Last updated: 14 May 2026
1.1. The definitions set out in Schedule 1 apply to this Agreement.
1.2. This agreement is made up of (i) the Order Form (including any annexes) (ii) the Data Processing Addendum (iii) for Partners located in the EU only, the Additional EU Terms (iv) the Service Level Agreement and (v) these general terms and conditions (the “Agreement”). If there is any conflict or ambiguity between the terms of the documents listed in this Clause, a term contained in a document higher in the list shall have priority over one contained in a document lower in the list.
2.1. This Agreement shall be effective on and from the Commencement Date and shall continue for the Initial Term unless extended in accordance with Clause 2.2 below.
2.2. The Partner may elect to extend the duration of the Agreement for a maximum number of Renewal Periods as set out in the Order From, provided it complies with the notice provisions set out in the Order Form.
3.1. The Services to be provided to the Partner by Skin Analytics in consideration for the Product Fee shall comprise:
3.1.1. a skin lesion screening service following the pathway set out in the Order Form;
3.1.2. access to the Platform;
3.1.3. Continued updates and improvements to the Platform.
3.1.4. Support from a dedicated Skin Analytics Transformation Manager to support the implementation and evolution of the operational parts of the Partner’s pathway based on learnings from other sites and best practices seen elsewhere.
3.1.5. Training to use the Platform:
(a) E-learning tools to support self-learning.
(b) Up to 4 on-site training days.
3.1.6. Data storage costs.
3.1.7. Monthly and quarterly reporting in a format agreed with Skin Analytics.
3.1.8. Ad-Hoc data requests to support local research and service optimisation.
3.2. In addition, Skin Analytics will provide the additional Services set out in the Order Form, subject to payment by the Partner of the additional costs set out in the Order Form. Any other additional services will be subject to the additional fees set out in Clause 9.2.
3.3. In consideration of the Fees payable by the Partner and subject to the terms and conditions of this Agreement, Skin Analytics will, during the term of this Agreement, make the Services available to the Partner in accordance with the Service Levels.
3.4. For the avoidance of doubt, at no time does Skin Analytics or any of its staff make or take clinical decisions or offer a clinical opinion. All clinical opinion, diagnoses and treatments are provided by a UK registered medical device with an appropriate regulatory clearance (UK CA / CE mark) and, where the Service includes a Clinician Review, a Clinician.
3.5. Where the Service includes a Clinician Review, Skin Analytics’ responsibilities are limited to the appointment and oversight of a clinically trained professional registered with the General Medical Council (GMC) employed by Skin Analytics to:
3.5.1. take responsibility for the quality and effectiveness of clinical governance structures, operational procedures, clinical audit, and standardised communications; and
3.5.2. ensure there is appropriate clinical risk management and medical indemnity in place.
4.1. The Parties shall at all times act in the best interests of the Patients and in accordance with prevailing medical ethics.
4.2. Where the Services include a Clinician Review, Skin Analytics shall procure that the quality of care to be provided to Patients by the Clinicians shall accord with pathway set out in the Order Form, Good Industry Practice, and the other provisions of this Agreement.
4.3. Skin Analytics shall provide the Services in accordance with:
4.3.1. the terms of this Agreement;
4.3.2. the Law; and
4.3.3. Good Clinical Practice.
4.4. Skin Analytics shall maintain an appropriate plan relating to continuity of all of the Services in the event of disruption (which, for the avoidance of doubt, shall include a plan in relation to the ongoing provision of the Platform and the Equipment or equivalent replacements thereof); and shall notify the Partner as soon as reasonably practicable of activation of the continuity plan and in any event no later than two (2) Business Days from the date of such activation.
5.1. Skin Analytics shall exercise reasonable care and skill in:
5.1.1. overseeing the use of any medical devices employed as part of the provision of the Services;
5.1.2. where the Service includes a Clinician Review, appointing Clinicians with an appropriate range of qualifications, skills and experience to oversee the Services offered under and during the Term of this Agreement;
5.1.3. arranging for the provision of Services to the Partner; and
5.1.4. devising appropriate procedures and systems to ensure that Skin Analytics promptly notifies the Partner of any complaints made or concerns raised by any Patient or any Patient’s GP in relation to any matter to which this Agreement relates (subject where appropriate to preserving Patient confidentiality).
6.1. Skin Analytics shall ensure that all Staff engaged in the performance of the Services shall have the appropriate qualifications, skill and experience to provide the Services in accordance with this Agreement.
6.2. Where the Services include a Clinician Review:
6.2.1. Skin Analytics shall ensure that every Clinician is registered with a recognised medical defence organisation in respect of liability for negligence and other risks and is as such adequately insured to a minimum of five million (£5,000,000) for each claim at all times in respect of:
(a) any actions, claims, demands and proceedings;
(b) all liabilities, loss and damages; and
(c) all payments, costs and expenses,
6.2.2. Skin Analytics shall check on an annual basis and use all other reasonable endeavours to ensure at all times during this Agreement that every Clinician shall:
(a) maintain full registration with the appropriate Governing Body (for the avoidance of doubt a Clinician will not be deemed to have full registration where they have been suspended, reported or under review);
(b) maintain up to date Continuing Professional Development (“CPD”); and
(c) not be the subject of any admonishments, warnings, conditions or other potential or real restrictions on practice and not have had any in place for at least 24 months.
6.3. Nothing in this Agreement shall establish or be deemed to constitute a relationship of employer and employee between the Partner and Skin Analytics or Skin Analytics’ employees or agents and Skin Analytics shall be entirely responsible for the employment and/or conditions of service of its Staff.
which they might from time to time be required to make or might incur as a result of any accident, injury or other loss that might be suffered by any Patient as a result of any act or omission by such Clinician.
7.1. Skin Analytics warrants and undertakes that:
7.1.1. it shall provide the Services in accordance with a level of skill, care, diligence and Good Clinical Practice;
7.1.2. it shall ensure that all Skin Analytics Personnel:
(a) are appropriately qualified and experienced to undertake their tasks; and
(b) use professional skill, care and Good Clinical Practice in performing their tasks;
7.1.3. it shall comply with:
(a) all Laws applicable to the provision of the Services; and
(b) any reasonable instructions and guidelines mutually agreed to in writing between Skin Analytics and the Partner from time to time;
7.1.4. it has full capacity and authority to enter into this Agreement and that it has or will obtain prior to the Commencement Date, any necessary licences, consents and permits required of it for the performance of the Services;
7.1.5. the information technology security standards at a minimum will comply with those required for ISO 27001: 2022; and
7.1.6. it shall comply with the SLAs set out in Schedule 3 (Service Level Agreement).
7.2. Subject to the liability limits set out in clause 15.3, Skin Analytics shall indemnify, keep indemnified and hold harmless the Partner against all costs, claims, losses, damages and expenses (including reasonable legal expenses) incurred by the Partner arising out of, or in connection with, to the extent of:
7.2.1. any breach of Clause 7.1.3(a);
7.2.2. any claim by a Patient and / or a third party and / or a regulatory body that Skin Analytics did not comply with the provisions of Clauses 7.1,
provided always that the Partner shall promptly give written notice of the claim to Skin Analytics, specifying the nature of the claim in sufficient detail. Skin Analytics may, to the extent permitted by Law, assume control of a third party action when notified by the Partner and, in such cases, the Partner shall provide to Skin Analytics reasonable assistance and access relating to any such action.
8.1. The Partner warrants, represents and undertakes that:
8.1.1. it shall provide services to Patients with a level of professional skill, care, diligence and Good Clinical Practice reasonably expected of a reputable medical practitioner;
8.1.2. it shall provide the service in accordance with a level of skill, care, diligence and Good Clinical Practice in accordance with the standards reasonably expected in the Partner’s industry.
8.1.3. it shall ensure that all of the Partner Personnel:
(a) are appropriately qualified and experienced to undertake their tasks;
(b) use Skin Analytics’ medical device DERM in line with its intended use which can be found at https://skin-analytics.com/derm-medical-device-resources-for-healthcare-organisations/ and;
(c) use professional skill, care and Good Clinical Practice;
8.1.4. it shall comply with:
(a) all Laws in provision of the Services; and
(b) any reasonable instructions and guidelines mutually agreed to in writing between Skin Analytics and the Partner from time to time;
8.1.5. it will ensure that all patients assessed by DERM receive a paper or digital copy of the DERM patient information leaflet. The latest copy of which can be found at https://skin-analytics.com/derm/patients.
8.1.6. It will ensure that all patients discharged by DERM with no review by a clinician receive a paper or digital copy of a discharge letter that has been approved by Skin Analytics.
8.1.7. it has full capacity and authority to enter into this Agreement and that it has or will obtain prior to the Commencement Date, any necessary licences, consents and permits required of it for the performance of the Services;
8.1.8. is shall ensure that Patients are provided with sufficient information such that they can give valid informed consent before receiving the services;
8.1.9. it shall appoint a senior stakeholder and project team to support the implementation of the Services at the Partner;
8.1.10. obtain all required internal permissions and approvals to implement the Services at the Partner; and
8.1.11. it shall co-operate with Skin Analytics in all matters relating to the Services.
8.2. Subject to the liability limits set out in clause 15.3, the Partner shall indemnify, keep indemnified and held harmless Skin Analytics against all costs, claims, losses and damages and expenses (including reasonable legal expenses) incurred by Skin Analytics arising out of, or in connection with, to the extent of:
8.2.1. any breach of Clause 8.1; and
8.2.2. any claim by a Patient and / or a third party and / or a regulatory body that the Partner did not comply with the provisions of Clause 8.1, provided always that Skin Analytics shall promptly give written notice of the claim to the Partner, specifying the nature of the claim in sufficient details.
9.1. As consideration for the provision of the Services in accordance with the terms of this Agreement, the Partner shall pay Skin Analytics the Product Fee set out in the Order Form.
9.2. In addition, the Partner shall pay Skin Analytics, the following fees for any additional services used:
| Additional Fee | Cost (subject to increase in accordance with Clause 9.5) |
| Any cases reviewed by a Clinician | £20 per case (VAT exempt) |
| Any additional hardware. Note that only approved hardware can be used with DERM, and will depend on choices made by the Partner | To be agreed between the Parties |
| Custom software development *Skin Analytics can contribute up to 50% of these development costs if features are reusable across multiple partners | £850 per person day +VAT* |
| Additional in-person training days | £850 per day +VAT |
9.3. Skin Analytics’ shall submit to the Partner within ten (10) Business Days:
9.3.1. of the Commencement Date and annually thereafter an invoice for the annual Product Fee; and
9.3.2. of the start of each calendar month, an invoice for the Additional Fees payable by the Partner for the preceding month.
9.4. The Partner shall pay the amount due in respect of each invoice not later than thirty (30) days following the date of receipt of such invoice. Any disputes in relation to invoices shall be resolved in accordance with Clause 19.
9.5. From the first anniversary of the Commencement Date and annually thereafter on not less than thirty days’ prior written notice, Skin Analytics shall be entitled to increase the Fees by a percentage equivalent to the increase in the Retail Price Index published by the UK Office of National Statistics or any successor index replacing it from time to time.
10.1. The Parties agree to exchange such information as is reasonably required for the effective operation of this Agreement.
10.2. The Partner acknowledges and agrees that, subject to consent on a patient by patient basis, or an alternative lawful basis as detailed in Schedule 2 (Data Processing Addendum), Skin Analytics shall be able to use the Patient Data and any Outcome Data provided for the purposes of improving the products and services provided to its existing and future clients and for research and development purposes.
10.3. Skin Analytics shall keep full and accurate accounting books and records in relation to its provision of the Services, such records being of sufficient detail to demonstrate and support the information provided to the Partner pursuant to Clause 10.1 above.
10.4. Nothing contained in this Clause 10 shall require either Party to disclose information or records where disclosure would place that Party in breach of Law concerning the dissemination of such information or records.
11.1. Each Party (Receiving Party) shall keep confidential and shall not disclose and shall procure that its employees, agents, subcontractors and officers keep confidential and do not disclose to any person other than a person authorised in writing by the other Party (Disclosing Party), except as is necessary in connection with this Agreement, any information acquired or received by the Receiving Party or otherwise as a result of this Agreement including:-
11.1.1. all relevant rules procedures and standards of the Disclosing Party;
11.1.2. the Patient Data; and
11.1.3. all information of whatever nature concerning the business or activities of Disclosing Party or the Patients.
11.2. The provisions of this Clause 11 shall survive expiry or earlier termination of this Agreement and shall at all times be subject to the provisions of the Public Interest Disclosure Act 1998.
Each Party undertakes to the other that it will comply with its obligations in Schedule 2 (Data Processing Addendum).
13.1. Skin Analytics shall at all times maintain such insurances as are necessary to cover the liability of Skin Analytics pursuant to this Agreement (the “Insurances”), including cover for:
13.2. the personal injury or death of any person under a contract of employment or service with Skin Analytics arising out of and in the course of such person’s employment or engagement;
13.2.1. Employers Liability: £10,000,000 any one occurrence
13.2.2. Public Liability: £5,000,000 any one occurrence
13.2.3. Combined Products & Professional Indemnity Liability – £5,000,000 any one claim and in the aggregate (£3,000,000 in respect of Professional Indemnity).
14.1. If by reason of a Force Majeure event, one Party’s performance of this Agreement or any obligation under it is prevented or interfered with, that Party (“the Affected Party“), upon giving prompt notice to the other Party, shall be excused from performance to the extent of the prevention, restriction or interference. The Affected Party shall use its best endeavours to avoid or remove such causes of non-performance and shall continue performance under this Agreement with the utmost despatch as soon as these causes are removed or diminished.
15.1. Nothing in this Agreement limits or excludes either Party’s liability for:
15.1.1. death or personal injury caused by its negligence;
15.1.2. fraud or fraudulent misrepresentation;
15.1.3. breach of the terms implied by section 2 of the Supply of Goods and Services Act 1982 (title and quiet possession); or
15.1.4. any other liability which cannot be limited or excluded by applicable law.
15.2. Neither Party shall be liable to the other, whether in contract, tort (including negligence), for breach of statutory duty, or otherwise, arising under or in connection with this Agreement for: (i) loss of profits (whether direct of indirect); (ii) loss of business opportunity (whether direct or indirect); (iii) loss of data (other than a loss of data resulting from a breach of either Party’s obligations under this Agreement) (whether direct or indirect), or (iv) any indirect or consequential loss.
15.3. Each Party’s total liability to the other, whether in contract, tort (including negligence), for breach of statutory duty, or otherwise, arising under or in connection with this Agreement in respect of each claim shall be limited to the total amount of Fees paid to Skin Analytics.
16.1. Either Party may terminate this Agreement with immediate effect by serving written notice on the other Party in any of the following circumstances:
16.1.1. the other Party commits a material breach of this Agreement which is not capable of remedy;
16.1.2. the other Party commits a material breach of this Agreement which is capable of remedy and such breach has not been remedied within a period of 30 days following written notice demanding remedy of the breach; or
16.1.3. the other Party becomes Insolvent, ceases to carry on its business or substantially the whole of its business or, referring to Skin Analytics, ceases to be capable of providing the Services.
16.2. Upon termination of this Agreement for any reason and without prejudice to any other rights or remedies any Party may have:
16.2.1. the Partner shall promptly pay any sums then outstanding and properly due to Skin Analytics;
16.2.2. Skin Analytics shall cease to accept any referrals and, subject to any appropriate arrangements made, Skin Analytics shall cease its provision of Services as soon as is practicable in accordance with Good Clinical Practice. For the avoidance of doubt, Skin Analytics will complete all outstanding instructions unless the termination is for breach of professional duty and best practice; and
16.2.3. the Partner shall deliver to Skin Analytics all materials, papers, documents and operating manuals owned or provided by Skin Analytics. For the avoidance of doubt, Skin Analytics may continue to use the Patient Data and Outcome Data following the termination of this Agreement in accordance with its privacy policy.
17.1. The Partner shall be permitted to use the Skin Analytics logo during the term of this Agreement for the purposes of this Agreement. Skin Analytics hereby grants a limited, non-exclusive, non-transferable, revocable, royalty free license to the Partner and its Personnel to use such of Skin Analytics’ Intellectual Property as necessary for the the Partner to perform its obligations under this Agreement for the duration of the Agreement only. The Partner shall use Skin Analytics’ trade marks, logos and ensure that its agents use the Platform, in accordance with any reasonable instructions given to them by Skin Analytics from time to time.
17.2. Skin Analytics shall be permitted to use the Partner’s logo during the Term of this Agreement for the purposes of this Agreement. The Partner hereby grants a limited, non-exclusive, non-transferable, revocable, royalty free license to Skin Analytics and its agents to use such of the Partner’s Intellectual Property, as necessary for Skin Analytics to perform its obligations under this Agreement for the duration of the Agreement. Skin Analytics shall use the Partner’s trade marks and logos in accordance with any reasonable instructions given to them by the Partner from time to time, and strictly in accordance with the brand use guidelines at all times.
17.3. Neither Skin Analytics nor the Partner will seek to register any of the other Party’s logos as a trade mark.
17.4. Neither Skin Analytics nor the Partner shall do or knowingly permit there to be done any act which may denigrate the value of, or diminish the distinctive nature or reputation of the other Party.
17.5. Each Party acknowledges and agrees that each Party’s Intellectual Property, including logo, shall at all times remain the property of that Party. This Agreement does not transfer or assign any Intellectual Property. To the extent that any new Intellectual Property is created in the course of Skin Analytics providing the Services, Skin Analytics shall be the sole owner of the new Intellectual Property.
17.6. Each Party undertakes to the other that it shall not:
17.6.1. damage the goodwill or reputation attaching to the other Party’s Intellectual Property;
17.6.2. register or seek to register or procure the registration of any Intellectual Property owned by the other Party or in any name or mark which is confusingly similar to the other Party’s brand; and
17.6.3. use any of the other Party’s Intellectual Property in any way that would allow them to become generic, to lose their distinctiveness, to mislead the public or otherwise be detrimental or inconsistent with the good name, goodwill, reputation or image of the other party.
17.7. Each Party acknowledges that any rights granted under this Agreement to use or exploit any of its Intellectual Property will terminate immediately upon the termination of this Agreement for any reason. All goodwill in respect of the Party’s Intellectual Property shall remain with that Party at all times.
17.8. Neither Party will use the other’s Intellectual Property except as expressly agreed between the Parties. All rights arising from the use of any pre-existing Intellectual Property of Skin Analytics shall be owned by Skin Analytics and all rights arising from the use of any pre-existing Intellectual Property of the Partner shall be owned by the Partner.
18.1. This Agreement is personal to the Partner and the Partner shall not assign, transfer, mortgage, charge, subcontract, delegate, declare a trust over or deal in any other manner with any of its rights under this Agreement.
18.2. Skin Analytics may at any time assign or transfer all its rights under this Agreement to any person to which it transfers all or substantially all its business.
19.1. If a dispute arises out of or in connection with this Agreement or the performance, validity, or enforceability of it, which cannot be settled amicably, the Parties will in the first instance refer the dispute to a senior management representative chosen by each Party.
19.2. If the Parties’ senior management representatives are unable to resolve the dispute within sixty (60) days, the Parties shall attempt to settle the dispute by reference to an independent mediator (“Mediator”) agreed by the Parties (or, failing agreement within five (5) Business Days of either Party first proposing a Mediator, such Mediator as may be appointed by the Centre for Effective Dispute Resolution (“CEDR”) upon the application of either Party). The Parties shall be jointly responsible for the costs associated with appointing a Mediator.
19.3. If Mediation fails to resolve the dispute then the courts of England and Wales shall have exclusive jurisdiction to resolve the dispute (including any non-contractual dispute or claim) and to hear and decide any suit action or proceedings relating to the dispute or claim and for these purposes each Party irrevocably submits to the exclusive jurisdiction of the courts of England and Wales.
At all times in connection with the Agreement, Skin Analytics shall be an independent contractor and nothing in the Agreement shall create a relationship of agency or partnership or a joint venture as between Skin Analytics or as between Skin Analytics and the Partner and accordingly no Party shall be authorised to bind any other Party.
A person who is not a Party to this Agreement shall have no rights pursuant to the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this Agreement.
If any provision of this Agreement is or becomes illegal, void or invalid this shall not affect the legality and validity of its other provisions.
The failure of a Party to seek redress for breaches or to insist on strict performance of any provision of this Agreement or the failure of a Party to exercise any right or remedy to which it is entitled under this Agreement shall not constitute a waiver thereof and shall not cause a diminution of the obligations under this Agreement.
Save as expressly set out herein no variation of this Agreement shall be valid unless it is in writing and signed by or on behalf of each of the Parties.
Neither the expiration nor the termination of this Agreement shall prejudice or affect any right of action or remedy which shall have accrued or shall thereafter accrue either to Skin Analytics or to the Partner.
26.1. This Agreement sets out the entire agreement and understanding of the Parties and supersedes any previous agreement made between the Parties relating to the subject matter of the Agreement.
26.2. No representations, warranties or undertakings, express or implied, written or oral, made by or on behalf of any Party to any other Party in connection with or arising out of the subject matter of the Agreement and which are not contained in this Agreement shall (save in the event of fraud) give rise to any liability on the part of the maker or makers of any such representations, warranties or undertakings.
26.3. Nothing in this Clause shall operate so as to limit or exclude any liability for fraud.
This Agreement may be executed in any number of counterparts, each of which shall be regarded as an original, but all of which together shall constitute one agreement binding on all of the Parties, notwithstanding that all of the Parties are not signatories to the same counterpart.
This Agreement (including any non-contractual dispute or claim arising out of it) shall be governed by and construed in accordance with English law. The courts of England shall have exclusive jurisdiction to settle any dispute or claim that arises out of or in connection with this Agreement or its subject matter or formation (including non-contractual disputes or claims).
Additional EU Terms
1. Medical Device Software
| “Importer” | means the importer of the Medical Device Software under the EU Medical Device Regulation that places the Medical Device Software in market. This shall be Advena Services Ltd. (Malta) or the successor importer as shall be appointed by Skin Analytics from time to time. |
1.1 The Parties agree that during the Term, Skin Analytics, as the manufacturer of the Medical Device Software, shall be solely responsible for: (i) ensuring that the Medical Device Software, and the provision of it under this Agreement complies with the EU Medical Device Regulation and any relevant Laws (ii) obtaining and maintaining the appropriate market certificates and submitting the same to the competent authorities (iii) providing required information leaflets about the Medical Device Software (including their translation to the official language of the country of the Partner) (iv) performing all post-marketing obligations of the medical device manufacturers. For the avoidance of doubt, the responsibilities of Skin Analytics include liaising with the competent authorities of the Partner’s country and application for relevant and appropriate market certificates in accordance with Laws applicable to deployments in the relevant jurisdiction.
1.2 Skin Analytics has engaged the Importer to import the Medical Device Software in Europe. Nothing in this Agreement causes the Partner to become a distributor or importer of the Medical Device Software.
The Partner will ensure that all patients assessed by DERM receive a paper or digital copy of the DERM patient information leaflet, as translated by Skin Analytics in accordance with this agreement to the official language of the Partner. The latest copy of which can be found at https://skin-analytics.com/derm-medical-device-resource-for-patients/ .
3.1 The parties acknowledge and agree that the reverse charge mechanism will apply. No UK VAT will be charged, and the Partner will be responsible for accounting for any VAT (or equivalent) due in its own country. The Partner shall provide a valid EU VAT registration number within ten (10) Business Days of the Commencement Date.
3.2 Additional in-person training days will be charged at £1,200 per day.
3.3 The Product Fee shall include up to 1 on-site training day.
Definitions
| “Additional EU Terms” | means the terms set out in the Appendix which, for the avoidance of doubt, only apply to Partners located in the EU; |
| “Business Day” | means any day which is not a Saturday, Sunday or public holiday in England; |
| “Clinician” | means a consultant dermatologist sub-contracted by Skin Analytics who holds a valid registration with the appropriate Governing Body for the type of service they provide to the Partner’s Patients; |
| “Clinician Review” | means where a Clinician may review a Patient’s case, as set out in more detail in the pathway in the Order Form; |
| “Commencement Date” | has the meaning given in the Order Form; |
| “Controller, processor, data subject, personal data, and personal data breach” | have the meaning provided in the Data Protection Legislation; |
| “Data Protection Legislation” | means the Laws relating to the processing (including use) of personal data and privacy in force from time to time that apply to a Party, including; the EU GDPR; the UK GDPR; the Data Protection Act 2018;the Privacy and Electronic Communications (EC Directive) Regulations 2003;any Laws which either implement or are made pursuant to the laws in (a) and (b); and any Laws that replace, extend, re-enact, consolidate or amend any of the foregoing, and any guidance, guidelines, codes of practice and codes of conduct issued by any relevant supervisory authority responsible for administering Data Protection Legislation, including the UK Information Commissioner (“Supervisory Authority”), relating to such Laws; |
| “Equipment” | means any equipment that Skin Analytics provides for use in the delivery of the Services (including the Medical Device Software); |
| “EU GDPR” | means the General Data Protection Regulation (EU) 2016/679; |
| “Fees” | means the fees set out in the Order Form (subject to any increase in accordance with Clause9.5); |
| “Force Majeure” | means the occurrence of any event beyond the reasonable control of the Party claiming to be subject to the Force Majeure event including acts of God, war, riot, civil commotion, epidemic, pandemic, extreme natural event, malicious damage, accident, breakdown of plant or machinery, fire, flood or storm, but not industrial action: |
| “Good Industry Practice” | means the exercise of that degree of skill, diligence, prudence and operating practice which would reasonably and ordinarily be expected from a skilled and experienced operator engaged in the same type of undertaking as that of Skin Analytics under the same or similar circumstances; |
| “Good Clinical Practice” | means using standards, practices, methods and procedures conforming to the Law and using that degree of skill and care, diligence and prudence which would reasonably and ordinarily be expected from a skilled, efficient and experienced person providing services the same as or similar to the Services at the time the Services are provided; |
| “Governing Body” | means one or more of the following, as the context requires: General Medical Councilor any successor or replacement bodies from time to time; |
| “Initial Term” “Insolvent” | has the meaning given in the Order Form; in respect of any Party: (a) a shareholders’ meeting is convened for the purpose of considering a resolution for winding up or a resolution for its winding up is passed (other than as part of, and exclusively for the purpose of, a bona fide reconstruction or amalgamation); or (b) that Party is, or is deemed for the purposes of any law to be, unable to pay its debts or insolvent; (c) that Party admits its inability to pay its debts as they fall due; (d) the value of that Party’s assets is less than its liabilities (taking into account contingent and prospective liabilities); (e) that Party suspends making payments on any of its debts or announces an intention to do so; (f) by reason of actual or anticipated financial difficulties, that Party commences negotiations with creditors generally with a view to rescheduling any of its indebtedness; (g) a moratorium is declared in respect of any of that Party’s indebtedness; (h) the suspension of payments, a moratorium of any indebtedness, winding-up, dissolution, administration, (whether out of court or otherwise) or reorganisation (by way of voluntary arrangement, scheme of arrangement or otherwise) of that Party; (i) a composition, assignment or arrangement with any creditor of any member of that Party; (j) the appointment of a liquidator, trustee in bankruptcy, judicial custodian, compulsory manager, receiver, administrative receiver, administrator or similar officer (in each case, whether out of court or otherwise) in respect of that Party or any of its assets; (k) a resolution of that Party or its directors is passed to petition or apply for that Party’s winding up or administration; (l) that Party’s directors giving written notice of their intention to appoint a liquidator, trustee in bankruptcy, judicial custodian, compulsory manager, receiver, administrative receiver, or administrator (whether out of court or otherwise); and (m) if that Party suffers any event analogous to the events set out in (a) to (l) of this definition in any jurisdiction in which it is incorporated or resident; |
| “Intellectual Property” | means any and all patents, trade marks, service marks, domain names, registered designs, utility models, applications for and the right to make applications for any of such rights, inventions, know-how, unregistered trade marks and service marks, trade and business names, including rights in any get-up or trade dress, copyrights, (including rights in computer software and in websites) unregistered design rights and other rights in designs and rights in databases, subsisting anywhere in the world; the right for the maker of a database to prevent extraction or reutilisation or both of the whole or a substantial part of the content of that database; rights under licences, consents, orders, statutes or otherwise in respect of any rights of the nature specified in this definition “Intellectual Property”; and rights of the same or similar effect or nature as or to those above in each case in any jurisdiction; |
| “Law” | means: (a) any applicable law, statute or proclamation or any delegated or subordinate legislation or regulation, including the Bribery Act 2010, as updated or amended from time to time; (b) any applicable judgment of a relevant court of law which is a binding precedent in England and Wales; and (c) any applicable code; in each case in force in England; |
| “Medical Device Software” | means any software that is regulated as a medical device which is made available to the Partner as part of the Services. For the purpose of this Agreement, “Medical Device Software” refers to Deep Ensemble for the Recognition of Malignancy (“DERM”); |
| “Outcome Data” | means the data provided to Skin Analytics by the Partner detailing the outcome of the diagnosis of Patients following the use of the Services; |
| “Patient” | means a person who is a customer or patient of the Partner and who has received or is to receive Services provided by Skin Analytics pursuant to this Agreement; |
| “Patient Data” “Personnel” | means all data in respect of Patients acquired and/or captured within the Platform by Skin Analytics in the course of performing the Services including the Patient’s date of birth, NHS or other hospital identifying number, gender and medical history relevant to skin cancer assessment (such as the location of particular moles for review, any changes to a Patient’s moles, as well as details of any past history of skin cancer, family history of skin cancer or previous sunbed usage); means, in relation to each Party respectively, its employees, contractors, and agents; |
| “Platform” | means Skin Analytics’ platform, as more particularly described in the Order Form and Schedule 3 (Service Level Agreement) which shall be used across the Service; |
| “Renewal Period” | means a period of the Renewal Period Length beginning on the expiry of the Initial Term or the immediately preceding Renewal Period; |
| “Renewal Period Length” | has the meaning given in the Order Form; |
| “Services” | means the services as described in the Order Form and Clause 3; |
| “Services Environment” | means each physical location from which the Partner provides the Skin Analytics Services; |
| “Service Levels” | means the service levels referred to in Schedule 3 (Service Level Agreement); |
| “Staff” | means any person engaged or employed by Skin Analytics in or about the provision of the Services; |
| “Term” | means the duration of this Agreement (being the Initial Term together with any subsequent Renewal Periods); and |
| “UK GDPR” | means the EU GDPR as it forms part of Retained EU Law (as defined in the European Union (Withdrawal) Act 2018), as amended from time to time) and as amended by the Data Protection, Privacy and Electronic Communications (Amendments etc) (EU Exit) Regulations 2019). |
1. The references to statutory provisions shall be construed as references to those provisions as subsequently amended, extended, re-enacted, incorporated, transposed, converted or consolidated (whether before or after the date of this Agreement) from time to time.
2. The headings are inserted for convenience only and shall not affect the construction of this Agreement.
3. Any words that follow ‘include’, ‘includes’, ‘including’, ‘in particular’ or any similar words and expressions shall be construed as illustrative only and shall not limit the sense of any word, phrase, term, definition or description preceding those words.
4. Words importing the singular number shall be deemed to include the plural number and vice versa.
For the purposes of this Schedule 2 the following terms shall have the following meanings:
|
Communication |
means a complaint, notice, request, enquiry or other communication (but excluding any Data Subject |
|
Controller |
has the meaning given to that term in Data Protection Legislation; |
|
Data Protection Supervisory Authority |
means any local, national or multinational agency, department, official, parliament, public or statutory person or any government or professional body, regulatory or supervisory authority, board or other body responsible for administering Data Protection Legislation Protection Legislation; |
|
Data Subject |
has the meaning given to that term in Data Protection Legislation; |
|
Data Subject Request |
means a request made by a Data Subject to exercise any right(s) of Data Subject Subjects under Data Protection Legislation in relation to any of the Shared Personal Data or concerning the Processing of such data; |
|
Independent Controller |
means, in respect of the relevant Processing of Personal Data, a situation in which a party is Controller but does not jointly determine the purposes and means of such Processing with the other party; |
|
Permitted Purpose |
the purposes set out in Annex A to this Schedule 2; |
|
Personal Data |
has the meaning given to that term in Data Protection Legislation; |
|
Personal Data Breach |
means any breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, any Shared Personal Data; |
|
Processing |
means, in respect of any information or data, any operation or set of operations which is performed on such information or data or on sets of such information or data, whether or not by automated means, including collection, recording, organisation, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction (and related terms such as Process, Processes and Processed have corresponding meanings); |
|
Processor |
has the meaning given to that term in Data Protection Laws; |
|
Shared Personal Data |
means Patient Data and Outcome Data; and |
|
Special Category Personal Data |
means special categories of Personal Data as referred to in Data Protection Legislation. |
1. BACKGROUND
1.1 The Parties acknowledge and agree that in relation to their obligations under this Agreement, in respect to transferring Shared Personal Data, they shall each act as Independent Controllers.
1.2 It is not envisaged that either Party will act as the Processor on behalf of the other Party. In the event that Personal Data are Processed by one Party on behalf of the other Party, the Parties shall enter into a separate data processing agreement setting out each Party’s respective obligations.
2.1 Each Party shall share the Shared Personal Data with the other in accordance with this Agreement.
2.2 Each Party shall comply with all Data Protection Legislation in connection with the Processing of Personal Data under or in connection with this Agreement.
2.3 This Schedule 2 allocates certain rights and responsibilities among the Parties as enforceable contractual obligations between themselves, however nothing in the Agreement or this Schedule is intended to limit or exclude either Party’s responsibilities or liabilities under Data Protection Legislation.
2.4 Each Party shall use its reasonable endeavours to assist the other to comply with any obligations under applicable Data Protection Legislation.
3.1 Each Party shall provide the Shared Personal Data in accordance with this Agreement. Such data shall be provided via use of the Platform and via other means as agreed between the Parties in writing.
4.1 The Partner shall ensure that:
4.2 The Partner shall ensure that each Patient is provided with such fair processing notice of Skin Analytics as may be provided by Skin Analytics from time to time prior to the collection of Patient Data and Outcome Data.
4.1.1 the Shared Personal Data has been collected, Processed and transferred by and on behalf of the Partner in accordance with the Data Protection Legislation as applicable to that Shared Personal Data; and
4.1.2 each Data Subject has been provided with sufficient information (including all information to be provided under Articles 5(1)(a), 13 and 14 of the UK GDPR and (if applicable) the EU GDPR so as to enable fair and lawful Processing of the Shared Personal Data as necessary to permit the sharing of the Personal Data with Skin Analytics for the Permitted Purposes.
5.1 The Partner shall, to the extent that Consent is necessary for the Permitted Purpose:
5.1.1 obtain the Consent of all Data Subjects of the Shared Personal Data required for the transfers and Processing of that Shared Personal Data undertaken by both Parties in connection with this Agreement and for each Party to lawfully Process such data for the Permitted Purpose;
5.1.2 ensure that each of the Consents referred to in paragraph 5.1.1 have been obtained and recorded accurately, and evidence of such Consents, and the applicable privacy notice and fair Processing information, shall be provided to Skin Analytics as part of the Shared Personal Data and as requested by Skin Analytics from time to time;
5.1.3 if, prior to the relevant Shared Personal Data being shared with Skin Analytics a Data Subject has withdrawn any Consent referred to in paragraph 5.1.1 then their Personal Data has not been included in the Shared Personal Data subsequently shared by the Partner; and
5.1.4 it shall promptly notify Skin Analytics if it becomes aware that any such Consent referred to in paragraph 5.1.1 is withdrawn
6.1 Where the Shared Personal Data includes data that has been received by the Partner from a third party, or has been Processed by a third party on behalf of the Partner, the Partner shall ensure that it has in place arrangements with those third parties that are adequate to permit the Partner to lawfully share the Shared Personal Data with Skin Analytics, and for Skin Analytics to lawfully Process such data for the Permitted Purpose.
7. FURTHER OBLIGATIONS
7.1 Each Party warrants that it shall Process the Shared Personal Data solely for the Permitted Purposes (except to the extent otherwise required by Law).
8.1 Each Party shall not transfer the Shared Personal Data to any country or territory outside the United Kingdom (or, where the Partner is located in the EU only, the EEA or any country deemed to provide adequate protection for personal data by the European Commission) without the other Party’s prior written consent except to the required by applicable Law.
9.1 Each Party shall at all times ensure that it has appropriate technical and organisational measures in place in connection with the Shared Personal Data: (i) as required by Data Protection Legislation; and (ii) to mitigate against accidental loss or destruction of, or damage or alteration to, such Shared Personal Data.
10.1 If a Personal Data Breach occurs in relation to the Shared Personal Data Processed by either Party, the Party suffering the Personal Data Breach shall notify the other Party of the Personal Data Breach without undue delay on becoming aware of it and provide such information as the other Party reasonably requires in relation to the Personal Data Breach.
11.1 Each Party shall respond to Data Subject Requests and Communications received by it concerning the Processing of the Shared Personal Data promptly and within the timeframes required by Applicable Laws.
11.2 Each Party shall provide any information and/or assistance as reasonably requested by the other Party to help the other Party respond to any Data Subject Request or Communication.
permitted purposes
| Description | Details |
| Permitted Purpose |
In this Agreement, Permitted Purpose means: Use of the Shared Personal Data in the case of the Partner to make referrals and diagnoses in respect of Patients, to manage claims made by Patients, to comply with legal obligations, for the exercise, defence or establishment of legal claims, and such other purposes as may be agreed between the Parties in writing from time to time. Use of Shared Personal Data in the case of Skin Analytics for the provision of Services, diagnosis, improving products and services provided to existing and future clients, for product development purposes, for adverse event reporting, to comply with legal obligations, for teaching purposes and for the exercise, defence or establishment of legal claims, and such other purposes as may be agreed between the Parties in writing from time to time. |
Uptime and maintenance
Uptime
The Platform shall have 99.9% uptime (excluding maintenance) on a six monthly basis subject to standard service levels of Amazon Web Services being available.
Regular Maintenance windows
Every evening, 7PM to 10PM London Time is defined as a regular maintenance window, where Skin Analytics may conduct maintenance to the Platform and infrastructure without prior notice, as long as downtime does not exceed two (2) hours during this window.
Scheduled Maintenance
Skin Analytics may conduct up to eight (8) hours per calendar month of scheduled maintenance for purposes of performing maintenance on the Platform, or installing upgrades, fixes or reconfigurations (“Scheduled Down Time”). Skin Analytics will inform the Partner of any Scheduled Maintenance by providing at least two (2) Working Days’ notice. Skin Analytics will use best endeavours to ensure the Scheduled Maintenance will occur within the Regular Maintenance windows and is not scheduled within the Partner trading hours, unless otherwise agreed, taken to be 7AM to 7PM.
Emergency Maintenance
Skin Analytics may conduct emergency maintenance with no prior notice in order to resolve severe security or safety issues or other emergency issues. Skin Analytics will use best endeavours to notify Clients at the beginning and end of such maintenance.
Updates
Notice for software updates
Where Skin Analytics are making upgrades or reconfigurations to the service that impact on the Partner users, Skin Analytics will use best endeavours to provide the Partner with two weeks’ notice before the changes are implemented where the Partner can review the details of the planned changes and preview these changes. This requirement does not apply to upgrades or reconfigurations that do not impact on the Partner users or fixes to existing functionality provided that they take place within Regular Maintenance windows.
Requirement to use latest version of DERM
In order to ensure DERM performance SLAs are met, the Partner is required to use the latest available version of DERM upon request from Skin Analytics.
DERM performance SLAs
DERM must be used in accordance with the Instructions for Use. Full details of the Instructions for Use for DERM can be found at https://skin-analytics.com/derm-medical-device-resources-for-healthcare-organisations/.
Minimum sensitivity settings are found in the Instructions for Use, but are copied below. DERM will be configured to identify the following lesion types.
| Suspected Diagnosis | Minimum Pathway Sensitivity[1] |
| Melanoma | 95% |
| Squamous Cell Carcinoma | 95% |
| Basal Cell Carcinoma | 90% |
| Bowen’s disease / Intraepidermal Carcinoma (IEC) | 90% |
| Actinic Keratosis | 90% |
| Atypical Nevus | n/a |
Clinical Performance
If anyone at the Partner becomes concerned about the performance of DERM against expected performance, they should contact Skin Analytics’ help desk or point of contact so that it can be investigated. You can also report any adverse events to the MHRA using the yellow card scheme: https://yellowcard.mhra.gov.uk/
[1] i.e. percentage of true positive cases of each disease type that will be referred on the agreed pathway for that disease type, or a more urgent pathway.
