INTRODUCTION
UNLESS OTHERWISE EXPRESSLY AGREED IN WRITING, THESE TERMS AND CONDITIONS SHALL APPLY TO ALL SALES BETWEEN ORMCO CORPORATION (AND/OR ITS AFFILIATES AS APPLICABLE) (“ORMCO”) AND ANY CUSTOMER OF ITS PRODUCTS AND/OR SERVICES (“CUSTOMER”) AS WELL AS THE USE OF THE ORMCO DTX PLATFORM (“ORMCO PORTAL”). THE FOLLOWING TERMS AND CONDITIONS OF SALE ARE HEREBY INCORPORATED BY THIS REFERENCE INTO ANY INVOICE ISSUED BY ORMCO TO CUSTOMER AND SHALL GOVERN THE RIGHTS AND OBLIGATIONS OF THE PARTIES WITH RESPECT TO ALL SALES OF PRODUCTS BY ORMCO TO CUSTOMER. CUSTOMER, BY ACCEPTING DELIVERY OF THE PRODUCTS DESCRIBED IN INVOICE (THE "PRODUCTS") PRESENTED BY ORMCO, ACCEPTS AND AGREES TO ABIDE BY THE TERMS AND CONDITIONS CONTAINED HEREIN. THESE TERMS AND CONDITIONS TAKE PRECEDENCE OVER CUSTOMER'S ADDITIONAL OR DIFFERENT TERMS AND CONDITIONS, TO WHICH NOTICE OF OBJECTION IS HEREBY GIVEN. ACCEPTANCE BY CUSTOMER IS LIMITED TO THESE TERMS AND CONDITIONS. NEITHER ORMCO'S COMMENCEMENT OF PERFORMANCE NOR DELIVERY SHALL BE DEEMED OR CONSTITUTED AS ACCEPTANCE OF CUSTOMER'S ADDITIONAL OR DIFFERENT TERMS AND CONDITIONS, INCLUDING ANY TERMS AND CONDITIONS CONTAINED IN CUSTOMER'S PURCHASE ORDER.
CREATION OF SPARK AND/OR ORMCO DIGITAL BONDING ACCOUNT AND USE OF ORMCO PORTAL
All Customers must have an active account on the Ormco Portal and all Spark Clear Aligner and Ormco Digital Bonding (“ODB”) cases must be submitted through the Ormco Portal. The Ormco Portal is for use by licensed medical professionals and their staff only and only for the purpose of treating patients with Ormco’s products and services. Each Customer must be a licensed doctor providing services in the jurisdiction in which they are licensed. Each Customer must be in good standing with Ormco. Ormco reserves the right to remove any Customer’s access to the Ormco Portal or to its goods and services if such Customer is in violation of these Terms and Conditions.
INACTIVE CASES AND/OR ACCOUNT
In the event a Customer has not accessed their Portal account for more than 24 months, Ormco reserves the right to delete such account and any data contained in such account, subject to applicable legal and regulatory requirements.
CASE TRANSFER
In the event Customer wishes to transfer any pending Spark or ODB case to another doctor or practice, it shall notify Ormco and, together with the transferee, shall complete Ormco’s Spark Case Transfer Authorization Form, available upon request.
PRICING AND REFINEMENTS
The pricing for each product shall be specified in Ormco’s invoice to Customer. The pricing on Spark Clear Aligners includes the following number of refinements:
Spark 10: one (1) refinement within five (5) years from delivery of the primary Spark Clear Aligners.
Spark 20: two (2) refinements within five (5) years from delivery of the primary Spark Clear Aligners.
Spark Advanced: unlimited refinements within five (5) years from delivery of the primary Spark Clear Aligners.
PAYMENT INFORMATION
Purchaser shall pay the balance due on the date specified on the equipment order.
Payment is due thirty (30) days after the date of the invoice unless otherwise specified on the front of the invoice. Ormco reserves the right to establish and /or change payment terms extended to Customer when, in Ormco's sole opinion, Customer's financial condition or previous payment record warrants that action.
In the event Customer is sixty (60) days past due, Ormco reserves right to restrict Customer’s purchase of Ormco product and/or initiation of a new Spark or ODB case.
Security Interest: Ormco retains a security interest in the Products delivered to the Customer, and in their accessories, replacements, accessions, proceeds and products, including accounts receivable (collectively, the "Collateral") to secure payments of amounts and performance due under this invoice. Customer acknowledges that this document or copies of this document may be filed with the appropriate authorities as a financing statement and agrees to execute and deliver such other documents as we may request in order to evidence or perfect our security interest.
Statutory Interest: For products sold in the European Union, any invoice or other outstanding balance not paid within thirty (30) days after the date of the invoice will be subject to a flat fee plus statutory interest payment due pursuant to directive 2011/7/EU in the amount of the sum of the specific EU Members reference rate plus 8%.For products sold anywhere else in the world, any invoice or other outstanding balance not paid within thirty (30) days after the date of the invoice will be subject to a carrying charge of 1 ½% per month, an amount equal to 18% annum or the maximum rate permitted by law, whichever is less.
SHIPMENT: TITLE TO GOODS
For all shipments from the United States:
DOMESTIC.
DOMESTIC. All domestic shipments will be made FOB (UCC § 2-319) Ormco's facility. Delivery will be deemed complete and legal title and all risk of loss or damage to the Products will pass to Customer, upon delivery to the carrier.
INTERNATIONAL.
All international shipments will be made FCA (lncoterms 2010) Ormco’s Facility. Delivery will be deemed complete and all risk of loss or damage to the Products will pass to Customer when the Products enter international water or airspace or upon delivery to the Customer's designated freight forwarder. Legal title will transfer when products enter international water or airspace.
International waters are defined as twelve (12) nautical miles from the last port of US export. International air space entry is defined at the time of aircraft departure/wheels up from the last US port of export. Land shipments (rail and truck) will be deemed complete and legal title passed to Customer once the shipment crosses out of the US.
In the event of a dispute, these terms will supersede any terms reflected on shipping documents.
For all shipments from all other locations:
All shipments will be made FCA Incoterms Ormco’s Facility. Delivery will be deemed complete and all risk of loss or damage to the Products will pass to Customer upon delivery to the carrier or, in the case of international shipments, when the Products enter international water or airspace or upon delivery to Customer’s designated freight forwarder. Legal title will transfer when products enter international water or airspace. International waters are defined as twelve (12) nautical miles from the last port of export by Ormco.
International airspace entry is defined at the time of aircraft departure/wheels up from the last port of export by Ormco. Land shipments (rail and truck) will be deemed complete and legal title passed to Customer once the shipment crosses the border out of country of residence of Ormco or Ormco’s affiliate.
In the event of a dispute, these terms will supersede any terms reflected on shipping documents.
RETURNS
Subject to the below, Ormco's non-custom product(s) that are not defective in material or workmanship may be returned at Customer's expense for full credit within thirty (30) days of shipment.
Subject to the below, Ormco's non-custom product(s) that are not defective in material or workmanship being returned within thirty-one to ninety (31-90) days of shipment will receive a full exchange to a product of equal value (as determined by the Ormco) and will be subject to a 20% restocking fee.
Product will not be approved for return later than ninety (90) days after shipment.
The foregoing does not apply to the sale of DEXIS scanners. All sales of DEXIS scanners are final and non-refundable.
All returned products must meet the following conditions for credit to be issued:
(a) Products must be unused, in the original unopened package and in resalable condition; (b) Products must be packaged so as to arrive at Ormco's facility undamaged; (c) Products must be shipped prepaid and insured for full invoice value; (d) Products must be of current design; (e) A copy of original invoice must accompany the products along with a note explaining the reason for this return; (f) Returns must be accompanied by a Return Material Authorization (RMA) that can be obtained from the Customer Care Department (800- 898-6261). Once Product has been returned and processed, the exchange Product will be issued.
Once Product has been returned and processed, the exchange Product will be issued.
NONRETURNABLE GOODS.
The following products are not returnable: (a) Any custom-made products; (b) Chemical or refrigerated products, (c) DEXIS scanners and training. An order for a custom-made product cannot be cancelled after the Customer has approved the product for manufacture.
INTERNATIONAL RETURNS.
For all international returns approval must be obtained from Customer Care prior to returning product to the United States. In addition to providing a copy of the invoice, the Customer must issue a new pro forma invoice in English to the Import-Export Department to include: (a) date of return shipment, Customer name and address; Ormco ship to address; plus the following for each product: product name, part number, quantity, value, country of origin, and schedule B number (all found on Ormco's invoice); (b) Statement: "Returned merchandise: value declared for customs purposes only." (c) Customers must send a shipment pre-alert to Import-Export Department to include the invoice, air bill, flight details and/or arrival information.
Ormco's Customer Returns Department's evaluation of the condition of products and count are final. When returning all or part of an order to the U.S., enclose a copy of the invoice, and return via a trackable, insurable shipping method to Customer Service Representative for local address.
PRODUCT INQUIRIES
In the event of any Customer inquiry related to a Spark product or service, please contact: gln.creditreturns@kavokerr.com. Additionally, you are welcome to contact our global headquarters at: 200 S. Kraemer Blvd, Brea, CA 92821 or contact your Customer Service Representative.
LIMITED WARRANTY
CUSTOMER MUST ASSUME FULL RESPONSIBILITY FOR THE SELECTION OF THE PRODUCT TO ACHIEVE CUSTOMER'S INTENDED PURPOSES, FOR THE PROPER INSTALLATIONS AND USE OF THE PRODUCT AND FOR VERIFYING THE RESULTS OBTAINED FROM ITS USE. Ormco assumes no responsibility for, and does not warrant the installation work of others nor does Ormco assume responsibility for overseeing or supervising the work of any person other than its own agents or personnel. All products manufactured are warranted to be free of defects in materials and manufacture for one year from date of delivery. Any material or manufacture defect covered by this limited warranty which occurs during normal use and is reported to Ormco in writing during the period of one (1) year from the date such product is shipped to the Customer. Ormco's obligation hereunder, upon verification of the defect or error, shall be to provide one of the following: (i) replacement at no charge to Customer; (ii) repair at no charge to Customer; or (iii) credit the purchase price to Customer. If, upon the inspection of any Ormco product to which this warranty applies, Ormco determines that a claimed defect was not due to its manufacture or materials, Ormco will proceed to service the Ormco product at Customer's expense and approval. This warranty shall be null and void upon service, repair or replacement of any portion of the Ormco product or any modification performed by anyone other than an authorized Ormco service representative, or under the direction of Ormco. Customer must use the Ormco approved hardware with the prescribed Ormco software and must use the Ormco software with the prescribed Ormco hardware.
Usage of any Ormco component with any non-prescribed component will render warranty coverage for the Ormco product null and void. Any modification of any Ormco product will also render warranty coverage for the Ormco product null and void. Customer's remedies under this limited warranty are exclusive of all others. Ormco's warranty obligation with respect to all components, equipment and accessories which are integrated into a Ormco product and not manufactured by Ormco shall be limited to those express written warranties made to Ormco by manufacturer which Ormco hereby assigns and transfers to Customer. THE FOREGOING WARRANTY IS MADE IN LIEU OF ALL OTHER WARRANTIES WHATSOEVER WITH RESPECT TO PRODUCT OR SERVICES SOLD HEREUNDER, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTIES OF MERCHANTABILTY OR FITNESS FOR A PARTICULAR PURPOSE. ALL WARRANTIES SHALL TERMINATE ONE YEAR FROM DATE OF DELIVERY OF PRODUCT TO YOU. THIS WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS. YOU MAY HAVE OTHERS, WHICH VARY FROM STATE TO STATE.
LIMITATION OF LIABILITY
IN NO EVENT SHALL ORMCO BE LIABLE AND CUSTOMER WAIVES ALL CLAIMS AGAINST ORMCO FOR CONSEQUENTIAL OR SPECIAL DAMAGES, WHETHER OR NOT BASED UPON ORMCO'S NEGLIGENCE OR BREACH OF WARRANTY OR STRICT LIABILTY IN TORT OR ANY OTHER CAUSE OF ACTION ARISING, DIRECTLY OR INDIRECTLY, IN RESPECT TO THE ORMCO PRODUCT OR SERVICES COVERED HEREUNDER, OR THE USE OR FAILURE THEREOF, INCLUDING, BUT NOT LIMITED TO, DAMAGES FOR LOST PROFITS, LOSS OF PRODUCTION OR INJURY TO PERSONS OR PROPERTY. IN ANY EVENT, ORMCO'S MAXIMUM LIABILITY SHALL NOT EXCEED THE PURCHASE PRICE OF THE PRODUCT FURNISHED BY ORMCO WHICH IS THE BASIS OF SUCH A CLAIM.
PATENT INDEMNIFICATION
Ormco shall defend any suit or proceeding brought against Customer so far as the same is based on a claim that any product of Ormco's design furnished hereunder or any part thereof, constitutes an infringement of any United States patents, if notified promptly in writing and given authority, information and assistance (at Ormco's expense) for the sole defense and settlement of the same and if such alleged infringement is not the result of a design or other special requirement specified by Customer or the result of the application or use to which such product is put by Customer or others. Ormco will pay all damages and costs awarded in such suit or proceeding against Customer. In case such product or part thereof are in such suit held to infringe any such patent and the use thereof is enjoined, Ormco shall, at its expense and option, either (a) obtain for Customer the right to continue using such product or part thereof, (b) replace the same with non-infringing product, or (c) modify the same so it becomes non-infringing, or (d) remove said product and refund the purchase price, less applicable depreciation, and the transportation and installation cost thereof. The foregoing states the entire liability of Ormco to Customer for patent infringement.
TRADEMARK
Ormco owns certain trademarks, slogans, trade names, service marks and logos (collectively the “Ormco’s Marks”). Customer shall not, without the written permission of Ormco, use Ormco’s Marks; associate its business with any Ormco Marks; register, maintain or use any Internet domain based on, containing, or similar to, Ormco’s Marks; or create or maintain any social media.
DATA PRIVACY
Ormco may transfer personal information to or store it in the United States or other destination outside of the country where it was collected. It may also be processed by staff outside of the country where it was collected who work for us or for one of our suppliers. Such staff may be engaged in, among other things, the fulfilment of your order, the processing of your payment details and the provision of support services. Where we transfer personal information to these countries, we will use appropriate approved safeguards or we will seek your explicit consent. For further information, please do not hesitate to contact us at privacy@ormco.com.
Ormco may collect personal information including name, email address, telephone number, profession or other information in relation to purchases and services that Customer orders from the Ormco. Such personal information may be used for business purposes, including to communicate with Customer, fulfil the order, customer service, commercial business analysis and other services such as sending Customer postal or e- mail marketing communications about other products or services that the Ormco believes may be of interest. If Customer does not wish to receive such marketing communications please inform Ormco by emailing privacy@ormco.com. Ormco (including its direct and indirect subsidiaries and affiliated companies) acts as a data controller with respect to the collection, use, and other processing of certain data about Customers relating to the relationship between the Customer and Ormco. To the extent permitted under applicable data protection and local employment laws, Ormco collects, uses, and processes personal information for (a) the performance and the administration of the contract agreement between the Customer and Ormco, (b) Ormco’s compliance with its legal obligations, or (c) Ormco’s legitimate business interests.
Ormco does not sell or disclose your personal information to third parties without your consent, except:
- To affiliates and third-party service providers to provide services and information on our sites, including online marketing and advertising, and to support our business operations. We require these parties to handle personal information accordance with this Privacy Notice.
- To affiliates to offer and provide information about related products and services. We do not share personal data from countries that require consent, unless consent has been obtained in advance to sharing with related affiliates. We require these parties to handle personal data in accordance with this Privacy Notice.
- To another company in connection with the sale or transfer of one of our product lines or divisions, which includes the services provided through one or more of Ormco’s affiliates.
- To governing regulatory authorities, including the US Food and Drug Administration, or as may therwise be necessary for Ormco to comply with a legal obligation or demand.
- Customers have the right to access, transfer, object, cancel, review, update, correct and request the deletion or restriction of their own personal information in accordance with applicable law. These rights may be limited in some situations; for example if it is determined not to be feasible to fulfill your request due to a legal requirement. Also, Customers are responsible for informing Ormco if there are any changes or inaccuracies to their personal information. The entire data privacy notice can be accessed online at www.ormco.com. Where Customer provides Ormco with health information or other personal information relating to the Customer’s patients to process on its behalf the paragraph below PATIENT DATA shall apply.
Purchasers have the right to access, transfer, object, cancel, review, update, correct and request the deletion or restriction of their own Purchaser data in accordance with applicable law. These rights may be limited in some situations; as if it is determined not to be feasible to fulfill your request due to a legal requirement. Also, Purchasers are responsible for informing Seller if there are any changes or inaccuracies to their Purchaser data. The entire data privacy notice can be accessed online at www.ormco.com. Where Purchaser provides Seller with health information or other personal information relating to the Purchaser’s patients to process on its behalf the paragraph below PATIENT DATA shall apply.
PATIENT DATA
Ormco offers certain products and services, including Insignia™, Spark™, ClearGuide Express™, and Digicast™ where the Customer may provide Ormco with personal information (including protected health information) of Customer’s patients (“Patient Data”).
Customer may be subject to the laws and regulations of one or more jurisdictions, including but not limited to, laws and regulations that may apply to your use, collection, disclosure, storage, transmission, retention of personal information, including health information (together, to “Process” or “Processing”). It is Customer’s responsibility to comply fully with all such applicable laws and regulations including but not limited to laws and regulations that require that Customer obtains and maintain the prior express, informed, written consent of the patient before conducting any personal data processing activity, including transmitting the patient’s data to third parties or to a destination outside the country where it was collected.
By sharing personal information with us to Process on your behalf Customer represents and warrants that (i) they have obtained all such information (including any protected health information and/or patient data) lawfully and, with the patient’s written consent, if necessary (ii) they have obtained the prior written approval, as required, of every patient for sharing the respective Patient Data with Ormco to Process in accordance with the Data Processing Addendum set out in Annex 2, (iii) they use such Patient Data only for lawful purposes and within the course of dental practice,(iv)they are allowed to transfer such Patient Data to a destination outside the country, province or territory where it was collected, including to Ormco to process on the Customer’s behalf in accordance with the terms of the data processing or business associate agreement set out in the Annex to these terms and conditions Your behalf in the United States and (v) they are compliant with applicable patient rights regulation and legislation, and data protection laws.
Customer will indemnify and hold Ormco harmless against any claim arising out of or related to the processing of personal information on your behalf including the sharing of any patient data or cross-border transfer of data that originates from Customer’s instructions.
To comply with applicable laws and to safeguard Patient Data, Ormco has implemented information policies to protect this information, including providing training to personnel with access to this information and conducting background checks on those personnel, implementing building access controls, security procedures as well as computer server security procedures and designed certain products and software with features such as encryption, anti-virus and intrusion detection as well as other measure to assist Customer and vendors in protecting Patient Data.
If the Customer is practicing in the United States, by accepting these terms, the Customer agrees to be bound by our business associate agreement that you can find as Annex 1 to this Agreement (HIPAA Business Associate Agreement) which shall form part of this Agreement. This business associate agreement covers Ormco’s relationship to the Customer with regards to certain protected health information, in accordance with the Health Insurance Portability and Accountability Act (HIPAA).
If the Customer is practicing in a country of the European Union, United Kingdom, Norway, Lichtenstein, Iceland ,Switzerland, Thailand, Japan, Ukraine Argentina, Saudi Arabia, Chile, Brazil, Columbia, Costa Rica, Taiwan Mexico, Canada or Australia or Russia by accepting these terms, the Customer agrees to be bound by our data processing agreement at Annex 2 of this Agreement or Annex 3 (if Customer is practicing in Russia) (Data Processing Addendum), which shall form part of this Agreement. This agreement covers our relationship when we act as a processor of the personal data for which the Customer is a controller, in accordance with the EU General Data Protection Regulation or other applicable data protection laws.
EXPORT CONTROLS AND SANCTIONS COMPLIANCE
In connection with this Agreement, Customer shall comply with all economic sanctions and export controls laws and regulations applicable to the Customer or Ormco, including those of the United States, European Union, and Switzerland. Customer will not export, share, or use the products or services or the Ormco Portal in connection with or involving any patients or other persons (i) located or resident in countries subject to comprehensive U.S. sanctions (at the time of this Agreement, Iran, Syria, Cuba, North Korea, and Crimea and the so-called Donetsk People’s Republic and Luhansk People’s Republic regions of Ukraine); or (ii) targeted or blocked under applicable economic sanctions, including but not limited to persons listed on sanctioned party lists maintained by the United States, European Union, or Switzerland.
GENERAL
Force Majeure. Ormco shall not be liable for delay in performance or for failure to render any performance, and any such delay or failure shall for all purposes be excused, when such delay or failure is caused by governmental regulation, fire, flood, wind, strike, labor disputes, accidents, embargo, riot, act of God, or any other causes or causes, whether of like or different nature., beyond the reasonable control of Ormco. Customer shall bear any costs incidental to Customer's delay or failure in accepting the Ormco's product or any other performance.
Established Business Relationship. By purchasing Ormco's product, you have entered into an established business relationship with Ormco formed by the Customer of Ormco's product, and hereby consent to receiving email and facsimile communications from Ormco concerning products and services.
Patented Products.Brackets, molar assemblies and archwires covered by Ormco patents are sold with license for single-use only.
Product Changes. Ormco reserves the right in its sole discretion, to change, update and enhance the products at any time including to add functionality or features, or to remove them from the products. Ormco may also, in its sole discretion, suspend the sale or production of any product.
Seller may also, in its sole discretion, suspend the sale or production of any product.
Governing Law. These terms and conditions shall be governed by and construed in accordance with the laws of the state of California, without regard to conflict of laws principles and Customer hereby submits to the exclusive jurisdiction of the courts located in Orange, California. The parties agree that the UN Convention on Contract for International Sale of Goods will not apply.
Waiver. No failure of either party to exercise any power or right hereunder or to insist upon strict compliance with these Terms and Conditions of Sale, and no custom or practice of the parties at variance with the terms hereof, will constitute a waiver of either party’s right to demand compliance with these Terms and Conditions.
Termination for Default. Ormco may terminate an order, in whole or in part, if Customer is in breach of any term contained in these Terms and Conditions of Sale and fails to remedy within ten (10) of Ormco’s notice.
Effect of Invalidity. The invalidity of any part of any section of the Terms and Conditions of Sale contained herein shall not affect the validity of any other section in whole or in part.
Statute of Limitation. Any action resulting from the breach on the part of Ormco as to any Ormco product delivered hereunder must be commenced within one year after the cause of action has accrued.
DISCOUNT & REBATE DISCLOSURE
Federal, state or local law may require the disclosure by Customer of discounts, rebates, or other reductions in price received, directly or indirectly, in claims, charges, or reports made to federal healthcare programs, including Medicare and Medicaid. Customer hereby acknowledges this obligation and warrants and represents that it will properly report and disclose, and appropriately reflect all reduction in price received and all amounts paid hereunder (including all rebates) as discounts to the extent required by applicable state and federal laws and regulations, including the Physician Payments Transparency Requirements of the Patient Protection and Affordable Care Act of 2010, 42 U.S.C. 1320a-7h, and implementing regulations, and the discount “safe harbor” regulations, published at 42 C.F.R. Section 101.952(h).