GENERAL TERMS AND CONDITIONS
Lineo By M-Labs
DEFINITIONS
Any further or different definition contained in this document, as well as terms and expressions beginning with a capital letter, shall have the following meaning when used in this Agreement:
ALIGNERS: The individual orthodontic trays used for treatment with the LINEO system.
PERSONAL AREA: The private, personalized page on the Micerium Lab operating platform, accessible via the www.miceriumlab.net website. The account is created by the individual Client and enabled by M-Labs, allowing them to manage each case treated with the LINEO system, view the treatment plan, request modifications (within the LINEO area), and interact with the Manufacturer.
TREATMENT ARCHIVING: A case is considered archived when it has been concluded; consequently, it can no longer be managed by the LINEO/M-Labs clinical staff, and no further refinement aligners can be produced.
CLIENT: The dentist, physician, or orthodontist—or the respective dental practice authorized by M-Labs to use the Personal Area within the platform.
RETAINERS: Aligners used at the end of the Treatment produced by M-Labs to retain and maintain the dentition in the position achieved at the end of the treatment.
DUPLICATE: An additional aligner that is a copy of one already included in the treatment, available upon request.
TREATMENT DURATION: The period starting from the date of the first shipment of the Aligner and ending with the archiving of the Treatment.
MANUFACTURER: M-LABS srl, a manufacturer of custom-made medical devices (Ministry of Health registration number ITCA01050445) with its registered office in Assago (MI) at Viale Milanofiori snc; the company designs, manufactures, and markets the custom-made product under the LINEO brand name.
SUPPLY: Shipment of a quantity of sequential aligners in accordance with a treatment plan.
LINEO VISION: A 3D computer-generated visualization of tooth movements achievable via the LINEO system, based on the prescription submitted by the Client to the Manufacturer using the “Treatment Plan Objectives/Prescription” form. It is a virtual simulation; the outcome is not entirely predictable and may not be fully achieved.
TREATMENT PLAN OBJECTIVES: The set of instructions provided by the Client via a written prescription in the Personal Area regarding a specific case/patient to be treated with the Product. Through the treatment plan, the Client specifies the design characteristics and confirms, under their own responsibility, that the Product is intended for use by a specific patient solely to address that patient’s individual needs and conditions.
PATIENT: The end-user of the Product.
PRODUCT: The Product is a custom-made medical device manufactured specifically based on a written prescription from a dentist who, under their own responsibility, specifies the design characteristics
required for the optimal orthodontic and functional treatment therapy. The Product consists of the complete series of LINEO orthodontic aligners designed according to a 3D plan in collaboration with the LINEO Clinical Staff and manufactured and marketed by M-Labs comprising multiple steps of transparent, removable polymer aligners that progressively move teeth through small, physiologically compatible movements.
PRELIMINARY RESPONSE: A written assessment by the LINEO Clinical Staff provided via the digital platform, outlining case considerations, treatment duration, and the necessity for extractions and/or attachments.
WITHDRAWAL: The Client’s express decision not to proceed with the production of the Aligners, or the Client’s failure to place an order within 90 (ninety) days of the date the information was uploaded to the platform by the LINEO Clinical Staff.
REFINEMENT: A series of aligners designed to correct any deviations in the case’s progression and steer it back toward the objective established in the LineoVision plan approved by the Client; these may be provided free of charge (included by default in the treatment type) or for a fee, within the treatment’s duration.
STEP: A specific phase in the treatment sequence corresponding to a single aligner or a pair of aligners.
TREATMENT: The combination of clinical, technical, and digital procedures aimed at resolving malocclusions, tooth misalignment, or aesthetic issues. It encompasses diagnosis, planning, design, application, and monitoring; the final outcome is not entirely predictable and may not be fully achieved.
ARTICLE I
Subject Matter of the Contract and LINEO Treatments
1.1 – The Definitions form an integral and substantial part of this agreement.
1.2 – The Manufacturer undertakes to produce and supply—under the terms and in the manner further described in the following articles—Products of the type ordered from time to time by the Customer from among those listed below:
L1 ONE: Single-arch orthodontic treatment of up to 10 aligners. Includes 1 FREE refinement.
Maximum treatment duration: 15 months from the initial shipment of aligners.
L1 ACTIVE: Dual-arch orthodontic treatment of up to 10 pairs of aligners. Includes 1 FREE refinement.
Maximum treatment duration: 15 months from the initial shipment of aligners.
L2 ONE: Single-arch orthodontic treatment of 11 to 20 aligners. Includes 2 FREE refinements.
Maximum treatment duration: 30 months from the initial shipment of aligners.
L2 ACTIVE: Dual-arch orthodontic treatment of up to 20 pairs of aligners. Includes 2 FREE refinements.
Maximum treatment duration: 30 months from the initial shipment of aligners.
L3 POWER: Single- or dual-arch orthodontic treatment of more than 20 aligners. Includes 3 FREE refinements.
Maximum treatment duration: 48 months from the initial shipment of aligners.
1.3 – The Products, in compliance with applicable regulations, shall be provided at the time of sale with packaging necessary to ensure their protection and preservation during transport, handling, and storage. Each product shall be labeled and accompanied by a certificate of conformity.
1.4 – When using the Product, the Customer undertakes to comply with the LINEO Guidelines provided by the Manufacturer and to apply the LINEO clinical protocol, which may be downloaded from the Personal Area when establishing the Treatment Plan Objectives/Prescription.
ARTICLE II
Price and Payments
2.1 – The price of each Product shall be calculated with reference to the prices indicated in the Price List provided by the Manufacturer and shall be determined based on the quantity and type of Products requested by the Customer.
2.2 – Cost of packaging, shipping, and transport:
amounts to €10 for the initial shipment of the case, as well as for retainers, duplicates, and paid refinements.
2.3 – The Customer agrees to pay the Manufacturer the price of the Product in a single payment via bank transfer by the deadline specified in the invoice issued by M-Labs S.r.l. upon receipt of the order for the aligner set. In the case of paid refinements, retainers, and duplicates, payment shall be made in accordance with the terms stated in the relevant invoice.
2.4 – It is expressly agreed between the parties that the Manufacturer shall not accept payments made directly by Patients, nor payments forwarded by the Customer on behalf of the Patient.
2.5 – If the Customer manages the case by submitting scans, no additional fee will be charged beyond the cost of the case; if physical impressions are submitted, a fee of €18 will be charged for the shipping, handling, and processing of the impressions.
ARTICLE III
Treatment plan objectives and LINEOVISION preparation
3.1 – The Client may select one of two procedural pathways for ordering LINEO cases: WE.DO and YOU.DO.
3.2 – The first pathway, WE.DO, requires the Client to complete the “Treatment Plan Objectives” and upload the patient’s photographs and radiographs via the Personal Area, requesting a Preliminary Case Assessment. The Manufacturer will provide the practitioner with a “Preliminary Response”—also via upload to the Personal Area—within 2 (two) business days. Upon the Client’s acceptance of the Preliminary Response (submitted via the Personal Area) and receipt of the impressions and bite registration (or arch scans with occlusion capture), the Manufacturer will prepare the LINEOVision and upload it to the Personal Area within the following 8 (eight) business days.
3.3 – The second pathway, YOU.DO, involves the Client opening the case via the Personal Area, entering the diagnosis and treatment prescription, and completing the information with the patient’s photographs and radiographs. Upon receipt of the impressions and bite registration (or arch scans with occlusion capture), the Manufacturer will prepare the LINEO VISION and upload it to the Personal Area within the following 8 (eight) business days.
3.4 – In the event of requests for modifications to the LINEO VISION, the Manufacturer undertakes to make the modified LINEO VISION available to the Client—by uploading it to the dedicated Personal Area—within the following 3 (three) business days.
3.5- It is expressly understood that the Manufacturer shall in no way be held liable for any delays in the dispatch of the LINEO VISION and/or errors in the production of the Product resulting from the absence or defects of the material required to process the LINEO VISION (e.g., impressions, bite registrations, scans, X-rays, and photographs submitted by the Client).
ARTICLE IV
Acceptance and Withdrawal
4.1 – The Client undertakes to approve or reject the LINEO VISION plan within 90 (ninety) days of the date it is uploaded to the platform by the LINEO Clinical Staff, using the specific “Order Treatment” or “Reject Treatment” commands located within the Personal Area.
4.2 – By accepting the LINEO VISION plan which must be done exclusively in the manner set forth in point 4.1 above the Client approves the plan and confirms the request for the Manufacturer to process the order.
4.3 – Withdrawal shall result in the cancellation of the virtual LINEO VISION plan without the Manufacturer producing any Product, and the Client shall be charged the applicable withdrawal fee as per the Price List. Unless the Client expresses a contrary intention in writing within 15 (fifteen) days of the date of Withdrawal, such Withdrawal entails without the need for further notice the immediate destruction of impressions, plaster models, and all ancillary documentation received (including X-rays, photographs, bite registration wax, any scans, and any other materials submitted in support of the LINEO VISION design request).
4.4 – The client submits the relevant patient documentation along with the prescription: intraoral scan of the patient’s arches in occlusion, precision impressions and silicone bite, intraoral and extraoral photographs, x-rays, clinical information on the case (prescription). This documentation must be a copy of the original kept by the Client, who is required to retain it for the legally prescribed periods, in accordance with the contractual obligations of dentists. If M-Labs receives impressions or plaster models from the Client; these will be used to duly fulfill the purpose of creating a digital file (scan). Upon completion of this process, M-Labs reserves the right to either destroy or retain them.
4.5 – In the event that documents or data in the restricted area are lost, or patient documentation is misplaced during transfer or processing, MLabs shall not be held liable in any way. In such cases, the Client agrees to resend the missing documents to enable the creation of the LINEO VISION.
4.6 – It is expressly understood between the Parties that:
a) If the deadline referred to in point 4.1 expires without the Client having expressed their intent, the LINEO VISION project shall be deemed automatically rejected, with the consequent effect cited in the preceding point 4.2.
b) Should the Client reject the Treatment within 24 (twenty-four) hours of its acceptance, the Manufacturer shall in any case charge the Client 80% (eighty percent) of the Product price listed in the Price List payable according to the terms and methods agreed upon in Article 2.3 and the procedure set out in point 4.2 shall be followed.
c) Should the Client request cancellation of the order after the Product has been shipped by the Manufacturer, the full invoiced amount shall remain due to the Manufacturer, and the Product shall remain the property of the Client.
4.7 – By accepting the LINEO VISION which must be done exclusively in accordance with the procedures set out in the preceding point 4.1 the Client approves the project and confirms the request for the Manufacturer to process the order.
ARTICLE V
Product Shipment
5.1 – The Manufacturer undertakes to produce and ship the Product to the Customer within 10 (ten) working days from the acceptance of the production order, as set out in point 4.1. In the case of Refinements, the timeframe begins on the date of approval of the new LINEO VISION plan.
5.2 – The Product will be shipped via “Carriage Paid” (freight prepaid) courier service.
5.3 – Regarding shipping costs, please refer to point 2.3 above.
5.4 – The supply of Aligners will take place as follows:
L3 POWER: 1st Supply of 20 pairs of Aligners; 2nd Supply containing the remaining number of Aligners specified in the LINEO VISION plan (or another 20 pairs in the case of significantly longer treatments).
For the 2nd Supply, once the treatment reaches Step 18, it is advisable to check the progress of the case.
Therefore, it is recommended to send photos of the patient wearing the 18th Aligner to the LINEO Clinical Staff (produzione@mlabsitalia.it) as soon as possible, in order to agree on whether to continue with the established supply plan or proceed with taking new impressions (or scans) for Refinement.
IMPORTANT
Whenever a Supply is requested, it will not be possible to proceed with further requests until at least one-third of the time required to wear the sent Aligners has elapsed (based on changing them every 10 (ten) days).
All other types of treatment will be shipped in a single supply.
5.5 – In compliance with current regulations, the manufacturer ships the product exclusively to authorized medical practices.
ARTICLE VI
Refinement
6.1 – If, during the course of the Treatment, the Aligners do not fit perfectly or deviations from the Treatment plan occur, the Manufacturer shall upon the Client’s request accompanied by new dental impressions (or scans) and corresponding photographs of the Patient prepare a new LINEO VISION within the following 8 (eight) working days. The Refinement shall be shipped within 10 (ten) working days following the date of acceptance of the LINEO VISION.
6.2 – The fee (or the provision free of charge) for the production and sale of Refinements is determined based on the Price List and the type of Treatment.
6.3 – It is expressly agreed between the parties that, should the Client fail to fulfill the obligation to pay for the Product pursuant to Art. 2.3, said Client shall forfeit the right to receive the Refinement and/or additional Aligner Steps free of charge.
ARTICLE VII
Treatment Archiving Period
7.1 – A maximum duration is established for each type of Treatment, within which all activities related to the production of the Aligners must be completed. Upon the expiration of this period, the Treatment will be considered archived; consequently, no new refinement or retention appliances may be sent to the Client.
ARTICLE VIII
Warranties and Customer Liability
8.1 – The Customer is solely and directly responsible for the Treatment provided using the Product, as well as for any decision and/or assessment related thereto; the Customer therefore agrees to waive any claims against, and/or to indemnify and hold the Manufacturer harmless from, any claims and/or demands for compensation of any kind—whether currently existing or arising in the future—brought by the Customer, the Patient, and/or third parties against the Manufacturer regarding the use of the Product. This includes, by way of example and not limitation: the preparation of “Treatment Plan Objectives”/”Prescriptions” and related documentation (e.g., impressions, scans, photographs); modifications and/or refinements made during and at the conclusion of the Treatment; the achievement of the desired result; and the decision to proceed with the Treatment.
8.2 – The Customer hereby declares and warrants:
a) that they are authorized to practice dentistry and/or orthodontics in the territory where the Treatment is performed;
b) that the use of LINEO Products, services, and/or Treatment options will comply with industry medical standards;
c) that they possess the knowledge and experience required to administer the LINEO Aligner Treatment to the Patient and to perform all related activities;
d) that they are solely and directly responsible for the execution of the Treatment and the achievement of the desired result;
e) that they are solely and directly responsible for the information conveyed to the patient and for any other decision regarding the LINEO Treatment;
f) that they undertake to regularly check the Personal Area to stay updated and informed of any changes made to these General Terms and Conditions of Sale for Lineo products and to the Price List; g) having provided the Patient with the “Guide to Proper Use” supplied by the Manufacturer via the Personal Area and having obtained the Patient’s signature on the study’s informed consent form.
h) providing, at the Manufacturer’s request, feedback regarding the Patient’s Treatment and the successful outcome of the Treatment or the use of the Product.
i) authorizing the Manufacturer to use all of the Patient’s medical documentation for internal purposes as well as for consulting, educational, and research purposes, without ever disclosing the Patient’s identity or any personal or sensitive data relating to the Patient or the Client.
j) having reviewed the “LINEO clinical protocol” provided by the Manufacturer via the Personal Area.
ARTICLE IX
Manufacturer’s Warranties
9.1 – The Manufacturer warrants solely the absence of non-conformities in the Product’s manufacturing process.
9.2 – This warranty is valid for the entire duration of the Treatment and shall expire on the Treatment end date specified in the Terms and Conditions, depending on the type of Product.
9.3 – It is expressly understood between the Parties that the warranty referred to in this article shall be void if the Product is used by the Customer and/or the Patient in combination with products supplied by third parties.
9.4 – Should a remake of the Aligners be required due to changes occurring or made to certain dental elements, such remake shall not be covered by the warranty; instead, one of the finishing options provided for the Product must be utilized.
ARTICLE X
Processing of Personal Data
10.1 – In order to enable the performance of the services contractually agreed upon and without prejudice to the Client’s obligation to collect and record the patient’s data (whether sensitive or otherwise) and the fact that such data shall be transmitted to Micerium Lab solely and exclusively to the extent strictly necessary for the fulfillment of the contractual obligations undertaken the parties hereby consent to the processing of the transmitted personal data and undertake to obtain the relevant consent from any entitled parties, acknowledging the necessity of documenting in writing the information provided to and the consent given by said parties, in accordance with EU Regulation No. 2016/679 (GDPR). It is expressly agreed that the data collected shall be used exclusively for the performance of the obligations arising from this Agreement and obligations ancillary thereto, as well as for accounting and statistical purposes.
ARTICLE XI
Miscellaneous
11.1 – This Agreement is governed by Italian law. Any dispute regarding the existence, validity, effectiveness, interpretation, performance, or termination of this Agreement shall be subject to Italian jurisdiction and the exclusive competence of the Court of Milan, to the exclusion of any derogation, including on grounds of relatedness or lis pendens.
11.2 – For matters not expressly provided for in this Agreement, the Parties agree to be bound by the relevant regulations and the provisions of the Italian Civil Code.
11.3 – The invalidity or ineffectiveness of one or more clauses shall not entail the invalidity, ineffectiveness, or termination of these General Terms and Conditions of Sale for the Lineo Product. In such an event, the Parties undertake to replace, in good faith, the invalid or ineffective clauses with others that achieve the same function to the greatest extent possible.
11.4 – Any delay or omission by either Party in enforcing rights arising from this Agreement shall not be construed as a waiver of the right to assert such rights at a later time.
11.5 – These General Terms and Conditions of Sale for the Lineo Product, including the annexes, constitute the entire agreement between the Parties, superseding any prior oral or written understanding.
ARTICLE XII
Approval of specific clauses
12.1 – Pursuant to and for the purposes of Articles 1341 and 1342 of the Italian Civil Code, the Client hereby specifically approves the clauses contained in the following articles of the General Terms and Conditions of the contract: Art. I (Subject matter of the contract and LINEO treatments); Art. II (Fees and Payments); Art. III (Treatment plan objectives and preparation of LINEO VISION); Art. IV (Acceptance and Withdrawal); Art. V (Product shipment); Art. VI (Finishing); Art. VII (Treatment archiving period); Art. VIII (Warranties and Client Liability); Art. IX (Manufacturer’s Warranties); Art. XI (Miscellaneous).
Registered office: M-LABS VIALE MILANOFIORI – 20122 ASSAGO (MI) ITALY
Operational headquarters: M-LABS VIA G. GOVI 35 – 16036 AVEGNO (GE) ITALY +39 0185 79121