Terms and Conditions

TERMS & CONDITIONS

INDEX OF PROVISIONS

  1. Introduction and Scope
  2. Placing Orders
  3. Payment Terms
  4. FDA Compliance and Regulatory Requirements
  5. Liability Release Statement
  6. Oral Appliance Warranty and Conditions
  7. Oral Appliance Remake Requests
  8. Not Covered by Warranty
  9. Delivery, Delays and Risk of Loss
  10. Force Majeure
  11. Oral Appliance Refunds and Oral Appliance Returns
  12. Exclusive Remedy for Defective Products
  13. Repair or Replacement
  14. Governing Law; Dispute Resolution
  15. Limitation of Liability
  16. Confidentiality
  17. General Provision

1.    INTRODUCTION AND SCOPE

These Terms and Conditions (these “Terms”) govern any and all sales of oral appliances (“Oral Appliances”), accessories, and other related products (collectively, “Products”) from SomnoMed®, Inc. (“SomnoMed®“) 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.

2.     PLACING ORDERS

After logging into or creating an online account with SomnoMed®, the Buyer may place orders through SomnoMed®‘s online portal, SomAccount (www.somaccount.com), 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.

SomnoMed® 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® will issue a refund to the Buyer in the amount of the charge.

If SomnoMed® 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® rejects or cancels an order, SomnoMed® will attempt to contact the Buyer by email and/or telephone to notify the Buyer of such rejection or cancellation.  

3.     PAYMENT TERMS

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®’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®.

Payment Due Date: 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® accepts MasterCard, Visa, American Express, and Discover.

Late Payment Fees: 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.

Collection Costs: The Buyer shall reimburse SomnoMed® for all costs incurred in collecting any late payments, including, without limitation, attorneys’ fees and collection agency fees.

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

Payment Application: Unless otherwise provided in writing, all payments shall be applied to the oldest unpaid invoice first, including any applicable late fees.

No Set-Off: The Buyer shall not withhold payment of any amounts due and payable by reason of any set-off of any claim or dispute with SomnoMed®, whether relating to SomnoMed®‘s breach, bankruptcy or otherwise.

Bona Fide Disputes: Should the Buyer have any bona fide dispute(s) regarding the amount of any invoice issued by SomnoMed® it shall notify SomnoMed® 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 “Bona-Fide Dispute”). 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 “Governing Law; Dispute Resolution” section below shall control.  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.

4.     FDA COMPLIANCE AND REGULATORY REQUIREMENTS

Buyer’s U.S. Food and Drug Administration (“FDA”) Compliance Obligations:

By purchasing Products from SomnoMed®, the Buyer represents, warrants, and agrees that:

  1. Professional Licensing: 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
  2. Facility Registration: The Buyer’s practice or facility maintains all necessary permits, licenses, and certifications.
  3. Quality System Compliance: The Buyer acknowledges that SomnoMed® 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
  4. Prescription Requirements: The Buyer agrees that all SomnoMed® 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.
  5. Adverse Event Reporting: The Buyer agrees to promptly report to SomnoMed® in writing any adverse events, device malfunctions, or safety concerns related to SomnoMed® Oral Appliances in accordance with FDA Medical Device Reporting (MDR) requirements under 21 CFR Part
  6. Labeling Compliance: The Buyer shall not remove, alter, or obscure any FDA-required labeling, instructions for use, or safety warnings provided with the Oral Appliances.
  7. Record Keeping: 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®, upon reasonable request, for FDA compliance
  8. Regulatory Changes: 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® Oral Appliances.

SomnoMed FDA Compliance:

SomnoMed® 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® reserves the right to modify Oral Appliances, specifications, or these Terms to maintain compliance with changing FDA requirements.

5.     LIABILITY RELEASE STATEMENT

SomnoMed® is a manufacturer that provides Products as prescribed by a licensed dental practitioner. SomnoMed® 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.

EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THESE TERMS, SOMNOMED® 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®, OR ANY OTHER PERSON ON SOMNOMED®‘S BEHALF, EXCEPT AS SPECIFICALLY PROVIDED IN THESE TERMS.

6.     ORAL APPLIANCE WARRANTY AND CONDITIONS                  

SomnoMed®‘s ability to provide quality Oral Appliances begins with the Buyer. The Buyer must provide SomnoMed® with accurate impressions, models, or digital scans along with a protrusive bite. Unless the Buyer explicitly instructs in writing otherwise, SomnoMed® retains the right to modify materials provided by the Buyer to achieve optimal device functionality. SomnoMed® 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® to deliver a defective Oral Appliance, as determined by SomnoMed® in its sole discretion, to any Buyer.

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® 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.

SomnoMed® 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.

IMPORTANT NOTE: SomnoMed® 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.

Warranty repair work may only be completed by the authorized SomnoMed® facility, or, at SomnoMed®’s sole discretion, the facility in which the SomnoDent® was originally manufactured.

WARRANTY PERIOD

IMPORTANT NOTE: Any Oral Appliance that is remade, repaired, or replaced by SomnoMed® 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.

Notwithstanding anything herein to the contrary, the warranty period begins on the date set forth on the applicable invoice.

Oral Appliance Standard Warranties:

Each warranty period begins on the original date set forth in the invoice from SomnoMed® for the applicable Oral Appliance. SomnoMed® warrants SomnoDent® Oral Appliances to be free from defects in materials and workmanship as follows:

a. SomnoDent® Classic: 3 years
b. SomnoDent® Flex: 3 years
c. SomnoDent Fusion®: 3 years
d. Herbst Advance®: 3 years
e. Morning Repositioner: 6 months
f. SomnoBrux: 1 year

3-Year Replacement Plan Warranty:

SomnoMed® offers a3-year “No Questions Asked” Replacement Plan concurrent to the above warranties for the first three years of those warranties as follows:

  • SomnoDent Avant®: 3 years
  • SomnoDent Herbst Advance Elite®: 3 years +2 years standard warranty as outlined above

Terms and conditions as follows:

  • The original device, regardless of condition, must be returned to SomnoMed®. If SomnoMed® does not receive the original device within 30 days of shipping the replacement device, a new device fee will be charged to your account.
    • Replacement device will be manufactured only from original scan image or impressions.

7.     ORAL APPLIANCE REMAKE REQUESTS

While SomnoMed® understands that many patients depend upon their oral appliances for improved and continued health, requests for a total remake—while the patient continues to use the current Oral Appliance—should neither be expected by the Buyer or prescribing dentist nor promised to the patient. For all remake requests, the Buyer is required to return the original Oral Appliance to SomnoMed® for evaluation. If the original appliance is not returned prior to initiating the remake, then SomnoMed® will charge full price for the remake. This requirement applies regardless of the reason for the remake request. Failure to return the original Oral Appliance for evaluation will result in the denial of the remake request or a remake at full cost, in SomnoMed®’s sole discretion.    

Oral Appliances in need of repair, replacement or adjustment are required to be returned to SomnoMed® for assessment within thirty (30) days as set forth in the “Exclusive Remedy” section below. If accessories (including, without limitation, a retainer case, a toolkit, a somgauge, etc.) are returned with the Oral Appliance, such accessories will be discarded and not replaced or returned.

8.     NOT COVERED BY WARRANTY   

The warranties under these Terms do not apply to, and SomnoMed® will not be liable for any defects or damage to any Oral Appliance caused by any of the following:

  • Midline Acrylic fractures
  • Buyer’s non-compliance with these Terms or patient’s non-compliance with prescriber’s instruction (patient chooses not to follow the prescribed treatment protocol, dislikes, or intolerant to prescribed device, etc.)
  • Buyer’s, a patient’s, or any other third party’s action or inaction (including without limitation, accident, neglect, device being lost, improper cleaning, storage, or hygiene, pet damage, etc.)
  • Delamination of hard/soft material due to mishandling
  • Staining or calculus build up
  • Changes in the patient’s dentition (including without limitation, loss or removal of teeth, restorations, failure of supportive tooth or tissue structures, orthodontics, )
  • Improper insertion or removal of the Oral Appliance
  • Improper adjustment or structural changes of the Oral Appliance
  • Concerns expressed to prescribing doctor (including without limitation, concerns regarding impressions, models, digital scans, bite registration, questionable indications, and authorization for Oral Appliance fabrication)
  • Incidental or consequential damages or costs (including without limitation,, due to patient canceling treatment, lost wages, chair time, pain, and suffering)
  • Resetting to current position or reset to new bite for sleep apnea devices
  • Clasp and Wing repairs
  • Normal wear and tear
  • Expedited production and shipping costs
  • Unauthorized alteration of the Oral Appliance by the Buyer, patient or any other third party
  • Use of the Oral Appliance in connection with any third-party product that has not been explicitly authorized in writing by SomnoMed®
  • Use of the Oral Appliance in violation of these Terms or contrary to any other instructions of SomnoMed®

9.     DELIVERY, DELAYS AND RISK OF LOSS

Unless otherwise agreed in writing, all Products will be sold “Ex works,” or FOB SomnoMed®‘s facility.

Delivery of Products to the carrier at SomnoMed®‘s facility shall constitute delivery to the Buyer and, thereafter, all risk of loss or damage shall be the Buyer’s responsibility, with claims to be submitted promptly to the carrier. SomnoMed® shall not be liable for any delays, loss, or damage in transit.

The Buyer shall be responsible for all freight, insurance, and other shipping expenses, unless otherwise agreed in writing.

Products will be shipped to the delivery address selected by the customer at the time the order is placed. SomnoMed® is not liable for any liability arising out of the Buyer’s failure to provide accurate and complete delivery details.

Any time quoted by SomnoMed® for delivery is an estimate only. SomnoMed® is not liable for any loss or damage arising from any delay in filling any order, failure to deliver, or delay in delivery. Any liability of SomnoMed® for non-delivery of any Products shall be limited to replacing the Products within a reasonable time or adjusting the invoice for such Products to reflect the actual quantity delivered. No delay in the shipment or delivery of any Products relieves the Buyer of its obligations under these Terms, including without limitation accepting delivery of any remaining installment(s) of Products.

SomnoMed® shall not be liable for any non-delivery of Products (even if caused by SomnoMed®‘s negligence) unless the Buyer gives written notice to SomnoMed® of the non-delivery within five (5) days of the date when the Products would in the ordinary course of events have been delivered.

  • If the Buyer fails to accept delivery of the Products within four (4) days of a notice from the delivery company that the Products are ready for delivery, or if SomnoMed® is unable to deliver the Products on the agreed date because the Buyer has not provided appropriate instructions or information, then the Products shall be deemed to have been delivered;
  • SomnoMed®, at its option, may store the Products until the Buyer picks them up, in which case the Buyer shall be liable for all related costs and expenses (including, without limitation, storage and insurance); and
  • for the avoidance of doubt, risk of loss to the Products shall pass to the

10.     FORCE MAJEURE

SomnoMed® shall not be liable for any default, delay in performance or damage as a result of any delay in performance or nonperformance, due to any cause, directly or indirectly, beyond its reasonable control, including, without limitation, an act of God, act of the Buyer, embargo or other governmental action, prohibition or regulation or request, fire, the elements, accident, strike, labor dispute, slowdown, war, force of arms, riot, delay in transportation or inability to readily obtain necessary labor, materials or facilities. SomnoMed® shall notify the Buyer of the happening of any contingency and of the contemplated effect thereof on the delivery of the Oral Appliance

11.    PRODUCT REFUNDS AND ORAL APPLIANCE RETURNS

  • Product refunds will not be provided for any The Buyer’s sole and exclusive remedy for any defects shall be as set forth in the “Exclusive Remedy for Defective Oral Appliances” section below.
  • All sales of shelf Products are final and are not eligible for return or credit.

12.     EXCLUSIVE REMEDY FOR DEFECTIVE ORAL APPLIANCES

This section contains the Buyer’s sole and exclusive remedies for Oral Appliances that allegedly do not comply with the warranties set forth in these Terms (“Defective Oral Appliances”). Buyer’s remedy under this section is conditioned upon Buyer’s compliance with its obligations under this section and the “If an Oral Appliance Requires a Repair or Replacement” section below.

During the applicable warranty period, with respect to any Defective Oral Appliances:

  • Buyer shall notify SomnoMed®, in writing, of any alleged claim or defect within thirty (30) days from the date Buyer discovers, or upon reasonable inspection should have discovered, such alleged claim or defect (but in any event before the expiration of the applicable warranty period);
  • Buyer shall ship, at its expense and risk of loss, such allegedly Defective Oral Appliances to SomnoMed®‘s designated facility for inspection and testing by SomnoMed®;
  • If SomnoMed®‘s inspection and testing reveals, to SomnoMed®‘s reasonable satisfaction, that such Oral Appliances are Defective Oral Appliances and any such defect has not been caused or contributed to by any of the factors described under the “Not Covered By Warranty” section above, SomnoMed® shall repair or replace such Defective Oral Appliances; and
  • SomnoMed® shall, after receiving the Buyer’s shipment of such Defective Oral Appliances, deliver to the Buyer, at SomnoMed®‘s expense, the repaired or replaced Oral Appliances (and such delivery of the repaired or replaced Oral Appliances shall be subject to the terms of the “Delivery, Delays, and Risk of Loss” section above).

In no event shall the Buyer reconstruct, repair, alter, or replace any Oral Appliance, in whole or in part, either itself or by or through any third party.

THIS SECTION SETS FORTH THE BUYER’S SOLE AND EXCLUSIVE REMEDY AND SOMNOMED®’S ENTIRE LIABILITY FOR ANY BREACH OF THE LIMITED WARRANTIES SET FORTH IN THESE TERMS.

13.     IF AN ORAL APPLIANCE REQUIRES A REPAIR OR REPLACEMENT

In the event that SomnoMed® is obligated hereunder to repair or replace any Oral Appliance, the Buyer shall comply with the following terms:

  1. Returns must be generated according to SomnoMed®‘s RMA policy (ttps://somnomed.com/en/wp-content/uploads/sites/2/2021/06/RMA-2021.pdf). The Buyer must begin the process by submitting its request on SomAccount (somaccount.com) or, if such Buyer does not have a SomAccount for any reason, by calling SomnoMed® and requesting the RMA team.
  2. Send new impressions, models, or digital scans along with a new bite
  3. Do not include any accessories or personal items.

14.     GOVERNING LAW; DISPUTE RESOLUTION

These Terms, including all orders of Products, and all matters arising out of or relating to these Terms, are governed by, and construed in accordance with, the laws of the State of Texas, United States of America, without regard to the conflict of laws provisions thereof to the extent such principles or rules would require or permit the application of the laws of any jurisdiction other than those of the State of Texas. If any dispute between the Parties arises out of any matter governed by these Terms, each Party shall give the other Party written notice of such dispute, and each Party will first attempt in good faith to reach a settlement through negotiation their respective appointed representatives. If a dispute cannot be resolved within thirty (30) days of one Party providing notice of such dispute to the other Party, the dispute shall be submitted to non-binding mediation before either Party pursues any other remedies hereunder. If the mediation does not resolve the dispute within thirty (30) days from its start, the dispute shall be resolved by binding arbitration, except that, in the event of a breach or threatened breach of a Party’s obligations of confidentiality under this agreement, either party shall be free to seek temporary injunctive relief or other equitable relief in court if such action is necessary to avoid irreparable damage or to preserve the status quo. Such arbitration shall be in the State of Texas, or another mutually agreed upon location, before a single arbitrator in accordance with the Commercial Arbitration Rules of the American Arbitration Association. The arbitrator shall be selected by mutual agreement of the Parties, or, if the Parties cannot agree, in accordance with the rules of the American Arbitration Association, each Party will bear one-half of the expenses of the arbitrator and other costs related to the arbitration. Each Party shall pay its own attorneys’ fees in the arbitration, and in any proceeding brought to enforce these arbitration provisions or any award rendered by the arbitrators. Judgment on the award rendered by the arbitrators shall be final and binding and may be entered in any court having jurisdiction thereof. The arbitration proceedings shall be confidential. The provisions of the Parties’ arbitration agreement set forth above are severable, so that if any provision or the application of any provision is held invalid or unenforceable, the remaining provisions shall remain valid and enforceable.

15.     LIMITATION OF LIABILITY

SOMNOMED® SHALL NOT BE LIABLE FOR CONSEQUENTIAL, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE OR ENHANCED DAMAGES, LOST PROFITS OR REVENUES OR DIMINUTION IN VALUE, ARISING OUT OF OR RELATING TO ANY BREACH OF THESE TERMS, REGARDLESS OF (A) WHETHER SUCH DAMAGES WERE FORESEEABLE, (B) WHETHER OR NOT IT WAS ADVISED OF THE

POSSIBILITY OF SUCH DAMAGES AND (C) THE LEGAL OR EQUITABLE THEORY (CONTRACT, TORT, OR OTHERWISE) UPON WHICH THE CLAIM IS BASED, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE.

SOMNOMED®‘S AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THESE TERMS, WHETHER ARISING OUT OF OR RELATED TO BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, SHALL NOT EXCEED THE TOTAL OF THE AMOUNTS PAID AND AMOUNTS ACCRUED BUT NOT YET PAID TO SOMNOMED® FOR THE PRODUCT PURSUANT TO THESE TERMS.

16.    CONFIDENTIALITY

Confidential Information Definition

For purposes of these Terms, “Confidential Information” means any and all non-public, proprietary, or confidential information disclosed by either party to the other, including but not limited to:

  • Patient Information: Any patient data, impressions, models, digital scans, medical records, treatment plans, or health information provided to SomnoMed® by Buyer
  • Technical Information: Product specifications, manufacturing processes, quality control procedures, design details, software, algorithms, and technical documentation
  • Business Information: Pricing structures, customer lists, marketing strategies, financial information, business plans, and commercial terms
  • Proprietary Methods: Clinical protocols, fitting techniques, treatment methodologies, and professional practices

Buyer’s Confidentiality Obligations

The Buyer agrees to:

  1. Protect Buyer Patient Privacy: Handle all patient information in accordance with HIPAA requirements and applicable privacy laws
  2. Secure Information: Implement appropriate safeguards to protect any SomnoMed® confidential information from unauthorized disclosure
  3. Limited Use: Use SomnoMed® confidential information solely for the purposes of these Terms and the proper use of Products
  4. No Disclosure: Not disclose SomnoMed® confidential information to any third parties without SomnoMed®’s prior written consent
  5. Return of Information: Upon termination of the business relationship, return or destroy all SomnoMed® confidential information

SomnoMed®‘s Confidentiality Obligations

SomnoMed® agrees to:

  1. Patient Data Protection: Maintain strict confidentiality of all patient information provided by Buyer in compliance with HIPAA and applicable privacy laws
  2. Secure Handling: Implement industry-standard technical and process related security measures to protect Buyer’s confidential information
  3. Limited Access: Restrict access to confidential information to employees and contractors who need such information to fulfill obligations under these Terms
  4. Data Retention: Maintain patient information only as long as necessary for manufacturing, warranty, and regulatory compliance purposes

Exceptions

The confidentiality obligations set forth in this section shall not apply to information that:

  • Is or becomes publicly available through no breach of this agreement
  • Was rightfully known prior to disclosure
  • Is independently developed without use of confidential information
  • Is required to be disclosed by law or regulatory authority (with prompt notice to the disclosing party where legally permissible)

Remedies

The parties acknowledge that any breach of this confidentiality section may cause irreparable harm for which monetary damages would be inadequate. Therefore, either party may seek injunctive relief and other equitable remedies for any breach or threatened breach of these confidentiality obligations.

Survival

The obligations set forth in this confidentiality section shall survive termination of these Terms and shall remain in effect for a period of five (5) years following such termination, except that obligations relating to patient information shall survive indefinitely.

17. GENERAL PROVISIONS

Entire Agreement: These Terms, including all orders of Products, constitute the sole and entire agreement of the parties with respect to the subject matter of these Terms and supersedes all prior and contemporaneous understandings, agreements and representations and warranties, both written and oral, with respect to such subject matter. To the extent any of these Terms differ from any of Buyer’s general terms and conditions of purchase, regardless of whether or when the Buyer has submitted its purchase order or such terms and conditions, these Terms shall prevail. To the extent any of these Terms differ from any pricing and purchasing agreement between SomnoMed® and the Buyer, if applicable, the pricing and purchasing agreement shall prevail.

Amendment and Modification; Waiver: No amendment to or modification of these Terms is effective unless it is in writing and signed by an authorized representative of each Party. No waiver by any Party of any of the provisions hereof will be effective unless explicitly set forth in writing and signed by the party so waiving. Except as otherwise set forth in these Terms, (i) no failure to exercise or delay in exercising, any rights, remedy, power or privilege arising from these Terms will operate or be construed as a waiver thereof and (ii) no single or partial exercise of any right, remedy, power or privilege hereunder will preclude any other or further exercise thereof or the exercise of any other right, remedy, power or privilege.

Assignment: Neither Party shall have the right to assign or transfer this agreement or any rights hereunder to any third party without the prior written consent of the other party. Notwithstanding the foregoing or anything to the contrary herein, SomnoMed® may assign or transfer this agreement or any of its rights hereunder to any of its affiliates or to any successor in interest in the event of a merger, sale of substantially all of its stock, a sale of all or substantially all of its assets or similar transaction without the consent of the Buyer.

Notice: Any notice or other document given by either Party to the other hereunder shall be in writing and sent to the address of the recipient set out hereunder or in the Order Form (or such other address as that Party may advise by notice). Any such notice may be delivered personally, by electronic mail (sent to the e-mail address supplied on request) or by first class pre-paid mail and shall be deemed to have been served if personally, when delivered, if by first class mail, three (3) business days after mailing, if by recorded delivery first class pre-paid mail, when signed for by the recipient and if by facsimile transmission or electronic mail the first business day after transmission.

SomnoMed®

Attn:Enrico Cairoli

6513 Windcrest Drive, Suite # 100, Plano, TX, 75024

Relationship: The Parties are independent contractors. These Terms, any order forms, prescription forms or any other documents or agreements do not create a partnership, franchise, joint venture, agency, fiduciary, or employment relationship between the Parties. Except as set out in these Terms, nothing in these Terms, expressed or implied, is intended to give rise to any third-party beneficiary relationship.