Master Surgical Agreement Terms

ROE Dental Laboratory and Clinician Agreement and Limited Warranty Statement

This Clinician Agreement and Limited Warranty Statement contains the terms to which each clinician acknowledges and agrees for the purchase and use of ROE Dental Laboratory's (Company) services and products.

WHEREAS, the Company provides products and services to the dentists, clinicians, laboratory and medical professionals (“Customer”) based upon records Customer provides and acknowledges as accurate, for a variety of dental and oral surgeries (“Surgical Guide”) and provides a surgical plan for the Surgical Guide (“Surgical Plan”);

WHEREAS, Company, desires Customer, ordering items such as, but not limited to, GuidedSMILE Chrome, GuidedSMILE Lite, CombiGuides, Surgical Guides, immediate load surgical prosthetics, scan appliances, and all related supplies, components, and dental devices (all, a “Device”), satisfaction with the Device(s) Customer purchases.

WHEREAS, the Customer desires to engage the Company for the supply of Surgical Plans and related Devices and the Company desires to provide Costumer the same pursuant to the terms herein;

NOW THEREFORE, in consideration of the above recitals and the covenants and promises hereinafter set forth, Company and Customer agree by their engagement with each other under this Agreement as follows:

Pre-Warranty Remedies

If a Device is not acceptable at the time of receipt or at the time of use or insertion, barring general limitations or limited warranty period conditions described below and provided prior Device history does not reveal an unwarranted order, Company shall adjust, repair, or replace the Device at its discretion at no charge, preserving the full limited warranty period. Limited warranty conditions and periods are listed below.

Limited Warranty

Company’s limited-service warranty covers each Device in use, against defects in workmanship and materials by adjustment, repair, or replacement of the Device only. If unsatisfactory material performance is experienced within the service warranty period, the repair or replacement of the Device, excluding clinical costs, is covered. In this event, the remainder of the warranty period from the original date of invoice remains intact.

Conditions to Warranty

To make a warranty claim, return the Device together with an explanation of the problem and your request for a Device adjustment, repair, or replacement. The original work authorization (or evidence of original purchase) must be included with a new completed work authorization and new Device models, the original Device and models must be returned including all original alloy (if applicable). The limited warranty will not be given if the complete work is not paid in full and the customer has an outstanding balance. ROE Dental Laboratory maintains the sole right to decide if adjustment or replacement of the Device is appropriate for the desired correction.

The Customer will provide the Company with patient records including but not limited to digitally imaged data or DICOM data (“Data”), files of the patient’s dentition ( STL ), photographs, and physical impressions and/or models for the patient. From this Data, the Company will prepare a preliminary virtual surgery for the Customer. The preliminary virtual surgery will be reviewed, modified and approved by the Customer. Upon the Customer’s approval and submission of the Work Authorization Form, the Company will obtain or manufacture the requested Surgical Guide and/or the requested Surgical Plan. Customer acknowledges Company’s reliance on the same. It is the sole responsibility of the Customer to inspect and approve the Surgical Guide and Surgical Plan and notwithstanding the limited warranties and periods for the same stated herein, Company shall assume no responsibility for errors or omissions in the Data or for liabilities caused by its reliance thereon.

The term “Scan Appliance” refers to the appliance that is used in select situations and is placed in the patient’s mouth while the CT or MRI is taken. It is from this scan that the Data is produced. Notwithstanding the limited warranty and periods for the same stated herein, if a Scan Appliance manufactured by a third party is used, and/or models from which the Scan Appliance is made is not provided to the Company for fit verification of the Surgical Guides, the Company is not responsible for inaccurate or defective Surgical Guides and/or Surgical Plans.

The Customer agrees to take full medical responsibility for the design and the application of the Surgical Plan and Surgical Guide. Customer represents that it is solely responsible for inspecting and approving the Surgical Guide and Surgical Plan and any requested changes thereto.

Limited Warranty Periods

ROE Dental Laboratory CombiGuides and Surgical Guides are intended for short term in the office surgical use only and warranted against defects for the time they are in use but no more than 30 days from the day of invoice. These temporary surgical appliances are subject to ill-fit caused by tooth movement, tooth wear or damage, skeletal, or muscular changes. All limited warranty periods begins on the date of invoice, not the insertion date.

Immediate load surgical prosthetics are warranted against defects for 120 days from the date of invoice from breakage, discoloration, or significant wear.

Supplies and components may be returned if unopened and unused in the original packaging within 90 days. Non-single-use products are warranted against defects for 30 days from date of invoice and may be returned (or a pictured emailed) for replacement or credit.

To obtain warranted coverage, please return all working models, previous impressions, and original product for evaluation. If a discrepancy arises you may be subject to additional fees. If the original product is not returned, the replacement product will be invoiced until the product is returned.

Customer Representations

If the Customer is the end user dentist, the Customer represents that he or she is a licensed dental professional qualified to (1) order the Data and review it for accuracy (2) review and approve the Surgical Plan and (3) to perform the dental procedures outlined in the Surgical Plan and/or to use the Surgical Guide. If the Customer is not the end user dentist, the Customer represents that (1) it is qualified to order the Data, Surgical Guide and Surgical Plan and review and approve them for accuracy and (2) that the end user dentist is a licensed dental professional qualified to review and approve the Surgical Guide and/or Surgical Plan and to perform the dental procedures outlined in the Surgical Plan and/or to use the Surgical Guide.

Disclaimer of All Other Warranties

ROE Dental Laboratory provides all Devices according to specifications as submitted to the lab. EXCEPT FOR THE EXCLUSIVE LIMITED WARRANTY OF ADJUSTMENT REPAIR AND REPLACEMENT FOR DEFECTS IN WORKMANSHIP AND MATERIALS AS PROVIDED ABOVE, ROE DENTAL LABORATORY HAS NOT MADE AND DOES NOT MAKE ANY OTHER WARRANTY OR REPRESENTATION WHATSOEVER, EITHER EXPRESSED OR IMPLIED, ORAL OR WRITTEN AS TO THE FITNESS, CONDITION, MERCHANTABILITY, DESIGN OR OPERATION OF ANY DEVICE, ITS FITNESS FOR ANY PARTICULAR PURPOSE, THE QUALITY OR CAPACITY OF MATERIALS IN THE DEVICE OR WORKMANSHIP IN THE DEVICE, NOR ANY OTHER REPRESENTATION OR WARRANTY WHATSOEVER. ROE Dental Laboratory shall not be liable to Customer for any loss, damage, or expense of any kind or nature caused, directly or indirectly, by the surgical insertion of the Device, the use thereof, or the failure or operation thereof.

Except where prohibited by law, ROE Dental Laboratory WILL NOT BE LIABLE FOR ANY LOSS OR DAMAGES ARISING FROM THE USE OF A DEVICE, WHETHER DIRECT, INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL, regardless of the theory asserted, including warranty, contract, negligence, medical malpractice, product liability, or strict liability and if such disclaimer is not permitted by law, the duration of any implied warranty is limited to the periods stated above.

Customer agrees and understands: that neither ROE Dental Laboratory nor its directors, officers, shareholders, partners or employees (collectively, “representatives”) is an insurer; that Customer currently has and shall always maintain insurance covering the Customer for use/insertion of a Device; that recovery for all such loss, damage and expense of insertion shall be limited to Customer and any such insurance coverage; and that ROE Dental Laboratory AND ITS REPRESENTATIVES ARE RELEASED FROM ALL LIABILITY, INCLUDING CONSEQUENTIAL AND INCIDENTAL DAMAGES, DUE TO ACTIVE OR PASSIVE SOLE, JOINT OR SEVERAL NEGLIGENCE OF ANY KIND OR DEGREE, BREACH OF CONTRACT, EXPRESS OR IMPLIED, BREACH OF WARRANTY, EXPRESS OR IMPLIED, OR BY LOSS OR DAMAGE RESULTING FROM INSERTION OF THE DEVICE OR THE DEVICE ITSELF.

CUTOMER’S REMEDIES UNDER THIS AGREEMENT ARE LIMITED EXCLUSIVELY TO ADJUSTMENT, REPAIR AND/OR REPLACEMENT OF THE DEVICE AS INDICATED IN THE EXPRESS LIMITED WARRANTY.

It is expressly understood and agreed that each and every provision of this Agreement which provides for the limitation of liability, disclaimer or warranties or exclusion of damages, is intended by the parties to be severable from any other provision and is a severable and independent element of risk allocation and is intended to be enforced as such with all other provisions hereof intended to be enforceable independently.

Indemnification

Customer shall indemnify, defend (with attorneys of ROE Dental Laboratory’s choice), and hold ROE Dental Laboratory harmless from (without any condition that ROE Dental Laboratory or representatives first pay) all losses, and claims for damages and expenses including, without limitation attorney’s fees, which may be asserted against or incurred by ROE Dental Laboratory or its agents, officers, and representatives. made by any third parties including the Customer’s patients, insurance company, and any third parties for (i) breach of contract or warranty, express or implied; (ii) active or passive sole, joint or several negligence of any kind or degree; (iii) product or strict liability; or (iv) a claim for indemnification or contribution.

Modification or Withdrawal of the Limited Warranty

ROE Dental Laboratory reserves the right to modify or withdraw this limited warranty statement at any time without notice. Any such modification or withdrawal will be made in a writing which will apply prospectively to new purchases and will not affect Devices already installed and fully paid by the Customer to ROE Dental Laboratory.

Miscellaneous Terms

This limited warranty Statement constitutes the entire agreement and understanding between Customer and ROE Dental Laboratory, superseding any prior agreements and understandings, and governs Customer’s use of ROE Dental Laboratory’s Devices and/or services. Customer also may be subject to additional terms and conditions that may apply when Customer uses affiliate services, third-party labs, or third-party devices or implants. ROE Dental Laboratory’s failure to enforce or exercise any right or provision of this Statement shall not constitute a waiver of such right or provision. If any provision of this Statement shall be unlawful, void, or unenforceable for any reason, the other provisions (and any partially enforceable provision) shall not be affected thereby and shall remain valid and in full force and effect. Customer agrees that this Statement and any other agreements referenced herein, including ROE Dental Laboratory’s General Conditions of Sale, are valid and enforceable and may be assigned by ROE Dental Laboratory, in it’s sole discretion, to a third party in the event of a merger or acquisition. The section titles and headings are for convenience only and have no legal or contractual effect. No changes, modifications, or adjustments to the terms and conditions of these warranty terms are valid unless made in a writing by ROE Dental Laboratory and specifically referencing a change to these terms and conditions.

No agency, partnership, joint venture, employee-employer, or franchiser-franchisee relationship is intended or created by this Agreement.

Any rights not expressly granted herein are reserved by and for ROE Dental Laboratory.

Certain sections in this Agreement may contain references to separate terms and conditions, which are in addition to this Agreement. In the event of a conflict, the additional terms and conditions will govern those sections.