Exhibit 10.63

 

LEKSELL GAMMA KNIFE PERFEXION

PURCHASED SERVICES AGREEMENT

 

THIS PURCHASED SERVICES AGREEMENT ("Agreement") is made and entered into as of
August 5, 2011 (the "Effective Date"), by and between JACKSONVILLE GK EQUIPMENT,
LLC, a Delaware limited liability company ("JGKE") and ST. VINCENT’S MEDICAL
CENTER, INC., a Florida non-profit corporation, ("Medical Center"), with
reference to the following facts:

 

RECITALS

 

WHEREAS, Medical Center wants to obtain the right to use (the "Service") a
Leksell Gamma Knife Perfexion, including all associated and necessary software
(the "Equipment"), manufactured by Elekta Instruments, Inc., a Georgia
corporation ("Elekta"); and

 

WHEREAS, JGKE is willing to provide Medical Center with the right to use the
Equipment which JGKE has acquired from Elekta, pursuant to the terms and
conditions of this Agreement.

 

AGREEMENT

 

NOW, THEREFORE, in consideration of the mutual covenants, conditions and
agreements set forth herein, and for such other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the parties hereto
agree as follows:

 

1.            Right to Use the Equipment. Subject to and in accordance with the
covenants and conditions set forth in this Agreement, JGKE hereby grants the
right to use the Equipment to Medical Center, including all software sublicensed
to Medical Center by Elekta pursuant to the End User License Agreement between
Elekta and Medical Center, and Medical Center hereby accepts the right to use
the Equipment from JGKE. The Equipment to be placed at the Medical Center
pursuant to this Agreement shall include the Gamma Knife technology as specified
in Exhibit 1, including all hardware and software related thereto.

 

2.            LGK Agreement. Simultaneously with the execution of this
Agreement, Medical Center and Elekta shall enter into that certain Leksell Gamma
Knife End User Agreement pertaining to the Equipment (the "LGK Agreement"), a
copy of which is attached hereto as Exhibit 2. Medical Center shall perform,
satisfy and fulfill all of its obligations arising under the LGK Agreement when
and as required thereunder. Medical Center acknowledges that JGKE is a third
party beneficiary of the LGK Agreement and, in that capacity, JGKE shall be
entitled to enforce the terms and provisions of the LGK Agreement.

 

 

 

 

3.            Term of the Agreement. The initial term of this Agreement (the
"Term") shall commence as of the date hereof and, unless earlier terminated or
extended in accordance with the provisions of this Agreement, shall continue for
a period of ten (10) years following the date of the performance of the first
clinical Procedure (as defined in Section 8) performed on the Equipment (the
"First Procedure Date") at the Site (as defined in Section 5.1). The parties
agree to amend this Agreement to memorialize the First Procedure Date upon the
performance of the first clinical Procedure performed on the Equipment. Medical
Center’s obligation to make the "Purchased Services Payments" to JGKE for the
Equipment described in Section 8 below shall commence as of the First Procedure
Date.

 

4.            User License. Medical Center shall apply for and use its
reasonable efforts to obtain in a timely manner a User License from the Nuclear
Regulatory Commission and, if necessary, from the applicable state agency
authorizing it to take possession of and maintain the Cobalt supply required in
connection with the use of the Equipment during the term of this Agreement.
Medical Center also shall apply for and use its best efforts to obtain in a
timely manner all other licenses, permits, approvals, consents and
authorizations which may be required by state or local governmental or other
regulatory agencies for the development, construction and preparation of the
Site, the charging of the Equipment with its Cobalt supply, the conduct of
acceptance tests with respect to the Equipment, and the use of the Equipment
during the Term, as more fully set forth in Article 2.1 of the LGK Agreement.
JGKE shall provide all necessary assistance to the Medical Center in applying
for and for obtaining all such licenses, permits, approvals, consents or
authorizations. If the applicable regulatory authorities affirmatively decline
to issue a required license, permit, approval, consent or authorization
notwithstanding Medical Center’s best efforts to obtain the same, all parties
shall be released from further performance or any obligations or duties arising
under this Agreement and this Agreement shall terminate immediately with no
penalty to Medical Center.

 

5.            Delivery of Equipment; Site.

 

5.1      JGKE shall coordinate with Elekta and Medical Center to have the
Equipment delivered to Medical Center at the site, as described in Exhibit 5.1
of this Agreement (the "Site"), which delivery is anticipated to be on or before
October 2011, a date which has been mutually agreed to by the parties, subject
to all approvals and User Licenses having been obtained by Medical Center.
Elekta and JGKE shall, at their cost, expense and risk, coordinate and cause all
Equipment to be delivered to Medical Center FOB Destination and C.I.F. For the
purposes of this Section, C.I.F. shall mean that the pricing set forth herein
includes the insurance, freight, and transport costs and that risk of loss of
the Equipment shall pass to Medical Center upon installation of Equipment at
Site.

 

5.2      Upon advance notice and at a mutually agreeable time, Medical Center
shall provide reasonable access to the Site for the delivery of Equipment.
Medical Center at its cost and expense shall prepare the Site for the Equipment
in accordance with Elekta’s guidelines, specifications, technical instructions
and site planning criteria (which site planning criteria are attached as Exhibit
3 of this Agreement) (collectively the "Site Planning Criteria"). The location
of the Site has been agreed upon by Medical Center and JGKE as described in
Exhibit 3 of this Agreement.

 

 

 

 

6.            Site Preparation and Installation of Equipment and Acceptance.

 

6.1      Medical Center, at its cost, expense and risk, shall prepare all plans
and specifications required to construct and improve the Site for the
installation, use and operation of the Equipment during the Term. The plans and
specifications shall comply in all respects with the Site Planning Criteria and
with all applicable federal, state and local laws, rules and regulations. All
plans and specifications prepared by or on behalf of Medical Center (and all
material changes thereto following approval by JGKE and Elekta) shall be subject
to the written approval of JGKE and Elekta prior to commencement of construction
at the Site. Medical Center shall provide JGKE and Elekta with a reasonable
period of time (not to exceed fourteen (14) days) for the review and
consideration of all plans and specifications following the submission thereof
for approval (and JGKE shall not unreasonably withhold or delay its approval).
Following approval of the plans and specifications by JGKE and Elekta, Medical
Center, at its cost and expense, shall use best efforts to obtain all permits,
certifications, approvals or authorizations required by applicable federal,
state or local laws, rules or regulations necessary to construct and improve the
Site for the installation, use and operation of the Equipment. JGKE and Elekta
will provide all necessary assistance to Medical Center in obtaining such
permits and/or approvals.

 

6.2      Based upon the plans and specifications approved by JGKE and Elekta,
Medical Center, at its cost, expense and risk, subject to the reimbursement
provided herein, shall prepare, construct and improve the Site as necessary for
the installation, use and operation of the Equipment during the Term, including,
without limitation, providing all temporary or permanent shielding required for
the charging of the Equipment with the Cobalt supply and for its subsequent use,
selecting and constructing a proper foundation for the Equipment and the
temporary or permanent shielding, aligning the Site for the Equipment, and
installing all electrical systems and other wiring required for the Equipment,
which are identified in the Site Planning Criteria, and secure/authorized badge
entry to the Site compatible with Medical Center’s systems. In connection with
the construction of the Site, Medical Center shall select, purchase and install
all radiation monitoring equipment, devices, safety circuits and radiation
warning signs required, if any, at the Site in connection with the use and
operation of the Equipment, all in accordance with applicable federal, state and
local laws, rules, regulations or custom. The foregoing construction and
radiation safety products and services shall not be considered a Medical Center
Direct Operating Expenses but shall be considered as part of the Program for
valuation purposes.

 

6.3      Medical Center, at its cost, expense and risk, shall be responsible for
the installation of the Equipment at the Site, including the positioning of the
Equipment on its foundation at the Site in compliance with the Site Planning
Criteria. Notwithstanding any of the above, such cost and expense shall not
exceed *.

 

 

 

 

6.4      Medical Center warrants and ensures that upon completion of
preparation, construction, and improvement of the Site, and delivery of
Equipment, (a) the Site shall comply in all material respects with the Site
Planning Criteria and all applicable federal, state and local laws, rules and
regulations, and (b) with respect to those portions of the Site that are not
addressed by the Site Planning Criteria, the Site shall be safe and suitable for
the ongoing use and operation of the Equipment during the Term.

 

6.5      The parties shall use their reasonable efforts to satisfy their
obligations under this Section 6 in a timely manner. The parties shall keep each
other informed on a regular basis of the progress in the design of the Site, the
preparation of plans and specifications, the construction and improvement of the
Site, and the satisfaction of its other obligations under this Section 6. In all
events, all construction and improvement of the Site required for the
installation, positioning and testing of the Equipment shall be completed on or
prior to the delivery date described in Section 5.1 above. During the Term,
Medical Center, at its cost and expense, shall maintain the Site in a good
working order, condition and repair, reasonable wear and tear excepted.

 

6.6       Medical Center shall have accepted the Equipment when Medical Center’s
physicist has approved the Equipment in accordance with Elekta’s technical
specifications which have been provided to Medical Center. Medical Center’s
physicist shall use best efforts to reasonably approve the Equipment and the
Equipment shall be accepted prior to any Procedures.

 

7.            Marketing.

 

7.1       Not less than ninety (90) days prior to the First Procedure Date and
the commencement of each succeeding twelve (12) month period during the Term,
JGKE and Medical Center shall jointly develop an annual marketing plan, budget
and timeline for the clinical service to be supported by the Equipment for the
succeeding twelve (12) month period of the Term (the "Plan"), which Plan shall
be implemented by Medical Center based on the approved budget and timeline. The
Plan shall require the approval of both JGKE and Medical Center; however,
neither party’s approval of such Plan shall be unreasonably withheld or delayed.
If Medical Center has not approved or disapproved the same within thirty (30)
days following its receipt, Medical Center shall be deemed to have approved the
same. Funds expended by Medical Center in accordance with the Plan shall be
deemed "Medical Center’s Direct Operating Expenses," and shall be reimbursed
from the "Gross Technical Component Collections" (as such quoted term is defined
in Section 8 below); provided that (a) if the Gross Technical Component
Collections during any month are insufficient to cover Medical Center’s Direct
Operating Expenses, then such expenses shall be carried forward until reimbursed
from future Gross Technical Component Collections; and (b) Medical Center shall
make available upon request invoices (together with documentary evidence
supporting the invoices) for marketing expenditures paid to unrelated third
parties that are included in the Plan. The annual marketing budget will not
exceed * in the aggregate.

 

Medical Center shall use commercially reasonable efforts to promote the Program
and to encourage the use thereof by the public and medical community.

 

 

 

 

8.            Purchased Services Payments.

 

8.1          The parties acknowledge that the compensation payable to JGKE for
the Equipment as set forth in this Agreement has been established by the parties
pursuant to a fair market value appraisal by an independent, qualified appraisal
firm. Based thereon, the Parties believe that the Purchased Services Payments
represent fair market value for the use of the Equipment, and the other services
provided hereunder.

 

8.2          In consideration for and as compensation to JGKE for the use of the
Equipment by Medical Center pursuant to this Agreement, Medical Center shall pay
to JGKE, on a monthly basis, the applicable "Purchased Services Payments" (as
defined below) for each "Procedure" that is performed by Medical Center, whether
on an inpatient or outpatient basis, and irrespective of whether the Procedure
is performed on the Equipment or using any other equipment or devices. As used
herein:

 

(a)       "Purchased Services Payments" shall be equal to the percentage (%)
(set forth in Schedule 1 of this Agreement) of the "Net Technical Component
Collections" for the applicable period relating to each Procedure performed
using the Equipment and/or any other equipment or devices at the Site during the
Term of this Agreement.

 

(b)       "Net Technical Component Collections" shall mean the *.

 

(c)       "Gross Technical Component Collections" means the total amount
actually collected (less any uncontested returns or refunds) by Medical Center
during each month from any and all payor sources, including, without limitation,
patients, insurance companies, state or federal government programs or any other
third party payors, including, without limitation, all copayments and
deductibles, as reimbursement for the technical component of all services
(including, but not limited to, treatment planning and delivery) pertaining to
each Procedure performed on the Equipment and/or any other equipment or devices
during the term of this Agreement. Subject to all applicable legal requirements,
Medical Center agrees that it will utilize best efforts to maximize third party
reimbursement for the Gamma Knife program and revenues from the Gamma Knife
program; provided, however, JGKE acknowledges and agrees that Medical Center may
perform Procedures on patients who qualify under Medical Center’s guidelines for
free or reduced cost care regardless of such patients’ ability to pay.

 

(d)       "JGKE's Direct Operating Expenses" shall equal *.

 

 

 

 

(e)       "Medical Center's Direct Operating Expenses" shall be *.

 

(f)        "Procedure" means any treatment that involves stereotactic, external,
single fraction, conformal radiation, commonly called radiosurgery, that may
include one or more isocenters during the patient treatment session, delivered
to any site(s) superior to the foramen magnum.

 

8.3          Within twenty (20) days after the last day of each month (or
portion thereof) during the term of this Agreement, (a) Medical Center shall
inform JGKE in writing as to (i) the number of Procedures performed during that
month utilizing the Equipment (and, if applicable, any other equipment or
devices); and (ii) the Gross Technical Component Collections during that month;
and (b) each party shall inform the other party in writing as to such party's
respective Direct Operating Expenses relating to that month which shall be
determined in good faith in accordance with Generally Accepted Accounting
Principles ("GAAP") consistently applied and the terms of this Agreement.
Notwithstanding anything to the contrary contained in this Agreement, neither
party shall have the right to recover its Direct Operating Expenses that are
known (or reasonably should have been known) but are submitted more than six (6)
months after being incurred by such party. Medical Center certifies that all
claims submitted for reimbursement to the appropriate payors shall be in
accordance with its standard billing and collection policies and procedures
which provide that claims shall be submitted within twenty (20) days of (i) each
outpatient Procedure and (ii) discharge for each inpatient Procedure. If no
Gross Technical Component Collections are received during any month, then, no
Purchased Services Payments shall be owing by Medical Center to JGKE for that
month, subject however, to each party’s right to recover its respective Direct
Operating Expenses as set forth in Section 8.5 below.

 

8.4          During the Term of this Agreement, Medical Center shall, by the
twenty-fifth (25th) day of each month, remit JGKE’s aggregate Purchased Services
Payment, together with JGKE's Direct Operating Expenses, for the immediately
preceding month, and, for a period of twenty-five (25) months following the
termination or expiration of this Agreement (the "Collections Run-Out Period"),
Medical Center shall, by the twenty-fifth (25th) day of each such month,
continue to remit JGKE’s aggregate Purchased Services Payment pertaining to
Gross Technical Component Collections received during the Collections Run-Out
Period (which Purchased Services Payments during the Collections Run Out Period
shall be calculated without deduction for any Direct Operating Expenses, unless
such Direct Operating Expenses were carried forward from, and relate to, any
period prior to the termination or expiration of the Agreement). All or any
portion of any Purchased Services Payment and/or JGKE’s Direct Operating
Expenses which are not paid in full within forty-five (45) days after its due
date shall bear interest at the rate of one and one-half percent (1.50%) per
month (or the maximum monthly interest rate permitted to be charged by law
between an unrelated, commercial borrower and lender, if less) until the unpaid
Purchased Services Payment and/or JGKE’s Direct Operating Expenses, together
with all accrued interest thereon are paid in full. JGKE will accept payment
from Medical Center in the following forms: check and electronic funds transfer.
If JGKE shall at any time accept any Purchased Services Payment and/or JGKE’s
Direct Operating Expenses from Medical Center after it shall become due, such
acceptance shall not constitute or be construed as a waiver of any or all of
JGKE’s rights under this Agreement, including the rights of JGKE set forth in
Section 19 hereof.

 

 

 

 

8.5          Notwithstanding the foregoing, with respect to any month for which
Gross Technical Component Revenues are equal to or less than the sum of each
party's respective Direct Operating Expenses, such Gross Technical Component
Revenues shall be used to pay the pro rata portion of Medical Center's Direct
Operating Expenses and JGKE's Direct Operating Expenses (which portion shall be
equal to the proportion that each party's Direct Operating Expenses bears to the
whole). Any shortfall in the reimbursement of each party's Direct Operating
Expenses shall be carried over to the next month(s) and shall be paid in full
from Gross Technical Component Revenues prior to the payment of any Purchased
Services Payment to JGKE.

 

8.6           Within thirty (30) days after the close of each month, Medical
Center shall provide JGKE with a written report indicating the status of
billings and collections for each Procedure performed during that month using
the Equipment and/or any other equipment or devices, including, without
limitation, the amount of the claim submitted and the amount received for each
such Procedure provided, however, Medical Center shall not identify the patient
or payor.

 

8.7           Inspection of Records and Record Retention. Throughout the initial
Term and any successive terms, and thereafter until final settlement of all
amounts owed to or claimed by either party under this Agreement, each party, at
its own expense, shall have the right upon request and from time-to-time, not
more than once annually, to inspect, audit and copy the other party's books and
records which relate to the accounting for and calculation of Gross Technical
Component Revenues, Net Technical Component Revenues, and each party’s
respective Direct Operating Expenses; provided that any patient names or
identifiers shall not be disclosed. JGKE acknowledges that Medical Center's
managed care contracts may contain confidentiality provisions that prohibit
Medical Center from disclosing payment rates to JGKE. Accordingly, Medical
Center agrees to provide payment rates to JGKE’s designated auditing firm for
purposes of auditing and monitoring the Purchase Services Payments and other
obligations contemplated by the parties under this Agreement. JGKE’s designated
auditing firm shall agree to (i) only use the payment rate information in
connection with this Agreement, and (ii) disclose to JGKE the minimum amount
information regarding payment rates as necessary for JGKE to audit and monitor
the Purchased Services Payments and other obligations contemplated by the
parties under this Agreement; provided, however, JGKE's auditing firm shall in
no case share Medical Center's payment rates with JGKE.

 

8.8          Reimbursement Rate for Gamma Knife Procedures. Medical Center shall
use commercially reasonable efforts to renegotiate Medical Center's existing
managed care contracts to include coverage for stereotactic radiosurgery
services utilizing the Equipment to be provided through the Program and to
include in new managed care contracts provisions covering such services. It is
understood that certain Procedures may be performed on the Equipment for
research or charity purposes. The parties shall mutually agree in advance as to
the number of research procedures that will be performed.

 

8.9          Survival. The provisions of this Section 8 shall survive the
termination or expiration of this Agreement.

 

 

 

 

8.10          Stark Law Compliance. The parties agree and acknowledge that
pursuant to the federal Stark Law, in the event any physician(s) (or immediate
family member) has a direct or indirect ownership or investment interest in JGKE
at any time during the term of this Agreement, such physician-owner(s) shall not
"refer" to Medical Center for any "designated health services," including but
not limited to laboratory, radiology, radiation therapy, and
inpatient/outpatient hospital services, and shall not direct any other physician
to make a "referral" to Medical Center, and shall not control the "referrals" of
any other physician to Medical Center. The parties further agree that for
purposes of the Stark Law, the term "referral" does not include a request by a
radiation oncologist for radiation therapy or ancillary services necessary for,
and integral to, the provision of radiation therapy, if the request results from
a "consultation" initiated by another physician; and (ii) the tests or services
are furnished by or under the supervision of radiation oncologist or another
radiation oncologist in the same group practice. A "consultation" means a
professional service furnished to a patient by a physician if the following
conditions are satisfied: (i) the physician's opinion or advice regarding
evaluation or management or both of a specific medical problem is requested by
another physician; (ii) the request and need for the consultation are documented
in the patient's medical record; and (iii) after the consultation is provided,
the physician prepares a written report of his or her findings, which is
provided to the physician who requested the consultation. With respect to
radiation therapy services provided by a radiation oncologist, a course of
radiation treatments over a period of time will be considered to be pursuant to
a consultation, provided that the radiation oncologist communicates with the
referring physician on a regular basis about the patient's course of treatment
and progress. On or before the Effective Date of this Agreement, JGKE shall
cause each physician (or immediate family member) with a direct or indirect
ownership or investment interest in JGKE to execute the Physician
Acknowledgement attached hereto as Attachment 1 and incorporated herein.

 

9.           Use of the Equipment.

 

9.1          The Equipment shall be used by Medical Center only at the Site and
shall not be removed therefrom. Medical Center shall use the Equipment only in
the regular and ordinary course of Medical Center’s business operations and only
within the capacity of the Equipment as determined by Elekta’s specifications,
unless otherwise authorized in writing by JGKE and Elekta. Medical Center shall
not use or permit the Equipment to be used in any manner or for any purpose
which, the Equipment is not designed or reasonably suitable, unless otherwise
authorized in writing by JGKE and Elekta.

 

9.2          Notwithstanding anything to the contrary contained in this
Agreement, this is an agreement of purchasing the Service only. JGKE shall only
offer to Medical Center the Service pursuant to the terms and conditions of this
Agreement. Nothing herein shall be construed as conveying to Medical Center any
right, title or interest in or to the Equipment, except for the express right to
use the Equipment granted herein to Medical Center during the Term. All
Equipment shall remain personal property (even though said Equipment may
hereafter become attached or affixed to real property) and the title thereto
shall at all times remain exclusively in JGKE.

 

 

 

 

9.3          During the Term, upon the request of JGKE, Medical Center shall
promptly affix to the Equipment an identifying label supplied by JGKE indicating
JGKE’s ownership of the Equipment, and shall keep the same affixed for the
entire Term. Medical Center hereby authorizes JGKE to cause this Agreement or
any statement or other instrument showing the interest of JGKE in the Equipment
to be filed or recorded, or refiled or re-recorded, with all governmental
agencies considered appropriate by JGKE. Medical Center also shall promptly
execute and deliver, or cause to be executed and delivered, to JGKE any
statement or instrument reasonably requested by JGKE for the purpose of
evidencing JGKE’s interest in the Equipment, including UCC financing statements
and other relevant statements and waivers with respect to rights in the
Equipment from any owners or mortgagees of any real estate where the Equipment
may be located.

 

9.4          At Medical Center's cost and expense, Medical Center shall use
commercially reasonable efforts to (a) protect and defend JGKE’s ownership of
and title to the Equipment from and against all persons claiming against or
through Medical Center, (b) at all times keep the Equipment free from any and
all liens, encumbrances, attachments, levies, executions, burdens, charges or
legal processes imposed against Medical Center, and (c) give JGKE written notice
of any matter described in this clause within five (5) business days of Medical
Center’s knowledge thereof, and (d) in the manner described in Section 21 below
indemnify JGKE harmless from and against any loss, cost or expense (including
reasonable attorneys’ fees) with respect to any of the foregoing.

 

10.          Additional Covenants of Medical Center. In addition to the other
covenants of Medical Center contained in this Agreement, Medical Center shall,
at its cost and expense:

 

10.1          Provide properly trained professional, technical and support
personnel and supplies required for the proper performance of Gamma Knife
procedures utilizing the Equipment. In this regard, Medical Center shall make
reasonable efforts to maintain on staff a minimum of two (2) Gamma Knife trained
teams comprised of neurosurgeons, radiation oncologists and physicists. The
Gamma Knife shall be available for use by all credentialed neurosurgeons,
radiation oncologists and physicists.

 

10.2          Direct, supervise and administer the provision of all services
relating to the performance of Procedures utilizing the Equipment in accordance
with all applicable laws, rules and regulations.

 

10.3          Keep and maintain the Equipment and the Site secure and free from
unauthorized access or use by any person to the extent that Medical Center
provides security for its other radiation oncology services.

 

10.4          Operate a radiation therapy department at the Site. JGKE
acknowledges that the Equipment will be located on the same campus as the
radiation therapy department, in a different but physically connected building.

 

 

 

 

11.          Additional Covenants of JGKE. In addition to the other covenants of
JGKE contained in this Agreement, JGKE, at its cost and expense, shall:

 

11.1          Use its best efforts to require Elekta to meets its contractual
obligations to JGKE and Medical Center upon delivery of the Equipment and put
the Equipment, as soon as reasonably possible, into good, safe and serviceable
condition and fit for its intended use in accordance with the manufacturer’s
specifications, guidelines and field modification instructions.

 

11.2          Cause Medical Center to enjoy the use of the Equipment, free of
the rights of any other persons except for those rights reserved by JGKE or
granted to Elekta under the LGK Agreement.

 

11.3          Cover the tuition costs for up to ten (10) Perfexion training
slots for physicians and physicists who will be using the Equipment. In
accordance with Medical Center’s policies, copies of which have been provided to
JGKE, all documented and incurred expenses for travel, lodging, and meals
associated with training course attendance shall be a JGKE Direct Operating
Expense as defined in this Agreement.

 

11.4          To the extent reasonably requested by Medical Center, JGKE agrees
to use best efforts to exercise JGKE’s rights to the warranty provided by Elekta
to JGKE and attached hereto as Attachment 2.

 

12.          Maintenance of Equipment; Damage or Destruction of Equipment.

 

12.1        During the Term and except as otherwise provided in this Agreement,
JGKE, shall (a) maintain the Equipment in good operating condition and repair,
reasonable wear and tear excepted. Medical Center shall promptly notify JGKE in
the event of any damage or destruction to the Equipment or of any required
maintenance or repairs to the Equipment, regardless of whether such repairs or
maintenance are covered or not covered by the Service Agreement. JGKE will work
with Medical Center in selecting a Service Agreement which shall be entered into
by and between JGKE and the service provider and shall be a JGKE Direct
Operating Expense as defined in this Agreement; provided, however, such JGKE
Direct Operating Expense shall be offset by any reduction in price offered by
Elekta to JGKE by virtue of Elekta's non-compliance with its uptime guarantee as
set forth in more detail in Section 12.6 hereof.

 

12.2       To the extent that JGKE is provided with software updates and
upgrades at no additional charge, then JGKE shall ensure that such equipment
software updates and upgrades will be provided at no additional cost to Medical
Center. Otherwise, Medical Center and JGKE shall mutually agree in writing to
the updates and upgrades, and such updates and upgrades shall be paid pro-rata
by the parties as set forth on Schedule 1 and shall not be considered either a
JGKE or Medical Center Direct Operating Expenses. JGKE and Elekta shall have the
right to reasonably access the Equipment for the purpose of inspection and the
performance of repairs at all reasonable times, upon reasonable advance notice
and with a minimum of interference or disruptions to Medical Center’s regular
business operations.

 

 

 

 

12.3       JGKE shall promptly provide Medical Center with a copy of all
communications from the Elekta or the FDA advising of a recall, request for a
recall, market withdrawal, safety alert, or an issue of Equipment availability.
JGKE shall provide Medical Center with written notice of any Class I recall,
whether voluntary or initiated by the FDA, affecting any of the Equipment within
twenty-four (24) hours of Elekta’s or JGKE's receipt of any such request for a
recall, or shorter period of time provided in the recall strategy.

 

12.4       Medical Center shall be liable for, and in the manner described in
Section 21 below shall indemnify JGKE from and against, any damage to or
destruction of the Equipment caused by the intentional and wrongful or negligent
acts or omissions of Medical Center’s officers, employees, agents, or
contractors. In the event the Equipment is damaged as a result of the
intentional and wrongful or negligent acts or omissions of Medical Center’s
officers, employees, agents, or contractors, to the extent such damage is not
covered by warranties or insurance, JGKE may service or repair the Equipment as
needed and the cost thereof shall be paid by Medical Center to JGKE within
thirty (30) day of written request. In the event that the costs are not paid to
JGKE within thirty (30) days, Medical Center shall pay interest thereon at the
rate of one percent (1%) per month (or the maximum monthly interest rate
permitted to be charged by law between an unrelated, commercial borrower and
lender, if less) and reasonable attorneys’ fees and costs incurred by JGKE in
collecting such amount from Medical Center. Any work so performed by JGKE shall
not deprive JGKE of any of its rights, remedies or actions against Medical
Center for such damages.

 

12.5       If the Equipment is rendered unusable as a result of any physical
damage to or destruction of the Equipment, Medical Center shall give JGKE
written notice thereof. JGKE shall use best efforts to determine, within fifteen
(15) days after it is given written notice of such damage or destruction,
whether the Equipment can be repaired provided, however, if JGKE cannot
determine whether the Equipment can be repaired within fifteen (15) days, then
JGKE shall have such additional time as may be reasonable and necessary for such
determination provided, however, JGKE shall provide Medical Center with weekly
status reports. In the event JGKE determines that the Equipment cannot be
repaired (a) subject to Section 12.4 above, JGKE, at its cost and expense, shall
replace the Equipment as soon as reasonably possible taking into account the
availability of replacement equipment from Elekta, Elekta’s other existing
orders for equipment, and the then existing limitations on Elekta’s
manufacturing capabilities, (b) the Term of this Agreement shall be extended for
the period of time the Equipment is unusable, and (c) this Agreement shall
continue in full force and effect as though such damage or destruction had not
occurred. In the event JGKE determines that the Equipment can be repaired, JGKE
shall cause the Equipment to be repaired as soon as reasonably possible
thereafter. Medical Center shall fully cooperate with JGKE to effect the
replacement of the Equipment or the repair of the Equipment (including, without
limitation, providing full access to the Site) following the damage or
destruction thereof.

 

 

 

 

12.6        To the extent reasonably requested by Medical Center, JGKE agrees to
use best efforts to exercise JGKE’s rights to the uptime guarantee provided by
Elekta to JGKE, a copy of which shall be provided to Medical Center upon
request.

 

13.          Alterations and Upgrades to Equipment.

 

13.1          Medical Center shall not make any modifications, alterations or
additions to the Equipment (other than normal operating accessories or controls)
without the prior written consent of JGKE. Medical Center shall not, and shall
not permit any person other than representatives of Elekta or any other person
authorized by JGKE to, effect any inspection, adjustment, preventative or
remedial maintenance, or repair to the Equipment without the prior written
consent of JGKE. All modifications, alterations, additions, accessories or
operating controls incorporated in or affixed to the Equipment (herein
collectively called "additions" and included in the definition of "Equipment")
shall become the property of the JGKE upon termination of this Agreement.

 

13.2          The necessity and financial responsibility for modifications,
additions or upgrades to the Equipment, including the reloading of the Cobalt-60
source, shall be mutually agreed upon by JGKE and Medical Center in advance. If
(a) JGKE and Medical Center agree to reload the Cobalt-60 source (i.e., on or
around the 72th month of the Term), then, notwithstanding any provisions to the
contrary herein, the initial Term shall be automatically extended for an
additional two (2) years. The necessity for modifications, additions or upgrades
to the Equipment, including the reloading of the Cobalt-60 source, shall be as
mutually agreed upon by JGKE and Medical Center, and the financial
responsibility for such modifications, additions and upgrades (excluding
repairs, which pursuant to Section 12.1 and subject to Section 12.5, are JGKE’s
and Medical Center’s responsibility, respectively) shall be paid either (i)
pro-rata by the parties as set forth on Schedule 1 and shall not be considered
either JGKE or Medical Center Direct Operating Expenses, or (ii) shall be paid
by JGKE provided that a mutually agreeable valuation firm with substantial
experience in health care valuations shall assess JGKE’s modifications,
additions or upgrades and shall determine whether the Purchased Services
Payments need to be adjusted to ensure that Purchased Services Payments for the
products and services provided by each party continues to be commensurate with
their fair market value, provided the Purchased Services Payments shall not be
adjusted more than annually.

 

14.          Financing of Equipment by JGKE. JGKE, in its sole discretion, may
finance the Equipment. Financing may be in the form of an installment loan, a
capitalized lease or other commercially available debt or financing instrument.
If JGKE finances the Equipment through an installment loan, JGKE shall be
required to provide the Equipment as collateral for the loan. If JGKE finances
the Equipment through a capitalized lease, title shall vest with the lessor
until such time as JGKE exercises its buy-out option under the lease, if any. If
required by the lender, lessor or other financing entity (the "Lender"), JGKE
may assign its interest under this Agreement as security for the financing.
Medical Center’s interest under this Agreement shall be subordinate to the
interests of the Lender.

 

 

 

 

15.          Taxes. JGKE shall pay all sales or use taxes imposed or assessed in
connection with the use or purchase of the Equipment and all personal property
taxes imposed, levied or assessed on the ownership and possession of the
Equipment during the Term. Unless Medical Center provides JGKE with a tax
exemption certificate, all other taxes, assessments, licenses or other charges
imposed, levied or assessed on the Equipment during the Term for which Medical
Center is not expressly exempt, shall be paid by Medical Center before the same
shall become delinquent, whether such taxes are assessed or would ordinarily be
assessed against JGKE or Medical Center; provided, however, Medical Center shall
not be required to pay any federal, state or local income, franchise,
corporation or excise taxes imposed upon JGKE's net income realized from the
Purchased Services Payments of the Equipment.

 

16.          No Warranties by Medical Center and JGKE. Medical Center warrants
that as of the First Procedure Date, it shall have (a) thoroughly inspected the
Equipment to the best of their knowledge, (b) determined that to the best of its
knowledge the Equipment is consistent with the size, design, capacity and
manufacture selected by it, and (c) satisfied itself that to the best of its
knowledge the Equipment is suitable for Medical Center intended purposes and is
good working order, condition and repair. JGKE represents and warrants that it
has and shall continue to have for the term of this Agreement, good title to the
Equipment delivered to Medical Center without violating the property rights or
interests of any third party inclusive of the intellectual property contained
therein. JGKE will work with Medical Center in good faith to remedy any problems
identified in writing by Medical Center during Medical Center's inspection. JGKE
SUPPLIES THE EQUIPMENT UNDER THIS AGREEMENT IN ITS "AS IS" CONDITION. JGKE, NOT
BEING THE MANUFACTURER OF THE EQUIPMENT OR THE MANUFACTURER’S AGENT, MAKES NO
WARRANTY OR REPRESENTATION, EITHER EXPRESSED OR IMPLIED, AS TO THE EQUIPMENT’S
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR USE, DESIGN, CONDITION,
DURABILITY, CAPACITY, MATERIAL OR WORKMANSHIP OR AS TO PATENT INFRINGEMENT OR
THE LIKE. Notwithstanding the foregoing, JGKE shall (i) to the extent reasonably
requested by Medical Center, use best efforts to exercise JGKE’s rights to the
warranty provided by Elekta to JGKE and attached hereto as Attachment 1, and
(ii) use its best efforts to ensure that all benefits under the manufacturer’s
warranty shall run to the Medical Center. JGKE shall not be liable for any
direct, indirect and consequential losses or damages suffered by Medical Center
or by any other person, and Medical Center expressly waives any right to hold
JGKE liable hereunder for, any claims, demands and liabilities arising out of or
in connection with the design, manufacture, possession or operation of the
Equipment, including, without limitation, injury to persons or property
resulting from the failure of, defective or faulty design, operation, condition,
suitability or use of the Equipment. All warranty or other similar claims with
respect to the Equipment shall be made by Medical Center solely and exclusively
against Elekta and any other manufacturers or suppliers, but shall in no event
be asserted against JGKE. In this regard and with prior written approval of
JGKE, Medical Center may, in JGKE’s name, but at Medical Center’s sole cost and
expense, enforce all warranties, agreements or representations, if any, which
may have been made by Elekta or manufacturers, suppliers or other third parties
regarding the Equipment to JGKE or Medical Center.

 

 

 

 

17.        Termination for Economic Justification. If, following the initial
twenty four (24) months after the First Procedure Date and following each
subsequent twelve (12) month period thereafter during the Term, based upon the
utilization of the Equipment and other factors considered relevant by JGKE in
the exercise of its reasonable discretion, within a reasonable period of time
after JGKE’s written request, Medical Center does not provide JGKE with a
reasonable economic justification to continue this Agreement and the utilization
of the Equipment at the Medical Center, then and in that event, JGKE shall have
the option to terminate this Agreement by giving a written notice thereof to
Medical Center not less than ninety (90) days prior to the effective date of the
termination designated in JGKE’s written notice. Without limiting the generality
of the foregoing, for purposes of this Section, "reasonable economic
justification to continue this Agreement" shall not be deemed to exist (and JGKE
shall have the option to terminate this Agreement) if, during the twelve (12)
month period immediately preceding the issuance of JGKE’s written notice of
termination, the "Net Cash Flow" is negative. As used herein, "Net Cash Flow"
shall mean, for the applicable period, (a) the aggregate Purchased Services
Payments actually received by JGKE during such period, minus the sum of the
aggregate debt service on the Equipment during such period. In the event of such
termination, Medical Center shall have no further obligation hereunder, except
for obligations accruing and becoming payable prior to the date of termination.

 

18.         Options to Extend Agreement. As of the end of the Term, Medical
Center shall have the option to:

 

18.1          Extend the Term of this Agreement for a specified period of time
and upon such other terms and conditions as may be agreed upon by JGKE and
Medical Center;

 

18.2          Purchase the Equipment from JGKE or to assume JGKE’s rights under
any lease of the Equipment upon expiration of the Term, provided, however, the
price, terms and conditions of the purchase or assumption shall be negotiated as
an arms-length transaction; or

 

18.3          Terminate this Agreement as of the expiration of the Term. Upon
the expiration of the Term and within a reasonable time thereafter, JGKE, at its
cost and expense, may enter upon the Site under Medical Center supervision and
remove the Equipment.

 

18.4          Medical Center shall exercise one (1) of the three (3) options
referred to above by giving an irrevocable written notice thereof to JGKE at
least one hundred eighty (180) days prior to the expiration of the initial Term.
Any such notice shall be sufficient if it states in substance that Medical
Center elects to exercise its option and states which of the three (3) options
referred to above Medical Center is exercising. If Medical Center fails to
exercise the option granted herein at least one hundred eighty (180) days prior
to the expiration of the initial Term, the option shall lapse and this Agreement
shall expire as of the end of the initial Term. Further, if Medical Center
exercises either option specified in Sections 18.1 or 18.2 above and the parties
are unable to mutually agree upon the price, terms or conditions applicable to
such option prior to the expiration of the Term, this Agreement shall expire as
of the end of the initial Term.

 

 

 

 

19.          Events of Default and Remedies.

 

19.1        Medical Center Event of Default. The occurrence of any one of the
following shall constitute a Medical Center event of default under this
Agreement (a "Medical Center Event of Default"):

 

19.1.1          Medical Center fails to pay any Purchased Services Payment when
due pursuant to Paragraph 8 above and such failure continues for a period of
thirty (30) days after written notice thereof is given by JGKE or its assignee
to Medical Center; however, if Medical Center cures the Purchased Services
Payment default within the applicable thirty (30) day period, such default shall
not constitute an Event of Default.

 

19.1.2          Medical Center attempts to remove, sell, transfer, encumber,
assign, sublet or part with possession of the Equipment or any items thereof,
except as expressly permitted herein or as otherwise authorized by JGKE in
writing.

 

19.1.3          Medical Center fails to observe or perform any of its covenants,
duties or obligations arising under this Agreement or the LGK Agreement and such
failure continues for a period of thirty (30) days after written notice thereof
by JGKE to Medical Center; however, if Medical Center cures the default within
the applicable thirty (30) day period or if the default reasonably requires more
than thirty (30) days to cure, Medical Center commences to cure the default
during the initial thirty (30) day period and Medical Center diligently
completes the cure within sixty (60) days following the end of the thirty (30)
day period, such default shall not constitute a Medical Center Event of Default;
provided that the foregoing cure periods shall not apply to a Medical Center
Event of Default under Subsections 19.1.1 or 19.1.2.

 

19.1.4          Medical Center ceases doing business, makes an assignment for
the benefit of creditors, admits in writing its inability to pay its debts as
they become due, files a voluntary petition in bankruptcy, is adjudicated
bankrupt or insolvent, files a petition seeking for itself any reorganization,
arrangement, composition, readjustment, liquidation, dissolution or similar
arrangement under any present or future statute, law or regulation or files an
answer admitting the material allegations of a petition filed against it in any
such proceeding, consents to or acquiesces in the appointment of a trustee,
receiver, or liquidator of it or of all or any substantial part of its assets or
properties, or it or its shareholders shall take any action looking to its
dissolution or liquidation.

 

19.1.5          Medical Center is suspended or terminated from participation in
the Medicare program.

 

 

 

 

19.2         JGKE Event of Default. The occurrence of any one of the following
shall constitute a JGKE event of default under this Agreement (a "JGKE Event of
Default"):

 

19.2.1         JGKE causes Medical Center’s quiet enjoyment and use of the
Equipment pursuant to this Agreement to be materially interfered with (other
than by reason of a Medical Center Event of Default or in connection with
servicing, maintenance or repairs as contemplated in this Agreement), and JGKE
fails to cure such default within thirty (30) days after written notice thereof
is given by Medical Center or its assignee to JGKE; however, if JGKE cures such
default within the applicable thirty (30) day period, such default shall not
constitute an JGKE Event of Default.

 

19.2.2         JGKE fails to pay or reimburse Medical Center for any monies
payable by JGKE to Medical Center pursuant to this Agreement and such failure
continues for a period of thirty (30) days after written notice thereof is given
by Medical Center or its assignee to JGKE; however, if JGKE cures the default
within the applicable thirty (30) day period, such default shall not constitute
a JGKE Event of Default.

 

19.2.3         JGKE fails to observe or perform any of its covenants, duties or
obligations arising under this Agreement and such failure continues for a period
of thirty (30) days after written notice thereof by Medical Center to JGKE;
however, if JGKE cures the default within the applicable thirty (30) day period
or if the default reasonably requires more than thirty (30) days to cure, JGKE
commences to cure the default during the initial thirty (30) day period and JGKE
diligently completes the cure within sixty (60) days following the end of the
thirty (30) day period, such default shall not constitute a JGKE Event of
Default; provided that the foregoing cure periods shall not apply to a JGKE
Event of Default under Subsections 19.2.1 or 19.2.2.

 

19.2.4         JGKE ceases doing business, makes an assignment for the benefit
of creditors, admits in writing its inability to pay its debts as they become
due, files a voluntary petition in bankruptcy, is adjudicated a bankrupt or
insolvent, files a petition seeking for itself any reorganization, arrangement,
composition, readjustment, liquidation, dissolution or similar arrangement under
any present or future statute, law or regulation or files an answer admitting
the material allegations of a petition filed against it in any such proceeding,
consents to or acquiesces in the appointment of a trustee, receiver, or
liquidator of it or of all or any substantial part of its assets or properties,
or it or its shareholders shall take any action looking to its dissolution or
liquidation.

 

19.2.5         JGKE is suspended or terminated from participation in the
Medicare program or any other federal or state health care program.

 

19.3        Upon the occurrence of a Medical Center Event of Default or a JGKE
Event of Default, the non-breaching party may at its option do any or all of the
following:

 

 

 

 

19.3.1         By written notice to JGKE, Medical Center may at its option
immediately terminate this Agreement as to the Equipment, wherever situated, but
only upon the occurrence of a JGKE Event of Default under Subsections 19.2.1 or
19.2.2. As a result of such termination, Medical Center may, at its option and
upon written notice to JGKE, demand that JGKE immediately enter upon the Site
and remove the Equipment at JGKE’s sole cost and expense. For the avoidance of
doubt, Medical Center shall not have the right to terminate this Agreement by
reason of a JGKE Event of Default, other than due to the occurrence of a JGKE
Event of Default under Subsections 19.2.1 and/or 19.2.2.

 

19.3.2         By written notice to Medical Center, JGKE may at its option
immediately terminate this Agreement as to the Equipment, wherever situated, but
only upon the occurrence of any of the Medical Center Events of Default as set
forth in Subsections 19.1.1 and 19.1.2, 19.1.5 and/or noncompliance with
Sections 10.1 and/or 10.4 above (which noncompliance has not been cured within
the periods set forth in Section 19.1.3 above) (collectively, the “Termination
Defaults”). For the avoidance of doubt, but without limiting JGKE’s rights under
Section 17 above (Termination for Economic Justification), JGKE shall not have
the right to terminate this Agreement by reason of a Medical Center Event of
Default, other than due to the occurrence of any Termination Default. As a
result of such termination pursuant to any Termination Default, JGKE may (a)
provide reasonable notice to Medical Center of its intention to remove the
Equipment, and upon such date as provided by notice, JGKE may then enter upon
the Site and remove the Equipment in a manner and at a time that causes the
least amount of disruption to patient care, or, at Medical Center’s election,
Medical Center shall remove and return the Equipment to JGKE, but in either
event at Medical Center’s sole cost and expense; and (b) may exercise any other
rights pursuant to this Agreement or permitted by law, equity or otherwise.

 

19.3.3         With respect to all other Medical Center Events of Default, JGKE
may:

 

A.              Sell, dispose of, hold, use or lease the Equipment (other than
on the premises of the Medical Center), as JGKE in its sole and absolute
discretion may determine (and JGKE shall not be obligated to give preference to
the sale, lease or other disposition of the Equipment over the sale, lease or
other disposition of similar Equipment owned or leased by JGKE).

 

B.              Exercise any other right or remedy which may be available to
JGKE under the Uniform Commercial Code or any other applicable law or proceed by
appropriate court action, without affecting JGKE’s title or right to possession
of the Equipment, to enforce the terms hereof or to recover damages for the
breach hereof or to cancel this Agreement as to the Equipment.

 

 

 

 

19.3.4         Upon termination of this Agreement or the exercise of any other
rights or remedies under this Agreement or available under applicable law
following a Medical Center Event of Default, Medical Center shall, without
further request or demand, pay to JGKE all Purchased Services Payments and other
sums owing under this Agreement. However, Medical Center acknowledges that JGKE
shall have no obligation to sell the Equipment. Medical Center shall in any
event remain fully liable for all damages as may be provided by law and for all
costs and expenses incurred by JGKE on account of such default, including but
not limited to, all court costs and reasonable attorneys’ fees.

 

19.3.5         Subject to Section 17 above, each party shall in any event remain
fully liable to the other non-defaulting party for all damages as may be
provided by law and for all costs and expenses incurred by the non-defaulting
party on account of such default, including but not limited to, all court costs
and reasonable attorneys’ fees.

 

19.3.6         Subject to Sections 19.3.1 and 19.3.2 above (regarding
limitations on the right to terminate this Agreement), the rights and remedies
afforded a non-defaulting party under this Agreement shall be deemed cumulative
and not exclusive, and shall be in addition to any other rights or remedies
available to the non-defaulting party provided by law or in equity.

 

20.          Insurance.

 

20.1         During the Term and during the construction of the Site and prior
to the First Procedure Date, JGKE shall, at its cost and expense, purchase and
maintain in effect an all risk property and casualty insurance policy covering
the Equipment and general liability and professional liability insurance
coverage/policies covering JGKE and its officers, directors, agents, employees,
or contractors. The general liability and professional liability insurance
policies shall provide coverage in amounts not less than One Million Dollars
($1,000,000.00) per occurrence and Five Million Dollars ($5,000,000.00) annual
aggregate. The all risk property and casualty insurance policy shall be for an
amount not less than the replacement cost of the Equipment. Medical Center shall
be named as an additional insured party on the all risk property and casualty
insurance policy to the extent of its interest in the Equipment arising under
this Agreement and under the general liability insurance coverage/policy to be
maintained by hereunder by JGKE. The coverage/policies to be maintained by JGKE
hereunder shall be evidenced by a certificate of insurance or other reasonable
documentation which shall be delivered by JGKE to Medical Center upon request
following the commencement of this Agreement and as of each annual renewal of
such policy during the Term.

 

20.2          During the Term, Medical Center shall, at its cost and expense,
purchase, and maintain in effect general liability and professional liability
insurance coverage/policies covering the Medical Center and the use or operation
of the Equipment by Medical Center or its officers, directors, agents,
employees, or contractors. The general liability and professional liability
insurance policies shall provide coverage in amounts not less than One Million
Dollars ($1,000,000.00) per occurrence and Five Million Dollars ($5,000,000.00)
annual aggregate. JGKE shall be named as additional insured party on the general
liability insurance coverage/policies to be maintained hereunder by Medical
Center. The coverage/policies to be maintained by Medical Center hereunder shall
be evidenced by a certificate of insurance or other reasonable documentation
which shall be delivered by Medical Center upon request to JGKE no later than
the First Procedure Date and as of each annual renewal of such policies during
the Term. Medical Center shall require any physicians using the Equipment to
show evidence of professional liability insurance consistent with Medical
Center’s Medical Staff Bylaws.

 

 

 

 

20.3          During the construction of the Site and prior to the First
Procedure Date, Medical Center, at its cost and expense, shall purchase, and
maintain a general liability insurance policy which conforms with the coverage
amounts and other requirements described in Section 20.2 above and which names
JGKE as an additional insured party. The policy to be maintained by Medical
Center hereunder shall be evidenced by a certificate of insurance or other
reasonable documentation which shall be delivered by Medical Center to JGKE
prior to the commencement of any construction at the Site.

 

20.4          During the Term, Medical Center and JGKE shall purchase and
maintain all workers compensation insurance to the maximum extent required by
applicable law.

 

20.5          Medical Center may maintain any insurance policies or coverage
required of it by this Agreement through a self-insurance program.

 

21.          Indemnification.

 

21.1          Medical Center shall be liable for and shall indemnify, defend,
protect and hold JGKE and its members, managers, officers, employees, agents and
contractors (collectively "JGKE") harmless from and against all losses, claims,
damages, liabilities, assessments, deficiencies, actions, proceedings, orders,
judgments, liens, costs and other expenses (including reasonable attorney’s
fees) of any nature or kind whatsoever asserted against or incurred by JGKE
(collectively "Damages") which in any manner arise out of or relate to (a) the
failure by Medical Center to fully perform, observe or satisfy its covenants,
duties or obligations contained in this Agreement or in the LGK Agreement; (b)
negligent, intentional or wrongful acts or omissions by Medical Center or any of
its officers, directors, agents, contractors (or their subcontractors), or
employees in connection with the use and operation of the Equipment during the
Term; (c) Damages to the Equipment caused by the negligent or wrongful acts or
omissions of Medical Center, its agents, officers, employees or contractors (if
the Equipment is destroyed or rendered unusable, subject to Section 21.7 below,
this indemnity shall extend up to (but not exceed) the full replacement value of
the Equipment at the time of its destruction less salvage value, if any); or (d)
the events or occurrences described in Article 7.3 of the LGK Agreement to the
same extent that Medical Center agrees to indemnify Elekta thereunder (other
than with respect to the failure of the Site to comply with the Site Planning
Criteria or defective maintenance of the Equipment under the Service Agreement).

 

 

 

 

21.2          JGKE shall be liable for and shall indemnify, defend, protect and
hold Medical Center and its directors, members, managers, officers, employees,
agents and contractors (collectively "Medical Center") harmless from and against
all losses, claims, damages, liabilities, assessments, deficiencies, actions,
proceedings, orders, judgments, liens, costs and other expenses (including
reasonable attorney’s fees) of any nature or kind whatsoever asserted against or
incurred by Medical Center (collectively "Damages") which in any manner arise
out of or relate to (a) the failure by JGKE to fully perform, observe or satisfy
its covenants, duties or obligations contained in this Agreement; (b) negligent,
intentional or wrongful acts or omissions by JGKE or any of its officers,
directors, agents, contractors (or their subcontractors), or employees in
connection with the installation, or removal of the Equipment, (c) the failure
by JGKE to maintain the Equipment as provided in this Agreement; and (d) any
other matters for which JGKE has specifically agreed to indemnify Medical Center
pursuant to this Agreement.

 

21.3          Upon the occurrence of an event for which JGKE or Medical Center
is entitled to indemnification under this Agreement ("Indemnitee"), such party
shall give written notice thereof to the other party setting forth the type and
amount of Damages. If the indemnity relates to a Third Party Claim (as defined
in Section 21.4 below), the matter shall be subject to Section 21.4 below. If
the indemnity relates to any Damages other than a Third Party Claim, not more
than thirty (30) days after written notice is given, the indemnifying party
shall acknowledge its obligation in writing to the Indemnitee to indemnify
hereunder and pay the Damages in full to the Indemnitee.

 

21.4          JGKE or Medical Center, as Indemnitee, shall give written notice
to the other party as Indemnitor as soon as reasonably possible after the
Indemnitee has knowledge of any third party claim or legal proceedings ("Third
Party Claim") for which the Indemnitee is entitled to indemnification under this
Section 21. Indemnitor shall (a) immediately assume, at its sole cost and
expense, the defense of the Third Party Claim with legal counsel approved by the
Indemnitee (which approval will not be unreasonably withheld, delayed or
conditioned), and (b) as soon as reasonably possible after Indemnitee’s written
notice is given to the Indemnitor, acknowledge in writing to Indemnitee its
obligation to indemnify Indemnitee in accordance with the terms of this
Agreement. If either party as the Indemnitor fails to assume the defense of a
Third Party Claim or fails to timely acknowledge in writing its obligation to
indemnify the Indemnitee, then, the Indemnitee may assume the defense of the
Third Party Claim in the manner described in Section 21.5 below. Each party
shall cooperate with the other in the defense of any Third Party Claim. Any
settlement or compromise of a Third Party Claim to which either party is a party
shall be subject to the express written approval of the other party, which
approval shall not be unreasonably withheld, delayed or conditioned as long as
an unconditional term of the settlement or compromise is the full and absolute
release of the Indemnitee from all Damages arising out of the Third Party Claim.
Either party as Indemnitee, at its own cost and expense, may participate on its
own behalf with legal counsel of its own selection in the defense of any Third
Party Claim which may have a material impact on it.

 

21.5          If either party having the obligation as Indemnitor fails to
promptly assume the defense of any Third Party Claim, the Indemnitee may assume
the defense of the Third Party Claim with legal counsel selected by the
Indemnitee, all at the Indemnitor’s cost and expense. The defense of an action
by an Indemnitee under this Section 21.5 shall not impair, limit or otherwise
restrict Indemnitor’s indemnification obligations arising under this Section 21
or Indemnitee’s right to enforce such obligations.

 

 

 

 

21.6          The indemnity obligations under this Section 21 shall expire on
the expiration of the applicable statute of limitations relating to the
underlying claim that is the subject of the indemnification claim. Any
indemnification obligation shall be in proportion to the amount of
responsibility found attributable to the Indemnitor.

 

21.7          The indemnification obligations set forth in this Agreement are
intended to supplement, and not supersede, supplant or replace, any coverage for
Damages which may be available under any insurance policies that may be
maintained by JGKE or Medical Center. In the event any Damages may be covered by
insurance policies, the parties shall exercise good faith and use their best
efforts to obtain the benefits of and apply the available insurance coverage to
the Damages subject to indemnification under this Agreement. In the event that
an insurer provides coverage under an insurance policy on the basis of a
"reservation of rights," the indemnification obligations under this Agreement
shall apply to all Damages which are finally determined as not being covered
under the insurance policy.

 

21.8          JGKE acknowledges Medical Center’s obligations to comply with
certain laws and regulations as well as the need for JGKE’s employees, agents,
and contractors to comply with reasonable requests, standard rules, and
regulations of Medical Center regarding personal and professional conduct,
including the use of an identification badge or personal protective equipment
and the adherence to health care facility laws or regulations, including in some
instances, criminal background checks, credit checks, health screening,
vaccinations and testing, and general safety practices or procedures, generally
applicable to such facilities. JGKE shall provide Medical Center with reasonable
assistance in ensuring JGKE employee, agent, and contractor compliance with (i)
laws and regulations affecting Medical Center’s facility(ies) and (ii) Medical
Center’s facility rules and regulations. JGKE warrants and represents that it
has enforceable written agreements with all of its employees, agents, and
contractors involved during the course of this Agreement in any provision of
services and Equipment under this Agreement, obligating such employees and
contractors upon terms and conditions no less restrictive than contained herein,
not to use or disclose any confidential information, proprietary rights, or
information learned or acquired during the course of such employment or
engagement. To the extent an employee of JGKE has access to Protected Health
Information as such is defined in HIPAA, JGKE warrants that it will educate such
employees about the obligation imposed by the HIPAA regulations. Medical Center
may, after written notice including an explanation of its concerns and a fifteen
(15) day cure period, require JGKE to replace any personnel provided by JGKE,
including any contractor personnel, if such personnel does not perform
satisfactorily, does not comply with Medical Center’s security requirements or
other rules and regulations applicable to the conduct of Medical Center’s
employees or contractors, or for other good cause. JGKE shall be solely
responsible for the acts and omissions of its employees, agents, and contractors
hereunder.

 

 

 

            

21.9          JGKE and its employees, agents, and contractors shall comply with
and abide by Medical Center’s rules, policies and/or procedures for vendor
credentialing, copies of which are available upon request. JGKE expressly
acknowledges and agrees that as a condition of access to Medical Center, JGKE
and its employees, agents, and contractors shall cooperate and work with any
third party vendor credentialing services entity with which Medical Center has a
contract and from which Medical Center requests JGKE and its employees, agents,
and contractors to obtain credentialing. No representatives of JGKE will be
given access to Medical Center absent successful completion of Medical Center’s
vendor credentialing program and continued strict compliance with Medical
Center’s rules, standards, policies and procedures (e.g., immunization policies,
identification requirements, HIPAA compliance, appointment requirements, etc.).
JGKE expressly agrees that it shall instruct all of its representatives of the
above requirements, and the fact that each representative, prior to admission to
Medical Center, must have a scheduled appointment in place. No standing
appointments are permissible or will be allowed. Nothing herein shall be
construed as granting a representative access or permission to any locations
within Medical Center, other than the main lobby of Medical Center. Any JGKE
representatives seeking access to Medical Center for the purpose of performing
Services must have a scheduled appointment with Medical Center’s Director of
Materials Management. Any JGKE representative that does not comply with the
above, will be removed from Medical Center and may be sanctioned and/or
permanently prohibited from access to Medical Center. Notwithstanding the
provisions of 21.8 and 21.9, Medical Center will use all reasonable efforts to
assist and promptly respond to JGKE, so as to ensure reasonable access to the
Medical Center, Equipment and all affiliated persons.

 

22.          Miscellaneous.

 

22.1          Binding Effect and Assignment. This Agreement shall be binding
upon and inure to the benefit of the parties hereto and their respective
successors and assigns, neither party may assign, subcontract, delegate, or
otherwise transfer this Agreement or any of its rights or obligations hereunder
except as contemplated herein, without the other party’s written consent;
provided, however that the Medical Center may assign this Agreement without
prior written consent of JGKE to an entity controlled by, controlling, or under
common control with the Medical Center and which entity is the holder of the
general acute care hospital license for the facility at which the Equipment is
located, and provided further, that such entity shall have credit rating and
financial position equivalent to or higher than that of Medical Center as
reasonably determined by JGKE. Unless otherwise agreed to in writing by the
parties, an assignment or sublease shall not relieve a party of any liability
for performance of this Agreement during the remainder of the Term. Any
purported assignment or sublease made without the other party’s prior written
consent shall be null, void and of no force or effect.

 

22.2          Agreement to Perform Necessary Acts. Each party agrees to perform
any further acts and execute and deliver any further documents which may be
reasonably necessary or otherwise reasonably required to carry out the
provisions of this Agreement.

 

22.3          Validity. If for any reason any clause or provision of this
Agreement, or the application of any such clause or provision in a particular
context or to a particular situation, circumstance or person, should be held
unenforceable, invalid or in violation of law by any court or other tribunal of
competent jurisdiction, then the application of such clause or provision in
contexts or to situations, circumstances or persons other than that in or to
which it is held unenforceable, invalid or in violation of law shall not be
affected thereby, and the remaining clauses and provisions hereof shall
nevertheless remain in full force and effect.

 

 

 

 

22.4           Compliance with Anti-Terrorism Plan. JGKE acknowledges that
Medical Center has in place an Anti-Terrorism Plan (“Plan”), a copy of which has
been provided to JGKE, and JGKE further acknowledges that the Equipment and
Cobalt source shall be in compliance with such Plan at all times. JGKE shall use
its best efforts to make any repairs or updates to the Equipment as soon as
practicable in order for such Equipment to be operating in accordance with the
Plan.

 

22.5          Entire Agreement; Amendment. This Agreement together with the
Exhibits attached hereto constitutes the full and complete agreement and
understanding between the parties hereto concerning the subject matter hereof
and shall supersede any and all prior negotiations written and oral agreements
and understandings between the parties with regard to such subject matter. This
Agreement may be modified or amended only by a written instrument executed by
all of the parties hereto. The parties agree that the electronic signature
provisions of the Electronic Signatures in the Global and National Commerce Act
shall not be applicable to this Agreement.

 

22.6          Number and Gender. Words in the singular shall include the plural,
and words in a particular gender shall include either or both additional
genders, when the context in which such words are used indicates that such is
the intent.

 

22.7          Effect of Headings. The titles or headings of the various
paragraphs hereof are intended solely for convenience or reference and are not
intended and shall not be deemed to modify, explain or place any construction
upon any of the provisions of this Agreement.

 

22.8          Counterparts. This Agreement may be executed in one or more
counterparts each bearing a handwritten signature of an authorized official,
collectively which shall constitute one and the same instrument. All
counterparts shall be construed together and shall constitute one agreement.

 

22.9          Governing Law. This Agreement shall be interpreted and enforced in
accordance with the internal laws, and not the law of conflicts, of the State of
Florida. Each party irrevocably agrees that any claim brought by it in any way
arising out of this Agreement must be brought solely and exclusively in state or
federal courts located in the Jacksonville, Duval County, Florida and each party
irrevocably accepts and submits to the sole and exclusive jurisdiction of each
of the aforesaid courts in personam, generally and unconditionally with respect
to any action, suit, or proceeding brought by it or against it by the other
party. THE EXCLUSIVE JURISDICTION REQUIREMENT SET FORTH IN THIS SECTION SHALL
NOT APPLY IN THE EVENT THAT THERE IS THIRD PARTY JOINDER BY EITHER PARTY OR A
THIRD PARTY INSTITUTES AN ACTION AGAINST ANY PARTY TO THIS AGREEMENT, AND SUCH
THIRD PARTY IS NOT AMENABLE TO JOINDER IN AN ACTION BROUGHT IN THE STATE OR
FEDERAL COURTS LOCATED IN JACKSONVILLE, DUVAL COUNTY, FLORIDA.

 

 

 

 

22.10          Exhibits. All exhibits attached hereto and referred to in this
Agreement are hereby incorporated by reference herein as though fully set forth
at length.

 

22.11          Priority of Documents. This Agreement shall take priority over
all agreements relating to Services executed prior to the Effective Date between
JGKE and Medical Center except to the extent JGKE and Medical Center expressly
agree otherwise. Except to the extent expressly agreed by Medical Center and
JGKE, the terms of this Agreement shall not be modified or conflicted by
subsequent agreements between JGKE and Medical Center. In the event of a
conflict between this Agreement and related documents, the terms of this
Agreement shall be given effect. The terms of any pre-printed form documents,
including invoices and purchase orders, between JGKE and Medical Center shall
have no effect on the relationship of the parties. The terms of this Agreement
shall supersede the terms and conditions on any purchase orders, invoices, price
quotes or other documents or agreements JGKE may utilize with Medical Center
relating to the Services covered under this Agreement. The general rule that
ambiguities are to be construed against the drafter shall not apply to this
Agreement. In the event that any provision of this Agreement is found to be
ambiguous, each party shall have an opportunity to present evidence as to the
actual intent of the parties with respect to such ambiguous provision.

 

22.12          Representations. Each of the parties hereto represents: (a) that
no representation or promise not expressly contained in this Agreement has been
made by any other party hereto or by any of its agents, employees,
representatives or attorneys; (b) that this Agreement is not being entered into
on the basis of, or in reliance on, any promise or representation, expressed or
implied, other than such as are set forth expressly in this Agreement; (c) that
it has been represented by counsel of its own choice in this matter or has
affirmatively elected not to be represented by counsel; (d) it is duly
organized, validly existing and in good standing under the laws of the
jurisdiction of its organization; (e) it has full power and authority to
execute, deliver and perform this Agreement; and (f) the execution, delivery and
performance of this Agreement has been duly authorized by all necessary
corporate or other similar action.

 

22.13         Publicity. JGKE agrees that it shall not, without prior written
consent of Medical Center in each instance, use in advertising, publicity, or
otherwise, the name of Medical Center, or any partner or employee of Medical
Center, or any trade name, trademark, trade device, or simulation thereof owned
by Medical Center, or represent, directly or indirectly, that any product or any
service provided by JGKE has been approved, recommended, certified, or endorsed
by Medical Center. In addition to the foregoing, the content and timing of any
public announcement including, but not limited to, any press release regarding
the arrangements outlined under this Agreement, shall require the mutual
agreement of the parties.

 

 

 

 

22.14         Non-Waiver. No failure or delay by a party to insist upon the
strict performance of any term, condition, covenant or agreement of this
Agreement, or to exercise any right, power or remedy hereunder or under law or
consequent upon a breach hereof or thereof shall constitute a waiver of any such
term, condition, covenant, agreement, right, power or remedy or of any such
breach or preclude such party from exercising any such right, power or remedy at
any later time or times.

 

22.15         Notices. All notices, requests, demands or other communications
required or permitted to be given under this Agreement shall be in writing and
shall be delivered to the party to whom notice is to be given either (a) by
personal delivery (in which case such notice shall be deemed to have been duly
given on the date of delivery), (b) by next business day air courier service
(e.g., Federal Express or other similar service) (in which case such notice
shall be deemed given on the business day following deposit with the air courier
service), or (c) by United States mail, first class, postage prepaid, registered
or certified, return receipt requested (in which case such notice shall be
deemed given on the third (3rd) day following the date of mailing), and properly
addressed as follows:

  

To JGKE:Four Embarcadero Center

Suite 3700

San Francisco, CA 94111

Attn: Chief Executive Officer

 

To Medical Center:St. Vincent’s Medical Center

1 Shircliff Way

Jacksonville, FL 32204

Attn: Chief Executive Officer 

 

A party to this Agreement may change his, her or its address for purposes of
this Section by giving written notice to the other parties in the manner
specified herein.

 

22.16      Special Provisions Respecting Medicare and Medicaid Patients

 

22.16.1       Medical Center and JGKE shall generate such records and make such
disclosures as may be required, from time to time, by the Medicare, Medicaid,
TriCare, HCAP and other third party payment programs with respect to this
Agreement in order to meet all requirements for participation and payment
associated with such programs, including but not limited to the matters covered
by Section 1861(v)(1)(I) of the Social Security Act.

 

 

 

 

22.16.2       For the purpose of compliance with Section 1861(v)(1)(I) of the
Social Security Act, as amended, and any regulations promulgated pursuant
thereto, both parties agree to comply with the following statutory requirements
(a) Until the expiration of four (4) years after the termination of this
Agreement, both parties shall make available, upon written request to the
Secretary of Health and Human Services or, upon request, to the Comptroller
General of the United States, or any of their duly authorized representatives,
the contract, and books, documents and records of such party that are necessary
to certify the nature and extent of such costs, and (b) if either party carries
out any of the duties of the contract through a subcontract with a value or cost
of $10,000 or more over a twelve month period, with a related organization, such
subcontract shall contain a clause to the effect that until the expiration of
four (4) years after the furnishing of such services pursuant to such
subcontract, the related organization shall make available, upon written request
to the Secretary, or upon request to the Comptroller General, or any of their
duly authorized representatives the subcontract, and books, documents and
records of such organization that are necessary to verify the nature and extent
of such costs.

 

22.17       Force Majeure. Failure to perform by either party will be excused in
the event of any delay or inability to perform its duties under this Agreement
directly or indirectly caused by conditions beyond its reasonable control,
including, without limitation, fires, floods, hurricane, tropical storm,
earthquakes, snow, ice, disasters, acts of God, accidents, riots, wars,
operation of law, strikes, governmental action or regulations, shortages of
labor, fuel, power, materials, manufacturer delays or transportation problems.
Notwithstanding the foregoing, all parties shall make good faith efforts to
perform under this Agreement in the event of any such circumstance. Further,
once such an event is resolved, the parties shall again perform their respective
obligations under this Agreement. Should either party to this Agreement be
notified by any governmental agency or its counsel that performance under this
Agreement creates a substantial risk of violation of any material state or
federal law or regulation, such party shall notify the other party, and the
parties shall, in good faith, attempt to amend this Agreement in all respects
necessary to comply with such laws or regulations. If such amendment is not in
compliance with applicable legal requirements in the written opinion of counsel
for either party to this Agreement, or if the parties cannot agree on an
alternative acceptable arrangement, then this Agreement may be terminated by
either party upon the delivery of written notice to the other party thirty (30)
days prior to the date of termination and all of the rights and obligations of
the parties hereunder shall cease and this Agreement shall become null and void.

 

22.18       Independent Contractor. It is mutually understood and agreed that
nothing in this Agreement is intended nor shall be construed to create between
JGKE and Medical Center, with respect to their relationship hereunder, an
employer/employee relationship, a partnership or joint venture relationship, or
a landlord/tenant relationship.

 

22.19       Anti-Kickback Statute. The sole purpose of this Agreement is to
enter into a commercially reasonable and fair market value arrangement. The
parties in good faith believe that this Agreement fully complies with the
provisions of 42 U.S.C. 1320a-7b (the "Anti-Kickback Statute"). Neither Medical
Center nor JGKE are, by virtue of this Agreement or otherwise, willfully
offering, paying, soliciting, or receiving remuneration in return for referring
an individual to or from each other for the furnishing of any item or service
reimbursed under the Medicare or state health care programs. Pricing hereunder
does not take into account the volume or value of any referrals or business
otherwise generated between the parties for which payment may be made in whole
or in part under Medicare or a state health care program.

 

 

 

 

22.20       Each party represents and warrants to the other party that neither
it, nor any of its employees or other contracted staff (collectively referred to
in this paragraph as "employees") has been or is about to be excluded from
participation in any Federal Health Care Program (as defined herein). Each party
agrees to notify the other party within five (5) business days of receipt of
notice of intent to exclude or actual notice of exclusion from any such program.
The listing of either party or any of its employees on the Office of Inspector
General’s exclusion list (OIG website), the General Services Administration’s
Lists of Parties Excluded from Federal Procurement and Nonprocurement Programs
(GSA website) for excluded individuals or entities, any state Medicaid exclusion
list, or the Office of Foreign Assets Control’s (OFAC’s) blocked list shall
constitute "exclusion" for purposes of this paragraph. In the event that either
party is excluded from any Federal Health Care Program or placed on the OFAC’s
blocked list, it shall be a material breach and this Agreement shall immediately
terminate without penalty to the other party, unless the other party elects in
writing to continue this Agreement. For the purpose of this paragraph, the term
"Federal Health Care Program" means the Medicare program, the Medicaid program,
TRICARE, any health care program of the Department of Veterans Affairs, the
Maternal and Child Health Services Block Grant program, any state social
services block grant program, any state children’s health insurance program, or
any similar program.

 

22.21        Each party shall keep strictly confidential all Non-Public
Information disclosed by the other party. For the purposes of this Agreement
"Non-Public Information" shall include the terms of this Agreement and all
information disclosed by the parties, inclusive of Medical Center purchasing
information and characteristics. The parties expressly acknowledge that Medical
Center is a member or affiliate of Ascension Health. The parties further agree
that, notwithstanding anything to the contrary herein, Medical Center may
disclose Non-Public Information to Ascension Health and its health ministries,
affiliates, business partners, consultants and those third-party entities with
whom Ascension Health and/or Medical Center have an agreement requiring the
third-party entity to maintain the confidentiality of such Non-Public
Information and to only use such Non-Public Information for the benefit of
Ascension Health and Medical Center. Each party shall use best efforts to return
any confidential information to the disclosing party upon request. Medical
Center and JGKE may freely disclose this Agreement internally within their
respective organizations and to their professional advisors.

 

22.22       Medical Center has in place a Corporate Responsibility Program
("Program") which has as its goal to ensure that Medical Center complies with
federal, state and local laws and regulations, a copy of which is available for
review at jaxhealth.com in the Patients and Visitors section. The Program
focuses on risk management, the promotion of good corporate citizenship,
including the commitment to uphold a high standard of ethical and legal business
practices, and the prevention of misconduct. JGKE acknowledges Medical Center's
commitment to Corporate Responsibility and agrees that it will not act or
conduct business in a manner that requires Medical Center to violate or act in a
manner that contravenes any legal requirement.

 

 

 

 

22.23       The parties acknowledge that the operations of Medical Center and
its affiliates are in accordance with the Ethical and Religious Directives for
Catholic Health Care Services, as promulgated by the United States Conference of
Catholic Bishops, Washington, D.C., of the Roman Catholic Church or its
successor ("Directives") and the principles and beliefs of the Roman Catholic
Church is a matter of conscience to Medical Center and its affiliates. The
Directives are located at http://www.usccb.org/bishops/directives.shtml. It is
the intent and agreement of the parties that neither this Agreement nor any part
hereof shall be construed to require Medical Center or its affiliates to violate
said Directives in their operation and all parts of this Agreement must be
interpreted in a manner that is consistent with said Directives.

 

22.24       JGKE represents and warrants that the Equipment, to JGKE’s
knowledge, complies with the requirements of all applicable federal, state and
local laws, ordinances, regulations and codes including those relating to the
privacy or security of information including, but not limited to, the Health
Insurance Portability and Accountability Act of 1996 ("HIPAA") and corresponding
regulations. The parties agree that based upon and in reliance upon the
representations, warranties and covenants set forth in this Section, JGKE is not
a Business Associate of Medical Center as defined in HIPAA. JGKE represents,
warrants and covenants that in the provision of Equipment under this Agreement,
JGKE does not require and shall not request access to, or attempt to access, any
Protected Health Information of Medical Center or any of its affiliates. If JGKE
inadvertently comes in contact with Protected Health Information, JGKE will keep
such information confidential and not further access, use or disclose it. If
JGKE becomes a Business Associate, it agrees to comply with all applicable
provisions of HIPAA and agrees to sign Medical Center's then-current business
associate agreement. For purposes of this Section, Protected Health Information
has the meaning set forth in 45 CFR §160.103.

 

22.25       Restrictive Covenants. During the term of the Agreement: (1) JGKE
covenants that it and any affiliate of JGKE will not be involved in any way in
the ownership, management, or operation of, or investment in, any gamma knife
models that perform Procedures within twenty-five (25) miles of Medical Center,
and (2) Medical Center covenants that St. Luke’s Hospital will not be involved
in any way in the ownership, management, or operation of, or investment in, any
gamma knife models on St. Luke's Hospital campus, located in Jacksonville,
Florida. Notwithstanding the above, the parties agree that as affiliates of
JGKE, Dr. Scot Akerman and Dr. Paul Ossi shall be permitted to continue to
perform Procedures on the current stereotactic radiosurgery system which is
owned by Iridium Holdings, Inc. as of the date of this Agreement, provided such
radiosurgery system shall not be modified, upgraded or replaced during the term
of this Agreement. In the event that this restrictive covenant (or element
thereof) shall be determined to be over-broad, then the terms of this Section
22.25 may be either stricken or reduced by a court of competent jurisdiction to
the extent such court deems reasonable, and this Section 22.25 may then be
enforced in accordance with any remaining and revised language of this Section
22.25.

 

 

 

  

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
as of the date first set forth above.

 

"JGKE" JACKSONVILLE GK EQUIPMENT, LLC   By: /s/ Ernest A. Bates, M.D.     Title:
Manager     Date: August 5, 2011       "MEDICAL CENTER" ST. VINCENT’S MEDICAL
CENTER, INC.         By: /s/ Moody Chisholm     Title: President & CEO     Date:
August 5, 2011

  

 

 

 

Exhibit 1

 

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Exhibit 2

 

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Saint Vincent’s Medical Center

Jacksonville, Florida

 

August 4, 2011

 

 

 

 

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LEKSELL GAMMA KNIFE® END USER AGREEMENT

THIS LEKSELL GAMMA KNIFE® END USER AGREEMENT ("AGREEMENT") is entered into as of
the_______day of 2011 by and between ELEKTA, INC., a corporation organized and
existing under the laws of Georgia (hereinafter referred to as "Elekta"). and
SAINT VINCENT'S MEDICAL CENTER, INC., (hereinafter referred to as "End User").

 

WITNESSETH:

 

WHEREAS, Elekta has agreed to sell the "Leksell Gamma Knife®" system
(hereinafter defined and referred to as the "LGK®") to Jacksonville GK
Equipment, LLC, hereinafter referred to as 'Buyer"); and

 

WHEREAS, Buyer has agreed to provide the right to use the LGK® to End User under
the Leksell Gamma Knife Perfexion Purchased Services Agreement ("Purchased
Services Agreement"), and

 

WHEREAS, Elekta and End User wish to enter this Agreement for their mutual
benefit;

 

NOW THEREFORE, in consideration of the mutual covenants and obligations,
warranties and indemnities herein contained and other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
parties hereto agree as follows:

 

TERMS AND CONDITIONS

 

ARTICLE I. DEFINED TERMS

 

The following words and terms shall have the meanings set forth opposite them in
this Article I:

 

"Acceptance Tests" are those tests which demonstrate that the LGK® meets the
manufacturer's specification and which are defined in the Purchased Services
Agreement between Buyer and Elekta.

 

"Charging" means all handling of the Cobalt Supply at the Site and the
installation of such Cobalt Supply in the LGK®.

 

"Cobalt Supply" means the supply of the Cobalt-60 sources to be installed in the
LGK®.

 

"Effective Date" is the date of execution of this Agreement by the End User, as
indicated in this Agreement.

 

"End User Data" means all data and information, including but not limited to End
User Confidential Information, Customer whether in written or electronic form,
submitted to Elekta by End User or a user, or obtained by Elekta in connection
with the LGP Software, including, without limitation, information relating to
End User's or an affiliate's users, vendors, employees, technology, operations,
facilities, consumer markets, products, capacities, systems, procedures,
security practices, research, development, business affairs and finances,
business methodologies, improvements, trade secrets, copyrightable subject
matter and other proprietary information, activities, and any ideas, concepts,
innovations, inventions and designs of End User.

 

"Hardware" shall mean that computer hardware and related equipment described in
the Specification.

 

"Installation Test Protocol" shall mean the manufacturer's instructions to
install and test the LGK® and LGP Software which are performed by Elekta under
the supervision of the Buyer and/or End User's Radiation Safety Officer which,
once completed satisfactorily demonstrates the LGK ® complies with the
Specification.

 

"LGK®" is the device, which is technically specified in Exhibit A hereto, to be
sold, delivered, and installed by Elekta at the Site.

 

"LGP Software" means the dose planning software for the LGK®, which is described
in the Specification and the software and software add-on's as attached hereto
as ExhrlD4 A (including but not limited to Standard LGP for Perfexion License,
Retreatment License, Warpseed Real-time Dose Update License, Functional Planning
License, lmagemerge License and a Color Pet License).

 

"Site" shall mean that location described on the Exhibit B hereto.

 

"Site Planning Criteria" are the requirements which the Site must meet to
properly accommodate the LGK® and are defined in the Purchased Services
Agreement between Elekta and Buyer.

 

"Specification" refers to the technical standards with which the LGK® shall
comply, as described in Exhibit A hereto.

  

 

 

 

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ARTICLE II. PERMITS

 

2.1 Permits. End User shall obtain any license (the "User License") from the
Nuclear Regulatory Commission (or relevant state agency if the Site is located
in an -Agreement State") authorizing it to lake possession of the Cobalt Supply
and shall obtain such other licenses, permits, approvals, consents and
authorizations which may be required by local governmental or other regulatory
agencies for the Site, its preparation, the Charging of the LGK® with its Cobalt
Supply, the conduct of Acceptance Tests, and the use of the LGK®. End User shall
not run, operate, or otherwise use the LGK®, except for the purpose of
conducting the Acceptance Tests, until the Acceptance Tests have been
successfully completed.

 

ARTICLE III. OPERATION, TRAINING, AND INTELLECTUAL PROPERTY.

 

3.1 Operation. End User warrants and covenants that the LGK® shall not be run,
operated or otherwise used, except by qualified employees, agents, independent
contractors, or physicians, who are suitably skilled and experienced to use the
LGK®.

 

3.2 Technical Training. Elekta shall provide as set forth in Exhibit A to four
(4) persons designated by End User instruction relating to the technical
operation and maintenance of the LGK®. Such instruction shall not exceed two (2)
consecutive days and will be provided on-site by installation personnel at the
time of install.

 

3.3 Introductory Clinical Training Program. Elekta shall reimbursement the
tuition costs for persons designated by End User in a Clinical Training Program
addressing indications, technique, literature, and other related areas as noted
in Exhibit A attached hereto.

 

3.4 Post Clinical Start Up Site Visit. Elekta shall provide a one (1) day Site
visit from one (1) Clinical Applications representative. The visit must be
arranged within 3-6 months post clinical start up. The commitment will expire
thereafter unless documented alternate arrangements are made. The purpose is to
ensure the End User is comfortable using all features in the LGP Software.

 

3.5 LGP Software. Elekta hereby consents to Buyer's sublicense to End User of
the LGP Software, to be utilized for the purpose of planning dosages of
treatments to be performed with the LGP Software and as otherwise may set forth
in this Agreement A copy of the LGP Software License from Elekta to Buyer is
attached hereto as Exhibit D. End User agrees that its sublicense to the LGP
Software shall be subject to the terms and conditions of Exhibit D hereto. End
User agrees. in favor of Elekta, to perform the obligations assigned to Buyer in
Exhibit D hereto. In the event the sublicense of the LGP Software from Buyer to
End User is terminated due to an act or omission of Buyer and without fault of
the End User, then End User shall have the right to obtain, at no additional
cost, from Elekta a direct royalty-free license to utilize the LGP Software on
the same terms and conditions set forth herein.

 

3.6 Intellectual Property.

 

(a)End User hereby acknowledges that the trademarks Gamma Knife® and Leksell
Gamma Knife® (collectively, the "Mark") are protected by United States federal
registrations and the Mark constitutes valuable intellectual property of an
affiliate of Elekta in which it has established substantial goodwill. End User
hereby acknowledges that proper use of the Mark in any advertising of End User's
own surgical services performed with the LGK® surgical instrument is highly
important to maintaining such value and goodwill.

 

(b)Subject to the terms and conditions of this section, Elekta, as agent for
Elekta AB. of Geneva, Switzerland, the owner of the Mark, hereby grants End User
a non-exclusive, royalty-free license without right to sublicense solely for the
purpose of using the Mark in connection with the promotion and advertising of
any of End User's own services to be performed by use of the LGK® surgical
instrument.

 

(c)End User, in the conduct of End User's business, is strictly prohibited from
using the Mark in or as its official legal name. However, End User may use the
trademark as part of the following fictitious trade name:

 

“Gamma Knife® Center of ____________________”

 

As long as End User utilizes a fictitious trade name which includes the Mark,
End User shall not perform radiosurgical services with any equipment other than
the LGK®. If End User performs any radiosurgical service with any equipment
other than the LGK® or if End User ceases to perform radiosurgical services with
the LGK®. End User shall immediately cease utilizing the Mark as part of its
fictitious trade name.

 

(d)In advertising, references to the Mark must include the registration symbol O
and such symbol must be used at least once per piece of advertising material
along with the words "Gamma Knife® and Leksell Gamma Knife® are U.S. federally
registered trademarks of Elekta AB" somewhere in the advertisement. Elekta
reserves the right to require End User to discontinue the use of advertising
that does not conform to such requirements.

 

(e)End User may use the words "Gamma Knife® Center of [add distinctive name)"
and/or "Add Distinctive Name" Gamma Knife® Center as part of any intemet domain
name, or URL, telephone number or other communications address or symbol
provided that the full name, "Gamma Knife® Center of [add distinctive name)" is
used. User may use a variation or abbreviation of such term only after obtaining
Elekta's prior written consent, to the proposed use in question. User may not
under any circumstances, use the words "Gamma Knife®" alone, for any intemet
domain name, or URL, telephone number or other communications address or symbol.

 

 

 

 

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(f)All advertising or promotional materials in which the mark is utilized shall
comply with all applicable laws and regulations as well as the standards of
proper advertising.

 

(g)Elekta shall have the right to terminate the license granted in this section
with immediate effect if End User violates any provision of this section or
utilizes the Mark in any manner which, in the sole opinion of Elekta, presents a
reasonable possibility of damage to the Mark, and does not cure the violation to
the satisfaction of Elekta or provide a written plan to cure the violation that
is satisfactory to Elekta within ten (10) business days following written notice
from Elekta.

 

(h)Upon termination of the license granted by this section. End User shall
immediately cease all use of the Mark, including, but not limited to, the use
permitted under subsection (e) of this section.

 

(i)End User acknowledges that a breach of any of its covenants or agreements
hereunder may cause immediate and irreparable harm to Elekta and Elekta
Instrument S.A. End User acknowledges and agrees that there may be no adequate
remedy at law for any such breach, and End User acknowledges that in the event
of such a breach Elekta may be entitled to seek Injunctive relief and such other
relief as any court with jurisdiction may deem just and proper.

 

(j)Notwithstanding anything to the contrary, End User shall retain all right,
title, and interest in all of the End User intellectual property.

 

3.7. Remote Access. Remote access to any End User's systems for maintenance and
support of LGP Software and for any other purpose allowed by this Agreement is
subject to compliance with the End User's remote access and other security
requirements attached as Exhibit F. Elekta's access may require prior
certification by the End User that Elekta complies with the End User's security
policies and standards. End User may modify these security requirements and
Elekta must comply with the most recent version of the End User's security
requirements. Elekta must ensure that each of its personnel having access to any
part of a End User's computer system: (i) is assigned a separate log-in ID by
the End User and uses only that ID when logging on to the End User's system;
(ii) logs-off the End User's system immediately upon completion of each session
of service; (iii) does not allow other individuals to access the End User's
computer system; and (iv) keeps strictly confidential the log-in ID and all
other information that enables access. If End User revises the requirements for
access to its computer system, then the End User must notify Elekta of the
changed or additional requirements and Elekta must conic*/ with them as a
prerequisite to further access. Any End User may require each individual who is
to be allowed access to that End User's computer system to acknowledge the
individual's responsibilities in connection with the access.

 

ARTICLE IV. CONFIDENTIALITY

 

4.1End User shall treat and maintain as confidential all technical information
and know-haw to it pursuant to this Agreement (including LGP Software), except
for know-how specifically designated as non-confidential pursuant to this
Agreemant or otherwise so designated by the Elekta. End User shall not disclose
any aspect of such know-how (including the LGP Software) to any other person,
includ:ng any corporation or governmental or quasi-governmental agency. provided
that, End User shall have the right to disclose such know-how to its employees,
agents and independent contractors to the extent necessary for use of the LGKCI,
but End User shall be responsible to ensure that such know-how is not disclosed
by such persons.

 

4.2 Elekta agrees that it shall not disclose or verify to any third party any
End User Data which it learned or had access to during the course of its
performance of this Agreement without the prior written consent of End User.
This obligation shall survive the cancellation or other termination of this
Agreement. The parties agree that any information furnished to one by the other
that is marked "confidential" or 'proprietary" or which consists of or relates
to patient information, a party's initiatives, business plans or intellectual
property, and employee and medical staff information, constitutes the sole and
exclusive proprietary information of the providing party ("Confidential
Information"). ''Confidential Information" shall also include any information
concerning a disclosing party (whether prepared by a disclosing party or its
representatives or otherwise and irrespective of the form of communication
(i.e., whether written or oral)) which is furnished to a receiving party or to
its representatives now or in the future by or on behalf of a disclosing party,
including, without limitation, any business, technical (including but not
limited to patented or patent-pending information), marketing, financial,
patient, customer, vendor, employee, manufacturing, marketing, sales, research
and development, or other Information which is communicated by or on behalf of a
disclosing party to a receiving party orally, in writing or other physical form.
"Confidential Information" shall also be deemed to include any notes, analyses,
compilations. studies, forecasts, interpretations or other documents prepared by
a receiving party or its representatives that contain, in whole or in part, the
information furnished to such receiving party or its representatives pursuant
hereto. Elekta and End User each agree to not disclose the other party's
Confidential Information for the benefit of itself or any other person or entity
except as expressly provided in this Agreement,

 

4.3 Elekta acknowledges that it will not acquire any rights in any of End User
Data. Any grant by End User of rights in its End User Data, including, without
limitation, for statistical analyses, must be approved by End User in writing in
advance. Elekta acknowledges that it may not use any of End User Data, even if
it is in 'cleansed" or "deidentified" form, for any purpose other than to
fulfill its contractual obligations to End User and, if applicable, for other
purposes that have been agreed to by End User and approved in a writing separate
from and referencing this Agreement.

 

 

 

 

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4.4 The provisions of this Article IV shall survive the termination of this
Agreement and shall apply with equal force to any technical information or
know-how concerning the LGK® acquired by End User other than pursuant to this
Agreement.

 

4.5 The obligations of confidentiality and restriction of access pursuant to
this Article IV shall not apply to any trade secret or confidential information
that was (a) in the public domain at the time of such access or subsequently
came in to the public domain through no fault of the person subject to the
provisions of Article IV; (b) rightfully known to the person given to such
access or developed independently by the person given such access; (c) received
by the person given such access as a matter of right from a source other than a
person subject to the provisions of this Article IV; or (d) required to be
disclosed by subpoena or court order, but End User shall give immediate notice
of such subpoena or court order to Elekta and shall request the court to grant
confidential treatment to the confidential information disclosed pursuant to
such subpoena or court order.

 

ARTICLE V. WARRANTY

 

5.1 Elekta provides the warranty for the LGK® and LGP Software set forth in
Exhibit C hereto.

 

ARTICLE VI. EXCUSABLE DELAYS

 

6.1 If the performance of this Agreement by Elekta or End-User, or any
obligation of Elekta or End-User hereunder is prevented, restricted or
interfered with by reason of fire. explosion, acts of God, labor disputes or
accidents affecting performance under this Agreement, or war, mobilization,
civil commotions, blockade or embargo, or any law, regulation, ordinance or
requirement of any government or regulatory agency. or any other act whatsoever
similar to those above enumerated, or any other circumstance being beyond the
reasonable control of Elekta or End-User, then and in that event Elekta or
End-User, as the case may be, shall promptly notify the other parties hereto of
the resulting difficulties there from, and any of the foregoing events shall
excuse any performance required under this Agreement.

 

ARTICLE VII. LIMITATION OF LIABILITY & INDEMNIFICATION.

 

7.1 The remedies of End User and Elekta's liabilities for breaches of this
Agreement shall include but not be limited to those specifically provided for in
Section 5.1 and in this Article VII. Except for acts of willful misconduct,
gross negligence, breaches of confidentiality, breaches of the Business
Associate Addendum, and indemnification obligations, in no event shall Elekta be
liable to End User for loss of revenue or profit, or for any other indirect,
incidental or consequential damage, whether arising in contract, tort or
otherwise.

 

7.2 Elekta shall defend and indemnify End User and its affiliates, agents,
servants and employees. and hold them harmless from and against all damages,
losses claims, judgments and liabilities by or to third parties (plus litigation
costs incurred) resulting from injury to or death of any person or physical loss
or damage to property arising out of defective materials, workmanship, or
manufacture of the LGK® or the defective maintenance of the LGK® (but, with
respect to maintenance, only to the extent performed by or on behalf of Elekta).
The foregoing indemnification obligations require that: (i) End User shall
notify Elekta in writing of a claim within a reasonable period of time after
becoming aware of such claim or Elekta’s potential capability: (ii) Elekta has
primary control of the defense and all related settlement negotiations: (iii) in
the case of real or tangible property, limiting such indemnification and save
harmless obligations to the cost of repair of such property or if repair is not
practicable. to the replacement cost of such property; and (iv) in the case of
destroyed data, limiting such indemnification and save harmless obligations to
complete recovery or input of lost data. Failure of the foregoing obligations
shall affect the indemnification obligation only to the extent such failure
materially and adversely impacts the ability of Elekta to successfully defend
against the claims. Elekta agrees that any settlement of such claim or cause of
action shall release End User and the Indemnitees fully, absolutely, and finally
from any liability related to such cause of action. Elekta shall use
commercially reasonable efforts to minimize, to the extent possible, publicity
adverse to End User or an Indemnitee associated with any such settlement. Elekta
shall not agree to a settlement which names End User or an Indemnitee as
culpable absent the prior written consent of such Indemnitee. In the event that
Elekta, in the reasonable judgment of End User, lacks the financial resources to
adequately and timely defend such claim or if Elekta has indicated in writing
its unwillingness to so defend such claim, End User may defend and Elekta shall
reimburse, all costs related to such defense.

 

7.3 If a third party claim is made or an action brought alleging that the LGP
Software infringes a U.S. Patent, or any copyright, trademark, trade secret or
other proprietary right, Elekta snail indemnify, hold harmless and defend End
User against such claim and shall pay ongoing and resulting costs of the
infringement claim, if any, including reasonable attorneys' and expert fees. End
User shall promptly notify Elekta in writing of the claim, and Elekta shall have
sole control of the defense and all related settlement negotiations. End User
shall reasonably cooperate in such defense so long as there is no expense to End
User. If the LGP Software, in whole or in part, or the use or operation thereof,
becomes or in the reasonable option of Elekta is likely to become, the subject
of such a claim. Elekta shall, at its sold expense, either procure the right for
Customer to continue using the LGP Software or, at the option of Elekta at
Elekta sole expense, replace or modify the same so that it becomes
non-infringing (provided such replacement or modification maintains the same
material functionality and does not adversely affect End User's use of the LGP
Software as contemplated hereunder). If neither of the alternatives is available
on terms which are reasonable in Elekta’s sole judgment, Elekta shall refund to
End User, upon receipt of the infringing LGP Software, all fees paid for such
infringing LGP Software, depreciated on a five (5) year straight line basis.

 

 

 

 

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ARTICLE VIII. MISCELLANEOUS PROVISIONS.

 

8.1 Assignment. No party hereto shall assign its respective rights or
obligations under this Agreement (including the LGP Software License) in whole
or in part to any person without the prior written consent of the other party,
except as provided in this Section 8.2 hereinafter. In the event of any
assignment or transfer by End User of its rights or duties under this Agreement
or the Lease or of any sale, transfer, lease or sublease of the LGK® or any
component thereof to a third party, End User shall obtain the prior approval of
Elekta of the proposed transferee (such approval not to be unreasonably
withheld) and cause such transferee, prior to such transfer, to sign ('.) an
agreement that any acquired interest In the LGK® System is subject to the terms
and conditions of this Agreement and evidencing such transferee's agreement to
be bound, to the same extent as End User, by the then-surviving provisions of
this Agreement, including but not limited to the technical and scientific
information provisions (Section 3.3), the confidentiality provisions (Article
IV), the provisions of Articles V and VII hereof, and the provisions of the LGK®
Software License or (2) a similar agreement otherwise approved by the Elekta,
which approval shall not be unreasonably withheld.

 

8.2 Subcontractors. Elekta shall be entitled to appoint subcontractors or any
other third parties for the performance or fulfillment in whole or in part of
Elekta's obligations under this Agreement without the consent of End User, and
Elekta shall be fully responsible and liable for the performance, acts, and
omissions of entities it appoints to perform Elekta's obligations hereunder.
Elekta shall be entitled to assign any of its rights or obligations hereunder to
any of its affiliates without the consent of End User, but Elekta agrees that it
will be fully responsible for any obligations assigned to Elekta's Affiliates
hereunder.

 

8.3 Entire Agreement. This Agreement constitutes the entire agreement between
the parties hereto and supersedes any prior or contemporaneous agreements,
negotiations or discussions between the parties with respect to the subject
matter hereof. No amendment of the provisions of this Agreement will be valid
unless made in writing and signed by both parties hereto.

 

8.4 Additional Obligations. Elekta acknowledges End User's obligations to comply
with certain laws and regulations as well as the need for Elekta's employees,
agents, and contractors to comply with reasonable requests, standard rules, and
regulations of End User regarding persona! and professional conduct as attached
in Exhibit G, including the use of an Identification badge or personal
protective equipment. Elekta will ensure that it's employees, agents, and
contractors comply to End User's facility laws or regulations, and general
safety practices or procedures, generally applicable to such facilities. Elekta
will perform, as applicable, criminal background checks, credit checks, health
screening. vaccinations and testing on its employees, agents. and contractors
and agrees to provide written verification to End User of any such required
checks, tests and screenings, and shall provide End User with reasonable
assistance in ensuring Elekta employee, agent, and contractor compliance with
(i) laws and regulations affecting End User's facllity(ies) and (ii) End User's
facility rules and regulations. Elekta warrants and represents that it has
enforceable written agreements with all of its employees, agents, and
contractors involved during the course of this Agreement in any provision of
services and Equipment under this Agreement, obligating such employees and
contractors upon terms and conditions no less restrictive than contained herein,
not to use or disclose any confidential information, proprietary rights, or
information learned or acquired during the course of such employment or
engagement, Elekta warrants and represents that any services performed by Elekta
or by a permitted subcontractor or agent of Elekta shall be performed in a
professional manner, consistent with industry standards and in a diligent,
workmanlike, and expeditious manner.

 

8.5 Personnel Requirements. Elekta and its employees, agents, and contractors
shall cum.* with and abide by End User's rules, policies and/or procedures for
vendor credentialing including those attached as Exhibit H. to the extent
allowed by law. Elekta expressly acknowledges and agrees that as a condition of
access to End User, Elekta and its employees, agents, and contractors shall
cooperate and work with any third party vendor credentialing services entity
with which End User has a contract and from which End User requests Elekta and
its employees, agents, and contractors to obtain credentialing. No
representatives of Elekta will be given access to End User absent successful
completion of End User's vendor credentialing program and continued strict
compliance with End User's rules, standards, policies and procedures. End User's
vendor credentialing program requires Elektra to provide the following
information to End User, which shall be kept on file at End User's Radiation
Oncology Department: (i) a criminal background check; (ii) verification of
Excluded Provider status; (iii) licensure verification, if any; (Iv) PPD test
(tuberculosis) within ninety (90) days of first visit and annually thereafter;
(v) a copy of a valid state photo identification; and (vi) a complete
orientation packet and confidentiality statement. End User acknowledges and
agrees that all information provided to End User by Elekta pursuant to this
Section 8.5 (i) through (v) shall be Confidential Information as defined herein
and subject to the restrictions and obligations set forth in Article IV above.
Elekta expressly agrees that it shall instruct all of its representatives of the
above requirements, and the fact that each representative, prior to admission to
End User, must have a scheduled appointment in place. End User may, in its sole
discretion, require Elekta to replace any personnel provided by Elekta,
including any contractor personnel, should they not comply with End User's
security requirements or other rules and regulations applicable to the conduct
of End User's employees or contractors while such Elekta personnel are
performing their obligations hereunder at the End User's °remises. No standing
appointments are permissible or will be allowed. Nothing herein shall be
construed as granting a representative access or permission to any locations
within End User, other than the main lobby of End User. Any Elekta
representatives seeking access to End User for the purpose of performing
Services must have a scheduled appointment with End User's Director of Materials
Management. Any Elekta representative that does not comply with the above, will
be removed from End User and may permanently prohibited from access to End User.

 

 

 

 

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8.6 Governing Law. This Agreement shall be interpreted and enforced in
accordance with the internal laws, and not the law of conflicts, of the State of
Florida.

 

8.7 Independent Contractor. It is mutually understood and agreed that nothing in
this Agreement is intended nor shall be construed to create between Elekta and
End User, with respect to their relationship hereunder, an employer/employee
relationship, a partnership or joint venture relationship, or a landlord/tenant
relationship.

 

8.8 Excluded Provider. Elekta represents and warrants that neither it nor any of
its employees or other contracted staff (collectively referred to in this
paragraph as "employees") has been or is about to be excluded from participation
in any Federal Health Care Program (as defined herein). Elekta agrees to notify
End User within five (5) business days of Elekta's receipt of notice of intent
to exclude or actual notice of exclusion from any such program. The listing of
Elekta or any of its employees on the Office of Inspector General's exclusion
list (01G website) the General Services Administration's Lists of Parties
Excluded from Federal Procurement and Nonprocurement Programs (GSA website) for
excluded individuals or entities, any state Medicaid exclusion list or the
Office of Foreign Assets Control's (OFAC's) blocked list shall constitute
"exclusion" for purposes of this paragraph. In the event that Elekta or any of
its employees is excluded from any Federal Health Care Program or placed on the
OFAC's blocked list, it shall be a material breach and this Agreement shall
immediately terminate without penalty to End User, unless End User elects in
writing to continue this Agreement. For the purpose of this paragraph, the term
"Federal Health Care Program" means the Medicare program, the Medicaid program,
TRICARE, any health care program of the Department of Veterans Affairs, the
Maternal and Child Health Services Block Grant program any state social services
block grant program, any state children's health insurance program, or any
similar program.

 

8.9 Corporate Responsibility Program. End User has in place a Corporate
Responsibility Program ("Program") which has as its goal to ensure that End User
complies with federal, state and local laws and regulations, a copy of which is
available for review at jaxhealth.com in the Patients and Visitors section. The
Program focuses on risk management, the promotion of good corporate citizenship,
including the commitment to uphold a high standard of ethical and legal business
practices, and the prevention of misconduct. Elekta acknowledges End User's
commitment to Corporate Responsibility.

 

8.10Religious and Ethical Directives. The parties acknowledge that the
operations of End User and its affiliates are in accordance with the Ethical and
Religious Directives for Catholic Health Care Services, as promulgates by the
United States Conference of Catholic Bishops Washington, D.C. of the Roman
Catholic Church or its successor ("Directives") and the principles and beliefs
of the Roman Catholic Church is a matter of conscience to End User and its
affiliates. The Directives are located at
http://www.usccb.org/bishops/directives.shtn-d. It is the intent of the parties
that neither this Agreement nor any part hereof shall be construed to require
End User or its affiliates to violate said Directives in their operation.

 

8.11Compliance with Laws. Elekta acknowledges that the equipment and LGP
Software complies with the requirements of all applicable federal, state and
local laws, ordinances, regulations and codes relating to the privacy or
security of information including, but not limited to, the Health Insurance
Portability and Accountability Act of 1996 "HIPAA" and corresponding
regulations. To the extent Elekta receives Individually Identifiable Health
Information ("11HI") as such term is used in 45 C.F.R. § 160.103, Elekta shall
execute the Business Associate Addendum ("BAA") attached hereto as Exhibit E,
and further agrees to execute any amendments thereto reasonably requested by End
User to meet End User's regulatory obligations. In the event of a conflict
between the BAA, as may be amended, and this Agreement, the BAA shall be given
priority.

 

8.12Insurance. Throughout the term of this Agreement Elekta shall maintain in
force, at a minimum, the insurance coverages described below. Elekta shall
obtain or otherwise arrange  for appropriate levels of insurance coverage for
all subcontractors providing services that shall also comply with required
insurance requirements as set forth below.

 

(a)commercial general liability insurance, including products/completed
operations, personal and advertising injury coverage, in a form equivalent to
CG0001 1207 or CG0002 1207, with a minimum combined single limit of $1 million
per occurrence and minimum general aggregate and products/completed operations
aggregate limits of $3 million;

 

(b)comprehensive automobile liability insurance covering use of all owned,
non-owned and hired automobiles with a minimum combined single limit of $1
million per accident for bodily injury and property damage liability;

 

(c)worker's compensation insurance and employer's liability insurance or any
alternative plan or coverage as permitted or required by applicable law, with a
minimum employer's liability limit of $1 million each accident, each employee
for disease, and policy limit for disease;

 

 

 

 

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(d)umbrella/excess liability insurance, with underlying coverage in subsections
(a) through (c) above, with a minimum limit of $5 million per occurrence and
minimum aggregate amount of $15 million, said amounts being in excess of the
named primary coverages;

 

(e)Elekta agrees to provide a certificate of insurance to End User upon written
notice of such a request.

 

IN WITNESS WHEREOF, the parties hereto have signed this Agreement in duplicate
as of the date first written above.

 

ELEKTA INC.

 

By: /s/ Michelle Crawley   Title: VP Contract Administration                
Date:  08/04/11

 

SAINT VINCENT’S MEDICAL CENTER, INC.

 

By : /s/ Moody Chisholm   Title: President & CEO                 Date: 8/11/11

 

 

 

 

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EXHIBIT A

SCOPE OF SUPPLY

 

Leksell Gamma Knife® PERFEXIONTM

 

 

PRODUCT SPECIFICATION

Standard turn-key system

  

Qty Description       Article no. 1   Leksell Gamma Knife® PERFEXIONTM  

715000

2   Leksell® Coordinate FrameTM Kit for PERFEXIONTM   1002407 1   Leksell
GammaPlan®   in BOM 1   PERFEXIONTM system tool kit     1   LSS Spare Part Kit
for Leksell® Coordinate FrameTM   1002406 I   Skull scaling instrument  
A0202-01 1   CT planning kit     1   MRI planning kit     I   X-ray planning kit
    1   Set of Co60 sources   2000000     Cobalt loading         Site planning  
      Installation and commissioning               1   Support and Education &
Training for PERFEXIONTM   SER PERFEXION         0001

 

 

 

 

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Leksell Gamma Knife® PERFEXIONTM

 

Radiation unit

-With radiation shielding doors and collimator system.

 

Patient Positioning SystemTM

-Patient couch and automatic Patient Positioning System.

 

Covers for radiation unit and Patient Positioning System

 

Electric cabinet

-Electric cabinet with cabling

-ECU - central unit and safety system electronic board, circuit breakers and
cabling.

-SDU - sector drive electronic board, circuit breakers and cabling

-PPC 1- software

-PPC 2- software

-Medical UPS

 

Operator area

-Office cabinet

-Keyboard and mouse

-Operator console with patient and operator audio/video, power supply, opto
insulators, cabling and connectors

Flat screen monitors

Office UPS

 

MCU kit

MCU PC with USB CAN
MCU software

 

Treatment couch

Height adjustable mattress

Manual controls for treatment setup

 

Frame adapter

Model "Standard G". For interfacing between Leksell Coordinate Frame model G and
Leksell Gamma Knife PERFEXIONTM.

 

Clearance check tool

Document set

Installation and supplementary documents

2 instructions for use

2 emergency routines

Signs and labels

 

 

 

 

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Leksell® Coordinate Frame® Kit for PERFEXIONTM

 

Includes:

 

Qty Consists Of: Article No.       1 Frame with Feet and Straight Front Piece
50487-01 1 Front Piece, Curved 60638-01 2 Insulated Fixation Post, Anterior
912462 2 Insulated Fixation Post, Short Posterior 912463 2 Insulated Fixation
Post, Long Posterior 912862 6 Locking Screw, 5 x 19 mm, Titanium 60490-03 6
Locking Piece for Fixation Post 60497-01 1 Ear Plug Holder, Right 50498-01 I Ear
Plug Holder, Left 50498-02 2 Ear Plug 60136-01 1 Fixation Screws, Titanium, kit
of 20 pairs 907999 2 Instrument Screw Driver, Double 50146-02 1 Sterilizing Tray
for Frame 50151-03 4 Disposable Inserts, 25x4 pieces 912464 1 Instruction for
Use, Leksell® Coordinate Frame kit 003818   1 Instructions for Use, Insulated
Fixation Posts 012594 1 Quick Reference Guide 014611

 

PERFEXIONTM system tool kit

Includes:

QA tool 1001182 -For radiation focus precision check.   Frame Cap 717960

 -The frame cap is used during patient preparation for a treatment with Leksell
Gamma Knife® PERFEXIONTM.

 

LSS Spare Part Kit for Leksell® Coordinate FrameTM

Consists of 4 pieces of each of the following;

-Locking Screw, 5 x 19 mm, Titanium

-Locking Piece for Fixation Post

-Screw, 4 x 10 mm, Titanium

 

Skull scaling instrument

For measurement of skull shape for Leksell GammaPlan® modeling

 

CT planning kit

Includes:

CT indicator A0800-11 -Fiducial box for CT imaging procedure   CT adapter
A0400-04 -Fixating the stereotactic frame to the CT table fixation   CT table
fixation A0401-XX

-Fixating the CT adapter to specified CT table.

 

 

 

 

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MRI planning kit

Includes:

MR adapter A0420-XX -Fixating the stereotactic frame to specified MR table.   MR
indicator A0820-07

-Fiducial box for MR imaging procedure

 

X-ray planning kit

Includes:

X-ray indicator A0860-04 -Fiducial box for angiography imaging procedure   X-ray
adapter and support A0440-XX

-Fixating the stereotactic frame to specified angiography table.

 

Standard LGP for LGK PERFEXION

Includes one (1) Leksell GammaPlan® (LOP) license for creating new treatment
plans for Leksell Gamma Knife® PERFEXIONTM. This main license allows the
addition, management and storage of an unlimited number patient records and
treatment plans. LGP also allows the visualization of treatment plans created at
other LGK units.

 

Leksell GammaPlan® for Leksell Gamma Knife® PERFEXIONTM includes:

 

1 STANDARD LGP FOR PERFEXION LICENSE

 

Includes one (1) Leksell GammaPlan® (LGP) license for creating new treatment
plans for Leksell Gamma Knife® PERFEXIONTM .This main license allows the
addition, management and storage of an unlimited number patient records and
treatment plans. LGP also allows the visualization of treatment plans created at
other LGK units.

 

1 RETREATMENTTM LICENSE

 

This software add-on facilitates planning of treatments days before surgery, the
assessment of treatments and re-treatments. Users are free to plan days ahead of
treatment, to prepare tomorrow's follow-ups and plan additional treatment.
Re-TreatmentTM also lets any user to integrate images and vital treatment
information from previous plans. It is a powerful tool to import and display
previous key treatment data in the new treatment images. Imported data are user
defined regions (targets, risk structures) and prescription isodose. It
increases the customer confidence when treating new lesions after an initial
treatment.

 

1 WARPSPEEDTM, REAL-TIME DOSE UPDATE LICENSE

 

This add-on speeds up planning by allowing the update of isodoses instantly
during planning. Isodoses displayed in any workspace are instantly updated
whenever one or several isocenters are added, modified, or removed. It is
possible to fully apprehend the potential of composite shots, while also
simplifying the elaboration of new dose plans. WarpSpeedTM provides a shorter
learning curve, more intuitive and faster planning.

 

1 FUNCTIONAL PLANNINGTM LICENSE

This software add-on allows users to perform some functional procedures based on
the definition on the AC-PC line the visualization of functional targets based
on functional target formulas.

 

 

 

 

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1 IMAGEMERGETM LICENSE

 

This software add-on allows an automatic or manual co-registration of any
frameless image studies with a frame based reference study. Once co-registered,
the frameless image can be used in LGP like any other study. Supports MR, CT and
PET images (requires the optional module ColorPETTM).

 

1 COLOR PETTM LICENSE

 

The ColorPETTM software add-on help users to can combine the physiological data
of PET images with the anatomical data of CT and MR images using predefined
color lookup tables. Requires the ImageMerge software add-on.

 

Color Printer 110V

Network color laser printer with

-    Ethernet connector, minimum speed 10/100

-    Support for Postscript Level 3 printing

-    Power supply 110 V

-    English menus and labels

-    Support for printing A4, US letter, US executive and US legal
Delivered model: HP Color Laser Jet or similar

 

1 LGP — DICOM RT License

DICOM RT provides an exclusive possibility to share treatment information with
any DICOM RT compatible system. It includes:

IMPORT of DICOM RT STRUCT allows displaying any user-defined region/volume
created on a DICOM RT system. Volumes can be target volumes, organ at risks,
isodoses or any other region of interest defined by the user.

EXPORT of treatment data via DICOM RT STRUCT and DICOM RT DOSE allows sharing
information with any compatible systems to perform dose comparison or dose
addition.

 

Additional Training for Leksell Gamma Knife® PERFEXIONTM

 

10Clinical Training

Principle and practice of Gamma Knife Surgery, clinical lectures, treatment
planning, patient treatment —5 days. Arranged by Elekta in collaboration with
participating End User.

 

 

 

 

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Technical Specifications

 

Workflow Automatic positioning system.  Couch integrated Typical repositioning
time  < 3 s Typical collimator size setup time  <- 3 s Blocked collimation setup
time < 3 s Mixed collimation setup time (Composite shot)  < 3 s Check and verify
100% QA procedure Automatic Accuracy Radiological accuracy  < 0.5 mm    
Positioning repeatability  < 0.05 mm Maximum patient weight 210 kg (460 pounds)
Treatment planning Treatment planning system PC/Linux based Dynamic shaping Yes
Remote planning Yes Image co-registration Yes PET supported Yes Mechanical
treatment range X/Y/Z 160/180/220 mm Shape of accessible volume Cylindrical Real
collimator sizes 4,8,16 mm diameter Radiation data Total cobalt-60 activity at
loading (approx.) < 6,600 Curie (2.44 x 1014 Bq) Number of radiation sources 192
Radiation dose rate at focal point at loading > 3 Gy/min Physical data Overall
length, including cover  4.46 m Overall width, including cover  2.12 m Overall
height, including cover  1.91 m Total weight (approximate)   20,000 kg

 

 

 

 

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Radiation unit

The radiation unit is the radiation delivery system. It houses 192 Cobalt-60
sources and the collimator system that directs the radiation to the focus point.
The radiation unit incorporates the management of the shielding doors and
electro-mechanics of the source sectors.

 

The following section describes selected components within the radiation unit.

All components are chosen from well-recognized suppliers to secure reliability
and to optimize performance of the system.

 

Collimator body with radiation shielding Collimator body Tungsten body with 576
collimator channels. Collimators Tungsten collimator inserts. Pre-collimator 576
lead pre-collimator channels. Outer shielding Cast iron. Inner shielding
Tungsten and lead. Bearing for collimator body Crossed roller bearing. Static
axial load 680000 N Shielding doors Steel. Shielding strips Stainless Steel.
Servo Controller High precision, fully digital servo drive with embedded
intelligence. Motor DC motor with 2000 line encoder Linear guide Linear guide
blocks Caged ball technology. Gear Planetary gear Clutch Ratchetting clutch 8
source carrying sector units Sector Aluminum. 24 source housing Shafts Induction
hardened stainless steel. Bearings Graphite bushings Motor 24V DC motor Encoder
500 impulses/turn Linear guide unit Repeatability ±0.003mm. Linear encoder
Absolute Linear encoder. Solenoid Photo-micro sensor Servo controllers
Intelligent servo card

 

 

 

 

 

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Patient Positioning System

The Patient Positioning System is the component of the PERFEXIONTM system that
the patient reclines on for treatment and is positioned relative the point of
focus in the radiation unit.

 

The following section describes selected components within the Patient
Positioning System.

All components are chosen from well-recognized suppliers to secure reliability
and to optimize the performance of Leksell Gamma Knife PERFEXION.

 

Couch framework with X/Y/Z drive Framework 20 mm zinc chromated steel Motors DC
motors with 2000 line encoders. Gear X/Y-axis Planetary gear 30:1 Z-axis
Planetary gear 4:1 Ball screws Bearing houses Support bearings X/Z -axis. Screw
jack Y-axis: Integrated safety nut. Linear guides   Linear guide blocks Caged
ball technology. Solenoid Y-axis: Photo-micro sensor. Linear encoders Absolute
Linear encoders. Accuracy grade +/- 0.005mm. Servo Controllers High precision.
fully digital: servo drive. with embedded intelligence. Frame fixation Hardened
stainless steel Comfort system   Mattress support Sandwich structure with
aluminum honeycomb core and steel sheets Actuator  DC actuator Ball bearing
Stainless steel. Covers   Radiation unit and couch covers 3 layers glass
reinforced polyester. Meets ASTM E84 with flame spread index less than 75.
Flammability rating V-0 according to UL 94.

 

 

 

 

 

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Control System

Office Cabinet

 

Includes:

 

MCU - Main Computer Unit

 

Office UPS – Uninterrupted Power Supply

 

Ethernet Switch

 

Operators Console

Includes:

CIU - Connection and Isolation Unit

The CIU is powered by the office UPS and the internal power supply converting
100-250VAC to 24VDC.

PSS - Patient Surveillance system

The PSS is included in the operator console as a separate unit and handles the
video/audio signals of the PERFEXIONTM system. It is possible to connect a video
recorder on the 'auxiliary' outputs.

External audio system. e.g., patients MP3 player, can be connected and played
over the sound system integrated in the radiation unit covers.

 

MCU Monitor

19" Flat screen, UL-approved.

The MCU Monitor shows the Graphical User Interface of the MCU.

 

PSS Monitor

19" Flat screen, UL-approved.

The PSS monitor shows the video from the patient camera and provides the sound
from the patient microphone.

 

Treatment room Monitor

19" Flat screen. UL-approved.

The treatment room monitor displays the same information as the MCU monitor on
the operators console.

 

Treatment room Camera

The treatment room camera provides video to the PSS Monitor in the Operators
Area. Medical Cabinet

 

Includes: SDU -Sector Drive Unit

 

The SDU contains 8 servo controllers (one for each sector).

 

ECU - Electronic Control Unit

The Control Unit consists of two complete Power PCs (PPC) with peripherals (RAM.
ROM, inputs, outputs, CAN interfaces).

 

Medical UPS - Uninterrupted Power Supply

The medical UPS delivers 24VDC and 48VDC needed for the PERFEXIONTM system. It
is approved for medical use.

 

Radiation Phantom

The Radiation Phantom with Cassettes is used for calibrating the absorbed dose
rate of Leksell Gamma Knife®.

 

 

 

 

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Support and Education & Training for PERFEXIONTM

Education & Training Services

 

On-site Clinical Start-Up

One week on-site application training with Gamma Knife experienced neurosurgeon
and/or radiation physicist certified by Elekta.

4 spaces in total selecting between the following two courses:

I) Leksell Gamma Knife® PERFEXIONTM Clinical Introductory Course

Principle and practice of Gamma Knife Surgery, clinical lectures, treatment
planning, patient treatment 4-5 days. Arranged by Elekta in collaboration with
participating hospital.. Elekta pays for the tuition at an approved Elekta
training site.

2) Leksell GammaKnife® PERFEXIONTM Technical / Application training

For use, care and maintenance of the equipment.

Stereotactic imaging, physics, dosimetry, treatment planning, technical training
on unloaded machine, QA procedures - 4 day arranged in Elekta Sweden. Elekta
pays for the tuition at an approved Elekta training site.

 

Support Services

The following support services are delivered in addition to parts warranty
during the term of the Purchased Services Agreement.

 

Maintenance System Management

Customization of the maintenance schedule for maximum equipment availability,
performance and safety with minimum disruption to clinical patient flow.

 

Planned Maintenance

Scheduled preventive maintenance inspections in accordance with Elekta
recommended maintenance intervals and procedures performed by Elekta certified
engineers. The service includes installation of software maintenance releases
and software upgrades. Also included is a service report detailing outstanding
service needs and/or recommended parts replacement to sustain equipment
performance at original design specifications. Parts, software and further
service activities are not included. The customer is responsible for equipment
availability for inspections at a mutually agreed time during regular Elekta
office hours.

 

Remote Technical Support

Unlimited remote technical support, via phone, e-mail, fax or suitable
equivalent, during regular Elekta office hours.

 

On-site Technical Support

Preplanned corrective maintenance by Elekta certified engineers to resolve
technical issues on-site during regular Elekta office hours. This service
includes a service report detailing the maintenance actions completed and
recommending further service actions to eliminate the root cause of the
problem(s). It is at the discretion of Elekta to determine whether an on-site
visit is required to solve the technical issue. Parts and further service
activities not included.

 

Remote Application Support

Unlimited remote application support, via phone, e-mail, fax or a suitable
equivalent, during regular Elekta office hours.

 

Leksell GammaPlan®, remote application support

Unlimited remote application support. via phone, e-mail, fax or a suitable
equivalent, during regular Elekta office hours.

 

 

 

 

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EXHIBIT B

DESCRIPTION OF SITE

 

Saint Vincent's Medical Center

1 Shircliff Way

Jacksonville, Florida 32204

 

 

 

 

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EXHIBIT C

ELEKTA'S WARRANTY

1.Subject to the exceptions set forth below, Elekta warrants to End User that
for one (1) year from the date of completed Installation Test Protocol, the LGK®
will perform consistently with the Specification and the LGK® will be free from
defects in design, materials, and workmanship which result in non-compliance
with the Specification, except as otherwise provided herein below.
Notwithstanding the foregoing, Elekta's warranty set forth in this Section 1
does not cover:

 

(i)defects arising out of materials or parts provided, modified or designed by
End User;

(ii)defects emanating from End User's improper use or maintenance;

(iii)normal deterioration or normal wear and tear, including radioactive decay
of the Cobalt Supply;

(iv)defects resulting from repairs or service of the LGK® supplied other than by
Elekta or its authorized representative;

(v)defects in the Hardware (and its operating software) (the warranty for which
is regulated in Section 7 below) or the LGP Software (the warranty for which is
regulated in Section 2 below).

(vi)the training referred to in Subsection 3.2 of the Terms and Conditions; or

(vii)defects in positioning or in the Site.

 

2.Elekta warrants that the LGP Software will, for a period of one (1) year from
the date of the completed Installation Test Protocol, perform substantially in
accordance with the Specification, and the documentation delivered with such LGP
Software and the Specifications. The warranty set forth in this Section 2 shall
not apply if the LGP Software is subject to unauthorized repair or modification,
improper application, improper installation by a party other than Elekta or
Elekta's authorized agents, accidental damage, negligence in use, improper
storage, acts of God, electrical power damage, equipment malfunction. or
abnormal operating conditions, and in the event of any of the foregoing,
End-User shall be responsible to pay Elekta's then standard charges for any
repairs, replacements or services performed by Elekta.

 

3.In the event that the LGK® or any part or component thereof shall fail to
conform with the relevant warranty described herein, Elekta shall (or cause one
of its affiliates to) promptly repair or replace, at its option and at its
expense, the defect in the LGK® or component thereof. Repair or replacement
parts furnished or work performed under this warranty shall be warranted for a
period of one (1) year from and after the date of such repair of replacement,
but in no event shall any such warranty with respect to repair or replacement
work or parts extend past that date which is two (2) years from and after the
date of completion of the Installation Test Protocol. The defective LGK® or part
thereof which is replaced in accordance with this warranty shall be the property
of Elekta, and Elekta will notify Buyer and End User in writing immediately
after repair or replacement as to what disposition Elekta desires of such LGK®
or part thereof, all at Elekta's cost.

 

4.In order to avail itself of its rights under this warranty, End User shall
immediately notify Elekta in writing of any defects that appear under the
warranty and shall give Elekta every reasonable opportunity of inspecting and
remedying such defects.

 

5.Year 2000 Compliance Warranty Elekta further warrants that the equipment, LGP
Software and use of data will be year 2000 compliant and accommodate a full year
calculation in its software. Licensor will guarantee that the equipment and
software will accept all data and perform to comply with the year 2000
warranties, assuring that the full four (4) positions (e.g. 1997) year is
utilized.

 

 

 

 

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6.THE WARRANTIES SET FORTH HEREIN ARE EXCLUSIVE AND GIVEN AND ACCEPTED IN LIEU
OF ALL OTHER WARRANTIES OF ELEKTA OR ITS REPRESENTATIVES WITH RESPECT TO
QUALITY, PERFORMANCE AND OPERATION OF THE LGK®, WRITTEN OR ORAL, EXPRESSED OR
IMPLIED. ALL OTHER WARRANTIES OF ELEKTA OR ITS REPRESENTATIVES, INCLUDING,
WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE ARE HEREBY EXPRESSLY DISCLAIMED. EXCEPT FOR ACTS OF WILLFUL MISCONDUCT,
GROSS NEGLIGENCE, BREACHES OF CONFIDENTIALITY, BREACHES OF THE BUSINESS
ASSOCIATE ADDENDUM AND INDEMNIFICATION OBLIGATIONS, IN NO EVENT SHALL ELEKTA BE
LIABLE FOR LOSS OF REVENUE OR PROFIT, OR FOR ANY OTHER, INDIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGE ARISING IN ANY RESPECT FROM THE LGK® OR ITS USE, OPERATION
OR PERFORMANCE. THE PROVISIONS OF THIS PARAGRAPH SHALL SURVIVE THE TERMINATION
OF THIS AGREEMENT.

 

7.Elekta shall assign to End User all of Elekta's rights under the warranty or
warranties provided by the manufacturer (the "Computer Manufacturer") for the
Hardware and operating software included in the LGK®. In the event the Hardware
or operating software exhibit defects which are covered by the warranty of the
Computer Manufacturer, End User may notify Elekta of the nature of such defects.
In such case, Elekta shall promptly inform the Computer Manufacturer thereof and
use its best efforts to arrange prompt repair service by the Computer
Manufacturer pursuant to the terms of the Computer Manufacturer's warranty or
warranties Elekta shall furnish End-User with such reasonable cooperation as End
User may request with respect to the purchase by Buyer of any extended warranty
or maintenance contract offered by the Computer Manufacturer.

 

8.Elekta represents and warrants that at the time of delivery, the LGP Software
does not and shall not contain any lock clock, timer trojan horse easter egg,
time bomb, counter copy protection feature replication devices or defect
("virus" or "worm" as such terms are commonly used in the computer industry) CPU
serial number references, or other device which: (i) might lock, disable or
erase the LGP Software; (ii) prevent End User from fully utilizing the LGP
Software; (iii) require action or intervention by Elekta or other persons or
entities to allow End User to utilize the LGP Software; or (iv) might damage End
User's network, data, computer equipment or other property as a result of
accessing the LGP Software.

 

 

 

 

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EXHIBIT D

LEKSELL GAMMAPLAN® PFX™ SOFTWARE LICENSE

1. LGP Software

 

1.1Elekta hereby licenses to Buyer the LGP Software at no additional cost, to be
utilized only for the purpose of planning dosages of treatments to be performed
with the LGK®. In case Buyer already has an existing Leksell Gamma Knife® Buyer
may also retain one license to the old Leksell Gamma Plan® software for archival
purposes. Such license is also subject to the license terms and conditions set
out in this Exhibit D. Such license is for the use by Buyer of the software at
one (1) workstation.

 

1.2Buyer shall not: (a) use LGP Software except in connection with the
radiosurgical operations performed with the LGK® at the Site; (b) except as
otherwise agreed upon in writing, make any modification to, adapt, translate,
decompile, disassemble or create derivative works based on LGP Software or merge
LGP Software into any other software; (c) reproduce LGP Software (or any portion
thereof) or any materials related thereto except for one (1) back-up copy made
as part of Buyer's regular computer software maintenance routines; (d) transfer,
assign or sublicense LGP Software to any person except to an assignee of all of
Buyer's rights in this Agreement in a manner permitted by Section 8.1 of the
Terms and Conditions of this Agreement: or (e) use LGP Software in connection
with any access terminal other than the Hardware which has been specifically
approved by Elekta in writing.

 

1.3All right, title, interest and ownership of, in and to LGP Software,
including but not limited to all trademarks, service marks, registrations,
copyrights, and all other proprietary rights not expressly granted in this
License, shall at all times remain the exclusive property of Elekta. Elekta
shall retain all rights to LGP Software recorded on the original disk(s) and all
subsequent copies of LGP Software, in whatever form recorded.

 

1.4The term of Buyers license to LGP Software shall continue until the earlier
of: (a) any sublicense, assignment or transfer or attempted sublicense,
assignment or transfer by Buyer of LGP Software without the consent of Elekta;
(b) the transport, movement or attempted transport or movement by the Buyer of
LGP Software, or the Hardware on which LGP Software is installed, from the Site
without prior written consent of Elekta; (c) any modification or adaptation of
LGP Software for use with any equipment other than the LGK®, (d) the use of LGP
Software in connection with more than one access terminal unless Buyer has
obtained the written consent of Elekta to the use of more than one access
terminal at the same time or in connection with any access terminal other than
the Hardware which has not been specifically approved by Elekta in writing; or
(E) the mutual written consent of Buyer and Elekta.

 

2 . Buyer's Responsibilities Concerning Hardware and LGP Software:

 

2.1To facilitate E-Mail/Internet support, Buyer shall provide for
E-Mail/Internet connectivity.

 

2.2If Buyer elects to transfer images by a data network, then:

 

(a)Buyer shall provide the format to and right to read the diagnostic images
generated by the user's diagnostic equipment and planned to be used as input for
LGP Software. The Buyer shall provide a sample image in digital and hard copy
form in the orientation intended for clinical use.

(b)Buyer is responsible for obtaining up-to-date and accurate scanner image
formals and any other scanner or PACS information from vendors necessary to
integrate images into LGP Software and providing this to Elekta.

 

 

 

 

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(c)The Hardware used to run LGP Software must be used solely for this and
related purpose. All changes and additions to LGP Software and/or Hardware
running LGP Software must receive prior written approval of Elekta.

(d)Buyer shall provide the images via an Ethernet connection using TCP/IP
protocol and will provide all physical cabling to the LGP Hardware compatible
with 100-Base-T or 1000-Base-T at the Installation location of the LGK®.

(e)Buyer shall provide all TCP/IP networking parameters such as IP address, net
mask, gateway address etc. for the HP workstation included as a part of the
Hardware.

 

 

 

 

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EXHIBIT E

 

HIPAA Business Associate Addendum

 

THIS HIPAA BUSINESS ASSOCIATE ADDENDUM (the "Addendum") is entered into
effective the 4th day of August, 2011 (the "Effective Date"), by and between
Elekta, Inc., ("Business Associate") and Saint Vincent's Medical Center, on
behalf of itself and its affiliates, if any (individually and collectively, the
"Covered Entity") and adds to the Leksell Gamma Knife® End User Agreement dated
8/4/11(the "Agreement") entered into between Business Associate and Covered
Entity.

 

Pursuant to the Agreement, Business Associate may perform functions or
activities on behalf of Covered Entity involving the use and/or disclosure of
protected health information received from, or created or received by, Business
Associate on behalf of Covered Entity ("PHI"). Therefore, if Business Associate
is functioning as a business associate to Covered Entity, Business Associate
agrees to the following terms and conditions set forth in this HIPAA Business
Associate Addendum.

 

1.Definitions. For purposes of this Addendum, the terms used herein, unless
otherwise defined, shall have the same meanings as used in the Health Insurance
Portability and Accountability Act of 1996, and any amendments or implementing
regulations ("HIPAA"), or the Health Information Technology for Economic and
Clinical Health Act (Title XIII of the American Recovery and Reinvestment Act of
2009), and any amendments or implementing regulations ("HITECH").

 

2.Compliance with Applicable Law. The parties acknowledge and agree that,
beginning with the relevant effective dates, Business Associate shall comply
with its obligations under this Addendum and with all obligations of a business
associate under HIPAA, HITECH and other related laws, as they exist at the time
this Addendum is executed and as they are amended, for so long as this Addendum
is in place.

 

3.Permissible Use and Disclosure of Protected Health Information. Business
Associate may use and disclose PHI to carry out its duties to Covered Entity
pursuant to the terms of the Agreement. Business Associate may also use and
disclose PHI (i) for its own proper management and administration, and (ii) to
carry out its legal responsibilities. If Business Associate discloses Protected
Health Information to a third party for either above reason, prior to making any
such disclosure, Business Associate must obtain: (i) reasonable assurances from
the receiving party that such PHI will be held confidential and be disclosed
only as required by law or for the purposes for which it was disclosed to such
receiving party; and (ii) an agreement from such receiving party to immediately
notify Business Associate of any known breaches of the confidentiality of the
PHI.

 

4.Limitations on Uses and Disclosures of PHL Business Associate shall not, and
shall ensure that its directors, officers, employees, and agents do not, use or
disclose PHI in any manner that is not permitted or required by the Agreement,
this Addendum, or required by law. All uses and disclosures of, and requests by
Business Associate, for PHI are subject to the minimum necessary rule of the
Privacy Standards and shall be limited to the information contained in a limited
data set, to the extent practical, unless additional information is needed to
accomplish the intended purpose, or as otherwise permitted in accordance with
Section 13405(b) of HITECH and any implementing regulations.

 

 

 

 

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5.Required Safeguards To Protect PHI. Business Associate agrees that it will
implement appropriate safeguards in accordance with the Privacy Standards to
prevent the use or disclosure of PHI other than pursuant to the terms and
conditions of this Addendum.

 

6.Reporting of Improper Use and Disclosures of PHI. Business Associate shall
promptly, but no later than five (5) business days, report to Covered Entity a
use or disclosure of PHI not provided for in this Addendum by Business
Associate, its officers, directors, employees, or agents, or by a third party to
whom Business Associate disclosed PHI.

 

7.Reporting of Breaches of Unsecured PHI. Business Associate shall promptly, but
no later than five (5) business days, report to Covered Entity a breach of
unsecured PHI, in accordance with 45 C.F.R. §§ 164.400-414. Business Associate
shall cooperate with Covered Entity's breach notification and mitigation
activities, and shall be responsible for all actual and direct costs, which
shall include credit monitoring services for affected individuals, incurred by
Covered Entity for those activities.

 

8.Mitigation of Harmful Effects. Business Associate agrees to mitigate, to the
extent practicable, any harmful effect of a use or disclosure of PHI by Business
Associate in violation of the requirements of this Addendum, including, but not
limited to, compliance with any state law or contractual data breach
requirements.

 

9.Agreements by Third Parties. Business Associate shall enter into an agreement
with any agent or subcontractor of Business Associate that will have access to
PHI. Pursuant to such agreement, the agent or subcontractor shall agree to be
bound by the same restrictions, terms, and conditions that apply to Business
Associate under this Addendum with respect to such PHI.

 

10.Access to Information. Within ten (10) business days from receipt of a
written request by Covered Entity for access to PHI about an individual
contained in a Designated Record Set, Business Associate shall make available to
Covered Entity such PHI for so long as such information is maintained by
Business Associate in the Designated Record Set, as required by 45 C.F.R. §
164.524. In the event any individual delivers directly to Business Associate a
written request for access to PHI, Business Associate shall within five (5) days
forward such request to Covered Entity.

 

11.Availability of PHI for Amendment. Within ten (10) business days from receipt
of a written request from Covered Entity for the amendment of an individual's
PHI or a record regarding an individual contained in a Designated Record Set
(for so long as the PHI is maintained in the Designated Record Set), Business
Associate shall provide such information to Covered Entity for amendment and
incorporate any such amendments in the PHI as required by 45 C.F.R. § 164.526.
In the event any individual delivers directly to Business Associate a written
request for amendment to PHI, Business Associate shall within five (5) days
forward such request to Covered Entity.

 

12.Documentation of Disclosures. Business Associate agrees to document
disclosures of PHI and information related to such disclosures as would be
required for Covered Entity to respond to a request by an individual for an
accounting of disclosures of PHI in accordance with 45 C.F.R. § 164.528.

 

 

 

 

 

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13.Accounting of Disclosures. Within ten (10) days from receipt of written
notice by Covered Entity to Business Associate that it has received a request
for an accounting of disclosures of PHI regarding an individual during the six
(6) years prior to the date on which the accounting was requested, Business
Associate shall make available to Covered Entity information to permit Covered
Entity to respond to the request for an accounting of disclosures of PHI, as
required by 45 C.F.R. § 164.528. In the case of an electronic health record
maintained or hosted by Business Associate on behalf of Covered Entity, the
accounting period shall be three (3) years and the accounting shall include
disclosures for treatment, payment and healthcare operations, in accordance with
the applicable effective date of Section 13402(a) of HITECH. In the event the
written request for an accounting is delivered directly to Business Associate,
Business Associate shall within five (5) business days forward such request to
Covered Entity.

   

14.Electronic PHI. To the extent that Business Associate creates, receives,
maintains or transmits electronic PHI on behalf of Covered Entity, Business
Associate shall:

 

(a)Comply with 45 C.F.R. §§164.308, 310, 312, and 316 in the same manner as such
sections apply to Covered Entity, pursuant to Section 13401(a) of HITECH, and
otherwise implement administrative, physical and technical safeguards that
reasonably and appropriately protect the confidentiality, integrity and
availability of electronic PHI;

 

(b)Ensure that any agent to whom Business Associate provides electronic PHI
agrees to implement reasonable and appropriate safeguards consistent with
industry standards designed to protect it; and

 

(c)Report to Covered Entity any security incident of which Business Associate
becomes aware.

 

15.Judicial and Administrative Proceedings. In the event Business Associate
receives a subpoena, court or administrative order or other discovery request or
mandate for release of PHI, Covered Entity shall have the right to control
Business Associate's response to such request. Business Associate shall notify
Covered Entity of the request as soon as reasonably practicable, but in any
event within two (2) business days of receipt of such request.

 

16.Availability of Books and Records. Business Associate hereby agrees to make
its internal practices, books, and records relating to the use and disclosure of
PHI available to the Secretary of the Department of Health and Human Services
for purposes of determining compliance with the Privacy Standards.

 

17.Breach of Contract by Business Associate. In addition to any other rights
Covered Entity may have in the Agreement, this Addendum or by operation of law
or in equity, Covered Entity may i) immediately terminate the Agreement if
Covered Entity determines that Business Associate has violated a material term
of this Addendum, or ii) at Covered Entity's option, permit Business Associate
to cure or end any such violation within the time specified by Covered Entity.
Covered Entity's option to have cured a breach of this Addendum shall not be
construed as a waiver of any other rights Covered Entity has in the Agreement,
this Addendum or by operation of law or in equity.

 

18.Effect of Termination of Agreement. Upon the termination of the Agreement or
this Addendum for any reason, Business Associate shall return to Covered Entity
or, at Covered Entity's direction, destroy all PHI received from Covered Entity
that Business Associate maintains in any form, recorded on any medium, or stored
in any storage system. This provision shall apply to PHI that is in the
possession of Business Associates or agents of Business Associate. Business
Associate shall retain no copies of the PHI. Business Associate shall remain
bound by the provisions of this Addendum, even after termination of the
Agreement or Addendum, until such time as all PHI has been returned or otherwise
destroyed as provided in this Section.

 

 

 

 

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19.Injunctive Relief. Business Associate stipulates that its unauthorized use or
disclosure of PHI while performing services pursuant to this Addendum may cause
irreparable harm to Covered Entity, and in such event, Covered Entity shall be
entitled to institute proceedings in any court of competent jurisdiction to
obtain damages and injunctive relief.

 

20.Indemnification. Business Associate agrees to defend and indemnify Covered
Entity for any actual direct damage or loss ("Loss"), including reasonable
attorneys' fees and costs, incurred by the Covered Entity as a direct result of
Business Associate's unlawful use or disclosure of PHI or electronic PHI; except
to the extent such Loss is caused by or contributed to by the Covered Entity.
Business Associate will reimburse the Covered Entity for such Loss following
determination of the Loss, including its causation.

 

21.Exclusion from Limitation of Liability. To the extent that Business Associate
has limited its liability under the terms of the Agreement, whether with a
maximum recovery for direct damages or a disclaimer against any consequential,
indirect or punitive damages, or other such limitations, all limitations shall
exclude any damages to Covered Entity arising from Business Associate's breach
of its obligations relating to the use and disclosure of PHI hereunder.

 

22.Owner of PHI. Under no circumstances shall Business Associate be deemed in
any respect to be the owner of any PHI used or disclosed by or to Business
Associate by Covered Entity.

 

23.Third Party Rights. The terms of this Addendum do not grant any rights to any
parties other than Business Associate and Covered Entity.

 

24.Independent Contractor Status. For the purposed of this Addendum, Business
Associate is an independent contractor of Covered Entity, and shall not be
considered an agent of Covered Entity.

 

25.Changes in the Law. The parties shall amend this Addendum to conform to any
new or revised legislation, rules and regulations to which Covered Entity is
subject now or in the future including, without limitation, HIPAA, HITECH, the
Privacy Standards, Security Standards or Transactions Standards.

 

26.Conflicts. If there is any direct conflict between the Agreement and this
Addendum, the terms and conditions of this Addendum shall control.

 

BUSINESS ASSOCIATE:   COVERED ENTITY:           By: /s/ Michelle Crawley   By:
/s/ Moody Chisholm Name: Michelle Crawley   Name: Moody Chisholm Title: VP
Contract Administration   Title: President & CEO Date: 8/4/11   Date: 8/11/11

 

 

 

  

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EXHIBIT F

 

End User Information Services Security Policy

 

 

 

 

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ST. VINCENT'S

HEALTHCARE

ADMINISTRATIVE MANUAL Subject: INFORMATION SERVICES    24.20     SECURITY POLICY
 

 

Original Date:       April 2005 References: 45 CFR Parts 160, 162 and 164
Present Date:         January 2010 Review Date:          December 2011
Supersedes:

Applicable To:

SVHC & Affiliate Companiesx    SVMCx    SCLMx    SLHx    FCPCx

 

GENERAL

St. Vincent's HealthCare (SVHC) is committed to the protection of its electronic
information. Information is one of the most valuable assets of SVHC. Electronic
information is to be protected from accidental or intentional, unauthorized use,
disclosure, modification or destruction. The intent of the Information Services
Security Policy is to provide a basis for an information security program that
would restrict electronic access to authorized individuals only, and provide for
patient privacy and the protection of the confidentiality of clinical and
business information. The following policy statements (Appendix A) have been
developed to protect the confidentiality, integrity and availability of SVHC's
electronic data.

 

The following policy statements (Appendix A) have been developed to protect the
confidentiality, integrity and availability of SVHC's electronic data.

 

The SVHC Information Services Security Policy defines the minimum set of
required security policies for SVHC security program. SVHC and its affiliates
are required to be in compliance with this policy.

 

PURPOSE

1.To protect SVHC applications, computer systems, networks, and electronic data
by ensuring adherence to all Health System information services security
policies.

 

2.To protect the confidentiality, integrity, and availability of SVHC Electronic
Protected Health Information (ePHI) in compliance with the Security regulations
set forth in the Health Insurance Portability and Accountability Act of 1996
("HIPAA").

 

3.To minimize the potential exposure to SVHC, its affiliates and its associates
from damages which may result from unauthorized use of SVHC resources. Potential
damages include, but are not limited to the loss and or unauthorized
modification of Protected Health Information (PHI), confidential Health System
data or intellectual property, damage to public image, damage to critical SVHC
internal systems, fines, civil monetary penalties, and criminal penalties.

 

 

 

 

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SCOPE

This policy applies to all SVHC associates, physicians, contractors,
consultants, volunteers and any other individuals or entities with access to
SVHC applications, systems, networks and/or electronic data. These personnel
will be referred to as the "workforce" throughout the policy.

 

ENFORCEMENT

Any associate found to have violated this policy will be subject to disciplinary
action pursuant to Administrative Policies 15.10 & 15.11 and may be subject to
civil and/or criminal penalties pursuant to local, state and/or federal law. Any
non-employed individual or non-owned entity found to be in violation of this
policy will be subject to loss of SVHC and its affiliates network access
privileges, confiscation of device with removal of data and potential civil
and/or criminal penalties pursuant to local, state and/or federal law.

 

DEFINITIONS

Access Control List (ACL): A list of users, programs, and/or processes and the
specifications of access categories to which each is assigned.    
Administrative Safeguards: Administrative actions, policies and procedures to
manage the selection, development, implementation and maintenance of security
measures to protect ePHI and to manage the conduct of the Business Associate's
workforce in relation to the protection of that information.     Availability:
The ability of an authorized person to use or access objects, resources, data,
or information when needed, without undue delay.     Breach: The successful
defeat of security controls which could result in a penetration of a system or
network. A violation of controls of a particular information system such that
information assets or system components are unduly exposed.     Business
Associate: An individual or organization who (1.) performs on behalf of SVHC and
its affiliates any function or activity involving the use or disclosure of
protected health information, and (2.) is not a member of SVHC workforce.    
Computer System: Hardware and software components that together allow a computer
to operate.     Confidentiality: The property that data or information is not
made available or disclosed to unauthorized persons or processes.     Covered
Entity: A health care provider, health plan, or clearing house required by
federal law to comply with the requirements of the HIPAA Privacy Rule and the
HIPAA Security Standards.     Data Backup: Process of copying all electronic
data to media for applications and computer systems for recovery purposes.    
Data Classification Matrix: A chart which denotes security features that must be
invoked for specific classes of data.

 

 

 

 

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Disaster: An event that would result in complete or near complete loss of
computer systems or any event that creates an inability of an organization's
part to provide critical business functions for some predetermined period of
time.     Electronic Protected Health Information (ePHI):     All individually
identifiable health information that is transmitted by electronic media or
maintained in electronic media.     Encryption: To modify or code data so that
it is illegible without specific key to decode it.     ePHI Application: Any
application that creates, modifies, processes or stores electronic protected
health information.     HIPAA: Health Insurance Portability and Accountability
Act of 1996:     HIPAA has been established to enforce standards for electronic
health information, enhance the security and privacy of health information,
curtail healthcare fraud and abuse, and assure health insurance portability for
employed persons.     Individually Identifiable Health Information:    
Information that is a subset of protected health information, including
demographic information collected from an individual, and: (1) Is created or
received by a health care provider, health plan, employer, or healthcare
clearinghouse; and (2) Relates to the past, present, or future physical or
mental health or condition of an individual; the provision of health care to an
individual; or the past, present or future payment for the provision of health
care to an individual; and (i) That identifies the individual; or (ii) With
respect to which there is a reasonable basis to believe the information can be
used to identify the individual. (42 C.F.R Section 160.103.)     Information
Systems Security Policies:     A defined course of action or behavior that is to
be followed with respect to the acquisition, deployment, implementation,
retirement, or use of information technology resources. They are rules or
regulations to be followed and enforced.     Integrity: The property that data
or information have not been altered or destroyed in an unauthorized manner.    
Least Privileges/Minimum Necessary Information Requirements:         Access
rules based on the principle that security and privacy are best maintained by
providing individuals with access only to the information and functionality they
need to perform their jobs.     Malicious software: Programs written and
distributed with the intent to cause damage to or disrupt network, systems,
devices, servers and/or data, including, but not limited to viruses, worms,
Trojan horses and email bombs.

 

 

 

 

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Malware: Malicious software, including viruses, worms, Trojans, Denial of
Service and other such attacks.     Mobile Device: Any portable computer/device
that allows for storing, accessing and organizing digital information. A mobile
device may feature a scaled-down keyboard, a pen-like stylus, or both. This
includes, but is not limited to, PDAs, laptop computers, palmtop computers, USB
memory sticks, wireless tablets, Blackberries or cell phones with this
capability.     Modality: A medical tool with electronic communication
capability. Examples would be a Computed Tomography (CT) scanner or fetal
monitor.     Perimeter Defense Access System:         A defined security access
method that could include firewall type systems that restricts external
unauthorized access through a variety of access control methods.     Physical
Safeguards: Physical measures, policies, and procedures to protect an
organization's electronic information systems and related buildings and
equipment, from natural and environmental hazards, and unauthorized intrusion.  
  Procedures: Procedures are documented step-by-step instructions to accomplish
specific tasks. Procedures may change frequently due to changes in technology,
products, or business processes. Documented procedures help ensure that systems
are implemented and maintained consistently across the organization. Procedures
support Standards in that they tell specifically how a Standard will be
implemented.         Protected Health Information (PHI):     All individually
identifiable health information created, used, stored, maintained, or
transmitted by any covered entity.     Public Network: All systems, servers,
routers and lines not owned or controlled by SVHC or any of its affiliates that
can be accessed through public access methods, including dial-up, DSL, ISDN,
cable, wireless and other connection methods.     Risk: The possibility of
suffering harm or loss.     Risk Analysis: Assessment of threats to, impacts on,
and vulnerabilities of information and information processing facilities and the
likelihood of their occurrence.     Sanction: A penalty that acts to ensure
compliance or conformity; the penalty for noncompliance specified in a law or
decree.

 

 

 

 

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Security Incident: The attempted or successful unauthorized access, use,
disclosure, modification or destruction of information or interference with
system operations in an information system.     Server: A computer or device on
a network that manages network resources.     Standards: Specific approaches,
solutions, methodologies, products, or protocols that must be adhered to in the
acquisition, deployment, implementation, retirement, or use of system or
procedures.  Standarts are intended to establish uniformity for technology
infrastructures, applications, procedures, or data.  Standards may be developed
as a subset of, and within the context of, a broader technology policy. 
Standards may define or limit the tools, proprietary product offerings or
technical solutions that may be used, developed or deployed by the
organization.  There may be business case exceptions where standards cannot be
followed.  These exceptions must be approved by the appropriate level of
management.  Standards provide specifics in support of more generic Policies.  
  System Administrator: The person in charge of managing a multi-user computer
system.     Technical Safeguards: The technology and the policy and procedures
for its use that protect ePHI and control access to it.

 

PROCEDURE

1.General

 

A.The workforce is accountable for information security, and is required to
know, understand, and follow all SVHC Information Services Security policies and
associated standards and procedures.

 

B.The designated Information Security Officer is required to carry out the
duties of development, implementation, and enforcement of policies and
procedures, and to oversee SVHC's overall information security program.

 

C.SVHC empowers its affiliates and departments to write and approve additional
information systems security policies that are intended to protect SVHC
applications, computer systems, networks, and electronic data (including ePHI)
and/or ensure adherence to regulatory requirements. These policies must meet or
exceed the minimum standards set in the SVHC Information Services Security
Policy, and must be periodically reviewed for compliance.

 

D.Any attempt to compromise information systems security measures is prohibited.
Proper documentation must be submitted and approved by SVHC Information Services
management to obtain authorization for any attempts to compromise information
systems security for testing purposes.

 

E.All personnel must immediately report suspected or verified information
systems security breaches or policy violations to the appropriate SVHC
management, who is then responsible for escalating/reporting the violation to
the Information Security Officer.

 

 

 

 

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F.Any attempts to bypass information systems security measures or any activities
involving the compromise of information systems security measures are
prohibited.

 

G.SVHC management reserves the right to monitor, inspect, or examine at any time
all SVHC information systems without the consent, presence, or knowledge of the
involved users. The types of information systems subject to this right of
monitoring and access include, but are not limited to, electronic mail system
files, access and resource usage reports, personal computer hard drives,
personal and/or shared network directories, and voicemail messages. All
examinations of this nature must be conducted after appropriate approval has
been obtained in accordance with SVHC Electronic Investigation Policy. SVHC
management retains the right to permanently remove from its information systems
any material it deems offensive, potentially illegal, inappropriate, or not
consistent with the mission or values of the organization.

 

II.Acceptable Use

 

A.Any individual using SVHC applications, systems, networks and/or electronic
data must restrict their activities to SVHC business purposes only. All
activities on SVHC information systems are subject to monitoring.

B.Use of SVHC applications, systems, networks and/or electronic data must be
protected to provide necessary assurance of confidentiality, integrity, and
availability by anyone entrusted with such use.

C.Under no circumstance is anyone authorized to use SVHC applications, systems,
networks, and/or electronic data for activities that are contrary to the SVHC
and Ascension Health Standards of Conduct or illegal under local, state, federal
or international law.

 

III.Authorization & Access Management

 

A.All access requests must be documented and approved, using the appropriate
forms located on the Intranet, according to SVHC procedures.

 

B.Authorization and access management procedures must follow the least
privileges /minimum necessary information requirements of the HIPAA Privacy
Rule.

 

C.Access must be granted and used only for authorized business purposes.

 

D.User IDs and passwords, or other authentication methods must uniquely identify
individuals accessing ePHI.

 

E.Sharing a user ID or using another user's ID is prohibited.

 

F.Users are responsible for all activities performed under their user IDs.

 

G.All user passwords must be kept confidential, must be periodically changed,
and are not to be shared with any other individual.

 

 

 

 

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H.Passwords must be at least 8 characters in length or the maximum length
allowed by an application. The configuration and/or use of strong passwords are
required when technically and operationally feasible.

 

I.A password must be changed if the security of the password is believed to be
breached or compromised.

 

J.Whenever possible, user IDs must not give any indication of administrative
privilege level assigned to the account.

 

K.Users must log out or invoke a password protected screen saver or equivalent
when leaving a workstation unattended.

 

L.Auto logoff must be implemented whenever technically feasible.

 

IV.Application Security

 

A.Any individual or group responsible for an ePHI Application must demonstrate
compliance with the HIPAA Security Standards.

 

B.Any individual or group using SVHC applications to create/maintain/inquire
electronic documents containing ePHI is required to keep those documents
confidential.

 

C.Any individual or group responsible for selection of a new ePHI Application
must ensure the application demonstrates compliance with the HIPAA Security
Standards.

 

V.Audit Controls

 

A.SVHC will implement hardware, software, and/or procedures that record and
examine activity in information systems that contain or use ePHI.

 

B.The content and level of detail included in the activity logs must be based on
an assessment of system events that are most likely to be correlated with risks
to the confidentiality, integrity, and availability of the information contained
in the system.

 

C.The auditing mechanisms should record information such as the user
identification associated with the event, the program or command used to
initiate the event, and the time/date of the event.

 

D.Security-related events or actions to consider logging include, but are not
limited to the following:

1.Log on attempts (including failed ones);

2.Changes to security settings or parameters (e.g., minimum password length);

3.User accounts added, changed (privileges), deactivated, and deleted; and

4.Password resets

 

VI.Business Associate, Non-Disclosure, and Confidentiality Agreements /Contracts

 

 

 

 

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A.Business Associate Agreements/Contracts (BAA/BAC) must be completed by
organizations that create, receive, maintain or transmit ePHI on behalf of SVHC
and its affiliates.

 

B.The Business Associate must agree to:

 

1.Implement administrative, physical and technical safeguards that reasonably
protects the confidentiality, integrity and availability of the ePHI;

2.Ensure that any agent, including a subcontractor, to whom it provides ePHI
agrees to implement reasonable and appropriate safeguards to protect it; and

3.Report to SVHC any security incident of which the Business Associate becomes
aware.

 

C.Non-Disclosure/Confidentiality agreements must be completed by organizations
that create, receive, maintain or transmit other (non-ePHI) confidential data on
behalf of SVHC or its affiliates.

 

VII. Contingency Operations

 

A.SVHC and its affiliates must have an overall contingency plan and supporting
procedures for responding to an emergency (i.e. system failure, fire, natural
disaster, vandalism, etc) that compromises the confidentiality, integrity and/or
availability of ePHI, or other mission critical, confidential and/or proprietary
data contained in their environment.

 

B.This plan must be documented and must include procedures for data backup,
periodic system criticality analysis, disaster recovery plan (DRP), emergency
mode operations plan, and procedures for periodic testing and revision of the
contingency plan.

 

VIII. Data Backup and Storage

 

A.SVHC and its affiliates will implement procedures to create, maintain and
verify retrievable exact copies of ePHI.

 

B.The frequency, retention and the storage location of data backups should be
based on criteria including but not limited to the following:

 

1.Patient care impact;

2.Governmental regulations;

3.Business operations; and

4.Security best practices.

 

C.Data backups of ePHI must be performed before movement of equipment as
appropriate.

 

D.Backup media must be stored in a safe environment, preferably in a different
location, and must be available in the event of a system failure or other
disaster.

 

E.The security of the media must be maintained at all times during transport and
storage.

 

 

 

 

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IX.Data Classification

 

A.SVHC will define a data classification scheme which classifies data with
respect to levels of sensitivity and confidentiality of the data. Security
mechanisms for storage, transmission, handling, and destruction must be
implemented to have a direct correlation to the classification of the data.

 

B.Appropriate security measures must be implemented that correspond with the
classification of the data.

 

X.Email Use

 

A.Email users are required to use the SVHC email systems in a professional,
ethical and lawful manner, and in accordance with the SVHC and Ascension Health
Standards of Conduct.

 

B.SVHC and its affiliates reserve the right to monitor, access, review, copy or
delete email messages, created on, received by, transmitted from or stored on
SVHC systems. In approved situations, SVHC may disclose such messages to others,
even when stored with a password.

 

C.Authorized users have no legitimate expectation of privacy in their use of
SVHC email systems. Email messages sent from or received by an SVHC system
belong to SVHC and are not considered private, even if they are accessed via a
personal access code.

 

D.Use of SVHC systems and hardware constitutes consent to email monitoring,
review, reproduction, and/or deletion. Any email message generated or received
by an SVHC system is subject to inspection, disclosure, scheduled retention and
disposition.

 

Xl.Facility Access Control

 

A.All servers and network electronics must be stored in environmentally safe and
secure areas.

 

B.Persons responsible for facilities that house servers or network electronics
must have documented standards and procedures for gaining access.

 

C.Persons requiring access to SVHC facilities that house electronic information
systems must follow established, documented procedures for gaining physical
entry.

 

D.Facility access control lists must be reviewed on a periodic basis.

 

E.A visitor log must be maintained for all non-employed staff (or individuals
that would not normally require access) entering secured computer facilities.

 

F.Management must practice appropriate security measures for terminated and
transferred employees to maintain site security, data integrity and
confidentiality.

 

XII. Incident Handling, Tracking and Response

 

 

 

 

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A.SVHC will implement procedures to identify and respond to suspected or
verified security incidents; mitigate to the extent practical, harmful effects
of security incidents that are known to SVHC Information Services; and document
security incidents and their outcomes.

 

B.Any known security incidents that may impact SVHC or its affiliates must be
reported to the Information Security Officer as soon as possible.

 

C.Documentation of each incident must be maintained for a period required by
local, state and federal regulations.

 

XIII. Internet Use

 

A.Use of the Internet must be conducted in a professional, ethical manner and in
accordance with the SVHC and Ascension Health Standards of Conduct.

 

B.Use of the Internet that would violate any local, state, or federal law is
strictly prohibited.

 

C.Downloading of applications, files or software must adhere to SVHC policies.

 

XIV. Malicious Software / Anti-virus

 

A.SVHC will deploy and maintain a current up-to-date anti-virus solution in
their environments.

 

B.With the exception of authorized security testing, any intentional creation or
deployment of malicious software on a SVHC and/or affiliates electronic device
is prohibited.

 

C.Any electronic devices (including medical devices) that are susceptible to
malicious code attacks must be protected or be isolated from the SVHC devices.

 

D.Infected devices that have the potential to infect other devices must be
immediately removed or isolated from the network until they are verified as
virus-free and have been updated with current security fixes and/or patches.

 

XV. Media Disposal & Re-use

 

A.Any individual responsible for the disposal or redeployment of electronic
devices or media that contain ePHI or other sensitive, confidential, or
protected data must be done in a manner that ensures that data cannot be
recreated or recovered.

 

XVI. Mobile Device Security

 

A.The individual in possession of a mobile device that contains SVHC data is
responsible for ensuring the physical security of that device.

 

B.Individuals must take appropriate measures to prevent unauthorized access to
mobile devices that contain SVHC data.

 

 

 

 

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C.All mobile devices must utilize access management procedures as defined in the
SVHC Information Services Remote Access policy.

 

D.When exchanging data between mobile devices, precautions must be taken to
ensure the integrity and confidentiality of the information being exchanged.

 

XVII. Perimeter Defense

 

A.Any individual connecting an SVHC network device to a public network is
required to deploy a firewall or similar perimeter defense system.

 

B.Firewall devices must be configured to grant access to the SVHC network based
on least privilege / minimum necessary information requirements.

 

C.Periodic maintenance and review of firewall configurations (including rule
sets) and vulnerability testing must be conducted to ensure continued
protection.

 

D.Any individual with a non-owned/non-supported device, or modality, is
prohibited from attaching to an SVHC network port or wireless access point
without proper authorization from Senior IT Management.

 

E.Once deployed, firewall device access logs must remain on file for an
appropriate pre-determined timeframe and be reviewed on a periodic basis.

 

F.With the exception of authorized security testing, any attempt to circumvent
the SVHC firewalls or other perimeter defenses is prohibited.

 

XVIII. Remote Access

 

A.All remote access requests must follow the procedures outlined by SVHC access
approval process.

 

B.Establishing a remote connection to or through an SVHC network from a public
network requires the use of an approved secure remote access method.

 

C.With the exception of authorized security testing, any attempt to bypass
information systems security measures and/or any activities involving the
compromise of information systems security measures is prohibited.

 

D.Anyone given remote access privileges to the SVHC network must only access the
applications, systems and/or electronic data as defined in an approved access
request. Any unauthorized attempt to access applications, systems and/or
electronic data is prohibited.

 

E.Remote access users must follow the access management procedures as defined in
the SVHC Information Services Remote Access policy.

 

 

 

 

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F.All point-to-point connections must connect through a SVHC perimeter security
device.

 

XIX. Risk Analysis & Risk Management

 

A.SVHC will perform a periodic risk analysis that identifies all known risks
associated with their systems containing ePHI and other confidential
information.

 

B.After identifying the risks associated with the systems, SVHC will develop,
document and implement a risk management program that either identifies
strategies to mitigate these risks or documents the justification on why these
risks are being accepted.

 

X.X. Sanctions

 

A.SVHC associates that do not adhere to SVHC and Ascension Health policies will
be subject to disciplinary actions as defined in SVHC Administrative Policies
15.10 and 15.11 - Human Resources corrective action / sanction policies.

 

XXI. Security Awareness & Training

 

A.St. Vincent will implement a security awareness and training program for all
members of its workforce.

 

XX11. Terminations & Transfers

 

A.All system or application owners and administrators providing or controlling
access to SVHC electronic data or physical security are responsible for
documenting and following standards and procedures for terminating, disabling,
and modifying access of the system(s) or application(s) they are responsible
for. These responsible parties are accountable for removing access or changing
access level rights for the terminated or transferred individual in a timely
manner once notification of the termination and/or transfer is received.

 

B.Managers/Supervisors of terminated or transferred associates, physicians,
contractors, volunteers, etc, must initiate the termination or transfer request
immediately upon notification of the termination or transfer or by the effective
date of the termination or transfer.

 

C.Managers/Supervisors must ensure that appropriate access levels are given to
or removed from individuals they supervise based on least privileges and minimum
necessary information requirements.

 

D.Managers/Supervisors are responsible for recovering 1D badges and other SVHC
property (i.e. keys, pagers, cell phones, laptop PCs, proximity cards, and other
SVHC assigned assets) from terminated individuals.

 

 

 

 

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E.All termination and transfer requests are to be considered confidential. All
groups and individuals involved in the termination/transfer process must treat
all such requests as confidential.

 

XXIII. Transmission Security

 

A.Highly sensitive data, including ePHI, transmitted over public networks must
be protected against unauthorized access. When appropriate, mechanisms to
encrypt and verify the integrity of highly sensitive data must be implemented.

 

B.Sensitive data, including ePHI, transmitted over public networks must use any
of the listed methods to ensure the integrity of the data and protect against
unauthorized access. The recommended methods are IPSEC, ESP, MD5, SHA I, 3DES,
HMAC or AES; other methods may be used with the approval of the Information
Security Officer (ISO).

 

XXIV. Vulnerability Management

 

A.SVHC will implement a process and procedures for identifying IT security
vulnerabilities; determining their applicability within the infrastructure;
defining an appropriate response; and implementing corrective action. The goal
of this process is to prevent exposures to the SVHC environment caused by
allowing vulnerabilities to go unmanaged.

 

XXV. Wireless Access

 

A.Any individual using a wireless device is prohibited from attaching the device
to any SVHC wireless network without proper authorization from the Director of
Information Technology or his designate.

 

B.All wireless access to the SVHC network must use strong passwords and
encryption methods.

 

C.With the exception of authorized security testing, any attempt to circumvent
the SVHC wireless security systems for wireless access to or though the SVHC
network is prohibited.

 

XXVI. Workstation/Printer Use & Security

 

A.Physical safeguards that restrict access to authorized users must be
implemented for all workstations that access ePHI.

 

B.Placement of all workstations and printers accessing and/or printing PHI/ePHI
should be in areas that are away from the general public whenever possible so
that unauthorized individuals cannot readily read nor have access to ePHI.

 

C.Any stationary computer screens that display ePHI within clear view of
unauthorized individuals must be equipped with privacy screens.

 

D.Documents containing PHI or other sensitive information must be removed from
printers and fax machines in a timely manner to avoid any possible unauthorized
viewing.

 

 

 

 

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E.Workstations in areas that are vulnerable to theft must be protected using
appropriate protection procedures and/or anti-theft technologies.

 

F.All users are prohibited from installing unlicensed software on any SVHC
system or device.

 

 

 

 

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EXHIBIT G

 

Ascension Health Vendor Access Policy

Purpose:

 

The purpose of this policy is to set forth guidelines for relationships with
Health Care Industry Representatives (HCIR). Ascension Health desires to provide
a safe and effective environment for patients, associates, physicians and other
allied health professionals, while complying with regulatory guidelines. This
Vendor Access Policy is part of a continual processes improvement towards that
end.

 

Objectives:

a. To establish a structured system throughout Ascension Health for education,
training, and introduction of products, procedures, techniques, technology, and
equipment to our associates and physicians.

 

b. Define conditions and requirements HCIRs must abide by to provide training,
knowledge transfer, expertise, products and/or services within Ascension Health
facilities.

 

Definitions:

Ascension Health: This term will be used throughout this document and is
intended to include Ascension Health as a multi-hospital health system, each of
our Health Ministries and/or individual locations dependent on the context of
its use.

 

Associate(s): Includes practicing health care professionals and employees
working at Ascension Health facilities.

 

Supply Chain Lead: An Ascension Health Associate responsible for managing
vendors within the Health Ministry or facility.

Vendor Credentialing Service (VCS): VCS is the Ascension Health contracted
vendor management/vendor credentialing system.

 

Health Care Industry Representative (HCIR): This is an industry accepted term
used to refer to a sales or service professional that represents a company or
companies to Ascension Health associate(s) including: physicians, nurses,
buyers, purchasing agents, executives and other associates that may be general
users or influencers of the company's product. HCIRs represent manufacturers,
distributors, service companies, and other organizations. HCIRs generate sales,
manage contracts, provide quotes, demonstrate products, make repairs, consult,
and perform many other duties generally associated with representing their
company. For the purposes of this policy, three (3) classifications of HCIRs are
defined:

 

Classification 1: Non-clinical, Credentialed, Health Care Industry
Representatives: HCIRs that do not serve primarily in clinical support roles but
engage Ascension Health associates in a manner that requires some level of
credentialing.

 

Classification 2: Clinical, Credentialed, Health Care Industry Representatives:
HCIRs that may serve in clinical support roles. The roles of these HCIRs require
them to typically work in patient care areas, and/or provide assistance to or
consult with patient care associates.

 

Classification 3: Non-Credentialed Representatives: These representatives are
typically delivery personnel or visiting administration. This classification
will be utilized on an exception only basis.

 

 

 

 

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Ascension Health's selected vendor credentialing system, VCS, further defines
classifications by access levels. The VCS level definitions incorporate
contracted personnel. (See addendum A)

 

Policy

 

Key points and rules

 

a.It is the responsibility of each HCIR to properly register with VCS and be
credentialed at the appropriate VCS Level for access to Ascension Health
facilities and personnel.

 

b.HCIRs will not be provided free or unlimited access to any floor, area, suite,
or operating room within Ascension Health. No standing appointments are
permitted. HCIRs will only be permitted to meet with associates in the Supply
Chain Department. Access to Ascension Health non-supply chain personnel will
only be permitted through VCS scheduling with approval of the Supply Chain Lead.

 

c.HCIRs must bring any instrument and/or implant to the sterile processing
department for wrapping and sterilizing 24 hours in advance of procedure. Flash
sterilization is prohibited except in the event of an emergency.

 

d.Any HCIR seeking access to an Ascension Health Ministry for the purpose of
performing maintenance services must have an appointment, scheduled at least
thirty (30) days in advance, with the Supply Chain Lead, or his or her designee.

 

e.HCIRs are not permitted access to any operating room or surgical suite within
Ascension Health without written request from a physician. Such request must
specify and demonstrate a critical clinical need for the presence of the
representative

 

f.In-services will require authorization from the Supply Chain Lead. HCIRs will
schedule an in-service at least 30 days in advance with the Supply Chain Office.
All in-services will be conducted in the Supply Chain Department or designated
education area.

 

a. All associates attending in-services will be provided CEUs by the HCIR's
education department and the appropriate accrediting organization.

 

g.Any distribution of samples and literature shall be coordinated and arranged
through the Supply Chain Lead.

 

h.HCIRs are strictly prohibited from providing demonstration model or loaner
equipment to Ascension Health without having submitted a proposal for such
equipment to the Supply Chain Lead and having received a zero dollar purchase
order for such equipment prior to its arrival on the premises. All equipment
brought in for demonstration/evaluation must have a safety check completed by
biomedical engineering before the equipment can be used at Ascension Health.

 

i.Vendor Products and/or services not expressly included within a contract
executed between Ascension Health, one of its Health Ministries, or a designated
GPO, vendor or product for which no purchase order was issued in advance
(collectively referred to herein as "off contract products") may not be
introduced or provided to the members of the medical staff or associates of
Ascension Health for use. Any off contract products that are provided to and
used by associates in violation of Ascension Health policy shall be deemed
vendor donated product. Vendor shall not invoice for, nor receive any
reimbursement for such off contract product from Ascension Health.

 

 

 

 

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a.Ascension Health recognizes that there may be instances where patient care
dictates use of an off contract product. In such rare circumstances, the Health
Ministry physician requesting use of the off contract product, with assistance
from the HCIR, may apply for an exception to the off contract product policy.
Please be aware that the exception process is time consuming and may take up to
one hundred and eighty (180) days to resolve.

 

j.Ascension Health initiates business with vendors by seeking bids or proposals
from potential sources and awards contracts based on a variety of criteria.
Copies of bids, quotations, special offers, etc. must only be submitted to
Ascension Health Supply Chain or the Health Ministry's Supply Chain Leader
regardless of the original requestor.

 

k.Vendors shall submit all product recall notices to the Supply Chain Leads and
to the attention of the appropriate hospital department designee within three
days of notice. Please refer to Health Ministry's specific protocol.

 

l.HCIRs are not permitted to take still or video pictures within the hospital
without prior authorization from Ascension Health's legal department.

 

m.Gifts and/or gratuities of any kind are prohibited. Displays and food items
are also prohibited unless formally approved by the Supply Chain Lead. Approval
shall be provided on an exception only basis.

 

Before Arriving

 

a. HCIRs must log in to VCS and generate an appointment request prior to each
requested appointment. All vendor appointment requests will be reviewed by the
Supply Chain Lead through the use of the VCS tool. Information required of
vendor for successful appointment request will minimally include:

 

i.Date of HCIR visit

 

ii.Purpose of the visit

 

iii.HCIR destination at the facility

 

iv.Time of entry to the facility

 

v.Time of exit from the facility by the HCIR

 

b. No HCIRs shall be given access to Ascension Health without the successful
completion of the Ministry's vendor credentialing program and strict continued
compliance to Ascension Health rules, standards, policies, and procedures.

 

c. HCIRs visiting Ascension Health must have an approved appointment prior to
arrival on the premises.

 

d. HCIRs must review Ascension Health parking policies for any visit.

 

Upon Arrival

 

a.HCIRs must comply with Ascension Health parking policies.

 

b.A vendor credentialing system will usually be located in the Supply Chain
Department, which may be at a different location than the main campus. An
additional system with limited access will also be located in the Operating
Room.

 

 

 

 

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c.HCIRs must register in at Ascension Health's designated VCS access point in
Supply Chain or, when circumstance permits, near the operating room to receive
their time/date sensitive identification for the appointment.

 

d.HCIRs are required to wear at all times the time stamped badge while on the
Ascension Health Campus.

 

While at the Ascension Health facility

 

a.HCIR is required to wear the time sensitive badge generated by the VCS system
throughout their visit to the facility.

 

b.Category 2 HCIRs are required to comply with department specific policies.

 

c.Medical staff, house staff, other associates, and visitors shall not be
approached on the Ascension Health premises outside of Supply Chain. HCIR
activities outside of approved appointments are prohibited.

 

Before Leaving

 

a. HCIRs must log out at a VCS access point at the conclusion of each scheduled
appointment.

  

Non-Compliance Ramifications

  

a. HCIR non-compliance to this policy will result in the following consequences:

 

i.First Violation: Supply Chain Lead will notify Ascension Health Regional
Supply Chain Officer and the System Office of HCIR non compliance of policy.
HCIR will be placed on probation for 30 days during which time they will not be
able to conduct business at any Ascension Health facility.

 

ii.Second violation: HCIR will be suspended from further business with Ascension
Health.

 

iii. Repeated violations by multiple HCIRs from the same company will result in
all HCIRs from that company being banned for a period of one year from all
Ascension Health facilities, or indefinitely if warranted.

 

b. Based on the severity of the violation, the Supply Chain Lead may determine
an immediate suspension is warranted. Any HCIR found in the violation of this
policy or found to be inappropriately visiting a Health Ministry location may be
charged with trespassing regardless of the number of violations.

HCIR signature/VCS acknowledgment of policy

 

I HAVE READ AND UNDERSTAND THE ABOVE REQUIREMENTS AND AGREE TO THE TERMS STATED
THEREIN.

 

SIGNATURE: ___________________________________ DATE: ______________________

 

PRINT NAME: __________________________________ POSITION:
_______________________________

 

COMPANY: _________________

 

 

 

 

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Addendum A to Exhibit G

 

Classification 1: Non-Clinical, Credentialed, Health Care Industry
Representative

 

VCS Level 1 (Red badge): Access to general hospital areas, non patient care or
procedure areas.

Examples: Pharmaceutical representatives and managers, general medical sales
representatives, laboratory representatives, distributor representatives and
service technicians.

 

VCS Level 7: (White badge): Reserved Pharmaceutical representatives that access
doctor offices but do not access hospitals. Pharmaceutical representatives that
access hospitals will need to be credentialed as a level 1 vendor. Hospitals
often require different policies and credentials.

 

Classification 2: Clinical, Credentialed, Health Care Industry Representative

 

VCS Level 2: (Blue badge) — Access to general hospital areas, patient care areas
and procedure areas. Examples: Medical device representatives, technicians and
company consultants. The required credentials allow you to be in live
procedures.

 

VCS Level 3: (Green badge) — Access to general hospital areas and patient care
areas. Vendor does not have access to procedure areas or live procedures.

 

VCS Level 6: Agency nurses, technicians, and any contracted representatives that
access patient care areas and have patient contact. Health Ministry will require
contractor to provide a competency document.

 

Classification 3: Non-Credentialed Representatives

 

VCS Level 4: (Yellow badge) — Administration and Delivery: Administrative and
Delivery representatives and GPO representatives that access general hospital
areas. Non vendors.

 

VCS Level 5: (Black badge) — Facilities Management: Maintenance, design and
construction workers that access general hospital grounds

 

VCS Level 8: Representatives that have access to Protected Health Information
(PHI). A Business Associate Agreement (BAA) is required. Examples: IT, Legal,
Financial, Consultants, Interpreters, etc. If accessing remotely you will only
need to sign policies.

 

 

 

 

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EXHIBIT H

Visiting Vendor Policy

St. Vincent’s HealthCare

Medical Imaging Department Policy and Procedure Manual

Subject:

VENDOR/SERVICE ENGINEER

VISITOR PASSES

#HR-04

 

Directive #: HR.04   Present Date: March 2011 Original Date: July 2005   Review
Date: February 2012

Applicable To:

SVHC & Affiliated
Companies  £      SVMC   S       SCLM      £      SLH     S       FCPC  £

 Approval:

  

POLICY:

  

Requirement for service engineers and vendors entering the Medical Imaging
Department to have a visitor/vendor badge.

 

PURPOSE:

 

To identify vendors/contractors as they provide services in the Medical Imaging
Department and to ensure safety of our associates and patients.

 

PROCEDURE:

 

1.Vendors and engineers scheduled to perform service on equipment, have been
contracted by St. Vincent's/St. Luke's to work in the Medical Imaging
Department, or have a scheduled appointment are requested to report to the
Security Department upon their arrival at St. Vincent's or St. Luke's.

 

2.Security will provide the vendor or engineer with a badge that must be worn
while in the Medical Imaging Department.

 

3.The vendor or engineer will be required to outline the hours he/she plans to
be on site and must return the badge at the end of each day.

 

4.If the vendor or engineer plans to be on site for more than one day, the badge
must be returned before leaving and reissued upon arrival the next day.

 

5.If the vendor or engineer will be on-site after normal working hours, Security
should be notified with the name, company, and duration of the visit.

 

6.A vendor must have a scheduled appointment with the Director, manager, or team
leader prior to entering the Medical Imaging Department.

 

 

 

 

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7.Upon arrival to the Medical Imaging Department, the vendor or engineer must
check in at the X-Ray waiting area in the hospital. The Medical Imaging manager
or team leader will be contacted to escort the visitor to the appropriate area.
   

8.No vendors will be seen by any Medical Imaging staff without a pre-scheduled
appointment.

 

9.Managers and Team Leaders are responsible for instructing vendors and
contractors as to the content of this policy and all associates are responsible
for enforcing this policy.

 

[END OF DOCUMENT]

 

 

 

 

 

Exhibit 3

 

 

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[pg-84.jpg]

 

 

 

 

[pg-85.jpg]

 

 

 

 

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Exhibit 5.1

 

St. Vincent's Medical Center

1 Shircliff Way

Jacksonville, FL 32204

 

 

 

 

Schedule 1

 

The Purchased Services Payment percentage and pro-rata share for capital
expenditures are as follows:

 

 

Purchased Services Payment

Percentage

Pro-rata Share for

Capital Expenditures

        *

Medical Center *

JGKE *

 

 

 

 

Attachment 1

 

Physician Acknowledgement

 

I, Paul Ossi, M.D., as an (direct or indirect) owner or investor in JGKE, hereby
represent and warrant that during the term of this Agreement, pursuant to the
federal Stark Law, I will not (i) "refer" to Medical Center for any "designated
health services," including but not limited to laboratory, radiology, radiation
therapy, and inpatient/outpatient hospital services, and/or (ii) direct any
other physician to make a "referral" to Medical Center, and/or (iii) control the
"referrals" of any other physician to Medical Center. For purposes of the Stark
Law, I agree and acknowledge that the term "referral" does not include a request
by a radiation oncologist for radiation therapy or ancillary services necessary
for, and integral to, the provision of radiation therapy, if the request results
from a "consultation" initiated by another physician; and (ii) the tests or
services are furnished by or under the supervision of radiation oncologist or
another radiation oncologist in the same group practice. I further understand
and acknowledge that a "consultation" means a professional service furnished to
a patient by a physician if the following conditions are satisfied: (i) the
physician's opinion or advice regarding evaluation or management or both of a
specific medical problem is requested by another physician; (ii) the request and
need for the consultation are documented in the patient's medical record; and
(iii) after the consultation is provided, the physician prepares a written
report of his or her findings, which is provided to the physician who requested
the consultation. With respect to radiation therapy services provided by a
radiation oncologist, I understand and acknowledge that a course of radiation
treatments over a period of time will be considered to be pursuant to a
consultation, provided that the radiation oncologist communicates with the
referring physician on a regular basis about the patient's course of treatment
and progress.

 

  Paul Ossi, M.D.       Signed:  /s/ Paul Ossi, M.D.   Date:     8/8/11

 

 

 

 

Attachment 1

 

Physician Acknowledgement

 

I, Scot N. Ackerman, M.D., as an (direct or indirect) owner or investor in JGKE,
hereby represent and warrant that during the term of this Agreement, pursuant to
the federal Stark Law, I will not (i) "refer" to Medical Center for any
"designated health services," including but not limited to laboratory,
radiology, radiation therapy, and inpatient/outpatient hospital services, and/or
(ii) direct any other physician to make a "referral" to Medical Center, and/or
(iii) control the "referrals" of any other physician to Medical Center. For
purposes of the Stark Law, I agree and acknowledge that the term "referral" does
not include a request by a radiation oncologist for radiation therapy or
ancillary services necessary for, and integral to, the provision of radiation
therapy, if the request results from a "consultation" initiated by another
physician; and (ii) the tests or services are furnished by or under the
supervision of radiation oncologist or another radiation oncologist in the same
group practice. I further understand and acknowledge that a "consultation" means
a professional service furnished to a patient by a physician if the following
conditions are satisfied: (i) the physician's opinion or advice regarding
evaluation or management or both of a specific medical problem is requested by
another physician; (ii) the request and need for the consultation are documented
in the patient's medical record; and (iii) after the consultation is provided,
the physician prepares a written report of his or her findings, which is
provided to the physician who requested the consultation. With respect to
radiation therapy services provided by a radiation oncologist, I understand and
acknowledge that a course of radiation treatments over a period of time will be
considered to be pursuant to a consultation, provided that the radiation
oncologist communicates with the referring physician on a regular basis about
the patient's course of treatment and progress.

 

  Scot N. Ackerman, M.D.       Signed:  /s/ Scot N. Ackerman, M.D. Date:
      8/8/11

 

 

 

 

Attachment 2

 

Purchase and License Agreement

 

EXHIBIT C
TERMS AND CONDITIONS FOR HARDWARE

 

C 1. Definitions. The following terms used in this Agreement shall have the
meaning set forth below:

C 1.1 "Contractual Delivery Date" means the date provided by Supplier at a
reasonable time before Delivery specifying the date for delivery.

 

C 1.2 "Requested Delivery Date" means the tentative date of delivery of Hardware
as requested by Customer in the Cover Page.

C 1.3 "Site Planning Criteria" are the technical data required for installation
of the Hardware set forth in general terms in the site planning criteria (if
any) provided by Supplier separately.

 

 

 

 

 

Purchase and License Agreement

 

C 8.      Warranty.

C 8.1    Supplier warrants that the Hardware will perform in accordance with the
Scope of Supply and the Hardware will be free from defects in design, materials,
and workmanship which result in non-compliance with the Scope of Supply for a
period of twelve (12) months from:

(a)       the date that the Acceptance Test Protocol has been successfully
completed in accordance with this Agreement;

(b)       if no Acceptance Test Protocol has been designated by Supplier, the
Delivery of the Hardware;

(c)       in case of deferred installation, the date as per 6.1 (e).

 

C 8.2 Notwithstanding the foregoing, Supplier's warranty does not cover:

(a)       defects arising out of materials or parts provided, modified or
designed by the Customer;

(b)       preventative maintenance;

(c)       defects emanating from the Customer's improper performance of this
Agreement or improper use or maintenance of the Hardware;

(d)       normal deterioration, decay or wear and tear;

(e)       storage or environmental conditions at the Site that induce premature
failure;

(f)       defects resulting from repairs or service of the Hardware supplied by
other than by Supplier or its authorized representative; or

(g)       Deliverables other than Hardware.

 

 

 

 

Purchase and License Agreement

 

C 8.3 In the event that the Hardware or any part or component thereof shall fail
to conform to the warranty, Supplier shall (or cause one of its Affiliates to)
promptly repair or replace, at its option and at its expense, the defect in the
Hardware or component thereof. Repair or replacement parts furnished or work
performed under this warranty shall be warranted for:

(a)     the remainder of the original Warranty Period; or

(b)     for a period of ninety (90) days from and after the date of such repair
or replacement.; whichever period of (a) and (b) that is the longer period.

 

C 8.4 The defective Hardware or part thereof which is replaced in accordance
with this warranty shall be the property of Supplier. Supplier may, at its sole
discretion replace parts with refurbished or modified parts of equal quality as
the original parts.

 

C 8.5 In order to avail itself of its rights under this warranty, the Customer
shall immediately notify Supplier in writing during the Warranty Period of any
defects that appear under the warranty and shall give Supplier every opportunity
of inspecting and remedying such defects.

 

 

 

 

Purchase and License Agreement

 

EXHIBIT D

TERMS AND CONDITIONS FOR SOFTWARE

 

D 1. Definitions. The following terms used in this Agreement shall have the
meaning set forth below:

D 1.1 "Designated Equipment" means collectively the designated network and
authorized workstation terminals, including but not limited to desktops,
laptops, and/or PDAs operated by or associated with the Customer and/or as
identified in the Scope of Supply.

 

D 1.2 "Documentation" means the specifications and other documentation relating
to the use and performance of the Software (if any), provided by Supplier, in
effect at the time such Software is licensed by the Customer.

 

D 1.3 "License Fee(s)" means the price for the Software license(s), if any, as
specified in the Scope of Supply for the Software.

 

 

 

 

Purchase and License Agreement

 

D 5. Warranty.

D 5.1 Supplier warrants that the Software will perform substantially as
described in the Documentation for a period of twelve (12) months from:

(a)      the date that the Acceptance Test Protocol has been successfully
completed in accordance with the terms of this Agreement; or

(b)      if no Acceptance Test Protocol has been designated by Supplier for the
Software, from the date of its acceptance in accordance with the acceptance
procedure for Software described in 8.2 of these Terms and Conditions for
Software.

 

D 5.2 Notwithstanding the foregoing, Supplier's warranty does not cover:

(a)      defects arising out of unauthorized repair, alteration or modification;

(b)     defects emanating from improper application, the Customer's improper
performance of this Agreement, improper installation, installation and operation
on other equipment than Designated Equipment;

(c)      accidental damage, negligence in use, improper storage, electrical
power damage, Deliverables malfunction; abnormal operating conditions; or

(d)      Deliverables other than Software.

 

D 5.3 In the event that the Software shall fail to conform with the warranty,
Supplier's sole liability to the Customer (subject to section D 5.4 below) shall
be to (or cause one of its Affiliates to) provide such assistance as is
necessary to cause the Software to perform substantially in accordance with
Supplier's Documentation by providing a suitable "fix," "patch," or "work
around" for the problem or a statement that an appropriate "fix" will be
included in a future release of the Software, the time period within which the
release is expected to be issued and a commitment to provide the release at no
cost to the Customer.

 

D 5.4 If Supplier is unable, after reasonable effort, to cause the Software to
perform substantially in accordance with the Documentation, then this Agreement
may be terminated with respect to the Software at the option of either Party
hereto without further obligation or liability and such termination shall
(subject to section D 5.5 below) be the Customer's exclusive remedy and
Supplier's sole liability in connection with the failure to remedy the breach of
warranty.

 

D 5.5 In the event of termination during the warranty period as per section D
5.4 above, Supplier shall refund to the Customer all License Fee paid by the
Customer for the affected Software. No refund shall be made if the License Fee
is included in the Scope of Supply for the Hardware.

 

D 5.6 In order to avail itself of its rights under this warranty, the Customer
shall immediately notify Supplier in writing during the Warranty Period of any
defects that appear under the warranty, adequately describe any such failure
encountered by the Customer and shall give Supplier every opportunity of
inspecting and remedying such defects.

 

D 5.7 Supplier does not warrant that any Software is error-free or that its use
will be uninterrupted.

 

D 5.8 Supplier shall not be obligated to remedy any Software defect which cannot
be adequately repeated. Further in the event the Supplier spends time looking
for a defect that cannot be found/repeated it shall be entitled to charge the
Customer for the time spent at its list price in force at that time for such
services.

 

D 6. DISCLAIMER OF WARRANTY.

D 6.1 EXCEPT AS EXPRESSLY PROVIDED IN SECTION 5. ABOVE, THE SOFTWARE IS PROVIDED
"AS-IS" WITHOUT ANY OTHER WARRANTY WHATSOEVER. ALL IMPLIED WARRANTIES; INCLUDING
IMPLIED WARRANTIES OF NON-INFRINGEMENT, MERCHANTABILITY, SATISFACTORY QUALITY
AND FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY EXCLUDED.

 

 

 

 

Purchase and License Agreement

 

EXHIBIT F

TERMS AND CONDITIONS FOR SERVICES

 

F 1. Definitions. The following terms used in this Agreement shall have the
meaning set forth below:

 

F 1.1 "Hardware Maintenance and Support Service Fee" means the Supplier's price
for the Services for the Hardware. The Hardware Maintenance and Support Service
Fee for the current year is specified in the Cover Page.

 

F 1.2 "Service Fee" means individually or collectively the fee for Hardware
Maintenance and Support Service and/or Software Maintenance and Support Service.

F 1.3 "Software Maintenance and Support Service Fee" means the Supplier's price
for the Services for the Software. The Software Maintenance and Support Service
Fee for the current year is specified in the Cover Page.

 

 

 

 

Purchase and License Agreement

 

 

 

 

Purchase and License Agreement

 

F 8. Warranties.

F 8.1 Supplier warrants that the Services will be carried out in a competent and
professional manner and with all reasonable care and skill.

 

F 8.2 Supplier warrants that all replacement parts installed outside of the
original Hardware warranty issued by Supplier are covered by a 90-day parts only
warranty unless otherwise stated. Any replacement parts installed within the
original Hardware warranty provided by Supplier are covered for the reminder of
the Hardware warranty for both parts and labor.

 

F 8.3 Supplier reserves the right to replace any spare parts with new, modified
or refurbished parts of substantially equal quality as the original parts in the
course of providing the Services and any defective part which is replaced when
providing the Services shall be the property of Supplier if Supplier so
requests.

 

F 8.4 To the extent the Services specified in the Scope of Supply includes that
the Hardware and/or Software shall perform substantially in accordance with its
Scope of Supply and/or Documentation, whichever is applicable, and if Supplier
is unable, after reasonable effort, to cause the Hardware and/ or Software
subject to the Services to perform substantially in accordance with its Scope of
Supply and/or Documentation, whichever is applicable, then the Services may be
terminated with respect to the Hardware and/ or Software so affected at the
option of either Party hereto without further obligation or liability. Such
termination shall be the Customer's exclusive remedy and Supplier's sole
liability in connection with the Services related to any such Hardware and/or
Software.

 

F 8.5 Supplier shall not be obligated to remedy any Hardware and/or Software
defect, failure, or error that cannot be adequately repeated.

 

F 8.6 New software products are not included in Supplier's standard Services and
will be offered by Supplier to the Customer at Supplier's then current published
prices and on such other terms and conditions as are acceptable to Supplier.