THE UNIVERSITY OF TEXAS, MEDICAL BRANCH AT GALVESTON
PRODUCT EVALUATION AGREEMENT (PEA)
___________________________________, located at ________________________________________________
(Company Name)
(Company Address)
___________________________________ (“Company”) agrees to furnish The University of Texas Medical Branch at
Galveston (“UTMB”) sample products or equipment (“Product(s)”), as described on the attached listing hereto, for UTMB’s
evaluation and testing purposes subject to the terms and conditions expressed below.
1.
Company agrees to furnish Product(s) at no charge to UTMB, including any and all necessary delivery and return
freight costs, installation and/or de-installation, as well as any related insurance; and
2.
Company agrees that its participation is voluntary, and that UTMB has made no representation, commitment or
guarantee to purchase these or additional Product(s) now or in the future; and
3.
Company warrants to UTMB, The University of Texas System, its regents, officers, customer, agents and
employees that the furnishing or use of any Product(s) hereunder does not infringe on any existing patent,
copyright, trademark, service mark or other third party intellectual property right, and Company agrees to indemnify
and hold harmless UTMB and The University of Texas System, its regents, officers, customer, agents and employees
from and against any and all claims, actions, damages, suits, proceedings, judgments, or liabilities incurred in
connection with any claim, suit, or action for actual or alleged infringement based upon UTMB’s use of said
Product(s). Company agrees to defend, at its sole expense, any such claim, suit or action brought against UTMB or
The University of Texas system, its regents, officers, customers, agents and employees individually or collectively;
and
4.
Company agrees to indemnify, defend and save harmless UTMB and The University of Texas System, their regents,
officers, customers, agents and employees (the “Indemnitees”) from and against any claims, actions, damages,
proceedings, judgments, or liabilities as a result of bodily injury (including death) and/or property damage arising
out of or in connection with the use of Product(s) furnished hereunder provided, however, that such indemnification
shall not be applicable to the extent that such claims, actions, damages, proceedings, judgments, or liabilities are
caused, by (a) the negligence or willful misconduct of an Indemnitee (b) the modification by an Indemnitee, or at
the direction of an Indemnitee, of the Product in any material way; or (c) the failure by an Indemnitee to follow an
applicable Product’s labeling or instructions provided by Company for such Product’s use; and
5.
Company agrees that UTMB’s sole responsibilities hereunder are to evaluate and to test Product(s) in good faith and
in such a manner and for such a time period as deemed reasonable, necessary and appropriate by UTMB.
6.
Company and UTMB agree that the number of evaluation Products provided at no charge hereunder does not exceed
the amount reasonably necessary to allow UTMB to assess the appropriate use and functionality of the Product. The
provision of Products hereunder shall be made in compliance with, and subject to the limitations set forth in, the
AdvaMed Code of Ethics on Interactions with Healthcare Professionals, and 42 U.S.C. § 1320a-7b(b) (the "AntiKickback Statute") and 42 U.S.C. § 1395nn (the "Stark Law"). In no event shall UTMB charge any patients or any
federal, state or commercial payor for any of the evaluation Products provided hereunder.
7.
Company hereby represents and warrants to UTMB that Company has never been excluded from participation in
any Federal or state health benefits program (including, without limitation, Medicare, Medicaid and CHAMPUS)
and Company shall immediately notify UTMB in writing if any such exclusion from program participation is
recommended, initiated, or implemented with respect to Company.
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Revision 02/17/2015
1
BY SIGNING BELOW, YOU REPRESENT AND WARRANT THAT THE COMPANY FOR WHOM YOU ARE ACTING
HAS DULY AUTHORIZED THE EXECUTION AND PERFORMANCE OF THIS DOCUMENT.
Company
_________________________________________
(Authorized Signature)
________________________________________
(Name – Print or Type)
_______________________________________
(Title)
_________________________________________
(Date)
Product(s)
Description
S/N (if any)
Additional Required Information:
Products are:
________
For Patient Use
Purpose/Use
Quantity
Evaluation Dates:
Start
End
_______NOT for Patient Use
Questions:
1. Describe your company's quality assurance program, what are your company’s requirements, and how are they
measured?
2. Is our company ISO 9000 certified?
3. Describe your company’s process for contacting UTMB of any recall’s or quality issues that may occur with the
sample products or equipment.
4. Provide the number of FDA Recalls that your companies sample products or equipment has been submitted and the
resolution of the issue.
5. If you have received complaints of equipment malfunction on the sample products or equipment please provide the
number of complaints, the nature of the complaint and the resolution (Equipment Evaluation Only)
6. Provide the recommend sterilization process for the sample products or equipment. (Equipment Evaluation Only)
UTMB Department Contact:
INSTRUCTIONS:
Department or Committee accepting such product(s) is responsible for completion of this from, obtaining signatures of
responsible individuals, forwarding copies to Purchasing and making arrangements with Material Management/Receiving
(409) 772-1161, if product(s) are to be received through UTMB – Materials Management Receiving. Any receipts made
through receiving facility must be identified on the container as “TRIAL” or “LOAN” and identify the using department,
employee name, telephone extension, and room number.
Revision 02/17/2015
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