SI-BONE, Inc. hereby agrees to provide Purchaser a one-time free replacement of any iFuse Implant™ (an “Eligible Product”) if a revision procedure requiring additional implants (to either supplement or replace previously implanted Eligible Products) is required within the one-year period following the index procedure using the Eligible Product (the “Warranty Period”) for any reason, other than the failure of the patient to follow post-operative instructions provided by the surgeon and subject to the additional conditions set forth below. In qualifying revision cases where more than one additional or replacement implants are required to fixate the initially treated joint, all additional or replacement implants will be provided at no charge.
SI-BONE further agrees, subject to the conditions below, to provide Purchaser a one-time credit equal to the original purchase price paid for one (1) iFuse Implant for use on future purchases for any revision procedure within the Warranty Period during which a replacement or implant addition is not required. The credit will be awarded to the Purchaser within thirty (30) days written notice by the Purchaser confirming the completion of the revision procedure.
Claim Procedure. In order to receive the benefits of the Warranty under this Agreement, Purchaser must, within five (5) days after the revision procedure wherein either (i) the Eligible Product was replaced or supplemented with additional implants, or (ii) a revision procedure was performed without additional implants, in either case have caused to be submitted a request for warranty replacement or credit to SI-BONE. The request shall be accompanied by: (i) the receipt or invoice for the Eligible Product for which the credit or replacement product is sought; (ii) a certification signed by the revising surgeon describing the failure and certifying that the index procedure was, to the best of such revising surgeon’s knowledge, performed in accordance with the iFuse Instructions for Use using a minimum of three (3) iFuse Implants per side (“per side”), that the revision did not become necessary as a result of the patient’s failure to follow post-operative instructions, and that that utilization of products for which the warranty claim is being made was medically necessary.
Conditions. In the case where a product other than a SI-BONE product is used in the revision procedure, either as an additional or replacement implant, no replacement product or credit will be provided. The foregoing warranty is available only if the revision procedure is performed in the same facility or an associated system facility as the index procedure and within the Warranty Period. No replacement product or credit will be given if fewer than three (3) iFuse Implants per side were used in the index procedure. The foregoing warranty is available only for revision procedures completed under a new admission episode to the hospital. Revision procedures occurring at the same time as the index procedure or under the same admission to the facility as the index procedure will not be covered under this warranty.
Safe Harbor Compliance. Any replacement products or credits provided by SI-BONE under this warranty represent a price reduction that Purchaser must fully and accurately report in applicable cost reports or claims for payment filed with federal or state health care programs in accordance with the warranty safe harbor provisions of the federal anti-kickback statute set forth at 42 C.F.R. § 1001.952(g). Purchaser must provide information upon request to Medicare, Medicaid and other federal health care programs on price reductions (including free items and purchase credits) obtained as part of this warranty.
Effective date 1/1/2017