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AGREEMENT

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This Agreement is made this kday of November, 2002, by and between the Office of
the Attorney General, Department of Legal Affairs. State of Florida (hereinafter uOAG")
and Purdue Pharma LP. and The Purdue Frederick Company, each with a principal
office at One Stamford Forum, Stamford, CT 06901 (collectively '1Purdue").
WlTNESSETH

WHEREAS, the OAG has been conducting an investigation, File No. L0l-3-2535, of the
sales and marketing activities of Purdue in the State of Florida in connection with
Purdue's prescription pain medication OxyContin® Tablets (..the Investigation"); and

WHEREAS. the Investigation has been terminated and a decision has been made to talce
no legal action against Purdue; and
\VHEREAS, Purdue continues to be fully committed to complying with all laws and
regulations concerning its.business operations; and

WHEREAS. both the OAG and Purdue recognize the potential synergy in working
together on a variety of programs that are designed to deal in a positive and proactive
way with the abuse and diversion of prescription medications, including OxyContin®
Tablets; and
\Y}lEREAS, Pw-due has expertise in the development and implementation of programs
for law enforcement officers and agencies, educating them about the abuse and diversion
of prescription drugs that are subject to the drug laws; and
WHEREAS, the OAG and Purdue now desire to work together on the development of
certain programs set forth in greater detail herein (the "Programs") directed at combating
· abuse and diversion of prescription medications in the State of Florida; and

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WHEREAS, the OAG and Purdue support the implementation of a Prescription
Monitoring Program (..P.MP") in the State of Florida; and
WHEREAS, no computer software program currently exists in the state of Florida to
support a state-wide P.MP; and

WHEREAS, Purdue has acquired technical knowledge in this field and desires to support
the development of such a software program for the benefit of the State of Florida as well
as any other State; and

WHEREAS, the OAG and Purdue believe that this Agreement is mutually beneficial to
the citizens of the State of Florida and Purdue;
NOW. THEREFORE, in consideration of the covenants, agreements. and releases set

forth herein, and for other good and valuable consideration, the sufficiency of which is
hereby acknowledged, it is agreed by the undersigned parties, intending to be legally
bound, as follows:
COVENANTS
Prescription Monitoring Software

LO

Purdue will provide a draft Scope of Services and Technical Specifications to the

OAG within sixty (60) days of the execution of this Agreement for the pro~urement by
the State of Florida of a software program designed to support the implementation ofa
PMP ("the Software"). Such draft will specify that the Software be capable of at least
performing the operations described in Exhibit A attached hereto.

1.1

Purdue will identify for the OAG and/or State of Florida, vendors it believes to be

qualified to produce the Software. The OAG/State of Florida will enter into a
development contract for the procurement of the Software from one such qualified
vendo.r, or any other vendor deemed qualified by experience, past performance and
technical competence, in a manner set forth by Chapter 287, Florida Statutes..
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1.2

Purdue will contribute the cost of said development contract up to but not

exceeding two million dollars ($2,000,000). Purdue shall make such contribution to the
State of Florida in periodic installments, at least sixty (60) days prior to the date the State
of Florida is required

to make corresponding payments to the Software vendor under the

terms of the development contract. This contribution is conditioned upon the
requirement that the Software shall become the property of the State of Florida and that
the State of Florida will make the Software available at no cost to any other State in the
United States which requests the Software. In the event the State of Florida is unable to
enter into a contract with a responsible vendor to develop the Software capable of at least
perfomting the operations described in Exhibit A, then Purdue is released from any
obligation under this Section pursuant to the tenns of Sections 2.1- 2.3 below.

1.3

To the extent reasonably requested, Purdue agrees to work with the State of

Florida during the procurement and development of the Software, and to provide
assistance and technical advice to the selected vendor. The contract shall provide for
periodic quality assurance audits of the work being performed by the selected vendor

pursuant to the development contract to assure that the agreed upon specifications are
utilized and that payment is due under the development contract.

1.4

In the event the cost of developing the Software exceeds $2,000,000, either the

State of Florida or Purdue shall have the right, but not the obligation, to make such
additional payments necessary to complete the development of the Softwarf

Alternative Performance

2.0

In the event the State ofFio~da is unable to enter into a contract with an

acceptable vendor under the tenns specified in Sections 1.1 and 1.2 above, Purdue is
released from all obligations set forth therein.

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2.1

If Purdue is released pursuant to Section 2.0, it shall instead provide to the OAG,

within thirty (30) days of the date the OAG advises Purdue in writing that the
procurement process referenced in Section 1.1 has failed, the sum of$500,000 for the
purpose of developing or purchasing a computer software program capable of
implementing a Piv[P. Said funds will be deposited in the OAG Revolving Escrow Trust.
Fund (RETF). This money will be available for use by the State of Florida
notwithstanding the nature and components of any PMP enacted by the State. In the
event the State of Florida fails to enact a Pl\tlP, the money will nevertheless be available
pursuant to Section 2.3 below.

2.2

Purdue will participate in the education of Florida legislators regarding the

positive merits of a P:rv.lP and will support publicly and use good faith efforts to obtain
the passage of appropriate PlvIP legislation in Florida. The parties acknowledge that in
the event the Florida Legislature fails to enact Piv!P legislation, such failure shall not
constitute a breach of Purdue's obligations pursuant to this Agreement.
2.3 ·

In the event the Legislature of the State of Florida fails to enact PM'P legislation

prior to July 1, 2004, Purdue and the OAG agree that the $500,000 paid under Section 2.1
shall be used for the purposes of drug abuse education and training for young people, law
enforcement officers, healthcare professionals and the general public, an~ Purdue's
obligations pursuant to Section 2.1 above shall be deemed fully satisfied.

Continuing Education

3.0

Purdue will collaborate with OAG and bear the expense of five (5) programs in

the State of Florida for law enforcement officers and agencies, educating them about the
abuse and diversion of prescription drugs that are subject to the drug laws (the
Programs).

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3.1

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The first Program will be scheduled for administrators for one full day. A draft

curriculwn is attached as Exhibit B. The parties acknowledge that while the curriculum
is not binding and understand there may be changes in topics and speakers, Purdue agrees
to remain true to the format and speaker qualifications as set forth in Exhibit B.

3.2

The remaining four (4) Program~ will be scheduled for law enforcement

personnel for one day each in four (4) separate regions of the State of Florida. The draft
curriculum shall be similar to that attached as Exhibit 8. Toe·parties acknowledge that

while this curriculwn is not binding and understand there may be changes in topics and
speakers, Purdue agrees to remain true to the format and speaker qualifications as set
forth in Exhibit B.

3.3

The parties anticipate enrollment of between approximately 100 and 200

atte~dees for each Program, although the Parties acknowledge that the number of actual
attendees at any one Program is not binding. Purdue will arrange for and fund the costs
related to the Programs, including but not limited to the venues, reception, meals, coffee·
breaks, copying and compilation of binders, speakers' fees, and lodging and
transportation for speakers, up to a total of$150,000.

3.4

Purdue will work with the Florida Atlantic University to ensure that all attendees

at each Program receive appropriate continuing education units.

3.5

If Purdue's obligations vest under Section 2.1 above, Purdue will set aside up to

an additional $100,000, which .sum shall cover the cost of the following for each attendee

at a.Program: a) a one year membership in the National Association of Drug Diversion
Investigators (NADDI); and b) a copy of the most recent version available of the Drug

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Identification Bible. If Purdue's obligations vest under Section 2.1 above, should any
money remain following the presentation of the Programs, Purdue agrees that such
money shall be made ava~lab le to produce a program or programs for the benefit of
medicaVhealthcare professionals regarding the abuse or diversion of prescription drugs in
the State of Florida as directed by the OAG.

3.6

The parties will use their best efforts to ensure that the first Program is held no

later than the first quarter of 2003, and that the remaining four (4) Programs are
completed prior to December 31, 2003.

RELEASE
4.0

Purdue, its representatives, agents, assignees, executives, and heirs, hereby

release and forever discharge the OAG from all claims, causes of actions, suits,
controversies, and damages, known or unknown, which Purdue had, might have, or will
have, against the OAG in connection with the above referenced investigation.

4.1

By execution of this Agreement, OAG hereby releases and forever discharges

Purdue from any and all claims, demands, liabilities, obligations, debts, actions, suits and
causes of action, whether joint or several in nature, whether known or unknown, that the
OAG ever had, now has, or hereafter can, shall, or may have on account of or in any way
arising out of Purdue's activities regarding the sale and marketing of OxyContin®
Tablets through the date of this Agreement.

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MISCELLAl~EOUS
5.0

The parties acknowledge that no charges or claims of any kind or nature have

been made by the OAG against Purdue, and that this Agreement, and any and all
negotiations, documents, and discussions associated with it, shall not be deemed or
construed to be an admission or evidence of any violation of any statute or law by Purdue

or its officers, employees, or directors, or of any liability on the part of or wrongdoing by
Purdue. OAG further acknowledges that it has not filed any action against Purdue for
any conduct in the State of Florida.

S.l

The individuals executing this Agreement on behalf of the OAG and Purdue,

respectively, have all requisite authority to bind said parties and to execute this
Agreement, and they have in fact been duly authorized to execute this Agreement.

5.2.

This Agreement constitutes the entire Agreement between Purdue and the OAG

pertaining to the Investigation. This Agreement shall not be modified or amended except
as set forth in a writing that expressly refers to this Agreement and is executed by a duly
authorized representative of Purdue and the OAG. Without limiting the foregoing, no
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modification, amendment or waiver shall be affected by or result from the receipt,
acceptance or signing of acknowledgments or other documents containing terms or

conditions in addition to or different from the tenns and conditions set forth herein.

5.3

This Agreement shall be binding upon, and inure to the benefit of, the successors

and assigns of PUidue and th~ OAG.

5.4
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This Agreement may be executed in counterparts by Purdue and the OAG.

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5.5

The headings set forth in this Agreement have been inserted for convenience of

reference only. Such headings shall not be considered a part of this Agreement, and
neither shall they limit, modify or affect in any way the meaning or interpretation of this
Agreement.

5.6

Neither Purdue nor the OAG shall be considered to be the drafter of this

Agreement or any of its provisions for the purpose of any starute, case law, or rule of
interpretation or construction that would or might cause any provision to be construed
against the drafter of this Agreement.
COMPLIANCE

6.0

The parties agree that the provisions set forth above constitute a complete

resolution of this matter. Upon execution of this Agreement, payment of all funds by
Purdue, and conclusion of all actions required by Purdue, Purdue will be considered in
full compliance with this Agreement.

6.1

If at any time prior to full compliance the OAG detennines that Purdue is not in
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compliance with the terms of this Agreement, and after providing Purdue.with ten (10)
business days written notice of OAG's determination of noncompliance and an
opportunity to dispute or correct any alleged noncompliance within thirty (30) days of
such notice, the OAG may seek recourse in the Circuit Court of Broward County,
Florida, for breach of contract, and may petition that Court. for the appropriate relief.

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ACKNOWLEDGIWENT

By the signatures below, the parties acknowledge their acceptance of the above

I tvo.J
Robert A. Butterworth
Attorney General
State of Florida

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2001.,

Executive Vice President/General Counsel
Purdue Pharma LP.

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Howard R. Udell
Executive Vice President/General Counsel
The Purdue Frederick Company

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Exhibit A
Software Requirements of a Model Prescription Monitoring Program

This document outlines the technical sofuvare requirements to support a model
state prescription monitoring program ("P:tv!P"). The goal of a model PIYIP involves the
utilization of prescription data to provide useful information for clinical management to
authorized health care professionals and assist in the detection of prescription fraud and
abuse. Such software should be capable of fulfilling this objective, while protecting
patient privacy and creating only minimal additional burden on the practices of
prescribers and dispensers. It is imperative t.1at any P!vfP sofuvare program capture all
necessary data in an intelligent fashion and not interfere with access to appropriate
pharmaceutical therapies for patients with legitimate medical need. The Pl\1P shall be
capable of on-line data entry and retrieval. In addition to these criteria, the contract for
development of the software for this Model Prescription Monitoring Program shall
mandate that any software created in the performance of that contract shall be delivered
to the State of Florida as owner with all licensing rights reserved to the State of Florida
and providing the right of the State of Florida to provide said software to any other state
upon request. The system software must be capable of supporting a PlvfP meeting the
following criterion:
1.

Prescription data must be collected in a common, non-proprietary digital format
in a timely manner with appropriate checks for accurate and complete data from
every eligible prescription.

2.

Prescription data must be collected and entered into an electronic database that is
searchable by any .field or combination of fields.

3.

Appropriate security measures must exist to protect the integrity of and access to
the data.

4.

Data from each prescription must include, at a minimum, identification of the
patient, prescriber, dispenser, the drug, quantity, strength, directiOJ?? for use,
refills and date of dispensing.
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5.

Prescription data involving every federally controlled substance in Schedule II,
ill, and IV and other drugs of concern can be entered into the database.

6.

Dispensing of controlled substances directly by non-pharmacy health care
professionals must be entered into the database.

7.

The PM:P must operate an ongoing continuous quality improvement program that
ensures, at a minimum, provisions to monitor the compliance of dispensers,
accuracy and completeness of the data, appropriate controls over access, and the
protection and integriry of the data.

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The software program must be compatible with existing electronic P:tvIP software
currently in use in various States that have the capability to generate and receive
data streams in a common, non-proprietary fonnat.

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Curriculum: Southeast Florida Diversion Training Program·
9-9:30

Welcoming Remarks - Broward Sheriff Ken Jenne

9;30-10-15

The Growing Illegal Use and Abuse of Prescription Narcotics
Charlie Cichon, President of the National Association of Drug Diversion

10:30-12:00 Networking - Law Eniorcement's Best Defense and Offense
(Mini-presentations detailing ''what we can and can't do for you'1
Moderator - Dr. David Kalinich, Professor and Chair, Department.
Dr. Zachariah Zachariah, Chair, Florida Board of Medicine.
Dr. John Tay·lor, Executive Director, Florida Board of Pharmacy.
Dr. J. David Haddox, Senior Medical Director for Health Policy, PurduePharma
Thomas Hanna, Assistant Chief, Florida Department of Health,
Investigative Services
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Danna Droz, Executive Branch Manager, Department of Public Health.
Mark Schlein. Director, Medicaid Fraud Unit, Office of the Florida Attorney
General.
Wilbert Corbet - Diversion Program Manager, Drug Enforcement
Administration
George Kararvetsos,, Assistant Chief Counsel, Food and Drug
Administration, Office of Criminal Investigations.
Jennifer Bolen, US Attorney's Office, Health Care Fraud Division.
John Gallagher, Broward State Attorney's Office, Drug Traffic Unit

12:00-1 :00

Luncheon - Remarks Florida Attorney General Bob Butterworth

1 :00-1 :30

Opiod Use and Abuse -Past, Present and Future
Dr. J. David Haddox, Senior Medical Director for Health Policy, PurduePharma

1:30-2:30

Prescription Narcotics Monitoring - An Effective Law Enforcement
Weapon n the War Against the Illegal Use and Abuse Prescription.
Narcotics. (Kentucy's KASPER Program -A Success S(ory.)
Danna Droz, Executive Branch Manager, Department of Public Health.

2:30-2:45

Break

2:45-4:00

Summary- Where Do We Go from Here?
Robert Butterworth, Florida Attorney General
Ken Jenne, Broward Sheriff
- RX Narcotic Monitoring Systam and the 2003 Florida Legislature.
- Agency Commitments for Networking

EXHIBIT

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AME~"DED AGREEiWENT

This Amended Agreement is made this _ _ day of April, 2003, by and between the

Office of the Attorney General, Deparnnent of Legal Affairs, State of Florida
(hereinafter "OAG") and Purdue Pbanna L.P. and the Purdue Frederick Company,

each with a principle office at One Stamford Forum, Stamford, _CT 06901
( collectively "Purdue").

WITNESSETH
WHEREAS, the OAG and Purdue entered into an Agreement dated November I,
2002 ("Original Agreement'') for the implementation of law enforcement training
programs and for the development of software to support a prescription moajtoring

program~ and
WHEREAS, the parties to the Original. Agreement are in full compliance with all the
tenns and conditions of such Agreement; and

\.VHEREAS, the Florida Department of Health has requested from the OAG a sum of
money from the Original Agreement to facilitate the procurement of such software
program; and
VIHEREAS, the OAG and Purdue agree that the immediate release of such funds will
forward the purposes of the Original Agreement;

NOW, THEREFORE, consistent with Section 5.2 of the Original Agreement, with
due consideration, the sufficiency of which is hereby reaffirmed, it is agreed by the

undersigned parties, intending to be legally bound, that the Original Agreement be
amended and revised as follows:

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Al\'fENDi\-lENT

Advance Pavment

1.0

Purdue will provide to the Florida Department of Health the sum of ten

thousand one hundred and fifty dollars (SI0,150.00) within five (5) days of the
execution of this Amended Agreement.

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In the event Purdue provides payment to the OAG pursuant to the terms of

Section 1.2 of the Original Agreement, such payment is hereby amended from an
amount not exceeding two million dollars ($2,000,000.00) to an amount not
exceeding $1,989,850.00.

1.2

In the alternative event that Purdue provides payment to the OAG pursuant to

the terms of Section 2.1 of the Original Agreement, such payment is hereby amended
from the sum of five hundred thousand dollars ($500,000.00) to the sum of
$489,850.00.

1\'ITSCELLAi"ffiO US
2.0

The individuals executing this Amended Agreement on behalf of the OAG and

Purdue, respectively, have all requisite authority to bind said parties and to execute
this Amended Agreement.

2.1.

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This Amended Agreement shall have no effect on the terms, covenants,

agreements and releases, other than as specified in Sections 1.0 - 1.3 above, of the
Original Agreement.

2.2

This Amended Agreement, in concert with the terms of the Original

Agreement, constitute the entire Agreement between Purdue and the OAG. The
Original Agreement and this Amended Agreement, shall not be modified or amended
except as set fonh in a writing that expressly refers to the Original Agreement and this
Amended Agreement and is executed by a duly authorized representative of Purdue
and the OAG. Without limiting the forgoing, no modification, amendment or waiver

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shall be affected by or result from the receipt, acceptance or signing of
acknowledgements or other documents containing tenns or conditions in addition to
or different from the terms and conditions set forth in the Original Agreement or
herein.
2.3

Toe Original Agreement, in concert with this Amended Agreement, shall be

binding upon, and inure to the benefit of, successors and assigns of Purdue and the
OAG.
2.4

Th.is Amended Agreement may be executed in counterparts by Purdue and the

OAG.
2.5

The headings set forth in this Amended Agreement have been inserted for

convenience of reference only. Such headings shall not be considered a part of this
Amended Agreement, and neither shall they limit, modify or affect in any way the
meaning or interpretation of this Amended Agreement.
2.6

Neither Purdue nor the OAG shall be considered to be the drafter of this

Amended Agreement or any of its provisions for the purposes of any statute, case law,
or rule of interpretation or construction that would or might cause any provision to be
construed against the drafter of this Amended Agreement

 ACKl~O\VLEDGEMENT

By the signatures below, the parties acknowledge their acceptance of the above
amendments to the Original Agreement.

Charlie Crist
Attorney General
State of Florida

Howard R. Udell
Executive Vice President/Chief Legal Officer
Purdue Pharma L.P.

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Howard R. Udell
Executive Vice President/Chief Legal Officer
The Purdue Frederick Company

Date