Terms and Conditions

TACTILE MEDICAL
AffloVest DME Provider Terms and Conditions
Effective December 1, 2021

Tactile Medical (“Tactile”) does business with durable/home medical equipment providers (hereinafter, “DME Provider”) under these Terms and Conditions (“Terms”). These Terms apply to all sales of AffloVest™ and its accessories (“AffloVest” or “Product(s)”) to any DME Provider that purchases AffloVest for resale. Acceptance of the Product(s) shall constitute acceptance of all express terms below. These Terms are available at www.afflovest.com and are subject to change without notice.

1.0 NEW ORDERS.
1.1 Placing New Orders. Orders for products sold by Tactile to a DME Provider must be submitted electronically to Tactile’s fax or email. Orders should be faxed or emailed to the following:

Emailed Orders [email protected]
Faxed Orders 866.569.1912

All orders will be subject to Product availability. Each order should include a 1) purchase order number; 2) part number, size and quantity of each being ordered; 3) shipping address if different than the DME Provider address on file; 4) shipping type (e.g., ground, second day air, or overnight); and 5) AffloVest sales representative.
1.2 Shipping on New Orders. Shipping costs on new orders will be charged to DME Provider unless Tactile authorizes different shipping arrangements.

2.0 TAXES. Prices are exclusive of Taxes. The DME Provider is responsible for all federal, state, local and foreign taxes, levies and assessments (including value added tax, excise, sales or use taxes) (collectively, “Taxes”) associated with the purchase of Products. Tactile will charge Taxes as required by applicable law or regulation. If the DME Provider provides Tactile with valid and complete tax exemption certificates, Tactile shall exclude qualifying Taxes from the invoice.

3.0 TERMS OF PAYMENT. Payment may be made by electronic wire transfer or ACH. Tactile’s invoice is past due if not fully paid within 30 days. If the DME Provider fails to timely pay an invoice, then, in addition to any other remedies allowed by law, Tactile reserves the right to charge the DME Provider an additional monthly interest charge equal to 1.5% per month, or the maximum interest rate allowable under applicable law, whichever is lower, from the date such payment was due until the date paid in full. In the event Tactile incurs any legal and/or other collection expenses in connection with any action taken by Tactile to collect past due payments, Tactile reserves the right to collect all reasonable legal fees and expenses incurred in connection with such collection action or proceeding, including any collection agency commission.

4.0 LIMITED WARRANTY. Tactile provides a warranty for the AffloVest device. The AffloVest and its internal oscillation motors, battery, AC power/charger supply, and hand-held controller are warranted to be free from defects in material and workmanship for a period of five (5) years from the date the product is shipped to the DME Provider. The Go Anywhere travel case is warranted to be free from defects in material and workmanship for a period of one (1) year from the date the product is shipped to the DME Provider. The limited warranty does not cover any lost items or abuse. Please see the AffloVest complete written warranty policy found in the User Manual for details and limitations

These warranties do not cover failures due to improper or negligent use of the product. Repairs or alterations to the product not conducted by Tactile Medical shall void these warranties

If you have questions or to obtain warranty service, contact Tactile Medical at 800-575-1900.

5.0 LIMITED WARRANTY RETURNS
5.1 Limited Warranty Returns. As cited above, items qualifying for a Warranty Return are those failures in which there are identified defects in material and workmanship.
5.2 Limited Warranty Return Process. To return an AffloVest due to a technical issue, the DME Provider must first perform the troubleshooting routine developed by Tactile. If troubleshooting does not correct the AffloVest issue, the DME Provider must contact Tactile to obtain return authorization. Authorization for any returns must be obtained from Tactile Customer Service before an AffloVest may be returned. Once the DME Provider is issued a return authorization number, the DME Provider may return the AffloVest and await the repair/replacement. Once the AffloVest is received, it will be assessed by Tactile. If Tactile determines that the reported issue cannot be duplicated or if the failure was due to abuse or not covered by the Limited Warranty, the return will be subject to the terms set forth in the Out of Warranty Returns section below. If Tactile determines that the reported issue falls under the Limited Warranty, the unit will be repaired or replaced as deemed necessary. The repaired or replaced AffloVest will ship back to the DME Provider within seven working days.
5.3 Advance Replacement on Limited Warranty Returns. If the DME Provider requires an expedited replacement of the original unit, the DME Provider may issue a new PO. If Tactile determines that the original unit can be repaired or no issue was found, however, the DME Provider will be responsible for paying both POs/Invoices. The 30-day return period will not apply since the replacement will have already been put on a patient.
5.4 Shipping on Limited Warranty Returns. Returns due to a Tactile error or Limited Warranty claim, may, with authorization, be returned freight collect or pre-paid freight issued by Tactile.

6.0 OUT OF WARRANTY RETURNS
6.1 Improper Use. Failures due to improper or negligent use of the product are ineligible for return or replacement. A new AffloVest must be purchased.
6.2 Incorrect Sizing Returns. Returns due to incorrect sizing do not fall under the Limited Warranty. To exchange an AffloVest due to incorrect sizing on the patient, the DME Provider must do so within 30 days of shipment to the DME Provider. The DME Provider must contact Tactile to obtain exchange authorization. Authorization for any sizing exchanges must be obtained from Tactile Customer Service before an AffloVest may be exchanged. Once the DME Provider is issued a exchange authorization number, the DME Provider has two options upon contacting and receiving return/exchange authorization from Tactile:
a. The DME Provider can return the incorrect size and await the replacement size, which will ship once the returned AffloVest is received and inspected to be free of damage by Tactile.
b. The DME Provider can place a new PO for the new size for the returned AffloVest and the new size will ship two-day delivery. The order will be invoiced and once the incorrectly sized AffloVest has been received and inspected to be free of damage at Tactile, the DME Provider will be issued a credit for that AffloVest.
6.3 Shipping on Out of Warranty Returns. Out of Warranty returns must ship freight prepaid by the DME Provider unless Tactile authorizes different shipping arrangements.

7.0 AFFLOVEST TRADE-IN & EXCHANGE PROGRAM
7.1 Trade-In & Exchange Program. Tactile Medical offers an exchange program in order to ensure a patient has a correctly sized AffloVest that meets the patient’s therapy needs as their body changes. The exchange can occur only once during the 5-year warranty of the original purchase of AffloVest, unless the patient is under the age of 19 at the time the exchange is requested. An exchange does not renew the original product warranty. Acceptance of a trade-in and exchange is at the sole discretion of Tactile Medical.
7.2 Participation Requirements. In order to participate in the AffloVest Trade-in & Exchange program, the following requirements must be met:
a. Authorization for the exchange must be obtained in advance from Tactile Medical as evidenced by the provision of an exchange number
b. The AffloVest being traded-in must be in good working condition, defined as operating according to manufacturer’s standards and free from rips, tears, stains, discoloration, surface damage, etc.
7.3 Shipping on Trade-In & Exchange Program. The DME Provider is responsible for charges to return the unit Tactile, whereas Tactile assume responsibility for shipping costs associated with the exchange.
7.4 Advance Replacement on Trade-In & Exchange Program. If the DME Provider requires an expedited replacement of the original unit, the DME Provider may issue a new PO. The order will be invoiced and once the trade-in AffloVest has been received and inspected to be free of damage at Tactile, the DME Provider will be issued a credit for that AffloVest. If the trade-in is not returned within 30 days, the DME Provider will be responsible for paying both POs/Invoices.
7.5 Trade-In & Exchange Program Limitations. After the 5th anniversary from date of shipment of an AffloVest to a DME Provider, a new AffloVest size may be purchased for the patient through insurance, if qualified. Billing can be initiated under the HCPCS code E0483. See your insurance or Medicare policy for specific details.

8.0 30-DAY MONEY BACK GUARANTEE. All AffloVest purchases by a DME Provider have a 30-day money back guarantee to allow the end user/patient and clinicians to evaluate the AffloVest and make sure it meets the needs of the patient. If the decision is made to return the AffloVest, DME Providers can obtain a credit in the amount of the original invoice, provided that the AffloVest and all accessories are returned to Tactile within 30 days of shipment to the DME Provider, in new condition, fully functioning and with no visible damage to the AffloVest or its components. This 30-day money back guarantee is for direct purchases from Tactile only. Lease purchases are subject to the return policy of leasing company. Returns made under the 30-day money back guarantee are subject to the terms set forth in the Out of Warranty Returns section, above. All sales are final and non-refundable after 30 days, but remain covered by the Limited Warranty, as well as the AffloVest Trade-In & Exchange Program described above.

9.0 DME PROVIDER INVENTORY. It is the DME Provider’s responsibility to carry sufficient inventory to properly service and support patients who own an AffloVest. A minimum of one each of the most common AffloVest sizes is expected to be carried in the DME Provider’s inventory.

10.0 DME PROVIDER RESPONSIBILITY. The DME Provider agrees to service its AffloVest patients for the entire five-year Useful Life that insurance attaches to durable medical equipment products.

11.0 GROUP PURCHASING ORGANIZATION. If the DME Provider is a member of a group purchasing organization or equivalent (“GPO”), the DME Provider must provide a Letter of Designation advising Tactile of the DME Provider’s GPO. If the DME Provider is a member of more than one GPO, the Letter of Designation must indicate the GPO through which it is purchasing the AffloVest. After such designation, the DME Provider may change GPOs for purposes of AffloVest purchases only upon 30 days’ prior written notice to Tactile. The DME Provider’s failure to provide the proper designation, or any disputes regarding a GPO designation regarding the AffloVest, will result in the DME Provider responsibility for excess GPO fees.

12.0 INVENTORY EXCHANGE PROGRAM. For any DME Provider, Tactile will exchange any new, unused, unopened, current model AffloVest within 60 days of purchase for a different size AffloVest at no charge. The DME Provider is responsible for all shipping charges associated with fulfilling exchange orders.

13.0 QUALITY AGREEMENT. By distributing Tactile products, the DME Provider agrees to immediately, (within 24 hours), notify Tactile of any product-related complaints, injuries, or adverse events. Product complaints are to be directed to [email protected] The DME Provider shall make all reasonable efforts to aid Tactile in complaint or reportable event investigations. By distributing Tactile products, the DME Provider agrees to maintain distribution records for all Tactile products. In the event of a Tactile product recall, the DME Provider shall make all reasonable efforts to aid Tactile in the recall of affected product. The DME Provider shall maintain distribution records for the useful life of the device, or five years from the date of distribution, whichever is longer.

14.0 NON-EXCLUSIVE SALES; UNAUTHORIZED DISTRIBUTION. All sales by Tactile are non-exclusive. Unless authorized by Tactile in writing in advance, the DME Provider agrees: (a) not to resell, ship, or distribute Products to anyone other than patients; (b) not to purchase or exchange Tactile Products from any source other than Tactile; (c) not to resell or distribute Tactile Products outside the country to which Tactile ships the DME Provider’s order; and (d) not to resell or distribute Tactile Products online. The sale of Tactile Products in violation of this section voids Tactile’s written and implied warranties where permitted by law.

15.0 TITLE AND RISK OF LOSS. Title and risk of loss passes from Tactile to the DME Provider upon shipment from Tactile’s warehouse (FOB Origin). Thereafter, Tactile accepts no liability for any loss of or damage to the Product. Freight charges will be added to the DME Provider’s invoice and will include transit insurance if the DME Provider uses Tactile’s carrier. If the DME Provider elects to use a different carrier, then the DME Provider assumes risk of insuring shipment.

16.0 COMPLIANCE.
16.1 Compliance with Applicable Laws. DME Provider represents and warrants that it has effective compliance programs, policies and procedures to address relevant risk areas associated with the durable/home medical equipment industry, and it will comply with the applicable law in each country and state in which it sells Products or otherwise performs its obligations hereunder. DME Provider shall comply with Health Insurance Portability and Accountability Act of 1996, as amended, General Data Protection Regulation (Regulation (EU) 2016/679), California Consumer Privacy Act, and other relevant privacy laws and regulations applicable in those countries in which Tactile does business and in which DME Provider performs its obligations hereunder.
16.2 Permits, Licenses, and Inspections. DME Provider, at its sole cost and expense, will obtain and maintain all licenses, permits, approvals, and inspections necessary for the sale of Products and performance of its obligations hereunder. Upon Tactile’s reasonable request, DME Provider promptly will deliver to Tactile copies of the applicable permits, written approvals, licenses and inspections.
16.3 Exclusion. DME Provider represents and warrants that it has not been nor is currently: (i) excluded from participation in Medicare, Medicaid or other federal healthcare programs by the Department of Health and Human Service’s Office of Inspector General, and are not using in any capacity persons or organizations, which are debarred, suspended or otherwise excluded by any federal agency including, without limitation, by the Food and Drug Administration (“FDA”) under the Generic Drug Enforcement Act, or barred from federal contracting by the General Services Administration, or (ii) subject to any similar sanction of the European Medicines Agency (“EMA”) or other equivalent authority.
16.4 Notice Requirement. DME Provider will immediately inform Tactile in writing of any debarment, exclusion, suspension, or proposed debarment, exclusion or suspension by any federal government agency, EMA, or other applicable authority of DME Provider or its personnel performing its obligations hereunder. In such event, Tactile will have the right, at its option, to immediately terminate any agreement with DME Provider or to request that DME Provider promptly remove and replace any such debarred individuals with a substitute individual having the necessary skills and training to perform services under such agreement.
16.5 Record-Keeping. DME Provider further agrees to comply with all laws, regulations and instructions relating to: (a) storage and distribution of durable/home medical equipment, (b) durable/home medical equipment record-keeping requirements (including but not limited to collection of prescriptions); and (c) maintaining records of serial and or batch numbers of Products dispensed to patients.
16.6 Right to Audit. The Products tracked by the FDA in accordance with 21 CFR 821 have specific traceability requirements. Tactile reserves the right to conduct periodic audits of DME Provider to assess DME Provider’s capabilities to properly track the Products. DME Provider will be required to keep accurate and current tracking information for the useful life of the Product and shall make any records required available to Tactile or FDA. A distributor, final distributor, or multiple distributors, after purchasing a Product shall promptly provide Tactile with accurate and current tracking information pursuant to the tracking requirements required by 21 CFR 821.30 or any other applicable regulation.

17.0 DISCLAIMER OF WARRANTIES. EXCEPT FOR THE LIMITED WARRANTY REFERENCED IN SECTION 5.0 ABOVE, TACTILE HEREBY DISCLAIMS AND EXCLUDES ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESSED OR IMPLIED, OF ANY TYPE WHATSOEVER, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT, OR ANY REPRESENTATION OR WARRANTY AS TO THE DESIGN, CONDITION, QUALITY, CAPACITY, MATERIAL, EQUIPMENT OR WORKMANSHIP IN OR OF ANY TACTILE PRODUCT. TACTILE FURTHER DISCLAIMS ANY REPRESENTATION OR WARRANTY THAT TACTILE PRODUCTS ARE COMPATIBLE WITH ANY COMBINATION OF NON-TACTILE PRODUCTS USED IN CONNECTION WITH THE TACTILE PRODUCTS.

18.0 LIMITATION OF LIABILITY. THE TOTAL LIABILITY OF TACTILE, IF ANY, AND THE DME PROVIDER’S SOLE AND EXCLUSIVE REMEDY FOR DAMAGES FOR ANY CLAIM OF ANY KIND WHATSOEVER, REGARDLESS OF LEGAL THEORY, WILL NOT BE GREATER THAN THE ACTUAL PURCHASE PRICE OF THE TACTILE PRODUCTS WITH RESPECT TO WHICH SUCH CLAIM IS MADE. ALSO, UNDER NO CIRCUMSTANCES WILL TACTILE BE LIABLE FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL, INCIDENTAL OR PUNITIVE DAMAGES IN CONNECTION WITH THE TACTILE PRODUCTS, ANY ORDER FOR TACTILE PRODUCTS, THE FURNISHING OF EQUIPMENT, GOODS, PARTS OR SERVICES HEREUNDER, OR THE PERFORMANCE, USE OF, OR INABILITY TO USE ANY EQUIPMENT OR ANY OTHER GOODS, PARTS OR SERVICES, OR ANY OTHER MATTER RELATING TO THE FOREGOING, WHETHER BASED ON CONTRACT, TORT OR ANY OTHER LEGAL OR EQUITABLE THEORY, INCLUDING, BUT NOT LIMITED TO, DAMAGES FOR COMPENSATION, REIMBURSEMENT OR LOSS OF PRESENT OR PROSPECTIVE PROFITS, EXPENDITURES, INVESTMENTS, COMMITMENTS, OR CLAIMS OF ANY THIRD PARTY, WHETHER MADE IN THE ESTABLISHMENT, DEVELOPMENT OR MAINTENANCE OF BUSINESS REPUTATION OR GOODWILL, COST OF CAPITAL OR ANY OTHER REASON WHATSOEVER. THIS LIMITATION WILL NOT AFFECT THE DME PROVIDER’S RIGHT TO SEEK APPROPRIATE RELIEF ARISING FROM OR INCIDENT TO ANY DEATH, PERSONAL INJURY OR PROPERTY DAMAGE CONNECTED TO TACTILE’S GROSS NEGLIGENCE, WILLFUL MISCONDUCT OR STRICT LIABILITY IMPOSED BY LAW.

19.0 CHOICE OF LAW; JURISDICTION; VENUE. These Terms are the entire understanding and agreement between the DME Provider and Tactile and supersede any prior oral or written agreements, representations, understandings or discussions between the DME Provider and Tactile. These Terms shall be governed by and interpreted in accordance with the laws of the United States and the State of [Minnesota], excluding choice of law. If any provision of these Terms is held invalid or unenforceable by any court, in whole or in part, that term or condition will be construed and enforced to the greatest extent possible, and the validity of the remaining terms and conditions will not be affected. Any action or proceeding between the parties shall be brought in the state or federal court in [Hennepin County, Minnesota]. The parties submit to the exclusive jurisdiction and venue of [Minneapolis] courts for any action and agree that service of process may be affected by delivery to the address used for communications. The parties waive any right to participate in a class action or consolidated action regarding a dispute by joining a disputed claim with the disputed claim of any other person or entity or to assert a disputed claim in a representative capacity on behalf of anyone else in any lawsuit or other proceeding.

20.0 INDEMNIFICATION. The DME Provider shall defend, indemnify, and hold harmless Tactile from and against any liability, damage, loss, or expense (including reasonable attorneys’ fees and expenses of litigation) in connection with any claims, suits, or proceedings arising out of or relating to the use or other exploitation of the Products, unless proximately caused by the sole gross negligence or willful misconduct of Tactile.

21.0 FORCE MAJEURE. Neither Party shall be liable to the other for failure or delay in the performance of a required obligation, other than payment of money due, if such failure or delay is caused by an act or event beyond its control, including, but not limited to, the act of any federal, state, local or other governmental authority, act of God or nature, act of terrorism, delay of the other party or any third party, strike or other labor dispute, difficulty, or shortage, government shutdown, civil disturbance, transportation problem, epidemic, riot, fire, flood, lightning, interruption of power supply or communications, natural disaster or other similar cause beyond its control. Each Party shall immediately provide written notice to the other of any such condition. The Parties shall take reasonable steps and make reasonable effort to mitigate their damages and minimize the effect of any such act or event. The foregoing notwithstanding, either Party may terminate this Agreement immediately without liability to the other due to such termination if such force majeure event or condition continues for a period of more than sixty (60) days.

22.0 DEFAULT, TERMINATION AND OTHER REMEDIES. In addition to any other remedies otherwise available to Tactile, all of which are expressly reserved, Tactile may immediately terminate these Terms and accelerate any payment owed by the DME Provider following an Event of Default. Upon any termination of these Terms, all rights and obligations of the DME Provider and Tactile will cease except those rights and obligations that have accrued before the termination, including but not limited to payment of any amounts due. The following will constitute an Event of Default; (a) a DME Provider’s breach, violation, or failure to perform any of its obligations under any agreement with Tactile; (b) a DME Provider’s failure to comply with any applicable policy set forth by Tactile; (c) a DME Provider’s insolvency, dissolution or merger with or acquisition by another entity; (d) a DME Provider making an assignment for the benefit of creditors; or ceasing to do business as a going concern; (e) the instituting by or against a DME Provider of any action of bankruptcy, reorganization, receivership, conservatorship or insolvency; or (f) a DME Provider failing to pay any sum owed to Tactile upon acquisition of any assets or equity of another Tactile DME Provider. The DME Provider agrees to pay all costs and attorneys’ fees for collection, appeal, or execution of judgment.

23.0 MISCELLANEOUS. Tactile’s failure to enforce any term or condition of the Terms or to exercise any right arising hereunder will not constitute a waiver of Tactile’s right to enforce such terms or conditions or exercise such right thereafter. If any provision in the Terms, for any reason, is held void or unenforceable, the remaining provisions will remain in full force and effect and will control.