Urolift™ Deployment Warranty
Notwithstanding anything to the contrary in Teleflex’s Standard Terms and Conditions of Sale or
any other agreement between Customer and Teleflex with respect to the subject matter of thiswarranty, if during an outpatient prostatic urethral lift procedure performed for a purpose clearedby the United States Food and Drug Administration and using Teleflex’s Urolift™ System(“Procedure”), which consists of a Urolift™ Delivery Device and Urolift™ Implants, a Urolift™
Implant’s capsular tab fails to fully deploy and seat on the capsular surface of the prostate (“NonDeployment”) as a result of (a) contact with the pelvic bone (“Bone Strike”) or (b) pulling throughthe adenoma towards the delivery device (“Pull Through”), due to anatomical variations, Teleflex
will provide to Customer a new, single Urolift™ Implant at no additional charge (the “Replacement
Urolift™ Implant”). This Urolift™ Deployment Warranty (“Warranty”) is subject to the following
conditions:1) Customer must fully and accurately report any price reduction of the items received as partof this Warranty in its applicable cost reports and must also provide, upon request byfederal or state government, information provided by Teleflex as specified in 42 C.F.R. §1001.952(g)(3).
2) Patients whose care is subject to this Warranty must have received a Procedure asprescribed by their physician. The Urolift™ System, which includes the Urolift™ Delivery
Device and Urolift™ Implant, must have been used in a manner consistent with all labelingand instructions for use, with all indications for use present and no contraindications
present prior to the Procedure.
3) The Non-Deployment must result from a Bone Strike or Pull Through due to anatomicalvariation.
4) Teleflex must receive Customer’s completed Urolift™ Deployment Warranty Form (formattached) for each claim made under this Warranty within ten business (10) days of thedate of the Procedure. If requested, Customer will allow Teleflex reasonable access to, orfurnish Teleflex with copies of, Customer’s books and records, sufficient to enable Teleflex
to confirm that Customer’s claim satisfies all conditions of this Warranty.
5) Following a determination by Teleflex of a valid Warranty claim, Teleflex will issue aReplacement Urolift™ Implant to Customer. Teleflex’s determinations as to eligibility andsatisfaction of Warranty conditions will be conclusive absent manifest error.
6) The following limitations apply to the Warranty Program:a. Claims by a Customer for any physician with more than twelve (12) months ofexperience with the Urolift™ System may not exceed 2.5% of that physician’s prioryear annualized deployments.
b. Claims by a Customer for any physician with less than six (6) months ofexperience with the Urolift™ System may not exceed four (4) Implants in thecalendar year for that physician. New Urolift™ System physicians who are still
within the New Start Training Period are not eligible for this Warranty.

c. Claims by a Customer for any physician with six (6) to twelve (12) months ofexperience with the Urolift™ System may not exceed the greater of four (4)Implants or 2.5% of that physician’s annualized deployments in the calendar year.
7) Customer must certify that it has not and will not submit for reimbursement nor charge thepatient for the Urolift™ Implant(s) with the capsular tab that did not fully deploy due to aBone Strike or Pull Through.
8) Customer must certify that physicians performing Procedures at Customer’s facility(ies)will, at all times, remain responsible for determining whether specific medical devices,
including the Urolift™ System as well as the Urolift™ Delivery Device and Urolift™ Implant,
are medically necessary and clinically appropriate for a particular patient.
This Warranty program is not contingent upon or in any way related to purchasing quotas,
minimums, or any other eligibility criteria tied to volume, value, or exclusivity.
This Warranty program does not apply to any Urolift™ Implant that was not purchased directlyfrom Teleflex by the Customer Facility at which the Procedure was performed.
Teleflex may terminate the Warranty program at any time for any reason upon written notice.
Warranty claims for a Urolift™ Implant used in a Procedure prior to termination of the Warranty
program will continue to be accepted and (if all conditions of this Warranty are satisfied) honoredby Teleflex, to the extent legally permissible.
This Warranty program is intended to comply with all applicable laws and regulations. Customer
will report Warranty price reductions and provide other information about this Warranty program
as required or as requested to third parties (including the U.S. Department of Health and HumanServices or state agencies) under laws and regulations that apply to Customer-2-

Urolift™ Deployment Warranty Claim Form
Please complete all fields below. An incomplete Deployment Warranty Claim Form may delay
receipt of a replacement implant or result in the rejection of a claim. All capitalized terms nototherwise defined herein shall have the same definition as specified in the Urolift™ Deployment
Warranty. Submit one form per patient case to ULWarranty@Teleflex.com
Customer Account Name:1
Teleflex Account #:Procedure Date:

1.

Facility where Procedure took place (if part of a health system, please indicate name ofhealth system):2.

Lot #(s) of Urolift™ Implant(s) used in Procedure that did not deploy due to anatomicalvariations. List Lot #, Qty & Model Type:______________

3.

Physician performing Procedure:

4.

Physician NPI No:

Initial next to each statement below, indicating agreement with each of the following:5.

_______ Urolift™ Implant’s capsular tab did not fully deploy and seat on the capsularsurface of the prostate as a result of a Bone Strike or Pull Through due to anatomicalvariation.

6.

_______ The use of the Urolift™ System, which includes the Urolift™ Delivery
Device and Urolift™ Implant, was consistent with all labeling and instructions foruse, with all indications for use present and no contraindications present prior to theProcedure.

7.

_______ Physicians performing Procedures at the Facility remain responsible fordetermining whether specific medical devices, including the Urolift™ System as well as
the Urolift™ Delivery Device and Urolift™ Implant, are medically necessary andclinically appropriate for a particular patient.

1“Customer” should be the name of the entity that purchased the Urolift™ Implant used in theProcedure.

8.

_______ A claim for reimbursement has not been nor will be submitted for the Urolift™
Implant with the capsular tab that did not fully deploy and seat on the capsular surface ofthe prostate.

9.

_______ The patient will not be billed for the Urolift™ Implant with the capsular tab that
did not fully deploy and seat on the capsular surface of the prostate.

10.

_______ Customer does not believe a device malfunction occurred with the Urolift™
System used in the Procedure, including the Urolift™ Delivery Device and Urolift™
Implant.2

11.

_______ Customer has discarded the Urolift™ Implant with the capsular tab that did not
fully deploy and seat on the capsular surface of the prostate OR Customer has returned
the Urolift™ Implant as a suspected device malfunction, and upon closure of theinvestigation, was notified by the Urolift™ Warranty Team they may be eligible for areplacement under this program.

By signing below, Customer certifies that all information provided above is true and correct,
and further certifies that the Deployment identified in this Deployment Warranty Claim Formsatisfies all of the conditions of the Urolift™ Implant Deployment Warranty Program.
Customer Account Name:
Signature:

Date Signed:

Name (Printed):
Title:
Contact Name (if different):
Phone:

Email:

Please remit complete, executed Deployment Warranty Claim Form to:Urolift™ Warranty Team
E: ULWarranty@Teleflex.com

2Should the Customer believe a device malfunction has occurred; he/she should contact theTeleflex Quality Department at USPLE-Complaints@Teleflex.com