PRODUCT PLACEMENT AGREEMENT Percutaneous Tibial Neuromodulation (PTNM)

NURO External Neuromodulation System

This agreement outlines the terms and conditions under which the NURO External Modulation System (the "Product") is being distributed to you by Medtronic, Inc. ("Medtronic") on behalf of AUS, LLC ("AUS"). If you retain or use the Product, you will be deemed to have accepted these terms.

  1. Ownership and Access. The Product is equipment currently owned by AUS, an entity which is affiliated with Medtronic, the sole distributor for AUS.  In consideration for Customer’s agreement to purchase NURO™ session kits, Medtronic is hereby transferring ownership of the Product to the Customer subject to the further conditions set forth in this Agreement. Customer agrees that Customer will return the Product to Medtronic and, by returning the Product to Medtronic, Customer will transfer ownership of the Product back to AUS if Customer decides to cease purchasing Products in the future and/or attempts to use non-Medtronic components with the Product. Customer may not sell, grant, donate or otherwise dispose of the Product other than by returning it to Medtronic. 
  2. Delivery Location. For traceability and access purposes, Customer understands that Customer must keep track of the Product’s location at all times so that it may be located upon Medtronic’s request promptly.
  3. Responsibility for Conduct of a Subcontractor to Whom Customer Provides the Product. Customer understands that if Customer provides the Product to a Subcontractor, Business Associate or other person or agent, Customer is nevertheless responsible for (i) maintaining the condition of the Product, (ii) returning it to Medtronic if you cease purchasing Products (or if you or such person attempts to use non-Medtronic components with the Product) and (iii) providing Medtronic with the location of the Product promptly.  No matter who is using this Product on Customer’s behalf, Customer is responsible for ensuring that the terms of this Agreement are met.  
  4. Term and Termination. This Agreement will be effective as stated above. Customer may terminate the terms governing the Product at any time, simply upon notice and return of the Product to Medtronic.  Medtronic may terminate this Agreement on an immediate basis if it appears in its sole discretion that the Product is in need of repair, upgrade or other corrective action, or in the event of market withdrawal of the Product, or any other reason deemed appropriate by Medtronic.  Customer may terminate this Agreement at any time, simply upon notice and return of the Product to Medtronic for any reason Customer deems appropriate. Customer shall return the Product to Medtronic, in good condition and repair (ordinary wear and tear excepted), within ten (10) days after the effective date of termination. Medtronic will be responsible for all shipping arrangements and costs associated with the return of the Product.
  5. Use of Product. Subject to the terms of this Agreement, the Product is being provided to Customer at no cost for Customer’s use in treating patients with Overactive Bladder (OAB) and associated symptoms of urinary urgency, urinary frequency, and urge incontinence (and any other indications for which the Product may be approved/cleared to treat in the future).
  6. No Alterations or Modifications. You agree that you shall not copy, alter, modify, attempt to repair or create derivative works from the Product, nor will you remove, alter or modify any of the labeling, warnings or other components of the Product.  You will not reverse engineer, decompile or disassemble the Product, nor will you  allow any other person to do so.  No rights or licenses are granted other than those expressly granted in this Agreement. 
  7. Governing Law, Construction and Venue. This Agreement shall be governed by and construed under the laws of the State of Minnesota, exclusive of its choice of law rules.
  8. Treatment of Discounts. The parties intend to establish a business relationship in which any rebates, discounts, payments and credits that may be provided to Customer comply with the exceptions to the Medicare and Medicaid Anti-Kickback statute set forth at 42 U.S.C. § 1320a-7b(b)(3) and the “Safe Harbor” regulations regarding discounts set forth in 42 C.F.R. § 1001.952(h); and the parties believe that the relationship contemplated by this Agreement is in compliance with those requirements. As to such discounts and rebates, the parties agree to fulfill their obligations under the Safe Harbor and the Customer agrees to report the discounts and rebates to its state or federal payors in accordance with the requirements of the Medicare/Medicaid Anti-Kickback Statute and Regulations and any applicable state or federal laws or regulations.