1. INTRODUCTION. These Terms and Conditions (“Terms and Conditions” or “Agreement”) shall apply to any order, purchase, and/or use by any dental or medical professional, clinician, doctor or dentist (“Customer”) of any products and services, including the Clear Aligner and Retainer products and services and the product packages described in Exhibit A attached hereto (collectively, “Products”) which are offered, sold or provided to any Customer hereunder by any of Henry Schein, Inc. or any of its subsidiaries, affiliates, sub-distributors or subcontractors, which are specified as the Product provider in the order form or contract to which these Terms and Conditions are attached or relate (each individually an “HSI Entity” and collectively, as the context requires, “HSI”). The parties hereby acknowledge and agree that, except as otherwise expressly provided in this Agreement, each individual HSI Entity is acting severally under this Agreement and, as such, any and all obligations and liabilities with respect to each such individual HSI Entity shall be several, not joint with the other HSI Entities, and relate only to such individual HSI Entity and the specific products or services being provided or performed by such individual HSI Entity.
2. TERM. The term of this Agreement for each Product shall begin on the date a Customer Order is submitted in accordance with this Agreement and end on the latest expiration date of any applicable warranties on the Products contained in this Agreement. This Agreement may be terminated earlier by a party for a breach of this Agreement by the other party which breach isn’t cured within 30 days of the non-breaching party’s notice of such breach to the breaching party.
3. CUSTOMER ORDERS. Orders are placed by Customer (“Customer Orders”) using the DDX Approver Portal (“DDX Portal”) (or by any other means designated by HSI from time to time) which can be accessed at www.ddxdental.com. Customer Orders may be rejected by HSI in its sole discretion and may be accepted by HSI by any means, including by HSI sending the Customer a confirmation or by shipment of the Products to Customer. Customer Orders are considered placed when and as follows: (a) if Treatment Setup (as defined in Exhibit A) is used, on the date the final Treatment Setup is approved by Customer, or (b) if no Treatment Setup is required, on the date of the submission of the order by Customer with all required patient records. Except as otherwise provided in this Agreement, once Customer has placed a Customer Order that is accepted by HSI, Customer cannot cancel or terminate the Customer Order unless HSI fails to provide the Products or Customer within a reasonable time frame.
4. HSI SYSTEMS SECURITY. Use by Customer of any applicable HSI software, website, platform or system, including the DDX Portal (collectively, “HSI Systems”), shall be subject to Customer’s registration for such use as directed by HSI, and Customer’s agreement with these Terms and Conditions and any end user license agreement and/or other policies, procedures, terms and conditions, including with respect to privacy of any data or information, communicated to Customer by HSI or included or contained in any HSI Systems (collectively, Privacy Policies”). Customer is responsible for maintaining the confidentiality of all login information for HSI Systems, including their DDX Portal login information, and is fully responsible for all activities that occur under that password or user name. Customer agrees to (a) immediately notify HSI of any unauthorized use of any password, login information or user name used by Customer to access any HSI Systems or any other breach of the security and/or any Privacy Policies of any HSI Systems, and (b) to ensure that Customer exit from their HSI Systems accounts at the end of each session.
5. Data Privacy Laws; USE OF PROTECTED INFORMATION.
(iv) For Customers located outside of Canada, the EU and the United States: For use of any Other Protected Information, HSI and Customer shall be subject to any applicable laws and regulations in the jurisdiction in which Customer is located (including any applicable privacy or secrecy legislation), including, without limitation, as set forth in Exhibit E attached hereto.
6. CUSTOMER REPRESENTATIONS AND OBLIGATIONS. As a condition of HSI’s sale of the Products to Customer, Customer agrees as follows:
a. Customer is licensed or registered to practice medicine, dentistry and/or orthodontics, as applicable, without restriction in the jurisdiction to which the Products are to be shipped and where Customer will install the Products and otherwise provide treatment to such patient;
b. Customer, (i) will not use the Products, and will promptly inform HSI, if any of their licenses or registrations to practice expires, is not valid, is revoked, suspended or otherwise jeopardized or restricted at any time during treatment of patients, and (ii) will allow HSI to take such actions as HSI considers appropriate in light of such circumstances;
c. Customer (i) has the necessary expertise, experience and training to properly perform procedures associated or in conjunction with treatment using the Products, and (ii) will use the Products only in accordance with generally accepted dental standards as well as any HSI clinical protocols designated by HSI.
d. The Products will not be used (i) by any other person other than the Customer who placed the order, (ii) on or for the benefit of any patient other than Customer’s patient for whom the Products were ordered and designed; or (iii) outside of the country where Customer and the applicable patient are located and to which such Products are shipped by HSI or its designee.
e. Customer shall provide HSI with Customer’s accurate and complete ownership information as requested by HSI if required to fulfill any of HSI’s legal or regulatory obligations, including with respect to transparency reporting obligations, if any, in the applicable jurisdiction where Customer is located.
f. Customer (i) shall be fully responsible, and directly and solely liable for the treatment of each patient, including the exercise of clinical judgment in the decision to use the Products and the design and implementation of each patient’s treatment plan, and for achieving the desired outcome for the Patient, (ii) will, upon request, provide feedback regarding the status of any patient’s treatment, experience and outcome with the Products; and (iii) promptly notify HSI of any event (with all available details) relating to the Products of which Customer or HSI is required to notify any governmental or regulatory authority.
a. HSI may begin to manufacture the ordered Products upon Customer’s approval of the Treatment Setup or Customer’s placement of the Customer Order for the Products. Customer may not cancel any Aligner Products order after the final Treatment Setup has been approved by Customer. Customer may not cancel any Customer Order for Products or Replacement Aligners after the Customer Order has been placed. A Customer Order for Products may be cancelled by Customer only as provided in these Terms and Conditions. If any Treatment Setup has been posted to the DDX Portal for more than 60 days without Customer response or feedback, such Customer Order may be cancelled by HSI without notice to the applicable Customer.
b. Cancellation Fees: Customer Orders cancelled by Customer before Treatment Setup approval by Customer will not incur cancellation fees. However, assessment of a cancellation fee per cancelled Customer Order and/or deactivation of a Customer’s HSI Systems account status may occur, if permitted under applicable laws in the jurisdiction in which Customer is located, if a Customer has an unreasonably high number of Customer Order cancellations. Full payment of all fees for a Customer Order for Products (including replacement Products orders) will be payable by Customer within 30 days of cancellation.
a. Current prices for Products and Services are available on the DDX Portal and are subject to change by HSI at any time without notice to Customer as of the date such pricing is updated in the DDX Portal pricing. Price changes will not affect orders which have already been placed. The price that applies to any Customer Order will be the price shown in the DDX Portal at the time Customer places the Customer Order in accordance with these Terms and Conditions.
b. Prices are in either U.S. dollars or, if designated by HSI consistent with applicable laws, the local currency of the country where the Customer is located and are exclusive of any applicable taxes (including sales tax, VAT, GST, and consumption tax) and shipping and insurance charges which shall be billed to Customer separately. Additional shipping charges may apply to Customer Orders for Clear Aligners and retainers, including replacement Products.
c. Customer will pay all HSI invoices as directed in the invoice in full and in cleared funds. Invoices are due for initial Aligner Products within 60 days of invoice and all other products and fees are due within 30 days of the date of invoice unless otherwise mutually agreed in writing by the parties or as otherwise stated in the invoice. Any invoice or other outstanding balance not paid by the invoice due date may be subject to the lesser of (i) 1.5% per month or (ii) the maximum monthly interest allowable by law.
a. Customer is wholly responsible for the use of the Products and the review and approval of the Treatment Setup, as well as the diagnosis and treatment of each patient.
b. Customer is responsible for carefully reviewing a proposed Treatment Setup prior to approval and for determining the suitability of the treatment for the applicable patient.
c. Customer acknowledges and understands that HSI is not providing and does not provide medical, dental or health care services or advice.
d. The Customer is responsible for ensuring that (i) they are aware of the content of the Products’ Instructions for Use (the “Product Instructions”), including the contraindications and risk factors, (ii) the Products are prescribed only to patients who do not have contraindications and to whom the risks of treatment with the Products have been properly and fully explained, and (iii) patients are provided with the Product Instructions applicable to patient’s use of the Products and ensuring that they understand them.
10. COMPLIANCE WITH LAWS. Customer agrees that, in carrying out its duties and responsibilities under this Agreement, it will neither undertake nor cause or permit to be undertaken, any activity which is illegal under any applicable laws, decrees, rules, regulations, codes, orders or other requirements, including, without limitation and as applicable in the jurisdiction in which Customer is located, any anti-bribery and anti-kickback laws, any transparency laws (as hereinafter defined) and any data privacy laws (including with respect to any Protected Information), all as amended from time to time, including, without limitation, as set forth in Exhibit E attached hereto.
11. DISCOUNTS AND REBATES. Customer shall be obligated to report and provide information concerning any discounts, rebates or other price reductions provided under this Agreement. Customer must claim the benefit of these discounts in the fiscal year in which the discounts are earned, or the following year. By signing this Agreement, Customer acknowledges its legal obligations to fully and accurately report the discounts, rebates and/or other price reductions received under this program. Customer should retain this Agreement and any other documentation of discounts, rebates or other price reductions and make such information available to any applicable governmental authorities and programs and other applicable payers upon request.
12. SUNSHINE ACT. For Customers located in the United States only, the parties acknowledge that the Physician Payments Transparency Requirements enacted as section 6002 of the Patient Protection and Affordable Act of 2010 (codified at 42 U.S.C. §1320a-7h) and the regulations of the Centers for Medicare and Medicaid Services (CMS) promulgated thereunder (collectively, the “Sunshine Act”) require pharmaceutical, medical device, group purchasing organizations and other companies to annually report certain information about compensation, expenses and other payments or transfers of value provided directly or indirectly to U.S. physicians and teaching hospitals to CMS, which will in turn publicly post the information. If Customer is located in the United States, Customer agrees: (a) not to contest any such reporting made by HSI in its reasonable judgment; (b) to provide HSI with any information requested to ensure its timely, accurate and complete reporting; and (c) to comply with its annual reporting obligations under the Sunshine Act, to the extent required, including filing appropriate ownership reports.
13. CONFIDENTIALITY OF INFORMATION. Customer will not use (except to undertake the activities contemplated by this Agreement), publish or otherwise disclose any confidential or proprietary information (including the terms of this Agreement) (“Confidential Information”) related to HSI or the Products that is disclosed by HSI or otherwise acquired by Customer in connection with the performance of this Agreement unless required by applicable law. This provision shall survive any expiration or termination of this Agreement.
14. PRODUCT WARRANTY.
15. OTHER MATTERS.
a. LIMITATION OF LIABILITY. TO THE EXTENT PERMITTED BY LAW, NEITHER PARTY SHALL BE LIABLE TO THE OTHER (OR, IN THE CASE OF HSI AND EACH HSI ENTITY, TO CUSTOMER’S PATIENTS) FOR INDIRECT, INCIDENTAL, PUNITIVE, SPECIAL OR CONSEQUENTIAL DAMAGES INCLUDING, BUT NOT LIMITED TO, LOST PROFITS AND LOSS OF GOODWILL, ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT (OR ANY DUTY OF COMMON LAW, AND WHETHER OR NOT OCCASIONED BY THE NEGLIGENCE OF A PARTY OR ITS AFFILIATES), REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES; PROVIDED THAT NOTHING IN THIS SECTION IS INTENDED TO, OR DOES, LIMIT THE CONFIDENTIALITY RIGHTS OR OBLIGATIONS OF EITHER PARTY SET FORTH HEREIN. IN NO EVENT WILL HSI’S (INCLUDING ALL OF THE HSI ENTITIES) AGGREGATE LIABILITY UNDER THIS AGREEMENT EXCEED THE AMOUNT OF FEES PAID BY CUSTOMER TO HSI UNDER THIS AGREEMENT IN THE PRECEDING 12 MONTHS. This Section shall survive any expiration or termination of this Agreement.
b. Indemnity. Customer agrees to indemnify, keep indemnified, defend and hold harmless HSI, including each HSI Entity against and from any and all claims, causes of actions, damages, debts, liabilities, losses, obligations, payments, costs and expenses (including reasonable legal expenses), arising from or relating to: (i) Customer’s breach of any term of this Agreement or of any agreement between Customer and their patient; (ii) any actions or omissions of Customer and including any act or failure to act in respect of a patient; (iii) Customer’s provision of incorrect or incomplete information, records, documents or impressions to HSI or any failure to timely provide HSI with any such information, records, documents or impressions; and (iv) any dealings with any applicable regulators, licensing or professional bodies in relation to Customer. This Section shall survive any expiration or termination of this Agreement.
c. Intellectual Property Rights, Confidentiality and Trademarks.
The parties hereby irrevocably waive the defense of an inconvenient forum to the maintenance of any such suit, action or proceeding.
Product and Product Package Descriptions and Definitions
Reveal Aligners Standard – Treatment package for moderate-to-severe cases with 21 or more steps. Includes Assurance Plan (as defined below) and one set of retainers.
Reveal Aligners Lite – This treatment option is for mild-to-moderate cases or single arch treatment with 11 to 20 steps or 21 to 40 individual aligners. Includes one refinement (if needed) and one set of retainers.
Reveal Aligners Express – This treatment option is for very mild cases with less than 10 steps or 20 or less individual aligners. Includes one refinement (if needed) and one set of retainers.
Reveal Plus Aligners Standard – Treatment package for moderate-to-severe cases with 21 or more steps. Includes Assurance Plan (as defined below) and one set of retainers.
Reveal Plus Aligners Lite – This treatment option is for mild-to-moderate cases or single arch treatment with 11 to 20 steps or 21 to 40 individual aligners. Includes one refinement (if needed) and one set of retainers.
Reveal Plus Aligners Express – This treatment option is for very mild cases with less than 10 steps or 20 or less individual aligners. Includes one refinement (if needed) and one set of retainers.
Reveal Plus Aligners Flex – This treatment option for large group practices is for cases with 20 or less steps or 40 individual aligners. Includes one refinement (if needed) and one set of retainers.
Assurance Plan is guaranteed refinements for three years calculated by the aligner case invoice date.
Elastic Button Technique (EBT) is a technique for using buttons and rubber bands as auxiliaries to aligners in order to achieve extrusion. The Clinician will be notified if EBT is recommended on the Treatment Setup, but those recommendations are not required to be accepted by the Clinician and it is up to the Clinician to promptly inform HSI of any necessary changes. If the Clinician approves the Treatment Setup with EBT, directions on the location and timing for EBT will be provided once the aligners have been manufactured. The Clinician must follow directions provided by creating cutouts on aligners in-office and adhering separately purchased buttons to the surface of the teeth near the gingiva. The Clinician has complete choice of what buttons and elastics to use. After aligners have been modified and buttons adhered, the Clinician must instruct patients on proper elastics wear.
Interproximal Reduction (IPR) is a procedure where the proximal surfaces of the teeth are reduced. This reshaping creates spaces between the teeth to allow them to move more easily during treatment. The Clinician will be notified if IPR is recommended on the Treatment Setup, but those recommendations are not required to be accepted by the Clinician and it is up to the Clinician to promptly inform HSI of any necessary changes. The Clinician will need to notify HSI of any preferences on when to perform IPR when submitting the case or requesting modifications of the treatment plan. If the Clinician approves the Treatment Setup with IPR, directions on the location and timing for IPR will be provided once the aligners have been manufactured. The Clinician has complete choice of what instruments and methods to use for completion of planned IPR. HSI recommends always getting signed consent from the patient before performing IPR.
Refinement – An option if further tooth movement is needed in order to meet the original approved Treatment Setup. Refinements are not an opportunity to modify the original Treatment Setup. HSI will provide the recommended number of aligners to achieve your approved Treatment Setup once appropriate records have been provided. Refinements may only be requested after half the number of steps provided have been used and before the Treatment Expiration Date.
Retainers – One set of upper and lower, made of slightly thicker material for longevity. May be ordered as replacement retainers, based on the original submitted intraoral scan and approved Treatment Setup.
Replacement Aligners – To replace lost or damaged aligner trays, Replacement Aligners are made from the original submitted intraoral scan and approved Treatment Setup. Dual arch Replacement Aligners constitute two replacement trays.
Note on Replacement Aligners: Direct patients to keep their most recently used aligners and temporarily use the previous set while replacements are being made. Replacement Aligners for more than one step are available for purchase and will generally ship within 7 to 10 business days after placing the order. If one set of aligners has been lost please instruct the patient to skip that step and increase the length of time the next step is worn until the teeth are fully seated.
Revision – An option if the treatment plan needs to be changed by the doctor to achieve new treatment goals. A new Treatment Setup will be provided for approval.
Treatment Expiration Date is calculated by the aligner delivery date plus 2 weeks per step, plus 120 days from completion of the final step.
Treatment Setup is a virtual three-dimensional representation of the patient’s expected tooth movement which is used for communicating the orthodontic treatment plan. Treatment Setups include the virtual model and the option for Interproximal Reduction (IPR), Attachments, Cutouts, Elastic Slits, and Elastic Button Technique (EBT) if needed. Prior to approving the final Treatment Setup, the Clinician is requested to thoroughly review the Treatment Setup and request changes or modifications in the DDX Portal. If the Clinician does not approve the Treatment Setup, he/she may cancel the case with no cancellation fees. The Clinician’s approval of the customized Treatment Setup is considered a prescription to HSI and HSI’s final authorization to manufacture the Henry Schein’s Aligners (when medically feasible for extraction cases, HSI recommends Treatment Setup approval prior to performing extractions). Results depicted in Treatment Setup are simulated; actual clinical results may vary and are not guaranteed.
New Treatment Setup – When new scans or impressions are required for Retainers or a new Treatment Setup is requested after one has already been approved by the customer.
This Warranty covers aligner Products (“Aligner Products”) and retainer Products (“Retainer Products”) (collectively, “Products”) sold to Customer hereunder. The warranty is exclusively for the benefit of eligible treating Customers (individually, a “Clinician”) and is not for the benefit of any other person or entity, including, but not limited to, any patients, practices, laboratories and/or other intermediate suppliers.
1. The “Warranty Period” is as follows and will apply to (i) Aligner Product packages until the “Treatment Expiration Date” (which is calculated by taking the date the applicable Aligner Product is delivered to Customer and adding two (2) weeks per step (per approved Treatment Setup), plus 90 days; and (ii) Retainer Products sold separately for up to six (6) months from the Treatment Expiration Date; provided that HSI only warrants the fit of the Retainer Products for up to 60 days from the date of shipment to Customer. (iii) Individual Aligner Products sold separately HSI only warrants the fit for up to 15 days from the date of shipment to Customer.
Exhibit C (For U.S. Customers Only)
HIPAA Business Associates Agreement
(PRIVACY AND SECURITY OF HEALTH INFORMATION)
This BUSINESS ASSOCIATE AGREEMENT (“Agreement”) is entered into between Henry Schein, Inc. and/or its affiliated companies (including, for clarity and to the extent applicable, Ortho Organizers, Inc.), as applicable (each a “Business Associate”, as applicable) and the Customer (as defined in the T&Cs) (“Provider”) together with the Clear Aligner Products Terms and Conditions (“T&Cs”). The parties hereby acknowledge and agree that each Business Associate is acting severally under this Agreement and as such, any and all obligations and liabilities with respect to each Business Associate shall be several, not joint, and relate only to the Business Associate and specific products or services being provided or performed by such individual Business Associate. Both parties agree as follows:
Capitalized terms used, but not otherwise defined, in this Agreement shall have the same meaning as those terms in the Standards for Privacy of Individually Identifiable Health Information, at 45 Code of Federal Regulations (“CFR”) part 160 and part 164 subpart E (the “Privacy Rule”), the Security Standards issued at 45 CFR part 160 and part 164 subpart C (the “Security Rule”), and the breach notification rules at 45 CFR Part 164, subpart D (“Breach Rules”) as they may be amended from time to time.
The following capitalized terms shall have the following meaning when used in this Agreement:
The parties agree that they will neither directly nor indirectly receive remuneration in exchange for any PHI of a Patient, unless a valid authorization, pursuant to 45 CFR 164.508, is executed by that Patient. Notwithstanding the foregoing, the parties agree that they may receive remuneration in exchange for PHI of a patient in accordance with 42 USC § 17935(d)(2) and 45 CFR 164.502(a)(5)(ii)(B)(2).
Any and all notices, requests, or reports, required or permitted to be given under any provision of this Agreement shall be in writing and shall be deemed given upon the mailing thereof by first class certified mail, return receipt requested, postage prepaid, or by overnight mail. If such notice is to the Business Associate, then it shall be sent to the attention of the HIPAA Compliance Officer at: Henry Schein, Inc., 135 Duryea Road, Melville, New York 11747, with a copy to the General Counsel; fax: 631-843-5660. If such notice is to the Provider, then it shall be sent to the address that the Business Associate then has on file for the Provider.
This GDPR Controller-Processor Agreement (“CPA”) is incorporated into and adds the following data privacy clauses to the Terms and Conditions to which this CPA is attached or relates (“T&Cs”), between the Customer (as defined in the T&Cs) (“Controller”) and the HSI Entity (as defined in the T&Cs) which is providing the Products (as defined in the T&Cs) (“Processor”) to the Customer; each a “Party” and both jointly the “Parties”.
Such measures shall include, as appropriate:
When receiving a right of erasure request, Processor will restrict processing of Personal Data within five (5) days relating to such request and communicate the same obligation to any Sub-Processor engaged with processing on behalf of Processor hereunder.
Processor represents that the same data privacy obligations as set out in this CPA have been imposed on each of its sub-processors (“Sub-Processors”) by contract, in particular with regard to providing sufficient guarantees to implement appropriate technical and organizational measures and that Processor shall remain fully liable for any data breach caused by an act, error or omission of its Sub-Processors.
COUNTRY/TERRITORY SPECIFIC CLAUSES AND LAWS
THE FOLLOWING COUNTRY/TERRITORY SPECIFIC LAWS AND CLAUSES ONLY APPLY TO CUSTOMERS LOCATED IN THE APPLICABLE COUNTRY/TERRITORY DESIGNATED BELOW:
For Italy, Sections 16 and 17 of the Terms and Conditions shall read as follows:
Agreed for the purposes of Art 1341 Italian Civil Code …………………………………..
Signature Customer or other means of acceptance designated by HIS