Technology License and Services Agreement - San Pedro Peninsula Hospital d/b/a Little Company of Mary - San Pedro Hostpial and Hythiam Inc.
TECHNOLOGY LICENSE AND SERVICES AGREEMENT
The terms of this Technology License and Services Agreement
("AGREEMENT") are agreed to by and between San Pedro Peninsula Hospital d.b.a.
Little Company of Mary - San Pedro Hospital ("HOSPITAL") and Hythiam, Inc.
("HYTHIAM") (each a "PARTY" and collectively "THE PARTIES").
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Agreement Effective Date: November 10, 2003
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Term of Agreement: Three (3) years
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Little Company of Mary - San Pedro Hythiam, Inc.
Hospital
By: /s/ Blair Contratto By: /s/ Terren S. Peizer
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Title: Chief Executive Officer Title: Chief Executive Officer
Address: 4102 Torrance Blvd. 11111 Santa Monica Blvd. #550
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Torrance, CA 90503 Los Angeles, CA 90025
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Contact: Contact:
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Phone: Phone:
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E-mail: E-mail:
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Attachments: Schedule A; Schedule B: Authorized Users; Schedule C:
Business Associate/Data Use Agreement
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AGREEMENT TERMS
1 PURPOSES
Hythiam provides through its proprietary protocol for treatment of
substance abuse, its Data Reports (as defined in Section 4.2) and other
associated Hythiam intellectual property and Services (as defined in Section 4)
(collectively "LICENSED TECHNOLOGY") a process for use by health care providers
and others in treating patients with or suspected of addiction to opiates,
cocaine, and/or alcohol and related conditions. Hospital desires to be able to
offer to its patients and third party payers services that include use of the
Licensed Technology.
2 AUTHORITY AND RELATIONSHIP OF THE PARTIES
Hospital and Hythiam are and shall remain independent contractors
throughout the Term. Nothing in this Agreement shall be construed to constitute
Hospital and Hythiam as partners, joint venturers, agents or anything other than
independent contractors.
3 HYTHIAM LICENSE
3.1 Grant of License Rights to Hospital
Subject to the terms and conditions of this Agreement, Hythiam hereby
grants to and Hospital hereby accepts, a limited nontransferable, restricted,
non-exclusive, revocable, commercial license to operate and use the Licensed
Technology identified generally in more detail on Schedule A at the Hospital
location(s) identified on Schedule A for the purposes set forth on Schedule A
without the right to sublicense the foregoing rights ("HYTHIAM LICENSE").
Hospital acknowledges that (i) this Agreement does not transfer any interest in
the ownership or title of any portion of the Licensed Technology; and (ii)
Hospital does not own any portion of the Licensed Technology.
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3.2 Term of License
The Hythiam License shall terminate simultaneously with the expiration or
termination for any reason of this Agreement.
3.3 License Restrictions
Hospital may use all or any part of the Hythiam Licensed Technology only
for the purposes set forth in this Agreement. Without limiting the generality of
the foregoing, Hospital shall not, nor shall permit any third party to, (a)
copy, modify, market, reproduce, sell or distribute the Hythiam Licensed
Technology other than as actually necessary and then only in strict accordance
with this Agreement for delivery of patient care services and billing third
parties for reimbursement of those services; (b) make the Licensed Technology or
Services available to any Person, except Hospital Personnel or Staff Physicians
(as those terms are defined in Section 4.1) who have been authorized by Hythiam
in writing as set forth on Schedule A and who have been informed of by Hospital,
and are bound by, the terms and conditions of this Agreement; (c) modify or
create derivative works based upon the Licensed Technology; (d) rent, lease,
grant a security interest in, or otherwise transfer or attempt to transfer any
rights in or to the Licensed Technology; or (e) remove, alter or deface any
legends, restrictions, product identification, copyright, trademark or other
proprietary notices from the Licensed Intellectual Property.
3.4 Exclusivity
Hythiam agrees that beginning on the Effective Date and continuing until
November 1, 2004, Hospital or any of its affiliates will be the sole hospitals
to which Hythiam grants a license to the Licensed Technology in the geographic
area defined on Schedule A.
3.5 Hospital Obligations
Hospital shall (a) keep the Licensed Technology free and clear of any and
all claims, liens and encumbrances incurred or caused by Hospital, and (b) be
responsible for all the cost and all liability or risk of loss associated with
the use by Hospital of the Licensed Technology as contemplated by and in this
Agreement. THE RIGHTS SET FORTH IN THIS SECTION 3 REPRESENT HOSPITAL'S ONLY
RIGHTS WITH RESPECT TO THE USE OF ALL OR ANY PORTION OF THE LICENSED TECHNOLOGY.
ANY USE OF ALL OR ANY PORTION OF THE LICENSED TECHNOLOGY OUTSIDE THE SCOPE OF
SUCH RIGHTS IS STRICTLY PROHIBITED.
4 HYTHIAM SERVICES
4.1 Provision of Licensed Technology
Hythiam will deliver to Hospital the Licensed Technology as set forth on
Schedule A. Only Hospital employees and non-physician independent contractors
(collectively "HOSPITAL PERSONNEL") or physicians practicing at Hospital ("Staff
Physicians") authorized by Hythiam as set forth on Schedule A shall have access
to or use the Licensed Technology.
4.2 Data Processing Services
Hythiam has developed proprietary business processes that it uses to
process and report data generated from the use of the Licensed Technology ("DATA
REPORTS"). As part of the Services, Hythiam will collect treatment and outcomes
data on behalf of Hospital, including follow-up patient surveys, and will
provide, or arrange for the provision of, Data Reports to Hospital for treatment
performed by or on behalf of Hospital using the Licensed Technology, all as set
forth in more detail on Schedule A.
4.3 Education Services
As part of the Services, Hythiam will provide education services as
reasonably necessary concerning the implementation and use of the Licensed
Technology.
4.4 Performance Standards
Hythiam will provide the Licensed Technology as set forth in Section 4.1,
the Data Reports as set forth in Section 4.2 and the education services as set
forth in Section 4.3 (collectively "SERVICES") in a competent and timely manner,
and in compliance with all applicable laws and regulations.
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5 FINANCIAL TERMS
5.1 Licensing and Services Fees
During the Term of this Agreement, Hospital shall arrange for the payment
by or on behalf of each individual treated using the Licensed Technology of the
Licensing and Services Fee ("FEES") to Hythiam as set forth on Schedule A.
During the Term the Fees may be modified only by mutual agreement of the
Parties. Any and all services requested by Hospital and provided by Hythiam
other than those set forth in Section 4 shall be subject to additional fees to
be agreed upon by the Parties.
5.2 Payment Terms
Hythiam will provide Hospital with periodic (no less frequently than
monthly and no more frequently than every two weeks) reports and invoices
("INVOICES") for the Fees due Hythiam by mailing or delivering them to the
address and person identified on the first page of this Agreement. For Fees paid
by patients in cash in advance to Hospital, Hospital will pay Hythiam within
[H-01 TEXT DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.] days
after receipt by Hospital of the cash payment. For Fees paid by third party
payers or by patients who do not pay in advance, Hospital will pay Hythiam
within [H-02 TEXT DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.]
days after collection by Hospital of the Fees. Also, within [H-03 TEXT
DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.] calendar days after
receipt by Hospital of each Invoice (1) for cases in which the Fee has been paid
to Hospital but not remitted to Hythiam, Hospital shall remit those Fees to
Hythiam; and (2) for cases in which Hythiam has received any amounts over and
above the Fees that should have been paid to Hospital, Hythiam will remit those
funds to Hospital. Notwithstanding any other provision of this Agreement,
Hythiam in no event or circumstance is or shall be responsible for any costs of,
or related to, patient care provided by Hospital, extended or unanticipated care
required for patients treated using the Licensed Technology or any Aftercare (as
that term is defined in defined in paragraph 8 on Schedule A).
5.3 Monthly Reconciliation
To facilitate payment and compliance with the terms of this Agreement, the
Parties will meet no less frequently than monthly and no more frequently than
every two weeks for purposes of reconciling payments and fees. In preparation
for this meeting, Hospital shall provide Hythiam with a list of all patients
receiving treatment during the prior month utilizing the Licensed Technology and
Hythiam shall provide Hospital with a list of all fees it has received for
treatment during that same time period. Each Party will provide reasonable
access to its books and records regarding any and all detail reasonably
necessary to reconcile payments and ensure Hythiam receives the Fees in
compliance with this Agreement. In addition, Hospital will investigate and
resolve promptly and thoroughly any evidence that the Licensed Technology is
being used at Hospital in cases for which Hythiam is not receiving its Fee.
5.4 Managed Care Contracts
Hospital and Hythiam each will use best efforts to identify opportunities to
include reimbursement for treatment utilizing the Licensed Technology in, and
will use commercially reasonable efforts to negotiate amendments to, Hospital's
existing managed care contracts to (and to negotiate all future managed care
contracts to) arrange for inclusion of coverage for treatment utilizing the
Licensed Technology.
6 GOVERNING TERMS AND OBLIGATIONS
6.1 Use of Licensed Technology
Hospital agrees that its use of the Licensed Technology will be in strict
accordance with the procedures and any training provided by Hythiam and will
comply with all applicable laws, rules and regulations and third party payer
requirements. Only Hospital Personnel or Staff Physicians who have received
training on the use of the Licensed Technology may use it and Hospital will
ensure (and provide Hythiam with evidence satisfactory to Hythiam) that all
Hospital Personnel or Staff Physicians who use any or all of the Licensed
Technology on its behalf are bound by the applicable terms of this Agreement and
will have and maintain, all training, licenses, approvals, certification,
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equipment and information necessary for them to safely and properly use the
Licensed Technology.
6.2 Clinical Activities
The Licensed Technology and Services are provided by Hythiam to Hospital
and/or to any Hospital Personnel or Staff Physicians as additional points of
information and not, in whole or in part, as medical advice, diagnosis or
treatment recommendations. The Parties acknowledge and agree that Hythiam in
performing its obligations under this Agreement is providing technology and
technology services only and will not be delivering patient care and will not be
sponsoring or performing human subjects research. Hospital, as between the
Parties, and/or Staff Physicians, as appropriate consistent with applicable law,
control and are fully responsible for any and all patient care, Aftercare and/or
research activity delivered using the Licensed Technology. Hospital Personnel
and Staff Physicians shall at all times exercise their independent medical
judgments when treating patients, arranging for Aftercare or referring to other
providers, or performing research using the Licensed Technology.
6.3 Hospital charges
Hospital charges for provision of care using the Licensed Technology are
set forth on Schedule A. During the Term these charges may be modified only by
mutual agreement of the Parties.
6.4 Billing and Collections
In billing any charges to patients or third-party payers that include
clinical services or research activities performed using the Licensed Technology
or Services Hospital shall comply with the provisions of 18 U.S.C. ss. 1347,
with Medicare/Medicaid and other Federal Health Care Program billing
requirements, and with the False Claims Act, 31 U.S.C. ss. 3729, et seq., and
analogous state or local laws.
6.5 Subject Data
Hospital shall provide to Hythiam for prompt downloading and/or processing
in an agreed upon format all patient data collected or maintained by Hospital,
Hospital Personnel or Staff Physicians with respect to each individual provided
care using all or part of the Licensed Technology ("SUBJECT DATA"). The Parties
shall execute the Business Associate/Data Use Agreement attached to this
Agreement, which shall govern the use and disclosure by Hythiam of the Subject
Data.
6.6 Patient Data Consents
Hospital shall be solely responsible for obtaining any and all patient
consents, authorizations and/or IRB approvals required by applicable laws,
rules, regulations or policy for its use of the Licensed Technology and the
provision of the Subject Data to Hythiam in accordance with this Agreement.
7 INTELLECTUAL PROPERTY RIGHTS
7.1 Reservation of Rights
All rights and licenses of any kind in the Licensed Technology and
Services not expressly granted in this Agreement are reserved exclusively to
Hythiam. There shall be no licenses by implication to the Hospital, any Hospital
Personnel or any Staff Physician under this Agreement, and Hospital agrees not
to attack or contest, in any way or in any forum, the validity, enforceability,
or Hythiam's ownership of, or rights in, the Licensed Technology and Services,
to the maximum extent permitted by law.
7.2 Preexisting Intellectual Property
Except as expressly provided for in this Agreement, Hythiam and Hospital
shall each retain all Intellectual Property that they owned prior to the
Effective Date, and this Agreement shall not be interpreted or construed to
grant a Party any rights, title, interest or license in the other Party's
preexisting Intellectual Property.
7.3 Improvements Produced During Term
Hythiam shall own all rights, title and interest in any Intellectual
Property related to, within the scope of or that enhances the Licensed
Technology made during the Term by Hythiam, the Hospital and/or Hospital
Personnel and/or any Staff Physician including without limitation, adaptations,
modifications, enhancements or changes to the Licensed Technology
("IMPROVEMENTS"). The Improvements shall be considered included in the
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definition of Licensed Technology for purposes of this Agreement, and the
Hospital, Hospital Personnel and Staff Physicians hereby assign all right, title
and interest in all Improvements to Hythiam. Hythiam shall have the right to
apply for copyrights, patents (including utility and design patents), or other
protection for such Improvements, and to enforce its rights in such
Improvements, anywhere in the world under its own name and at its own expense.
Hospital, Hospital Personnel and Staff Physicians agree to take all actions and
execute all documents at Hythiam's expense and as Hythiam may reasonably
request, to effectuate Hythiam's ownership of any such Improvements.
7.4 Use of Trademarks
Each Party recognizes that the name, logo and trademarks of the other
Party represent valuable assets of such entity and that substantial recognition
and goodwill are associated with such assets. Each Party hereby agrees that
neither it nor any of its affiliates shall use the name, logo or any other
trademarks of the other Party without the prior written consent of the other
party, which may be withheld at the sole discretion of the other Party. No Party
will acquire any right, interest or license in any trademark or service mark of
the other Party by virtue of this Agreement. Where possible, Hospital will
approve the use of its name in documents for broad dissemination such that
Hythiam, once securing approval for use in a brochure or other document, will
not need to secure approval for each use of the brochure or document.
8 INDEMNIFICATION
8.1 Hythiam Indemnification of Hospital
Hospital shall not be liable to Hythiam or its affiliates or any of their
respective officers, directors, employees or other agents for, and Hythiam shall
indemnify, defend and hold harmless Hospital and its directors, officers,
employees and agents (collectively, the "HOSPITAL INDEMNITEES") from and
against, any and all liabilities, losses, suits, claims, costs, expenses
(including reasonable attorneys fees and disbursements), interest, penalties,
fines, judgments and actual or direct damages of any kind whatsoever
(collectively "LOSSES") to the extent and proportion that such Losses relate to
or arise from (i) negligent acts or omission or willful misconduct of Hythiam or
any of the Hythiam Indemnitees (as that term is defined in Section 8.2); or (ii)
breach of this Agreement by the Hythiam Indemnitees. Notwithstanding other
provisions of this Section 8.1, Hospital Indemnitees shall not include
physicians who are not Hospital employees to the extent those physicians are
providing patient care, but shall include physicians who are not Hospital
employees to the extent those physicians are providing medical director or other
administrative services to or on behalf of Hospital.
8.2 Hospital Indemnification of Hythiam
Hythiam shall not be liable to Hospital or its affiliates or any of their
respective officers, directors, employees or other agents for, and Hospital
shall indemnify, defend and hold harmless Hythiam and its directors, officers,
employees and agents (collectively, the "HYTHIAM INDEMNITEES") from and against
any Losses to the extent and proportion that such Losses relate to or arise from
(i) negligent acts or omissions or willful misconduct of Hospital or any of the
Hospital Indemnitees; or (ii) breach of this Agreement by Hospital or any of the
Hospital Indemnitees.
9 CONFIDENTIALITY AND NON-DISCLOSURE
9.1 Confidential Information
Hospital acknowledges and agrees that the Licensed Technology constitutes
valuable trade secrets and confidential information of Hythiam. Hospital agrees
that it shall take, and shall ensure that Hospital Personnel and Staff
Physicians shall take, all reasonable steps to preserve and protect the
confidentiality of such trade secrets and confidential information. Such trade
secrets and information shall be deemed "CONFIDENTIAL INFORMATION." In addition,
Confidential Information shall include the terms of this Agreement and all other
proprietary business information Hospital, Hospital Personnel or Staff
Physicians have received or receive from Hythiam or obtain as a result of use of
the Confidential Information.
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9.2 Non-Disclosure
Hospital agrees to maintain as confidential the Confidential Information
and further agrees not to disclose the Confidential Information other than as
specifically permitted by this Agreement. At no time shall Hospital use, or
allow others to use or have access to, the Confidential Information for any
purpose other than performance of Hospital's obligations or exercise of
Hospital's rights under and in accordance with this Agreement or disclose the
Confidential Information to any third party without the prior written consent of
Hythiam, which may be withheld in its sole discretion, and then only after the
party to whom such disclosure will be made has agreed in writing to comply with
and be bound by the applicable terms of this Agreement, including but not
limited to this Section 9. In the event of any legal action or proceeding or
asserted requirement under applicable law or government regulations requesting
or demanding disclosure by Hospital of all or any part of the Confidential
Information, Hospital shall immediately notify Hythiam in writing of such
request or demand, the terms and circumstances surrounding such request or
demand, and the documents requested or demanded so that Hythiam may seek an
appropriate protective order or take other protective measures and/or waive
Hospital's compliance with the provisions of this Section 9. If in the absence
of a protective order or a waiver under this Section 9 from Hythiam, if
Hospital, in the reasonable opinion of Hospital's legal counsel, is compelled to
disclose any such Confidential Information or otherwise stand liable for
contempt or suffer other substantial penalty, Hospital may disclose such
Confidential Information as so required without liability under this Section 9;
provided, however, that Hospital: (a) shall give Hythiam written notice of the
Confidential Information to be so disclosed as far in advance of its disclosure
as is practicable; (b) shall furnish only that portion of the Confidential
Information which in the reasonable opinion of Hospital's counsel is legally
required; and (c) shall cooperate with Hythiam (at Hythiam's expense) to obtain
an order or other reliable assurance that confidential treatment will be
accorded to such Confidential Information.
10 TERMINATION
This Agreement may be terminated prior to the expiration of the Term only
for Cause (as defined in this Section 10), which cause shall constitute an
"Event of Default." A termination for Cause must be effected by giving written
notice to the defaulting Party describing the Event of Default with reasonable
specificity and shall be subject to the cure periods set forth in this Section
10. In the event of termination of this Agreement for any reason, each Party
shall take all reasonable action and refrain from taking any action to the
extent necessary to mitigate that Party's damages arising from or related to the
termination.
10.1 Termination by Hospital
Hospital shall have Cause for termination of this Agreement under the
following circumstances:
10.1.1 If Hythiam shall apply for or consent to the appointment of a
receiver, trustee or liquidator of all or substantially all of its assets,
file a voluntary petition in bankruptcy or admit in writing the inability
to pay its debts as they become due, make a general assignment for the
benefit of creditors or take advantage of any insolvency law, subject to a
thirty (30) day cure period after written notice of termination by
Hospital;
10.1.2 If Hospital finally determines to, takes diligent action to
and does, close down and eliminate its provision of chemical dependency
treatment services, subject to a 180 day advance written notice to Hythiam
and subject to Hospital's written covenant that it will not reinstate its
provision of such services for a period of at least two (2) years
following termination.
10.1.3 If Hospital presents reasonable evidence that continuation of
the Agreement will result directly in a sustained lack of profitability to
Hospital, subject to a 180 day advance written notice to Hythiam; or
10.1.4 If Hythiam materially defaults in its performance of any of
its material obligations under this Agreement, subject to a thirty (30)
day cure period.
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10.2 Termination by Hythiam
Hythiam shall have Cause for termination of this Agreement under the
following circumstances:
10.2.1 If Hospital shall apply for or consent to the appointment of
a receiver, trustee or liquidator of all or substantially all of its
assets, file a voluntary petition in bankruptcy or admit in writing the
inability to pay its debts as they become due, make a general assignment
for the benefit of creditors or take advantage of any insolvency law,
subject to a thirty (30) day cure period after written notice of
termination by Hythiam;
10.1.2 If Hospital loses its license to provide chemical dependency
services;
10.1.3 If Hythiam presents reasonable evidence that continuation of
the Agreement will result directly in a sustained lack of profitability to
Hythiam subject to 180 days advance written notice to Hospital;
10.1.4 If Hospital materially defaults in its performance of any of
its material obligations under this Agreement, subject to a thirty (30)
day cure period.
11 DISCLAIMER OF WARRANTIES
HOSPITAL ACKNOWLEDGES AND AGREES THAT THE LICENSED TECHNOLOGY AND SERVICES
PROVIDED, BEING LOANED, AND/OR LICENSED TO HOSPITAL ARE PROVIDED ON AN "AS IS"
AND "AS AVAILABLE" BASIS WITH NO WARRANTY OF ANY KIND. WITH RESPECT TO THIS
AGREEMENT HYTHIAM MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT
LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, DATA ACCURACY, SYSTEM INTEGRATION, OR NON-INFRINGEMENT, REGARDING THE
LICENSED TECHNOLOGY OR ANY OTHER MATERIALS OR INFORMATION PROVIDED UNDER THIS
AGREEMENT. ADDITIONALLY, WITH RESPECT TO THIS AGREEMENT HYTHIAM MAKES NO
REPRESENTATIONS OF ANY KIND, EXPRESS OR IMPLIED, REGARDING THE SAFETY OR
EFFICACY OF THE LICENSED TECHNOLOGY, THAT THE LICENSED TECHNOLOGY WILL OPERATE
IN A MANNER THAT IS UNINTERRUPTED OR ERROR-FREE, OR REGARDING ANY OTHER SUBJECT
MATTER OF THE AGREEMENT.
12 LIMITATION OF LIABILITY
SUBJECT TO SECTION 8, HYTHIAM ASSUMES NO LIABILITY OR RESPON-SIBILITY FOR
HOW HOSPITAL, ANY HOSPITAL PERSONNEL OR ANY STAFF PHYSICIAN USES THE LICENSED
TECHNOLOGY FOR OR IN CONNECTION WITH ANY DIAGNOSIS OR TREATMENT MADE OR PROVIDED
IN CONNECTION WITH OR RELIANCE ON THE LICENSED TECHNOLOGY, OR FOR INJURY TO
PERSONS OR PROPERTY ARISING FROM THE USE OF THE LICENSED TECHNOLOGY. NOT
WITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, IN NO EVENT SHALL HYTHIAM
HAVE ANY LIABILITY FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL, PUNITIVE OR
EXEMPLARY DAMAGES OF ANY KIND, INCLUDING BUT NOT LIMITED TO LOST REVENUES OR
LOST PROFITS, LOSS OF BUSINESS OR GOODWILL OR LOSS OF DATA, IN ANY WAY ARISING
OUT OF, RELATED TO OR IN CONNECTION WITH THIS AGREEMENT, EVEN IF HYTHIAM HAS
BEEN ADVISED OR OTHERWISE HAS REASON TO KNOW OR KNOWS OF THE POSSIBILITY OF SUCH
DAMAGES. HOSPITAL FURTHER AGREES THAT IN NO EVENT WILL THE TOTAL AGGREGATE
LIABILITY OF HYTHIAM FOR ANY CLAIMS, LOSSES, OR DAMAGES ARISING UNDER THIS
AGREEMENT, WHETHER IN CONTRACT, TORT, PRODUCT LIABILITY, OR OTHERWISE, EXCEED
$[H-04 TEXT DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.].
13 DEBARMENT OR EXCLUSION
Each Party hereby represents and warrants that neither it, nor its
principals, officers, employees or agents providing services under this
Agreement, is and at no time has been excluded from participation in any
federally funded health care program, including Medicare and Medi-Cal. Each
Party hereby agrees to immediately notify the other Party of any threatened,
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proposed, or actual exclusion from any federally funded health care program,
including Medicare and Medi-Cal. In the event that either Party is excluded from
participation in any federally funded health care program during the term of
this Agreement, or if at any time after the Effective Date of this Agreement it
is determined that the excluded Party is in breach of this Section and this
Agreement shall, as of the effective date of such exclusion or breach,
automatically terminate.
14 GOVERNMENT ACCESS
If applicable, the Parties shall comply with the provisions of Section
1861(v)(1)(l) of the Social Security Act and shall make available, upon written
request of the Comptroller General of the United States or the Secretary of the
United States Department of Health and Human Services or any of their duly
authorized representatives, any books, documents and records that are necessary
to verify the nature and extent of the costs incurred by either Party under this
Agreement. In addition, each Party shall cooperate with the other Party and
provide reasonable access to books and records pertaining to this Agreement and
the performance of its obligations to the extent reasonably necessary for
compliance with any governmental agency review or audit of the other Party.
15 MISCELLANEOUS
15.1 Assignment
Except as expressly provided in this Agreement, neither this Agreement nor
any right under this Agreement is assignable in whole or in part by either Party
without the prior written consent of the other Party, and any attempted
assignment without such consent shall be null and void, except that either Party
may assign its rights and obligations under this Agreement to its parent, a
subsidiary or other controlled affiliate, or to any successor entity without the
consent of the other Party by providing the other Party with notice of such
permitted assignment.
15.2 Complete Agreement
This Agreement including any and all Schedules and attachments listed on
the first page of this Agreement, which are hereby incorporated by reference
into this Agreement, constitutes the complete and integrated understanding of
the Parties with respect to the subject matter of this Agreement and supersedes
all prior understandings and agreements, whether written or oral, with respect
to the same subject matter.
15.3 Amendment
This Agreement may only be amended by a written agreement duly signed by
persons authorized to sign agreements on behalf of each Party.
15.4 Severability
The Parties to this Agreement acknowledge and agree that it is their
intent and understanding that this Agreement complies with all applicable laws,
rules, regulations, court decisions and governmental restrictions (collectively
"LAWS AND REGULATIONS"), and that at all times they intend to be in compliance
with such laws and regulations. Should any term or provision of this Agreement
be deemed invalid or void or unenforceable either in its entirety or in a
particular application because it is in conflict with or violates any law or
regulation, the remainder of this Agreement shall nonetheless remain in full
force and effect and, if the subject term or provision is deemed to be invalid,
void or unenforceable only with respect to a particular application, such term
or provision shall remain in full force and effect with respect to all other
applications. In addition, the Parties agree to amend this Agreement to bring
this Agreement in compliance with said law or regulation. Notwithstanding the
foregoing, if the law or regulation is deemed by either Party to be so
materially adverse that, in either Party's reasonable judgment, the Agreement
cannot or should not be so modified; then after discussion and determination by
the Parties that it is so materially adverse, the Parties agree that, as a part
of the consideration of this Agreement, they will declare this Agreement null
and void and, except for the sections specifically surviving termination, of no
further force and effect; provided, however, if either Party intends to enforce
such declaration of termination but the other Party opposes termination (the
"OPPOSING PARTY"), then the Opposing Party may veto such termination so long as
the Opposing Party pays for the cost to comply with the law or regulation or
decision at issue (if compliance may be achieved by the payment of money alone),
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in which event this Agreement shall continue in full force and effect; and
provided further that this Section 15.4 shall not be construed as providing
either Party a basis for terminating this Agreement if the material adverse
effect results solely from a change in reimbursement levels as a result of a
change in law or regulation.
15.5 Notwithstanding anything to the contrary set forth in this Agreement,
Sections 3, 5.2, 5.3, 6, 7, 8, 9, 11, 12 and 15 shall survive the termination of
this Agreement for a period of ten (10) years; provided that this ten year
limitation on survival is not intended to and does not give Hospital any rights
to or in the Licensed Technology following expiration of the ten years.
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SCHEDULE A
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1. DESCRIPTION OF LICENSED TECHNOLOGY TO BE PROVIDED TO HOSPITAL:
Any and all Hythiam treatment protocols provided during the Term to
Hospital for rapidly administered neurological addiction recovery, including but
not limited to: Hythiam's Addiction Neuro-Restoration Detox System ("HANDS(TM)")
for Addictions; HANDS(TM) for Alcohol; HANDS(TM) for Cocaine; HANDS(TM) for
Crack Cocaine; HANDS(TM) for Poly-Drug; HANDS(TM) for Alcohol and Cocaine;
FITSM; HANDS(TM) for Opiates; U.S. Patent VO. 6,103,734; all materials and
information provided by Hythiam with respect to the protocols or patent; and all
related business processes; services; improvements or enhancements; U.S. or
international patents, patent filings or PCT applications; instructions,
brochures, manuals, or labels; analyses, data compilations, databases, or Data
Reports.
2. LOCATION FOR USE OF LICENSED TECHNOLOGY:
Little Company of Mary - San Pedro Hospital
1300 West Seventh Street
San Pedro, CA 90732
3. AUTHORIZED PURPOSES FOR USE OF LICENSED TECHNOLOGY:
For provision of substance abuse and/or addiction treatment only in
accordance with the terms of this Agreement.
4. AUTHORIZATION TO BE PROVIDED BY HYTHIAM:
Hythiam will designate each individual authorized to use the Licensed
Technology upon the execution by qualified individuals of confidentiality and
proprietary information agreements with Hythiam (each an "Authorized User"). The
list of Authorized Users is set forth on Schedule B, as amended from time to
time. Unless a shorter period is specified in writing by Hythiam, during the
Term each Authorized User must undergo reauthorization at least every
twenty-four (24) months ("Authorized Period"). Any Hospital Personnel or Staff
Physicians who are not reauthorized within the specified time frame must
immediately cease any and all use of the Licensed Technology at the end of the
Authorized Period. Notwithstanding the foregoing, all Hospital Personnel and
Staff Physicians must immediately cease any and all use of the Licensed
Technology upon termination of this Agreement for any reason.
5. TERMS FOR PROVISION BY HOSPITAL OF SUBJECT DATA TO HYTHIAM:
Hospital will provide Hythiam access to its files and records to the
extent reasonably necessary for Hythiam to access and make use of the Subject
Data in compliance with all applicable laws and this Agreement.
6. TERMS FOR PROVISION BY HYTHIAM OF DATA REPORTS TO HOSPITAL:
Hythiam will provide data aggregation services to Hospital in
accordance with the HIPAA Privacy Rule, including the following reports:
Pre-registration intake of demographic and financial information; Brief
clinical screening data; [H-05 TEXT DELETED--CONFIDENTIAL TREATMENT
REQUESTED BY HYTHIAM, INC.]; Patient and Hospital satisfaction surveys;
Identification and assessment of counseling services outside the Hospital
service area.
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The list of data aggregation reports may be modified or expanded upon agreement
of the parties, including for additional fees. Notwithstanding any other
provision of this Agreement, Hospital may share the Data Reports internally for
its own internal business purposes.
7. GEOGRAPHIC EXCLUSIVITY AREA
The exclusive area provided to San Pedro Peninsula Hospital by Hythiam in
accordance with Section 3.4 is set forth below.
The exclusive area shall consist of the [H-06 TEXT DELETED--CONFIDENTIAL
TREATMENT REQUESTED BY HYTHIAM, INC.] and shall extend west to include [H-07
TEXT DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.]. The exclusive
shall also include the area east of [H-08 TEXT DELETED--CONFIDENTIAL TREATMENT
REQUESTED BY HYTHIAM, INC.], and south and east of the [H-09 TEXT
DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.]. The area is located
within the perimeter demarcated by intersection of the [H-10 TEXT
DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.] Freeway ([H-11 TEXT
DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.]) and [H-12 TEXT
DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.] Road taking [H-13
TEXT DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.] Road south to
the intersection of [H-14 TEXT DELETED--CONFIDENTIAL TREATMENT REQUESTED BY
HYTHIAM, INC.] Road and the Pacific Coast Highway; the intersection of the [H-15
TEXT DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.] and [H-16 TEXT
DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.] freeway traveling
east on the [] until it intersects with highway [H-17 TEXT DELETED--CONFIDENTIAL
TREATMENT REQUESTED BY HYTHIAM, INC.]; traveling south on highway [H-18 TEXT
DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.] until it intersects
with highway 90; traveling west on highway 90 until it intersects with highway
39 (Beach Blvd); traveling south on highway 39 until it intersects with the
Pacific Coast Highway. See the attached map(s).
8. LICENSE AND SERVICES FEE:
Use of Licensed Technology for:
Each episode of Treatment for alcohol dependency-- $[H-19 TEXT
DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.].
Each episode of Treatment for psycho stimulant (cocaine) dependency--
$[H-20 TEXT DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.].
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Each episode of Treatment for opiate dependency--$[H-21 TEXT
DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.].
The License and Services fees set forth in this paragraph 8 do not include
costs for any services other than those set forth in Section 4 and do not
include any Aftercare or other services required or requested as a result of any
extended stays, complications or subsequent episodes of treatment, the total
cost for which as between the Parties is the responsibility of Hospital. For
purposes of this Agreement, Aftercare shall mean any and all related follow-up
care, recovery care, services, referrals or consultations.
9. HOSPITAL CHARGES
Each episode of Treatment for alcohol dependency, with Aftercare--$[H-22
TEXT DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.].
Each episode of Treatment for psycho stimulant (cocaine) dependency, with
Aftercare--$[H-23 TEXT DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM,
INC.].
Each episode of Treatment for opiate dependency, with Aftercare--$[H-24
TEXT DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.].
As part of its education services Hythiam will provide a list of Aftercare
providers or agencies that are familiar with the requirements for recovery
follow-up on treatment using the Licensed Technology. This list is for
information purposes only and Hythiam does not endorse or recommend any specific
provider. In the alternative, Hospital may contract with Hythiam to arrange for
Aftercare on its behalf. In the event Hospital does not arrange for Aftercare,
does not contract with Hythiam to arrange for Aftercare on its behalf or is
unable to arrange for Aftercare in compliance with applicable laws or
regulations, the charges set forth in this paragraph 9 shall each be reduced by
$[H-25 TEXT DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.].
Any Hospital charges for extended stays, complications or follow-on care
or treatment shall be in accordance with Hospital's normal and customary
charges. Except for reconciliations of payments received in error as set forth
in Section 5, Hythiam shall have no responsibility for payment of any Hospital
costs or charges for any reason.
o For purposes of this Agreement, an episode of care shall include: Alcohol
dependency- [H-26 TEXT DELETED--CONFIDENTIAL TREATMENT REQUESTED BY
HYTHIAM, INC.] administrations of the protocol provided during a [H-27
TEXT DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.] night
stay.
o Psycho-stimulant dependency- [H-28 TEXT DELETED--CONFIDENTIAL TREATMENT
REQUESTED BY HYTHIAM, INC.] administrations of the protocol provided
during an aggregate of [H-29 TEXT DELETED--CONFIDENTIAL TREATMENT
REQUESTED BY HYTHIAM, INC.] nights ([H-30 TEXT DELETED--CONFIDENTIAL
TREATMENT REQUESTED BY HYTHIAM, INC.] nights for the initial treatment
plus a follow-up treatment [H-31 TEXT DELETED--CONFIDENTIAL TREATMENT
REQUESTED BY HYTHIAM, INC.] weeks later requiring a [H-32 TEXT
DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.] night stay).
o Opiate dependency- [H-33 TEXT DELETED--CONFIDENTIAL TREATMENT REQUESTED BY
HYTHIAM, INC.] administration of the protocol in the operating room with a
[H-34 TEXT DELETED--CONFIDENTIAL TREATMENT REQUESTED BY HYTHIAM, INC.]
night stay
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SCHEDULE B
AUTHORIZED USERS
Blair ContraTto, ceo
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<PAGE>
SCHEDULE C
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BUSINESS ASSOCIATE AND DATA USE AGREEMENT
------------------------------------------------------------------------------
LITTLE COMPANY OF MARY - SAN PEDRO HOSPITAL
AND
HYTHIAM, INC.
------------------------------------------------------------------------------
This Business Associate Agreement ("B.A. Agreement"), effective as of
___________, 2003 ("Effective Date"), is entered into by and between San Pedro
Peninsula Hospital, d.b.a. Little Company of Mary-San Pedro Hospital ("Covered
Entity") and Hythiam, Inc. ("Hythiam") (each a "Party" and collectively the
"Parties").
1. BACKGROUND AND PURPOSE. The Parties have entered or are entering into an
agreement for the provision by Hythiam of technology and services to
Covered Entity ("Agreement"). Performance of the Agreement may involve
Protected Health Information (as defined in 45 C.F.R. ss.164.501) ("PHI")
subject to the federal privacy regulations issued pursuant to the Health
Insurance Portability and Accountability Act ("HIPAA") and codified at 45
C.F.R. parts 160 and 164 ("Privacy Rule"). The purpose of this B.A.
Agreement is to amend the Agreement to the extent and only to the extent
necessary to allow for Covered Entity's compliance with the Privacy Rule.
2. DEFINITIONS. Unless otherwise defined in this B.A. Agreement, all
capitalized terms used in this B.A. Agreement have the meanings ascribed
in HIPAA and/or the Privacy Rule.
3. OBLIGATIONS OF THE PARTIES WITH RESPECT TO PHI.
3.1 Uses and Disclosures of PHI by Hythiam. Except as otherwise specified in
this B.A. Agreement, Hythiam may make any and all uses and disclosures of
PHI necessary to perform and enforce the Agreement. In addition, unless
otherwise limited in this B.A. Agreement, Hythiam may (a) use the PHI in
its possession for its proper management and administration and to carry
out the legal responsibilities of Hythiam; (b) disclose the Minimum
Necessary information in its possession to a third party for the purpose
of Hythiam's proper management and administration or to carry out the
legal responsibilities of Hythiam, provided, that such disclosure is
required by law or Hythiam obtains reasonable assurances from the third
party regarding the confidential handling of such PHI as required under
the Privacy Rule; (c) provide Data Aggregation services relating to the
health care operations of the Covered Entity; (d) use the PHI to create a
Limited Data Set ("LDS"), the use and disclosure of which shall be
governed by the Data Use Agreement set forth in Section 5 of this B.A.
Agreement and by the Privacy Rule; and (e) de-identify any and all PHI
obtained by Hythiam under this B.A. Agreement, and use such de-identified
data, all in accordance with the de-identification requirements of the
Privacy Rule.
3.2 Obligations of Hythiam. With regard to its use and/or disclosure of PHI
that is not in an LDS, Hythiam agrees to:
a. not use or further disclose the PHI other than as permitted or
required by this B.A. Agreement or as Required By Law;
b. use appropriate safeguards to prevent use or disclosure of PHI
other than as permitted in Section 3.2(a);
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c. report to Covered Entity in writing any use or disclosure of
PHI not permitted in Section 3.2(a) of which Hythiam's
management becomes aware and, to the extent practicable,
minimize harmful effects of that use or disclosure;
d. ensure that any agents and subcontractors to which Hythiam
provides PHI agree to the same restrictions and conditions
that apply to Hythiam with respect to such PHI;
e. make available within twenty (20) days after request by the
Covered Entity PHI necessary for Covered Entity to respond to
an Individuals' request for access to PHI about them in the
event that the PHI in Hythiam's possession constitutes a
Designated Record Set;
f. make available PHI for amendment and incorporate within ten
(10) days after request by Covered Entity any amendments to
the PHI in accordance with the Privacy Rule in the event that
the PHI in Hythiam's possession constitutes a Designated
Record Set;
g. document such disclosures of PHI as would be required for
Covered Entity to respond to a request by an Individual for an
accounting of disclosures in accordance with 45 CFR ss.
164.528 and provide, within 20 days after Covered Entity
requests the information in writing, an accounting of any
disclosures of PHI for up to the six-year period preceding the
date of the request for an accounting that includes the date
of the disclosure, the name and address of the person or
entity to whom the PHI was disclosed, a brief description of
the PHI disclosed and a brief statement of the purpose of the
disclosure and an explanation of the basis for the disclosure;
h. make its internal practices, books and records relating to the
use and disclosure of PHI available to the Secretary of HHS
within a reasonable timeframe as required by the Secretary for
purposes of determining Covered Entity's compliance with the
Privacy Rule; and
i. return to Covered Entity or destroy, within ninety (90) days
of the termination of this B.A. Agreement, the PHI in its
possession as a result of the Agreement and retain no copies,
if it is feasible to do so. If Hythiam in its discretion
determines that return or destruction is infeasible, Hythiam
agrees to extend all protections contained in this B.A.
Agreement to Hythiam's use and/or disclosure of any retained
PHI, and to limit any further uses and/or disclosures to the
purposes that make the return or destruction of the PHI
infeasible. Notwithstanding the foregoing, this Section 3.2(i)
shall not apply to any PHI in an LDS, the use and disclosure
of which shall be governed by Section 5 of this B.A.
Agreement.
3.3 Obligations of Covered Entity. Covered Entity agrees to timely notify
Hythiam in writing of any arrangements between Covered Entity and the
individual that is the subject of PHI that may impact in any manner the
use and/or disclosure of that PHI by Hythiam under this B.A. Agreement.
3.4 Effect of Changes to the Privacy Rule. To the extent that any relevant
provision of the Privacy Rule is materially amended in a manner that
changes the obligations of Business Associates or Covered Entities that
are embodied in the terms of this B.A. Agreement, the Parties agree to
negotiate in good faith appropriate amendment(s) to this B.A. Agreement to
give effect to these revised obligations.
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4. TERMINATION BY COVERED ENTITY. With respect to the Agreement, upon Covered
Entity's knowledge of a material breach of the terms of this B.A.
Agreement by Hythiam, Covered Entity shall provide Hythiam written notice
of that breach in sufficient detail to enable Hythiam to understand the
specific nature of that breach and afford Hythiam an opportunity to cure
the breach. If Hythiam fails to cure the breach within a reasonable time
specified by Covered Entity (in any event not less than ten (10) days and
if Hythiam is making reasonable efforts to cure, Covered Entity may extend
the cure period to allow for that cure), Covered Entity may terminate this
B.A. Agreement as well as terminate those portions, but only those
portions, of the Agreement that, by their express terms, require or permit
Hythiam access to PHI and only to the extent of that requirement or
permission. In such instance, the remaining provisions of the Agreement
that do not, by their express terms, require or permit Hythiam access to
PHI shall remain in full force and effect, including any and all of
Covered Entity's payment and performance obligations (to the extent any
such performance obligations do not require Hythiam access to PHI);
provided that, notwithstanding the foregoing, Covered Entity shall be
entitled to terminate the Agreement in its entirety if and to the extent
that the overall intent and purpose of the Agreement (i) is directly and
materially related to and dependent upon Hythiam access to PHI, and (ii)
would be frustrated if Covered Entity were not permitted to terminate the
Agreement. In addition, if Hythiam, in its sole discretion, can perform
the Agreement with information that has been de-identified under the
Privacy Rule or with an LDS, the Agreement will remain in full force and
effect, except with respect to, and only with respect to, those provisions
that require or permit Hythiam access to PHI that is not in an LDS, which
provisions shall be deemed modified to provide Hythiam access to PHI that
has been de-identified under the Privacy Rule and access to PHI in an LDS.
5. DATA USE AGREEMENT.
5.1 Preparation of the LDS. Hythiam may prepare an LDS in accordance with the
Privacy Rule and Section 3.1(d) of this B.A. Agreement.
5.2 Minimum Necessary Data. In preparing the LDS, Hythiam will include only
those data fields which are the minimum necessary to accomplish the
purposes set forth in Section 5.3 of this B.A. Agreement.
5.3 Permitted Uses and Disclosures of the LDS. Hythiam may use the LDS for its
Research and Public Health activities, for the Health Care Operations of
Covered Entity, and as Required By Law. Hythiam may disclose the LDS for
the same purposes in accordance with the Privacy Rule.
5.4 Responsibilities of Hythiam. With regard to its use and/or disclosure of
the LDS, Hythiam agrees to:
a. not use or further disclose the LDS other than as permitted by
Section 5.3 of this B.A. Agreement;
b. use appropriate safeguards to prevent use or disclosure of the
LDS other than as permitted by Section 5.3 of this B.A.
Agreement;
c. report to Covered Entity in writing any use or disclosure of
the LDS that is not permitted by Section 5.3 of this B.A.
Agreement of which Hythiam's management becomes aware and, to
the extent practicable, minimize harmful effects of that use
or disclosure;
d. ensure that any agents, subcontractors, or other third parties
to which Hythiam provides the LDS agree to the same
restrictions and conditions that apply to Hythiam with respect
to such LDS; and
e. not use the information in the LDS to identify or contact
individuals who are the data subjects.
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6. MISCELLANEOUS.
6.1 Agreement. The Agreement is hereby amended to incorporate the terms of
this B.A. Agreement. The terms of this B.A. Agreement shall prevail in the
case of any conflict with the terms of the Agreement to the extent and
only to the extent necessary to allow Covered Entity to comply with the
Privacy Rule.
6.2 Survival. With respect to the Agreement, Sections 1, 2, 3.2, 3.3, 3.4,
4.and 6 of this B.A. Agreement shall survive termination of this B.A.
Agreement and continue indefinitely solely with respect to PHI Hythiam
retains in accordance with Section 3.2.i. With respect to the Agreement,
Section 5 of this B.A. Agreement shall survive termination of this B.A.
Agreement and continue indefinitely solely with respect to any LDS that
Hythiam possesses.
6.3 No Third Party Beneficiaries. Nothing in this B.A. Agreement shall confer
upon any person other than the Parties and their respective successors or
assigns, any rights, remedies, obligations, or liabilities whatsoever.
IN WITNESS WHEREOF, each of the undersigned has caused this B.A. Agreement to be
duly executed in its name and on its behalf.
LITTLE COMPANY OF MARY-SAN PEDRO HYTHIAM, INC.
HOSPITAL
By: By:
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Print Name: Print Name:
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Print Title: Print Title:
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