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ROUTE 92 STANDARD TERMS AND CONDITIONS

These Route 92 Standard Terms and Conditions (“Standard Terms”) govern the purchase of Route 92 Medical products (“Products”) by Customer from Route 92 Medical (“Route 92”).

  1. PURCHASE.  Customer shall purchase the Products from Route 92 at the pricing provided to Customer by Route 92.
  1. SHIPPING.  Products shall be delivered F.O.B. Point of Origin to Customer’s specified destination, freight prepaid and added to the invoice. Customer shall send all purchase orders to [email protected].
  1. NOTIFICATION OF DEFECT.  Customer shall report to Route 92 any discrepancy in the quantity of Products billed and the quantity of Products received by Customer resulting from damage or defect, shortages, overages, or wrong Product, within fifteen (15) days of the date such Product shipment is received by Customer.
  1. PAYMENT TERMS.  Customer payments are due within thirty (30) calendar days following the date of invoice. 
  1. RETURNS.  Returns are accepted only at Route 92’s sole discretion.  If Customer desires to return a Product, Customer shall contact [email protected] to determine if a return is possible and request a Return Goods Authorization (“RGA”) from Route 92 for shipping and other directions for the return.  
  1. COMPLIANCE WITH LAW.  Customer and Route 92 each represent and warrant that it shall comply with all applicable federal and state laws and regulations, including, without limitation, the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b, any applicable “exceptions” or “safe harbors” under the Federal Anti-Kickback Statute with respect to the Standard Terms, and any state laws comparable to the Federal Anti-Kickback Statute. Both parties expressly acknowledge that the Federal Anti-Kickback Statute prohibits “illegal remuneration” as defined therein, in connection with the provision of goods or services for which payment is made in whole or in part under Medicare. It is the intention of the parties hereto that these Standard Terms shall in all respects comply with the Discount Safe Harbor, 42 C.F.R. § 1001.952(h) or the Statutory Discount Exception, 42 U.S.C. § 1320a-7b(b)(3)(A). Customer agrees that, if Customer is required to report its costs on a cost report, then (i) any discounts provided must be based on purchases of the same good bought within a fiscal year; (ii) Customer must claim the benefit in the fiscal year in which the discount is earned or in the following year; and (iii) Customer must fully and accurately report any discounts in applicable cost reports. Furthermore, Customer represents and warrants that it has independently determined that the Product is in the best interest of Customer’s patients. Customer agrees not to bill any third party, including payers or patients, for any Product samples received from Route 92 at no charge.
  1. LIMITED WARRANTY.  The Products (i) are manufactured in accordance with good manufacturing practices, as required by the United States Food and Drug Administration; (ii) are true to label; (iii) conform to specifications; (iv) are free from defects in materials and workmanship; and (v) are not adulterated or misbranded within the meaning of the Federal, Food, Drug and Cosmetic Act as amended. Route 92 does not warrant a good effect or against any ill effect following the Products’ use, and Route 92 makes no warranties that the Products are effective under all circumstances. THE FOREGOING WARRANTIES ARE EXCLUSIVE, ARE IN LIEU OF, AND SUPERSEDE ALL OTHER WARRANTIES OF ANY KIND, WHETHER WRITTEN, ORAL, EXPRESS, OR IMPLIED. THERE ARE NO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NONINFRINGEMENT.
  1. USE OF PRODUCT.  Customer acknowledges and agrees the Product is single use only per the Instructions for Use. Customer shall not attempt to repurpose, relabel, recondition, reuse or reverse engineer any Product. Customer shall not use the Product in any manner that does not comply with the Product Instructions for Use. 
  1. OWN USE.  Customer represents and warrants that the Products are for Customer’s own use, and Customer will not resell the Products.
  1. LIMITATION OF LIABILITY.  CUSTOMER’S SOLE AND EXCLUSIVE REMEDY FOR A BREACH OF WARRANTY HEREUNDER IS TO HAVE ROUTE 92 PROMPTLY REPAIR, REPLACE OR MODIFY ANY PRODUCT. CUSTOMER SHALL HAVE NO OTHER REMEDIES UNDER THIS AGREEMENT.  IN NO EVENT SHALL ROUTE 92 BE LIABLE TO ANY OTHER OR ANY THIRD PARTY FOR INCIDENTAL, PUNITIVE, SPECIAL, INDIRECT, OR CONSEQUENTIAL LOSS, DAMAGE OR EXPENSE ARISING FROM OR IN RELATION TO THESE STANDARD TERMS, WHETHER IN WARRANTY, CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY, BY STATUTE OR OTHERWISE. THIS LIMITATION SHALL APPLY EVEN IF A PARTY HAS BEEN ADVISED OR IS AWARE OF THE POSSIBILITY OF SUCH DAMAGES.
  1. GOVERNING LAW.  These Standard Terms shall be governed by and construed in accordance with the Laws of the State of California. The parties agree that the federal and state courts located in the State of California shall have exclusive jurisdiction in any suit or proceeding arising out of or relating to these Standard Terms or their subject matter. 

APM 0160-05.B