{"id":14501,"date":"2022-07-03T19:37:37","date_gmt":"2022-07-03T23:37:37","guid":{"rendered":"https:\/\/somnomed.com\/en\/?page_id=14501"},"modified":"2025-11-06T12:04:53","modified_gmt":"2025-11-06T11:04:53","slug":"terms-and-conditions","status":"publish","type":"page","link":"https:\/\/somnomed.com\/en\/terms-and-conditions\/","title":{"rendered":"Terms and Conditions"},"content":{"rendered":"\t\t
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Terms and Conditions <\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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TERMS & CONDITIONS<\/strong><\/span><\/h3>

INDEX OF PROVISIONS<\/strong><\/span><\/h2>
  1. Introduction and Scope<\/u><\/span><\/li>
  2. Placing<\/u> Orders<\/u><\/span><\/li>
  3. Payment <\/u>Terms<\/u><\/span><\/li>
  4. FDA<\/u> Compliance<\/u> and<\/u> Regulatory<\/u> Requirements<\/u><\/span><\/li>
  5. Liability<\/u> Release<\/u> Statement<\/u><\/span><\/li>
  6. Oral Appliance <\/u>Warranty<\/u> and<\/u> Conditions<\/u><\/span><\/li>
  7. Oral Appliance<\/u> Remake<\/u> Requests<\/u><\/span><\/li>
  8. Not<\/u> Covered<\/u> by Warrant<\/u>y<\/span><\/li>
  9. Delivery<\/u>, Delays<\/u> and<\/u> Risk<\/u> of<\/u> Loss<\/u><\/span><\/li>
  10. Force<\/u> Ma<\/u>jeure<\/u><\/span><\/li>
  11. Oral Appliance<\/u> Refunds<\/u> and<\/u> Oral Appliance<\/u> Returns<\/u><\/span><\/li>
  12. Exclusive<\/u> Remedy<\/u> for<\/u> Defective<\/u> Products<\/u><\/span><\/li>
  13. <\/u>Repair<\/u> or<\/u> Replacement<\/u><\/span><\/li>
  14. Governing<\/u> Law<\/u>; Dispute<\/u> Resolution<\/u><\/span><\/li>
  15. Limitation of Liabilit<\/u>y<\/span><\/li>
  16. Confidentiality<\/u><\/span><\/li>
  17. General Provision<\/u><\/span><\/li><\/ol>

    1.\u00a0\u00a0\u00a0 INTRODUCTION AND SCOPE<\/strong><\/span><\/h1>

    These Terms and Conditions (these “Terms”) govern any and all sales of oral appliances (\u201cOral Appliances\u201d), accessories, and other related products (collectively, “Products”) from SomnoMed\u00ae<\/sup>, Inc. (“SomnoMed\u00ae<\/sup>“) to a third-party purchaser (the “Buyer”). These Terms prevail over any of the Buyer’s general terms and conditions of purchase, regardless of whether or when the Buyer has submitted its purchase order or such terms. Fulfillment of the Buyer’s order does not constitute acceptance of any of the Buyer’s terms and conditions and will not be deemed to modify or amend these Terms.<\/span><\/p>

    2.\u00a0\u00a0\u00a0\u00a0 PLACING ORDERS<\/strong><\/span><\/h1>

    After logging into or creating an online account with SomnoMed\u00ae<\/sup>, the Buyer may place orders through SomnoMed\u00ae<\/sup>‘s online portal, SomAccount (www.somaccount.com<\/a>), and submit an order electronically. Once the Buyer has submitted an order through SomAccount, the Buyer will be assigned an order number for reference purposes only (which does not constitute acceptance of the order). Submitted orders are binding on the Buyer, and the Buyer may not cancel an order once it has been submitted.<\/span><\/p>

    SomnoMed\u00ae<\/sup> may cancel or reject any order for any reason or no reason, at any time. If an order is canceled after the Buyer’s credit card (or other payment account) has been charged, SomnoMed\u00ae<\/sup> will issue a refund to the Buyer in the amount of the charge.<\/span><\/p>

    If SomnoMed\u00ae<\/sup> accepts an order, the Buyer will be notified via email confirmation, which will be effective upon the date such confirmation is sent. In the event SomnoMed\u00ae<\/sup> rejects or cancels an order, SomnoMed\u00ae<\/sup> will attempt to contact the Buyer by email and\/or telephone to notify the Buyer of such rejection or cancellation.\u00a0\u00a0<\/span><\/p>

    3.\u00a0\u00a0\u00a0\u00a0 PAYMENT TERMS<\/strong><\/span><\/h1>

    All prices are exclusive of all sales, use and excise taxes, and any other similar taxes, duties and charges of any kind imposed by any governmental authority on any amounts payable by the Buyer. The Buyer shall be responsible for all such charges, costs, and taxes; provided, that, the Buyer shall not be responsible for any taxes imposed on, or with respect to, SomnoMed\u00ae<\/sup>’s income, revenues, gross receipts, personnel, real or personal property or other assets. Additionally, all prices are exclusive of any handling fees of any kind charged by SomnoMed\u00ae<\/sup>.<\/span><\/p>

    Payment<\/strong> Due<\/strong> Date:<\/strong> Payment of invoices is due within thirty (30) days from the date set forth in the applicable invoice. The Buyer shall make all payments by Autopay, ACH, check, or acceptable credit cards. SomnoMed\u00ae<\/sup> accepts MasterCard, Visa, American Express, and Discover.<\/span><\/p>

    Late Payment Fees: <\/strong>If the Buyer does not pay any amounts when due, a late payment fee of the greater of (i) three percent (3%) of the outstanding balance (or the maximum amount of interest allowed by law if such amount is less than three percent (3%)) or (ii) Fifty Dollars ($50.00) will be assessed for each thirty (30) day period or portion thereof that payment remains overdue. Late fees shall be assessed beginning on the thirty-first (31st) day after the invoice date.<\/span><\/p>

    Collection<\/strong> Costs:<\/strong> The Buyer shall reimburse SomnoMed\u00ae<\/sup> for all costs incurred in collecting any late payments, including, without limitation, attorneys’ fees and collection agency fees.<\/span><\/p>

    Credit Limits and Holds: <\/strong>SomnoMed\u00ae<\/sup> reserves the right to set credit limits on individual or practice accounts. If an account has not cleared its outstanding invoices, SomnoMed\u00ae<\/sup> reserves the right to place the account on credit hold after which no additional orders will be accepted. SomnoMed\u00ae<\/sup> may, at its sole discretion, require all future orders to be prepaid.<\/span><\/p>

    Payment<\/strong> Application:<\/strong> Unless otherwise provided in writing, all payments shall be applied to the oldest unpaid invoice first, including any applicable late fees.<\/span><\/p>

    No<\/strong> Set-Off:<\/strong> The Buyer shall not withhold payment of any amounts due and payable by reason of any <\/span>set-off of any claim or dispute with SomnoMed\u00ae<\/sup>, whether relating to SomnoMed\u00ae<\/sup>‘s breach, bankruptcy or otherwise.<\/span><\/p>

    Bona Fide Disputes<\/strong>: Should the Buyer have any bona fide dispute(s) regarding the amount of any invoice issued by SomnoMed\u00ae<\/sup> it shall notify SomnoMed\u00ae<\/sup> within fifteen (15) days of the date of receipt of the relevant invoice and provide reasonable grounds in respect of the disputed amount (such dispute, a \u201cBona-Fide Dispute\u201d). Any Bona-Fide Dispute properly submitted in accordance with the above shall be escalated and dealt with by senior finance personnel from each Party and discussed in good faith for a period of up to thirty (30) days from the date of the escalation, provided that, if after such efforts no resolution is reached, the provisions of the \u201cGoverning Law; Dispute Resolution\u201d section below shall control.\u00a0 If a dispute is resolved, the amount shall be paid within fifteen (15) days of the date of resolution. For purposes of clarity, any undisputed amounts set forth in an invoice shall be paid within the thirty (30) days from the date set forth in the relevant invoice, whether or not there is a Bona-Fide Dispute with respect to any other amounts set forth on such invoice.<\/span><\/p>

    4.\u00a0\u00a0\u00a0\u00a0 FDA<\/strong> COMPLIANCE<\/strong> AND<\/strong> REGULATORY<\/strong> REQUIREMENTS<\/strong><\/span><\/h1>

    Buyer’s U.S. Food and Drug Administration (\u201cFDA\u201d) Compliance Obligations:<\/span><\/h2>

    By purchasing Products from SomnoMed\u00ae<\/sup>, the Buyer represents, warrants, and agrees that:<\/span><\/p>

    1. Professional Licensing: <\/strong>The Buyer is a licensed dental or medical professional in good standing, authorized to prescribe and fit Oral Appliances for the treatment of (i) sleep apnea and snoring and\/or (ii) bruxism, in the jurisdiction where such Oral Appliances will be<\/span><\/li>
    2. Facility<\/strong> Registration:<\/strong> The Buyer’s practice or facility maintains all necessary permits, licenses, and certifications.<\/span><\/li>
    3. Quality System Compliance: <\/strong>The Buyer acknowledges that SomnoMed\u00ae<\/sup> Oral Appliances are manufactured in accordance with FDA Quality System Regulation (21 CFR Part 820) and agrees to handle, store, and supply Oral Appliances in compliance with applicable FDA<\/span><\/li>
    4. Prescription Requirements: <\/strong>The Buyer agrees that all SomnoMed\u00ae<\/sup> Oral Appliances will only be provided to patients with a valid prescription from a licensed physician for the treatment of (i) obstructive sleep apnea and\/or snoring (ii) bruxism, and that proper patient evaluation and fitting procedures will be followed.<\/span><\/li>
    5. Adverse<\/strong> Event<\/strong> Reporting:<\/strong> The Buyer agrees to promptly report to SomnoMed\u00ae<\/sup> in writing any adverse events, device malfunctions, or safety concerns related to SomnoMed\u00ae<\/sup> Oral Appliances in accordance with FDA Medical Device Reporting (MDR) requirements under 21 CFR Part<\/span><\/li>
    6. Labeling Compliance: <\/strong>The Buyer shall not remove, alter, or obscure any FDA-required labeling, instructions for use, or safety warnings provided with the Oral Appliances.<\/span><\/li>
    7. Record<\/strong> Keeping:<\/strong> The Buyer shall maintain adequate records of the supply of the Oral Appliance and patient fittings as required by applicable FDA regulations and shall make such records available to SomnoMed\u00ae<\/sup>, upon reasonable request, for FDA compliance<\/span><\/li>
    8. Regulatory<\/strong> Changes:<\/strong> The Buyer acknowledges that FDA regulations may change and agrees to comply with any additional requirements that may affect the use, supply, or handling of SomnoMed\u00ae<\/sup> Oral Appliances.<\/span><\/li><\/ol>

      SomnoMed\u00a0FDA Compliance:<\/span><\/h2>

      SomnoMed\u00ae<\/sup> represents that its Oral Appliances are manufactured in FDA-registered facilities under appropriate quality systems and that applicable Oral Appliances have received necessary FDA clearances. SomnoMed\u00ae<\/sup> reserves the right to modify Oral Appliances, specifications, or these Terms to maintain compliance with changing FDA requirements.<\/span><\/p>

      5.\u00a0\u00a0\u00a0\u00a0 LIABILITY<\/strong> RELEASE<\/strong> STATEMENT<\/strong><\/span><\/h1>

      SomnoMed\u00ae<\/sup> is a manufacturer that provides Products as prescribed by a licensed dental practitioner. SomnoMed\u00ae<\/sup> does not assume, and expressly disclaims, any and all responsibility and liability for techniques used and the use and\/or misuse of the Products by the prescribing dental practitioner or its staff or patients.<\/span><\/p>

      EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THESE TERMS, SOMNOMED\u00ae<\/sup> MAKES NO WARRANTY WHATSOEVER WITH RESPECT TO ANY PRODUCT, INCLUDING ANY (a) WARRANTY OF MERCHANTABILITY; (b) WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE; (c) WARRANTY OF TITLE; OR (d) WARRANTY AGAINST INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS OF A THIRD PARTY; WHETHER ARISING BY LAW, COURSE OF DEALING, COURSE OF PERFORMANCE, USAGE OF TRADE, OR OTHERWISE. THE BUYER ACKNOWLEDGES THAT IT HAS NOT RELIED UPON ANY REPRESENTATION OR WARRANTY MADE BY SOMNOMED\u00ae<\/sup>, OR ANY OTHER PERSON ON SOMNOMED\u00ae<\/sup>‘S BEHALF, EXCEPT AS SPECIFICALLY PROVIDED IN THESE TERMS.<\/span><\/p>

      6.\u00a0\u00a0\u00a0\u00a0 <\/span>ORAL APPLIANCE WARRANTY AND CONDITIONS\u00a0<\/span>\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0<\/strong><\/span><\/h1>

      SomnoMed\u00ae<\/sup>‘s ability to provide quality Oral Appliances begins with the Buyer. The Buyer must provide SomnoMed\u00ae<\/sup> with accurate impressions, models, or digital scans along with a protrusive bite. Unless the Buyer explicitly instructs in writing otherwise, SomnoMed\u00ae<\/sup> retains the right to modify materials provided by the Buyer to achieve optimal device functionality. SomnoMed\u00ae<\/sup> cannot, and will not, accept scans with traditional bite registrations. Notwithstanding anything in these Terms to the contrary, nothing in these Terms shall require SomnoMed\u00ae<\/sup> to deliver a defective Oral Appliance, as determined by SomnoMed\u00ae<\/sup> in its sole discretion, to any Buyer.<\/p>

      Certain Oral Appliances are covered by the warranties herein for a period of between six (6) months and five (5) years and certain Oral Appliances are covered for a period of one (1) year, as set forth in the “Warranty Period” section below. During the applicable warranty period, SomnoMed\u00ae<\/sup> represents and warrants to the Buyer that, except to the extent set forth in the “Not Covered By Warranty” section below, the Oral Appliances will: (a) conform to the specifications provided by the Buyer in the Buyer’s prescription form and (b) be free from significant defects in materials and workmanship.<\/span><\/p>

      SomnoMed\u00ae<\/sup> is responsible only for the custom fabrication of Oral Appliances in accordance with the specifications provided from the Buyer’s prescription form and within the manufacturing specifications of the Oral Appliances. SomnoMed can only warrant that its custom-made Oral Appliances will fit the working models that were provided by Buyer for use in connection with the Oral Appliances construction.<\/span><\/p>

      IMPORTANT<\/strong> NOTE:<\/strong> SomnoMed\u00ae<\/sup> does not make any warranties, and hereby expressly disclaims all warranties, with respect to Oral Appliances that are fabricated from impressions, models or digital scans that were created more than 360 days from date of invoice. For the avoidance of doubt, Buyer shall ensure that all impressions, models, and digital scans provided for any Oral Appliance were taken less than 360 days from the date set forth on the invoice for such Oral Appliance.<\/span><\/p>

      Warranty repair work may only be completed by the authorized SomnoMed\u00ae<\/sup> facility, or, at SomnoMed\u00ae<\/sup>\u2019s sole discretion, the facility in which the SomnoDent\u00ae<\/sup> was originally manufactured.<\/span><\/p>

      WARRANTY PERIOD<\/strong><\/span><\/p>

      IMPORTANT NOTE: <\/strong>Any Oral Appliance that is remade, repaired, or replaced by SomnoMed\u00ae<\/sup> pursuant to these Terms shall remain subject to the original warranty period applicable to the initial purchase of such Oral Appliance. For the avoidance of doubt, the warranty period for any remade, repaired, or replaced Oral Appliance does not restart or extend; rather, it continues from the original date of invoice for the first purchase of the Oral Appliance. The expiration date of the warranty for a remade, repaired, or replaced Oral Appliance shall be the same as if the original Oral Appliance had not been remade, repaired, or replaced.<\/span><\/p>

      Notwithstanding anything herein to the contrary, the warranty period begins on the date set forth on the applicable invoice.<\/span><\/p>

      Oral Appliance Standard Warranties:<\/span><\/h2>

      Each warranty period begins on the original date set forth in the invoice from SomnoMed\u00ae<\/sup> for the applicable Oral Appliance. SomnoMed\u00ae<\/sup> warrants SomnoDent\u00ae<\/sup> Oral Appliances to be free from defects in materials and workmanship as follows:<\/span><\/p>

      a. SomnoDent\u00ae<\/sup> Classic: 3 years
      b. SomnoDent\u00ae<\/sup> Flex: 3 years
      c. SomnoDent Fusion\u00ae<\/sup>: 3 years
      d. Herbst Advance\u00ae<\/sup>: 3 years
      e. Morning Repositioner: 6 months
      f. SomnoBrux: 1 year<\/p>

      3-Year Replacement Plan Warranty:<\/u><\/strong><\/span><\/p>

      SomnoMed\u00ae<\/sup> offers a3-year \u201cNo Questions Asked\u201d Replacement Plan concurrent to the above warranties for the first three years of those warranties as follows:<\/span><\/p>