EPIC SYSTEMS CORPORATION
SIXTEENTH AMENDMENT TO LICENSE
This Sixteenth Amendment to License ("{¡Açndmeú") is entered into by and between Epic Systems Corporation ("Epic") and The
County of Santa Clara ("þ9").
BACKGROUND
Epic and You entered into a License and Support Agreement dated January 10,2012, which has since been amended (as amended,
the ",{grcenqgnl").
Epic and You would like to amend the Agreement to add the Blood Product Administration Module (the
Program Property licensed under the Agreement.
"Bl,{M")
as an Item
of
AGRDEMENT
In consideration of the mutual covenants set forth below and in the Agreement, the parties agree as follows:
All
capitalized terms used in this Amendment and not defined herein but defined in the Agreement
will
have the meanings
assigned to such terms in the Agreement.
1.
Addition of Program Property. The Agreement is amended by adding the following as an ltem of Program Property listed
on Exhibit l(a) of the Agreement, subject to the restrictions stated herein and in the Agreement:
Program Property
License Fee (US$)
Initial Monthly
Maint. Fee (US$)
Estimated
Implementation
Fees (US$)*
Blood Product Administration Module
(including the Incoming Blood Product
Administratio n Mo dule Interface)
The above Item is limited for use solely in accordance with the Documentation Manuals and with the Items
Property licensed by You under the Agreement. See Section 3 below for additional terms applicable to the BPAM.
!þ!14¡¡!qq:
of Program
*
Installation, modifications, and support of testing of the above Item will be billed at Epic's then cunent in-house hourly rates. On-site
if needed, will be charged at Epic's then cunent on-site hourly rates. The estimated implementation fees for the above Item are as set
forth above and have been provided by Epic based on its experience with "other similarly situated customers and other information available
to Epic as of the date of this Amendment. Actual implementation fees may vary from such estimate, and You agree to pay Epic the actual
time,
implementation fees.
2.
License and Maintenance Fees.
provided in Section
I
The initial monthly maintenance fee for the BPAM is as
of this Amendment Maintenance fees will be due and payable, and may be adjusted, as provided in the
Agreement.
3.
Blood Product Administration Module Terms. You acknowledge that, as of the date of this Amendment, Epic has listed
the BPAM as a medical device with the United States Food and Drug Administration ("IDA"), and You agree to the
following additional terms with respect to the BPAM:
a.
Intended Use/Indicationsþr Use. As of the date of this Amendment, the BPAM's intended use/indications for use
are as follows: The BPAM is a software module intended for use by healthcare professionals to assist in the
identification of patients and blood products for transfusion. The BPAM is based on a modular design allowing it to
be used with a host electronic health record system. The BPAM can, through use of barcode technology, assist
healthcare professionals in verifying patient identity at the bedside. The BPAM receives and manages information
from orders placed from a host system and blood product information from an external blood bank system. The
BPAM incorporates system-controlled logic that can require a positive match of the patient, the blood product to be
administered, and information received from the extemal blood bank system. The BPAM can also check a blood
product's documented expiration date for appropriateness. Blood administration information entered in the BPAM is
transmitted to the host system for storage.
b.
Clinical Judgnent Requíred. Although the BPAM can display warning messages that may help inform a clinician of
potential safety concerns (e.g,, the blood product to be administered not matching the relevant order, or the blood
product being expired), You agree that the clinician can also manually verify that he is administering the intended
blood product and that the blood product hasn't expired. You also agree that the BPAM is not intended to serve as a
substitute for a clinician's professional judgment and decision making, and a clinician should not delay a needed
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blood transfusion because of documentation or software workflow issues. You agree that You are responsible for
training Your Personnel accordingly.
c
Testing. You agree to conduct the installation, inspection, and any required testing of the BPAM in accordance with
Epic's instructions and procedures. Befole using the BPAM or any related Updates in a Production Directory, You
agree to test and inspect such ltem or Update to Your satisfaction, using testing materials provided by Epic where
available, and You agree to document such testing and inspection. You also agree to perform such testing in an
environment other than a Production Directory, and to confirm that the testing indicates no unresolved failure points
or signs of improper installation before using the BPAM in a Production Directory.
e.
Reporting. You acknowledge that both manufacturers and user facilities of medical devices listed with the FDA are
subject to reporting obligations, including, but not limited to, the requirements of 21 C.F.R. Part 803. You agree to
cooperate with requests for information by Epic with respect to any potentially reportable event involving the BPAM.
You also agree to promptly inform Epic of any report You decide to make to the FDA about the BPAM.
f.
Recalls. If at any time Epic determines, in its sole discretion, it is appropriate to recall the BPAM (as such term is
defined in 21 C.F.R. PartT), You agree to cooperate with such action (which may include Epic disabling the BPAM).
C.
Marketing. You acknowledge that medical devices are subject to certain FDA marketing restrictions. You agree to
h.
Labeling. You agree not to substantively change any labeling (as such term is defined in 21 U.S.C $ 321(m) and
comply with such restrictions. For the sake of clarity, this includes that You will not market the BPAM for any use
other than the intended use/indications for use listed in Section 3(a) above.
interpreted by the FDA) for the BPAM that is provided by Epic.
4.
Miscellaneous. The addition of the Program Property listed in Section I may require additional licenses, including but not
limited to InterSystems Caché licenses, or other third-party software and may increase Your use of processor cycles, disk
space and memory. You agree to obtain any other third party licenses for any software or data that may be required from third
parties, including without limitation any license to use CPT codes from the American Medical Association. In connection
with the addition of the Program Property, You may also require (i) installation, implementation and training services
(including analysis and consultation services), modifications (including customizations), and other services from Epic, which
rvill be billed to You at Epic's then current standard rates for such services, and (ii) additional computer hardware, storage, or
other infrastructure, which may result in additional costs (including from Your hosting or infrastructure providers). Except as
otherwise expressly provided in this Amendment, all terms and conditions previously set forth in the Agreement will remain
in effect as set forth in the Agreement. In the event that this Amendment and the Agreement are inconsistent, the terms and
provisions of this Amendment will supersede the terms and provisions of the Agreement, but only to the extent necessary to
satisfy the purposes of this Amendment. Upon Epic's signature, this Amendment will be effective as of the date of Your
signature below.
<signature page attached>
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COUNTY OF SANTA CLARA
EPIC SYSTEMS CORPORATION
By:
DAVE CORTESE, President
By:
Name: Erik J. Phelps
Board of Supervisors
Title:
General Counsel
Date:
Date:
ATTEST:
By:
MEGAN DOYLE
Clerk of the Board of Supervisors
Date:
APPROVED AS TO FORM AND LEGALITY
Deputy County Counsel
Date: Stro¡16
APPROVED BY SCVHHS F'INANCE
By:
JOHN COOKINHAM
SCVHHS Chief Financial Officer
Date:
The terms offered by this Amendment will expire if You have not returned an executed copy to Epic within sixty (60) days
of March 1,20L6.
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