General
Clear Aligners
Clear Aligners Terms and Conditions

Argen manufactures custom clear Aligners designed to move teeth in small increments based on a treatment plan approved by a qualified medical dental professional. These Terms and Conditions of Sale for Clear Aligners apply to all Orders between Argen and Buyer for the manufacture and supply of Aligners by Argen using the Manufacturing Files supplied by Buyer for such Aligners and shall be effective as of the date of acceptance by Argen of Buyer’s Order.
1. DEFINITIONS. As used in these Terms and Conditions of Sale for Clear Aligners:
  1. “Aligner Terms” means these Terms and Conditions of Sale of Clear Aligners.
  2. “Aligner Design” means the design for clear aligners developed by Buyer or a third party engaged by Buyer for such purpose.
  3. “Aligners” means the clear aligners manufactured by Argen pursuant to the Manufacturing Files, and any accompanying supplies and accessories identified in the applicable order.
  4. “Approved Design” means, in each case, the Proposed Design approved by a dental medical professional.
  5. “Argen” means The Argen Corporation, including any division or subsidiary thereof.
  6. “Argen Standard Terms” means the Argen Standard Terms and Conditions.
  7. “Argen Onboarding Materials” means Argen’s materials that provide guidance and requirements to place a successful order for the manufacture of Clear Aligners with Argen.
  8. “Buyer” means the person or entity that placed the Order with Argen.
  9. “cGMP” means current good manufacturing practice requirements set forth in the quality systems (QS) regulation (21 C.F.R. Part 820) for devices or current good manufacturing practices (21 C.F.R. 4, Subpart A) for combination products, as applicable.
  10. “Confidential Information” has the meaning defined in Section 17.
  11. "Design Center" means any third party design center engaged by Buyer for teh design of clear aligners.
  12. “FDA” means the United States Food and Drug Administration or any successor agency.
  13. “Force Majeure” means acts of God, strikes, lockouts, or other industrial disturbances, acts of public enemies, wars, insurrections, riots, earthquakes, fires, storms, floods, inability with reasonable diligence to obtain materials, delay in transportation by common carrier, and any other causes not within the control of the party claiming a suspension which by the exercise of due diligence such party shall not have been able to avoid or overcome.
  14. “Indemnified party” has the meaning defined in Section 11.
  15. “Intellectual Property Rights” means all United States and worldwide trademarks, service marks, trade dress, copyrights, patents, trade secrets, rights under unfair competition and/or unfair trade practices laws, and all other intellectual and industrial property rights related thereto.
  16. “Manufacturing Files” means the output of the Approved Design
  17. “Order” means written or, if agreed by the parties, electronic order placed by Buyer for Aligners.
  18. “Patient” means each end-user patient of Aligners.
  19. “Patient Informed Acknowledgement and Consent” means a Patient informed acknowledgement and consent form to be signed by the Patient substantially similar to the form provided by Argen to Buyer.
  20. “Purchase Agreement” means the written agreement between Buyer and Argen for the purchase of Aligners, which shall consist of these Aligner Terms, the Argen Standard Terms, and the applicable Order.
  21. “Purchase Price” means the price payable to Argen by Buyer for Aligners.
  22. “RMA” shall mean the return material authorization form provided by Argen to Buyer.
  23. “Recall Action” has the meaning defined in Section 13.c.
  24. “Specifications” means, with respect to each Order, the corresponding Manufacturing Files supplied to Argen by Buyer.
  25. “Term” means the time period in which this Purchase Agreement shall be in full force and effect as set forth in Section 15.a.
  26. “UN Convention” has the meaning defined in Section 24.
2. AGREEMENT; INCONSISTENT TERMS; ONBOARDING.
  1. Agreement; Inconsistent Terms. Argen and Buyer agree that all purchases of Aligners by Buyer will be governed by this Purchase Agreement. Buyer acknowledges and agrees that acceptance by Argen of any Order from Buyer is expressly made conditional upon Buyer’s assent and shall be subject to these Aligner Terms and the Argen Standard Terms. In the event of any conflict among these Aligner Terms, the Argen Standard Terms, and the applicable Order, or in the event no written or formal Order is issued, these Aligner Terms shall control unless otherwise expressly agreed to in writing by Argen and Buyer. Buyer’s acceptance of Aligners shall be deemed Buyer’s assent to all Aligner Terms and Argen Standard Terms even if no written or formal Order is issued by Buyer. For the avoidance of doubt, Argen shall not be bound by the provisions of other documents, including any terms and conditions set forth in the Order or other purchase order, order confirmations, acceptance, or other instruments from Buyer, unless signed by an officer of Argen.
  2. Onboarding. Buyer shall review and accept the Argen Onboarding Materials prior to submitting any Orders for Aligners.
3. ORDERS.
  1. Ordering Procedure. Each Order shall be in a form approved by Argen and shall specify (a) the Aligners being ordered, (b) the requested delivery location, (c) other appropriate information as may be required by Argen to complete the Order, (d) the location to which the applicable invoice shall be rendered for payment, and (e) any other terms included in Argen’s approved Order, as may be amended by Argen from time to time.
  2. Buyer is responsible for providing Argen with all information necessary for Argen to manufacture Aligners. Argen is not responsible for the accuracy or inaccuracy of any information received from Buyer or third parties in connection with the applicable Order. Aligners shall be manufactured using the information Buyer provides to Argen. Argen is not responsible for the accuracy and quality of the information provided to Argen incident to the Order, including the Manufacturing Files, and the results of all reliance on and use of such information.
  3. Acceptance of Orders. Argen shall have the right, at its sole and absolute discretion, to accept or reject any Order (or any portion thereof) for any reason. No Order shall be binding upon Argen unless and until shipment is tendered to the carrier.
  4. Cancellation of Orders. Once accepted by Argen, Orders not be canceled, reduced, changed, or suspended by Buyer
  5. Returns. Returns are only permitted in the event that Aligners do not meet their applicable Specifications. All other Aligner issues to be discussed with the dental medical professional who approved the Aligner Design. Buyer shall first obtain an RMA and return instructions before returning any Aligners to Argen. The value of Aligners returned shall not exceed the original Purchase Price paid for such Aligners.
  6. No Modification of Manufacturing Files. If an alteration of the treatment plan is required once approved by the dental medical professional then Buyer must submit a new substitute Order, which shall include the new Manufacturing Files.
4. SHIPMENT AND DELIVERY.
  1. Aligners manufactured by Argen pursuant to the applicable Order will be delivered using the method and instructions specified by Buyer. Any estimated shipping dates provided by Argen to Buyer are based upon conditions existing at the time the applicable Order is received by Argen. Argen shall endeavor to ship the applicable Aligners by Argen’s estimated shipping date, but shall not be responsible for any loss or damage resulting from delay in any shipment. Other than with respect to unusual or bulk Orders, the applicable Aligners are typically dispatched within ten (10) business days from the date of Argen’s acceptance of the applicable Order. With respect to unusual or bulk Orders, Argen will provide Buyer with an estimated shipping date for Aligners applicable to such Orders. Argen will notify Buyer in the event that Argen experiences a delay in shipment of applicable Aligners due to a backlog of Orders and endeavor to begin shipment of the applicable Aligners as soon as reasonably practicable thereafter. Argen shall deliver all applicable Aligners FOB Destination unless otherwise agreed upon by the parties in writing. Argen shall have the right to ship goods from any factory anywhere in the world, as specified by Argen. Notwithstanding the foregoing, all costs of shipping will be borne by Buyer, including without limitation any charges for any special shipping arrangements (such as cartage, air freight, express, parcel post, and multiple deliveries on one order). Any loss or damage that occurs during shipment to any Aligners delivered to Buyer shall be the sole responsibility of Argen, provided that the shipment in question was sent using Argen’s carrier account of choice. Any loss or damage that occurs prior to shipment shall be the sole responsibility of Argen and, in such event, Argen’s responsibility shall be limited to replacement or refund of the applicable Aligners, in Argen’s sole discretion.
  2. Packaging. Buyer may provide instructions for packaging for Aligners. The cost of all custom packaging for all Aligners shall be charged to Buyer.
  3. Passage of Title. Title to, ownership of, and risk of loss or damage to Aligners manufactured pursuant to the applicable Order shall transfer to Buyer upon delivery of such Aligners to the designated carrier at Argen’s point of shipment.
5. MANUFACTURING FILES.
  1. Approved Design. Buyer acknowledges and agrees that the Aligner Design shall be reviewed and approved by a qualified medical dental professional prior to being submitted to Argen for manufacturing. Buyer further acknowledges and agrees that Argen (a) is not a provider of medical, dental, or any other health care services, (b) does not practice medicine, dentistry, or give any medical advice, and (c) is relying on the Manufacturing Files to manufacture the applicable Aligners. A qualified medical dental professional shall be solely responsible for providing medical services to the Patient relating to the applicable Aligners, including without limitation determining the diagnosis and appropriate treatment options for the Patient and informing the Patient of the general and specific risks associated with using Aligners.
  2. Design Bureau Services. Buyer acknowledges and agrees that Buyer shall be solely responsible for obtaining all required licenses in connection with any and all design services, including without limitation any and all software, needed to create, manipulate, store, or transmit the Aligner Design and Manufacturing Files. Accordingly, Buyer shall enter in to separate agreements with Design Centers and obtain digital scanners and software as necessary to create, manipulate, store and transmit the Aligner Design and Manufacturing Files. For the avoidance of doubt, any Design Center engaged by Buyer to provide the Aligner Design shall be acceptable so long as such Design Center uses software for the Aligner Design that meets Argen's minimum specifications, as provided from time to time. Argen shall have no liability whatsoever for any and all consequences related to Argen’s compliance to the Manufacturing Files provided to Argen by or on behalf of Buyer or for any underlying impressions, dental scans, scan models, treatment plan(s), or the Aligner Design.
  3. Suitability. The determination of medical or feasibility of the Aligner Design and suitability of the Aligners manufactured pursuant thereto with respect to the Patient, compliance with all applicable medical and dental standards for prescriptions to use the Aligners, and compliance with all applicable Federal and state laws regulating the design and use of Aligners is the sole responsibility of Buyer.
6. COMPLIANCE. Buyer acknowledges and agrees that Buyer is solely responsible for obtaining and maintaining, at its own expense, all approvals, including without limitation licenses and permits, as may be required to create, or have created, the Manufacturing Files and to prescribe and sell Aligners, and for keeping all such approvals in full force and effect.
7. USE OF ALIGNERS. Prior to selling and delivering Aligners to the Patient, Buyer shall cause the applicable medical dental professional to have such Patient execute a Patient Informed Acknowledgement and Consent. Buyer shall require the medical dental professional to retain in its patient records the executed Patient Informed Acknowledgement and Consent for a minimum of seven (7) years from the date of receipt thereof or such longer period as may be required by applicable law. Buyer shall promptly upon request provide to Argen copies of any executed Patient Informed Acknowledgement and Consent.
8. IMPORT/EXPORT AND USE. Buyer shall be solely responsible for obtaining and paying the applicable fees for all licenses, permits, or any other requirements for the import, export, and/or use, of Aligners shipped by Argen. Aligners may not under any circumstances be shipped or transshipped to any country on which the U.S. Government has an embargo or to any company in any country which appears from time to time on the excluded entity list.
9. PRICING. The Purchase Price of Aligners shall be in accordance with Argen’s prices as in effect at the time of Argen’s acceptance of the applicable Order. Argen may update the Purchase Price at any time and without notice in its sole and absolute discretion. Any changes to the Purchase Price will not affect existing Orders that have been accepted by Argen prior to the effective date of the Purchase Price change. The Purchase Price does not include sales, use, excise, or any similar tax unless otherwise specified by Argen in writing. Any tax or other government charge upon the production, sales, shipment, or use of Aligners that Argen is required to pay or collect from Buyer shall be paid by Buyer to Argen unless Buyer furnishes Argen with a tax exemption certificate or another document acceptable to the applicable taxing authority. Buyer shall be responsible for obtaining all necessary governmental clearances if and when required by any government other than the United States. Buyer agrees to pay any taxes, duties, and or tariffs that Buyer is required to pay to any Federal, state, provincial, or local governmental taxing authority or agency in connection with any Order. Buyer agrees to abide by all custom and/or import laws and regulations that are applicable to any Order.
10. PAYMENT TERMS. Unless otherwise approved by Argen in writing, all Purchase Price payments shall be made by Buyer: (a) prior to shipment of the applicable Aligners; and (b) in U.S. dollars unless the parties previously agreed in writing to do business in another currency. All overdue accounts will accrue a late charge at a rate equal to the lesser of one and a half percent (1.5%) per month or the maximum rate permissible by applicable law. Argen reserves the right, in its sole discretion, to modify or withdraw any credit terms extended to Buyer at any time without prior notice to Buyer and/or suspend, credit, or cancel any unfilled Orders without any liability to Argen in the event that Argen believes Buyer’s credit is impaired. Argen may, in its sole discretion, require full or partial payment or payment guarantee from Buyer, including, but not limited to, a bank guarantee or irrevocable standby letter of credit from an institution approved by Argen, in advance of manufacturing or shipping Aligners whenever, in its opinion, the financial condition of Buyer so warrants. Payment by credit card may be subject to a service charge.
11. LIMITED WARRANTY.
  1. Aligners. Argen warrants that on the date of shipment of the applicable Aligners to Buyer, the Aligners will conform to their applicable Specifications.
  2. The foregoing warranty shall not apply to any Aligners or Aligner parts which have been (a) repaired or altered by any party other than Argen, unless such repair or alteration has been specifically approved in writing by Argen, (b) subjected to misuse, mishandling, alteration, improper storage, repackaging, negligence, or accident, or (c) used in a manner or in an application other than that recommended by Argen. Argen will not be responsible for any damage to any Aligner or Aligner part that occurs after delivery or during or after use by the Patient.
  3. No warranty is made as to (i) the quality, suitability, or performance characteristics of Aligners, or (ii) any raw materials used in the manufacturing of Aligners.
  4. Buyer’s Limited Remedy for Argen’s Breach. BUYER’S SOLE AND EXCLUSIVE REMEDY FOR ARGEN’S BREACH OF THE LIMITED WARRANTY DESCRIBED IN SECTION 10.a SHALL BE LIMITED TO REPAIR, REPLACEMENT, OR EXTENSION OF CREDIT, IN ARGEN’S SOLE DISCRETION, OF THE DEFECTIVE ALIGNERS OR ALIGNER PARTS PROVIDED BY ARGEN AND REPORTED AS DEFECTIVE TO ARGEN WITHIN THIRTY (30) DAYS AFTER THE PRESCRIBED FIRST USE OF THE CORRESPONDING NON-CONFORMING ALIGNER TRAY.
  5. Disclaimer of Warranties. EXCEPT WITH RESPECT TO THE LIMITED WARRANTY PROVIDED IN SECTION 10.a, ALIGNERS ARE PROVIDED “AS-IS,” “WITH ALL FAULTS,” AND “AS-AVAILABLE” AND THE ENTIRE RISK AS TO SATISFACTORY QUALITY AND REPAIR OF ALIGNERS RESTS WITH BUYER AND NOT ARGEN. EXCEPT AS SET FORTH IN SECTION 10, ARGEN EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES REGARDING ALIGNERS, WHETHER EXPRESS, IMPLIED OR STATUTORY, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OF THIRD PARTY RIGHTS, OR BASED ON COURSE OF CONDUCT OR TRADE CUSTOM OR USAGE.
12. BUYER INDEMNIFICATION OBLIGATIONS. Buyer is solely responsible for the use of Aligners and all consequences of such. Buyer will indemnify, defend and hold Argen and its officers, agents, directors, and employees (each an “Indemnified party”) harmless against any and all losses, damages, liabilities, deficiencies, claims, actions, judgments, settlements, interest, awards, penalties, fines, costs, or expenses of any kind, including without limitation reasonable attorneys’ fees, that are awarded against any Indemnified party, arising out of or related to any third-party claim made in connection with any use, misuse or alteration of Aligners, including, but not limited to, any injury or death to any person or persons allegedly caused by the use, misuse or alteration of Aligners.
13. LIMITATION OF LIABILITY; COMMENCEMENT OF ACTIONS. NOTWITHSTANDING ANYTHING TO THE CONTRARY STATED HEREIN, IN NO EVENT SHALL ARGEN, ITS AFFILIATES, OR THEIR RESPECTIVE OFFICERS, DIRECTORS, AND EMPLOYEES, BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE OR CONSEQUENTIAL DAMAGES OF ANY KIND RELATED TO, OR OTHERWISE ARISING IN CONNECTION WITH THIS PURCHASE AGREEMENT AND THE MANUFACTURE, SALE AND SUPPLY OF ALIGNERS BY ARGEN. IN ADDITION, IN NO EVENT SHALL ARGEN, ITS AFFILIATES, AND THEIR RESPECTIVE OFFICERS, DIRECTORS, AND EMPLOYEES, BE LIABLE FOR ANY LIABILITY, LOSSES AND DAMAGES, INCLUDING, BUT NOT LIMITED TO, THOSE RELATED TO COST OF REPAIRING ALIGNERS AND LOSS OF USE OF ALIGNERS, ARISING FROM OR RELATED TO THE APPROVED ALIGNER DESIGN OR THE USE, MISUSE OR REPAIR OF ALIGNERS, NOR SHALL ARGEN, ITS AFFILIATES, OR THEIR RESPECTIVE OFFICERS, DIRECTORS, AND EMPLOYEES, BE LIABLE TO INDEMNIFY BUYER, ITS AFFILIATES, AND THEIR RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES AND CUSTOMERS, FOR ANY CLAIMS FOR ANY OF THE FOREGOING. FURTHER, IN NO EVENT WILL ARGEN’S LIABILITY TO BUYER EXCEED THE PURCHASE PRICE FOR THE SPECIFIC ALIGNERS GIVING RISE TO BUYER’S ACTION. ANY ACTION, REGARDLESS OF FORM, ARISING OUT OF THIS PURCHASE AGREEMENT MUST BE COMMENCED BY BUYER WITHIN ONE (1) YEAR AFTER THE CAUSE OF ACTION HAS OCCURRED.
14. QUALITY ASSURANCE; RECALLS.
  1. Complaints. Buyer must have and maintain, as required by applicable law and for the corresponding period required thereunder, a complaint tracking system and a complaint handling system to record, track and manage all complaints concerning Aligners. Upon written request from either party, the parties agree to cooperate with each other to investigate any complaints concerning Aligners, including, without limitation, any complaint concerning an adverse event. If deemed necessary by Argen, or upon the request of Buyer, Argen shall use commercially reasonable efforts to analyze the applicable Aligners and produce a written report of its analysis. Buyer shall bear all costs and expense for any testing performed by Argen at the request of Buyer, including, any testing that is outside Argen’s usual course of investigation under its applicable standard operating procedures (SOPs) for complaints, or not otherwise required by regulation. In the event either party determines that any additional physical, chemical, biological, or other evaluation is necessary to fully investigate a complaint concerning Aligners, the party making such determination shall so advise the other party in writing and Argen shall conduct the necessary evaluations, at Buyer’s sole cost and expense, and shall produce a written report (a copy of which shall be delivered to Buyer) of the results. Buyer shall correspond with complainants on all product complaints associated with Aligners; provided, however, that Argen shall have the right, if it so elects, to communicate directly with any complainants, and take all necessary steps as may be appropriate and/or required to remedy any non-conforming raw materials, manufacture process, or modify the Specifications (in accordance with all laws, requirements and regulations of FDA, and/or cGMP, as applicable). Any filings with FDA that may be required shall be filed by Argen.
  2. Recall Action/Market Withdrawal. If either party becomes aware of or initiates a recall, market withdrawal or field correction of any Aligners hereunder (collectively, “Recall Action”), such party shall immediately notify the other party of such Recall Action, and agrees to coordinate and cooperate with the other party in any manner reasonably necessary to timely comply with all necessary actions, and applicable laws and regulations relating to such Recall Action subject to the terms set forth in Section 13.e below.
  3. Recall Action Initiated by Buyer. In the event that Buyer should voluntarily decide to initiate a Recall Action of any Aligners supplied to Buyer by Argen under this Purchase Agreement, Buyer shall notify Argen in writing setting forth the reason for such Recall Action, together with an outline of Buyer’s proposed action plan and a copy of all proposed correspondence, bulletins or other communication that will be distributed in connection with such action plan. Under no circumstances shall Buyer commence any activities relating to a Recall Action initiated by Buyer without first notifying Argen in writing as provided in this Section. All activities relating to a Recall Action initiated by Buyer shall be handled by Buyer, unless otherwise notified by Argen in writing that Argen will handle such coordination, and the parties shall fully cooperate with the other party to the extent reasonably necessary to assist in the investigation and related due diligence to determine the cause and the extent of the issue or matter necessitating such Recall Action.
  4. Expenses. Buyer shall bear all of the costs and expenses of any Recall Action (regardless if such action is initiated by Argen, Buyer or FDA) including without limitation expenses related to communications and meetings with all required regulatory agencies, expenses of replacement stock, the cost of notifying Buyers, and the costs associated with shipment of recalled Aligners from Buyers and shipment of an equal amount of replacement Aligners to those Buyers (collectively, “Recall Costs”); provided, however, that if such Recall Action is shown to be solely a result of (i) the failure of Argen to supply Aligners that conforms to Argen’s limited warranty set forth in Section 10.a, (ii) Argen’s failure to comply with cGMP in the event of any FDA initiated Recall Action, or (iii) the gross negligence or intentional wrongful act of Argen, Argen shall bear all of costs and expenses of such Recall Action, including without limitation all Recall Costs.
  5. Recall Records. Each party shall maintain complete and accurate records relating to the shipment, transportation, distribution and sale of Aligners under this Purchase Agreement in accordance with all applicable FDA law and regulations, but in no event shall such records be maintained for a period less than (i) three (3) years, or (ii) the period consistent with their respective internal record-keeping procedures, whichever period is longer.
  6. Safety Procedures. Argen and Buyer shall adhere to safety procedures for the handling and manufacture of Aligners and treatment or disposal of wastes relating thereto that comply with all federal and state environmental and occupational safety and health requirements.
15. INSURANCE.
  1. Argen’s Insurance. Argen shall maintain (i) products liability insurance with a minimum limit of $5,000,000, and (ii) comprehensive general liability insurance with minimum limits of $1,000,000 for each of bodily injury and property damage. Such policies of insurance shall provide that Buyer will be notified at least thirty (30) days prior to any cancellation. Certificates evidencing such insurance shall be provided to Buyer upon receipt of written request.
  2. Buyer’s Insurance. Buyer shall maintain (i) products liability insurance with a minimum limit of $2,000,000, and (ii) comprehensive general liability insurance with minimum limits of $1,000,000 for each of bodily injury and property damage. Such policies of insurance shall provide that Argen will be notified at least thirty (30) days prior to any cancellation. Certificates evidencing such insurance shall be provided to Argen upon request.
16. TERM AND TERMINATION.
  1. Term. This Purchase Agreement with respect to each Order shall commence on the date of Argen’s acceptance of the applicable Order and shall continue with respect to each such Order for the applicable warranty period under Section 10.a., unless earlier terminated as provided hereunder (the “Term”).
  2. Termination for Breach. Either party may terminate this Purchase Agreement for a material breach by the other party by giving the breaching party written notice, specifying the breach relied on, and giving the breaching party sixty (60) days to cure such breach, except any breach by Buyer to make a payment when due hereunder must be cured within fifteen (15) days from the due date. If the breach has not been cured (or the breaching party has not commenced a good faith effort to cure) at the end of the sixty (60) day period, then, upon notice thereof to the breaching party by the other, this Purchase Agreement shall terminate.
  3. Effect of Termination. The termination of this Purchase Agreement shall not relieve the parties hereto of any obligation accruing prior to termination, including without limitation Buyer’s payment for all Aligners supplied by Argen prior to the effective date of termination. Without limitation as to other rights and obligations that may survive, Sections 1, 2, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14,16.c, and 17-33 shall survive any termination of this Purchase Agreement.
17. FORCE MAJEURE. In the event either party is prevented by Force Majeure from performing any of its obligations under this Purchase Agreement, other than its payment obligations hereunder, such party shall give notice in writing to the other party with full particulars of such Force Majeure as soon as practicable after the occurrence of the Force Majeure event. Upon delivery of such notice, the obligations of the party delivering the notice, so far as they are affected by such Force Majeure, shall be suspended during the period of such Force Majeure and shall be remedied as far as and as soon as practicable by the party giving such notice. Argen shall not be responsible for any loss, delay or damage caused by a Force Majeure event.
  
  If for any reason any licenses, authorizations or approvals are denied or revoked, or if there is a change in any such applicable laws, regulations, orders or requirements that would prohibit Argen from fulfilling this Purchase Agreement, or would in the reasonable judgment of Argen otherwise expose Argen to a risk of liability under applicable laws, regulations, orders or requirements, Argen shall be relieved without liability of all obligations under this Purchase Agreement. If either party is delayed or prevented from performance of its obligations by reason of this clause for more than one hundred and eighty (180) consecutive calendar days, either party may terminate the then unperformed portion of this Purchase Agreement by notice in writing given to the other party, without liability provided that Buyer shall be obliged to pay the reasonable cost and expense of any work in progress and to pay for Aligners as at the date of termination. Argen may deliver by installments, and each delivery shall constitute a separate Purchase Agreement. Failure by Argen to deliver any one or more of the installments in accordance with their terms shall not entitle Buyer to terminate the whole Purchase Agreement or treat it as repudiated.
18. CONFIDENTIAL INFORMATION.
  1. “Confidential Information” for purposes of this Purchase Agreement means any and all information, trade secrets and know-how of or data about each of the parties, their clients, or their operations and other matters of a confidential or proprietary nature, including, without limitation, Aligners and their Specifications, but shall not include any of the following information:
    1. information which was known to the receiving party, prior to receipt from the delivering party, as evidenced by the receiving party’s written records;
    2. information which can be shown to have been in the public domain or generally known to the trade at the time of receipt from the delivering party;
    3. information which, other than by breach of this Purchase Agreement, can be shown to have entered the public domain or becomes generally known to the applicable trade in which the parties participate;
    4. information which is disclosed to the receiving party by a third party unrelated to either party who is free to make such disclosure;
    5. information which that can be shown to have been independently developed by the receiving party without use of any Confidential Information of the delivering party; or
    6. information which is required to be disclosed by law, regulatory, administrative or judicial order.
  2. Prohibited Use. During the Term, including any extension thereof, and for a period of five (5) years thereafter, the parties shall not disclose, communicate or otherwise make available to any third party, and shall not use or deal with in any manner (except as permitted by this Purchase Agreement) any Confidential Information of the other party, nor shall a party utilize Intellectual Property Rights disclosed in any patent of either party, other than as required to manufacture or supply Aligners or any other purpose as may be required for the parties to perform its respective obligations under this Purchase Agreement; provided, however, for any Confidential Information that constitutes a trade secret of a party shall continue for as long as the same remains a trade secret of that party notwithstanding any limitation or exceptions provided herein.
  3. Permitted Use. Each party (i) agrees to use the Confidential Information of the other party only for the purpose of performing its obligations under this Purchase Agreement, (ii) shall not copy any Confidential Information of the other except as necessary to perform its obligations under this Purchase Agreement, (iii) shall limit dissemination of the Confidential Information of the other party to only those persons or other third parties of who have a need to know in order to consummate the intent of this Purchase Agreement, and (iv) shall return all Confidential Information (delivered in physical or electronic form) of the other party, including, without limitation, any copies, upon the earlier of such party’s request or the termination of this Purchase Agreement; provided, however, a party may retain a copy of any Confidential Information of the other party for record keeping purposes if required by law or regulation.
  4. Permitted Disclosure. A party may disclose Confidential Information of the other party to a third person if it is required to do so by subpoena, court order, law or regulation. In such event, the party shall, in advance of the disclosure if practical, notify the other of such required disclosure.
  5. Enforcement Rights. Each party agrees that the Confidential Information of each party is vital to the business interests of each party and that any disclosure or unauthorized use thereof would cause irreparable harm. Each party may specifically enforce the obligations of the other under this paragraph, by injunction or otherwise, in addition to and not in limitation of any other remedies that a party may have at law or in equity.
19. INDEPENDENT CONTRACTOR. Notwithstanding anything to the contrary provided herein, Argen is an independent contractor for Buyer, and the parties are not partners or joint venturers, and Argen shall have the right to establish and follow its own internal procedures to comply with its obligations hereunder. Except for any special shipping or handling instructions provided by Buyer in a particular Order, all decisions pertaining to labor, components necessary for the manufacture and the supply of Aligners, maintenance of required governmental permits and compliance with all laws regarding the facilities or the manufacture of Aligners shall be the sole responsibility of Argen and not subject to any direction or rights of Buyer.
20. NON-SOLICITATION. During the Term, and for a period of one (1) year following the termination or expiration of this Agreement, Buyer will not, to the extent not prohibited by applicable law, directly or indirectly, solicit, recruit, or encourage any of Argen's employees to terminate their employment with Argen; provided, however, that this section will not prevent Buyer party from (a) causing to be placed any general advertisements in newspapers and/or other media of general circulation (including without limitation advertisements posted on the internet) that is not targeted specifically at any Argen employees or (b) engaging any recruiting firm or similar organization to identify and solicit persons for employment on nehalf of Buyer, so long as such recruiting firm or organization is not instructed to target any such employees of the other party and it's representative Argen.
21. ENTIRETY OF PURCHASE AGREEMENT; AMENDMENT. This Purchase Agreement, including these Aligner Terms, the Argen Standard Terms, and the applicable Order, embody the entire agreement between the parties regarding the subject matter hereof and supersedes any other agreements and arrangements, whether in written oral form, regarding the subject matter hereof. Except as otherwise provided in this Purchase Agreement, this Purchase Agreement may not be amended, extended or supplemented in any manner whatsoever except by the express written agreement executed by duly authorized corporate officers of both parties.
22. NOTICES. Any notice, agreement, or other communication required to be given under this Purchase Agreement shall be in writing and either personally delivered, delivered by certified U.S. mail (return receipt requested), postage prepaid, or delivered by overnight delivery by a nationally recognized courier, addressed to the parties at [such addresses as furnished in writing by each party to the other, as may be updated from time to time]. Each notice or communication shall be deemed to have been received three (3) business days after the same was deposited in certified mail, or, if delivered in person via an internationally recognized overnight delivery carrier, as of the date so delivered. Notwithstanding the foregoing, Orders and other ordinary course of business communications may be sent by email or mail to the address identified by the parties from time to time, or by first class mail, postage prepaid.
23. SEVERABILITY. In the event that one or more of the provisions of this Purchase Agreement is declared or held invalid, illegal or unenforceable by a court of competent jurisdiction, such provision(s) shall be interpreted as modified so as to be enforceable to the maximum extent permitted by law, and all other provisions hereof shall be given effect separately therefrom and shall not be affected thereby.
24. CHOICE OF LAW; VENUE. For purposes of venue and jurisdiction, this Purchase Agreement shall be deemed made and to be performed in San Diego, California and shall be governed by the laws of the State of California. The parties hereby consent to and submit to the jurisdiction of the federal and state courts located in the San Diego County, California and any action or suit under this Purchase Agreement will only and exclusively be brought by the parties in the federal or state court with appropriate jurisdiction over the subject matter thereof established or sitting in San Diego County, California. The parties will not raise in connection with, and hereby waive, any defenses based upon the venue, the inconvenience of the forum, the lack of personal jurisdiction, the sufficiency of service of process, or the like in any such action or suit brought in the State of California.
25. U.N. Convention. Pursuant to Article 6 of the United Nations Convention on Contracts for the International Sale of Goods (the “UN Convention”), the parties agree that the UN Convention shall not apply to this Purchase Agreement.
26. DISPUTES. In the event a dispute arises regarding the subject matter of this Purchase Agreement, the prevailing party shall be entitled to recover reasonable attorneys’ fees and costs incurred in addition to damages and any other relief to which it is entitled.
27. NO WAIVER. No failure by Argen to require Buyer’s strict performance of any provision of this Purchase Agreement at any time shall be deemed a waiver of such provision nor shall it affect Argen’s right thereafter to enforce and require strict compliance with each and every provision of this Purchase Agreement. No waiver shall be binding unless executed in writing by the party making the waiver.
28. ASSIGNMENT. Neither Argen nor Buyer may assign or transfer any right or obligation under this Purchase Agreement without the consent of the other, whether pursuant to a change of control, asset sale, by operation of law or otherwise and any such attempted assignment shall be deemed null and void. Buyer agrees to notify Argen immediately upon a change of control (through stock transfer or otherwise) or sale of all or substantially all of the assets of its business to which this Purchase Agreement relates. Argen may assign this Purchase Agreement and/or delegate its rights and obligations hereunder in whole or in part to one or more divisions, affiliates and/or third parties without notice to Buyer. In such case, such divisions, affiliates and/or third parties shall have the right to enforce the provisions hereof as if they were a part of this Purchase Agreement.
29. SUCCESSORS AND ASSIGNS. This Purchase Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and permitted assigns.
30. AUTHORITY. Each party represents and warrants that (a) it is duly organized, validly existing and in good standing under the laws of the state of its organization, and has full power and authority to enter into and perform its obligations under the Purchase Agreement, (b) it agrees to be bound by the Purchase Agreement, and (c) the person executing the Purchase Agreement on behalf of such party has been properly authorized and empowered to enter into the Purchase Agreement.
31. ATTORNEY CONSULTATION. Each party represents that it has had an opportunity to consult with independent legal counsel prior to signing this Purchase Agreement.
32. HEADINGS NOT CONTROLLING. The headings used in this Purchase Agreement are for reference purposes only and shall not be deemed part of this Purchase Agreement.
33. ACKNOWLEDGEMENT. BY CLICKING ON THE "ACCEPT CLEAR ALIGNER TERMS AND CONDITIONS" BUTTON BELOW AND LOGGING INTO YOUR ACCOUNT, YOU ARE AGREEING TO BE BOUND BY, AND ARE BECOMING A PARTY TO, THESE ALIGNER TERMS, AND THE PURCHASE AGREEMENT INCORPORATED HEREIN BY REFERENCE. IF YOU DO NOT AGREE TO THESE ALIGNER TERMS, DO NOT CLICK ON THE "ACCEPT CLEAR ALIGNER TERMS AND CONDITIONS" BUTTON. SELECTING "ACCEPT CLEAR ALIGNER TERMS AND CONDITIONS" BUTTON AND LOGGING INTO YOUR ACCOUNT TO AUTHENTICATE YOUR ACCEPTANCE WILL BE THE LEGAL EQUIVALENT OF YOUR SIGNATURE ON A WRITTEN CONTRACT, AND EQUALLY BINDING. YOU MUST AGREE TO THESE ALIGNER TERMS IN ORDER TO BE ABLE TO PLACE ORDERS FOR AND BUY ALIGNERS FROM ARGEN AND SELL ALIGNERS TO ANY DOCTOR AND/OR PATIENT.
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Clear Aligners Terms and Conditions

Argen manufactures custom clear Aligners designed to move teeth in small increments based on a treatment plan approved by a qualified medical dental professional. These Terms and Conditions of Sale for Clear Aligners apply to all Orders between Argen and Buyer for the manufacture and supply of Aligners by Argen using the Manufacturing Files supplied by Buyer for such Aligners and shall be effective as of the date of acceptance by Argen of Buyer’s Order.

DEFINITIONS. As used in these Terms and Conditions of Sale for Clear Aligners:
1. “Aligner Terms” means these Terms and Conditions of Sale of Clear Aligners.
2. “Aligner Design” means the design for clear aligners developed by Buyer or a third party engaged by Buyer for such purpose.
3. “Aligners” means the clear aligners manufactured by Argen pursuant to the Manufacturing Files, and any accompanying supplies and accessories identified in the applicable order.
4. “Approved Design” means, in each case, the Proposed Design approved by a dental medical professional.
5. “Argen” means The Argen Corporation, including any division or subsidiary thereof.
6. “Argen Standard Terms” means the Argen Standard Terms and Conditions.
7. “Argen Onboarding Materials” means Argen’s materials that provide guidance and requirements to place a successful order for the manufacture of Clear Aligners with Argen.
8. “Buyer” means the person or entity that placed the Order with Argen.
9. “cGMP” means current good manufacturing practice requirements set forth in the quality systems (QS) regulation (21 C.F.R. Part 820) for devices or current good manufacturing practices (21 C.F.R. 4, Subpart A) for combination products, as applicable.
10. “Confidential Information” has the meaning defined in Section 17.
11. "Design Center" means any third party design center engaged by Buyer for teh design of clear aligners.
12. “FDA” means the United States Food and Drug Administration or any successor agency.
13. “Force Majeure” means acts of God, strikes, lockouts, or other industrial disturbances, acts of public enemies, wars, insurrections, riots, earthquakes, fires, storms, floods, inability with reasonable diligence to obtain materials, delay in transportation by common carrier, and any other causes not within the control of the party claiming a suspension which by the exercise of due diligence such party shall not have been able to avoid or overcome.
14. “Indemnified party” has the meaning defined in Section 11.
15. “Intellectual Property Rights” means all United States and worldwide trademarks, service marks, trade dress, copyrights, patents, trade secrets, rights under unfair competition and/or unfair trade practices laws, and all other intellectual and industrial property rights related thereto.
16. “Manufacturing Files” means the output of the Approved Design
17. “Order” means written or, if agreed by the parties, electronic order placed by Buyer for Aligners.
18. “Patient” means each end-user patient of Aligners.
19. “Patient Informed Acknowledgement and Consent” means a Patient informed acknowledgement and consent form to be signed by the Patient substantially similar to the form provided by Argen to Buyer.
20. “Purchase Agreement” means the written agreement between Buyer and Argen for the purchase of Aligners, which shall consist of these Aligner Terms, the Argen Standard Terms, and the applicable Order.
21. “Purchase Price” means the price payable to Argen by Buyer for Aligners.
22. “RMA” shall mean the return material authorization form provided by Argen to Buyer.
23. “Recall Action” has the meaning defined in Section 13.c.
24. “Specifications” means, with respect to each Order, the corresponding Manufacturing Files supplied to Argen by Buyer.
25. “Term” means the time period in which this Purchase Agreement shall be in full force and effect as set forth in Section 15.a.
26. “UN Convention” has the meaning defined in Section 24.
AGREEMENT; INCONSISTENT TERMS; ONBOARDING.
1. Agreement; Inconsistent Terms. Argen and Buyer agree that all purchases of Aligners by Buyer will be governed by this Purchase Agreement. Buyer acknowledges and agrees that acceptance by Argen of any Order from Buyer is expressly made conditional upon Buyer’s assent and shall be subject to these Aligner Terms and the Argen Standard Terms. In the event of any conflict among these Aligner Terms, the Argen Standard Terms, and the applicable Order, or in the event no written or formal Order is issued, these Aligner Terms shall control unless otherwise expressly agreed to in writing by Argen and Buyer. Buyer’s acceptance of Aligners shall be deemed Buyer’s assent to all Aligner Terms and Argen Standard Terms even if no written or formal Order is issued by Buyer. For the avoidance of doubt, Argen shall not be bound by the provisions of other documents, including any terms and conditions set forth in the Order or other purchase order, order confirmations, acceptance, or other instruments from Buyer, unless signed by an officer of Argen.
2. Onboarding. Buyer shall review and accept the Argen Onboarding Materials prior to submitting any Orders for Aligners.
ORDERS.
1. Ordering Procedure. Each Order shall be in a form approved by Argen and shall specify (a) the Aligners being ordered, (b) the requested delivery location, (c) other appropriate information as may be required by Argen to complete the Order, (d) the location to which the applicable invoice shall be rendered for payment, and (e) any other terms included in Argen’s approved Order, as may be amended by Argen from time to time.
2. Buyer is responsible for providing Argen with all information necessary for Argen to manufacture Aligners. Argen is not responsible for the accuracy or inaccuracy of any information received from Buyer or third parties in connection with the applicable Order. Aligners shall be manufactured using the information Buyer provides to Argen. Argen is not responsible for the accuracy and quality of the information provided to Argen incident to the Order, including the Manufacturing Files, and the results of all reliance on and use of such information.
3. Acceptance of Orders. Argen shall have the right, at its sole and absolute discretion, to accept or reject any Order (or any portion thereof) for any reason. No Order shall be binding upon Argen unless and until shipment is tendered to the carrier.
4. Cancellation of Orders. Once accepted by Argen, Orders not be canceled, reduced, changed, or suspended by Buyer
5. Returns. Returns are only permitted in the event that Aligners do not meet their applicable Specifications. All other Aligner issues to be discussed with the dental medical professional who approved the Aligner Design. Buyer shall first obtain an RMA and return instructions before returning any Aligners to Argen. The value of Aligners returned shall not exceed the original Purchase Price paid for such Aligners.
6. No Modification of Manufacturing Files. If an alteration of the treatment plan is required once approved by the dental medical professional then Buyer must submit a new substitute Order, which shall include the new Manufacturing Files.
SHIPMENT AND DELIVERY.
1. Aligners manufactured by Argen pursuant to the applicable Order will be delivered using the method and instructions specified by Buyer. Any estimated shipping dates provided by Argen to Buyer are based upon conditions existing at the time the applicable Order is received by Argen. Argen shall endeavor to ship the applicable Aligners by Argen’s estimated shipping date, but shall not be responsible for any loss or damage resulting from delay in any shipment. Other than with respect to unusual or bulk Orders, the applicable Aligners are typically dispatched within ten (10) business days from the date of Argen’s acceptance of the applicable Order. With respect to unusual or bulk Orders, Argen will provide Buyer with an estimated shipping date for Aligners applicable to such Orders. Argen will notify Buyer in the event that Argen experiences a delay in shipment of applicable Aligners due to a backlog of Orders and endeavor to begin shipment of the applicable Aligners as soon as reasonably practicable thereafter. Argen shall deliver all applicable Aligners FOB Destination unless otherwise agreed upon by the parties in writing. Argen shall have the right to ship goods from any factory anywhere in the world, as specified by Argen. Notwithstanding the foregoing, all costs of shipping will be borne by Buyer, including without limitation any charges for any special shipping arrangements (such as cartage, air freight, express, parcel post, and multiple deliveries on one order). Any loss or damage that occurs during shipment to any Aligners delivered to Buyer shall be the sole responsibility of Argen, provided that the shipment in question was sent using Argen’s carrier account of choice. Any loss or damage that occurs prior to shipment shall be the sole responsibility of Argen and, in such event, Argen’s responsibility shall be limited to replacement or refund of the applicable Aligners, in Argen’s sole discretion.
2. Packaging. Buyer may provide instructions for packaging for Aligners. The cost of all custom packaging for all Aligners shall be charged to Buyer.
3. Passage of Title. Title to, ownership of, and risk of loss or damage to Aligners manufactured pursuant to the applicable Order shall transfer to Buyer upon delivery of such Aligners to the designated carrier at Argen’s point of shipment.
MANUFACTURING FILES.
1. Approved Design. Buyer acknowledges and agrees that the Aligner Design shall be reviewed and approved by a qualified medical dental professional prior to being submitted to Argen for manufacturing. Buyer further acknowledges and agrees that Argen (a) is not a provider of medical, dental, or any other health care services, (b) does not practice medicine, dentistry, or give any medical advice, and (c) is relying on the Manufacturing Files to manufacture the applicable Aligners. A qualified medical dental professional shall be solely responsible for providing medical services to the Patient relating to the applicable Aligners, including without limitation determining the diagnosis and appropriate treatment options for the Patient and informing the Patient of the general and specific risks associated with using Aligners.
2. Design Bureau Services. Buyer acknowledges and agrees that Buyer shall be solely responsible for obtaining all required licenses in connection with any and all design services, including without limitation any and all software, needed to create, manipulate, store, or transmit the Aligner Design and Manufacturing Files. Accordingly, Buyer shall enter in to separate agreements with Design Centers and obtain digital scanners and software as necessary to create, manipulate, store and transmit the Aligner Design and Manufacturing Files. For the avoidance of doubt, any Design Center engaged by Buyer to provide the Aligner Design shall be acceptable so long as such Design Center uses software for the Aligner Design that meets Argen's minimum specifications, as provided from time to time. Argen shall have no liability whatsoever for any and all consequences related to Argen’s compliance to the Manufacturing Files provided to Argen by or on behalf of Buyer or for any underlying impressions, dental scans, scan models, treatment plan(s), or the Aligner Design.
3. Suitability. The determination of medical or feasibility of the Aligner Design and suitability of the Aligners manufactured pursuant thereto with respect to the Patient, compliance with all applicable medical and dental standards for prescriptions to use the Aligners, and compliance with all applicable Federal and state laws regulating the design and use of Aligners is the sole responsibility of Buyer.
COMPLIANCE. Buyer acknowledges and agrees that Buyer is solely responsible for obtaining and maintaining, at its own expense, all approvals, including without limitation licenses and permits, as may be required to create, or have created, the Manufacturing Files and to prescribe and sell Aligners, and for keeping all such approvals in full force and effect.
USE OF ALIGNERS. Prior to selling and delivering Aligners to the Patient, Buyer shall cause the applicable medical dental professional to have such Patient execute a Patient Informed Acknowledgement and Consent. Buyer shall require the medical dental professional to retain in its patient records the executed Patient Informed Acknowledgement and Consent for a minimum of seven (7) years from the date of receipt thereof or such longer period as may be required by applicable law. Buyer shall promptly upon request provide to Argen copies of any executed Patient Informed Acknowledgement and Consent.
IMPORT/EXPORT AND USE. Buyer shall be solely responsible for obtaining and paying the applicable fees for all licenses, permits, or any other requirements for the import, export, and/or use, of Aligners shipped by Argen. Aligners may not under any circumstances be shipped or transshipped to any country on which the U.S. Government has an embargo or to any company in any country which appears from time to time on the excluded entity list.
PRICING. The Purchase Price of Aligners shall be in accordance with Argen’s prices as in effect at the time of Argen’s acceptance of the applicable Order. Argen may update the Purchase Price at any time and without notice in its sole and absolute discretion. Any changes to the Purchase Price will not affect existing Orders that have been accepted by Argen prior to the effective date of the Purchase Price change. The Purchase Price does not include sales, use, excise, or any similar tax unless otherwise specified by Argen in writing. Any tax or other government charge upon the production, sales, shipment, or use of Aligners that Argen is required to pay or collect from Buyer shall be paid by Buyer to Argen unless Buyer furnishes Argen with a tax exemption certificate or another document acceptable to the applicable taxing authority. Buyer shall be responsible for obtaining all necessary governmental clearances if and when required by any government other than the United States. Buyer agrees to pay any taxes, duties, and or tariffs that Buyer is required to pay to any Federal, state, provincial, or local governmental taxing authority or agency in connection with any Order. Buyer agrees to abide by all custom and/or import laws and regulations that are applicable to any Order.
PAYMENT TERMS. Unless otherwise approved by Argen in writing, all Purchase Price payments shall be made by Buyer: (a) prior to shipment of the applicable Aligners; and (b) in U.S. dollars unless the parties previously agreed in writing to do business in another currency. All overdue accounts will accrue a late charge at a rate equal to the lesser of one and a half percent (1.5%) per month or the maximum rate permissible by applicable law. Argen reserves the right, in its sole discretion, to modify or withdraw any credit terms extended to Buyer at any time without prior notice to Buyer and/or suspend, credit, or cancel any unfilled Orders without any liability to Argen in the event that Argen believes Buyer’s credit is impaired. Argen may, in its sole discretion, require full or partial payment or payment guarantee from Buyer, including, but not limited to, a bank guarantee or irrevocable standby letter of credit from an institution approved by Argen, in advance of manufacturing or shipping Aligners whenever, in its opinion, the financial condition of Buyer so warrants. Payment by credit card may be subject to a service charge.
LIMITED WARRANTY.
1. Aligners. Argen warrants that on the date of shipment of the applicable Aligners to Buyer, the Aligners will conform to their applicable Specifications.
2. The foregoing warranty shall not apply to any Aligners or Aligner parts which have been (a) repaired or altered by any party other than Argen, unless such repair or alteration has been specifically approved in writing by Argen, (b) subjected to misuse, mishandling, alteration, improper storage, repackaging, negligence, or accident, or (c) used in a manner or in an application other than that recommended by Argen. Argen will not be responsible for any damage to any Aligner or Aligner part that occurs after delivery or during or after use by the Patient.
3. No warranty is made as to (i) the quality, suitability, or performance characteristics of Aligners, or (ii) any raw materials used in the manufacturing of Aligners.
4. Buyer’s Limited Remedy for Argen’s Breach. BUYER’S SOLE AND EXCLUSIVE REMEDY FOR ARGEN’S BREACH OF THE LIMITED WARRANTY DESCRIBED IN SECTION 10.a SHALL BE LIMITED TO REPAIR, REPLACEMENT, OR EXTENSION OF CREDIT, IN ARGEN’S SOLE DISCRETION, OF THE DEFECTIVE ALIGNERS OR ALIGNER PARTS PROVIDED BY ARGEN AND REPORTED AS DEFECTIVE TO ARGEN WITHIN THIRTY (30) DAYS AFTER THE PRESCRIBED FIRST USE OF THE CORRESPONDING NON-CONFORMING ALIGNER TRAY.
5. Disclaimer of Warranties. EXCEPT WITH RESPECT TO THE LIMITED WARRANTY PROVIDED IN SECTION 10.a, ALIGNERS ARE PROVIDED “AS-IS,” “WITH ALL FAULTS,” AND “AS-AVAILABLE” AND THE ENTIRE RISK AS TO SATISFACTORY QUALITY AND REPAIR OF ALIGNERS RESTS WITH BUYER AND NOT ARGEN. EXCEPT AS SET FORTH IN SECTION 10, ARGEN EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES REGARDING ALIGNERS, WHETHER EXPRESS, IMPLIED OR STATUTORY, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OF THIRD PARTY RIGHTS, OR BASED ON COURSE OF CONDUCT OR TRADE CUSTOM OR USAGE.
BUYER INDEMNIFICATION OBLIGATIONS. Buyer is solely responsible for the use of Aligners and all consequences of such. Buyer will indemnify, defend and hold Argen and its officers, agents, directors, and employees (each an “Indemnified party”) harmless against any and all losses, damages, liabilities, deficiencies, claims, actions, judgments, settlements, interest, awards, penalties, fines, costs, or expenses of any kind, including without limitation reasonable attorneys’ fees, that are awarded against any Indemnified party, arising out of or related to any third-party claim made in connection with any use, misuse or alteration of Aligners, including, but not limited to, any injury or death to any person or persons allegedly caused by the use, misuse or alteration of Aligners.
LIMITATION OF LIABILITY; COMMENCEMENT OF ACTIONS. NOTWITHSTANDING ANYTHING TO THE CONTRARY STATED HEREIN, IN NO EVENT SHALL ARGEN, ITS AFFILIATES, OR THEIR RESPECTIVE OFFICERS, DIRECTORS, AND EMPLOYEES, BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE OR CONSEQUENTIAL DAMAGES OF ANY KIND RELATED TO, OR OTHERWISE ARISING IN CONNECTION WITH THIS PURCHASE AGREEMENT AND THE MANUFACTURE, SALE AND SUPPLY OF ALIGNERS BY ARGEN. IN ADDITION, IN NO EVENT SHALL ARGEN, ITS AFFILIATES, AND THEIR RESPECTIVE OFFICERS, DIRECTORS, AND EMPLOYEES, BE LIABLE FOR ANY LIABILITY, LOSSES AND DAMAGES, INCLUDING, BUT NOT LIMITED TO, THOSE RELATED TO COST OF REPAIRING ALIGNERS AND LOSS OF USE OF ALIGNERS, ARISING FROM OR RELATED TO THE APPROVED ALIGNER DESIGN OR THE USE, MISUSE OR REPAIR OF ALIGNERS, NOR SHALL ARGEN, ITS AFFILIATES, OR THEIR RESPECTIVE OFFICERS, DIRECTORS, AND EMPLOYEES, BE LIABLE TO INDEMNIFY BUYER, ITS AFFILIATES, AND THEIR RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES AND CUSTOMERS, FOR ANY CLAIMS FOR ANY OF THE FOREGOING. FURTHER, IN NO EVENT WILL ARGEN’S LIABILITY TO BUYER EXCEED THE PURCHASE PRICE FOR THE SPECIFIC ALIGNERS GIVING RISE TO BUYER’S ACTION. ANY ACTION, REGARDLESS OF FORM, ARISING OUT OF THIS PURCHASE AGREEMENT MUST BE COMMENCED BY BUYER WITHIN ONE (1) YEAR AFTER THE CAUSE OF ACTION HAS OCCURRED.
QUALITY ASSURANCE; RECALLS.
1. Complaints. Buyer must have and maintain, as required by applicable law and for the corresponding period required thereunder, a complaint tracking system and a complaint handling system to record, track and manage all complaints concerning Aligners. Upon written request from either party, the parties agree to cooperate with each other to investigate any complaints concerning Aligners, including, without limitation, any complaint concerning an adverse event. If deemed necessary by Argen, or upon the request of Buyer, Argen shall use commercially reasonable efforts to analyze the applicable Aligners and produce a written report of its analysis. Buyer shall bear all costs and expense for any testing performed by Argen at the request of Buyer, including, any testing that is outside Argen’s usual course of investigation under its applicable standard operating procedures (SOPs) for complaints, or not otherwise required by regulation. In the event either party determines that any additional physical, chemical, biological, or other evaluation is necessary to fully investigate a complaint concerning Aligners, the party making such determination shall so advise the other party in writing and Argen shall conduct the necessary evaluations, at Buyer’s sole cost and expense, and shall produce a written report (a copy of which shall be delivered to Buyer) of the results. Buyer shall correspond with complainants on all product complaints associated with Aligners; provided, however, that Argen shall have the right, if it so elects, to communicate directly with any complainants, and take all necessary steps as may be appropriate and/or required to remedy any non-conforming raw materials, manufacture process, or modify the Specifications (in accordance with all laws, requirements and regulations of FDA, and/or cGMP, as applicable). Any filings with FDA that may be required shall be filed by Argen.
2. Recall Action/Market Withdrawal. If either party becomes aware of or initiates a recall, market withdrawal or field correction of any Aligners hereunder (collectively, “Recall Action”), such party shall immediately notify the other party of such Recall Action, and agrees to coordinate and cooperate with the other party in any manner reasonably necessary to timely comply with all necessary actions, and applicable laws and regulations relating to such Recall Action subject to the terms set forth in Section 13.e below.
3. Recall Action Initiated by Buyer. In the event that Buyer should voluntarily decide to initiate a Recall Action of any Aligners supplied to Buyer by Argen under this Purchase Agreement, Buyer shall notify Argen in writing setting forth the reason for such Recall Action, together with an outline of Buyer’s proposed action plan and a copy of all proposed correspondence, bulletins or other communication that will be distributed in connection with such action plan. Under no circumstances shall Buyer commence any activities relating to a Recall Action initiated by Buyer without first notifying Argen in writing as provided in this Section. All activities relating to a Recall Action initiated by Buyer shall be handled by Buyer, unless otherwise notified by Argen in writing that Argen will handle such coordination, and the parties shall fully cooperate with the other party to the extent reasonably necessary to assist in the investigation and related due diligence to determine the cause and the extent of the issue or matter necessitating such Recall Action.
4. Expenses. Buyer shall bear all of the costs and expenses of any Recall Action (regardless if such action is initiated by Argen, Buyer or FDA) including without limitation expenses related to communications and meetings with all required regulatory agencies, expenses of replacement stock, the cost of notifying Buyers, and the costs associated with shipment of recalled Aligners from Buyers and shipment of an equal amount of replacement Aligners to those Buyers (collectively, “Recall Costs”); provided, however, that if such Recall Action is shown to be solely a result of (i) the failure of Argen to supply Aligners that conforms to Argen’s limited warranty set forth in Section 10.a, (ii) Argen’s failure to comply with cGMP in the event of any FDA initiated Recall Action, or (iii) the gross negligence or intentional wrongful act of Argen, Argen shall bear all of costs and expenses of such Recall Action, including without limitation all Recall Costs.
5. Recall Records. Each party shall maintain complete and accurate records relating to the shipment, transportation, distribution and sale of Aligners under this Purchase Agreement in accordance with all applicable FDA law and regulations, but in no event shall such records be maintained for a period less than (i) three (3) years, or (ii) the period consistent with their respective internal record-keeping procedures, whichever period is longer.
6. Safety Procedures. Argen and Buyer shall adhere to safety procedures for the handling and manufacture of Aligners and treatment or disposal of wastes relating thereto that comply with all federal and state environmental and occupational safety and health requirements.
INSURANCE.
1. Argen’s Insurance. Argen shall maintain (i) products liability insurance with a minimum limit of $5,000,000, and (ii) comprehensive general liability insurance with minimum limits of $1,000,000 for each of bodily injury and property damage. Such policies of insurance shall provide that Buyer will be notified at least thirty (30) days prior to any cancellation. Certificates evidencing such insurance shall be provided to Buyer upon receipt of written request.
2. Buyer’s Insurance. Buyer shall maintain (i) products liability insurance with a minimum limit of $2,000,000, and (ii) comprehensive general liability insurance with minimum limits of $1,000,000 for each of bodily injury and property damage. Such policies of insurance shall provide that Argen will be notified at least thirty (30) days prior to any cancellation. Certificates evidencing such insurance shall be provided to Argen upon request.
TERM AND TERMINATION.
1. Term. This Purchase Agreement with respect to each Order shall commence on the date of Argen’s acceptance of the applicable Order and shall continue with respect to each such Order for the applicable warranty period under Section 10.a., unless earlier terminated as provided hereunder (the “Term”).
2. Termination for Breach. Either party may terminate this Purchase Agreement for a material breach by the other party by giving the breaching party written notice, specifying the breach relied on, and giving the breaching party sixty (60) days to cure such breach, except any breach by Buyer to make a payment when due hereunder must be cured within fifteen (15) days from the due date. If the breach has not been cured (or the breaching party has not commenced a good faith effort to cure) at the end of the sixty (60) day period, then, upon notice thereof to the breaching party by the other, this Purchase Agreement shall terminate.
3. Effect of Termination. The termination of this Purchase Agreement shall not relieve the parties hereto of any obligation accruing prior to termination, including without limitation Buyer’s payment for all Aligners supplied by Argen prior to the effective date of termination. Without limitation as to other rights and obligations that may survive, Sections 1, 2, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14,16.c, and 17-33 shall survive any termination of this Purchase Agreement.
FORCE MAJEURE. In the event either party is prevented by Force Majeure from performing any of its obligations under this Purchase Agreement, other than its payment obligations hereunder, such party shall give notice in writing to the other party with full particulars of such Force Majeure as soon as practicable after the occurrence of the Force Majeure event. Upon delivery of such notice, the obligations of the party delivering the notice, so far as they are affected by such Force Majeure, shall be suspended during the period of such Force Majeure and shall be remedied as far as and as soon as practicable by the party giving such notice. Argen shall not be responsible for any loss, delay or damage caused by a Force Majeure event.

If for any reason any licenses, authorizations or approvals are denied or revoked, or if there is a change in any such applicable laws, regulations, orders or requirements that would prohibit Argen from fulfilling this Purchase Agreement, or would in the reasonable judgment of Argen otherwise expose Argen to a risk of liability under applicable laws, regulations, orders or requirements, Argen shall be relieved without liability of all obligations under this Purchase Agreement. If either party is delayed or prevented from performance of its obligations by reason of this clause for more than one hundred and eighty (180) consecutive calendar days, either party may terminate the then unperformed portion of this Purchase Agreement by notice in writing given to the other party, without liability provided that Buyer shall be obliged to pay the reasonable cost and expense of any work in progress and to pay for Aligners as at the date of termination. Argen may deliver by installments, and each delivery shall constitute a separate Purchase Agreement. Failure by Argen to deliver any one or more of the installments in accordance with their terms shall not entitle Buyer to terminate the whole Purchase Agreement or treat it as repudiated.
CONFIDENTIAL INFORMATION.
1. “Confidential Information” for purposes of this Purchase Agreement means any and all information, trade secrets and know-how of or data about each of the parties, their clients, or their operations and other matters of a confidential or proprietary nature, including, without limitation, Aligners and their Specifications, but shall not include any of the following information:
  1. information which was known to the receiving party, prior to receipt from the delivering party, as evidenced by the receiving party’s written records;
  2. information which can be shown to have been in the public domain or generally known to the trade at the time of receipt from the delivering party;
  3. information which, other than by breach of this Purchase Agreement, can be shown to have entered the public domain or becomes generally known to the applicable trade in which the parties participate;
  4. information which is disclosed to the receiving party by a third party unrelated to either party who is free to make such disclosure;
  5. information which that can be shown to have been independently developed by the receiving party without use of any Confidential Information of the delivering party; or
  6. information which is required to be disclosed by law, regulatory, administrative or judicial order.
2. Prohibited Use. During the Term, including any extension thereof, and for a period of five (5) years thereafter, the parties shall not disclose, communicate or otherwise make available to any third party, and shall not use or deal with in any manner (except as permitted by this Purchase Agreement) any Confidential Information of the other party, nor shall a party utilize Intellectual Property Rights disclosed in any patent of either party, other than as required to manufacture or supply Aligners or any other purpose as may be required for the parties to perform its respective obligations under this Purchase Agreement; provided, however, for any Confidential Information that constitutes a trade secret of a party shall continue for as long as the same remains a trade secret of that party notwithstanding any limitation or exceptions provided herein.
3. Permitted Use. Each party (i) agrees to use the Confidential Information of the other party only for the purpose of performing its obligations under this Purchase Agreement, (ii) shall not copy any Confidential Information of the other except as necessary to perform its obligations under this Purchase Agreement, (iii) shall limit dissemination of the Confidential Information of the other party to only those persons or other third parties of who have a need to know in order to consummate the intent of this Purchase Agreement, and (iv) shall return all Confidential Information (delivered in physical or electronic form) of the other party, including, without limitation, any copies, upon the earlier of such party’s request or the termination of this Purchase Agreement; provided, however, a party may retain a copy of any Confidential Information of the other party for record keeping purposes if required by law or regulation.
4. Permitted Disclosure. A party may disclose Confidential Information of the other party to a third person if it is required to do so by subpoena, court order, law or regulation. In such event, the party shall, in advance of the disclosure if practical, notify the other of such required disclosure.
5. Enforcement Rights. Each party agrees that the Confidential Information of each party is vital to the business interests of each party and that any disclosure or unauthorized use thereof would cause irreparable harm. Each party may specifically enforce the obligations of the other under this paragraph, by injunction or otherwise, in addition to and not in limitation of any other remedies that a party may have at law or in equity.
INDEPENDENT CONTRACTOR. Notwithstanding anything to the contrary provided herein, Argen is an independent contractor for Buyer, and the parties are not partners or joint venturers, and Argen shall have the right to establish and follow its own internal procedures to comply with its obligations hereunder. Except for any special shipping or handling instructions provided by Buyer in a particular Order, all decisions pertaining to labor, components necessary for the manufacture and the supply of Aligners, maintenance of required governmental permits and compliance with all laws regarding the facilities or the manufacture of Aligners shall be the sole responsibility of Argen and not subject to any direction or rights of Buyer.
NON-SOLICITATION. During the Term, and for a period of one (1) year following the termination or expiration of this Agreement, Buyer will not, to the extent not prohibited by applicable law, directly or indirectly, solicit, recruit, or encourage any of Argen's employees to terminate their employment with Argen; provided, however, that this section will not prevent Buyer party from (a) causing to be placed any general advertisements in newspapers and/or other media of general circulation (including without limitation advertisements posted on the internet) that is not targeted specifically at any Argen employees or (b) engaging any recruiting firm or similar organization to identify and solicit persons for employment on nehalf of Buyer, so long as such recruiting firm or organization is not instructed to target any such employees of the other party and it's representative Argen.
ENTIRETY OF PURCHASE AGREEMENT; AMENDMENT. This Purchase Agreement, including these Aligner Terms, the Argen Standard Terms, and the applicable Order, embody the entire agreement between the parties regarding the subject matter hereof and supersedes any other agreements and arrangements, whether in written oral form, regarding the subject matter hereof. Except as otherwise provided in this Purchase Agreement, this Purchase Agreement may not be amended, extended or supplemented in any manner whatsoever except by the express written agreement executed by duly authorized corporate officers of both parties.
NOTICES. Any notice, agreement, or other communication required to be given under this Purchase Agreement shall be in writing and either personally delivered, delivered by certified U.S. mail (return receipt requested), postage prepaid, or delivered by overnight delivery by a nationally recognized courier, addressed to the parties at [such addresses as furnished in writing by each party to the other, as may be updated from time to time]. Each notice or communication shall be deemed to have been received three (3) business days after the same was deposited in certified mail, or, if delivered in person via an internationally recognized overnight delivery carrier, as of the date so delivered. Notwithstanding the foregoing, Orders and other ordinary course of business communications may be sent by email or mail to the address identified by the parties from time to time, or by first class mail, postage prepaid.
SEVERABILITY. In the event that one or more of the provisions of this Purchase Agreement is declared or held invalid, illegal or unenforceable by a court of competent jurisdiction, such provision(s) shall be interpreted as modified so as to be enforceable to the maximum extent permitted by law, and all other provisions hereof shall be given effect separately therefrom and shall not be affected thereby.
CHOICE OF LAW; VENUE. For purposes of venue and jurisdiction, this Purchase Agreement shall be deemed made and to be performed in San Diego, California and shall be governed by the laws of the State of California. The parties hereby consent to and submit to the jurisdiction of the federal and state courts located in the San Diego County, California and any action or suit under this Purchase Agreement will only and exclusively be brought by the parties in the federal or state court with appropriate jurisdiction over the subject matter thereof established or sitting in San Diego County, California. The parties will not raise in connection with, and hereby waive, any defenses based upon the venue, the inconvenience of the forum, the lack of personal jurisdiction, the sufficiency of service of process, or the like in any such action or suit brought in the State of California.
U.N. Convention. Pursuant to Article 6 of the United Nations Convention on Contracts for the International Sale of Goods (the “UN Convention”), the parties agree that the UN Convention shall not apply to this Purchase Agreement.
DISPUTES. In the event a dispute arises regarding the subject matter of this Purchase Agreement, the prevailing party shall be entitled to recover reasonable attorneys’ fees and costs incurred in addition to damages and any other relief to which it is entitled.
NO WAIVER. No failure by Argen to require Buyer’s strict performance of any provision of this Purchase Agreement at any time shall be deemed a waiver of such provision nor shall it affect Argen’s right thereafter to enforce and require strict compliance with each and every provision of this Purchase Agreement. No waiver shall be binding unless executed in writing by the party making the waiver.
ASSIGNMENT. Neither Argen nor Buyer may assign or transfer any right or obligation under this Purchase Agreement without the consent of the other, whether pursuant to a change of control, asset sale, by operation of law or otherwise and any such attempted assignment shall be deemed null and void. Buyer agrees to notify Argen immediately upon a change of control (through stock transfer or otherwise) or sale of all or substantially all of the assets of its business to which this Purchase Agreement relates. Argen may assign this Purchase Agreement and/or delegate its rights and obligations hereunder in whole or in part to one or more divisions, affiliates and/or third parties without notice to Buyer. In such case, such divisions, affiliates and/or third parties shall have the right to enforce the provisions hereof as if they were a part of this Purchase Agreement.
SUCCESSORS AND ASSIGNS. This Purchase Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and permitted assigns.
AUTHORITY. Each party represents and warrants that (a) it is duly organized, validly existing and in good standing under the laws of the state of its organization, and has full power and authority to enter into and perform its obligations under the Purchase Agreement, (b) it agrees to be bound by the Purchase Agreement, and (c) the person executing the Purchase Agreement on behalf of such party has been properly authorized and empowered to enter into the Purchase Agreement.
ATTORNEY CONSULTATION. Each party represents that it has had an opportunity to consult with independent legal counsel prior to signing this Purchase Agreement.
HEADINGS NOT CONTROLLING. The headings used in this Purchase Agreement are for reference purposes only and shall not be deemed part of this Purchase Agreement.
ACKNOWLEDGEMENT. BY CLICKING ON THE "ACCEPT CLEAR ALIGNER TERMS AND CONDITIONS" BUTTON BELOW AND LOGGING INTO YOUR ACCOUNT, YOU ARE AGREEING TO BE BOUND BY, AND ARE BECOMING A PARTY TO, THESE ALIGNER TERMS, AND THE PURCHASE AGREEMENT INCORPORATED HEREIN BY REFERENCE. IF YOU DO NOT AGREE TO THESE ALIGNER TERMS, DO NOT CLICK ON THE "ACCEPT CLEAR ALIGNER TERMS AND CONDITIONS" BUTTON. SELECTING "ACCEPT CLEAR ALIGNER TERMS AND CONDITIONS" BUTTON AND LOGGING INTO YOUR ACCOUNT TO AUTHENTICATE YOUR ACCEPTANCE WILL BE THE LEGAL EQUIVALENT OF YOUR SIGNATURE ON A WRITTEN CONTRACT, AND EQUALLY BINDING. YOU MUST AGREE TO THESE ALIGNER TERMS IN ORDER TO BE ABLE TO PLACE ORDERS FOR AND BUY ALIGNERS FROM ARGEN AND SELL ALIGNERS TO ANY DOCTOR AND/OR PATIENT.

Terms and Policies

As an Argen customer, you agree to adhere to the terms, policies and warranties listed below.

Clear Aligners Terms and Conditions