ODS Aligners™ terms & conditions

Introduction

The following terms and conditions (“Terms and Conditions”) constitutes a binding contract between You and Orthodontic Solutions (P) Ltd, a company with its principal place of business at E-1802, Sethi Max Royal, Sector 76, NOIDA 201307-India (“we”/“us”/“ODS”). You and ODS Aligners may each be referred to herein as a “Party” or collectively as the “Parties”. By placing an order with us, you agree to be bound by these Terms and Conditions.

Orders and virtual treatment setups

ODS Aligners™ manufactures custom orthodontic devices (“Appliances”) designed to adjust or retain the position of patients’ teeth based on doctors’ prescriptions. When both arches are being treated, a pair of Appliances (one for each arch) is referred to as a “set” (or “step”). When only one arch is being treated, one Appliance constitutes a set or step. You can prescribe Appliances on our website for doctors (“Doctor’s Portal”). You may restrict treatment to a specific number of Appliances, or allow us to recommend a number of Appliances appropriate for your prescribed goals, based on our standard movement protocols. If your prescription requires the design of new Appliances intended to move teeth(“active” Appliances), we will generate a 3D representation of the Appliances to be produced, based on your prescription (a treatment “setup”), for your approval. We won’t start producing Appliances until you approve a treatment setup. You will only be charged for treatment setups when you approve them. If you only prescribe Appliances intended to retain the position of teeth (“passive” Appliances) or reproductions of existing Appliances, a treatment setup will not be generated. An “order” is placed when a treatment setup is approved (or, if a treatment setup is not needed, when Appliances are prescribed). Payment is due in full when an order is placed. To the extent permitted by applicable law, overdue payments may be subject to finance charges computed at a periodic rate of1-1/2% per month (18% per year).Amounts owed by you with respect to which there is no dispute must be paid without setoff for any amounts which you may claim are owed by us and regardless of any other disagreements which may exist. You shall also pay or reimburse us for all costs and expenses (including reasonable attorneys’ fees) incurred or paid by us in collecting amounts due from you or in enforcing your obligations hereunder.

Product Portfolio


We offer three different pricing options:
  • Flexi: You pay for each setup that you approve and each appliance that you order. No complimentary revision aligners or retainers are included
  • ULTRA: For mild cases, including one revision with up, to 8 sets of aligners, and one set of retainers.
  • NON-COMPLEX: For moderate cases, including one revision, with up to 16 sets of aligners, and one set of retainers.
  • COMPLEX: For moderate to severe cases, including one revision with up to 24 sets of aligners, and one set of retainers.
  • EXTENDED: For severe cases, including one revision with up to 40 sets of aligners, and one set of retainers.
  • COMPREHENSIVE: You pay one flat rate, which covers as many setups and reasonable no. of appliances as you need to treat and retain the teeth of one patient for five full years (the “Unlimited Treatment” period). After Unlimited Treatment expires, you may order additional products at standard Flexi prices. You may select either pricing option, regardless of the number of appliances that you order. For more details, visit our website under product portfolio section or contact your clinician

Retainers

Retainers can either be based on a previous step or on new impressions or scans. During Unlimited Treatment, you may order up to two sets of retainers every six months at no additional cost. During ULTRA, NON-COMPLEX,COMPLEX & EXTENDED Treatment, you may order up to one set of retainers at the end of treatment, within one year of original case submission. All other retainers are available at standard Flex prices.

Revisions

If your patient’s teeth do not move as expected, you may request a “revision” for any patient treated with ODS Aligners™ Appliances. A new treatment setup will be created, starting from the current position. Minimal adjustments can be accommodated to the final set up during revision, like reducing expansion, overcorrection of rotation, or virtual elastics; but comprehensive re-planning of the final setup will not be possible except with the Unlimited treatment option. With the Unlimited treatment option, revisions are available at no additional cost for 5 years from original case submission. Under the ULTRA, NON-COMPLEX, COMPLEX & EXTENDED treatment options, one complimentary revision is included if case is submitted before the treatment expiry date. All other revisions are available at standard Flexi prices. Revisions may be based on new scans or impressions, or on a previous step.

Pricing

You can connect with your ODS account manager for the current pricing and packages. Products and prices are inclusive of taxes where permissible and assessed in a separate invoice in other instances. Prices are subject to change. We reserve the right to offer alternative products and pricing to individuals or groups at our sole discretion. We are not responsible for any taxes or fees that third parties may charge you, including foreign transaction fee or expedite courier fee or international courier fee.

Appliance Restrictions

We reserve the right to refuse to apply vouchers, coupons or volume discounts to select services or products at ODS’s sole discretion. We reserve the right to terminate our relationship with you; end Unlimited Treatment early without refund; if you fail to comply with these Terms and Conditions; or if you abuse these policies.

Volume discounts

You can connect with your ODS account manager for current pricing and discuss for volume discounts. Volume discounts may not be combined with other discounts

Cancellation and refunds

All sales are final. If an order is cancelled for any reason, we will not credit or refund any portion of the fees paid for that order.

Records

In addition to any required patient, provider, and treatment information, the following records must be provided in a timely manner. For all new patients: • Scans or PVS impressions of both arches • Photos from multiple angles (full face, smiling, profile, upper & lower occlusal, left & right lateral, and front) For any retainers that are not based on a previous step: • Scans or PVS impressions of requested arches All records must accurately represent the current condition of the patient’s teeth. You are solely and entirely responsible for the accuracy of the records you provide, and for maintaining same. Distorted or incomplete scans and impressions may impact the fit and performance of Appliances. We will not be liable for any issues caused by inaccurate records. Digital x-rays are recommended, but not required. Photos and x-rays may only be submitted via the Doctor’s Portal. Hard copies of records may be shipped to ODS Aligners or an authorized regional representative. These and all other submitted materials become the property of ODS Aligners™ and will not be returned. Additionally, any treatment records submitted through the doctor portal; included but not limited to STL files, physical impressions, bite registrations, x-rays, or any other submitted records become the property of ODS Aligners™ and will not be returned. Alginate impressions, stone models, and metal impression trays will be rejected

Shipment and delivery

After an order is placed, all Appliances will be shipped together (if purchased under Flexi, Ultra, Non-Complex pricing), or periodically in phases (if purchased under Complex, Extended & Comprehensive pricing). We shall not be liable for any damages, losses or expenses that you incur if we fail to meet targeted delivery dates. Title and risk of loss of all Appliances shipped to You are FOB shipping point.

Your representations

You represent and warrant to us that: (i) You are licensed to practice dentistry and/or orthodontics in the location(s) where, and at all times during which, treatment is being provided, and you conduct your practice in accordance with all dental laws, regulations and standards of care in effect and applicable to your practice location(s); (ii) You have all necessary training and expertise to treat patients using our products and Appliances; (iii) Your use of our products or Appliances will be in accordance with all applicable medical and dental standards and in compliance with our Instructions for Use; and (iv) You have properly explained the products and Appliances to your patients before starting treatment. (v) You have obtained the appropriate patient consent before starting treatment, including disclosure that You may share their medical records with third parties in order to facilitate treatment at your direction.

Warranties and disclaimer

ODS Aligners™ is a medical device manufacturer and does not practice dentistry or give medical advice. VDS(Virtual Diagnostic Simulation) software represents planned tooth movements based on the setup and does not reflect actual tooth movements; tooth movement data should be used as a reference only. You are solely responsible for prescribing and administering orthodontic treatment and maintaining all patient medical records. If you get access to Treatment Planning Services through the Doctor Portal please note that these services shall only be considered as recommendations and that the ultimate decision on whether or not to apply the Treatment Planning Services or to adapt them to the conditions of the specific patient remains with you as the treating doctor. Neither ODS Aligners™ nor any provider of Treatment Planning Services shall become liable for any damages, claims, liabilities etc. that may result or arise in context with the Treatment Planning Services provided to you. Clear aligner therapy is unpredictable. We do not guarantee a successful treatment outcome. Individual results will vary. We warrant that our products: (i) shall conform to the specifications represented in the treatment setup that you approve; and (ii) are free from defects in material and workmanship. We shall not be liable for: (i) any defects that are caused by neglect, misuse, or mistreatment of its products by you, the patient, or any third party; (ii) any defects that are caused by patients’ failure to follow directions including (but not limited to) wearing aligners out of sequence or wearing aligners for less than 22 hours per day; (iii) any products that have been altered or modified in any way by an individual or entity other than Us; (iv) any products being used in combination with other third party products; or (v) any defects that result from errors in your submitted records or prescription. The limited warranty for each Appliance expires 90 days after delivery date of the Appliance. Delays to a patient’s wear schedule after products are shipped do not extend the limited warranty period. If any ODS Aligners™ product fails to conform to the limited warranty set forth above, our sole liability, at our option, shall be to: (i) replace such product or Appliance; or (ii) credit your account for the cost paid for such product or Appliance. You may be required to return such product or Appliance in order to receive a replacement or credit. If we elect to replace such product or Appliance, replacements will be provided based on your account case profile and outlined turnaround times. If you have questions about your case profile please contact helpdesk@orthodonticsolutions.in. Replaced products or Appliances shall be covered under the limited warranty period described above. EXCEPT AS SET FORTH ABOVE, WE HEREBY EXPRESSLY DISCLAIM ANY AND ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY, OR FITNESS FOR ANY SPECIFIC PURPOSE.

Data privacy

The account information you provide through our Doctor’s Portal (including doctor or user names, specialties, degrees, training level, experience level, practice names, practice addresses, billing addresses, websites, contact information, payment methods and preferences, treatment methods and preferences and any other user information) is used to provide the products and services outlined herein, and may also be used to help patients identify You through our Doctor Locator service. In respect of your patient you are considered a separate controller for the health care services and treatments you provide and prescribe to your patient. ODS Aligners™ acts as a separate controller under applicable data protection laws and regulations for the patient data you provide to ODS Aligners for the specific purpose of processing and manufacturing the orders. For more information on how personal information will be processed by ODS Aligners™ and the Orthodontic Solutions (P) Ltd, please refer to the applicable Orthodontic Solutions (P) Ltd Privacy Policy accessible at any time on your Doctor Portal, and which you accepted before you placed an order on the Doctor Portal.

Limitations of liability

In no event shall we be liable for any consequential, incidental, indirect, exemplary, punitive or special damages in connection with or arising out of the use of the products provided hereunder, or breach of the Terms and Conditions however caused, and under any theory of liability whether in negligence, breach of warranty, strict liability, contract, tort, indemnity or any other cause or theory whatsoever. Excluded damages include loss of profits, loss of use and costs of replacement or substitute products. In no event shall our aggregate monetary liability for damages of any kind arising out of or in connection with or any use of any product provided hereunder, or breach of the Terms and Conditions exceed the total amount paid to us by you for the particular products sold for which losses or damages are claimed.

Indemnification You agree to indemnify, defend and hold harmless Orthodontic Solutions (P) Ltd and/or its officers, agents, employees, contractors, successors and assigns from and against any and all liability, obligations, losses, claims, actions, damages, penalties, fines, demands or suits and all related costs, attorney’s fees and expenses of any kind and nature whatsoever arising under any theory of legal liability (a ”Claim”) that may be asserted against us arising out of, or resulting from, or relating to: (i) use of products sold under this agreement; (ii) any breach of or failure of you to abide by any of the Terms and Conditions; (iii) any breach or alleged breach of any representations or warranties made by you or any incorrect information provided by you or your patient; or (iv) our provision of or failure to provide products or Appliances to you, unless the provision of or failure to provide such products or Appliances was due to our willful misconduct or gross negligence. Your obligation to defend us against any Claim is separate and distinct from the obligation of indemnity set for thin this above. You have the right and obligation to assume the defense of any Claim with counsel chosen by you and reasonably acceptable to Orthodontic Solutions (P) Ltd provided that counsel to Orthodontic Solutions (P) Ltd may participate in the defense of the Claim with counsel for you, at our expense. You will not have the right to assume the defense of a Claim made against both Orthodontic Solutions (P) Ltd and you if counsel for Orthodontic Solutions (P) Ltd advises in writing that a conflict in interest between Orthodontic Solutions (P) Ltd and you would under applicable ethical principles preclude a single counsel or firm from defending both Parties.Relationship of parties The Parties are and at all times shall be an independent party and not the agent or employee of ODS. Neither these Terms and Conditions nor any contract with ODS nor any course of dealing or practice shall be interpreted as creating, or shall be deemed to create, any employer-employee, principal-agent, partnership, joint venture or other relationship between you and ODS. Assignment These Terms and Conditions shall not be assigned by either Party hereto without the prior written consent of the other Party. Successor and assigns These Terms and Conditions shall be binding upon and shall inure solely to the benefit of the Parties hereto and their respective successors and shall not be for the benefit of any other person, persons, or legal entities. Entire agreement and amendment These Terms and Conditions, your prescription, and the Patient Informed Consent Form shall constitute and contain the entire agreement of the Parties and supersede any and all prior negotiations, correspondence, understandings and agreements between the Parties respecting the subject matter hereof, unless otherwise specified inwriting by an authorized representative of ODS. These Terms and Conditions can only be modified by an authorized representative of ODS. Severability If any provision of these Terms and Conditions is or shall be deemed a violation of any applicable law, rule or regulation, such legal invalidity shall not void or affect the remaining terms and provision of these Terms and Conditions. Force majeure We cannot be in default or breach by reason of any failure of its performance under this agreement if such failure results, whether directly or indirectly, from fire, explosion, strike, freight embargo, act of God, or of war, civil disturbance, act of any government, epidemic, pandemic or other occurrences beyond our control. Notices All notices, demands, requests, approvals and other communications given or made pursuant hereto shall be in writing and shall be deemed to have been given or made as of the date delivered or mailed if delivered personally or mailed by certified mail(postage prepaid, return receipt requested), or on the date transmitted if transmitted by facsimile or electronic mail, to You, at the address You provide. Waiver The failure of either Party at any time or times to require performance of any provision hereof shall in no manner affect the right to enforce the same. No waiver by either Party of any condition, or of the breach of any term, provision, covenant or warranty contained in these Terms and Conditions , shall be deemed to be or construed as a further or continuing waiver of any such condition or breach or a waiver of any other condition or of the breach of any other term, provision, covenant or warranty. Governing law These Terms and Conditions shall be construed and governed under and by the laws of the State of Uttar Pradesh, India. The Parties agree that the exclusive venue for any legal action authorized hereunder shall be in Prayagraj, U.P