OMED Health – Terms and Conditions

OMED Health® is the registered brand for a patient-centric digital platform that offers breath-based devices and supporting resources, currently focused on digestive disease and gut health, performed within Owlstone Medical to patients in England, Wales and Scotland. While the name OMED Health is used throughout these Terms, all rights and obligations pertaining to OMED Health under these terms and conditions are those of Owlstone Medical.

Further information about OMED Health, its products and services is available via https://omedhealth.com/. Alternatively, you can:
• email the Customer Support Team at support@omedhealth.com
• submit the Contact Us form https://omedhealth.com/contact-us.

Owlstone Medical Limited is a private limited company registered in England and Wales (company number 04955647) with its registered office and main trading address at 183 Cambridge Science Park, Milton Road, Cambridge, United Kingdom, CB4 0GJ. Our VAT number is GB260449214.

Owlstone Medical Limited is registered with the Care Quality Commission (CQC). Further CQC details are available via the CQC website: https://www.cqc.org.uk/provider/1-20629696230. The Company is also a registered Food Business Operator with the South Cambridgeshire District Council.

App: means the OMED Health mobile application software designed for connecting to the Breath Analyzer and recording and storing Test Data. It is available to download free of charge from the Apple Store (for Apple smartphones), or Google Play Store (for Android smartphones) and pair with the Breath Analyzer.

App Services: means facilitation of the App, including but not limited to the registration and secure running of the Patient’s user account necessary for the recording, viewing, editing and storing of all Test Data. Essential maintenance includes troubleshooting and other technical and Customer/Patient support services relating to the use of the App.

Breath Analyzer: means the UKCA marked OMED Health® Breath Analyzer, a hand-held electronic battery-operated medical device (General IVD compliant with Part IV of the UK Medical Devices Regulations 2002) when it connects to the App to measure constituents of exhaled breath as an aid in the diagnosis of gastrointestinal conditions.

Business Day: means Monday to Friday, 9am to 5pm (excluding Bank Holidays) in England, UK. Orders and other communications received after 5pm on a Friday, may not be responded to until Monday (or Tuesday, if the Monday is a Bank Holiday).

Company: means Owlstone Medical Limited, a private limited company registered in England and Wales (company number 04955647) with its registered office and main trading address at 183 Cambridge Science Park, Milton Road, Cambridge, United Kingdom, CB4 0GJ. VAT number is GB260449214. Owlstone Medical includes its patient-centric brand OMED Health®, under which Healthcare Services are performed and regulated by the Care Quality Commission.

Contract: means a purchase made by the Customer (for or on behalf of Patients), or by Research Customer for use with Participants, when confirmed in writing by the Company.

Customer: means an organisation that agree to make regular patient referrals to the Company for the provision of Healthcare Services, as confirmed in writing by OMED Health.

Eligibility Conditions: means the Medical Declaration, being at least 18 years of age, resident in Great Britain (England, Scotland, Wales); having reliable access to a smartphone device (Apple or Android) and internet connection, ability to download the App on to the smartphone, creation of a user account, and the ability to use and breathe unaided through the Breath Analyzer in order to provide breath samples.

Getting Started Guide: means an OMED Health instructions manual accompanying the Research Product which sets out important manufacturer’s information covering certain regulatory, health & safety, battery care and other information for the benefit of its end-users.

Healthcare Services: means the provision of the Test by the Company for the benefit of Patients, or such other medical services as the Company may agree in writing from time to time with its Customers.

Instructions for Use: means an OMED Health instructions manual accompanying the Breath Analyzer which sets out important manufacturer’s information covering certain regulatory, health & safety, battery care and other information for the benefit of its end-users.

Medical Declaration: means a signed current statement by the Patient provided to the Customer confirming (i) Patient’s acknowledgment and understanding that the Test is not a substitute for medical assessment of potentially serious conditions, and (ii) that said Patient has not suffered any of the following symptoms: unexplained or unintentional weight loss in the three months leading up to the Test; new blood in the stool; black, tarry stools (melaena); persistent change in bowel habits (such as new or worsening diarrhoea or constipation, particularly if lasting more than 6 weeks); difficulty swallowing or persistent pain when swallowing; persistent vomiting without clear cause; severe or worsening abdominal pain; a lump or swelling in the abdomen; unexplained fatigue or night sweats.

Patient: means a new or existing registered patient of the Customer who satisfies the Eligibility Conditions as part of the Customer’s referral of that Patient to the Company for the Test.

Research Customer: means any organisation or an entity, whether commercial or non-commercial, that purchases Research Products for use in a clinical trial or a research study.

Research Data: means the data recorded or generated by the Research Product for Research Customers.

Research Product: means the consumer version of the OMED Health Breath Analyzer and research version of the App, together intended for general consumer or research use without any medical diagnosis.

Research Services: means making a pre-agreed number of the Research Products available to Research Customers subject to these Terms.

Results: means the output generated by the Test, together with the Test Data and any diagnosis.

Test: means the OMED Health SIBO Test comprising up to 12 weeks’ use of the Breath Analyzer and one (1) sachet/dose of lactulose or glucose, unless agreed otherwise with Customers.

Test Data: means information provided or recorded by the Patient as part of the Test performance (e.g. hydrogen and methane measurements, food diary, symptoms).

• The Company will perform Healthcare Services on Customer request in accordance with applicable professional standards and reasonable skill and care of the Company’s medical staff. For the purposes of these Terms, treatment plans, medical prescriptions or any other services other than the provision of the Results are excluded in connection with the Test, unless agreed otherwise in writing.
• The Company reserves the right to amend certain features or specifications of the Breath Analyzer and/or the App, as well as its Healthcare Services, if necessary to comply with any applicable law or regulatory requirement, and in any event if the amendment will not materially affect the nature or quality of the objectives intended under the Contract.
• The Company will notify the Customer (and the Patients, where applicable) in the event of any material changes in how Healthcare Services are delivered or relevant deliverables to Customer and/or Patients.
• The Company may decline, suspend, delay or terminate the performance of Healthcare Services, in part or in full, in the event of any safety, regulatory or operational concerns, or where the Patient does not meet the Eligibility Conditions, it has not received accurate or adequate information about the Patient, or their medical condition that might deem the Test unsuitable, or if any other essential information has been withheld from the Company.

The Customer shall be responsible for and/or must ensure that:

• it provides accurate and truthful information to the Company at all times, including any material updates;
• it has placed a valid order for the purchase of the Test using the link provided by the Company, including a payment, and provided accurate information with the Patient’s name and delivery address where the Breath Analyzer should be shipped to;
• it refers to the Company only those Patients who meet all Eligibility Conditions;
• it takes reasonable steps to ensure validity of the Medical Disclaimer;
• on a timely basis, it makes available to the Patient adequate information about the Test and the Patient’s responsibilities, and that it draws all important information relating to the Test (including any re-tests) and the Company as the Test provider to the attention of the Patient by all reasonable means;
• it ensures timely notification of all relevant privacy notices to Patients and obtains any necessary consents from Patients to enable any data sharing with the Company;
• it correctly interprets the Results and any diagnosis when informing its decision about the Patient’s treatment and any follow-on care, or it will advise the Patient and the Company if it is not licensed or regulated to diagnose, treat or prescribe medicinal products;
• if additional lactulose or glucose is required for the Test, this be purchased exclusively from the Company, as purchasing from any other parties will invalidate the Results and any diagnosis;
• when prompted, it enters into a Data Sharing Agreement with the Company as a condition to being granted access to the Test Data and Results via the Patient’s App user account;
• it informs the Company without delay if and as soon as it becomes aware of any safety concerns or data incidents (or any breach) in connection with the Patients’ use of the Breath Analyzer, the App, and/or the Test;
• where applicable, only promote the Test as permitted by these Terms and within the scope of any further agreed guidelines or instructions provided by the Company from time to time, in particular ensuring compliance with any advertising laws and standards, competition law and consumer protection regulations.

Unless expressly agreed otherwise in writing, the Company provides diagnostic testing only, which excludes treatment, prescription of medication (except as set out in section 5.2) or any ongoing care.

The Results should always be considered by the Customer together with any additional symptoms, medical history and other investigations which might not be known to the Company.

The Results may be affected by the Patient’s use of the various components and requirements of the Test, such as improper following of instructions, poor quality or inconsistency of breath sampling, timing and other factors. Neither the Company nor its doctors are able to guarantee 100% accuracy of the Test at all times.

By accepting these Terms, each Research Customer acknowledges and agrees as follows:

• Research Customer may purchase a pre-agreed number of the Research Product by placing a purchase order.
• Research Services are limited to the provision of the research version of the App, assistance with the Participant account set-up, storage of all relevant data input provided by the Participants on the instructions of the Research Customer, and the generation of a report upon completion of the study or clinical trial.
• The Company accepts no responsibility for Participant recruitment or obtaining their consents, for any action, inaction or omission relating to or concerning any study approvals, licenses or associated documentation.
• Research Customer shall ensure that all relevant information received from the Company relating to or concerning the use, application, availability, outcomes, risks/benefits of the Research Product and Research Services, as well as the role of the Company in the clinical trial or research study is communicated to the Participants and other concerned parties accurately and in a transparent manner. Research Customer shall take all steps necessary to ensure that each Participant is familiar with how to use the Research Product in a safe and responsible manner and in a manner that achieves the Research Customer’s objectives in relation to the research in question. This may involve translations of essential information into Participant’s local language.
• Research Customer must be available to attend any training provided by the Company and/or follow any instructions provided, and it may only use the Research Product within the permitted scope of these Terms, including the scope of any regulatory permissions or restrictions known to it (and not authorise any other party to do otherwise).
• Research Customer must advise the Company without delay of any reported health or safety concerns or adverse events relating to or concerning the Research Product in the course of the trial or study in question.

If you have agreed to take part in a clinical trial or a research study run by a Research Customer (not Owlstone Medical / OMED Health), which involves the use of our Research Product, you should know that:

1. the Research Product is supplied by the Company, but you should receive all relevant information from the organisation sponsoring the clinical trial or study, and the best point of contact at that organisation to answer your questions;
2. Owlstone Medical and OMED Health merely act as the Research Product supplier and have no direct contact with the Participants; therefore any concerns, difficulties or technical issues relating to any aspect of the Research Product should be all addressed to sponsor of the particular trial or study who will in turn contact us for assistance, if necessary;
3. the version of the App which we make available in research will not generate any medical or diagnostic information, or suggest any treatment for any medical conditions you might suffer from;
4. your trial sponsor should make arrangements for the return of any hardware as the Company does not accept any responsibility for the ongoing use of the Research Product after Research Services have been completed.

If you are a Patient being referred to us for SIBO Test, we rely on the person referring you or you, to provide us with certain information, and therefore it is your responsibility to ensure that you:

• provide accurate details to the person referring you for the Test (e.g. name and delivery address);
• confirm the Medical Disclaimer honestly and truthfully;
• ensure you satisfy all Eligibility Conditions prior to agreeing to the Test;
• notify us without delay by emailing support@omedhealth.com if any items within your delivery are damaged, there is something missing, or if the delivery is taking longer than expected (such as longer than 7 days);
• read and follow the Instructions for Use booklet, a copy of which can be found inside the Breath Analyzer packaging;
• follow all our instructions sent to you via email for the use of the Breath Analyzer, creating the App user account, recording the Test Data, accessing your Results and for the return of the Breath Analyzer at the end of the Test.

In certain limited circumstances on a Customer’s request, such as due to the Customer not having the regulatory scope to prescribe antibiotics, the Company can provide treatment for the Patient in the form of antibiotics, in response to a positive Test result. Where applicable, the Company will communicate with the Patients concerned directly to make necessary arrangements. Consultation charges apply and will be set out in writing.

Cancelling your consultation appointment. If you need to cancel your video appointment, you should provide as much notice as possible. The option and link to cancel is available in your original email booking confirmation. Any cancellations with less than 24 hours’ notice of your scheduled appointment are not refundable. To make a new appointment following a cancellation, please contact support@omedhealth.com for further assistance.

Each time a Customer or Research Customer places an order with the Company and receives a written confirmation of that order from the Company, a contract is formed between the Company and the Customer or Research Customer, as the case may be. These Terms shall apply to each purchase and explicitly exclude any other standard terms and conditions, whether implied or otherwise, unless specifically agreed to in writing and signed by both parties. All orders are confirmed by an email from OMED Health which sets out important next steps and provides information about when delivery of the order can be expected.

The Company is not responsible for any actions or omissions, including non-payments between the Customer and Patient.

The Company is currently able to provide Healthcare Services for individuals resident in England, Wales and Scotland due to the regulatory scope of its products and services. The connected App may not be available in all regions, or may only be available for limited use in research.

Please contact support@omedhealth.com for further information.

The Company reserves the right to make necessary changes to its products and services if and when required to reflect changes in relevant laws and regulatory requirements, to make minor technical adjustments and improvements, for example to address a security threat, or to update the App digital content as a result of which end-user might be asked to install relevant updates.

The majority of any such changes should not affect access to or the use of the Healthcare Services or Research Services, however should any changes cause a significant disruption or adversely impact the quality or standard of any services provided, or the user experience, the Company will notify those concerned in advance.

All Customer prices include the cost of goods (or rental) and standard shipping cost.

Research Customer prices exclude shipping costs, any duties, customs, local taxes or otherwise.

The cost of all returns is excluded from the price, except where a pre-paid returns packaging has been provided or the return has been accepted by the Company (in writing) as return of faulty or damaged goods.

Prices shown or quoted are exclusive of VAT which will be added at the current rate, if/where applicable. Any increases in VAT will be passed on to relevant customers.

Payment of our invoices. Any invoices must be paid within 14 days of the date stated on the invoice. Late payments of invoices will incur a charge as set by the statute from time to time.

Shipping (GB). The Company aims to process each order and ensure timely dispatch promptly, however delivery times are outside of our control. When possible, orders placed before 1 pm on a Business Day will be shipped on the same day, or on the earliest next Business Day. The Company aims to select the most appropriate shipping service based on the size, weight, and destination to ensure efficient and cost-effective delivery.

Delivery (GB). Delivery times may vary, but please let us know if you have not received your order within 5 Business Days of receiving our email confirmation. Please allow extra time during exceptionally busy periods such as between 15 December and 6 January. Delivery is considered to be complete when the goods are unloaded at the address provided to us. We accept no responsibility for any goods left outside your door, residential address or business premises, if there is no one available to accept them.

Returns at the end of the Test. If you have completed the Test, please return the Breath Analyzer promptly using the pre-paid return packaging provided on delivery and send it back to us. We reserve the right to charge a fee up of up to the full value of the Breath Analyzer for any unreturned devices.

Address for returns. Returns should be sent to the address below (with the RMA number provided, in case of warranty claims).
FAO: OMED Health Customer Support
Owlstone Medical Limited
183 Cambridge Science Park
Milton Road
Cambridge CB4 0GJ
United Kingdom

Shipping. In the absence of any written agreement to the contrary, the Company will ship to an agreed delivery business location (DAP, Incoterms® 2020) specified on the Research Customer’s purchase order. International deliveries can take 3 – 5 Business Days. The Company will use reasonable commercial efforts to meet any agreed delivery timeframes, however these are approximate only and not within the Company’s control.

Delivery by instalments. The Company may effect delivery in one or more instalments. Any delay in delivery or defect in an instalment shall not entitle the Research Customer to cancel any other instalment.

Title and risk. The legal and equitable ownership of any consignment of goods (excluding any intellectual property or rights vested therein) shall remain vested solely in the Company until payment in full of all amounts due in respect of the Research Customer’s order and any previous orders have been received by the Company. All goods within each delivery shall be at the Research Customer’s own risk in accordance with DAP, Incoterms 2020. Accordingly, the Research Customer shall be responsible for obtaining and maintaining adequate insurance cover.

Licenses and permissions. The Research Customer shall be responsible for obtaining, at its own cost, such permissions, licenses and other relevant consents in relation to its own use of the Research Products, as may be necessary by applicable law.

Each Contract becomes effective on the date of the Company’s confirmation of order placement or purchase and shall continue, subject to earlier termination, as follows:

• Contract with Customer: for as long as the Customer continues to refer Patients to the Company, and the duration of the Test up until the Company’s receipt of the returned Breath Analyzer from the Patient;
• Contract with Research Customer: for the duration of the clinical trial or research study concluding with the transfer of Research Data to the Research Customer;
• Contract with Patient (where applicable): limited to the video appointment in connection with positive Results, which Contract will conclude at the end of the appointment and payment receipt.

Without prejudice to any other rights that may exist or be available to a party, any party to which these Terms apply may also terminate the Contract prior to its expiry or natural conclusion, on a written notice to the other party in the event of any material breach by a party (including non-payment, breach of applicable laws, regulations or professional standards such as those within the medical industry, failure to obtain or the loss of any consents, regulatory licences or approvals), safety concerns to Patients or Participants.

The Company warrants that on delivery and for a period of 12 months from delivery, the Breath Analyzer shall: (a) conform in all material respects with its description; (b) be free from material defects in design, material and workmanship; (c) be of satisfactory quality; and (d) be fit for any purpose held out by the Company. The Company will endeavour to replace or repair defective devices, provided that (a) it has received a written notification of any warranty claim within reasonable time of discovery; and (b) the Company has had a reasonable opportunity to examine the issue.

Examples of a faulty Breath Analyzer might include: unexplained battery degradation (e.g. you are prompted to recharge the Breath Analyzer after only one breath sample or before you take any breath sample), sensor failures, haptic no longer vibrating.

Mobile App. The App is provided and made available to all end-users strictly subject to either the Apple or Google End-user License Agreement, as applicable (which must be accepted as part of downloading the App) depending on whether the end-user has an Apple or Android smartphone. The data recorded and stored on the App is processed as set out in the Mobile App Privacy Policy which each end-user is required to accept when downloading the App. While the Company takes steps and precautions to ensure service levels and protections that should be expected of similar service providers, it does not guarantee that the use of the App will be uninterrupted or entirely error-free; or that the App software will be free from bugs or vulnerabilities; the Company might also not be able to prevent any delays, delivery failures, or any other loss or damage resulting from the transfer of data over third party communications networks and facilities, including the internet, and each of the Customer, Research Customer, Patient and Participant acknowledges that the App services may be subject to limitations, delays and other problems inherent in the use of such communications facilities.

Please report any issues without delay with as much detail, including photos if possible, to our Customer Services team at support@omedhealth.com.

Company compliance. The Company shall comply with applicable healthcare and professional standards and requirements relating to the provision of Healthcare Services by its employees and any medical professionals, as well as regulatory standards and requirements relating to its products. As such, the Company maintains appropriate registrations, certifications and insurance.

Customer compliance. Customer shall comply with applicable regulatory, professional and (where and to the extent applicable) healthcare standards and requirements, having regard to its business activities. Accordingly, Customer maintains appropriate registrations, certifications and insurance.

Research Customer compliance. Research Customer shall comply with applicable laws and regulations relating to or concerning the conduct of clinical trials or any research activities which involve the use of Research Products by Participants. Accordingly, Research Customer maintains appropriate registrations, certifications, licenses, approvals as well as adequate insurance covering its research activities.

Duty to notify. Customer and Research Customer must inform the Company without delay if and immediately on becoming aware of any safety concerns relating to the Breath Analyzer and/or the App.

Company’s recall. The Company may issue a notice to recall or withdraw any of its products from the market (Voluntary Recall Notice): (a) if the supply or use of such products infringes, or may infringe, a third party’s intellectual property rights; (b) if the products are, or may be, unsafe; (c) if the products are, may be, or may become illegal or non-compliant with any law, regulation or industry standard; or (d) if a defect in the product may cause harm to the Company’s reputation or brand.

Responding to recall request. If a Customer or Research Customer becomes aware of or is the subject of a request, court order or other directive of a governmental or regulatory authority to withdraw Company’s products from the market (Recall Notice), it must immediately notify the Company in writing and attach a copy of the Recall Notice.

Assistance with recall. Customer/Research Customer must give such assistance to the Company as the Company reasonably requires to recall or withdraw the products in question from the market, and comply with the Company’s instructions about the process of implementing that recall or withdrawal.

Duty to keep records. Research Customers providing Breath Analyzers to Participants during for the purposes of their research must maintain appropriate, up-to-date and accurate records of all devices so distributed in order to enable immediate recall of any devices. Such records must include records of deliveries to customers (including batch numbers, delivery date, name and address of addressee, telephone number and email address).

Acknowledgment. Each user of the Breath Analyzer and/the App hereby acknowledges and accepts that all information, in any form or nature, tangible or intangible, including any intellectual property and rights therein, not limited to know-how, trade secrets, technical or analytical information that subsist in or is concerning the Breath Analyzer, the App and/or associated products, services, documents, data and other information constitutes proprietary information of the Company and it might be confidential (“Proprietary Information”) whether or not such information is marked as confidential or Proprietary Information. The Proprietary Information includes commercially valuable information, the design and development of which reflect the effort of skilled development experts and investment of considerable amounts of time and money. Any reputation in any trademarks affixed or applied to the Breath Analyzer and/or the App shall accrue to the sole benefit of the Company or any other owner of the trademarks from time to time.

Protection of trademarks. Unless agreed otherwise in writing, no individual or organisation is permitted to repackage any of the Company’s products and/or remove any labelling, logos, trademarks, copyright notices, confidential or proprietary legends or identification from them. No individual or organisation is permitted to use (other than pursuant to these Terms) or seek to register any trademark or trade name (including any company name) which is identical to, confusingly similar to or incorporates any trademark or trade name which the Company (or its affiliates) owns or claims rights in anywhere in the world.

Limited license for use. Research Customer, Participant and Patient is hereby granted a limited non-exclusive, non-transferable, royalty-free licence to the extent necessary to use the Breath Analyzer for the purpose for which it has been purchased (or rented) pursuant to these Terms.

Notification of infringement. Each Customer and Research Customer must notify the Company in writing if it becomes aware of: any infringement or alleged infringement by any third party of the rights in any intellectual property contained in or relating to the Company’s products or services; or any allegation by any third party that the sale, use or exploitation of the Company’s products or services infringes any intellectual property rights of any third party; and subsequently provide the Company with such detailed information concerning the same as is available to it and extend such co-operation as the Company may reasonably request (at its expense) in countering it.

Irreparable damage. Each user of the Company’s products and/or services hereby acknowledges that any use or threatened use of the Company’s products or services in a manner inconsistent with these Terms or other misuse of the Proprietary Information is likely to cause immediate irreparable harm to the Company for which there is no adequate remedy of law. Accordingly, the Company shall be entitled to immediate and permanent injunctive relief from a court of competent jurisdiction in the event of any such breach.

Reverse Engineering and Decompilation. No individual or organisation is permitted to modify, disassemble, reverse engineer, analyse, or decompile any part of the Company’s products or services.

Each party to the Contract undertakes that it shall not at any time during the Contract and for a period of five (5) years after termination or expiry of the Contract, disclose to any person any confidential information concerning the Proprietary Information or other intellectual property of the other party, business, affairs, customers, clients or suppliers of the other party, except that each party may disclose the other party’s confidential information: (a) to its employees, officers, representatives, contractors, subcontractors or advisers who need to know such information for the purposes of exercising the party’s rights or carrying out its obligations under the contract. Each party shall ensure that its employees, officers, representatives, contractors, subcontractors or advisers to whom it discloses the other party’s confidential information comply with this section 6.12; and (b) as may be required by law, a court of competent jurisdiction or any governmental or regulatory authority. Neither party shall use the other party’s confidential information for any purpose other than to exercise its rights and perform its obligations under or in connection with the Contract.

For information about how the Company may use personal data collected by OMED Health when someone interacts with the OMED Health website, please see OMED website Privacy Notice.

For information about how the Company may use personal (including health) data collected by OMED Health through the App, please read the Mobile App Privacy Notice available through the App.

Our privacy notices also contain information on how to complain about the Company’s use of personal data, handling of any requests for personal information or an individual’s data protection rights.

Acknowledgment by Customers and Research Customers. Each Customer and Research Customer acknowledges and accepts that the Company will process personal data of Patients and Participants in the following capacity, subject to specific circumstances:
Company as a controller. Where the Company/OMED Health collects and processes personal data of Patients while performing Healthcare Services, the Company acts as the controller in relation to such data due to its regulatory responsibilities and obligations. The Company relies on each Patient reading and accepting the Mobile App Privacy Policy presented upon downloading the App.

Sharing data with Customers. The Company accepts that Customers might require direct access to the Results via the Patient’s App. Such access can be facilitated but will only be provided strictly subject to the Data Sharing Agreement between the Company and the Customer in question, and the Patient’s consent.

Company as a processor. Where the Company/OMED Health facilitates the Research Product for use with Participants as part of research, following the Research Customer’s instructions, the Company is considered a processor in relation to any identifiable or pseudonymised data relating to the Participants. However, it is very common in research settings that the Participant user accounts will be created using non-identifiable log in details over which the Company has no control and as such, even in combination with any other data processed through the App, the Company would not be able to identify any of the Participants.

The Company accepts no responsibility for any personal data shared directly or indirectly between any end-user of the App and any third party/(ies).

Third-party services/sub-processors. The Company uses certain external providers as part of its offering, as follows:

• All our medical prescriptions are dispensed and delivered using a third-party registered online pharmacy – Signature Pharmacy through their prescription service platform, SignatureRX (“Pharmacy”).
• All our Consultation appointments and video links are facilitated through Cliniko, a third-party clinical software provided by Red Guava Pty Ltd.
• All payments will be processed via Stripe, Inc.
• Our communications (including marketing) are facilitated by Zendesk, Inc., Salesforce, Inc. and Marketo, Inc.

If you have any questions, requests, concerns or complaints relating to your personal data, please contact our Data Privacy Team at privacy@owlstone.co.uk.

Our Customers and Research Customers are generally authorised to make referrals and recommendations for OMED Health products and services, subject always to the following:

• unless expressly agreed otherwise in writing, nothing in these Terms alone is intended to, or shall be deemed to establish any agency, distribution, partnership or joint venture between the Company and any Customer or Research Customer;
• no Customer or Research Customer is authorised to make or enter into any commitments for or on behalf of the Company such as enter into agreements, pledge the Company’s credit, provide any warranties on the Company’s behalf;
• any publications or press releases concerning the Company, OMED Health and its products and services must be submitted in a draft form to the Company for its prior written approval;
• any and all public communications by Customer or Research Customer must be in compliance with applicable laws, regulations and standards, including without limitation advertising laws, consumer protection regulations, competition laws etc; and
• no organisation or an individual may act outside of any specific written guidance or instructions issued by the Company brought to the attention of the relevant party.

Liability that cannot be excluded. Nothing in these Terms shall act to exclude or restrict the Company’s liability which cannot legally be limited, including liability for death or personal injury resulting from the negligence of the Company, its employees, contractors or agents, or in any other manner precluded by law; fraud or fraudulent misrepresentation.

No liability where Company not at fault. Other than where the Company’s liability cannot legally be excluded or limited, the Company shall not be liable for any losses arising from any use or misuse of its products by any individual or organisation, such as (without limitation): fair wear and tear; wilful damage; the user’s negligence, or that of its agents or employees, infringement of third-party’s intellectual property rights, or any failure to follow the Company’s instructions for use of its products; abnormal working conditions; or any alteration or repair of the products any manufacturing process or otherwise; any misstatements or misrepresentations about the Company’s products and/or services; any Patient treatment or medical negligence or malpractice by the Customer or any third party.

No liability where notification requirements not followed. The Company shall not be liable for issues related to delivery or non-delivery, unless the Customer, Research Customer or Patient notifies the Company of the facts as soon as practically and reasonably possible following discovery – such issues might include shortages in the quantity of products delivered, any damage or loss during shipment (where the Products are carried by the Company’s own transport or by a carrier on behalf of the Company).

Disclaimer. THE COMPANY’S PROMISE TO REMEDY NON-DELIVERY OR PRODUCT QUALITY ISSUES AS SET OUT IN THESE TERMS SHALL BE ACCEPTED BY CUSTOMER AND RESEARCH CUSTOMER IN LIEU OF AND TO THE EXCLUSION OF ALL CONDITIONS AND WARRANTIES WHETHER EXPRESSED, IMPLIED, STATUTORY OR OTHERWISE. SAVE AS PROVIDED IN THE REMAINING PROVISIONS OF THIS SECTION 6.15, THE COMPANY’S LIABILITY FOR LOSS OR DAMAGE INCLUDING CONSEQUENTIAL OR INDIRECT LOSS OR DAMAGE TO CUSTOMER OR RESEARCH CUSTOMER (INCLUDING WITHOUT LIMITATION LOSS UNDER CURRENT AND FUTURE CONTRACTS, LOSS OF BUSINESS AND DISASTER RECOVERY COSTS) SHALL NOT IN ANY EVENT EXCEED THE TOTAL PRICE OF THE PRODUCTS PURCHASED IN CONNECTION WITH SUCH LIABILITY WHETHER SUCH LIABILITY ARISES IN CONTRACT, IN TORT (INCLUDING NEGLIGENCE AND BREACH OF STATUTORY DUTY), MISREPRESENTATION OR OTHERWISE.

Customer Indemnity. The Customer shall indemnify and keep indemnified the Company (including its affiliates, directors, officers, employees, contractors, agents) against all claims, proceedings, losses and expenses (including reasonable legal and other expenses) arising out of or in connection with the Customer’s negligent misstatement or misrepresentation concerning any of the Patients, any medical negligence, misconduct, treatment or any other action or omission by the Customer (including where the lactulose or glucose used for the Test was sourced from a party other than the Company); any misuse or breach of Patient personal data by the Customer (or any of its affiliates, directors, officers, employees, contractors, subcontractors, agents or other authorised representatives).

Research Customer Indemnity. Research Customer shall indemnify and keep indemnified the Company (including its affiliates, directors, officers, employees, contractors, agents) against all claims, proceedings, losses and expenses (including all legal and other expenses or fines) arising out of or in connection with (i) its use of the Research Product to the extent that such use infringes any legal or regulatory requirements or is otherwise inconsistent with the permitted use under these Terms; (ii) any action or inaction, negligence, misstatements (including fraudulent misstatements), or any inaccuracy in information concerning the Research Product and/or the overall clinical trial or study, submitted, shared, disclosed or otherwise provided by the Research Customer to the Participants or any third parties, including but not limited to information or omissions within its clinical trial protocols, participant recruitment, information sheets, consents; (iii) any reliance by the Research Customer, its Participants or any third party on the outcomes of the clinical trial or research study in question.

Exceptions to indemnity. An indemnifying party will not be liable under the above indemnities to the extent that any claims or losses result from a deliberate act or omission, negligence, fraud or an interference with the safety of any products or systems by the indemnified party seeking to rely on or benefit from the indemnity in question. A party indemnified under this section may not benefit from its indemnity if it has not notified its indemnifying party of the claim and it has not been given an opportunity to respond to or defend the relevant claim.

Participants in research are required to contact their study sponsor whenever possible in order to preserve confidentiality of all Participants.

General queries, feedback, performance issues. Company’s support team at support@omedhealth.com is the best place to start for all Customer/Research Customer or Patient queries and concerns. The team will do their best to resolve any problems without unnecessary delays. Please allow up to 2 Business Days for our initial response. All queries and concerns are subsequently allocated by the field of expertise, e.g. technical product or quality queries, medical or legal.

If you are not entirely happy with OMED Customer Support. If our team of experts have not been able to resolve your query or concern to your full satisfaction, please send us a letter using the following details:

FAO: Chief Financial Officer
Owlstone Medical Limited
183 Cambridge Science Park
Milton Road
Cambridge CB4 0GJ, UK

Personal data related requests or complaints. Individuals who wish to make a data subject access request or a complaint relating to how their personal data has been used should email the Data Privacy Team directly at privacy@owlstone.co.uk in the first instance. We will acknowledge receipt of your complaint within 30 days. We will then consider and respond to your complaint without undue delay, including by making any appropriate enquiries and keeping you informed. You also have the right to complain to the Information Commissioner’s Office: https://ico.org.uk/make-a-complaint/.

Resolving disputes without going to court. If we have not been able to resolve your complaint through our internal complaints procedure, alternative dispute resolution is an optional process available to you, where an independent body considers the facts of a dispute and seeks to resolve it, without you having to go to court. Once we have provided you with the outcome of our internal review process, you can submit a complaint to the Health and Social Care Complaint Adjudication Management Partners (HSCAMP) through their website at https://hscamp.co.uk/complaint-process/. HSCAMP does not charge you for making a complaint and if you’re not satisfied with the outcome you can still go to court.

Going to court. These Terms are governed by English law and wherever you live you can bring claims against us in the English courts. If you live in Wales, Scotland or Northern Ireland, you can also bring claims against us in the courts of the country you live in. We can claim against you in the courts of the country you live in.