STANDARD TERMS AND CONDITIONS

Version: 1.0

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These Standard Terms & Conditions form part of the Customer Account Agreement between Clear Aligner Ltd ("the Company") and the Customer.

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1. Definitions

In these Terms:

Company means Clear Aligner Ltd.

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Customer means the dental practice, clinic or authorised healthcare professional placing an order with the Company.

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Prescription means the written prescription, digital prescription, treatment request and associated clinical information submitted by the Customer.

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Products means clear aligners, retainers, bleaching trays, bite guards and any other laboratory products manufactured by the Company.

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Services means treatment planning, digital simulations, appliance manufacture and all associated laboratory services.

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Working Day means Monday to Friday excluding public holidays in England and Wales.

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2. Orders

2.1 Orders may be submitted through the Company's online portal, by email or by another method approved by the Company.

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2.2 Every order must include sufficient information for manufacture, including the prescribed treatment and any supporting records requested by the Company.

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2.3 The Company reserves the right to refuse or delay any order where information is incomplete or unsuitable for manufacture.

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2.4 An order shall not enter production until all required records have been received and, where applicable, the treatment plan has been approved by the Customer.

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3. Prescription and Clinical Responsibility

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3.1 The Company manufactures Products strictly in accordance with the Prescription supplied by the Customer.

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3.2 The Customer remains solely responsible for:

• diagnosis;

• patient assessment;

• determining suitability for treatment;

• obtaining informed consent;

• taking accurate impressions or digital scans;

• providing accurate clinical records;

• prescribing attachments, IPR and auxiliaries;

• monitoring treatment;

• prescribing retention.

3.3 The Company provides laboratory and treatment planning services only and does not provide clinical diagnosis or direct patient care.

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3.4 The Company is entitled to rely upon the Prescription and clinical information supplied by the Customer and shall have no obligation to verify its clinical appropriateness, completeness or accuracy.

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4. Treatment Planning

4.1 Treatment plans and digital simulations are produced using the information supplied by the Customer.

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4.2 Treatment plans are intended to assist the prescribing clinician and do not constitute clinical advice.

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4.3 Digital simulations are estimates of predicted tooth movement and are not guarantees of clinical outcome.

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4.4 The Customer is responsible for reviewing every treatment plan before approval.

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5. Treatment Plan Approval

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5.1 Manufacture shall not commence until the treatment plan has been approved by the Customer via the portal or email.

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5.2 Approval confirms that the Customer:

• has reviewed the treatment plan;

• accepts the proposed tooth movements;

• authorises manufacture;

• accepts responsibility for the prescribed treatment.

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5.3 Approval provided electronically through the Company's online portal or by email shall constitute legally binding approval.

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5.4 Once a treatment plan has been approved, manufacture may commence immediately. Approved treatment plans cannot be withdrawn once manufacture has commenced.

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5.5 Clinical Preference Changes

The Company manufactures Products strictly in accordance with the Customer's approved treatment plan and Prescription. A request to alter tooth movements, staging, attachments, interproximal reduction (IPR), treatment objectives or other treatment parameters after approval shall constitute a variation requested by the Customer and shall not indicate any defect in the Products or Services supplied by the Company. Any resulting redesign, additional treatment planning, refinement or manufacture may be charged at the Company's prevailing rates.

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5.6 Where Products have been manufactured in accordance with the approved treatment plan and Prescription, the applicable charges shall remain payable irrespective of whether the Customer subsequently elects not to fit the Products, changes the treatment plan or discontinues treatment.

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6. Accuracy of Records

6.1 The Customer warrants that all impressions, scans, photographs, radiographs and other records supplied are complete and accurate.

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6.2 The Company accepts no responsibility for Products manufactured from:

• distorted impressions;

• poor quality scans;

• scans of plaster or stone models;

• incomplete records;

• inaccurate prescriptions;

• damaged digital files.

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6.3 Where scans of plaster models are supplied, additional digital clean-up may be required. Whilst reasonable care will be taken, the Company accepts no liability for any reduction in fit or accuracy resulting from the quality of the original records.

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6.4 Where treatment is delayed after records have been taken, or tooth movement occurs before appliance fitting, the Company accepts no responsibility for any resulting reduction in fit or need for remanufacture.

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7. Manufacture

7.1 Products shall be manufactured in accordance with the approved Prescription.

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7.2 Minor manufacturing tolerances are normal and shall not constitute defects.

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7.3 The Company reserves the right to decline manufacture where records are considered unsuitable or where manufacture may compromise patient safety.

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7.4  All Products supplied by the Company are custom-made medical devices manufactured in accordance with applicable UK medical device legislation. Products are intended solely for the individual patient named in the Prescription and must not be reused, transferred to another patient or modified by any third party without the Company's written consent.

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8. Clinical Outcomes

8.1 Orthodontic tooth movement is a biological process and varies between patients.

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8.2 The Company does not guarantee:

• treatment success;

• predicted tooth movement;

• treatment duration;

• final occlusion;

• stability of treatment;

• the number of aligners required;

• that refinements will not be necessary.

8.3 The Company shall not be liable for treatment outcomes resulting from biological variation, patient compliance, inaccurate records or clinical decisions made by the prescribing clinician.

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9. Refinements

9.1 Unless specifically included within the agreed commercial terms, refinement aligners shall be charged at the Company's prevailing rates.

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9.2 Approval of an initial treatment plan does not include future refinements unless expressly agreed in writing.

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9.3 Additional treatment plans, redesigns or revised simulations requested after approval may be charged separately.

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10. Delivery

10.1 Estimated turnaround times are provided for guidance only.

10.2 Turnaround times commence only when all required records have been received, and the case is ready for manufacture.

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10.3 The Company shall not be liable for delays caused by:

• courier services;

• customs;

• public holidays;

• force majeure;

• delays in receiving customer approval;

• incomplete records.

10.4 Risk in the Products passes to the Customer upon delivery.

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11. Title to Goods

Ownership of all Products shall remain with the Company until all invoices relating to those Products have been paid in full.

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12. Payment

12.1 Invoices are payable in full on or before the 10th day of the month following the invoice date.

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12.2 Where the due date falls on a Saturday, Sunday or public holiday, payment shall be due on the next Working Day.

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12.3 The Company reserves the right to:

• suspend manufacture;

• suspend deliveries;

• suspend portal access; or

• withdraw credit facilities,

where invoices remain overdue.

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12.4 Interest may be charged on overdue accounts in accordance with the Late Payment of Commercial Debts (Interest) Act 1998 together with any applicable debt recovery costs.

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12.5 Once a treatment plan has been approved and manufacture has commenced, the applicable charges shall remain payable irrespective of whether the Customer subsequently elects not to proceed with fitting the Products or discontinues treatment.

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13. Returns

13.1 As all Products are custom manufactured, Products may not be returned for credit except where a manufacturing defect exists.

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13.2 Warranty claims shall be dealt with in accordance with the Warranty & Remake Policy.

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13.3 The Customer shall inspect all Products promptly upon receipt and notify the Company of any apparent defect before the Products are fitted to a patient wherever reasonably practicable.

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14. Limitation of Liability

14.1 To the fullest extent permitted by law, the Company's total aggregate liability arising out of or in connection with the supply of any Products or Services, whether in contract, tort (including negligence), breach of statutory duty or otherwise, shall not exceed the total amount paid by the Customer for the relevant order giving rise to the claim.

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14.2 The Company shall not be liable for any loss, damage, cost or expense arising from:

• clinical treatment outcomes;

• diagnosis, treatment planning or clinical decisions made by the Customer;

• inaccurate, incomplete or unsuitable prescriptions, impressions, digital scans or other records supplied by the Customer;

• biological variation in tooth movement or patient response to treatment;

• patient non-compliance with prescribed treatment;

• retreatment costs;

• chair time;

• patient refunds or compensation;

• third-party laboratory costs;

• loss of profit;

• loss of revenue;

• loss of business;

• loss of contracts;

• loss of goodwill or reputation; or

• any indirect, incidental, special or consequential loss or damage.

14.3 The Customer shall indemnify and keep indemnified the Company against any claim, liability, loss, cost or expense arising from:

• inaccurate or incomplete information supplied by the Customer;

• the Customer's clinical decisions or treatment of a patient;

• any breach by the Customer of applicable laws, regulations or professional obligations; or

• any claim made by a patient arising from treatment provided by the Customer, except to the extent that such claim results directly from a proven manufacturing defect for which the Company is responsible.

14.4 Nothing in these Terms & Conditions shall exclude or limit either party's liability for:

• death or personal injury caused by negligence;

• fraud or fraudulent misrepresentation; or

• any liability which cannot lawfully be excluded or limited under applicable law.

15. Confidentiality and Data Protection

15.1 Both parties shall keep confidential all commercial and technical information received from the other.

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15.2 The Company shall process personal data in accordance with applicable UK data protection legislation.

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15.3 The Customer confirms that it has obtained all necessary patient consents to enable patient data to be transferred to the Company for the purpose of treatment planning and manufacture.

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16. Intellectual Property

16.1 All treatment plans, digital simulations, manufacturing methods, documentation, graphics and software remain the intellectual property of the Company unless otherwise agreed in writing.

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16.2 The Customer shall not copy, reproduce or distribute any treatment plan or software output except for the treatment of the relevant patient.

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17. Force Majeure

The Company shall not be liable for any failure or delay caused by events beyond its reasonable control, including industrial disputes, supplier failure, equipment breakdown, cyber incidents, pandemics, natural disasters or interruption of utilities or transport services.