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PATIENT NOTICE

Last Modified: 31 July 2020

LEGAL NOTICES TO PATIENTS IN THE SIX MONTH SMILES® EVERYONE™ PROGRAM

THIS DOCUMENT CONTAINS VERY IMPORTANT INFORMATION REGARDING YOUR RIGHTS AND OBLIGATIONS, AS WELL AS CONDITIONS, LIMITATIONS AND EXCLUSIONS THAT APPLY TO YOU. PLEASE READ IT CAREFULLY.

THESE TERMS AND CONDITIONS (THESE “TERMS”) APPLY TO THE PURCHASE AND SALE OF SIX MONTH SMILES’ PRODUCTS AND SERVICES, INCLUDING SALES MADE THROUGH OUR WEBSITES https://www.sixmonthsmiles.com AND/OR http://www.6monthsmiles.com (COLLECTIVELY, THE “SITE”). BY PLACING AN ORDER FOR OUR PRODUCTS OR SERVICES OR BY CLICKING TO ACCEPT OR AGREE TO THESE TERMS WHEN THAT OPTION IS MADE AVAILABLE TO YOU ON OUR SITE, YOU ACCEPT AND ARE BOUND BY THESE TERMS. THESE TERMS ARE ENTERED BY AND BETWEEN YOU AND SMS OPCO, LLC (“6MS”, “WE”, “OUR” AND “US”).

YOU MAY NOT ORDER OR OBTAIN PRODUCTS OR SERVICES FROM 6MS IF YOU (A) ARE UNDER THE AGE OF 18; (B) RESIDE OUTSIDE THE UNITED STATES OR ITS TERRITORIES; ( OR (C) TO THE EXTENT YOU ARE PURCHASING PRODUCTS OR SERVICES FROM OUR SITE, ARE PROHIBITED FROM ACCESSING OR USING THE SITE OR ANY OF THE SITE’S CONTENTS, PRODUCTS OR SERVICES BY APPLICABLE LAW.

THESE TERMS ARE SUBJECT TO CHANGE WITHOUT PRIOR WRITTEN NOTICE AT ANY TIME, IN OUR SOLE DISCRETION. THE LATEST VERSION OF THESE TERMS WILL BE POSTED ON OUR SITE, AND YOU SHOULD REVIEW THESE TERMS PRIOR TO PURCHASING ANY PRODUCT OR SERVICES.

THESE TERMS ARE AN INTEGRAL PART OF THE WEBSITE TERMS OF USE THAT APPLY GENERALLY TO THE USE OF THE SITE. YOU SHOULD ALSO CAREFULLY REVIEW 6MS’ PRIVACY POLICY HTTPS://WWW.6MONTHSMILES.COM/LEGAL/WEBSITE-PRIVACY-POLICY BEFORE USING THIS SITE OR ANY OF ITS FEATURES.

 

1. Introduction and Services

6MS has developed an approach to guided orthodontic treatment using clear aligners, that is focused on improving your smile by gently straightening and aligning your teeth. Working in conjunction with a licensed provider (your Dentist or Orthodontist), 6MS utilizes digital scanning, computer aided software and 3D printing to produce the 6MS Patient Tray Kit. Our CONFIDEX™ Treatment planning is also included with the Aligner PTK.

 

Aligners PTK: The 6MS Aligners Patient Tray Kit (or “PTK”) contains a plurality of aligners, aligner template(s) to bond attachments, dental supplies to help with the procedure, patient take home kit to manage at-home care of their aligners and detailed instructions. The PTK also includes CONFIDEX™ Digital Treatment Planning.

1.1.     CONFIDEX™ Treatment Planning: CONFIDEX™ is a computerized approximation of desired tooth movement for a specific patient, prepared by a specially trained orthodontist. CONFIDEX™ simulations are prepared for fixed appliances, mixed appliances and aligner cases. CONFIDEX™ software results are simulated approximations and actual clinical results may vary. Your provider must review the CONFIDEX™ treatment plans thoroughly. Your provider’s approval of the customized CONFIDEX™ treatment plan is considered a prescription to 6MS and 6MS’ final authorization to manufacture the Patient Tray Kit. 6MS recommends that your provider delays extraction of any teeth until after approval of the CONFIDEX™ treatment plan, if medically feasible. Note that CONFIDEX™ treatment planning is not provided if the case is deemed to be out of scope for Six Month Smiles® treatment, and you will not be charged. CONFIDEX™ includes each of the following:

1.2.     CONFIDEX 360® Viewer: The CONFIDEX 360® Viewer is an interactive, on-line program that allows your provider to evaluate your proposed treatment plan and projected outcome. It is a tool to be used by Provider as part of Provider’s complete diagnosis and treatment of you. Results that may be achieved by using a portion or all of the CONFIDEX™ treatment plan will depend on your compliance and on Provider’s own examination, diagnosis, and treatment to the particulars of the individual case.

1.3.     Treatment Planning: A treatment plan with instructions for Inter-Proximal Reduction ( or “IPR”), biteguards, auxiliaries (if applicable), and attachment locations are included in the PTK. The treatment plan is also available to review/ download on the Provider Resource Center. Provider approval is required in order to proceed with final case fabrication

Retainers: 6MS offers multiple types of retainers, bonded lingual wire retainers, clear removable retainers and Hawley retainers. All retainers are fabricated based on the standard 6MS protocols. Modifications as requested by your provider on the 6MS online script will be included to the degree possible given patient anatomy and based on the quality of the impressions (PVS or digital) provided by your provider. Deviations from protocol or from the provided script will be documented and communicated to your provider prior to completion of the retainer. One set of clear removable retainers are included with the Aligners PTK as part of the Six Month Smiles® EVERYONE™.

2. Payment

Your provider will order the products and services. You have arranged for payment for the products with a third party provider, ClearGage®. ClearGage® is not affiliated in any way with 6MS, and 6MS makes no representations or commitments to you with regard to the terms and conditions of your transactions with ClearGage®. Additional fees may apply if a shipping method is requested other than 6MS’ standard shipping procedure. Prices and other terms and conditions are subject to change by 6MS without prior notice (but will not be varied with respect to a particular order once such order has been placed). Unless otherwise agreed to by 6MS in writing, all fees and costs will be charged in U.S. dollars, and 6MS will not be responsible for any foreign currency exchange fees.

3. Cancellations

Once an order has been submitted by your provider using the 6MS online order system, or other acceptable means at the discretion of 6MS, the order is considered binding and cannot be cancelled. You will be responsible for payment of the full amount of the order once CONFIDEX™ treatment plan has been approved by your provider.

4. Shipping

The Aligners PTK will be shipped to your Provider within approximately ten business days of approval of the CONFIDEX™ treatment plan. 6MS will make reasonable efforts to contact your Provider within four days of order receipt if the order submission is not complete or if the impressions/scans are incomplete or insufficient. Incomplete order submissions will result in delays in manufacturing and shipping of products. Upon shipment, the Patient Tray Kit or retainers are non-returnable and related fees are non-refundable (other than where such items are damaged or defective due to a fault in manufacturing or handling by 6MS).

5. Records

Your provider may require your consent in order for records to be disclosed to 6MS in accordance with these Terms. For the avoidance of doubt, such consent should include approval for transmission of records to a jurisdiction outside of the United States or the European Economic Area. 6MS will comply with the applicable requirements of relevant laws, which may include obligations to provide personal information that 6MS holds about a patient to such patient on request by such patient.

 

Subject to applicable law, records submitted to 6MS become the property of 6MS and will not be returned to the provider. For cases shipped to 6MS from a US address, 6MS may choose to return case records, such as impression material to your provider. Records such as impressions and intra-oral scans require inspection, and 6MS may deem such records unacceptable. If deemed unacceptable, 6MS may request replacement records. 6MS will maintain physical materials such as impressions and study models only for a short time period, until they are discarded and/or archived at the discretion of 6MS.

6. Patient Tray Kit and Ancillary Products Limited Warranty

Each party acknowledges that local, state and federal laws may imply certain conditions and warranties into these Terms and confer certain rights and remedies that cannot be excluded or modified (“Rights”). Nothing in this Section or otherwise in these Terms excludes or modifies any of those rights if to do so would contravene such rights or make any part of these Terms void.

6MS WARRANTS THAT ALL PATIENT TRAY KITS AND THEIR CONTENTS, RETAINERS, TOOLS AND ANCILLARY SUPPLIES ARE FREE FROM DEFECTS IN MATERIAL AND WORKMANSHIP WHEN USED PROPERLY IN THE APPLICATIONS FOR WHICH THEY WERE INTENDED.

EXCEPT AS PROVIDED IN THIS SECTION, 6MS MAKES NO WARRANTY OF ANY KIND, WHETHER EXPRESS, IMPLIED, STATUTORY OR OTHERWISE WITH RESPECT TO 6MS

TREATMENT OPTIONS AND/OR PRODUCTS OR SERVICES OR THE OUTCOME OF TREATMENT WITH SUCH TREATMENT OPTIONS AND/OR PRODUCTS OR SERVICE. SIX MONTHS SMILES SPECIFICALLY DISCLAIMS ALL IMPLIED WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT AND ANY OTHER IMPLIED WARRANTIES.

Where 6MS (i) cannot exclude any express or implied condition or warranty or Rights, or (ii) the Patient Tray Kit fails to conform to the warranty in this Section, then 6MS’ sole and exclusive liability (other than in circumstances where by law, liability cannot be limited) and Provider’s sole and exclusive remedy is, at the sole discretion of 6MS, (a) to repair or replace the products or (b) to pay the cost of having those products repaired or replaced.

No representative, employee or agent of 6MS is authorized to incur warranty obligations on behalf of 6MS or modify the limitations set forth herein.

THESE WARRANTIES ARE VOID IF THE PATIENT TRAY KIT, RETAINERS, OR OTHER PRODUCTS OR SERVICES HAVE BEEN MISUSED, MODIFIED OR HAVE BEEN USED IN COMBINATION WITH OTHER THIRD-PARTY PRODUCTS. NO WARRANTY IS MADE REGARDING THE OUTCOME OF ANY TREATMENT USING THE PRODUCTS OR ANY COMBINATION OF 6MS PRODUCTS OR SERVICES WITH THIRD-PARTY PRODUCTS.

Returns, complaints, or other feedback on 6MS products or services should be directed to the Customer Experience Department at 1-866-957-7645 or customercare@sixmonthsmiles.com for authorization to return for inspection and determination of replacement.

7. Provider Responsibility and Product Usage

6MS is not a provider of medical, dental or health care services and does not and cannot practice medicine, dentistry or give medical advice. 6MS offers services containing factual advice and documentation for use by your provider in creating or evaluating the effectiveness of a proposed treatment plan and/or use of a Patient Tray Kit. The services are not a substitute for dental or medical advice, and your provider has the sole responsibility for evaluating whether a treatment plan is appropriate for you. Following digital treatment planning guidance does not guarantee a successful or safe outcome. Individual results may vary, and conditions may become apparent that warrant additional or alternative treatment that deviate from the treatment plan. In some cases, additional dental procedures may be necessary to complete treatment. 6MS does not make any guarantees or assurances concerning the outcome of any treatment and assumes no liability or responsibility for treatment plans. It is your provider’s responsibility to adhere to relevant state, national, and local laws and regulations and any professional obligations regarding patient care or otherwise.

In certain, but rare, circumstances, 6MS may not be able to adhere to the specifications of a treatment guidance plan or your provider’s prescription. In those situations, 6MS will not initiate, edit or modify a patient’s treatment guidance plan nor modify Provider’s prescription unless otherwise noted by 6MS on a Lab Deviation Form, which will be returned to your provider with the completed case.

6MS may, from time to time, provide information or recommendations to your provider and his/her staff however, 6MS will not control or pressure your provider in the exercise of his or her professional judgment. Decisions about your treatment are to be made by your provider and your provider is solely responsible for review and approval of treatment plans to determine whether 6MS products and/or treatment options are appropriate for you. Some 6MS products and/or treatment options offerings incorporate default or preset treatment staging protocols, which are accepted by the provider as part of the provider’s prescription when submitting an order to which these protocols apply. Information about treatment staging protocols can be accessed via the 6MS doctor site at time of order submission. It is within your provider’s sole discretion to implement any of 6MS’ recommendations, including but not limited to proceeding with order submission. Each order is subject to acceptance by 6MS and will become a binding contract only if accepted by 6MS.

7.1. Contraindications and general guidelines for using Six Month Smiles® orthodontic appliances

The statements bulleted below apply to Six Month Smiles® (6MS) aligners unless otherwise noted.

7.1.1.    Not to be used by individuals who are allergic to plastics.

7.1.2.   Orthodontic therapy is not advised for patients with active periodontal disease.

7.1.3.   During orthodontic therapy, call your dentist or seek medical care and attention if you:

7.1.3.1.     During orthodontic therapy, call your dentist or seek medical care and attention if you:

7.1.3.2.   Experience persistent joint paint, headaches or ear problems

7.1.3.3.   Swallow or aspirate your aligner or brackets

7.1.4.    Tooth decay, permanent stains/decalcification and periodontal disease (inflammation of the gums) may occur if proper oral hygiene is not followed and preventive maintenance is not followed.

7.1.5.     Sensitivity and tenderness to teeth may occur during treatment

7.1.6.     The health of gums and bone, both of which support your teeth, can be affected by orthodontic treatment.

7.1.7.   Orthodontic appliances can aggravate teeth; previously traumatized, significantly restored or not. In rare occurrence, additional dental treatment Orthodontic appliances can aggravate teeth; previously traumatized, significantly restored or not. In rare occurrence, additional dental treatment

7.1.8.     Root resorption (shortening of the root of the tooth) can occur during any orthodontic treatment, which can result in a threat to the longevity of the teeth.

7.1.9.   Uncharacteristically shaped teeth and missing teeth can potentially extend treatment time and may affect the potential to achieve desired results.

7.1.10.   Existing fixed dental restorations (crowns, bridges) may become dislodged during orthodontic appliance wear and may require re-cementing or replacement.

7.1.11.   Any new fixed dental restorations placed during aligner treatment may result in the need for a revised treatment plan and new aligner(s).

7.1.12.   Orthodontic appliances are not effective in the movement of dental implants.

7.1.13.   Certain medications and medical conditions can affect orthodontic treatment. Consult your physician before beginning treatment.

7.1.14.   Orthodontic appliance wear may temporarily affect speech, resulting in a slight lisp.

7.1.15.   Patients may experience an increase in salivation or dryness of the mouth.

7.1.16.   Extended treatment time may occur as a result of poor compliance to doctor’s instructions, wearing aligners less than the prescribed hours, missing appointments, poor oral hygiene, excessive bone growth, or broken appliances. Increased cost and/or the ability to achieve the desired results may occur.

7.1.17.   Some treatment plans may require “attachments” (small bumps of tooth colored composite material) to be temporarily bonded to one or more teeth to assist with tooth movement. These are critical to proper movement and should be replaced if they fall off. All “attachments” will be removed upon treatment completion.

7.1.18.   In the presence of severe crowding, interproximal reduction (IPR – reducing the thickness of enamel on the tooth) may be required to produce enough space for proper tooth movement and alignment. Risk associated with IPR as part of treatment should be considered.

7.1.19.   Throughout the course of treatment, the bite will change and may result in temporary patient discomfort in the jaw joint. Although rare, patient may experience Patients should inform doctor if any of these symptoms occur.

7.1.20.   At the end of the treatment, it may be necessary to make adjustments to the bite.

7.1.21.   All teeth should be at least partially covered by aligners to avoid supra-eruption of teeth.

7.1.22.   Other fixed and/or removable orthodontic appliances may be required for more complicated treatment plans where aligners alone will not be adequate to achieve the desired outcome.

7.1.23.   Some cases may be out of scope for Six Month Smiles® orthodontic therapy

7.1.24.   Once treatment has been completed, teeth may shift positions if proper and consistent wearing of retainers is not followed.

Upon completion of orthodontic treatment, some cases may require enhancement with additional aligners, and/or cosmetic restorations such as veneers or crowns to complete ideal results. Successful treatment outcome cannot be guaranteed.

8. Liability

OTHER THAN LIABILITY REFERRED TO IN THE FOLLOWING PARAGRAPH, IN NO EVENT WILL 6MS TOTAL CUMULATIVE LIABILITY ARISING OUT OF OR RELATED TO THESE TERMS UNDER ANY THEORY OF LAW EXCEED THE SUM OF FEES PAID OR PAYABLE FOR SUCH 6MS PRODUCT OR SERVICES. THE EXISTENCE OF ONE OR MORE CLAIMS SHALL NOT EXPAND SUCH LIMIT. IN NO EVENT WILL 6MS, ITS LICENSORS OR SUPPLIERS BE LIABLE TO YOU OR TO ANY THIRD PARTY FOR ANY INDIRECT, SPECIAL, INCIDENTAL, EXEMPLARY, PUNITIVE OR CONSEQUENTIAL DAMAGES HOWEVER CAUSED AND UNDER ANY THEORY OF LIABILITY WHETHER IN CONTRACT, TORT, INDEMNITY OR OTHER CAUSE OR THEORY WHATSOEVER (INCLUDING NEGLIGENCE, DELAY IN DELIVERY, INJURY TO REPUTATION, GOOD WILL, ETC.), WHETHER OR NOT 6MS HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. IN NO EVENT

WILL 6MS, OR ANY OF ITS LICENSORS OR SUPPLIERS HAVE ANY LIABILITY FOR ANY LOST PROFITS, LOSS OF DATA, LOSS OF USE OR COSTS OF PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES.

The following claims against 6MS and its employees, agents, contractors, officers or directors are hereby waived by you: (i) claims based on the failure of 6MS products to achieve a successful or desirable outcome; and (ii) injury, either alone or in combination with other treatment appliances.

9. Force Majeure

6MS will not be deemed to be in breach of these Terms for any failure or delay in performance caused by or results from reasons beyond its reasonable control, if 6MS makes reasonable efforts to perform.

10. Governing Law and Jurisdiction

These Terms will be governed by and construed in accordance with the internal laws of the State of Delaware without giving effect to any choice or conflict of law provision or rule (whether of the State of Texas or any other jurisdiction) that would cause the application of laws of any jurisdiction other than those of the State of Delaware. Any legal suit, action or proceeding arising out of or related to these Terms or 6MS products and services will be instituted exclusively in the federal courts of the United States or the courts of the State of Texas, and each party irrevocably submits to the exclusive jurisdiction of such courts in any such suit, action or proceeding; provided, however, upon the election of the parties, the parties may submit any dispute and other matter in question arising out of, or relating to these Terms or the performance thereof, to binding arbitration.

11. No Waiver

The failure of either party at any time to require performance by the other party of any provision will not affect in any way the full right to require such performance at any time thereafter.

12. Severability

If any provision of these Terms is held by a court of competent jurisdiction to be contrary to law, such provision will be changed by the court and interpreted so as to best accomplish the objectives of the original provision to the fullest extent allowed by law and the remaining provisions of these Terms will remain in full force and effect.

13. Termination and Modification; Survival

6MS reserves the right to cancel these Terms or refuse an order of product for any reason at any time. These Terms supersede all prior communications, whether oral or written, by any officer, employee, or representative of 6MS, and prevail over any conflicting or additional terms of any quote, order, invoice or other communication. Provisions of these Terms which by their nature should apply beyond their terms will remain in force after any termination or expiration of these Terms including, but not limited to, the following Sections: Section 7 (Provider Responsibility and Product Usage), Section 8 (Liability), and Section 10 (Governing Law), and this Section.

14. Third Party

These Terms are not intended to confer any rights or remedies against 6MS upon any person other than you.

15. Notice

All notices, requests, consents, claims, demands, waivers and other communications hereunder shall be in writing and shall be deemed to have been given (a) when delivered by hand (with written confirmation of receipt); (b) when received by the addressee if sent by a nationally recognized overnight courier (receipt requested); or (c) on the third day after the date mailed, by certified or registered mail, return receipt requested, postage prepaid to 6MS at the following address:

6270 Morning Star Drive, Suite 120,
The Colony, TX 75056
Attention: President and Chief Executive Officer