Terms & Conditions

1.1 Contracting Parties

These General Terms and Conditions ("Terms") apply to all legal transactions between Aligner Steps GmbH, Immermannstraße 34, 40210 Düsseldorf, Germany (hereinafter referred to as “Aligner Steps”), and its contractual partners (hereinafter referred to as “Customer”). Customers within the meaning of these Terms include:

• licensed dentists and orthodontists,
• distributors, commercial partners, and business clients

acting in the course of their commercial or professional activity within the meaning of § 14 BGB. These Terms do not apply to consumers within the meaning of § 13 BGB.

1.2 Subject Matter of the Agreement

Aligner Steps provides services and products within the field of digital orthodontics, including but not limited to:

• digitally supported treatment planning services,
• provision of custom-made clear aligner systems,
• access to digital platforms (doctor portal and applications),
• logistics, order processing, and delivery coordination,
• technical and customer support services.

Aligner Steps operates as a provider of digitally driven orthodontic solutions and places custom-made dental devices on the market in accordance with applicable regulatory requirements.

1.3 Medical Responsibility

Aligner Steps does not provide medical or clinical treatment. All decisions relating to:

• diagnosis,
• treatment planning validation,
• patient suitability,
• and execution of orthodontic treatment

remain the sole and exclusive responsibility of the treating dentist or orthodontist. Any treatment planning proposals or digital setups provided by Aligner Steps are non-binding technical support services and do not replace professional medical judgment.

1.4 Indirect Patient Relationship

Aligner Steps may support Customer workflows that involve patient interaction through digital tools and communication interfaces. However, any contractual or medical relationship with patients exists exclusively between the treating healthcare professional and the patient. Aligner Steps does not enter into any contractual relationship with patients.

1.5 Precedence of Individual Agreements

Individual agreements concluded between Aligner Steps and the Customer shall take precedence over these Terms, provided they are made in writing or confirmed through the official digital platform.

1.6 Future Applicability

These Terms shall also apply to all future business relationships between the parties, even if not expressly agreed again. Continued use of Aligner Steps’ services, platforms, or products constitutes acceptance of the latest version of these Terms.

1.7 Exclusivity of Terms

These Terms apply exclusively. Any conflicting or deviating terms and conditions of the Customer shall not apply unless expressly agreed in writing by Aligner Steps.

1.8 Geographic Scope

These Terms apply to all transactions conducted within Europe and internationally.

2.1 Non-Binding Nature of Offers

All offers, quotations, and information provided by Aligner Steps GmbH, including those presented on the website, portal, marketing materials, or other communication channels, are non-binding and subject to change unless explicitly stated otherwise. The presentation of products or services does not constitute a legally binding offer but rather an invitation to submit an order.

2.2 Submission of Cases and Requests

The Customer may submit patient cases, data, and documentation through Aligner Steps’ designated digital platform (“Portal”). The submission of a case via the Portal constitutes a request for:

• treatment planning services, and
• the potential production of a custom-made aligner system.

Such submission does not yet constitute a binding contract.

2.3 Treatment Plan Proposal

Based on the data and documentation provided, Aligner Steps will prepare and provide a treatment plan proposal, which may include:

• digital setup,
• treatment staging,
• and a corresponding commercial offer.

This proposal constitutes a non-binding offer, valid for a period of 60 days from the date of issuance, unless otherwise specified.

2.4 Conclusion of Contract (Binding Order)

A legally binding contract is concluded only when the Customer explicitly approves the treatment plan via the Portal. Upon such approval:

• the order becomes binding,
• production and/or service execution is initiated,
• and the Customer assumes full responsibility for the approved treatment plan.

Any approval outside the Portal shall not be considered legally valid unless explicitly confirmed by Aligner Steps.

2.5 Pricing of Treatment Planning Services

Treatment planning services may be provided under a hybrid pricing model:

• In principle, treatment planning may be offered free of charge for approved cases.
• However, Aligner Steps reserves the right to charge for treatment planning services in

cases where:

• submitted treatment plans are not approved, and
• the Customer demonstrates a low approval rate , in particular below a defined

internal threshold (e.g., excessive rejection behavior). Aligner Steps retains sole discretion in determining whether treatment planning fees apply, based on internal performance and usage criteria.

2.6 Communication and Form Requirements

All legally relevant actions, including but not limited to:

• case submissions,
• approvals,
• modifications,
• and confirmations

must be performed through the official Portal. Email communication is permitted for operational purposes but shall not be considered legally binding unless explicitly confirmed within the Portal. Verbal agreements, side agreements, or informal communications shall have no legal effect.

2.7 Right to Reject Orders

Aligner Steps reserves the right to reject, suspend, or refuse any case, order, or request at its sole discretion, including but not limited to cases where:

• submitted data is incomplete, inaccurate, or of insufficient quality,
• the case is deemed clinically unsuitable for aligner treatment,
• regulatory or compliance concerns arise,
• or the Customer fails to meet operational or contractual requirements.

There is no obligation to justify such decisions.

2.8 Responsibility for Submitted Data

The Customer is solely responsible for the completeness, accuracy, and quality of all submitted data, including but not limited to:

• patient records,
• scans, impressions, and images,
• and clinical information.

Aligner Steps shall not be liable for any errors, delays, or treatment outcomes resulting from incomplete, incorrect, or misleading data provided by the Customer.

2.9 Role of Distributors and Partners

Distributors and commercial partners act as independent contractual parties and not as representatives of treating healthcare professionals. Each Customer placing an order is solely responsible for:

• the submitted cases,
• the associated obligations,
• and compliance with these Terms.

3.1 Initiation of Treatment Planning

Treatment planning services by Aligner Steps GmbH commence once the Customer has submitted the required case data and documentation through the Portal. Aligner Steps will review the submitted materials and prepare a treatment plan proposal based on the provided information. Any preliminary assessment or feedback provided prior to formal plan approval is non-binding and intended solely for general guidance.

3.2 Required Documentation

To enable accurate treatment planning, the Customer is expected to provide complete and sufficient case documentation, including but not limited to:

• intraoral scans or physical impressions,
• clinical photographs,
• radiographs where applicable,
• and relevant patient information.

If a case is submitted with incomplete or insufficient documentation, the Customer assumes full responsibility for any resulting limitations, inaccuracies, or suboptimal outcomes.

3.3 Nature of Treatment Planning Services

Treatment planning services provided by Aligner Steps constitute technical and digital support services. Any treatment plan proposal:

• is non-binding from a medical perspective,
• serves as a technical visualization and planning aid,
• and must be reviewed, validated, and approved by the treating dentist or orthodontist.

The Customer retains full responsibility for all clinical decisions and treatment execution.

3.4 Modification and Interaction via Portal

The Customer may review, comment on, and request modifications to treatment plans directly through the Portal. Aligner Steps will make reasonable efforts to incorporate such feedback and support iterative plan adjustments within the scope of the selected product and service level.

3.5 Product Types and Refinement Policy

Aligner Steps offers different product tiers with defined refinement conditions:

• Steps Ultimate

Includes unlimited refinements within the applicable treatment period.

• Steps 34

Includes up to two (2) refinements.

• Steps 22 and Steps 10

Each includes one (1) refinement. Refinements beyond the included limits may be subject to additional charges and require a new order or agreement.

3.6 Treatment Plan Validity

All treatment plans remain valid for a maximum period of three (3) months from the date of issuance. If a treatment plan is not approved within this period:

• the plan may expire,
• pricing or conditions may be adjusted,
• and a new submission may be required.

Aligner Steps reserves the right to charge for treatment planning services in such cases.

3.7 Manufacturing and Quality Standards

Upon approval of a treatment plan, aligners are produced in accordance with defined quality standards and controlled processes. Aligner Steps ensures that manufacturing follows established quality requirements and utilizes appropriate materials and production workflows.

3.8 Force Majeure

Aligner Steps shall not be liable for delays or failure to perform its obligations due to events beyond its reasonable control, including but not limited to:

• natural disasters,
• pandemics,
• labor disputes,
• supply chain disruptions,
• governmental actions or restrictions.

In such cases, performance obligations may be suspended for the duration of the disruption and a reasonable restart period. If such events persist for more than 90 days , either party may terminate the affected contract without liability.

4.1 Changes Prior to Approval

The Customer may request changes or modifications to a submitted case or treatment plan at any time prior to approval, exclusively through the Portal. Such requests will be processed within the scope of the selected service and subject to technical feasibility.

4.2 Cancellation Prior to Approval

The Customer may cancel a submitted case free of charge prior to approval of the treatment plan, provided that the Customer maintains a reasonable approval rate. Aligner Steps reserves the right to charge for treatment planning services in cases where:

• treatment plans are repeatedly rejected, and
• the Customer demonstrates an excessive rejection behavior, in particular where the

approval rate falls below a reasonable threshold (e.g., below 70%). The assessment of such behavior shall be at the sole discretion of Aligner Steps.

4.3 Binding Effect After Approval

Once a treatment plan has been approved via the Portal, the order becomes legally binding. Upon approval:

• the Customer is obligated to pay the agreed treatment plan and/or product price,
• production and/or service execution is initiated,
• and cancellation is no longer possible.

4.4 Non-Cancellability After Production Start

Once the manufacturing or production process has commenced, the order is strictly non-cancellable. The Customer shall remain fully liable for the total agreed amount, regardless of:

• subsequent changes in treatment decisions,
• patient-related circumstances,
• or internal decisions of the Customer.

4.5 Right of Aligner Steps to Cancel or Refuse Orders

Aligner Steps GmbH reserves the right to cancel, suspend, or refuse any order or request at its sole discretion, including but not limited to cases involving:

• incomplete or inaccurate data,
• suspected misuse of services,
• regulatory or compliance concerns,
• or breach of these Terms.

In such cases, Aligner Steps may terminate the affected order without further obligation, except for services already performed.

5.1 General Duty to Cooperate

The Customer is obligated to cooperate in good faith with Aligner Steps GmbH and to take all necessary steps to ensure the proper execution of services and orders. In particular, the Customer shall:

• provide all required information and documentation in a complete, accurate, and timely

manner,

• ensure that submitted data meets professional and technical standards,
• and actively support the processing of each case.

5.2 Timely Communication and Updates

The Customer must inform Aligner Steps without undue delay of any circumstances that may affect a submitted case or approved treatment plan. Such information must be communicated:

• promptly, and

• no later than 24 hours after becoming aware of relevant changes.

Failure to provide timely updates may result in delays, errors, or additional costs, for which Aligner Steps shall not be held liable.

5.3 Compliance with Medical Standards

The Customer is solely responsible for ensuring that all treatments are carried out in accordance with:

• applicable medical standards,
• professional guidelines,
• and all relevant legal and regulatory requirements.

Aligner Steps does not verify or guarantee compliance with such standards.

5.4 Clinical Responsibility and Decision-Making

All clinical responsibilities remain exclusively with the Customer. This includes, but is not limited to:

• patient assessment and case selection,
• diagnosis,
• treatment planning approval,
• treatment execution and monitoring,
• and evaluation of treatment outcomes.

The Customer is solely responsible for determining whether the services and products provided by Aligner Steps are suitable for a specific patient.

5.5 Patient Consent

The Customer is solely responsible for obtaining and documenting all necessary patient consents prior to:

• submitting case data,
• initiating treatment planning,
• and commencing treatment.

This includes, in particular:

• consent to treatment,
• consent to data processing and transfer,
• and any other legally required patient authorizations.

Aligner Steps assumes no responsibility for verifying the existence or validity of such consent.

5.6 Use of Services and Training

Use of Aligner Steps’ products and services does not require formal certification. However, the Customer acknowledges that:

• orthodontic treatment using aligners requires appropriate professional knowledge and

experience,

• and training, education, or onboarding materials provided by Aligner Steps are

recommendations only. The Customer remains fully responsible for the competent use of all services and products.

5.7 Responsibility for Data and Instructions

The Customer is fully responsible for:

• the accuracy and completeness of submitted data,
• the correctness of the instructions provided,
• and any modifications requested during treatment planning.

Aligner Steps shall not be liable for any consequences resulting from:

• incorrect or incomplete data,
• delayed communication,
• or improper use of the services or products.

6.1 Prices and Applicable Charges

All prices provided by Aligner Steps GmbH, including price lists, quotations, or other communications, are non-binding unless explicitly confirmed in a final treatment plan approval or individual agreement. Binding prices shall be those confirmed:

• upon treatment plan approval via the Portal, or
• within a separate written agreement between the parties.

All prices are exclusive of applicable taxes, shipping, packaging, and other ancillary costs, unless expressly stated otherwise.

6.2 Additional Services and Costs

Any additional services requested by the Customer, including but not limited to:

• refinements beyond included limits,
• modifications,
• expedited services,
• or special delivery requirements

may be charged separately. Aligner Steps reserves the right to determine the appropriate charges for such additional services.

6.3 Payment Terms

Invoices issued by Aligner Steps are due for payment within 14 days from the invoice date, unless otherwise agreed in an individual contract. Payment shall be made without deduction unless expressly agreed otherwise.

6.4 Payment Methods

Aligner Steps accepts various payment methods, including but not limited to:

• bank transfer,
• electronic payment methods,
• and other commonly used commercial payment solutions.

The availability of specific payment methods may depend on operational or regional conditions.

6.5 Allocation of Payments

Aligner Steps is entitled to allocate incoming payments at its discretion, particularly to:

• outstanding older debts,
• accrued interest,
• and then to the principal claim.

A payment shall be deemed received only when Aligner Steps has full disposal of the funds.

6.6 Late Payment and Interest

In the event of late payment, Aligner Steps reserves the right to charge statutory default interest at a rate of 9 percentage points above the base interest rate in accordance with applicable German law. Further claims for damages caused by delay remain unaffected.

6.7 Suspension of Services

In the event of:

• overdue payments,
• repeated delays,
• or reasonable doubts regarding the Customer’s solvency,

Aligner Steps reserves the right to:

• suspend ongoing services,
• withhold deliveries,
• and refuse acceptance of new orders

until all outstanding amounts have been fully settled.

6.8 Set-Off and Retention Rights

The Customer shall only be entitled to set off or assert a right of retention if:

• the counterclaim is undisputed, or
• has been legally established by a final court decision.

7.1 Performance and Processing Times

Any timeframes indicated by Aligner Steps GmbH for:

• treatment planning,
• production,
• or delivery

are non-binding and indicative only , unless expressly agreed otherwise in writing. Processing times may vary depending on:

• case complexity,
• data quality and completeness,
• operational workload,
• and external factors.

7.2 Commencement of Performance

Processing of a case shall commence only once:

• all required documentation has been submitted in full, and
• the treatment plan has been approved via the Portal (where applicable).

Delays caused by incomplete submissions or missing information shall not be attributed to Aligner Steps.

7.3 Delivery and Shipping

Delivery of products is carried out from Germany. Unless otherwise agreed, Aligner Steps shall determine:

• the shipping method,
• carrier,
• and logistics arrangements

based on operational efficiency. Special shipping requests by the Customer may result in additional charges.

7.4 Transfer of Risk

The risk of accidental loss or deterioration of goods shall transfer to the Customer once the shipment is handed over to the carrier or transport provider. This applies regardless of:

• who bears the shipping costs,
• or whether partial deliveries are made.

If shipment is delayed at the request of the Customer, the risk shall transfer upon notification that the goods are ready for dispatch.

7.5 International Shipping and Compliance

The Customer is responsible for complying with all applicable:

• import and export regulations,
• customs requirements,
• and local legal obligations

in the destination country. Aligner Steps shall not be liable for:

• delays,
• additional costs,
• or non-delivery

resulting from customs procedures, regulatory restrictions, or governmental actions.

7.6 Partial Deliveries

Aligner Steps reserves the right to make partial deliveries where reasonable. Each partial delivery may be invoiced separately unless otherwise agreed.

7.7 Delivery Delays

Aligner Steps shall not be liable for delays caused by:

• force majeure events,
• supply chain disruptions,
• carrier-related issues,
• or circumstances beyond its reasonable control.

8.1 Inspection and Notification of Defects

The Customer shall inspect all delivered goods immediately upon receipt, insofar as this is feasible in the ordinary course of business. Any defects must be reported to Aligner Steps GmbH without undue delay, and no later than five (5) working days after delivery. If the Customer fails to notify defects within this period, the goods shall be deemed accepted, unless the defect was not reasonably detectable during inspection. In such cases, notification must be made immediately upon discovery. The provisions of § 377 HGB shall apply.

8.2 Warranty Period

The limitation period for claims arising from defects in delivered products or services shall be one (1) year from the date of delivery. This limitation does not apply in cases of:

• intent or fraudulent concealment,
• injury to life, body, or health,
• or where mandatory statutory provisions require otherwise.

8.3 Scope of Warranty

In the event of a justified defect, Aligner Steps shall, at its discretion:

• remedy the defect, or
• provide a replacement.

The right to withdraw from the contract or reduce the price shall only apply if remediation fails after a reasonable number of attempts.

8.4 Exclusion of Liability for Treatment Outcomes

Aligner Steps shall not be liable for:

• treatment results,
• clinical outcomes,
• or the success of orthodontic treatment.

All treatment-related decisions and outcomes remain the sole responsibility of the treating dentist or orthodontist.

8.5 Limitation of Liability

Aligner Steps shall be liable for damages only in cases of:

• intent,
• gross negligence,
• or culpable injury to life, body, or health.

In cases of simple negligence, Aligner Steps shall only be liable for the breach of essential contractual obligations (cardinal duties), and such liability shall be limited to the foreseeable damage typical for the contract.

8.6 Exclusion of Indirect Damages

To the fullest extent permitted by law, Aligner Steps shall not be liable for:

• loss of profit,
• loss of revenue,
• business interruption,
• or any indirect or consequential damages.

8.7 No Liability for Customer Data or Misuse

Aligner Steps shall not be liable for damages resulting from:

• incomplete, inaccurate, or incorrect data provided by the Customer,
• failure to follow instructions or recommendations,
• improper handling or use of products,
• or deviations from professional or medical standards.

8.8 Liability of Employees and Partners

Any limitations of liability set out in these Terms shall also apply to:

• employees,
• representatives,
• agents,
• and subcontractors

of Aligner Steps.

9.1 Ownership of Intellectual Property

The Customer expressly acknowledges and agrees that all intellectual property rights related to the services and products of Aligner Steps GmbH remain the sole and exclusive property of Aligner Steps. This includes, but is not limited to:

• treatment plans and digital setups,
• staging protocols and workflows,
• software, portal systems, and applications,
• designs, specifications, and production processes,
• algorithms, methodologies, and technical know-how,
• trademarks, branding elements, and marketing materials.

9.2 Limited Right of Use

The Customer is granted a limited, non-exclusive, non-transferable right to use the provided materials solely for:

• the treatment of the specific patient for whom the case was created, and
• internal professional purposes directly related to such treatment.

Any use beyond this scope requires prior written consent from Aligner Steps.

9.3 Prohibited Uses

The Customer shall not, under any circumstances:

• copy, reproduce, or modify any intellectual property,
• reverse-engineer, decompile, or attempt to extract underlying logic or methodologies,
• create derivative works based on Aligner Steps’ services or outputs,
• disclose, distribute, sublicense, or transfer any materials to third parties,
• use the intellectual property for competing or commercial purposes outside the agreed

scope.

9.4 Protection of Digital Systems

The Customer shall not:

• attempt to access restricted areas of the Portal or systems,
• interfere with system integrity or security,
• or use the platform in a manner that could impair functionality or availability.

9.5 Infringement and Remedies

Any unauthorized use, reproduction, or disclosure of Aligner Steps’ intellectual property shall constitute a material breach of contract. In such cases, Aligner Steps reserves the right to:

• immediately terminate the contractual relationship,
• suspend access to its services and platforms,
• and pursue all available legal remedies, including injunctive relief and damages.

10.1 Reference to Privacy Policy

The processing of personal data in connection with the services of Aligner Steps GmbH is governed exclusively by the applicable data protection laws and the Privacy Policy of Aligner Steps. The current version of the Privacy Policy is available on the official website and forms an integral part of the overall contractual framework.

10.2 Responsibility of the Customer

The Customer is solely responsible for ensuring that:

• all personal data, including patient data,
• is collected, processed, and transferred

in compliance with applicable data protection laws.

In particular, the Customer must ensure that all necessary:

• patient consents,
• authorizations,
• and legal requirements

are properly obtained prior to submitting any data to Aligner Steps.

10.3 Limitation of Responsibility

Aligner Steps processes data only to the extent necessary for the provision of its services. Aligner Steps shall not be responsible for:

• the legality of data collection by the Customer,
• or the validity of patient consent obtained by the Customer.

11.1 Retention of Data and Documentation

All documents, data, and materials submitted to Aligner Steps GmbH in connection with its services may be stored and retained for the duration necessary to:

• fulfill contractual obligations,
• ensure operational continuity,
• comply with legal and regulatory requirements,
• and maintain internal records.

Aligner Steps shall not be obligated to return submitted materials. The Customer is responsible for maintaining its own records in accordance with applicable professional and legal requirements.

11.2 Use of Anonymized Data

Aligner Steps reserves the right to use case data in anonymized form for purposes including:

• internal analysis and quality improvement,

• research and development,
• educational and training materials,
• and marketing or promotional content.

Such use shall not allow identification of individual patients.

11.3 Termination for Cause

Aligner Steps reserves the right to terminate contractual relationships with immediate effect in the event of a material breach by the Customer. Material breaches include, but are not limited to:

• non-payment or repeated delays in payment,
• misuse of services or platforms,
• violation of intellectual property rights,
• breach of confidentiality obligations,
• or non-compliance with applicable laws and regulations.

Termination shall not affect any payment obligations already incurred.

11.4 Amendments to the Terms

Aligner Steps reserves the right to amend or update these Terms at any time. Customers will be informed of such changes in advance through appropriate communication channels. Continued use of the services, Portal, or products after such notification shall constitute acceptance of the updated Terms.

12.1 Governing Law and Jurisdiction

All legal relationships between Aligner Steps GmbH and the Customer shall be governed exclusively by the laws of the Federal Republic of Germany. The place of performance and exclusive place of jurisdiction for all disputes arising out of or in connection with these Terms shall be Düsseldorf, Germany. For international transactions, these Terms and all resulting contracts shall likewise be governed exclusively by German law.

12.2 Exclusion of International Conventions

The application of the United Nations Convention on Contracts for the International Sale of Goods (CISG) is expressly excluded.

12.3 Written Form Requirement

Any amendments, modifications, or supplements to these Terms or to any related agreements must be made in writing. This also applies to any waiver of the written form requirement itself.

12.4 Assignment and Transfer

The Customer shall not assign or transfer any rights or obligations arising from these Terms without the prior written consent of Aligner Steps. Any unauthorized assignment shall be deemed invalid.

12.5 Set-Off and Retention

The Customer may only exercise rights of set-off or retention if:

• the counterclaims are undisputed, or
• have been legally established by a final court decision.

12.6 Severability Clause

Should any provision of these Terms be or become invalid or unenforceable, the validity of the remaining provisions shall remain unaffected. In place of the invalid provision, a valid provision shall be deemed agreed upon which most closely reflects the economic intent of the original provision.