Terms and Conditions of Sale
EZ Align® Systems
U.S.A. Doctor Direct
- Effective Date of Terms and Conditions; Modification; Website
These Terms and Conditions of Sale (“Terms”) are effective for all purchases and orders placed by any buyer (“Buyer” or “You”) with Ortho Solutions, LLC (“DynaFlex” or “Company” or “we/us”) on or after September 6, 2019 (the “Effective Date”). Unless otherwise agreed in writing by DynaFlex, on and after the Effective Date, these Terms will supersede all prior terms and conditions regarding the purchase by Buyer and sale by DynaFlex of any and all dental or medical devices or other dental or medical products manufactured or sold by DynaFlex (the “Products”). Dyna Flex reserves the right to further modify these Terms from time to time (the “Modified Terms”) either upon written notification to Buyer by U.S. mail, electronic mail or by posting any changes on the EZ Align website (www.ezalign.com) (the “EZ Align website”), with the most current terms on the website and the Effective Date of these Terms to be at the time Buyer thereafter places an order or purchases the Products. THE MODIFIED TERMS SHALL BE EFFECTIVE FOR ALL ORDERS PLACED BY BUYER AND ALL PURCHASES WITH DYNAFLEX ON OR AFTER THE EFFECTIVE DATE SET FORTH THEREIN. BUYER SHALL BE DEEMED TO HAVE ACCEPTED THESE TERMS AND ANY MODIFIED TERMS UPON THE EARLIER TO OCCUR OF (1) BUYER SIGNING OR OTHERWISE AUTHENTICATING THESE TERMS OR (2) BUYER CONTINUING TO USE THE WEBSITE AND/OR PLACING AN ORDER WITH DYNAFLEX OR MAKING A PURCHASE FROM DYNAFLEX BY ANY METHOD AFTER THE APPLICABLE EFFECTIVE DATE. PLEASE NOTE THAT BY ACCESSING OR USING ANY PART OF THE WEBSITE OR PLACING ANY ORDER OR MAKING ANY PURCHASE, BUYER AGREES THAT BUYER HAS READ, UNDERSTANDS AND AGREES TO BE BOUND BY THESE TERMS AND ANY MODIFIED TERMS, INCLUDING THE APPLICABLE LAW AND VENUE PROVISIONS. IF BUYER DOES NOT AGREE TO BE SO BOUND, BUYER SHOULD NOT ACCESS OR USE THE WEBSITE OR MAKE A PURCHASE FROM DYNAFLEX.
- The Practice of Buyer
Our customer is the doctor who orders the Product and not the doctor’s patient. If a practice, partnership, corporate body or other legal entity for or with which the doctor works is named on the invoice and/or that practice pays the invoice(s), then we are entitled to assume that it is the doctor who uses the EZ Align system and places orders with the authorization of, for and on behalf of that entity (the ”Practice”). Under these circumstances the Practice will also be our customer, and the doctor and the Practice shall be jointly and severally liable for obligations in these Terms which are obligations of “Buyer.” The doctor and the Practice must read and understand these Terms before downloading any materials or software, uploading patient information or placing any order, because in each case, a contract will be formed, and Buyer will be bound by these Terms which will govern that contract.
- Limitation of Liability
DynaFlex is a medical device manufacturer and does not practice dentistry or any other practice of medicine. Buyer is responsible for both the assessment and treatment of the patient and the content of the submitted prescription form, whether or not any employee of DynaFlex offers input or guidance regardless of their qualifications. The final medical/dental/orthodontic decision remains at all times with Buyer. Buyer is solely responsible for prescribing and administering dental and orthodontic treatment. Buyer must assess the patient for orthodontic treatment, dentition, oral health and overall suitability for treatment prior to submitting the prescription form. EZ-Align products require regular clinical monitoring to achieve the predicted clinical result. Patient treatments are for both adults and teens from the age of 14 and up; however, dentition should be fully erupted and not mixed. If DynaFlex and doctor agree in consultation, exceptions to this age can be made for certain circumstances. Receipt and acceptance of the prescription form constitutes a binding order between Buyer and DynaFlex.
EXCEPT AS EXPRESSLY PROVIDED IN DYNAFLEX’S WRITTEN WARRANTY STATEMENT BELOW FOR THE PRODUCT AND THESE TERMS, THE PRODUCT IS SOLD “AS IS”, AND DYNAFLEX MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, AND THE PARTIES EXPRESSLY EXCLUDE ALL WARRANTIES INCLUDING, BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND PRODUCT QUALITY. IN NO EVENT, WHETHER AS A RESULT OF BREACH OF CONTRACT, WARRANTY, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, PRODUCT LIABILITY OR INDEMNIFICATION OR OTHERWISE, SHALL DYNAFLEX BE LIABLE TO BUYER OR ANY PATIENT OF BUYER FOR ANY, DIRECT, INDIRECT, SPECIAL, CONSEQUENTIAL, PUNITIVE DAMAGES OR DAMAGE OF ANY KIND ARISING OUT THE SALE, FUNCTIONING OR THE USE OF ANY OF THE PRODUCT PROVIDED, EVEN IF DYNAFLEX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. DYNAFLEX SHALL HAVE NO LIABILITY TO BUYER (EXCEPT AS EXPRESSLY PROVIDED IN THESE TERMS) OR TO ANY PATIENT OF BUYER HEREUNDER, AND BUYER AGREES TO HOLD HARMLESS AND INDEMNIFY DYNAFLEX FOR ANY SUCH CLAIMS. In addition to the foregoing, DynaFlex’s warranty obligations shall not apply to the negligence of Buyer, or patients using the Products, including without limitation (i) any use, modification maintenance, repair or combination with other devices not in accordance with written instructions (ii) exposure of the Product to accident or natural causes (such as fire); or (iii) operation of the Product beyond its normal useful life. Except as otherwise stated, in no event shall the Company’s liability exceed the purchase price of the Products in respect of which damages are claimed. This is on the basis that Buyer will be able to use this sum to pay a different provider for equivalent products.
In the case of loss or damage to physical property while we are on Buyer’s premises or Buyer is on our premises or on a third party’s premises at our invitation, the sum of Fifty Thousand US dollars ($50,000) is the limit of liability for it is the amount we have estimated is the maximum value of property which we might reasonably foresee might be damaged.
Nothing in these Terms shall exclude or limit in any way our liability for: death or personal injury caused by our negligence, fraud or fraudulent misrepresentation, any breach of obligations implied by applicable law and in respect of which obligations the law prohibits us from so limiting or excluding its liability for those losses or any other matter for which it would be illegal or unlawful for us to so limit or exclude or attempt to so limit or exclude our liability
- Warranty and Conditions
DynaFlex warrants that the Products (including replacements) will conform to their description, they will be free from defects in material and workmanship, and they will be of satisfactory quality within the industry for the following periods.
- Until three (3) months after the expected first use of each aligner, with an expected change interval of three months; and
- Until three (3) months after the expected first use of each EZ Clear Retainer.
DynaFlex warrants the fit of EZ Clear Retainers for up to thirty (30) days after shipment.
EZ-Align Products should be initially installed in the patient’s oral cavity and fitted by the supervising dentist within thirty (30) days of receipt from EZ-Align. The fit of the initial aligner may be compromised if this procedure is not strictly followed. DynaFlex does not warrant fit of EZ-Align Products if the installation is delayed.
THESE WARRANTIES ARE VOIDED IF THE ALIGNERS OR RETAINERS HAVE BEEN MISUSED, MODIFIED OR BEEN USED IN COMBINATION WITH THIRD PARTY PRODUCTS OR EXPOSED TO ACCIDENT OR NATURAL CAUSES (SUCH AS FIRE OR EXTREME TEMPERATURES). NO WARRANTY IS MADE REGARDING THE OUTCOME OF ANY TREATMENT USING THE ALIGNERS, RETAINERS OR ANY COMBINATION OF EZ ALIGN PRODUCTS WITH THIRD PARTY PRODUCTS. No representative, employee or agent of DynaFlex is authorized to give any other warranties on behalf of DynaFlex or modify the limitations set forth in these Terms.
Buyer must return Products to DynaFlex for replacement or refund at our sole discretion if the Products do not meet the warranties in the Term above or any terms implied by law or imposed by mandatory statutory law and which we have not expressly and lawfully excluded. Except where the law requires otherwise, this replacement or refund will be Buyer’s only remedy; however, this does not affect Buyer’s rights under any applicable mandatory law. In no event shall a claim against the warranty be received more than four (4) months after delivery of the Product. Buyer is responsible for Products being returned to us. All returns should be completed via a reputable courier who provides insurance for the full replacement value. The package must be addressed to the Returns Department, EZ Align. DynaFlex will cover the cost of postage for returns. DynaFlex will inspect the Product for which a warranty claim is being made to determine if such failure is confirmed. Buyer shall retain title to the Product until we verify the Product does not meet specifications. If an exclusion applies (e.g. abuse of the Product) or the warranty is otherwise inapplicable, or the Product is not defective, we will contact you to determine whether or not you wish us to send back the Product. You agree to promptly respond so the matter can be resolved in a timely manner. If a replacement is warranted, the Company will manufacture the replacement and ship to Buyer, at the Company’s expense, the replacement Product and retain or destroy the original Product.
- Cancellation and Cancellation Fees
DynaFlex begins manufacture upon Buyer’s approval of the EZ Align Treatment Review System (“TRS”) treatment plan or placement of the order for retainers or replacement aligners. Buyer cannot cancel any order for aligners (including replacement aligners) or retainers after the TRS treatment plan has been approved. Buyer cannot cancel an order for retainers or replacement aligners after the order has been placed. Any monies paid in advance are non-refundable from the date Buyer approves the TRS plan or places the order for retainers or replacement aligners.
Except as described below, an order for a EZ Align Product will be cancelled without incurring any cancellation fees upon the first of the following to occur (i) the order has aged longer than ninety (90) days from receipt due to one or more of the missing requirements (e.g. prescription form, missing or unacceptable impressions, patient informed consent form), or (ii) a TRS treatment plan is not approved for more than ninety (90) days from the first TRS treatment plan posting.
However, assessment of a cancellation fee and/or deactivation of EZ Align account status may occur if a Buyer has an unreasonably high cancellation rate. Buyer shall be subject to a fee of $100 per case for each cancellation after the 2nd cancellation in any one-year period.
Full lab and manufacturing fees shall be applied as a cancellation fee if an order is cancelled after the TRS treatment plan is approved by the Buyer. Buyer agrees to pay all cancellation fees within thirty (30) days of the invoice date.
Buyer shall indemnify, defend and hold DynaFlex and its affiliates, and each of their respective members, shareholders, managers, officers, directors, employees, agents, representatives and assigness (the “Indemnified Persons”) from any claim, liability, actual or consequential damages, lawsuits, taxes and costs (including attorney’s fees and costs), whether for personal injury, property damage or other, brought by or incurred by the Buyer, Buyer’s employees or any other person, arising out of (i) improper selection, improper application or other (mis)use of the Products purchased by Buyer from the Company, (ii) Buyer’s breach of any agreement with the Company (iii) Buyer’s breach of any agreement between the Buyer and Buyer’s patient or any acts or failures in respect of a patient (iv) Buyer’s incorrect or incomplete information, documents or impressions to Company or any information it requests from Buyer or the Practice (v) dealings with Buyer’s national regulators, licensing or professional bodies in relation to Buyer or the Practice (vi) Buyer’s failure to comply with all applicable foreign, U.S. federal, state or local laws, ordinances, rules, orders and regulations, including without limitation U.S. export control laws and any regulations and orders thereof or failure to provide Company adequate information related thereto (vii) the acts or omissions of Buyer, its agents and employees and others under its direction or control except to the extent such liabilities are caused by or are the direct result of the gross negligence or willful misconduct of the Company. Buyer shall give Company immediate written notice of any demand, investigation, inquiry, action, suit, proceeding or claim. Company shall have the right to defend at Buyer’s expense any such liability or claim in which either the Company or Buyer or both are named as defendants, or reasonably are expected to be named. DynaFlex’s conduct of the defense shall not diminish Buyer’s obligation to indemnify the Company hereunder. This indemnity shall continue in full force and effect subsequent to and notwithstanding any termination of these Terms.
- Price List and Product Changes
DynaFlex has a EZ Align published price list which is updated periodically. The Company reserves the right to amend, change, add or discontinue any product (including the design, construction and type of materials) published with the price list at any time without advance notice. This policy also applies to the published price list. The price that applies to any order will be the published price at the time Buyer places the order with final approval by Buyer and acceptance by the Company. Prices are exclusive of applicable duty tax/sales tax/use tax/VAT/GST/consumption tax and any other governmental tax, charge or fee and exclusive of shipping, packing and insurance charges. No shipping charges shall be incurred by Buyer in the event of a replacement or rework of the Product exclusively the fault of DynaFlex.
The Company may terminate any credit availability within its sole discretion. If the amount of credit extended to Buyer is limited, Buyer is expected to manage Buyer’s patients and their expectations of the timing of their treatment. Buyer understands that Company is relying on the truth and accuracy of the information provided to Company in any application for credit as well as any other information provided to Company regarding Buyer or Buyer’s Practice. Buyer authorizes Company to conduct any credit investigation of Buyer deemed necessary, including but not limited to personal credit information about guarantors, general partners, proprietors and individual applicants. Buyer hereby explicitly authorizes trade and bank creditors to release credit information to the Company on a periodic basis in the sole discretion of the Company.
- Payment Terms
Payment terms are strictly thirty (30) days from the date of invoice to be paid in cleared funds in US Dollars. Time of payment is of the essence. In addition to other repercussions, Company reserves the right to add 1 ½ % interest per month (18% A.P.R.) (or the maximum interest allowed by law if less) for all amounts past due until paid in full. Interest shall accrue on a daily basis. Buyer agrees to pay the interest together with the overdue amount. Buyer agrees to pay all amounts due in full without any set-off, counterclaim, deduction or withholding (except for any deduction or withholding required by law). Company does not accept payments from patients, including payments in the patient’s name forwarded by Buyer or Buyer’s Practice. Buyer is responsible for payment of the Company invoices. In addition, and without prejudice to the responsibility of Buyer, the Practice, if named on the invoice or if the practice habitually pays the Company invoices, is jointly and severally liable with Buyer for the payment of all Company invoices. Company may therefore claim payment of any sums owed under any agreement against Buyer personally and/or against the Practice. Buyer waives diligence, demand, presentment for payment, notice of nonpayment and protest.
DynaFlex reserves the right to set credit limits on individual or Practice accounts. If an account has not cleared its outstanding invoices, the Company reserves the right to place the account on credit hold for which no further Product manufacture will be undertaken or further orders shall be C.O.D., at the option of the Company. Buyer agrees to pay a $50 service fee for any returned check. We reserve the right to institute a fee for use of credit or debit cards to pay for product. Unless otherwise stated, all payments shall be applied to the oldest unpaid invoice first. Buyer shall be responsible to reimburse the Company for all collection costs, including but not limited to reasonable attorney’s fees.
- Taxes and Fees
Buyer shall be responsible for any duty tax/ sales tax/use tax/VAT/GST or consumption tax, fee or charge of any nature imposed by any governmental authority upon the sale of any Product to Buyer. In the event Company is required to pay such tax, fee or charge, Buyer agrees to reimburse Company within ten (10) days of notice of same. Alternatively, at the Company’s option, Buyer shall remit payment directly to such taxing authority.
- Delivery, Delays and Risk of Loss
Unless otherwise agreed in writing, all Products will be sold “Ex works,” Dynaflex’s works, factory, warehouse or distribution center. Delivery of Products to Buyer’s carrier shall constitute delivery to Buyer; thereafter all risk of loss or damage shall be Buyer’s responsibility, with claims submitted promptly to Buyer’s carrier by Buyer with notice to the Company of the matter. Buyer shall be responsible for all freight, insurance and other shipping expenses, unless otherwise agreed in writing.
Products are generally manufactured and shipped from the site of manufacture within 7-10 days of approval of the TRS treatment plan. Add 3-5 days to turnaround time for use of impressions. All dates are approximate only and the time of dispatch is not of the essence.
The Company shall not be liable for any default, delay in performance or damage as a result of any delay in performance or nonperformance, due to any cause, directly or indirectly, beyond our reasonable control, including, without limitation, an act of God, act of Buyer or patient, delays cause by our suppliers or subcontractors, embargo or other governmental action, prohibition or regulation or request, fire, the elements, accident, strike, labor dispute, slowdown, war, force of arms, riot, delay in transportation or inability to readily obtain necessary labor, materials or facilities. DynaFlex shall notify Buyer of the happening of any contingency and of the contemplated effect thereof on the manufacture and/or delivery of the Product.
Products will be shipped to the delivery address selected by Buyer at the time the order is placed. Company is not liable for any liability arising out of the Buyer’s failure to provide accurate and complete delivery details.
If the Products are not delivered, Buyer shall inform the Company promptly who will determine the cause of the delay and, if in accordance with these Terms, DynaFlex is under an obligation to deliver, the Company shall manufacture and ship replacement Products and this will be Buyer’s sole remedy in respect of a failed delivery.
If Buyer fails to accept delivery of the Products within four (4) days of a notice from the delivery company that the Products are ready for delivery, then delivery of the Products will be deemed to have been completed at 9 AM CST on the fifth (5th) day after such notice. DynaFlex shall charge Buyer for redelivery, including insurance, but shall have no obligation to redeliver the Products seven (7) days after the notice to Buyer of the Products readiness for delivery.
- Inspection of Shipment; Claims; Commencement of Action
Claims for shortages, errors in delivery or defects apparent on visual inspection must be made in writing to Company within ten (10) days after receipt of shipment. Buyer’s failure to give timely notice of the same shall constitute unqualified acceptance of such shipment.
No other claims against the Company will be allowed (including a request for replacement) unless asserted in writing within ninety (90) days after delivery (regardless of the date of installation), or, in the case of an alleged breach of warranty, thirty (30) days after the date within the warranty period on which the defect is or should have been discovered by Buyer and/or Buyer’s patient.
Any legal action based upon a breach of these Terms or upon any other claim arising out of the sale of a Product to Buyer (other than an action by the Company for any amount due to DynaFlex by Buyer) must be commenced within one (1) year from the date of the tender of delivery by the Company, or in the case of a cause of action based upon an alleged breach of warranty, six (6) months from the date within the warranty period on which the defect is or should have been discovered.
- Refinement Aligners
Refinement Aligners is an option to order new aligners during treatment if further tooth movement is needed or if clinical results have deviated to such an extent that the aligner(s) no longer fit as long as the original treatment goal has not changed, as determined solely by DynaFlex. Refinement aligners are included in the original price for certain products and are available at a reasonable charge for other products, but the order must be received prior to the Treatment Expiration Date (see below). See our EZ Align Pricing Guide. We reserve the right, in our sole discretion, to charge an additional fee for excessive use or excessive time lapse between orders for an individual patient’s treatment up to a maximum of 40% of the price of the original treatment option purchased. Note that with the original case, teeth need to be reset to ideal with the maximum number of trays, as determined by DynaFlex, following alignment settings, in order to follow up with Refinement Trays. Otherwise the additional aligners will be billed as standard EZ Align trays and not Refinement Aligners.
- Treatment Expiration Date
Treatment Expiration Date is calculated as:
- 6 years from the date of shipment of the initial set of aligners for the EZ Align Complete and EZ Align Plus (EZ-X + Complete);
- 2 years from the date of shipment of the initial set or Refinement Set of aligners for all other EZ Align Systems.
Upon reaching the Treatment Expiration Date, the treatment order shall be closed and any extra aligner treatment for the patient shall be considered a new order and will incur an additional charge at the then current pricing for the EZ Align treatment option.
Replacement Retainers and Refinement Aligners may be ordered at any time prior to or after the Treatment Expiration Date, and will be charged at the then current pricing, and will not affect the Treatment Expiration Date.
- Clinical Risks of Clear Aligners
As with other orthodontic treatments, clear aligners may carry some of the potential risks described below:
- Treatment time may exceed estimates. Poor compliance with the doctor’s instructions, wearing aligners less than 23 hours per day, missing appointments, excessive bone growth, poor oral hygiene and broken appliances can lengthen treatment time, increase the cost, and affect the quality of the end results.
- Unusually shaped teeth can also extend treatment time and affect results. For instance, short clinical crowns can cause problems with aligner retention and slow or prevent teeth movement.
- Tooth decay, periodontal disease, decalcification (permanent markings on the teeth) or inflammation of the gums may occur if proper oral hygiene and preventative maintenance are not maintained, whether wearing aligners or otherwise.
- Sores and irritation of the soft tissue of the mouth (gums, cheeks, tongue and lips) are possible but rarely occur due to wearing aligners.
- Initially, the aligners may temporarily affect speech. Patients generally adapt quickly to wearing aligners and it is rare that speech is impaired for an extended period of time.
- While wearing aligners, the patient may experience a temporary increase in salivation or dryness of the mouth. Certain medications can increase this.
- It may be necessary to temporarily affix attachments (small bumps of composite material) to the patient’s teeth to assist with difficult tooth movements. When the patient is not wearing the aligners, these attachments can feel awkward to the mouth.
- In cases of crowding, IPR, also known as interproximal reduction (reducing the thickness of a tooth’s enamel), may be required to create enough space to allow the teeth movement.
- Any medication the patient may be taking, and the patient’s overall medical condition can affect the orthodontic treatment.
- Though uncommon, allergic reactions to the material used during treatment may occur. If the patient believes he or she is experiencing an adverse reaction, they must inform the doctor immediately.
- Tooth sensitivity and tenderness of the mouth may occur during treatment, especially when advancing from one aligner to the next.
- Bone and gums, both of which support the teeth, can be affected by wearing aligners. In some cases, their health may be impaired or aggravated.
- Oral surgery may be required to correct excessive crowding or severe, pre-existing jaw imbalances. All risks of oral surgery, such as those associated with anesthesia and proper healing, must be considered before treatment.
- Wearing aligners may aggravate teeth, previously traumatized or not. Though a rare occurrence, such teeth may require additional dental treatment such an endodontic treatment or other restorative treatment, the useful life of the teeth may be shortened, or the teeth may be lost completely.
- Existing dental restorations, such as crowns and bridges, may be affected by wearing aligners. They may become dislodged and require re-cementation or in some instances, replacement. Before any dental restorations are replaced or added, the doctor must be consulted, as they can affect the way the aligners fit.
- Teeth may supra-erupt (come out of the gums more than the other teeth) if not at least partially covered by the aligner.
- Root resorption (shortening) can occur during any type of orthodontic treatment, including clear aligners. Shortened roots are of no disadvantage under health conditions. In rare cases, root resorption can result in loss of teeth.
- In cases of severe crowding or multiple missing teeth, it is more likely that the aligner may break.
- Because orthodontic appliances are worn in the mouth, accidentally swallowing or aspirating the aligner, in whole or in part may occur.
- Though rare, problems may occur in the jaw joint, causing joint pain, discomfort, headache or ear problems.
- Aligners worn out of their intended sequence can delay treatment results and result in complications including (but not limited to) patient discomfort.
- In some cases, a “black triangle” of missing gingival tissue may be visible below the interproximal contact when teeth are aligned after being overlapped for an extended period of time.
- Results may relapse if proper retainer wear is not followed as directed by the doctor.
A successful treatment outcome cannot be guaranteed. After the final planned aligners have shipped, some cases may require refinement with additional clear aligners, traditional orthodontic techniques, and/or cosmetic procedures like crowns or veneers to achieve ideal results.
- Warranties of Buyer
Buyer expressly warrants and represents that:
- It shall not introduce any EZ Align product into a clinical trial or similar testing without the express written approval of DynaFlex;
- The doctor is licensed or registered to practice dentistry and/or orthodontics without restriction in the country and state to which the Products are to be shipped;
- The Practice has all licenses and authorizations to provide dental treatment, including EZ Align treatment, in the country and state in which it operates;
- It has the necessary expertise, experience and training to properly perform procedures associated or in conjunction with the EZ Align treatment; and
- It is not purchasing or acquiring Products with the intent that they will be used by any other doctor and/or for the benefit of any patient other than Buyer’s own patient or otherwise outside the country to which the Products are shipped.
Further Buyer undertakes that Buyer will (with these obligations being conditions of our contract with Buyer):
- Not use the Products if Buyer’s license or registration to practice expires, is not valid, is revoked, suspended or otherwise jeopardized or restricted at any time during the treatment of patients, but will promptly inform the Company of this fact so the Company has the option to mitigate the impact on the outcome of the Products;
- Use the Products only in accordance with generally accepted dental standards;
- Be fully responsible, and directly and solely liable for the EZ Align treatment of the patient, including the exercise of clinical judgement in the decision to use the Products, the patient’s treatment plan, the continued use of the Products, the patient’s ongoing treatment, and achieving the desired outcome for the patient;
- Obtain a completed and signed Patient Informed Consent Form prior to TRS treatment acceptance of the EZ Align treatment;
- Ensure that the Buyer understands and properly assesses in relation to the particular patient the clinical risks, and that the patient is aware of the risks relevant to their own treatment prior to commencing their EZ Align treatment;
- Regularly reviews the EZ Align website to verify Buyer is aware of any changes to pricing or other Terms;
- Provide, upon request, feedback regarding the status of any patient’s treatment, details of their experience and patient and Buyer’s EZ Align experience as well as the success of the Products;
- Promptly notify DynaFlex, and in any event within ten (10) days of any event (in all available detail) relating to Product use on any patient which the Company and/or the Buyer is required to notify any governmental or regulatory authority;
- Not allow any other person to use the Products; and
- Only use the Products in relation to the patient they were ordered for.
It is Buyer’s responsibility to provide for each patient all material records requested by DynaFlex and to accept the treatment using the Treatment Review System. We will only manufacture the Products once the necessary materials and the TRS approval are received. Buyer must manage the patient’s expectations on the timing of their EZ Align treatment, particularly where delays are caused by Buyer’s own delays or failures to act. Materials will not be returned to the Buyer.
- Scans by Buyer
DynaFlex can accept scans taken through any intra-oral scanner, including but not limited to CEREC Omnicam, 3Shape TRIOS, Carestream CS3500, 3M True Definition, Planmeca and Itero. See How to Connect from your Scanner here. We can accept “.stl files” from any scanner. If your scanner is not listed, call our 3D ortho department at 1-800-489-4020 for more details. Setup is quick and easy.
- Physical Models by Buyer
We can accept traditional records such as models. Models are scanned to create the working files necessary to review and print the progressive models to achieve the intended results. If you are mailing models, please make sure to wrap each model individually to avoid damage. All models should be marked with both the patient and doctor’s name for proper identification. Submit Rx through the mail or digitally.
- Impressions by Buyer
EZ Align is based upon two phase putty and wash polyvinyl siloxane (PVS) materials being used for the impressions. We also accept VPS impressions. We do not accept impregum or alginate impressions. The impressions will be discarded after use unless Buyer stipulates their return in advance for which a service fee will be charged. The accuracy of the impressions will ensure correct fitting of the aligners. Any impression that has defects (air bubbles or drags) may be rejected prior to manufacture. If the impressions have been rejected, Buyer will be notified by email and asked to resubmit new impressions. The Company is not responsible for any additional costs that may be incurred either by the patient or the practice when resubmitting new impressions. It is the Buyer’s responsibility to ensure all impressions are of the highest standards and free from imperfections. All impressions shall also be free from contamination and be cleaned per the appropriate disinfection guidelines. Add 3-5 days turnaround time for use of impressions in lieu of other methods. Submit Rx through the mail or digitally.
- Patient Treatment (prior and during)
Buyer is responsible to ensure the patient both signs and understands the terms and conditions of the Patient Consent Form by which the treatment is undertaken. Inappropriate compliance or use by the patient (or Buyer) may result in unsuccessful treatment. The Company does not guarantee a successful treatment outcome. Individual results vary especially if the patient does not strictly comply with all instructions. If the patient has not complied with the published wear time or product use, Company cannot be held responsible for incomplete treatment results. Each set of aligners are to be worn for one week 24/7 (minimum 23 hours per day) except for eating and cleaning in order to fulfill the treatment requirements. In addition to patient use, tissue reactions can impair the outcome of the treatment.
A case has been deemed complete or closed if a period of twelve (12) weeks has lapsed without further written contact with the Company regarding treatment. If the Buyer decides to restart treatment, this will be subject to digital assessment and additional charges. Should the patient and Buyer decide to continue with the treatment, new impressions and a prescription form will be required. The Company may deem this a new treatment and Buyer will be charged at the full published list price.
- Interproximal Reductions (IPR)
Interproximal reduction is a procedure done during orthodontic treatment to reduce the interproximal enamel of teeth. In clear aligner therapy, IPR allows for more efficient movement of teeth especially in dentitions with crowding and/or rotated teeth. It is important to know how much enamel can be removed in individual teeth, know which cases are suitable for IPR and which cases are indicated for other treatment procedures (such as arch development or extraction). It is best to judiciously perform IPR to prevent creation of too much space. The IPR procedures must be performed in sequence, removing only minimal amounts of enamel as needed for tooth movement. Each EZ Align case is provided with an IPR card showing suggestions for IPR. DynaFlex also sells an EZ Align IPR Kit to assist the doctor. In general, our suggestions will be conservative so no more than what is needed for tooth alignment will be removed from any single tooth surface. Avoid creating too much space which may result in treatment delays and an increase in the number of aligners. At all times, the final professional judgement of the doctor is paramount even if DynaFlex provides recommendations to assist in that decision. DynaFlex does not practice dentistry.
- Good Standing Matters
If any of the following circumstances occur, the doctor and/or Practice will not be in Good Standing with DynaFlex:
- The EZ Align doctor leaves the Practice; or
- The EZ Align doctor ceases practicing dentistry/orthodontics, whether permanently or temporarily, but for a period of time that the Company considers has potential to detrimentally affect the on-going treatment of patients in EZ Align treatment; or
- The EZ Align Doctor ID is used by other doctors for ordering EZ Align treatment for patients who are not wholly or mainly under the EZ Align doctor’s care and responsibility; or
- Buyer consistently fails to timely pay invoices from the Company or an amount remains due for more than ninety (90) days or Buyer’s ability to timely pay Buyer’s debts is in doubt; or
- Patients, any regulatory body, the EZ Align doctor’s professional regulator or licensing body contact DynaFlex with concerns about the EZ Align treatment provided by the EZ Align doctor and these are considered by the Company, in its sole discretion, sufficiently significant to likely prejudice the on-going, proper and timely EZ Align treatment of the EZ Align doctor’s patients;
- The EZ Align doctor breaches local laws on the practice of dentistry or the professional rules;
- Buyer ships Products out of the country to which they were shipped;
- Buyer misuses the Intellectual Property of DynaFlex;
- The EZ Align doctor is not able (in our sole discretion) to continue to provide EZ Align treatments for any reason, including without limitation if the EZ Align doctor’s professional registration is withdrawn or limited.
If any of those circumstances do occur, Buyer agrees that
- EZ Align may by notice in writing having immediate effect, suspend Buyer’s right to use the Buyer’s Customer ID, to order any further Products and/or to access the EZ Align systems.
- Buyer shall make arrangements to responsibly transfer patients in the EZ Align system to another EZ Align doctor. The Company has referral names upon request.
- Confidential Information and Intellectual Property Rights
Buyer may become familiar with trade secrets and confidential information of DynaFlex which derive independent economic value, actual or potential, from not being generally known to the public or to other persons who can obtain economic value from their disclosure or use (“Confidential Information”). Buyer agrees not to disclose or utilize any Confidential information including, without limitation, Product specifications, prices, discounts, manufacturing plans and ideas, technical data, customer lists and sales reports to which Buyer has been privy.
All rights in Intellectual Property (including all patents, trademarks, service marks, registered designs, utility models, design right, database rights, copyright, trade secrets) and other Confidential Information, know-how, and all other intellectual and industrial property and rights of a similar or corresponding nature in any part of the world in or relating to the Products, TRS software, systems and website, EZ Align Systems documents or items that the Company prepares or produces for Buyer or patient or makes available to Buyer belong to DynaFlex absolutely and exclusively.
Buyer shall inform us promptly if Buyer becomes aware of any infringement of our trademarks or other Intellectual Property rights by any person.
Buyer may use EZ Align trademarks and weblink to the EZ Align website for a limited purpose of promoting the EZ Align Products to current and prospective patients if (i) Buyer has placed an order accepted by the Company and approved under the TRS within one year (ii) Buyer remains in good standing with the Company or (iii) Buyer obtains approval in advance and in writing. However, Buyer undertakes to verify (including by obtaining local legal advice) that any advertising or promotion that Buyer undertakes is compliant with local law, regulations or professional obligations and Buyer understands that this is not the responsibility of the Company to do so.
- Data Protection
Buyer is the controller of any Patient Data processed for the purpose of providing EZ Align treatment and shall comply with all data protection laws with respect to Patient Data. Both Buyer and DynaFlex agree to adhere to the principles of medical confidentiality in relation to Patient Data. The Company shall ensure that any person it authorizes to process Patient Data has committed themselves to keep such Patient Data confidential (save where such person is already subject to a statutory duty of confidentiality that applies to such processing.)
Buyer agrees to keep any key, PIN or password received from DynaFlex for use in the EZ Align process confidential and secure.
Buyer agrees that DynaFlex may use Patient Data for promotional, educational and/or research purposes, publication in professional journals or use in professional collateral materials, provided such Patient Data has first been anonymized in a way that neither Buyer nor patient are identifiable.
See our HIPAA Policy here.
If you have further questions regarding data protection, please contact our Data Protection Officer, Matt Malabey at 1-800-489-4020.
Once Buyer has placed an order that is accepted by DynaFlex, Buyer cannot cancel or terminate the order unless we fail to provide the Products within a reasonable time.
We have the right to give Buyer written notice terminating any or all contract(s) with immediate effect (without the need for a court order) if the following occur, or we consider in our sole discretion that they are likely to occur (and which might refer to either the EZ Align doctor, the Practice, or both):
- Buyer is not in Good Standing (per Term 23); or
- Any of the warranties and representations in Term 17 or undertakings in Term 17 are breached or not met;
- Admits Buyer’s inability to pay debts; or
- Is insolvent or bankrupt or subject to an insolvency or bankruptcy petition or order, or appointed an insolvency practitioner, receiver, liquidator, or administrator or similar, as defined by the local law applicable in the country in which Buyer practices dentistry and/or in which the Practice is located, or any person becomes entitled to make such an appointment; or
- Buyer makes any arrangement with Buyer’s creditors for payment of Buyer’s debts in any circumstances and for any reason; or
- Any of Buyer’s creditors or encumbrances enforces their right as such over any of Buyer’s assets; or
- Where the Terms are solely with Buyer, the EZ Align Doctor and not (also) with a Practice, Buyer is subject to a bankruptcy petition or order or dies or by reason of illness or incapacity (physical or dental) is incapable of managing Buyer’s affairs or becomes a patient under any mental health legislation.
Termination will not affect either party’s outstanding rights or duties, including the right of DynaFlex to recover from Buyer any money Buyer owes the Company under these Terms or any other agreement. Upon termination Buyer shall immediately pay DynaFlex all outstanding invoices and interest and cease any use of our Trade Marks (or other Intellectual Property or weblinks) or other materials.
Terms which expressly or by implication survive termination of these terms shall continue in full force and effect.
Upon termination or expiry of the contract of these Terms, we shall (at Buyer’s election) destroy or return to Buyer all patient data in its possession. This requirement shall not apply to the extent we are required by applicable law to retain some or all of such patient data, a claim or potential claim is pending or to patient data that DynaFlex has archived on backup systems.
- Promotional Materials
Buyer authorizes DynaFlex or a third party on the Company’s behalf to send programs, training, event, sales and marketing promotions and materials, surveys or other information related to the EZ Align products to Buyer’s office via courier, post, facsimile, e-mail and other means unless Buyer has indicated otherwise in writing to the Company. Buyer has the right to withdraw this consent in writing at any time.
All notices sent by Buyer to DynaFlex must be sent to the main corporate offices. The Company may give notice to Buyer at either the e-mail or physical address provided to us in the Buyer’s order. However, this does not apply to the service of any proceedings or other documents in any legal action.
Notice will be deemed received and properly served 24 hours after an e-mail is sent or three (3) days after the date of posting or provision to a reputable courier service of any letter. In proving the service of any notice, it will be sufficient to prove, in the case of a letter, that the letter was properly addressed, stamped and placed in the post, or recorded by the courier service as received, and in the case of an e-mail that the e-mail was sent to the specified e-mail address of the addressee.
- Attorney’s fees
In the event DynaFlex institutes a legal proceeding against Buyer to collect any monies due under the Terms, or if the Company successfully defends any lawsuit instituted by Buyer, whether based on contract, tort or any other legal theory of recovery, DynaFlex shall be entitled to recover its costs and expenses, including without limitation, reasonable attorney’s fees, collections costs and other expenses incurred by the Company in connection therewith from Buyer.
- Interpretation of these Terms
Any phrase introduced by the terms, “including”, “include”, “in particular” or any similar expression shall be construed as illustrative and shall not limit the sense of the words preceding those terms. A reference to writing or written includes emails. A reference to a statute or statutory provision is a reference to such statute or provision as amended or re-enacted. A reference to a statute or statutory provisions includes any subordinate legislation made under that statute or statutory provision, as amended or re-enacted. A person includes a natural person, corporate or unincorporated body (whether or not having a separate legal personality). A reference to a “party” is either DynaFlex or the Buyer, and parties includes both of us, and a “party” includes personal representatives, successors or permitted assigns. All defined terms shall be deemed to refer to the masculine, feminine, neuter, singular and/or plural, in each instance as the context and/or particular facts may require. Use of the terms “hereunder”, “herein”, “hereby”, and similar terms refer to these Terms. The headings in these Terms are for the convenience of the parties only and have no effect on the construction or interpretation of the Terms.
Nothing in these Terms is intended to, or shall be deemed to, establish any partnership or joint venture between any of the parties, constitute any party the agent or employee of another party, or authorize any party to make or enter into any commitments for or on behalf of any other party. These Terms are personal to the Buyer (whether the doctor or the Practice). DynaFlex only provides Products to and for patients under the personal care of Buyer.
- Implied Terms
All terms implied by law and which we may by law exclude, are excluded from these Terms. Other than the Terms and terms which are implied by trade, custom, practice or course of dealing or by law, or by mandatory statutory law and which cannot by law be excluded by us, there are no other terms included in these Terms.
Any statements made by our employees or representatives or in any documents produced by us are not terms included in these Terms and Buyer agrees that Buyer has not relied upon any such statement, promises, representations, assurances or warranties when entering into the Terms and shall not have any remedy in respect of any statement, representation or warranty (whether negligently or innocently made) or any person other than as expressly set out in these Terms.
Nothing in this section shall however operate to limit or exclude any liability for fraud. Products supplied under these Terms shall be as described in the Buyer’s Order, but any other brochures are not part of these Terms.
- Binding Effect; Assignment; Third Parties
These Terms shall be binding upon and inure to the benefit of the parties hereto and their respective heirs, successors, subsidiaries, affiliates and permitted assigns of the parties. DynaFlex may at any time assign, transfer, mortgage, charge, subcontract or deal in any other manner with all or any of its rights or obligations under these Terms. Customer may not assign, transfer, mortgage, charge, subcontract, declare a trust over or deal in any other manner with any or all of Buyer’s rights or obligations under these Terms without the prior written consent of the Company. A person who is not party to the Terms shall not have any rights under or in connection with these Terms. DynaFlex shall have rights against the doctor and the doctor’s Practice under any Terms.
- No Waiver
If DynaFlex fails, at any time while these Terms are in force, to insist that Buyer perform any of Buyer’s obligations under these Terms, or if the Company does not exercise any of its right or remedies under these terms, that will not mean that the Company has waived such rights or remedies and will not mean that Buyer does not have to comply with those obligations. If DynaFlex waives a default by Buyer, that waiver will not mean that the Company will automatically waive any subsequent default by Buyer. No waiver by the Company of these Terms shall be effective unless DynaFlex expressly says that it is a waiver and tells the Buyer so in writing. All waivers shall be strictly construed.
If one of the parties gives notice to the other of the possibility that any provision or part of a provision of these Terms is invalid, illegal or unenforceable, the parties shall negotiate in good faith to amend such provision so that, as amended, it is legal, valid and enforceable, and to the greatest extent possible, achieves the intended commercial result of the original provision. In the event that any provision hereof shall be found invalid, illegal or unenforceable, that provision shall be ineffective as to the extent of its violation without invalidating any other provision.
The provisions of these Terms that, by their sense and context, are intended to survive performance by either or both parties, including specifically but not limited to provisions on warranty, limitation of liability, indemnity and confidential information, shall also survive the completion, expiration, termination or cancellation of these Terms or any order by Buyer.
- Force Majeure
DynaFlex will not be liable or responsible for any failure to perform, or delay in performance of, any of its obligations under these Terms that is cause by events outside our reasonable control (“Force Majeure Event”). Any failure to pay sums due to the Company shall not be excused by reason of any Force Majeure Event. The Company’s obligations under these Terms are suspended for the period that the Force Majeure Event continues, and DynaFlex will extend the time to perform these obligations for the duration of that period but will make reasonable efforts to perform.
Any variation of these Terms or any agreement with DynaFlex can only be made in writing. The Company has the right to revise and amend these Terms from time to time. Changes will not affect orders placed by Buyer already accepted by the Company. Failure by the Company to object to provisions contained in any purchase order (or equivalent document) shall not be construed as a waiver of these Terms or an acceptance of any other terms.
These Terms are drafted in the English language. If these Terms are translated into any other language, the English language version shall prevail.
- Law; Jurisdiction; Service of Process
These Terms and the sale and delivery of all Products hereunder shall be deemed to have taken place in and shall be governed and construed in accordance with the laws of the State of Missouri, as applicable to contracts executed and wholly performed therein and without regard to its conflicts of law principles. Any proceeding arising out of or related to these Terms or any order by Buyer to the Company shall be brought in the courts of the State of Missouri, County of St. Louis, or if it has or can acquire jurisdiction, in the United States District Court for the Eastern District of Missouri. Each of the parties (including doctor’s Practice) irrevocably submits to the exclusive jurisdiction of each such court in any proceeding, waives any objection it may now or hereafter have to venue or to convenience of forum, agrees that all claims in respect of the proceeding shall be heard and determined only in any such court and agrees not to bring any proceeding arising out of or relating to these Terms or any order by Buyer in any other court. The parties agree that any of them may file a copy of this paragraph with any court as written evidence of the knowing, voluntary and bargained-for agreement between the parties irrevocably to waive any objections to venue or to convenience of forum. Process in any proceeding related to these Terms of any order of Buyer may be served on any party anywhere in the world.
- Entire Agreement
These Terms together with the EZ Align Pricing Guide and all other documents attached hereto represent the entire agreement between DynaFlex and Buyer and constitutes the complete and exclusive expression of the Terms. All prior or contemporaneous oral and written negotiations with respect to the subject matter are herein merged.
The rights and remedies of the parties are cumulative and not alternative.
- Trial by Jury Waiver
THE PARTIES HEREBY WAIVE ANY RIGHT TO TRIAL BY JURY IN ANY PROCEEDING ARISING OUT OF OR RELATING TO THESE TERMS OR ANY ORDER BY BUYER TO DYNAFLEX, WHETHER NOW EXISTING OR HEREAFTER ARISING, AND WHETHER SOUNDING IN CONTRACT, TORT OR OTHERWISE. THE PARTIES AGREE THAT ANY OF THEM MAY FILE A COPY OF THIS PARAGRAPH WITH ANY COURT AS WRITTEN EVIDENCE OF THE KNOWING, VOLUNTARY AND BARGAINED-FOR AGREEMENT AMONG THE PARTIES IRREVOCABLY TO WAIVE TRIAL BY JURY AND THAT ANY PROCEEDING WHATSOEVER AMONG THEM RELATING TO THESE TERMS OR ANY ORDER BY BUYER TO THE COMPANY SHALL INSTEAD BE TRIED BY A COURT OF COMPETENT JURISDICTION BY A JUDGE SITTING WITHOUT A JURY.