidental, consequential or punitive loss or damage, or for any lost profits, lost savings or loss of revenue, arising out of or in connection with the Agreement. 

17.2  Subject to clauses 17.3, 17.4 and 17.5, each party’s total aggregate liability under the Agreement, in aggregate for all claims and whether arising from a single event or a series of related events, shall not exceed the amount paid by the Institution to SmartStep under the Agreement in the twelve (12) months preceding the first event giving rise to a claim. 

17.3  Nothing in the Agreement limits or excludes either party’s liability for death or personal injury caused by its negligence, for fraud or fraudulent misrepresentation, for a party’s gross negligence or wilful misconduct, for breach of clause 14, or for any liability which cannot be limited or excluded by applicable law. 

17.4  Each party’s total aggregate liability under the indemnities at clauses 16.1 and 16.3, in aggregate for all claims and whether arising from a single event or a series of related events, shall not exceed five (5) times the Fees paid or payable by the Institution under the Agreement in respect of the twelve (12) months preceding the first event giving rise to a claim. That limit applies in place of, and not in addition to, the limits at clauses 17.2 and 17.5, and is subject to clause 17.3. 

17.5  Notwithstanding clauses 2.2 and 8.2, each party’s total aggregate liability arising out of or in connection with any breach of clause 8 of these Standard Trading Terms, of the BAA, or otherwise in respect of Protected Health Information, in aggregate for all claims and whether arising from a single event or a series of related events, shall not exceed five (5) times the Fees paid or payable by the Institution under the Agreement in respect of the twelve (12) months preceding the first event giving rise to a claim. That limit applies in place of, and not in addition to, the limits at clauses 17.2 and 17.4, and is subject to clause 17.3. Nothing in this clause limits or affects any civil monetary penalty or other sanction imposed on a party by a regulatory authority, or either party’s obligations under the BAA to notify, mitigate or remediate a breach of Protected Health Information. 

17.6  An indemnity obligation under clause 16 is owed regardless of whether, or to what extent, the underlying third-party claim seeks recovery of consequential or other indirect damages, and shall not be reduced or excluded by clause 17.1 because the underlying claim includes an asserted right to recover such damages. 

17.7  This clause survives termination of the Agreement for any reason. 

18.  COMPLIANCE WITH LAWS 

18.1  Each party shall comply, at its own expense, with all federal, state and local laws applicable to it in connection with the Agreement. 

18.2  Healthcare fraud and abuse. Neither party shall offer, pay, solicit or receive any remuneration to induce or reward referrals in violation of the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Physician Self-Referral Law (42 U.S.C. § 1395nn) or any applicable state equivalent. The parties intend that the Fees represent fair market value for the Platform, have been negotiated at arm’s length, and have not been determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties. 

18.3  Exclusion screening. Each party represents that neither it nor any of its personnel engaged in performing the Agreement is excluded from participation in any federal health care program, debarred by the Food and Drug Administration, or listed on the OIG List of Excluded Individuals/Entities or the System for Award Management exclusion list. Each party shall screen its personnel against those lists and notify the other promptly if that representation ceases to be true. 

18.4  Records access. To the extent required by 42 U.S.C. § 1395x(v)(1)(I) and 42 C.F.R. § 420.300 et seq., SmartStep shall, until four (4) years after the furnishing of services under the Agreement, make available to the Secretary of the U.S. Department of Health and Human Services or the Comptroller General, on request, the Agreement and such books, documents and records as are necessary to verify the nature and extent of the costs of those services. 

18.5  Anti-corruption. Each party shall comply with the Foreign Corrupt Practices Act and all other applicable anti-bribery and anti-corruption laws, and shall maintain adequate policies and procedures to ensure compliance. 

18.6  Without prejudice to its other rights, SmartStep may suspend performance of the Agreement in whole or in part with immediate effect if the Institution is in breach of this clause 18. 

19.  ASSIGNMENT AND SUBCONTRACTING 

19.1  SmartStep may assign, novate, charge or subcontract all or any of its rights and obligations under the Agreement, including to any group company. Any subcontractor which creates, receives, maintains or transmits PHI shall be bound by obligations equivalent to those in the BAA. 

19.2  The Institution may not assign, novate, charge or subcontract its rights or obligations without SmartStep’s prior written consent (not to be unreasonably withheld), save that it may assign the Agreement to a person acquiring all or substantially all of its assets or business, provided that the assignee agrees in writing to assume the Institution’s obligations. 

19.3  Any subcontractor engaged by the Institution must be subject to obligations equivalent to those imposed on the Institution, and the Institution remains responsible for its compliance. 

20.  AUDIT AND REGULATORY ACCESS 

20.1  The Institution shall keep complete, accurate and up-to-date records adequate to demonstrate compliance with the Agreement. 

20.2  On reasonable prior notice and during normal business hours, the Institution shall allow SmartStep or a third party appointed by SmartStep access to those records for the purpose of auditing compliance, and shall provide reasonable assistance and permit copies to be taken without charge. 

20.3  The Institution shall permit any legal or regulatory body having jurisdiction over either party access to records, products and services relating to the Platform, subject always to patient confidentiality and the BAA. 

21.  REGULATORY STATUS OF THE PLATFORM 

21.1  The parties acknowledge that the Platform may include one or more software modules that constitute medical device software or Software as a Medical Device under the Federal Food, Drug, and Cosmetic Act. 

21.2  SmartStep shall: 

(a)  ensure that the intended use, functionality, interfaces and module boundaries of any such module are clearly defined, documented and controlled; 

(b)  maintain a quality management system in accordance with 21 C.F.R. Part 820 and software lifecycle controls appropriate to the regulatory classification and risk profile of the relevant module; 

(c)  hold and maintain the clearances, approvals, registrations and listings required to market the Platform in the United States; 

(d)  provide, on reasonable request, documentation and technical information reasonably required to support the Institution’s regulatory obligations, including information relating to safety and performance, verification and validation, cybersecurity, usability, risk management and change history; 

(e)  operate change control procedures and give the Institution written notice of any substantial change that may reasonably affect intended use, safety, performance, regulatory classification, interoperability or clinical evaluation; and 

(f)  promptly notify the Institution of any defect, malfunction, cybersecurity vulnerability, complaint, adverse event, correction or removal, or regulatory inquiry relating to the Platform that could reasonably affect safety, performance or regulatory compliance, and cooperate in good faith with any investigation, corrective action or regulatory submission. 

21.3  The Institution shall not make any statement, labelling claim or representation regarding the medical purpose, clearance status or regulatory classification of any module except as documented, substantiated and agreed in writing by SmartStep. 

21.4  The Institution shall maintain a record of complaints received and forward all complaint information to SmartStep within five (5) Business Days. SmartStep shall handle all complaints and any consequent reporting to regulatory authorities, including medical device reporting under 21 C.F.R. Part 803 and reports of corrections and removals under 21 C.F.R. Part 806, where applicable. 

22.  INSURANCE 

22.1  Each party shall maintain, at its own cost, insurance appropriate to its obligations and risks under the Agreement, including in SmartStep’s case cyber liability cover with limits of not less than $2million per claim and $2million in the aggregate, and in the Institution’s case professional and general liability cover with limits of not less than $2 million per claim. Each party shall maintain that cover throughout the Term and for two (2) years following expiry or termination, shall provide certificates of insurance on reasonable request, and shall notify the other promptly of any cancellation, non-renewal or material reduction in cover. 

23.  NOTICES 

23.1  Any notice under the Agreement must be in writing and in English and delivered by hand or nationally recognised overnight courier, sent by certified mail (return receipt requested), or sent by email, in each case to the addresses stated in the Commercial Terms Sheet or such other address as notified in accordance with this clause. 

23.2  A notice is deemed given: if delivered by hand or courier, at the time it is left at the address; if sent by certified mail, on the third Business Day after posting; and if sent by email, at the time of transmission, provided no notice of non-delivery is received. A notice delivered or transmitted after 5:30 p.m. local time in the place of receipt, or on a day that is not a Business Day, is deemed given at 9:00 a.m. on the next Business Day. 

24.  THIRD PARTY BENEFICIARIES 

24.1  The Agreement is entered into for the benefit of SmartStep and its group companies, each of which may enforce its provisions. Save as stated in this clause, the Agreement is for the sole benefit of the parties and their permitted successors and assigns, and confers no rights on any other person, including any Authorised User or patient. 

25.  GENERAL 

25.1  SmartStep may set off any undisputed and due amounts owed by the Institution against any undisputed and due amounts owed by SmartStep to the Institution. 

25.2  The Agreement constitutes the entire agreement between the parties in respect of its subject matter and supersedes all previous agreements and understandings relating to it. 

25.3  The Agreement may be executed in counterparts, and signatures transmitted electronically or by facsimile are treated as original signatures. 

25.4  No variation of the Agreement is effective unless made in writing and signed by each party. No purchase order or other communication of the Institution operates to vary the Agreement. 

25.5  No failure or delay in exercising a right or remedy constitutes a waiver of it, and no waiver is effective unless in writing and signed by the waiving party. 

25.6  If any term of the Agreement is held invalid or unenforceable, it shall be severed and the remaining terms continue in full force and effect. 

25.7  The rights and remedies provided by the Agreement are cumulative and not exclusive of any rights or remedies provided by law. 

25.8  Nothing in the Agreement creates a partnership, joint venture, agency or employment relationship between the parties, and neither party has authority to bind the other. 

25.9  Neither party is liable for any failure or delay in performing its obligations (other than an obligation to pay) to the extent caused by circumstances beyond its reasonable control, provided that it gives prompt notice and uses reasonable efforts to resume performance. 

25.10  Each party bears its own costs in connection with the negotiation and preparation of the Agreement. The Institution enters into the Agreement as principal and not as agent for any person. 

25.11  Each party may include the other party’s name and logo in customer or vendor lists. SmartStep may refer to the Institution’s use of the Platform in its marketing materials with the Institution’s prior written consent, not to be unreasonably withheld. 

26.  GOVERNING LAW AND DISPUTE RESOLUTION 

26.1  The Agreement and any dispute or claim arising out of or in connection with it are governed by the laws of the State of Ohio, without regard to its conflict of laws principles. The parties disclaim the application of the United Nations Convention on Contracts for the International Sale of Goods. 

26.2  Any dispute arising out of or in connection with the Agreement shall first be escalated to a senior representative of each party, who shall seek to resolve it within thirty (30) Business Days of referral. 

26.3  If the dispute is not resolved within that period, it shall be referred to and finally resolved by the state and federal courts located in the State of Ohio, which shall have exclusive jurisdiction. Each party consents to the personal jurisdiction and venue of those courts. 

26.4  Nothing in this clause prevents either party from seeking interim or injunctive relief in any court of competent jurisdiction. 

26.5  In any proceedings arising out of or related to the Agreement, the prevailing party is entitled to recover its reasonable attorneys’ fees, costs and expenses.