3013 Opioid LitigationResolution No. 2022-3013
A Resolution of the City of Sanford, Florida pertaining to the Opioid
Litigation in which the City has joined; delegating authority to Mayor
Art Woodruff with regard to the Opioid Litigation and the execution of
and array of various documents; providing for legislative findings and
intent; providing for implementing administrative actions; providing
for a savings provision; providing for conflicts; providing for
severability and providing for an effective date.
Whereas, the City of Sanford has suffered harm from the opioid epidemic that
has been inflicted upon the United States and all governments, state and local, within the
United States; and
Whereas, there are approximately 2,200 counties and cities that are plaintiffs
in litigation seeking damages against manufacturers and distributors of opioids with the
claims being asserted against a multitude of wrongdoers involved in the Nation's opioid
epidemic (in re: National Prescription Opiate Litigation, MDL No. 2804 (N.D. Ohio)) and
the State of Florida also has filed an action pending in Pasco County (together referred
to as the "Opioid Litigation") and City of Sanford is a litigating class participant being
represented by attorney Eric Romano, of the Romano Law Group; and
Whereas, the City of Sanford desires to maximize and enhance the use of
funds available to the City of Sanford resulting from Opioid Litigation settlement dollars
for the benefit of the citizens of the City; and
Whereas, many documents must be approved and executed to implement
actions and settlement of the Opioid Litigation from time -to -time to include, but not be
limited to, settlement documents with various parties which array of documents are often
very time sensitive; and
Whereas, the City of Sanford desires to maximize and enhance the use of
funds available to the City of Sanford resulting from settlement dollars arising from the
Opioid Litigation collaboratively with other Seminole County cities, the Government of
Seminole County and other appropriate agencies of government for the benefit of the
citizens of the City and to minimize the administrative time and costs that would result
from processing such documents; and
Whereas, the City Commission of the City of Sanford has deemed approval of
this Resolution to be in the best interest of the residents and citizens of the City of
Sanford, to further the public health, safety and welfare and would be in the public interest
and serve a public purpose; and
Whereas, the City Commission of the City of Sanford has the power and
authority to adopt this Resolution under the controlling provisions of State law such as,
by way of example only, the provisions of Article V111, Section 2 of the Constitution of the
State of Florida and the provisions of Chapter 166, Florida Statutes, and the controlling
case law of the State of Florida.
Now, Therefore, Be It Adopted And Resolved By The City Commission Of
The City Of Sanford, Florida As Follows:
Section 1. Legislative Findings And Intent.
(a). The City Commission of the City of Sanford hereby adopts and incorporates
into this Resolution the recitals (whereas clauses) to this Resolution as well as the City
Commission agenda memorandum presented to the City Commission and, with
specificity, the attachments to the agenda memorandum.
(b). The City Commission of the City of Sanford hereby determines that the
adoption of this Resolution and taking the actions set forth herein would be in the public
interest and serve a public purpose.
(c). The City of Sanford has complied with all requirements and procedures of
Florida law in processing and adopting this Resolution.
(d). Section 2.04 of the City Charter of the City of Sanford relates to the general
powers and duties of the City Commission and provides that "[a]ll powers of the City shall
be vested in the Commission, except as otherwise provided by law or this charter, and
the Commission shall provide for the exercise thereof and for the performance of all duties
and obligations imposed on the City by law" and Section 3.04 of the City Charter of the
City of Sanford relates to the powers and duties of the City Manager and provides, in
pertinent part that "[t]he City Manager shall be the chief administrative officer of the City.
The City Manager shall be responsible to the Commission for the administration of all City
affairs placed in his or her charge by or under this Charter". Section 4.03 of the City
Charter of the City of Sanford relates to the City Attorney and provides that the City
Attorney " . . . shall act as legal advisor to the municipality and its officers in matters
relating to their official duties."
Section 2. Delegation Of Authority To Mayor Art Woodruff; Opioid
Litigation Documents.
(a). The City Commission of the City of Sanford hereby delegates plenary
authority to Mayor, Art Woodruff, to execute any and all documents relative to the Opioid
Litigation to specifically include, but not be limited to, settlements with various parties and
the use of the funds in the course of an agreement with other Seminole County
governments.
(b). The City Attorney shall bring matters that require actions under the authority
of Subsection (a) to the attention of the Mayor and the City Manager and shall seek action
as needed to further the City's efforts in the ongoing Opioid Litigation, settlement matters
that arise, and intergovernmental actions and relations with regard to the Opioid Litigation.
Section 3. Implementing administrative actions.
The City Manager, City Clerk and City Attorney are hereby generally authorized to
take any and all actions necessary and appropriate to implement the provisions of this
Resolution.
Section 4. Savings.
All prior actions of the City Commission relating to the matter of the Opioid
Litigation, and all related activities, are hereby ratified and affirmed.
Section 5. Conflicts.
All resolutions or parts of resolutions in conflict with this Resolution are hereby
repealed.
Section 6. Severability.
If any section, sentence, phrase, word, or portion of this Resolution is determined
to be invalid, unlawful or unconstitutional, said determination shall not be held to invalidate
or impair the validity, force or effect of any other section, sentence, phrase, word, or
portion of this Resolution not otherwise determined to be invalid, unlawful, or
unconstitutional.
Section 7. Effective Date.
This Resolution shall become effective immediately upon adoption.
Passed and adopted this 24th day of January, 2022.
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CITY OF OEM, Item No.
SANFORD
FLORIDA
CITY COMMISSION MEMORANDUM 22-045
JANUARY 24, 2022 AGENDA (ADD ON)
To: Honorable Mayor and Members of the City Commission
PREPARED BY: Lonnie N. Groot, Assistant City Attorney
SUBMITTED BY: Norton N. Bonaparte, Jr., lCMA-CM, City Manager
SUBJECT: Proposed Statewide Settlement with Endo, Opioid Litigation Settlement;
Resolution NO. 2022-3013; Delegation to Execute Documents
STRATEGIC PRIORITIES:
F] Unify Downtown & the Waterfront
F-1 Promote the City's Distinct Culture
F] Update Regulatory Framework
n Redevelop and Revitalize Disadvantaged Communities
SYNOPSIS:
Request that the City Commission approve a proposed Statewide settlement with Endo pertaining to
the Opioid Litigation and ongoing settlement matters as well as Resolution No. 2022-3013 which
provides for the delegation of authority to the Mayor to execute documents relating to the Opioid
Litigation.
FISCAL/STAFFING STATEMENT:
No negative fiscal impacts arise as the City Commission previously approved involvement in the
through legal counsel and involvement in the Opioid Litigation. Numerous other documents and
actions need to be taken as the Opioid Litigation winds down and numerous documents need to be
acted upon on a recuring basis. The adoption of the proposed Resolution delegating authority to
Mayor Art Woodruff to execute all documents relative to the Opioid Litigation as well as the
settlement relating thereto would be a sound administrative means of expeditiously and efficiently
addressing the approval and execution of these documents as well as the intergovernmental decision-
making pertaining to the use of settlement funds.
BACKGROUND:
This matter relates to the continuing evolution City's involvement as addressed in litigation seeking
appropriate legal remedies against distributors, manufacturers and others involved in causing public
harm in the context of the National crisis involving opioid pain medications. As is well chronicled,
a local, state and National crisis arose as a result of the manufacture, distribution and over-
prescribing of opioid analgesics ("opioids") and resulted in opioid overdoses and addictions
throughout municipalities, counties, states and the Nation. Seminole County and the municipalities
of the County such as the City of Sanford were not immune from the impacts of this Nationwide
crisis. The City Commission has brought the impacts of the opioid crisis to the forefront by engaging
in the litigation.
As the City Commission is well aware, the City is represented in the Nationwide opioid litigation/
the National Prescription Opiate Litigation, based upon past City Commission actions, by a legal
team that is spearheaded by the Romano Law Group, of West Palm Beach. The City of Oviedo and
Seminole County also entered the National Prescription Opiate Litigation. As a result of this
litigation, multiple defendants have begun to negotiate settlements. The City Commission has
received past briefings relative to this ongoing complex litigation and has previously taken actions
relative to certain matters as presented from time -to -time such as approving proposed settlements
with distributors such as AmerisourceBergen, Cardinal Health, and McKesson, and Janssen/Johnson
& Johnson and by approving a Memorandum of Understanding (MOU) with the State which
provides for apportionment of funds. The City has also recently registered to be eligible to receive
Participation Agreements from the settlement administrator for the litigation and has entered those
Agreements. Also, at its last meeting, the City Commission approved an Interlocal Agreement which
provides that Seminole County Regional Funding will be used to fund opioid abatement in
accordance with the requirements of the MOU and any guidelines set forth by the County.
Mr. Romano has reported that the State has now reached a proposed Statewide settlement with Endo,
a manufacturer of opioid drugs. This settlement provides for a total payment of $65 million from
Endo, $55 million of which will be used for opioid abatement, with the remainder for legal fees.
These funds will be allocated between the State and local governments as set forth in the MOU with.
Mr. Romano has provided the following documents to the City (all attached) as to the Endo matter:
1. A letter explaining the terms of the settlement and the action steps that the
City will need to take in order to participate.
2. A copy of the Florida -Endo Settlement Agreement
3. A spreadsheet showing the allocation of settlement funds to each litigating
subdivision
4. The Participation Form that must be executed by the City to participate in the
settlement
The executed Participation Form is needed on or before February 9, 2022. If the City does not
execute the Participation Form, it will not be eligible to participate in this settlement. The Seminole
County distributions in the proposed Endo settlement are as follows:
Jurisdiction: Amount.
Seminole County
$124,467.27
Altamonte Springs
$
6,707.71
Casselberry
$
6,602.85
Lake Mary
$
6,580.83
Longwood
$
5,091.08
Oviedo
$
8,508.30
Sanford
$13,550.09
Winter Springs
$
5,136.62
Mr. Romano recommends that the City participate in this settlement with Endo, based on the scope
of Endo's activities in Florida and the risks of continued litigation. In particular, he states, there is a
substantial risk that Endo could file for bankruptcy in the absence of settlement, which would
prolong resolution and jeopardize the assets available for recovery. Also, the settlement amount is
in line with those which have been reached in other states, and the presence of a "most favored
nation" clause ensures that if larger settlements are reached in smaller states by population, or if
there were a global resolution which would result in a larger amount payable to Florida, this
settlement amount will be supplemented.
The City Attorney's office maintains communications with the County Attorney's office (Chief
Assistant County Attorney Desmond Morrell) and the Sherriff's legal counsel Marry Ann Klein) as
to all matters pertaining to the Opioid Litigation.
Detailed information about the settlements may be found at the following website which is
supplemented from time -to -time with updated information: https://nationalopioidsettlement.com/.
This national settlement website also includes links to helpful summary information including risks,
assumptions, FAQs and flow charts describing how the settlements are being implemented in
Florida, and how settlement funds will be allocated within Florida, including information about, and
links to, any applicable allocation agreement or legislation.
LEGAL REVIEW:
The Assistant City Attorney has been involved in this matter from its inception and has no legal
objection to the City Commission approving the recommendation of Attorney Eric Romano, of the
Romano Law Group. The Assistant City Attorney has prepared Resolution No. 2022-3013, to allow
for the smooth, expeditious and less administratively complex method of approving future matters
involved in the Opioid Litigation and settlement matters.
RECOMMENDATION:
City staff recommends that the City Commission approve the Florida -Endo Settlement Agreement
and Resolution No. 2022-3013.
SUGGESTED MOTION:
"1 move to approve the Florida -Endo Settlement Agreement and Resolution No. 2022-3013."
Attachments: (1). Letter from attorney Eric Romano, of the Romano Law Group
explaining the terms of the settlement, etc.
(2). Copy of the Florida -Endo Settlement Agreement.
(3). Spreadsheet showing the allocation of settlement funds.
(4). Participation Form for execution.
(5). Resolution No. 2022-3013.
Navigate Life.
CONFIDENTIAL ATTORNEY-CLIENT PRIVILEGE
PROTECTED COMMUNICATION
January 21, 2022
ACTION STEP: Please have the individual authorized to bind your local community
promptly execute the Attached Endo Participation Agreement and return it via email to
eric npRou-nanol-awGroup.com no later than February 9, 2022.
Re: Endo Settlement in Florida
Dear Client:
While we expect multiple and rolling settlements related to the National Opioid Litigation,
many of us expected that Purdue would be the next to settle after the Distributor and J&J national
deals. As many of you know, a Purdue resolution is now delayed, as a New York district court
recently overturned the bankruptcy court's confirmation of Purdue's Chapter 11 Plan. Instead,
based on pressure applied by the MDL and the upcoming trial date in Florida, Endo Health
Solutions Inc. and Endo Pharmaceuticals Inc. ("Endo) are now ready to settle.
The proposed Endo settlement is a lump -sum payment of $65 million to Florida. We
anticipate that the lump -sum remediation payments will be made at or about the same time as the
first payments in the Distributors' and J&J monies flow into Florida, which should be in the I"
quarter of 2022. Endo has already settled with New York for $50 million, and we believe Endo is
also attempting to settle in other states. The settlement agreement will include a most favored
nations clause, which requires Endo to supplement this proposed settlement if it pays more to
settle with any state other than California. Of the $65 million settlement, Endo will pay nearly $55
million to the state and litigating subdivisions, and $10 million to compensate the attorneys
representing the state and local governments.
This settlement process should be a bit more streamlined and efficient than the previous
Distributor and J&J settlements. The Subdivision Settlement Participation Agreement ("PA") is
nearly identical to the PA's utilized with the Distributors and J&J deals. The only differences are
that there is no arbitration provision, and the time to file a dismissal is 7 days instead of 14.
Likewise, the allocation of settlement funds within the State will be based on the previously
Palm Beach International Towers
John F. Romano, Board Certified by the Florida Bar and the National Board of Trial Advocacy in Civil Trial Law
1601 Belvedere Road, Suite 500-S
Eric Romano, Board Certified by the Florida Bar and the National Board of Trial Advocacy in Criminal Trial Law
West Palm Beach Florida, 33406-1551
Todd k Romano, Attorney at Law
801 Spencer Drive
Hall E. Marsocci, Attorney at Law
West Palm Beach, FL 33409
Corey B. Friedman, Attorney at Law (also admitted in California, New York and District of Columbia)
Destiny R. Barbosa, Attorney at Law
OFFICE: 561.533.6700
Jessica L. Latour, Attorney at Law
TOLL FREE: 866.533.6700
Marjorie H. Levine, Attorney at Law
FAX: 561.533.1285
Mikayla T. Taylor, Attorney at Law
WEB: romanolawgroup.com
Elliot B. Richman, Chief Operating Officer (admitted in New York & Connecticut only)
Endo Settlement in Florida
January 21, 2022
adopted Statewide Allocation Agreement. Thus, 15% of the available remediation funds will be
provided as direct payments to participating Litigating Subdivisions. Attached is a spreadsheet
showing the amount you will receive under the 15% direct payment. The remaining funds will go
to the Regional Fund and the State Fund.
As opposed to the Distributors and J&J deal, if sufficient participation takes place within
the next 30 days, you will receive your direct lump sum payment in or about April/May of this
year. The 30 -day deadline will expire on February 14, 2022. In order to effectuate the settlement,
and allow us to timely submit this participation form, you must complete the attached
Subdivision Settlement Participation Agreement and return it to
ei-ic(ii),R,oiiiiiiiol.,awGr(,)tii).coiii no later than February 9, 2022.
It is important to note that any Litigating Subdivision that does not sign an Endo
Subdivision Settlement Participation Agreement will be deemed a Non -Joining Subdivision. At
Endo's request, any Non -Joining Subdivision's share of the Remediation Payment shall be
returned to Endo.
`e ask thatyogic have the individual authorized to bind your local conununitvpronlptAy execute
the attached Subdivision Settlement Participation Agreement and return it to its at
c,i,ic(ib,Roiiiaiii LawGi-ot,iL).cont on or before February 9, 2022.
If you have any questions, please contact us.
Best regards,
ERIC ROMANO
Romano Law Group
SETTLEMENT AGREEMENT AND RELEASE
This Settlement Agreement is made and entered into this 15th day of January 2022, among
Endo, (defined below), the State of Florida and its Office of the Attorney General ("Plaintiff 'or
"State") (collectively, the "Settling Parties"), and State Outside Litigation Counsel (defined below)
in the lawsuit captioned State of Florida, Office of the Attorney General, Department of Legal
Affairs v. Purdue Pharma, L. P., et al. (Case No. 2018 -CA -001438) (Fla. Cir. Ct. Pasco County)
(the "Florida AG Action"). This Settlement Agreement is intended by the Settling Parties to fully,
finally and forever resolve, discharge and settle the Released Claims (as defined below), upon and
subject to the terms and conditions hereof (the "Settlement")
WHEREAS, Plaintiff filed its complaint in the Florida AG Action (i) alleging, among other
things, that Endo, among others, violated Florida law by deceptively marketing opioid pain
medications so as to overstate their efficacy and downplay the associated risk of addiction, which
resulted in a public nuisance in Florida; (ii) alleging that Endo, among others, violated the law by
failing to monitor, report and not ship allegedly suspicious orders of opioid pain medications; (iii)
alleging that Endo, among others, violated Fla. Stat. § 895.03(3), (4); and (iv) asserting Claims (as
defined below) for damages, equitable abatement, civil penalties, attorneys' fees and reimbursed
litigation costs, and other relief,
WHEREAS, Plaintiff brought the Florida AG Action in its sovereign capacity as the
people's attorney in order to protect the public interest, including the interests of the State of
Florida, its governmental subdivisions and its citizens;
WHEREAS, numerous Litigating Subdivisions (defined below) have filed Actions (defined
below) in various forums against Endo, among others, raising Claims or allegations concerning,
related to, based upon, or in connection with the Covered Conduct (defined below) and seeking
relief that overlaps in whole or in part with the relief sought in the Florida AG Action;
1
WHEREAS, there are numerous Subdivisions (defined below) that are not Litigating
Subdivisions ("Non -Litigating Subdivisions") that could seek to file additional Actions raising
Claims or allegations concerning, related to, based upon, or in connection with the Covered
Conduct and seeking relief that overlaps in whole or in part with the relief sought in the Florida
AG Action and the Actions filed by Litigating Subdivisions;
WHEREAS, Endo (i) denies each and all of the Claims and allegations of wrongdoing made
by Plaintiff in the Florida AG Action and by the Litigating Subdivisions in each of the Actions and
maintains that it has meritorious defenses; (ii) denies all assertions of wrongdoing or liability
against Endo arising out of any of the conduct, statements, acts or omissions alleged, or that could
have been alleged, in the Florida AG Action or in other Actions already brought by Litigating
Subdivisions or that could be brought by such plaintiffs or by Non -Litigating Subdivisions, and
contends that the factual allegations made in the Florida AG Action and the Litigating
Subdivisions' Actions relating to Endo are false and materially inaccurate; (iii) denies that Plaintiff,
or any Litigating Subdivision, or any other Subdivision, or any Florida resident, was harmed by
any conduct of Endo alleged in the Florida AG Action, the Litigating Subdivisions' Actions, or
otherwise; (iv) denies liability, expressly denies any wrongdoing, and denies it violated any federal
or state statute or common law; and (v) maintains that Endo would be able to successfully defend
against Plaintiff's Claims and allegations at trial, that the facts do not support the allegations, that
Endo engaged in no misconduct or unlawful activity, and caused no harm to Plaintiff or to the
Litigating Subdivisions, other Subdivisions, or any Florida residents;
WHEREAS, the Parties have investigated the facts and analyzed the relevant legal issues
regarding the Claims and defenses that have been or could have been asserted in the Florida AG
Action and any other Actions;
2
WHEREAS, the Parties have each considered the costs and delays and uncertainty
associated with the continued prosecution and defense of the Florida AG Action and the other
Actions;
WHEREAS, the Parties believe the Settlement set forth herein avoids the uncertainties of
litigation and assures that the benefits reflected herein are obtained;
WHEREAS, Plaintiff has concluded that the terms of the Settlement are fair, reasonable
and adequate and in the best interest of Plaintiff and all Subdivisions and Florida citizens and
residents;
WHEREAS, Plaintiff has determined that continuation or commencement of Actions
against Endo by Litigating Subdivisions or other Subdivisions would unduly interfere with
Plaintiff's litigation authority to bring and resolve litigation in which the State has an interest and
frustrate Plaintiff's efforts to obtain a favorable settlement;
WHEREAS, the Parties agree that neither this Agreement nor any statement made in the
negotiation thereof shall be deemed or construed to be a concession as to any Claim, an admission,
evidence of any violation of any statute or law, evidence of any liability or wrongdoing by Endo,
or evidence of the truth of any of the Claims, allegations, denials, or defenses made in the Florida
AG Action or the Litigating Subdivisions' Actions; and
WHEREAS, arm's-length settlement negotiations have taken place over the course of
several weeks between Endo and Plaintiff,
WHEREAS, Plaintiff views prompt settlement on the terms enclosed herein to be in the
public interest and crucial to the State of Florida and its citizens; recognizes that Subdivisions may,
notwithstanding their willingness to sign on to this settlement, wish to reserve the right to challenge
the Attorney General's authority to bind them in other litigation that does not arise out of or relate
to the Covered Conduct; and represents that Plaintiff shall not use those Subdivisions' acceptance
3
of the terms of this Settlement as precedent in any litigation matter that does not arise out of or
relate to the Covered Conduct;
NOW, THEREFORE, IT IS HEREBY AGREED by and between Plaintiff and Endo,
by and through their respective counsel, as follows:
A. Definitions. As used in this Agreement, the following capitalized terms have the
meanings specified below.
(a) "Actions" means the Florida AG Action and any lawsuit by a Subdivision
asserting any Released Claim against any Releasee.
(b) "Agreement," "Settlement" or "Settlement Agreement" means this
Settlement Agreement, together with any exhibits attached hereto, which are incorporated
herein by reference.
(c) "Bankruptcy Code" means Title 11 of the United States Code, 11 U.S.C.
§ 101, et seq.
(d) `Bar" means either: (1) a law barring all Subdivisions in the State of Florida
from maintaining Released Claims against Releasees (either through a direct bar or through
a grant of authority to release Claims and the exercise of such authority in full) or (2) a
ruling by the Florida Supreme Court (or a District Court of Appeal if a decision is not
subject to further review by the Florida Supreme Court) setting forth the general principle
that Subdivisions in the State of Florida may not maintain any Released Claims against
Releasees, whether on the ground of this Agreement (or the release in it) or otherwise. For
the avoidance of doubt, a law or ruling that is conditioned or predicated upon payment by
a Releasee (apart from the payments by Endo contemplated under this Agreement) shall
not constitute a Bar.
(e) "Claim" means any past, present or future cause of action, claim for relief,
cross-claim or counterclaim, theory of liability, demand, derivative claim, request,
assessment, charge, covenant, damage, debt, lien, loss, penalty, judgment, right, obligation,
dispute, suit, contract, controversy, agreement, parens patriae claim, promise, performance,
warranty, omission, or grievance of any nature whatsoever, whether legal, equitable,
statutory, regulatory or administrative, whether arising under federal, state or local
common law, statute, regulation, guidance, ordinance or principles of equity, whether filed
or unfiled, whether asserted or unasserted, whether known or unknown, whether accrued
or unaccrued, whether foreseen, unforeseen or unforeseeable, whether discovered or
undiscovered, whether suspected or unsuspected, whether fixed or contingent, and whether
existing or hereafter arising, in all such cases, including, but not limited to, any request for
declaratory, injunctive, or equitable relief, compensatory, punitive, or statutory damages,
absolute liability, strict liability, restitution, subrogation, contribution, indemnity,
apportionment, disgorgement, reimbursement, attorney fees, expert fees, consultant fees,
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fines, penalties, expenses, costs or any other legal, equitable, civil, administrative or
regulatory remedy whatsoever.
(f) "Claim -Over" means a Claim asserted by any entity that is not a Releasor
against a Releasee on the basis of contribution, indemnity, or other claim -over on any
theory relating to Claims arising out of or related to Covered Conduct (or conduct that
would be Covered Conduct if engaged in by a Releasee) asserted by a Releasor.
(g) "Consent Judgment' means a consent decree, order, judgment, or similar
action; in connection with this Agreement, the Parties have agreed to the entry of the
Consent Judgment attached hereto as Exhibit H, which provides for the release set forth
below and the dismissal with prejudice of any Released Claims that the State of Florida
Office of the Attorney General has brought against Releasees, on the terms and conditions
specified herein.
(h) "Court" means the Sixth Judicial Circuit Court in and for Pasco County,
State of Florida.
(i) "Covered Conduct" means any actual or alleged act, failure to act,
negligence, statement, error, omission, breach of any duty, conduct, event, transaction,
agreement, misstatement, misleading statement or other activity of any kind whatsoever
from the beginning of time through the Effective Date of the Release (and any past, present
or future consequence of any such act, failure to act, negligence, statement, error, omission,
breach of duty, conduct, event, transaction, agreement, misstatement, misleading statement
or other activity) arising from or relating in any way to: (1) the discovery, development,
manufacture, packaging, repackaging, marketing, promotion, advertising, labeling, recall,
withdrawal, distribution, delivery, monitoring, reporting, supply, sale, prescribing,
dispensing, physical security, warehousing, use or abuse of, or operating procedures
relating to, any Product, or any system, plan, policy or advocacy relating to any Product or
class of Products, including, but not limited to, any unbranded promotion, marketing,
programs or campaigns relating to any Product or class of Products; (2) the characteristics,
properties, risks or benefits of any Product; (3) the reporting, disclosure, non -reporting or
non -disclosure to federal, state or other regulators of orders placed with any Releasee; (4)
the purchasing, selling, acquiring, disposing of, importing, exporting, applying for quota
for, procuring quota for, handling, processing, packaging, supplying, distributing,
converting, or otherwise engaging in any activity relating to, precursor or component
Products, including, but not limited to, natural, synthetic, semi -synthetic, or chemical raw
materials, starting materials, active pharmaceutical ingredients, drug substances or any
related intermediate Products; and (5) diversion control programs or suspicious order
monitoring.
0) "Effective Date of the Agreement" means 3 business days after the Initial
Participation Date, provided that either a Bar exists or a sufficient number of Subdivisions
have become Participating Subdivisions by the Initial Participation Date. The Parties may
alter the Effective Date of the Agreement by mutual written agreement.
(k) "Effective Date of the Release" means the date on which the Court enters
the Consent Judgment.
(1) "Endo" means Endo Health Solutions Inc. and Endo Pharmaceuticals Inc.
(m) "Execution Date" means the date on which this Agreement is executed by
the last party to do so.
(n) "Initial Participation Date" means the date by which Litigating Subdivisions
must join to become initial Participating Subdivisions. The Initial Participation Date shall
be 30 days after the Execution Date. The Parties may alter the Initial Participation Date by
mutual written agreement.
(o) "Litigating Subdivision" means a Subdivision (or Subdivision official) that
has brought any Released Claim against any Releasees on or before December 31, 2021,
including, but not limited to, the agreed list of Litigating Subdivisions set forth in Exhibit
A.
(p) "Litigation Costs" means attorneys' fees and investigative and litigation
costs and expenses incurred in connection with Claims asserted against any Releasee in the
Florida AG Action or any Litigating Subdivision's Action.
(q) "Non -Joining Subdivision" means any Litigating Subdivision or Principal
Subdivision that does not execute a subdivision settlement participation form attached as
Exhibit D by the Post Effective Date Sign -on Deadline.
(r) "Non -Litigating Subdivision" means a Subdivision that is not a Litigating
Subdivision.
(s) "Non -Participating Subdivision" means a Subdivision that is not or is not
yet a Participating Subdivision.
(t) "Opioid Remediation" means care, treatment and other programs and
expenditures (including reimbursement for past such programs or expenditures, except
where this Agreement restricts the use of funds solely to future Opioid Remediation)
designed to (1) address the misuse and abuse of opioid products, (2) treat or mitigate opioid
use or related disorders, or (3) mitigate other alleged effects of, including on those injured
as a result of, the opioid epidemic. Exhibit C provides a non -exhaustive list of expenditures
that qualify as being paid for Opioid Remediation. Qualifying expenditures may include
reasonable related administrative expenses.I
(u) "Participating Subdivision" means any Subdivision that executes a
subdivision settlement participation form attached as Exhibit D.
(v) "Parties" and "Settling Parties" means Endo and Plaintiff, with each being
a "Party" and "Settling Party."
' Opioid Remediation includes amounts paid to satisfy any future demand by another governmental entity to
make a required reimbursement in connection with the past care and treatment of a person.
6
(w) "Post -Effective Date Sign -on Deadline" means the deadline for
Subdivisions to execute a subdivision settlement participation form attached as Exhibit D.
which shall be 150 days after the Effective Date of the Agreement.
(x) "Principal Subdivision" means: (1) a County, regardless of population; or
(2) a Subdivision that is not a County, but is a General Purpose Government entity
(including a municipality, city, town, township, parish, village, borough, gore or any other
entities that provide municipal -type government) with a population of more than 10,000,
including, but not limited to, the agreed list of Principal Subdivisions attached hereto as
Exhibit B.
(y) "Product" means any chemical substance, whether used for medicinal or
non -medicinal purposes, and whether natural, synthetic, or semi -synthetic, or any finished
pharmaceutical product made from or with such substance, that is: (1) an opioid or opiate,
as well as any product containing any such substance; or (2) benzodiazepine, carisoprodol,
or gabapentin; or (3) a combination or "cocktail" of chemical substances prescribed, sold,
bought or dispensed to be used together that includes opioids or opiates. "Product" shall
include, but is not limited to, any substance consisting of or containing buprenorphine,
codeine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine,
oxycodone, oxymorphone, tapentadol, tramadol, opium, heroin, carfentanil, diazepam,
estazolam, quazepam, alprazolam, clonazepam, oxazepam, flurazepam, triozolam,
temazepam, midazolam, carisoprodol, gabapentin, or any variant of these substances or any
similar substance. Notwithstanding the foregoing, nothing in this definition prohibits a
Releasor from taking administrative or regulatory action related to benzodiazepine
(including, but not limited to, diazepam, estazolam, quazepam, alprazolam, clonazepam,
oxazepam, flurazepam, triozolam, temazepam, and midazolam), carisoprodol, or
gabapentin that is wholly independent from the use of such drugs in combination with
opioids, provided such action does not seek money (including abatement and/or
remediation) for conduct prior to the Execution Date.
(z) "Qualified Settlement Fund" means the Florida Qualified Settlement Fund
contemplated by this Agreement, into which all payments by Endo shall be made and which
shall be established under the authority and jurisdiction of the Court and which shall be a
"qualified settlement fund" within the meaning of 26 C.F.R. § 1.46813-1.
(aa) "Qualified Settlement Fund Administrator" means the Administrator
appointed to administer the Qualified Settlement Fund under the authority and jurisdiction
of the Court. The duties of the Qualified Settlement Fund Administrator shall be governed
by this Agreement. The identity of the Qualified Settlement Fund Administrator and a
detailed description of the Qualified Settlement Fund Administrator's duties and
responsibilities, including a detailed mechanism for paying the Qualified Settlement Fund
Administrator's fees and costs, will be set forth in a separate document to be prepared by
the Parties and filed with the Court to establish the fund and be attached later to this
Agreement as Exhibit E.
(bb) "Released Claims" means any and all Claims that directly or indirectly are
based on, arise out of, or in any way relate to or concern the Covered Conduct occurring
prior to the Effective Date of the Release. Without limiting the foregoing, Released Claims
N
include any Claims that have been asserted against the Releasees by Plaintiff or any
Litigating Subdivision in any federal, state or local Action or proceeding (whether judicial,
arbitral or administrative) based on, arising out of or relating to, in whole or in part, the
Covered Conduct, or any such Claims that could be or could have been asserted now or in
the future in those Actions or in any comparable Action or proceeding brought by Plaintiff,
any of its Subdivisions, or any Releasor (whether or not such State, Subdivision, or
Releasor has brought such Action or proceeding). Released Claims also include all Claims
asserted in any proceeding to be dismissed pursuant to this Agreement, whether or not such
Claims relate to Covered Conduct. The Parties intend that this term, "Released Claims,"
be interpreted broadly. This Agreement does not release Claims by private individuals for
damages for any alleged personal injuries arising out of their own use of any Product. It is
the intent of the Parties that Claims by private individuals be treated in accordance with
applicable law. Released Claims is also used herein to describe Claims brought or
maintained by any Subdivision in the future that would have been Released Claims if they
had been brought by a Releasor against a Releasee.
(cc) "Releasees" means: (i) Endo Health Solutions Inc.; (ii) Endo
Pharmaceuticals Inc.; (iii) all of their respective past and present direct or indirect
parents, subsidiaries, divisions, affiliates, joint ventures, predecessors, successors, assigns
and insurers (in their capacity as such), including, but not limited to, Par Pharmaceutical,
Inc., Par Pharmaceutical Companies, Inc., and Endo International plc; and (iv) the past
and present officers, directors, members, shareholders (solely in their capacity as
shareholders of the foregoing entities), partners, trustees, employees, agents, attorneys and
insurers of each of the foregoing entities and persons referenced in clauses (i) through (iii)
above for actions or omissions that occurred during and related to their work for, or
employment with, any of the foregoing entities with respect to the Released Claims.
(dd) "Releasors" means with respect to Released Claims: (1) the State; (2) each
Participating Subdivision; and (3) without limitation and to the maximum extent of the
power of each of the State, the Florida Attorney General and/or Participating Subdivision
to release Claims, (a) the State of Florida's and each Subdivision's departments, agencies,
divisions, boards, commissions, Subdivisions, districts, instrumentalities of any kind and
any person in his or her official capacity, whether elected or appointed to lead or serve any
of the foregoing, and any agency, person or entity claiming by or through any of the
foregoing; (b) any public entities, public instrumentalities, public educational institutions,
unincorporated districts, fire districts, irrigation districts, water districts, law enforcement
districts, emergency services districts, school districts, hospital districts and other special
districts in the State of Florida, and (c) any person or entity acting in a parens patriae,
sovereign, quasi -sovereign, private attorney general, qui tam, taxpayer, or other capacity
seeking relief on behalf of or generally applicable to the general public with respect to the
State of Florida or any Subdivision in the State of Florida, whether or not any of them
participates in this Agreement. Nothing in this definition shall be construed to limit the
definition of "Subdivision" in subsection A(gg) below. In addition to being a Releasor as
provided herein, a Participating Subdivision shall also provide a subdivision settlement
participation form (attached as Exhibit D) providing for a release to the fullest extent of the
Participating Subdivision's authority, an executed copy of which shall be attached as an
exhibit to and deemed to be a part of this Agreement.
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(ee) "State Outside Litigation Counsel" means Kellogg, Hansen, Todd, Figel &
Frederick P.L.L.C.; Drake Martin Law Firm, LLC; Harrison Rivard Duncan & Buzzett,
Chartered; Newsome Melton, P.A.; and Curry Law Group, P.A.
(ff) "State -Subdivision Agreement" means a separate agreement among
Plaintiff and all Participating Subdivisions providing for an allocation of, among other
things, the Remediation Payment (defined below). The State -Subdivision Agreement is
attached hereto as Exhibit I.
(gg) "Subdivision" means (1) any General Purpose Government entity
(including, but not limited to, a municipality, county, county subdivision, city, town,
township, parish, village, borough, gore or any other entities that provide municipal -type
government), School District, or Special District within a State, and (2) any other
subdivision or subdivision official or sub -entity of or located within a State (whether
political, geographical or otherwise, whether functioning or non-functioning, regardless of
population overlap, and including, but not limited to, nonfunctioning governmental units
and public institutions) that has filed or could file a lawsuit that includes a Released Claim
against a Releasee in a direct, parens patriae, or any other capacity. "General Purpose
Government," "School District," and "Special District" shall correspond to the "five basic
types of local governments" recognized by the U.S. Census Bureau and match the 2017 list
of Governmental Units. The three (3) General Purpose Governments are county, municipal,
and township governments; the two (2) special purpose governments are School Districts
and Special Districts. "Fire District," "Health District," "Hospital District," and "Library
District" shall correspond to categories of Special Districts recognized by the U.S. Census
Bureau. References to a State's Subdivisions or to a Subdivision "in," "of," or "within" a
State include Subdivisions located within the State even if they are not formally or legally
a sub -entity of the State.
B. Release and Dismissals in the Florida AG Action and other Actions.
1. It is the intention of the Settling Parties to fully and finally resolve all Released
Claims that have been or could be brought against the Releasees by Plaintiff or any Subdivision
with respect to the Covered Conduct, and that the release of such Claims does not affect Plaintiff s
or the Subdivisions' Claims as to any other defendant. Plaintiff represents and warrants that it will
use its best efforts to obtain a consensual release of any and all Claims involving Covered Conduct
that Plaintiff and all Subdivisions, including any Litigating Subdivision or Non -Litigating
Subdivision, have asserted or could assert against the Releasees. Regardless whether such
consensual release is obtained, Plaintiff represents and warrants under this Agreement that it is
exercising its authority under law to release any and all Claims involving Covered Conduct that
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Plaintiff and all Subdivisions, including any Litigating Subdivision or Non -Litigating Subdivision,
have asserted or could assert against the Releasees. Plaintiff further represents and warrants that
it will use all available authority to bind, and under this Agreement is exercising such authority to
bind, Plaintiff and all Subdivisions, including all Litigating Subdivisions and Non -Litigating
Subdivisions, regardless of whether they become Participating Subdivisions or Non -Joining
Subdivisions, to the terms of this Agreement.
2. In addition to the general release and dismissal to be provided by Plaintiff set forth
in Sections D & E, Plaintiff will deliver to Endo signed agreements from: (a) each Subdivision
that executes a signed agreement by the Initial Participation Date; and (b) each Subdivision that
executes a signed agreement by the Post -Effective Date Sign -on Deadline (i.e., within 150 days
following the Effective Date of the Agreement). Such agreements shall include: (a) the
Subdivision's acceptance of the terms and conditions of this Agreement by signing the subdivision
settlement participation form attached as Exhibit D; (b) in the case of a Litigating Subdivision,
such Litigating Subdivision's agreement to implement an immediate cessation of any and all
litigation activities relating to such Litigating Subdivision's Action as to all Releasees; (c) in the
case of a Litigating Subdivision, an agreement that Plaintiff may represent that the Litigating
Subdivision supports the Consent Judgment to be entered in accordance with Section F below; and
(d) in the case of a Litigating Subdivision, such Litigating Subdivision's agreement to file, within
the later of seven (7) days of the Effective Date of the Release, or seven (7) days of signing the
subdivision settlement participation form, a notice or stipulation of voluntary dismissal with
prejudice of any and all Released Claims asserted by the Litigating Subdivision against the
Releasees, with each party to bear its own costs.
3. Between the Execution Date and the Initial Participation Date, Plaintiff agrees to
furnish to Endo a report listing the Subdivisions that have executed the signed agreements
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described in Section B.2 and copies of such signed agreements on a weekly basis. Plaintiff further
agrees to furnish to Endo no later than noon Eastern Time on the day after the Initial Participation
Date and a final report listing the Subdivisions that have executed the signed agreements described
in Section B.2 by the Initial Participation Date and copies of all such signed agreements. After the
Initial Participation Date, the parties shall confer and establish a schedule for the regular provision
of such reports and copies of signed agreements.
4. Plaintiff represents and warrants that, if any Action remains pending against one or
more Releasees after the Effective Date of the Agreement or is filed by a Subdivision against any
Releasee on or after the Execution Date, Plaintiff will seek to obtain dismissal of such Action as
to such Releasees as soon as reasonably possible. Depending on facts and circumstances, Plaintiff
may seek dismissal, among other ways, by intervening in such Action to move to dismiss or
otherwise terminate the Subdivision's Claims in the Action or by commencing a declaratory
judgment or other action that establishes a Bar to the Subdivision's Claims and Action. For
avoidance of doubt, Plaintiff will seek dismissal of an Action under this paragraph regardless
whether the Subdivision in such Action is a Participating Subdivision.
5. In the event that the actions required of Plaintiff in Section B.4 fail to secure the
prompt dismissal or termination of any Action by any Subdivision against any Releasee, Plaintiff
shall seek enactment of a legislative Bar as defined in Section A(d)(1) and will endeavor to achieve
enactment as soon as is practicable. Participating Subdivisions agree not to oppose any effort by
Plaintiff to achieve enactment of a legislative Bar.
6. Plaintiff further represents and warrants that no portion of the Remediation
Payment or the Litigation Costs Payments will be distributed to or used for the benefit of any
Subdivision unless and until Plaintiff has delivered to Endo a signed agreement from such
Subdivision providing for the Subdivision's acceptance of the terms and conditions of this
11
Agreement, including its express agreement to be bound by the irrevocable releases set forth in
Section D below.
C. Settlement Consideration.
1. Remediation Payment and Litigation Costs Payments.
(a) On or before the later of (a) seven (7) days after the Effective Date of the
Release, or (b) seven (7) days after (i) the Qualified Settlement Fund has been established
under the authority and jurisdiction of the Court, and (ii) Endo has received a W-9 and wire
instructions for the Qualified Settlement Fund, Endo Pharmaceuticals Inc. shall pay into
the Qualified Settlement Fund the sum of sixty-five million dollars ($65,000,000),
consisting of (a) fifty-five million dollars ($55,000,000) for opioid remediation (the
"Remediation Payment"), to be allocated in accordance with subsection C.3 below; (b) five
million dollars ($5,000,000) to be available to reimburse the State's Litigation Costs in
accordance with subsection C. I (c) below (the "State Litigation Cost Payment"); and (c)
five million dollars ($5,000,000) to be available to reimburse the Litigation Costs of
Litigating Subdivisions in accordance with subsection C.1(b) below (the "Litigating
Subdivision Litigation Cost Pam"). The State Litigation Cost Payment and the
Litigating Subdivision Cost Payment shall collectively be referred to herein as the
"Litigation Costs Payments." The Qualified Settlement Fund Administrator shall allocate
each of the Remediation Payment, the State Litigation Cost Payment, and the Litigating
Subdivision Litigation Cost Payment into separate sub -funds within the Qualified
Settlement Fund. Release of the Remediation Payment and the Litigation Costs Payments
from the Qualified Settlement Fund shall be subject to the conditions specified below.
(b) An agreement on the handling of Litigating Subdivision Litigation Costs is
attached as Exhibit G and incorporated herein by reference. The Litigating Subdivision
Litigation Cost Payment is to be available to reimburse counsel for Litigating Subdivisions
that become Participating Subdivisions and who waive any other right(s) they may have to
compensation in connection with this Settlement for reasonable Litigation Costs incurred
in connection with their Claims against Releasees.
(1) The Qualified Settlement Fund Administrator shall allow eligible
counsel reimbursement for reasonable Litigation Costs as provided
in Exhibit G. Such Litigation Costs shall be divided among
Participating Subdivisions as provided in Exhibit G under the
jurisdiction and authority of the Court. Any amount remaining in
the Litigation Subdivision Litigation Costs Payment sub -fund after
such allocation shall be returned to Endo.
(2) No funds may be used to compensate Litigation Costs incurred by
Non -Participating Subdivisions or Non -Litigating Subdivisions, or
Litigation Costs arising out of representation of any such
Subdivision.
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(3) No attorney for any Litigating Subdivision may receive any share of
the Litigating Subdivision Litigation Cost Payment unless the
following eligibility requirements are met and certified by the
attorney;
i. The attorney must represent that s/he has no present intent to
represent or participate in the representation of any
Subdivision or any Releasor with respect to the litigation of
any Released Claims against any Releasees.
ii. The attorney must represent that s/he will not charge or
accept any referral fees for any Released Claims asserted or
maintained against Releasees by any Subdivision or any
Releasor.
iii. The attorney may not have, and must represent that s/he does
not have, a claim for fees, costs or expenses related to the
litigation of any Released Claims against any Releasees by
any Subdivision or any Releasor after December 31, 2021.
iv. Notwithstanding the foregoing, nothing in this subsection
C. l (b)(3) is intended to operate as a "restriction" on the right
of any attorney to practice law within the meaning of Rule
5.6(b) of the Florida Rules of Professional Conduct or any
equivalent provision of any other jurisdiction's rules of
professional conduct.
(c) Plaintiff shall file in the Court a motion for the State's Litigation Costs up
to $5,000,000. Endo shall not oppose the motion so long as the State does not seek more
than $5,000,000 in Litigation Costs. If any amount of the $5,000,000 is not awarded by
the Court, that amount shall be returned to Endo. As set forth in Section C.2 below, in the
event the Court awards the State Litigation Costs in excess of $5,000,000, the Releasees
shall have no obligation to pay any amount in excess of the State Litigation Cost Payment.
2. No Other Payments by Releasees as to Covered Conduct, Released Claims, the
Florida AG Action, Other Actions, Plaintiff, Subdivisions or State Outside Litigation
Counsel or Litigation Costs. Other than the Remediation Payment and the Litigation Costs
Payments by Endo Pharmaceuticals Inc. referenced in Section C.1(a), none of the Releasees shall
have any obligation to make any further or additional payments in connection with Claims for
Covered Conduct or Litigation Costs or this Settlement.
13
3. Apportionment of the Remediation Payment.
(a) It is the intent of the Parties that the Remediation Payment in Section C.1(a)
be used exclusively for Opioid Remediation.
(b) In accordance with the State -Subdivision Agreement in Exhibit 1, the
Remediation Payment shall be allocated by the Qualified Settlement Fund Administrator
into three sub -funds: an Abatement Accounts Sub -Fund (also known as a regional fund),
a State Sub -Fund, and a Subdivision Sub -Fund to be allocated to the Abatement Accounts
Sub -Fund or to another Participating Subdivision.
(c) A detailed mechanism consistent with the foregoing for a Qualified
Settlement Fund Administrator to follow in allocating, apportioning and distributing
payments that will be filed with the Court and later attached as Exhibit J.
(d) Endo shall have no duty, liability, or influence of any kind with respect to
the apportionment and use of the Remediation Payment by the Qualified Settlement Fund
Administrator. Plaintiff specifically represents, however, that any such apportionment and
use by the Qualified Settlement Fund Administrator shall be made in accordance with all
applicable laws.
4. Release of the State Fund. Within a reasonable period after the Effective Date of
the Agreement or otherwise as ordered by the Court, the Qualified Settlement Fund Administrator
shall release the State Fund to Plaintiff.
5. Subdivision Payments to Subdivisions that Become Participating Subdivisions
Prior to the Initial Participation Date. A Participating Subdivision that (a) completes a
subdivision settlement participation form prior to the Initial Participation Date, (b) joins the Florida
Opioid Allocation and Statewide Response Agreement (Exhibit I), and (c) in the case of a
Litigating Subdivision, dismisses with prejudice any and all Released Claims asserted by the
Litigating Subdivision against the Releasees shall be eligible to receive payment of a share of the
Remediation Payment within a reasonable period after the Effective Date of the Agreement.
6. Subdivision Payments to Subdivisions that Become Participating Subdivisions
After the Initial Participation Date. A Participating Subdivision that (a) completes a subdivision
settlement participation form after the Initial Participation Date and by no later than the Post -
14
Effective Date Sign -on Deadline, (b) joins the Florida Opioid Allocation and Statewide Response
Agreement (Exhibit 1), and (c) in the case of a Litigating Subdivision, dismisses with prejudice
any and all Released Claims asserted by the Litigating Subdivision against the Releasees shall be
eligible to receive payment of a share of the Remediation Payment within a reasonable period after
the Post -Effective Date Sign -on Deadline.
7. Reversion to Endo of Amounts Forfeited by Non -Joining Subdivisions. Any
Litigating Subdivision or Principal Subdivision that does not sign a participation agreement by the
Post -Effective Date Sign -on Deadline will be deemed a Non -Joining Subdivision. At Endo's
request to the Qualified Settlement Fund Administrator, any Non -Joining Subdivision's share of
the Remediation Payment (and to the extent any such subdivision is a Litigating Subdivision the
Litigation Cost Payments) shall be returned to Endo within a reasonable time after the Post -
Effective Date Sign -on Deadline.
8. Agreement Null and Void if the Agreement Does Not Become Effective. In the
event that the Effective Date of the Agreement does not occur and the Parties fail to agree to extend
the Effective Date of the Agreement, the Agreement shall be null and void.
9. Use of Evidence at Trial in the Florida AG Action. Plaintiff agrees that none of
the Releasees will be a defendant in any trial of the Florida AG Action, that no Releasee will be
subpoenaed or called to testify by Plaintiff in any trial of the Florida AG Action and that any
evidence that references the Releasees or the Products will be used solely against other defendants
in the Florida AG Action.
10. Verdict Form. Plaintiff agrees that it will not seek to have any of the Releasees
included on the verdict form in any trial related to the Florida AG Action and will oppose the
efforts of any other party in the Florida AG Action to include any of the Releasees on the verdict
form.
15
11. Injunctive Relief. As part of the Consent Judgment to be entered in accordance
with Section F below, the Parties agree to the entry of injunctive relief terms attached in Exhibit
F.
D. Settlement of Claims and General Release.
1. Scope. On the Effective Date of the Release, Plaintiff and each Releasor shall be
deemed to have fully, finally and forever released all Releasees from all Released Claims.
Plaintiff, on behalf of itself and all other Releasors (whether or not they have signed this Agreement
or the subdivision settlement participation form in Exhibit D), hereby absolutely, unconditionally
and irrevocably covenants not to bring, file, or claim, or to cause, assist, or permit to be brought,
filed, or claimed, any Released Claims of any type in any forum whatsoever against Releasees.
For the avoidance of doubt, Plaintiff agrees that this Settlement Agreement and the releases
contained herein shall fully and completely resolve any past, present or future liability that any
Releasee may have arising from, relating to or based on the Covered Conduct occurring prior to
the Effective Date of the Release, whether in the Actions or otherwise. The releases provided for
in this Agreement are intended by the Settling Parties to be broad and shall be interpreted so as to
give the Releasees the broadest possible bar against any and all Released Claims. This Settlement
Agreement is, will constitute, and may be pleaded as a complete bar to any Released Claim asserted
against Releasees, whether against Plaintiff, any Participating Subdivision, or any other
Subdivision, including any Non -Joining Subdivision.
2. General Release. In connection with the releases provided pursuant to this
Settlement Agreement, Plaintiff, on behalf of itself and all other Releasors referenced in Section
D.1, expressly waives, releases and forever discharges any and all provisions, rights and benefits
conferred by any law of any state or territory of the United States or other jurisdiction, or principle
16
of common law, which is similar, comparable or equivalent to § 1542 of the California Civil Code,
which reads:
General Release; extent. A general release does not extend to claims that the
creditor or releasing party does not know or suspect to exist in his or her favor at
the time of executing the release that, if known by him or her, would have
materially affected his or her settlement with the debtor or released party.
A Releasor may hereafter discover facts other than or different from those that he, she, or it knows
or believes to be true with respect to the Released Claims, but Plaintiff, on behalf of itself and all
other Releasors, hereby expressly waives and fully, finally and forever settles, releases and
discharges, upon the Effective Date of the Release, any and all Released Claims against the
Releasees that may exist as of this date but which they do not know or suspect to exist, whether
through ignorance, oversight, error, negligence or otherwise, and which, if known, would
materially affect their decision to enter into this Settlement Agreement.
3. Claim -Over and Non -Party Settlement.
(a) Statement of Intent. It is the intent of the Parties that:
(1) The Remediation Payment and Litigation Cost Payments made
under this Agreement shall be the sole payments made by the
Releasees to the Releasors involving, arising out of, or related to
Covered Conduct (or conduct that would be Covered Conduct if
engaged in by a Releasee);
(2) Claims by Releasors against non -Parties should not result in
additional payments by Releasees, whether through contribution,
indemnification or any other means; and
(3) The Settlement effects a good faith "release and covenant not to sue"
Z:)
within the meaning of Florida Statute § 768.31(5) and meets the
requirements of the Uniform Contribution Among Joint Tortfeasors
Act and any similar state law or doctrine, including, but not limited
to, Fla. Stat. § 768.31(5), that reduces or discharges a released
party's liability to any other parties, such that Releasees are
discharged from all liability for contribution to any other alleged
tortfeasor in the Florida AG Action and in any other Action,
whenever filed.
17
(4) The provisions of this Section D.3 are intended to be implemented
consistent with these principles. This Agreement and the releases
and dismissals provided for herein are made in good faith.
(b) No Releasee shall seek to recover for amounts paid under this Agreement
based on indemnification, contribution, or any other theory, from a manufacturer,
pharmacy, hospital, pharmacy benefit manager, health insurer, third -party vendor, trade
association, distributor, or health care practitioner; provided that a Releasee shall be
relieved of this prohibition with respect to any entity that asserts a Claim -Over against
it. For the avoidance of doubt, nothing herein shall prohibit a Releasee from recovering
amounts owed pursuant to insurance contracts.
(c) To the extent that, on or after the Effective Date of the Agreement, any
Releasor settles any Claims arising out of or related to Covered Conduct (or conduct that
would be Covered Conduct if engaged in by a Releasee) ("Non -Party Covered Conduct
Claims") it may have against any entity that is not a Releasee (a "Non -Released Entity')
that is, as of the Effective Date of the Agreement, a defendant in the Florida AG Action or
any other Action and provides a release to such Non -Released Entity (a "Non -Party
Settlement"), including in any bankruptcy case or through any plan of reorganization
(whether individually or as a class of creditors), the Releasor will seek to include (or in the
case of a Non -Party Settlement made in connection with a bankruptcy case, will cause the
debtor to include), unless prohibited from doing so under applicable law, in the Non -Party
Settlement a prohibition on seeking contribution or indemnity of any kind from Releasees
substantially equivalent to that required from Endo in subsection D.3(b) (except limited to
such claims against Releasees), or a release from such Non -Released Entity in favor of the
Releasees (in a form equivalent to the releases contained in this Agreement) of any Claim -
Over. The obligation to seek to obtain the prohibition and/or release required by this
subsection is a material term of this Agreement.
(d) Claim -Over. In the event that any Releasor obtains ajudgment with respect
to a Non -Party Covered Conduct Claim against a Non -Released Entity that does not contain
a prohibition like that in subsection D.3(b), or any Releasor files a Non -Party Covered
Conduct Claim against a Non -Released Entity in bankruptcy or a Releasor is prevented for
any reason from obtaining a prohibition/release in a Non -Party Settlement as provided in
subsection D.3(c), and such Non -Released Entity asserts a Claim -Over against a Releasee,
Endo and that Releasor shall meet and confer concerning any additional appropriate means
by which to ensure that Releasees are not required to make any payment with respect to
Covered Conduct (beyond the amounts that will already have been paid by Endo under this
Settlement Agreement).
(e) In no event shall a Releasor be required to reduce the amount of a settlement
or judgment against a Non -Released Entity in order to prevent additional payments by
Releasees, whether through contribution, indemnification, or any other means.
4. Cooperation. Releasors, including Plaintiff and Participating Subdivisions, agree
that they will not publicly or privately encourage any other Releasor to bring or maintain any
18
Released Claim. Plaintiff further agrees that it will cooperate in good faith with the Releasees to
secure the prompt dismissal of any and all Released Claims.
E. Cessation of Litigation Activities. It is the Parties' intent that all litigation
activities in the Florida AG Action relating to Released Claims against the Releasees shall
immediately cease as of the Execution Date. Within seven (7) days after the Execution Date,
Plaintiff agrees to take all steps reasonably necessary to implement the prompt cessation of such
litigation activities, including by, for example, jointly requesting a severance of Endo from any
trial in the Florida AG Action and/or a stay of further proceedings against Endo pending the
implementation of this Settlement.
F. Entry of Consent Judgment Providing for Dismissal of All Claims Against
Endo in the Florida AG Action with Prejudice. As soon as practicable following the Effective
Date of the Agreement, Plaintiff shall file in the Court a Consent Judgment substantially in the
form of Exhibit H, including a dismissal of the Florida AG Action with prejudice. Notwithstanding
the foregoing, the Consent Judgment shall provide that the Court shall retain jurisdiction for
purposes of enforcing compliance with the injunctive terms set forth in Exhibit F. The parties shall
confer and agree as to the final form and time of filing prior to filing of the Consent Judgment.
G. No Admission of Liability. The Settling Parties intend the Settlement as described
herein to be a final and complete resolution of all disputes between Endo and Plaintiff and between
Endo and all Releasors. Endo is entering into this Settlement Agreement solely for the purposes
of settlement, to resolve the Florida AG Action and all Actions and Released Claims and thereby
avoid significant expense, inconvenience and uncertainty. Endo denies the allegations in the
Florida AG Action and the other Actions and denies any civil or criminal liability in the Florida
AG Action and the other Actions. Nothing contained herein may be taken as or deemed to be an
admission or concession by Endo of: (i) any violation of any law, regulation, or ordinance; (ii)
19
any fault, liability, or wrongdoing; (iii) the strength or weakness of any Claim or defense or
allegation made in the Florida AG Action, in any other Action, or in any other past, present or
future proceeding relating to any Covered Conduct or any Product; or (iv) any other matter of fact
or law. Nothing in this Settlement Agreement shall be construed or used to prohibit any Releasee
from engaging in the manufacture, marketing, licensing, distribution or sale of branded or generic
opioid medications or any other Product in accordance with applicable laws and regulations.
H. Miscellaneous Provisions.
1. Use of Agreement as Evidence. Neither this Agreement nor any act performed or
document executed pursuant to or in furtherance of this Agreement: (i) is or may be deemed to be
or may be used as an admission or evidence relating to any matter of fact or law alleged in the
Florida AG Action or the other Actions, the strength or weakness of any claim or defense or
allegation made in those cases, or any wrongdoing, fault, or liability of any Releasees; or (ii) is or
may be deemed to be or may be used as an admission or evidence relating to any liability, fault or
omission of Releasees in any civil, criminal or administrative proceeding in any court,
administrative agency or other tribunal. Neither this Agreement nor any act performed or
document executed pursuant to or in furtherance of this Agreement shall be admissible in any
proceeding for any purpose, except to enforce the terms of the Settlement, and except that
Releasees may file this Agreement in any action in order to support a defense or counterclaim
based on principles of res judicata, collateral estoppel, release, good -faith settlement, judgment
bar or reduction or any other theory of claim preclusion or issue preclusion or similar defense or
counterclaim or to support a claim for contribution and/or indemnification.
2. Voluntary Settlement. This Settlement Agreement was negotiated in good faith
and at arm's-length over several weeks, and the exchange of the Remediation Payment and
20
Litigation Costs Payment for the releases set forth herein is agreed to represent appropriate and
fair consideration.
3. Authorization to Enter Settlement Agreement. Each party specifically
represents and warrants that this Settlement Agreement constitutes a legal, valid and binding
obligation of such Party. Each signatory to this Settlement Agreement on behalf of a Party
specifically represents and warrants that he or she has full authority to enter into this Settlement
Agreement on behalf of such Party. Plaintiff specifically represents and warrants that it has
concluded that the terms of this Settlement Agreement are fair, reasonable, adequate and in the
public interest, and that it has satisfied all conditions and taken all actions required by law in order
to validly enter into this Settlement Agreement. Plaintiff specifically represents and warrants that,
other than the Claims asserted in the Florida AG Action and the other Actions (whether filed
previously or in the future), it has no interest (financial or otherwise) in any other Claim against
any Releasee related to the Covered Conduct. In addition, Plaintiff specifically represents and
warrants that (i) it is the owner and holder of the Claims asserted in the Florida AG Action; (ii) it
has not sold, assigned or otherwise transferred the Claims asserted in the Florida AG Action, or
any portion thereof or rights related thereto, to any third party; and (iii) it believes in good faith
that it has the power and authority to bind all persons and entities with an interest in the Florida
AG Action and all Subdivisions.
4. Representation With Respect to Participation Rate. The State of Florida
represents and warrants for itself that it has a good -faith belief that all Litigating Subdivisions and
all Principal Subdivisions will become Participating Subdivisions. The State acknowledges the
materiality of the foregoing representation and warranty. State Outside Litigation Counsel, in good
faith, believe this is a fair Settlement. Therefore, State Outside Litigation Counsel will, in their
best efforts, recommend this Settlement to all Subdivisions within Florida.
21
5. Dispute Resolution. If Plaintiff believes Endo is not in compliance with any term
of this Settlement Agreement, then Plaintiff shall (i) provide written notice to Endo specifying the
reason(s) why Plaintiff believes Endo is not in compliance with the Settlement Agreement; and
(ii) allow Endo at least thirty (30) days to attempt to cure such alleged non-compliance (the "Cure
Period"). In the event the alleged non-compliance is cured within the Cure Period, Endo shall not
have any liability for such alleged non-compliance. The State may not commence a proceeding to
enforce compliance with this Agreement before the expiration of the Cure Period.
6. No Third -Party Beneficiaries. Except as to Releasees, nothing in this Settlement
Agreement is intended to or shall confer upon any third party any legal or equitable right, benefit
or remedy of any nature whatsoever.
7. Notices. All notices under this Agreement shall be in writing and delivered to the
persons specified in this paragraph ("Notice Designees") via: (i) e-mail; and (ii) either hand
delivery or registered or certified mail, return receipt requested, postage pre -paid.
Notices to Plaintiff shall be delivered to:
Attorney General
Florida State Capitol, PL -01
Tallahassee FL 32399-1050
W1
David C. Frederick
Kellogg, Hansen, Todd, Figel & Frederick P.L.L.C.
1615 M Street, NW
Washington D.C. 20036
dfrederick@kellogghansen.com
Notices to Endo shall be delivered to:
Geoffrey M. Wyatt
Skadden, Arps, Slate, Meagher & Flom LLP
1440 New York Avenue N.W.
22
Washington, D.C. 20005
geoffrey.wyatt@skadden.com
Matthew J. Maletta
Executive Vice President and Chief Legal Officer
Endo
1400 Atwater Drive
Malvern, Pennsylvania 19355
maletta.matthew@endo.com
8. Taxes, Each of the Parties acknowledges, agrees and understands that it is its
intention that, for purposes of Section 162(f) of the Internal Revenue Code, the Remediation
Payment by Endo constitutes restitution for damage or harm allegedly caused by the potential
violation of a law and/or is an amount paid to come into compliance with the law. The Parties
acknowledge, agree and understand that only the Litigation Costs Payments represent
reimbursement to Plaintiff or any other person or entity for the costs of any investigation or
litigation, that no portion of the Remediation Payment represents reimbursement to Plaintiff or any
other person or entity for the costs of any investigation or litigation, and no portion of the
Remediation Payment represents or should properly be characterized as the payment of fines,
penalties or other punitive assessments. Plaintiff acknowledges, agrees and understands that Endo
intends to allocate the cost of the Remediation Payment among the Releasees using a reasonable
basis. If requested by Endo, Plaintiff` shall complete and file Form 1098-F with the Internal
Revenue Service, identifying the Remediation Payment as remediation/restitution amounts, and
shall furnish Copy $ of such Form 1098-F to Endo. Endo makes no warranty or representation to
Plaintiff as to the tax consequences of the Remediation Payment or the Litigation Costs Payments
or any portion thereof.
23
9. Binding Agreement. This Agreement shall be binding upon, and inure to the
benefit of, the successors and assigns of the Parties hereto.
10. Choice of Law. Any dispute arising from or in connection with this Settlement
Agreement shall be governed by Florida law without regard to its choice -of -law provisions.
11. Jurisdiction. The Parties agree to submit and consent to the jurisdiction of the
Court for the resolution of any disputes arising under the Settlement Agreement.
12. No Conflict Intended. The headings used in this Agreement are intended for the
convenience of the reader only and shall not affect the meaning or interpretation of this Agreement.
The definitions contained in this Agreement or any Exhibit hereto are applicable to the singular as
well as the plural forms of such terms.
13. No Party Deemed to be the Drafter. None of the Parties hereto shall be deemed
to be the drafter of this Agreement or any provision hereof for the purpose of any statute, case law
or rule of interpretation or construction that would or might cause any provision to be construed
against the drafter hereof.
14. Amendment; Waiver. This Agreement shall not be modified in any respect except
by a writing executed by all the Parties hereto, and the waiver of any rights conferred hereunder
shall be effective only if made by written instrument of the waiving Party. The waiver by any
Party of any breach of this Agreement shall not be deemed or construed as a waiver of any other
breach, whether prior, subsequent or contemporaneous.
15. Execution in Counterparts. This Agreement may be executed in one or more
counterparts. All executed counterparts and each of them shall be deemed to be one and the same
instrument.
MAI
16. Severability. In the event any one or more provisions of this Settlement Agreement
shall for any reason be held to be invalid, illegal or unenforceable in any respect, such invalidity,
illegality or unenforceability shall not affect any other provision of this Settlement Agreement.
17. Statements to the Press. Any press release or other public statement concerning
this Settlement Agreement will describe it positively and will not disparage any other Party. No
Party or attorney, agent, or representative of any Party shall state or suggest that this Settlement
Agreement may be used to predict the value of any Claim or any future settlement agreement in
any action or proceeding.
18. Integrated Agreement. This Agreement constitutes the entire agreement between
the Settling Parties and no representations, warranties or inducements have been made to any Party
concerning this Agreement other than the representations, warranties and covenants contained and
memorialized herein.
19. Bankruptcy. The following provisions shall apply if, (i) within ninety (90) days
of Endo's payment pursuant to Section C. I (a) above, a case is commenced with respect to Endo
under the Bankruptcy Code, and (ii) a court of competent jurisdiction enters a final order
determining such payment to be an avoidable preference under Section 547 of the Bankruptcy
Code, and (iii) pursuant to such final order such payment is returned to Endo:
(a) this Agreement, including all releases and covenants not to sue with respect
to the Released Claims contained in this Agreement, shall immediately and automatically
be deemed null and void as to Endo; and
(b) the State and Subdivisions may assert any and all Released Claims against
Endo in its bankruptcy case and seek to exercise all rights provided under the federal
Bankruptcy Code (or other applicable bankruptcy or non -bankruptcy law) with respect to
their Claims against Endo.
20. Most Favored Nations. If, after execution of this Agreement, there is a collective
resolution—through settlement, bankruptcy or other mechanism --of substantially all claims
PAI
against Endo brought by states, counties, and municipalities (a "Global Resolution") under which,
but for this Agreement, the Florida allocation would be greater than the sum of the Remediation
Payment and Litigation Cost Payments on a net present value basis, Endo shall pay the difference
between the sum of the Remediation Payment and Litigation Cost Payments and the amount that
would have been allocated to Florida under the terms and in accordance with any such Global
Resolution. Additionally, if at any time within the ten months following the Execution Date Endo
enters into a settlement with the attorney general of any state with a smaller population than Florida
for a total settlement amount that exceeds $65,000,000, Endo shall pay the excess amount to
Florida.
IN WITNESS WHEREOF, the Parties hereto, through their fully authorized
representatives, have executed this Agreement as of the dates set forth below.
ENDO HEALTH SOLUTIONS INC.
By;
Name: Blaise Coleman
President and CEO
Date: Oa 1 S /399a
ENDO PHARMACEUTICALS INC.
r,
By: /<
Name: Blaise Coleman
President and CEO
Date; 0 r 14 c
4 A-
M.,
PLAINTIFF
STATE OF FLORII)A.
hicludhig the OFFICE
OF/Tt-M�ATTORNEY
G EN r.
By:
Namid'.",foil Guard
Chief Deputy Attornev General of Florida
PUI-Stiallt to the autliority delegated to 11im by
Ashley Moody., Attorney General of Florida
Date, -
STATE OUTSIDE LITiGATION COUNSEL
Kellogg, Hamm, Todd, Figel & Frederick,
P.L.LC.
Name: David C. Frederick
Date -
Drake -Ma - w Firm, LLC
Bv:
Namc� Drake Martin
Date: 1-15-2022
27
Exhibit A
LITIGATING SUBDIVISIONS
Counties
Alachua County
Bay County
Bradford County
Brevard County
Broward County
Calhoun County
Clay County
County Commission of Monroe County
Dixie County
Escambia County
Gilchrist County
Gulf County
Hamilton County
Hernando County
Hillsborough County
Holmes County
Jackson County
Lake County
Lee County
Leon County
Levy County
Manatee County
Marion County
Miami -Dade County
Okaloosa County
Orange County
Osceola County
Palm Beach County
Pasco County
Pinellas County
Polk County
Putnam County
Santa Rosa County
Sarasota County
Seminole County
St. Johns County
St. Lucie County
Suwannee County
Taylor County
Union County
Volusia County
Walton County
Washington County
Cities
City of Apopka
City of Bradenton
City of Clearwater
City of Coconut Creek
City of Coral Gables
City of Coral Springs
City of Daytona Beach
City of Deerfield Beach
City of Delray Beach
City of Deltona
City of Florida City
City of Fort Lauderdale
City of Fort Pierce
City of Hallandale Beach
City of Homestead
City of Jacksonville
City of Lauderhill
City of Lynn Haven
City of Miami
City of Miami Gardens
City of Miramar
City of New Port Richey
City of Niceville
City of North Miami
City of Ocala
City of Ocoee
City of Orlando
City of Ormond Beach
City of Oviedo
City of Palatka
City of Palm Bay
City of Palmetto
City of Panama City
City of Pembroke Pines
City of Pensacola
City of Pinellas Park
City of Pompano Beach
City of Port St. Lucie
City of Sanford
City of Sarasota
City of St. Augustine
City of St. Petersburg
City of Stuart
City of Sweetwater
City of Tallahassee
City of Tampa
Town of Eatonville
Hospital Districts
Halifax Hospital Medical Center
Lee Memorial Health System
North Broward Hospital District
Sarasota County Public Hospital District
West Volusia Hospital Authority
School Board
School Board of Miami -Dade County
Exhibit S
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Exhibit C
List of Opioid Remediation Uses
Schedule A
Core Strategies
Subdivisions shall choose from among the abatement strategies listed in Schedule B. However,
priority shall be given to the following core abatement strategies ("Core Strategies").2
A. NALOXONE OR OTHER FDA -APPROVED MEDICATION
TO REVERSE OPIOID OVERDOSES
1 Expand training for first responders, schools, community
support groups and families; and
2. Increase distribution to individuals who are uninsured or
whose insurance does not cover the needed service.
B. MEDICATION -ASSISTED TREATMENT ("MAI")
DISTRIBUTION AND OTHER OPIOID -RELATED
TREATMENT
1. Increase distribution of MAT to individuals who are
uninsured or whose insurance does not cover the needed
service;
2. Provide education to school-based and youth -focused
programs that discourage or prevent misuse;
3. Provide MAT education and awareness training to
healthcare providers, EMTs, law enforcement, and other
first responders; and
4. Provide treatment and recovery support services such as
residential and inpatient treatment, intensive outpatient
treatment, outpatient therapy or counseling, and recovery
housing that allow or integrate medication and with other
support services.
' As used in this Schedule A, words like "expand," "fund," "provide" or the like shall not indicate a
preference for new or existing programs.
Schedule B
Approved Uses
Support treatment of Opioid Use Disorder (OUD) and any co-occurring Substance Use Disorder
or Mental Health (SUD/MH) conditions through evidence -based or evidence -informed programs
or strategies that may include, but are not limited to, the following:
I PART ONE: TREATMENT I
A. TREAT OPIOID USE DISORDER (OUD)
Support treatment of Opioid Use Disorder ("OUD") and any co-occurring Substance Use
Disorder or Mental Health ("SUDIMIT') conditions through evidence -based or evidence -
informed programs or strategies that may include, but are not limited to, those that: 3
I Expand availability of treatment for OUD and any co-occurring SUD/MH
conditions, including all forms of Medication -Assisted Treatment ("MAT')
approved by the U.S. Food and Drug Administration.
2. Support and reimburse evidence -based services that adhere to the American
Society of Addiction Medicine ("ASA M') continuum of care for OUD and any co-
occurring SUD/MH conditions.
Expand telehealth to increase access to treatment for OUD and any co-occurring
SUD/MH conditions, including MAT, as well as counseling, psychiatric support,
and other treatment and recovery support services.
4. Improve oversight of Opioid Treatment Programs ("OTPs") to assure evidence -
based or evidence -informed practices such as adequate methadone dosing and low
threshold approaches to treatment.
5. Support mobile intervention, treatment, and recovery services, offered by
qualified professionals and service providers, such as peer recovery coaches, for
persons with OUD and any co-occurring SUD/MH conditions and for persons
who have experienced an opioid overdose.
6. Provide treatment of trauma for individuals with OUD (e.g., violence, sexual
assault, human trafficking, or adverse childhood experiences) and family
members (e.g., surviving family members after an overdose or overdose fatality),
and training of health care personnel to identify and address such trauma.
7. Support evidence -based withdrawal management services for people with OUD
and any co-occurring mental health conditions.
' As used in this Schedule B, words like "expand," "fund," "provide" or the like shall not indicate a preference
for new or existing programs.
8. Provide training on MAT for health care providers, first responders, students, or
other supporting professionals, such as peer recovery coaches or recovery
outreach specialists, including telementoring to assist community-based providers
in rural or underserved areas.
9. Support workforce development for addiction professionals who work with
persons with OUD and any co-occurring SUD/MH conditions.
10. Offer fellowships for addiction medicine specialists for direct patient care,
instructors, and clinical research for treatments.
11. Offer scholarships and supports for behavioral health practitioners or workers
involved in addressing OUD and any co-occurring SUD/MH or mental health
conditions, including, but not limited to, training, scholarships, fellowships, loan
repayment programs, or other incentives for providers to work in rural or
underserved areas.
12. Provide funding and training for clinicians to obtain a waiver under the federal
Drug Addiction Treatment Act of 2000 ("DATA 2000") to prescribe MAT for
OUD, and provide technical assistance and professional support to clinicians who
have obtained a DATA 2000 waiver.
13. Disseminate web -based training curricula, such as the American Academy of
Addiction Psychiatry's Provider Clinical Support Service—Opioids web -based
training curriculum and motivational interviewing.
14. Develop and disseminate new curricula, such as the American Academy of
Addiction Psychiatry's Provider Clinical Support Service for Medication—
Assisted Treatment.
B. SUPPORT PEOPLE IN TREATMENT AND RECOVERY
Support people in recovery from OUD and any co-occurring SUD/MH conditions
through evidence -based or evidence -informed programs or strategies that may include,
but are not limited to, programs or strategies that:
Provide comprehensive wrap-around services to individuals with OUD and any
co-occurring SUD/MH conditions, including housing, transportation, education,
job placement, job training, or childcare.
2. Provide the full continuum of care with respect to treatment and recovery services
for OUD and any co-occurring SUD/1\4H conditions, including supportive
housing, peer support services and counseling, community navigators, case
management, and connections to community-based services.
3. Provide counseling, peer -support, recovery case management and residential
treatment with access to medications for those who need it to persons with OUD
and any co-occurring SUD/MH conditions.
4. Provide access to housing for people with OUD and any co-occurring SUD/MH
conditions, including supportive housing, recovery housing, housing assistance
programs, training for housing providers, or recovery housing programs that allow
or integrate FDA -approved mediation with other support services.
5. Provide community support services, including social and legal services, to assist
in deinstitutionalizing persons with OUD and any co-occurring SUD/MH
conditions.
6. Support or expand peer -recovery centers, which may include support groups,
social events, computer access, or other services for persons with OUD and any
co-occurring SUD/MH conditions.
7. Provide or support transportation to treatment or recovery programs or services
for persons with OUD and any co-occurring SUD/MH conditions.
8. Provide employment training or educational services for persons in treatment for
or recovery from OUD and any co-occurring SUD/MH conditions.
9. Identify successful recovery programs such as physician, pilot, and college
recovery programs, and provide support and technical assistance to increase the
number and capacity of high-quality programs to help those in recovery.
10. Engage non -profits, faith -based communities, and community coalitions to
support people in treatment and recovery and to support family members in their
efforts to support the person with OUD in the family.
11. Provide training and development of procedures for government staff to
appropriately interact and provide social and other services to individuals with or
in recovery from OUD, including reducing stigma.
12. Support stigma reduction efforts regarding treatment and support for persons with
OUD, including reducing the stigma on effective treatment.
13. Create or support culturally appropriate services and programs for persons with
OUD and any co-occurring SUD/MH conditions, including new Americans.
14. Create and/or support recovery high schools.
15. Hire or train behavioral health workers to provide or expand any of the services or
supports listed above.
C. CONNECT PEOPLE WHO NEED HELP TO THE HELP THEY NEED
(CONNECTIONS TO CARE)
Provide connections to care for people who have—or are at risk of developing—OUD
and any co-occurring SUD/MH conditions through evidence -based or evidence -informed
programs or strategies that may include, but are not limited to, those that:
I Ensure that health care providers are screening for OUD and other risk factors and
know how to appropriately counsel and treat (or refer if necessary) a patient for
OUD treatment.
2. Fund SBIRT programs to reduce the transition from use to disorders, including
SBIRT services to pregnant women who are uninsured or not eligible for
Medicaid.
3. Provide training and long-term implementation of SBIRT in key systems (health,
schools, colleges, criminal justice, and probation), with a focus on youth and
young adults when transition from misuse to opioid disorder is common.
4. Purchase automated versions of SBIRT and support ongoing costs of the
technology.
5. Expand services such as navigators and on-call teams to begin MAT in hospital
emergency departments.
6. Provide training for emergency room personnel treating opioid overdose patients
on post -discharge planning, including community referrals for MAT, recovery
case management or support services.
7. Support hospital programs that transition persons with OUD and any co-occurring
SUD/MH conditions, or persons who have experienced an opioid overdose, into
clinically appropriate follow-up care through a bridge clinic or similar approach.
8. Support crisis stabilization centers that serve as an alternative to hospital
emergency departments for persons with OUD and any co-occurring SUD/MH
conditions or persons that have experienced an opioid overdose.
9. Support the work of Emergency Medical Systems, including peer support
specialists, to connect individuals to treatment or other appropriate services
following an opioid overdose or other opioid -related adverse event.
10. Provide funding for peer support specialists or recovery coaches in emergency
departments, detox facilities, recovery centers, recovery housing, or similar
settings; offer services, supports, or connections to care to persons with OUD and
any co-occurring SUD/MH conditions or to persons who have experienced an
opioid overdose.
11. Expand warm hand-off services to transition to recovery services.
12. Create or support school-based contacts that parents can engage with to seek
immediate treatment services for their child; and support prevention, intervention,
treatment, and recovery programs focused on young people.
13. Develop and support best practices on addressing OUD in the workplace.
14. Support assistance programs for health care providers with OUD.
15. Engage non -profits and the faith community as a system to support outreach for
treatment.
16. Support centralized call centers that provide information and connections to
appropriate services and supports for persons with OUD and any co-occurring
SUD/MH conditions.
D. ADDRESS THE NEEDS OF CRIMINAL JUSTICE -INVOLVED PERSONS
Address the needs of persons with OUD and any co-occurring SUD/MH conditions who
are involved in, are at risk of becoming involved in, or are transitioning out of the
criminal justice system through evidence -based or evidence -informed programs or
strategies that may include, but are not limited to, those that:
1. Support pre -arrest or pre -arraignment diversion and deflection strategies for
persons with OUD and any co-occurring SUD/MH conditions, including
established strategies such as:
Self -referral strategies such as the Angel Programs or the Police Assisted
Addiction Recovery Initiative ("PAARI" );
2. Active outreach strategies such as the Drug Abuse Response Team
("DART") model;
3. "Naloxone Plus" strategies, which work to ensure that individuals who
have received naloxone to reverse the effects of an overdose are then
linked to treatment programs or other appropriate services;
4. Officer prevention strategies, such as the Law Enforcement Assisted
Diversion ("LEAD") model;
5. Officer intervention strategies such as the Leon County, Florida Adult
Civil Citation Network or the Chicago Westside Narcotics Diversion to
Treatment Initiative; or
6. Co -responder and/or alternative responder models to address OUD-related
911 calls with greater SUD expertise.
2. Support pre-trial services that connect individuals with OUD and any co-
occurring SUD/MH conditions to evidence -informed treatment, including MAT,
and related services.
3. Support treatment and recovery courts that provide evidence -based options for
persons with OUD and any co-occurring SUD/MH conditions.
4. Provide evidence -informed treatment, including MAT, recovery support, harm
reduction, or other appropriate services to individuals with OUD and any co-
occurring SUD/MH conditions who are incarcerated in jail or prison.
5. Provide evidence -informed treatment, including MAT, recovery support, harm
reduction, or other appropriate services to individuals with OUD and any co-
occurring SUD/MH conditions who are leaving jail or prison or have recently left
jail or prison, are on probation or parole, are under community corrections
supervision, or are in re-entry programs or facilities.
6. Support critical time interventions ("CTT'), particularly for individuals living with
dual -diagnosis OUD/serious mental illness, and services for individuals who face
immediate risks and service needs and risks upon release from correctional
settings.
7. Provide training on best practices for addressing the needs of criminal justice -
involved persons with OUD and any co-occurring SUD/MH conditions to law
enforcement, correctional, or judicial personnel or to providers of treatment,
recovery, harm reduction, case management, or other services offered in
connection with any of the strategies described in this section.
E. ADDRESS THE NEEDS OF PREGNANT OR PARENTING WOMEN AND
THEIR FAMILIES, INCLUDING BABIES WITH NEONATAL ABSTINENCE
SYNDROME
Address the needs of pregnant or parenting women with OUD and any co-occurring
SUD/MH conditions, and the needs of their families, including babies with neonatal
abstinence syndrome ("NAS"), through evidence -based or evidence -informed programs or
strategies that may include, but are not limited to, those that:
I Support evidence -based or evidence -informed treatment, including MAT,
recovery services and supports, and prevention services for pregnant women --or
women who could become pregnant—who have OUD and any co-occurring
SUD/MH conditions, and other measures to educate and provide support to
families affected by Neonatal Abstinence Syndrome.
2. Expand comprehensive evidence -based treatment and recovery services, including
MAT, for uninsured women with OUD and any co-occurring SUD/MH conditions
for up to 12 months postpartum.
3. Provide training for obstetricians or other healthcare personnel who work with
pregnant women and their families regarding treatment of OUD and any co-
occurring SUD/MH conditions.
4. Expand comprehensive evidence -based treatment and recovery support for NAS
babies; expand services for better continuum of care with infant -need dyad; and
expand long-term treatment and services for medical monitoring of NAS babies
and their families.
5. Provide training to health care providers who work with pregnant or parenting
women on best practices for compliance with federal requirements that children
bom with NAS get referred to appropriate services and receive a plan of safe care.
6. Provide child and family supports for parenting women with OUD and any co-
occurring SUD/MH conditions.
7. Provide enhanced family support and child care services for parents with OUD
and any co-occurring SUD/MH conditions.
8. Provide enhanced support for children and family members suffering trauma as a
result of addiction in the family; and offer trauma -informed behavioral health
treatment for adverse childhood events.
9. Offer home-based wrap-around services to persons with OUD and any co-
occurring SUD/MH conditions, including, but not limited to, parent skills
training.
10. Provide support for Children's Services—Fund additional positions and services,
including supportive housing and other residential services, relating to children
being removed from the home and/or placed in foster care due to custodial opioid
use.
PART TWO: PREVENTION
F. PREVENT OVER -PRESCRIBING AND ENSURE APPROPRIATE
PRESCRIBING AND DISPENSING OF OPIOIDS
Support efforts to prevent over -prescribing and ensure appropriate prescribing and
dispensing of opioids through evidence -based or evidence -informed programs or
strategies that may include, but are not limited to, the following:
Funding medical provider education and outreach regarding best prescribing
practices for opioids consistent with the Guidelines for Prescribing Opioids for
Chronic Pain from the U.S. Centers for Disease Control and Prevention, including
providers at hospitals (academic detailing).
2. Training for health care providers regarding safe and responsible opioid
prescribing, dosing, and tapering patients off opioids.
Continuing Medical Education (CME) on appropriate prescribing of opioids.
4. Providing Support for non -opioid pain treatment alternatives, including training
providers to offer or refer to multi -modal, evidence -informed treatment of pain.
5. Supporting enhancements or improvements to Prescription Drug Monitoring
Programs ("PDMPs"), including, but not limited to, improvements that:
1. Increase the number of prescribers using PDMPs;
2. Improve point -of -care decision-making by increasing the quantity, quality,
or format of data available to prescribers using PDMPs, by improving the
interface that prescribers use to access PDMP data, or both; or
3. Enable states to use PDMP data in support of surveillance or intervention
strategies, including MAT referrals and follow-up for individuals
identified within PDMP data as likely to experience OUD in a manner that
complies with all relevant privacy and security laws and rules.
6. Ensuring PDMPs incorporate available overdose/naloxone deployment data,
including the United States Department of Transportation's Emergency Medical
Technician overdose database in a manner that complies with all relevant privacy
and security laws and rules.
7. Increasing electronic prescribing to prevent diversion or forgery.
8. Educating dispensers on appropriate opioid dispensing.
G. PREVENT MISUSE OF OPIOIDS
Support efforts to discourage or prevent misuse of opioids through evidence -based or
evidence -informed programs or strategies that may include, but are not limited to, the
following:
1. Funding media campaigns to prevent opioid misuse.
2. Corrective advertising or affirmative public education campaigns based on
evidence.
3. Public education relating to drug disposal.
4. Drug take -back disposal or destruction programs.
5. Funding community anti-drug coalitions that engage in drug prevention efforts.
6. Supporting community coalitions in implementing evidence -informed prevention,
such as reduced social access and physical access, stigma reduction—including
staffing, educational campaigns, support for people in treatment or recovery, or
training of coalitions in evidence -informed implementation, including the
Strategic Prevention Framework developed by the U.S. Substance Abuse and
Mental Health Services Administration ("SAMHSA").
7. Engaging non -profits and faith -based communities as systems to support
prevention.
8. Funding evidence -based prevention programs in schools or evidence -informed
school and community education programs and campaigns for students, families,
school employees, school athletic programs, parent -teacher and student
associations, and others.
9. School-based or youth -focused programs or strategies that have demonstrated
effectiveness in preventing misuse of prescription medications and seem likely to
be effective in preventing the uptake and use of opioids.
10. Create or support community-based education or intervention services for
families, youth, and adolescents at risk for OUD and any co-occurring SUD/MH
conditions.
11. Support evidence -informed programs or curricula to address mental health needs
of young people who may be at risk of misusing opioids or other prescription
medications, including emotional modulation and resilience skills.
12. Support greater access to mental health services and supports for young people,
including services and supports provided by school nurses, behavioral health
workers or other school staff, to address mental health needs in young people that
(when not properly addressed) increase the risk of opioid or another prescription
medication misuse.
H. PREVENT OVERDOSE DEATHS AND OTHER HARMS (HARM REDUCTION)
Support efforts to prevent or reduce overdose deaths or other opioid -related harms
through evidence -based or evidence -informed programs or strategies that may include,
but are not limited to, the following:
Increased availability and distribution of naloxone and other medications that treat
overdoses for first responders, overdose patients, individuals with OUD and their
friends and family members, schools, community navigators and outreach
workers, persons being released from jail or prison, or other members of the
general public.
2. Public health entities providing free naloxone to anyone in the community.
3. Training and education regarding naloxone and other medications that treat
overdoses for first responders, overdose patients, patients taking opioids, families,
schools, community support groups, and other members of the general public.
4. Enabling school nurses and other school staff to respond to opioid overdoses, and
provide them with naloxone, training, and support.
5. Expanding, improving, or developing data tracking software and applications for
overdoses/naloxone revivals.
6. Public education relating to emergency responses to overdoses.
7. Public education relating to immunity and Good Samaritan laws.
8. Educating first responders regarding the existence and operation of immunity and
Good Samaritan laws.
9. Syringe service programs and other evidence -informed programs to reduce harms
associated with intravenous drug use, including supplies, staffing, space, peer
support services, referrals to treatment, fentanyl checking, connections to care,
and the full range of harm reduction and treatment services provided by these
programs.
10. Expanding access to testing and treatment for infectious diseases such as HIV and
Hepatitis C resulting from intravenous opioid use.
11. Supporting mobile units that offer or provide referrals to harm reduction services,
treatment, recovery supports, health care, or other appropriate services to persons
that use opioids or persons with OUD and any co-occurring SUD/MH conditions.
12. Providing training in harm reduction strategies to health care providers, students,
peer recovery coaches, recovery outreach specialists, or other professionals that
provide care to persons who use opioids or persons with OUD and any co-
occurring SUD/MH conditions.
13. Supporting screening for fentanyl in routine clinical toxicology testing.
I PART THREE: OTHER STRATEGIES
I. FIRST RESPONDERS
In addition to items in section C, D and H relating to first responders, support the
following:
I Education of law enforcement or other first responders regarding appropriate
practices and precautions when dealing with fentanyl or other medications.
2. Provision of wellness and support services for first responders and others who
experience secondary trauma associated with opioid -related emergency events.
J. LEADERSHIP, PLANNING AND COORDINATION
Support efforts to provide leadership, planning, coordination, facilitations, training and
technical assistance to abate the opioid epidemic through activities, programs, or
strategies that may include, but are not limited to, the following:
I Statewide, regional, local or community regional planning to identify root causes
of addiction and overdose, goals for reducing harms related to the opioid
epidemic, and areas and populations with the greatest needs for treatment
intervention services, and to support training and technical assistance and other
strategies to abate the opioid epidemic described in this opioid abatement strategy
list.
2. A dashboard to (a) share reports, recommendations, or plans to spend opioid
settlement funds; (b) to show how opioid settlement funds have been spent; (c) to
report program or strategy outcomes; or (d) to track, share or visualize key opioid -
or health-related indicators and supports as identified through collaborative
statewide, regional, local or community processes.
3. Invest in infrastructure or staffing at government or not-for-profit agencies to
support collaborative, cross -system coordination with the purpose of preventing
overprescribing, opioid misuse, or opioid overdoses, treating those with OUD and
any co-occurring SUD/MH conditions, supporting them in treatment or recovery,
connecting them to care, or implementing other strategies to abate the opioid
epidemic described in this opioid abatement strategy list.
4. Provide resources to staff government oversight and management of opioid
abatement programs.
In addition to the training referred to throughout this document, support training to abate
the opioid epidemic through activities, programs, or strategies that may include, but are
not limited to, those that:
I Provide funding for staff training or networking programs and services to improve
the capability of government, community, and not-for-profit entities to abate the
opioid crisis.
2. Support infrastructure and staffing for collaborative cross -system coordination to
prevent opioid misuse, prevent overdoses, and treat those with OUD and any co-
occurring SUD/MH conditions, or implement other strategies to abate the opioid
epidemic described in this opioid abatement strategy list (e.g., health care,
primary care, Manufacturers, PDMPs, etc.).
19 0 0 0 V M3 AN I'lua me
Support opioid abatement research that may include, but is not limited to, the following:
I Monitoring, surveillance, data collection and evaluation of programs and
strategies described in this opioid abatement strategy list.
2. Research non -opioid treatment of chronic pain.
3. Research on improved service delivery for modalities such as SBIRT that
demonstrate promising but mixed results in populations vulnerable to
opioid use disorders.
4. Research on novel harm reduction and prevention efforts such as the
provision of fentanyl test strips.
5. Research on innovative supply-side enforcement efforts such as improved
detection of mail -based delivery of synthetic opioids.
6. Expanded research on swift/certain/fair models to reduce and deter opioid
misuse within criminal justice populations that build upon promising
approaches used to address other substances (e.g., Hawaii HOPE and
Dakota 24/7).
7. Epidemiological surveillance of OUD-related behaviors in critical
populations, including individuals entering the criminal justice system,
including, but not limited to approaches modeled on the Arrestee Drug
Abuse Monitoring ("ADAM") system.
Qualitative and quantitative research regarding public health risks and
harm reduction opportunities within illicit drug markets, including surveys
of market participants who sell or distribute illicit opioids.
9. Geospatial analysis of access barriers to MAT and their association with
treatment engagement and treatment outcomes.
Exhibit D
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amid ReleaseLL C[a air'is, and, 4,vithru the lutc-rtil` 7days fbilowirq,
Consent Jtjt gpnent or 7; days of the Execution Datic (Y-fthis SuM ivision Setttemcnt
Participation Form volumaril-v' ismiss With pvojuduceanv Rete uset?i Clal;Tvs that it bas
fil
3. The - iovernmenta.; Entity afire to zlic ternis of :lie Elido Settienientperm-111itiq 1c)
4. By ag7ccing t(-,,. the terms of the End") Sottlement am! expn,sty ag�rxlrmg to, tb..!
providr therteizl, tile Gr
ovetit-nerrual Elifi
-rv, is enti
ed fiOtlet u) the be -left:; prwvidied rhavein,
including, if applic-abic, mor o-ary paTncnls ;Qgpming uftcr the Dow ol-lhw,
Aor emem.
5. The Gwernmetiml 1-`.ntity agrees to use any mcmies itreceiv, s dirough the Endo
Selflenwrit sold y 1-ur the purpmes provided therei7l.
61. The Governmental Entit-,,-, sub-mits to Olic jurisdiction of the Cour for PUTPOS CJS I im-ited' to
.he Cctut-Cs- role as provided in, and for rcsolvin disputes to the extent provided in, the
srlcltietLEetxretF
7, The Ciovenirnerital Entity has the Ciglit to enforee the rights 91 0 arn thiven t th in e Endo
8. 'TheGjovt�rnrnental Entity, as a Participating Subdivision, her6by bee)mvs a Relca sor fo. r
all pit scs in the EndOSattlement, including, but not limit ;l u-f, all provisions of
Section D and E� and along- with all departments-, visci s, divisions, boards,
commissions, districts, instramertta-lities of any kind and attomeys, and any person in
their official capacity el ected or �appointcd to serve any cit` he fiow-going and any k4e4cy,
person, or other entity claimirtg by op through any of the forcgoingand any other entity
identified in The definition of Rcleasor, prrwidcs for a release to the ful I est extant of its
authonm�y. As a Rel scar,, the Govemmental Ent ity hereby absolutely, unconditionally,
and i ms vocably covenantsnot to faring, file, or claim, or to cause, a&s ist or perruit to be
broug, ht, filedor claimed, (if to otherwisc sem to establish tiah - � I any Released
g . ility
Clahw�"'kpimit awy Relcasec in any forum v4hatm,')evcr, The releascs provided for in the,
Endo Setticnient are. intended ky 1.1ic Partics to k, broad and shall be interprcted so as to
give the Relcasecs. the broadest possible bar against any liability, relating in any waiy to
Released Claims and extend to thfijll rxicut of the power of the 0ovenirricrital Entity to
release Clajrrjs< -Me Endo Seftlernent shall be a complete bar to any Released Claim.
9. The Governmental Entity hereby takes an all rifts and obligations of a Participating
Subdivision as set Ibrthin tht Endo ScUlcm ent.
10- In connection lwitfi the releases provided R)r i o t1w, Et do Scit1cmemt, each Governmental,
Entity tmpTrssly Waives" Measas,,,. and forever discharges any and all provisions,
and benefiv; conferred by any law of any state or territory of the United States or other
.,jurisdiction., or principle of conmion law, which is similar, comparable., or equivaleni to
1542 eft ie California (.ivil (` ode, whieli reads
Genc al. Release: extent. A gencral release, does not extend to clai ins that
the creditor or releasing i.,, i
,, party doh knmv or stmpecL to ex St n bis arr
her favor at the time of ex cutin the release, and that if kttb%v-n by'hint or
her,would haveinaterially affected his or he., settlernent with The -debtor or
released pwrty.
,A Releasor may Itereafter discover facts other than or different fmin those whtch it
kno,,vs- bdieves,, or assumcs to tvc truewith rcspczt to the Released Claims, but cacti
40ove-Mmeotal Entity b=by cxpssly waives andfully, finally, and forcvvr sctfics,
release-, and dischar&ps, 4poti theEffbetive Date eft e Release, any and all Releasod
Clainis that ray' i tims of Durlt date but which Releasors, tic) not kmw or suspect to
exist, whctber through ignor.,mcc�ovcTsight, crroT, neglignec or through no fault
whatsoev. er, and which, if known, would material ly atTect thetiovernmenurl I" jitities`'
(ILN-kibn tea 2diCipMe, in the RM -10 SCUIeffteCat_
I I - Nothing herein is intended to modify in any way the tenor of the Endo S"ettlement, to
Which the (11ove"Imeatal l ntity hereby ag
!ree*�. 'To the extorttbis Subdivisirm S-calt-mcut
Participatitm Fomi is interpretcvJ clifl-t=jitly fiom th(: Endo �cuhnneru in my respeO, Ific
i-`Iudo Settlement coritroks.
I Inivc Al neccs.yary power, ad 0:131horizzitim to e"m!(:jj1g!
I this Subdivis.m Soitl cart Pan'W'Pflioii
Form m lnehah'ol-tht: Gowmmema.]
ignalure:
L I F f -
the --Executi6ll 111-1-elell- f1bis Suhdivision
S
"er
ticnicia ParLiI,cjp'II'iI) f"O I
MEMBIMMMA
of Sanford, Florida
Affost:
Ni s ire z MPAC, FCRM
�pc i
r%
hppr tr td� aas to f f3Qr T 1 aTd I Zgefi t
OArt.L. Colbert.E�quir4'
it m
City Attorney
Exhibit E
QUALIFIED SETTLEMENT FUND ADMINISTRATOR
[TO BE ADDED]
Exhibit F
I. Definitions Specific to this Exhibit
A. "Cancer -Related Pain Care" means care that provides relief from pain resulting
from a patient's active cancer or cancer treatment as distinguished from treatment
provided during remission.
B. "Downstream Customer Data" shall mean transaction information that Endo
collects relating to its direct customers' sales to downstream customers, including
chargeback data tied to Endo providing certain discounts, "867 data" and IQVIA
data.
C. "End -of -Life Care" means care for persons with a terminal illness or at high risk
for dying in the near future in hospice care, hospitals, long-term care settings, or at
home.
D. "Endo" shall mean Endo Pharmaceuticals Inc. ("EPI"), Par Pharmaceutical, Inc.
("PPI") and all of their parents, subsidiaries, predecessors, successors, joint
ventures, divisions, assigns, officers, directors, agents, partners, principals, current
employees, and affiliates acting on behalf of EPI or PPI in the United States.
E. "Health Care Provider" shall mean any U.S.-based physician or other health care
practitioner who is licensed to provide health care services and/or prescribe
pharmaceutical products and any medical facility, practice, hospital, clinic or
pharmacy.
F. "Including but not limited to", when followed by a list or examples, shall mean that
list or examples are illustrative instances only and shall not be read to be restrictive.
G. "In -Kind Support" shall mean payment or assistance in the form of goods,
commodities, services, or anything else of value.
H. "Lobby" and "Lobbying" shall have the same meaning as "lobbying activities" and
"lobbying contacts" under the federal lobbying disclosure act, 2 U.S.C. § 1602 et
seq., and any analogous state or local provisions governing the person or entity
being lobbied in that particular state or locality. As used in this document, "Lobby"
and "Lobbying" include Lobbying directly or indirectly, through grantees or Third
Parties.
I. "Opioid(s)" shall mean all natural, semi -synthetic, or synthetic chemicals that
interact with opioid receptors and act like opium. For the avoidance of doubt, the
term Opioid shall not include the opioid antagonists naloxone or naltrexone.
J. "Opioid Product(s)" shall mean all current and future medications containing
Opioids approved by the U.S. Food & Drug Administration ("FDA") and listed by
the Drug Enforcement Administration ("DEA") as Schedule 11, 111, or IV pursuant
to the federal Controlled Substances Act (including but not limited to
buprenorphine, codeine, fentanyl, hydrocodone, hydromorphone, meperidine,
methadone, morphine, oxycodone, oxymorphone, tapentadol, and tramadol). The
term "Opioid Products(s)" shall not include (i) methadone, buprenorphine, or other
substances when used exclusively to treat opioid abuse, addiction, or overdose; or
(ii) raw materials, immediate precursors, and/or active pharmaceutical ingredients
("APIs") used in the manufacture or study of Opioids or Opioid Products, but only
when such materials, immediate precursors, and/or APIs are sold or marketed
exclusively to DEA -licensed manufacturers or DEA -licensed researchers.
K. "OUD" shall mean opioid use disorder defined in the Diagnostic and Statistical
Manual of Mental Disorders, Fifth Edition (DSM 5), as updated or amended.
L. "Promote," "Promoting," "Promotion," and "Promotional" shall mean
dissemination of information or other practices intended or reasonably anticipated
to increase sales or prescriptions, or that attempts to influence prescribing practices
of Health Care Providers in the United States.
M. "Qualified Researcher" shall mean any researcher holding a faculty appointment or
research position at an institution of higher education, a research organization, a
nonprofit organization, or a government agency.
N. "Suspicious Order" shall have the same meaning as provided by the Controlled
Substances Act, 21 U.S.C. §§ 801-904, and the regulations promulgated thereunder
and analogous Florida state laws and regulations.
O. "Third Party" shall mean any person or entity other than Endo or a government
entity.
P. "Treatment of Pain" shall mean the provision of therapeutic modalities to alleviate
or reduce pain.
"Unbranded Information" shall mean any information that does not identify a
specific branded or generic product(s).
11. Iniunctive Relief
A. General Provisions
Endo shall not make any written or oral statement about Opioids or any
Opioid Product that is false, misleading, deceptive, unfair or
unconscionable as defined under the law of Florida.
2. Endo shall not represent that Opioids or any Opioid Products have approvals,
characteristics, uses, benefits, or qualities that they do not have.
1. Endo shall not engage in Promotion of Opioids or Opioid Products,
including but not limited to, by:
a. Employing or contracting with sales representatives or other persons
to Promote Opioids or Opioid Products to Health Care Providers,
patients, or persons involved in determining the Opioid Products
included in formularies;
b. Using speakers, key opinion leaders, thought leaders, lecturers,
and/or speaking events for Promotion of Opioids or Opioid Products;
C. Sponsoring, or otherwise providing financial support or In -Kind
Support to medical education programs relating to Opioids or
Opioid Products;
d. Creating, sponsoring, operating, controlling, or otherwise providing
financial support or In -Kind Support to any website, network, and/or
social or other media account for the Promotion of Opioids or
Opioid Products;
e. Creating, sponsoring, distributing, or otherwise providing financial
support or In -Kind Support for materials Promoting Opioids or
Opioid Products, including but not limited to brochures, newsletters,
pamphlets, journals, books, and guides;
f. Creating, sponsoring, or otherwise providing financial support or In -
Kind Support for advertisements that Promote Opioids or Opioid
Products, including but not limited to internet advertisements or
similar content, and providing hyperlinks or otherwise directing
internet traffic to advertisements; or
g. Engaging in Internet search engine optimization or other techniques
designed to Promote Opioids or Opioid Products by improving
rankings or making content appear among the top results in an
Internet search or otherwise be more visible or more accessible to
the public on the Internet.
2. Notwithstanding subsection II.B.I directly above, Endo may:
a. Maintain a corporate website;
b. Maintain a website that contains principally the following content
for any Opioid Product: the FDA -approved package insert,
medication guide, and labeling, and a statement directing patients or
caregivers to speak with a licensed Health Care Provider;
C. Provide information or support the provision of information as
expressly required by law or any state or federal government agency
with jurisdiction in the state where the information is provided;
d. Provide the following by mail, electronic mail, on or through Endo's
corporate or product websites or through other electronic or digital
methods: FDA -approved package insert, medication guide,
approved labeling for Opioid Products or other prescribing
information for Opioid Products that are published by a state or
federal government agency with jurisdiction in the state where the
information is provided;
e. Provide scientific and/or medical information in response to an
unsolicited request by a Health Care Provider consistent with the
standards set forth in the FDA's Draft Guidance for Industry,
Responding to Unsolicited Requests for Off -Label Information
About Prescription Drugs and Medical Devices (Dec. 2011), as
updated or amended by the FDA, and Guidance for Industry, Good
Reprint Practices for the Distribution of Medical Journal Articles
and Medical or Scientific Reference Publications on Unapproved
New Uses of Approved Drugs and Approved or Cleared Medical
Devices (Jan. 2009), as updated or amended by the FDA;
f. Provide a response to any unsolicited question or request from a
patient or caregiver, directing the patient or caregiver to the FDA -
approved labeling or to speak with a licensed Health Care Provider
without describing the safety or effectiveness of Opioids or any
Opioid Product or naming any specific provider or healthcare
institution; or directing the patient or caregiver to speak with their
insurance carrier regarding coverage of an Opioid Product;
9. Provide Health Care Economic Information, as defined at 21 U.S.C.
§ 352(a), to a payor, formulary committee, or other similar entity
with knowledge and expertise in the area of health care economic
analysis consistent with standards set forth in the FDA's Draft
Questions and Answers Guidance for Industry and Review Staff,
Drug and Device Manufacturer Communications With Payors,
Formulary Committees, and Similar Entities (Jan. 2018), as updated
or amended by the FDA;
h. Provide information relating solely to the pricing of any Opioid
Product;
i. Provide information, through a product catalog or similar means,
related to an Opioid or Opioid Product, including, without limitation,
pricing information, weight, color, shape, packaging size, type,
reference listed drug, National Drug Code ("NDC") label, and such
other descriptive information (including information set forth in a
standard Healthcare Distribution Alliance Form or technical data
sheet and the FDA approval letter) sufficient to identify the products
available, to place an order for a product, and to allow the product
to be loaded into a customer's inventory and ordering system or
Third Party pricing compendia;
j. Sponsor or provide financial support or In -Kind Support for an
accredited or approved continuing medical education program
required by either an FDA -approved Risk Evaluation and Mitigation
Strategy ("REMS") program or other federal or state law or
regulation applicable in the state where the program is provided
through an independent Third Party, which shall be responsible for
the continuing medical education program's content without the
participation of Endo;
k. Provide information in connection with patient support information
on co -pay assistance and managing pain in End -of -Life Care and/or
Cancer -Related Pain Care relating to the use of Opioids for
managing such pain, as long as the information identifies Endo as
the source of the information; and
1. Provide rebates, discounts, and other customary pricing adjustments
to DEA -registered customers and contracting intermediaries, such
as Buying Groups, Group Purchasing Organizations, and Pharmacy
Benefit Managers, except as prohibited by Section II.G.
Endo shall not engage in the following specific Promotional activity relating
to any products indicated for the treatment of Opioid -induced side effects
(for the avoidance of doubt, "Opioid -induced side effects" does not include
addiction to Opioids or Opioid Products):
a. Employing or contracting with sales representatives or other persons
to Promote products indicated for the treatment of Opioid -induced
side effects to Health Care Providers or patients;
b. Using speakers, key opinion leaders, thought leaders, lecturers,
and/or speaking events to Promote products indicated for the
treatment of Opioid -induced side effects;
C. Sponsoring, or otherwise providing financial support or In -Kind
Support to medical education programs that Promote products
indicated for the treatment of Opioid -induced side effects; or
d. Creating, sponsoring, or otherwise providing financial support or In -
Kind Support for advertisements that Promote products indicated for
the treatment of Opioid -induced side effects, including but not
limited to intemet advertisements or similar content, and providing
hyperlinks or otherwise directing internet traffic to advertisements.
4. Notwithstanding subsection II.B.3 directly above, Endo may Promote
products for the treatment of Opioid -induced side effects (i) so long as such
Promotion does not associate the product with Opioids or Opioid Products,
or (ii) where such Promotion concerns a product's indication to reverse
overdoses and/or treat Opioid addiction. Nothing herein shall prevent Endo
from linking to the FDA label associated with a product.
5. Treatment of Pain
a. Endo shall not, either through Endo or through Third Parties, engage
in Promotion of the Treatment of Pain in a manner that encourages
the utilization of Opioids or Opioid Products.
b. Endo shall not, either through Endo or through Third Parties,
Promote the concept that pain is undertreated in a manner that
encourages the utilization of Opioids or Opioid Products.
Endo shall not disseminate Unbranded Information, including
Unbranded Information about a medical condition or disease state,
that contains links to branded information about Opioid Products or
otherwise Promotes Opioids or Opioid Products.
6. Notwithstanding subsection II.B.5 directly above, Endo may Promote or
provide educational information about the Treatment of Pain with non -
Opioid products or therapies, including Promoting or providing educational
information about such non -Opioid products or therapies as alternatives to
Opioid use, or as part of multimodal therapy which may include Opioid use,
so long as such non -Opioid Promotional or educational information does
not Promote Opioids or Opioid Products.
C. No Financial Reward or Discipline Based on Volume of Opioid Sales
I Endo shall not provide financial incentives to its sales and marketing
employees or discipline its sales and marketing employees based upon sales
volume or sales quotas for Opioid Products. For the avoidance of doubt,
this provision shall not prohibit financial incentives (e.g., customary raises
or bonuses) based on the performance of the overall company or business
segment, as measured by EBITDA, revenue, cash flow, or other similar
financial metrics.
2. Endo shall not offer or pay any remuneration (including any kickback, bribe,
or rebate) directly or indirectly, to or from any person in return for the
prescribing, sale, or use of an Opioid Product. For the avoidance of doubt,
this provision shall not prohibit rebates or chargebacks to the extent
permitted by other sections of this Consent Judgment.
3. Endo's compensation policies and procedures shall ensure compliance with
this Consent Judgment.
D. Ban on Funding/Grants to Third Parties
I Endo shall not, directly or indirectly, provide financial support or In -Kind
Support to any Third Party for Promotion of or education about Opioids,
Opioid Products, or products indicated for the treatment of Opioid -induced
side effects (subject to subsections II.B.2, 4 and 6). For the avoidance of
doubt, this provision does not prohibit support expressly allowed by this
Consent Judgment or required by a federal or state agency.
2. Endo shall not create, sponsor, provide financial support or In -Kind Support
to, or otherwise operate or control any medical society or patient advocacy
group that primarily engages in conduct that Promotes Opioids or Opioid
Products.
3. Endo shall not provide links to any Third Party website or materials or
otherwise distribute materials created by a Third Party for the purpose of
Promoting Opioids, Opioid Products, or products indicated for the treatment
of Opioid -induced side effects (subject to subsections II.B.2, 4 and 6).
4. Endo shall not use, assist, or employ any Third Party to engage in any
activity that Endo itself would be prohibited from engaging in pursuant to
this Consent Judgment.
5. Endo shall not enter into any contract or agreement with any person or entity
or otherwise attempt to influence any person or entity in such a manner that
has the purpose or reasonably foreseeable effect of limiting the
dissemination of information regarding the risks and side effects of using
Opioids.
6. Endo shall not compensate or provide In -Kind Support to Health Care
Providers (other than Endo employees) or organizations to advocate for
formulary access or treatment guideline changes for the purpose of
increasing access to any Opioid Product through third -party payers, i. e., any
entity, other than an individual, that pays or reimburses for the dispensing
of prescription medicines, including but not limited to managed care
organizations and pharmacy benefit managers. Nothing in this provision,
however, prohibits Endo from using independent contractors who operate
under the direction of Endo to provide information to a payor, formulary
committee, or other similar entity as permitted in subsection II.B.2 provided
that any such persons are bound by the terms of this Consent Judgment. Nor
does this provision prohibit the payment of customary rebates or other
pricing concessions to third -party payers, including state Medicaid
programs, as part of an overall pricing agreement.
7. No officer or management -level employee of Endo may concurrently serve
as a director, board member, employee, agent, or officer of any entity other
than Endo International plc or a direct or indirect wholly-owned subsidiary
thereof, that primarily engages in conduct that Promotes Opioids, Opioid
Products, or products indicated for the treatment of Opioid -related side
effects. For the avoidance of doubt, nothing in this provision shall preclude
an officer or management -level employee of Endo from concurrently
serving on the board of a hospital.
8. Endo shall play no role in appointing persons to the board, or hiring persons
to the staff, of any entity that primarily engages in conduct that Promotes
Opioids, Opioid Products, or products indicated for the treatment of Opioid -
induced side effects. For the avoidance of doubt, nothing in this paragraph
shall prohibit Endo from fully and accurately responding to unsolicited
requests or inquiries about a person's fitness to serve as an employee or
board member at any such entity.
9. For the avoidance of doubt:
a. Nothing in this Section II.D shall be construed or used to prohibit
Endo from providing financial or In -Kind Support to:
i. medical societies and patient advocate groups, who are
principally involved in issues relating to (I) the treatment of
OUD; (II) the prevention, education and treatment of opioid
abuse, addiction, or overdose, including medication -assisted
treatment for opioid addiction; and/or (III) rescue
medications for opioid overdose; or
ii. universities, medical institutions, or hospitals, for the
purpose of addressing, or providing education on, issues
relating to (I) the treatment of OUD; (II) the prevention,
education and treatment of opioid abuse, addiction, or
overdose, including medication -assisted treatment for opioid
addiction; and/or (III) rescue medications for opioid
overdose.
b. The prohibitions in this Section ILD shall not apply to engagement
with Third Parties based on activities related to (i) medications with
an FDA -approved label that lists only the treatment of opioid abuse,
addiction, dependence and/or overdose as their "indications and
usage," to the extent they are sold to addiction treatment facilities;
(ii) raw materials, APIs and/or immediate precursors used in the
manufacture or study of Opioids or Opioid Products, but only when
such materials, APIs and/or immediate precursors are sold or
marketed exclusively to DEA registrants or sold outside the United
States or its territories; or (iii) education warning about drug abuse
or promoting prevention or treatment of drug misuse.
C. Endo will be in compliance with subsections II.D.2 and II.D.3 with
respect to support of an individual Third Party to the extent that the
State of Florida determines that such support does not increase the
risk of the inappropriate use of Opioids and that Endo has not acted
for the purpose of increasing the use of Opioids.
E. Lobbying Restrictions
I Endo shall not Lobby for the enactment of any federal, state, or local
legislative or regulatory provision that:
a. encourages or requires Health Care Providers to prescribe Opioids
or sanctions Health Care Providers for failing to prescribe Opioids
or failing to treat pain with Opioids; or
b. pertains to the classification of any Opioid or Opioid Product as a
scheduled drug under the Controlled Substances Act.
2. Endo shall not Lobby against the enactment of any federal, state or local
legislative or regulatory provision that supports:
a. The use of non -pharmacologic therapy and/or non -Opioid
pharmacologic therapy to treat chronic pain over or instead of
Opioid use, including but not limited to third party payment or
reimbursement for such therapies;
b. The use and/or prescription of immediate release Opioids instead of
extended release Opioids when Opioid use is initiated, including but
not limited to third party reimbursement or payment for such
prescriptions;
C. The prescribing of the lowest effective dose of an Opioid, including
but not limited to third party reimbursement or payment for such
prescription;
d. The limitation of initial prescriptions of Opioids to treat acute pain;
e. The prescribing and other means of distribution of naloxone to
minimize the risk of overdose, including but not limited to third
party reimbursement or payment for naloxone;
f. The use of urine testing before starting Opioid use and annual urine
testing when Opioids are prescribed, including but not limited to
third party reimbursement or payment for such testing;
9. Evidence -based treatment (such as using medication -assisted
treatment with buprenorphine or methadone in combination with
behavioral therapies) for OUD, including but not limited to third
party reimbursement or payment for such treatment; or
h. The implementation or use of Opioid drug disposal systems.
3. Endo shall not Lobby against the enactment of any federal, state or local
legislative or regulatory provision expanding the operation or use of
prescription drug monitoring programs ("PDMPs"), including but not
limited to provisions requiring Health Care Providers to review PDMPs
when Opioid use is initiated and with every prescription thereafter.
4. Notwithstanding the foregoing restrictions in subsections II.E.l -3, the
following conduct is not restricted;
a. Lobbying against the enactment of any provision of any state,
federal, municipal, or county taxes, fees, assessments, or other
payments;
b. Challenging the enforcement of, or suing for declaratory or
injunctive relief with respect to legislation, rules or regulations
referred to in subsection II.E.1;
C. Communications made by Endo in response to a statute, rule,
regulation, or order requiring such communication;
d. Communications by an Endo representative appearing before a
federal or state legislative or administrative body, committee, or
subcommittee as a result of a mandatory order or subpoena
commanding that person to testify;
e. Responding, in a manner consistent with this Consent Judgment, to
an unsolicited request for the input on the passage of legislation or
the promulgation of any rule or regulation when such request is
submitted in writing specifically to Endo from a government entity
directly involved in the passage of that legislation or promulgation
of that rule or regulation;
f. Lobbying for or against provisions of legislation or regulation that
address other subjects in addition to those identified in subsections
II.E.1-3, so long as Endo does not support specific portions of such
legislation or regulation covered by subsection. II.E.1 or oppose
specific portions of such legislation or regulation covered by
subsections II.E.2-3;
g. Communicating with a federal or state agency in response to a
Federal Register or similar notice or an unsolicited federal or state
legislative committee request for public comment on proposed
legislation;
h. Responding to requests from the DEA, the FDA, or any other federal
or state agency, and/or participating in FDA or other agency panels
at the request of the agency; and
F.
G
H.
Participating in meetings and other proceedings before the FDA,
FDA advisory committee or other FDA committee in connection
with the approval, modification of approval, or oversight of Endo's
own products.
5. Endo shall provide notice of the prohibitions in Section II.E to all employees
engaged in Lobbying; incorporate the prohibitions in Section ILE into
trainings provided to Endo employees engaged in Lobbying; and certify that
it has provided such notice and trainings to Endo employees engaged in
Lobbying.
Ban on Certain High Dose Opioids
1. Endo shall not commence manufacturing, Promoting, or distributing any
Opioid Product in strengths exceeding 34 milligrams of oxycodone per pill.
For the avoidance of doubt, this restriction shall not apply to the
manufacture or distribution of injectable Opioid Products used primarily in
hospice, hospital, or other inpatient settings.
Ban on Prescription Savings Programs
1. Endo shall not directly or indirectly offer any discounts, coupons, rebates,
or other methods which have the effect of reducing or eliminating a patient's
co -payments or the cost of prescriptions (e.g., free trial prescriptions) for
any Opioid Product.
2. Endo shall not directly or indirectly provide financial support to any Third
Party for discounts, coupons, rebates, or other methods which have the
effect of reducing or eliminating a patient's co -payments or the cost of
prescriptions (e.g., free trial prescriptions) for any Opioid Product.
Monitoring and Reporting of Direct and Downstream Customers.
1. Endo shall operate an effective monitoring and reporting system in
compliance with federal law, that shall include processes and procedures
that:
a. Utilize all reasonably available transaction information to identify a
Suspicious Order of an Opioid Product by a direct customer;
b. Utilize all reasonably available Downstream Customer Data to
identify whether a downstream customer poses a material risk of
diversion of an Opioid Product;
C. Utilize all information Endo receives that bears upon a direct
customer's or a downstream customer's diversion activity or
potential for diversion activity, including reports by Endo's
employees, customers, Health Care Providers, law enforcement,
state, tribal, or federal agencies, or the media; and
d. Upon request (unless otherwise required by law), report to the
Florida Attorney General or State controlled substances regulatory
agency any direct customer or downstream customer in Florida
identified as part of the monitoring required by (a) -(c), above, and
any customer relationship in Florida terminated by Endo relating to
diversion or potential for diversion. These reports shall include the
following information, to the extent known to Endo:
i. The identity of the downstream registrant and the direct
customer(s) identified by Endo engaged in the controlled
substance transaction(s), to include each registrant's name,
address, business type, and DEA registration number;
ii. The dates of reported distribution of controlled substances
by direct customers to the downstream registrant during the
relevant time period;
iii. The drug name, drug family or NDC and dosage amounts
reportedly distributed;
iv. The transaction or order number of the reported distribution;
and
V. A brief narrative providing a description of the
circumstances leading to Endo's conclusion that there is a
risk of diversion.
2. Endo shall not provide to any direct customer an Opioid Product to fill an
order identified as a Suspicious Order unless Endo investigates and finds
that the order is not suspicious.
3. Upon request, Endo shall promptly provide reasonable assistance to law
enforcement investigations of potential diversion and/or suspicious
circumstances involving Opioid Products in the United States.
4. Endo agrees that it will refrain from providing an Opioid Product directly
to a retail pharmacy or Health Care Provider.
Miscellaneous Terms
To the extent that any provision in this Consent Judgment conflicts with
federal or relevant state law or regulation, the requirements of the law or
regulation will prevail. To the extent that any provision in this Consent
Judgment is in conflict with federal or relevant state law or regulation such
that Endo cannot comply with both the law or regulation acid the provision
of this Consent Judgment, Endo may comply with such law or regulation.
2. Endo will enter into this Consent Judgment solely for the purpose of
settlement, and nothing contained therein may be taken as or construed to
be an admission or concession of any violation of law, rule, or regulation,
or of any other matter of fact or law, or of any liability or wrongdoing, all
of which Endo expressly denies. No part of this Consent Judgment,
including its statements and commitments, shall constitute evidence of any
liability, fault, or wrongdoing by Endo. This Consent Judgment is not
intended for use by any Third Party for any purpose, including submission
to any court for any purpose.
3. For the avoidance of doubt, this Consent Judgment shall not be construed
or used as a waiver or limitation of any defense otherwise available to Endo
in any action, and nothing in this Consent Judgment shall be construed or
used to prohibit Endo in any way whatsoever from taking legal or factual
positions with regard to any Opioid Product(s) in litigation or other legal or
administrative proceedings.
4. Nothing in this Consent Judgment shall be construed to limit or impair
Endo's ability (a) to communicate its positions and respond to media
inquiries concerning litigation, investigations, reports, or other documents
or proceedings relating to Endo or its Opioid Products, or (b) to maintain a
website explaining its litigation positions and responding to allegations
concerning its Opioid Products.
5. Upon the request of the Attorney General of the State of Florida, Endo shall
provide the Attorney General of the State of Florida with copies of the
following, within 34 days of the request:
a. Any litigation or civil or criminal law enforcement subpoenas or
Civil Investigative Demands relating to Endo's Opioid Product(s);
and
b. Warning or untitled letters
Opioid Product(s) and all
FDA related to such letters.
issued by the FDA regarding Endo's
correspondence between Endo and the
6. The parties by stipulation may agree to a modification of this Consent
Judgment; provided that the parties may jointly agree to a modification only
by a written instrument signed by or on behalf of both Endo and the
Attorney General of the State of Florida.
J. Compliance with State Laws and Regulations Relating to the Sale, Promotion, and
Distribution of Any Opioid Product
I Subject to subsection ILGA above, Endo shall comply with all applicable
state laws and regulations that relate to the sale, Promotion, distribution, and
disposal of Opioids or Opioid Products, including but not limited to:
a. Florida controlled substances laws, including all guidance issued by
the applicable state regulator(s);
b. Florida consumer protection and unfair trade practices acts; and
C. Florida laws and regulations related to opioid prescribing,
distribution, and disposal.
111. Clinical Data Transparency
A. Data to Be Shared
I Endo shall continue to share truthful and balanced summaries of the results
of all Endo -Sponsored Studies through its publicly available website (see
http://www.endo.com/endopharma/r-d/clinical-research):
a. "Endo -Sponsored Studies" means pre -marketing clinical research
and post -marketing clinical research that Endo "takes responsibility
for and initiates" as "sponsor," as "sponsor" is defined in 21 C.F.R.
§ 312.3(b), and that involves an intervention with human subjects
with an Opioid Product.
b. The summaries may include redactions to protect personal
identifying information, trade secret and confidential commercial
information, and information that may provide a road map for
defeating a product's abuse -deterrent properties.
2. With respect to any Endo -Sponsored Studies relating to any new Endo
Opioid Product or new indication for an existing Endo Opioid Product,
Endo shall, within 30 days after regulatory approval or 18 months after
study completion, whichever occurs later, make the following clinical data
available through a third -party data archive that makes clinical data
available to Qualified Researchers with a bona fide scientific research
proposal:
a. Fully analyzable data set(s) (including individual de -identified
participant -level data);
b. The clinical study report(s) redacted for commercial or personal
identifying information;
C. The full protocol(s) (including the initial version, final version, and
all amendments); and
d. Full statistical analysis plan(s) (including all amendments and
documentation for additional work processes) and analytic code.
B. Third -Party Data Archive
The third -party data archive referenced above shall have a panel of
reviewers with independent review authority to determine whether the
researchers are qualified, whether a research application seeks data for bona
fide scientific research, and whether a research proposal is complete.
2. The panel may exclude research proposals with a commercial interest.
3. Endo shall not interfere with decisions made by the staff or reviewers
associated with the third -party data archive.
4. Any data sharing agreement with a Qualified Researcher who receives
shared data via the third -party data archive shall contain contact information
for Endo's pharmacovigilance staff. Every agreement shall require the lead
Qualified Researcher to inform Endo's pharmacovigilance staff within 24
hours of any determination that research findings could bear on the risk -
benefit assessment regarding the product. The lead Qualified Researcher
may also share findings bearing on the risk -benefit assessment regarding the
product with regulatory authorities. Endo's pharmacovigilance staff shall
take all necessary and appropriate steps upon receipt of such safety
information, including but not limited to notifying the appropriate
regulatory authorities or the public.
S. Endo shall bear all costs for making data and/or information available to the
third -party data archive.
IV. Compliance
A. Compliance Duration
Sections 11 and III of this Exhibit shall be effective for 8 years from the date
the Consent Judgment is entered.
2. Nothing in this Consent Judgment shall relieve Endo of its independent
obligation to fully comply with the laws of the State of Florida after
expiration of the 8 -year period specified in this subsection.
B. Compliance Deadlines
Endo must be in full compliance with the provisions included in this
Consent Judgment by the date it is entered. Nothing herein shall be
construed as permitting Endo to avoid existing legal obligations.
V. Enforcement
A. If the State believes that Endo is not in compliance with any term of this Consent
Judgment, then the State shall:
Provide written notice specifying the reason(s) why the State believes Endo
is not in compliance with this Consent Judgment; and
2. Allow Endo at least thirty (30) days to attempt to cure such alleged non-
compliance (the "Cure Period").
B. In the event the alleged non-compliance is cured within the Cure Period, Endo shall
not have any liability for such alleged non-compliance.
C. The State may not commence a proceeding to enforce compliance with this Consent
Judgment before the expiration of the Cure Period.
D. All of the provisions of this Consent Judgment and any injunction entered pursuant
to it shall apply to Endo, even if Endo subsequently files for or emerges from
bankruptcy.
E. This Consent Judgment will be enforceable in the Court where it is entered. In
connection with any Chapter 11 Cases, if one is filed, this Agreement is also
enforceable in the Bankruptcy Court. After emergence, discharge, or dismissal of
any bankruptcy, this Consent Judgment will continue to be enforceable in Court
where it is entered.
Exhibit G
Litigating
Subdivisions
Litigati ng %
Alachua County
1.05816035129%
Bay County
0.67445165516%
Lynn Haven
0.04901751350%
Panama City
0.19398376765%
Bradford County
0.23690587434%
Brevard County
2.98448370497%
Palm Bay
0.50612989069%
Broward County
5.07936492081%
Coconut Creek
0.12644166587%
Coral Springs
0.40434454263%
Deerfield Beach
0.25308310671%
Fort Lauderdale
1.03844846403%
Hallandale Beach
0.19372950859%
Lauderhill
0.18051711842%
Miramar
0.34917486807%
Pembroke Pines
0.57866409659%
Pompano Beach
0.41942982316%
Calhoun County
0.05892226579%
Clay County
1.49210564229%
Dixie County
0.12970844069%
Jacksonville
6.62096027198%
Escambia County
1.26401710873%
Pensacola
0.41338436010%
Gilchrist County
0.08043439796%
Gulf County
0.07490880386%
Hamilton County
0.05993930201%
Hernando County
1.88799834150%
Hillsborough County
8.15563160424%
Tampa
2.47011763704%
Holmes County
0.10203733694%
Jackson County
0.19871253203%
Lake County
0.97714478977%
Lee County
2.68855794752%
Leon County
0.58912731073%
Tallahassee
0.53261142529%
Levy County
0.31405760629%
Manatee County
2.86126568069%
Bradenton
0.47501493885%
Palmetto
0.06610054375%
Marion County
1.66558296312%
Ocala
0.46134170415%
Stuart
0.10155152053%
Miami -Dade County
5.40366326457'7-0'
Coral Gables
0.08974436568%
Florida City
0.00491264817%
Homestead
0.03117624643%
Miami
0.36606947420%
Miami Gardens
0.05086543199%
North Miami
0.03798221649%
Sweetwater
0.00514647569%
Monroe County
0.48548042317%
Okaloosa County
0.79330868262%
Niceville
0.02718755751%
Orange County
3.91426593527%
Apopka
0.12154490889%
Eatonville
0.01041022990%
Ocoee
0.08326757029%
Orlando
1.45062055328%
Osceola County
1.04678452875%
Palm Beach County
7.45692091104%
De I ray Beach
0.43990221742%
Pasco County
5.53810273982%
New Port Richey
0.18738892341%
Pinellas County
5.99320147610%
Clearwater
0.79249823188%
Pinellas Park
0.31465012070%
St. Petersburg
1.82113048025%
Polk County
2.00253750537%
Putnam County
0.42251271420%
Palatka
0.05870659963%
Santa Rosa County
0.81846897819%
Sarasota County
2.46153185360%
Sarasota
0.60547934620%
Seminole County
1.88627074203%
Oviedo
0.12894112318%
Sanford
0.20534823933%
St. Jahns Cou nty
0.82995603906%
St. Augustine
0.05815040794%
St. Lucie County
1.19561688264%
Fort Pierce
0.19946168818%
Port St. Lucie
0.48860871761%
Suwannee County
0.23881962776%
Taylor County
0.11525199728%
Union County
0.08146278503%
Volusia County
2.23101196784%
Daytona Beach
0.55956515527%
Deltona
10.24921473680%
Ormond Beach
10.14333627199%
Walton County 10.33576951344%
Washington County 10.15018764545%
Exhibit H
IN THE CIRCUIT COURT OF THE SIXTH JUDICIAL CIRCUIT
IN AND FOR PASCO COUNTY, STATE OF FLORIDA
WEST PASCO CIVIL DIVISION
STATE OF FLORIDA, OFFICE OF THE
ATTORNEY GENERAL, DEPARTMENT
OF LEGAL AFFAIRS,
Plaintiff,
V. No. 2018 -CA -001438
lalfflafixmlvg��, �W
Defendants.
CONSENT JUDGMENT
Plaintiff, the State of Florida, Office of the Attorney General, Department of Legal
Affairs ("Plaintiff'), brought the above -captioned action against Defendants Endo Health
Solutions Inc. and Endo Pharmaceuticals Inc. (together, "Endo"), among others, alleging: that
Endo violated Florida law by deceptively marketing opioid pain medications so as to overstate
their efficacy and downplay the associated risk of addiction, which resulted in a public nuisance
in Florida; that Endo violated the law by failing to monitor, report and not ship allegedly
suspicious orders of opioid pain medications; and that Endo violated Fla. Stat. § 895.03(3) & (4)
(the "Florida AG Action"). Plaintiff brought the Florida AG Action in its sovereign capacity as
the people's attorney in order to protect the public interest, including the interests of the State of
Florida, its governmental subdivisions and its citizens.
In addition, numerous governmental entities in Florida, including counties, cities, hospital
districts and school boards ("Subdivisions") have brought separate lawsuits ("Actions") in
various forums against Endo, among others. These Actions assert claims that arise out of or
relate to alleged conduct that is substantially similar to or overlaps with the conduct alleged in
the Florida AG Action (the "Covered Conduct")
Endo denies the allegations in the Florida AG Action and other Actions and claims to
have no liability whatsoever to Plaintiff or to any Subdivision or other governmental entity
(whether such governmental entity has brought or is a party to another Action or not). Plaintiff
and Endo (the "Parties"), by their counsel, have agreed to a resolution of the Florida AG Action
("Agreement," attached to this judgment) and the entry of this Consent Judgment (including the
injunctive terms incorporated herein) by the Court without trial or finding of admission or
wrongdoing or liability of any kind. Furthermore, under the Agreement, and as effectuated in
this Consent Judgment, the Florida AG is exercising its authority to act in the public interest and
release its own Claims as well as those of all Subdivisions, whether asserted previously or in the
future, that arise out of or relate to the Covered Conduct. Unless otherwise specified, capitalized
terms used herein shall have the meanings specified in the Agreement.
NOW THEREFORE, without trial or adjudication of any issue of fact or law presented in
the Florida AG Action or the other Actions, without this Consent Judgment constituting evidence
against or admission by anyone with respect to any issue of fact or law, and upon the Parties'
consent, IT IS HEREBY ORDERED AS FOLLOWS:
I. PARTIES
1. Defendants Endo Health Solutions Inc. and Endo Pharmaceuticals Inc. are both
Delaware corporations with their principal places of business in Pennsylvania.
2. Plaintiff has the authority to act in the public interest and on behalf of the people
of Florida as the people's attorney.
II. JURISDICTION
3. This Court has jurisdiction over the Parties and the subject matter of this action.
III. AGREEMENT
4. The Parties have agreed to resolution of the Florida AG Action under the terms of
their Agreement, which is attached hereto as Exhibit A. This Consent Judgment summarizes and
gives effect to those terms. In the event of a conflict between the terms of the Exhibits and this
summary document, the terms of the Agreement shall govern.
IV. FINANCIAL TERMS
5. On or before the later of (a) seven (7) days after the entry of this Consent Judgment,
or (b) seven (7) days after (i) the Qualified Settlement Fund contemplated by the Agreement has
been established under the authority and jurisdiction of the Court, and (ii) Endo has received a W-
9 and wire instructions for the Qualified Settlement Fund, Endo Pharmaceuticals Inc. shall pay the
sum of $65,000,000 into the Qualified Settlement Fund as specified in the Agreement, consisting
of $55,000,000 to be allocated for opioid remediation, $5,000,000 to be available to reimburse
State Litigation Costs, and $5,000,000 to be available to reimburse Litigating Subdivision
Litigation Costs.
V. INJUNCTIVE TERMS
6. The Parties have agreed that Endo shall be subject to the injunctive terms set forth
in Exhibit _ to their Agreement. Those agreed injunctive terms are expressly incorporated into
and are given full force and effect by this Consent Judgment, and Endo shall comply with the
injunctive terms as of the entry of this Consent Judgment.
7. Compliance with injunctive terms may be enforced in this Court consistent with
the terms specified in the injunctive provisions set forth in the Parties' Agreement.
VI. RELEASES AND DISMISSAL WITH PREJUDICE
8. Plaintiff and Endo have agreed to the Release of certain Claims as provided in
Sections D and E of the Agreement. Such Releases are given in good faith within the meaning of
Fla. Stat. § 768.31(5) and upon entry of this Consent Judgment shall be effective as to all Releasors.
9. Plaintiffs Claims against Endo are hereby DISMISSED WITH PREJUDICE,
with each Party to bear its own costs except as specified in the Agreement.
VII. MISCELLANEOUS
10. This Court retains jurisdiction to enforce the terms of this Consent Judgment. The
parties may jointly seek to modify the terms of this Consent Judgment, subject to the approval of
this Court. This Consent Judgment may be modified only by order of this Court.
11. This Consent Judgment shall remain in full force and effect for eight years from
the date it is entered, at which time Endo's obligations under the Consent Judgment shall expire.
12. Entry of this Consent Judgment is in the public interest.
IT IS SO ORDERED, ADJUDGED AND DECREED in Chambers at New Port Richey,
Pasco Cunty, Florida, this _ day of January 2022.
Honorable Kimberly Sharpe Byrd
Circuit Court Judge
JOINTLY APPROVED AND
SUBMITTED FOR ENTRY:
FOR STATE OF FLORIDA, OFFICE OF THE ATTORNEY GENERAL, DEPARTMENT OF
LEGAL AFFAIRS
ASHLEY MOODY
ATTORNEY GENERAL
[to come]
Date:
[Additional approvals on subsequent pages]
OUTSIDE LITIGATION COUNSEL FOR STATE OF FLORIDA, OFFICE OF THE
ATTORNEY GENERAL, DEPARTMENT OF LEGAL AFFAIRS
[to come]
Date:
Matthew J. Maletta
Executive Vice President and Chief Legal Officer
Endo
1400 Atwater Drive
Malvern, Pennsylvania 19355
Date:
DEFENDANT ENDO PHARMACEUTICALS INC.
am
Matthew J. Maletta
Executive Vice President and Chief Legal Officer
Endo
1400 Atwater Drive
Malvern, Pennsylvania 19355
Date:
COUNSEL FOR DEFENDANTS ENDO HEALTH SOLUTIONS INC. AND ENDO
PHARMACEUTICALS INC.
LI -A
Geoffrey M. Wyatt
Skadden, Arps, Slate, Meagher & Flom LLP
1440 New York Avenue, N.W.
Washington, D.C. 20005
Exhibit I
I - I-- I'll I'll I 1 11 1
STATEWEDE RESPONSE
AGREEMENT
STATE OF FLORIDA DEPARTMENT OF LEGAL AFFAIRS,
OFFICE OF THE ATTORNEY GENERAL
M
CERTAIN LOCAL GOVERNMENTS IN THE STATE OF FLORIDA
This Florida Opioid Allocation and Statewide Response Agreement (the "Agreement") is
entered into between the State of Florida ('State") and certain Local Governments ("Local
Governments" and the State and Local Governments are jointly referred to as the "Parties" or
individually as a "Party"). The Parties agree as follows:
Whereas, the people of the State and its communities have been harmed by misfeasance,
nonfeasance and malfeasance committed by certain entities within the Pharmaceutical Supply
Chain; and
Whereas, the State, through its Attorney General, and certain Local Governments, through
their elected representatives and counsel, are separately engaged in litigation seeking to hold many
of the same Pharmaceutical Supply Chain Participants accountable for the damage caused by their
misfeasance, nonfeasance and malfeasance as the State; and
Whereas, certain of the Parties have separately sued Pharmaceutical Supply Chain
participants for the harm caused to the citizens of both Parties and have collectively negotiated
settlements with several Pharmaceutical Supply Chain Participants; and
Whereas, the Parties share a common desire to abate and alleviate the impacts of that
misfeasance, nonfeasance and malfeasance throughout the State; and
Whereas, it is the intent of the State and its Local Governments to use the proceeds from
any Settlements with Pharmaceutical Supply Chain Participants to increase the amount of funding
presently spent on opioid and substance abuse education, treatment, prevention and other related
programs and services, such as those identified in Exhibits "A" and "B," and to ensure that the
funds are expended in compliance with evolving evidence -based "best practices;" and
Whereas, the State and its Local Governments enter into this Agreement and agree to the
allocation and use of the proceeds of any settlement described herein
Wherefore, the Parties each agree to as follows:
A. Definitions
As used in this Agreement:
1. "Approved Purposes)" shall mean forward-looking strategies, programming and
services used to expand the availability of treatment for individuals impacted by substance use
disorders, to: (a) develop, promote, and provide evidence -based substance use prevention
strategies; (b) provide substance use avoidance and awareness education; (c) decrease the
oversupply of licit and illicit opioids; and (d) support recovery from addiction. Approved Purposes
shall include, but are not limited to, the opioid abatement strategies listed in Exhibits "A" and "B"
which are incorporated herein by reference.
2. "Local Governments" shall mean all counties, cities, towns and villages located
within the geographic boundaries of the State.
3. "Managing Entities" shall mean the corporations selected by and under contract with
the Florida Department of Children and Families or its successor ("DCF") to manage the daily
operational delivery of behavioral health services through a coordinated system of care. The
singular "Managing Entity" shall refer to a singular of the Managing Entities.
4. "County" shall mean a political subdivision of the state established pursuant to s. 1,
Art. VIII of the State Constitution.
5. "Dependent Special District" shall mean a Special District meeting the requirements
of Florida Statutes § 189.012(2).
6. "Municipalities" shall mean cities, towns, or villages located in a County within the
State that either have: (a) a Population greater than 10,000 individuals; or (b) a Population equal
to or less than 10,000 individuals and that has either (i) filed a lawsuit against one or more
Pharmaceutical Supply Chain Participants; or (ii) executes a release in connection with a
settlement with a Pharmaceutical Supply Chain participant. The singular "Municipality" shall
refer to a singular city, town, or village within the definition of Municipalities.
7. "`Negotiating Committee" shall mean a three-member group comprised by
representatives of the following: (1) the State; and (2) two representatives of Local Governments
of which one representative will be from a Municipality and one shall be from a County
(collectively, "Members") within the State. The State shall be represented by the Attorney General
or her designee.
8. "Negotiation Class Metrics" shall mean those county and city settlement allocations
which come from the official website of the Negotiation Class of counties and cities certified on
September 11, 2019 by the U.S. District for the Northern District of Ohio in In re National
Prescription Opiate Litigation, MDL No. 2804 (N.D. Ohio). The website is located at
https:Hallocation,map.iclaimsonline.com.
9. "Opioid Funds" shall mean monetary amounts obtained through a Settlement.
10. "Opioid Related" shall have the same meaning and breadth as in the agreed Opioid
Abatement Strategies attached hereto as Exhibits "A" or "B."
11. "Parties" shall mean the State and Local Governments that execute this Agreement.
The singular word "Party" shall mean either the State or Local Governments that executed this
Agreement.
12. "PEC" shall mean the Plaintiffs' Executive Committee of the National Prescription
Opiate Multidistrict Litigation pending in the United States District Court for the Northern District
of Ohio.
13. "Pharmaceutical Supply Chain" shall mean the entities, processes, and channels
through which Controlled Substances are manufactured, marketed, promoted, distributed or
dispensed.
14. "Pharmaceutical Supply Chain Participant" shall mean any entity that engages in, or
has engaged in the manufacture, marketing, promotion, distribution or dispensing of an opioid
analgesic.
15. "Population" shall refer to published U.S. Census Bureau population estimates as of
July 1, 2019, released March 2020, and shall remain unchanged during the term of this Agreement.
These estimates can currently be found at https://www.census.gov. For purposes of Population
under the definition of Qualified County, a County's population shall be the greater of its
population as of the July 1, 2019, estimates or its actual population, according to the official U.S.
Census Bureau count, which was released by the U.S. Census Bureau in August 2021.
16. "Qualified County" shall mean a charter or non -chartered County that has a
Population of at least 300,000 individuals and: (a) has an opioid taskforce or other similar board,
commission, council, or entity (including some existing sub -unit of a County's government
responsible for substance abuse prevention, treatment, and/or recovery) of which it is a member or
it operates in connection with its municipalities or others on a local or regional basis; (b) has an
abatement plan that has been either adopted or is being utilized to respond to the opioid epidemic;
(c) is, as of December 31, 2021, either providing or is contracting with others to provide substance
abuse prevention, recovery, and/or treatment services to its citizens; and (d) has or enters into an
interlocal agreement with a majority of Municipalities (Majority is more than 50% of the
Municipalities' total Population) related to the expenditure of Opioid Funds. The Opioid Funds to
be paid to a Qualified County will only include Opioid Funds for Municipalities whose claims are
released by the Municipality or Opioid Funds for Municipalities whose claims are otherwise
barred. For avoidance of doubt, the word "operate" in connection with opioid task force means to
do at least one of the following activities: (1) gathers data about the nature, extent, and problems
being faced in communities within that County; (2) receives and reports recommendations from
other government and private entities about activities that should be undertaken to abate the opioid
epidemic to a County; and/or (3) makes recommendations to a County and other public and private
leaders about steps, actions, or plans that should be undertaken to abate the opioid epidemic. For
avoidance of doubt, the Population calculation required by subsection (d) does not include
Population in unincorporated areas.
3
17. "SAMESA" shall mean the U.S. Department of Health & Human Services,
Substance Abuse and Mental Health Services Administration.
18. "Settlement" shall mean the negotiated resolution of legal or equitable claims against
a Pharmaceutical Supply Chain Participant when that resolution has been jointly entered into by
the State and Local Governments or a settlement class as described in (B)(1) below,
19. "State" shall mean the State of Florida.
B. Terms
1. Only Abatement - Other than funds used for the Administrative Costs and Expense
Fund as hereinafter described or to pay obligations to the United States arising out of Medicaid or
other federal programs, all Opioid Funds shall be utilized for Approved Purposes. In order to
accomplish this purpose, the State will either: (a) file a new action with Local Governments as
Parties; or (b) add Local Governments to its existing action, sever any settling defendants. In either
type of action, the State will seek entry of a consent judgment, consent order or other order binding
judgment binding both the State and Local Governments to utilize Opioid Funds for Approved
Purposes ("Order") from the Circuit Court of the Sixth Judicial Circuit in and for Pasco County,
West Pasco Division New Port Richey, Florida (the "Court"), except as herein provided. The
Order may be part of a class action settlement or similar device. The Order shall provide for
continuing jurisdiction by the Court to address non-performance by any party under the Order.
2. Avoid Claw Back and Recoupment - Both the State and Local Governments wish
to maximize any Settlement and Opioid Funds. In addition to committing to only using funds for
the Expense Funds, Administrative Costs and Approved Purposes, both Parties will agree to utilize
a percentage of funds for the Core Strategies highlighted in Exhibit A. Exhibit A contains the
programs and strategies prioritized by the U.S. Department of Justice and/or the U.S. Department
of Health & Human Services ("Core Strategies"). The State is trying to obtain the United States'
agreement to limit or reduce the United States' ability to recover or recoup monies from the State
and Local Government in exchange for prioritization of funds to certain projects. If no agreement
is reached with the United States, then there will be no requirement that a percentage be utilized
for Core Strategies.
3. No Benefit Unless Fully Participating - Any Local Government that objects to or
refuses to be included under the Order or refuses or fails to execute any of documents necessary
to effectuate a Settlement shall not receive, directly or indirectly, any Opioid Funds and its portion
of Opioid Funds shall be distributed to, and for the benefit of, the Local Governments. Funds that
were a for a Municipality that does not join a Settlement will be distributed to the County where
that Municipality is located. Funds that were for a County that does not join a Settlement will be
distributed pro rata to Counties that join a Settlement. For avoidance of doubt, if a Local
Government initially refuses to be included in or execute the documents necessary to effectuate a
Settlement and subsequently effectuates such documents necessary to join a Settlement, then that
Local Government will only lose those payments made under a Settlement while that Local
Government was not a part of the Settlement. If a Local Government participates in a Settlement,
that Local Government is thereby releasing the claims of its Dependent Special District claims, if
any,
4
4. .Distribution Scheme — If a Settlement has a National Settlement Administrator or
similar entity, all Opioids Funds will initially go to the Administrator to be distributed. If a
Settlement does not have a National Settlement Administrator or similar entity, all Opioid Funds
will initially go to the State, and then be distributed by the State as they are received from the
Defendants according to the following distribution scheme. The Opioid Funds will be divided into
three funds after deducting any costs of the Expense Fund detailed below. Funds due the federal
government, if any, pursuant to Section B-2, will be subtracted from only the State and Regional
Funds below:
(a) Cita/Count,, Fund- The city/county fund will receive 15% of all Opioid Funds
to directly benefit all Counties and Municipalities. The amounts to be distributed to each
County and Municipality shall be determined by the Negotiation Class Metrics or other
metrics agreed upon, in writing, by a County and a Municipality, which are attached to this
Agreement as Exhibit "C." In the event that a Municipality has a Population less than
10,000 people and it does not execute a release or otherwise join a Settlement that
Municipalities share under the Negotiation Class Metrics shall be reallocated to the
County where that Municipality is located.
(b) Regional Fund- The regional fund will be subdivided into two parts.
(i) The State will annually calculate the share of each County within the State
of the regional fund utilizing the sliding scale in paragraph 5 of the Agreement, and
according to the Negotiation Class Metrics.
(ii) For Qualified Counties, the Qualified County's share will be paid to the
Qualified County and expended on Approved Purposes, including the Core Strategies
identified in Exhibit A, if applicable.
(iii) For all other Counties, the State will appropriate the regional share for
each County and pay that share through DCF to the Managing Entities providing
service for that County. The Managing Entities will be required to expend the monies
on Approved Purposes, including the Core Strategies as directed by the Opioid
Abatement Task Force or Council. The Managing Entities shall expend monies from
this Regional Fund on services for the Counties within the State that are non -
Qualified Counties and to ensure that there are services in every County. To the
greatest extent practicable, the Managing Entities shall endeavor to expend monies
in each County or for citizens of a County in the amount of the share that a County
would have received if it were a Qualified County.
(c) State Fund - The remainder of Opioid Funds will be expended by the State
on Approved Purposes, including the provisions related to Core Strategies, if applicable.
(d) To the extent that Opioid Funds are not appropriated and expended in a
year by the State, the State shall identify the investments where settlement funds will be
deposited. Any gains, profits, or interest accrued from the deposit of the Opioid Funds to
the extent that any funds are not appropriated and expended within a calendar year, shall
be the sole property of the Party that was entitled to the initial amount.
5
(e) To the extent a County or Municipality wishes to pool, comingle, or
otherwise transfer its share, in whole or part, of Opioid Funds to another County or
Municipality, the comingling Municipalities may do so by written agreement. The
comingling Municipalities shall provide a copy of that agreement to the State and any
settlement administrator to ensure that monies are directed consistent with such
agreement. The County or Municipality receiving any such Opioid Funds shall assume
the responsibility for reporting how such Opioid Funds were utilized under this
Agreement.
5. Regional Fund Sliding Scale- The Regional Fund shall be calculated by utilizing the
following sliding scale of the Opioid Funds available in any year after deduction of Expenses and
any funds due the federal government:
A. Years 1-6: 40%
B. Years 7-9: 35%
C. Years 10-12: 34%
D.Years 13-15: 33%
E. Years 16-18: 30%
6. Opioid Abatement Taskforce or Council - The State will create an Opioid Abatement
Taskforce or Council (sometimes hereinafter "Taskforce" or "Council") to advise the Governor,
the Legislature, DCF, and Local Governments on the priorities that should be addressed by
expenditure of Opioid Funds and to review how monies have been spent and the results that have
been achieved with Opioid Funds.
(a) Size - The Taskforce or Council shall have ten Members equally balanced
between the State and the Local Government representatives.
N Ai)vointrrents Local Governments - Two Municipality representatives will be
appointed by or through Florida League of Cities. Two county representatives, one from a
Qualified County and one from a county within the State that is not a Qualified County, will
be appointed by or through the Florida Association of Counties. The final representative
will alternate every two years between being a county representative (appointed by or
through Florida Association of Counties) or a Municipality representative (appointed by or
through the Florida League of Cities). One Municipality representative must be from a city
of less than 50,000 people. One county representative must be from a county of less than
200,000 people and the other county representative must be from a county whose population
exceeds 200,000 people.
(c) A)pointments State -
(i) The Governor shall appoint two Members.
(ii) The Speaker of the House shall appoint one Member.
Z
(iii) The Senate President shall appoint one Member.
(iv) The Attorney General or her designee shall be a Member.
(d) Chair - The Attorney General or designee shall be the chair of the Taskforce
or Council.
(e) Term - Members will be appointed to serve a four-year term and shall be
staggered to comply with Florida Statutes § 20.052(4)(c).
(f) Sport DCF shall support the Taskforce or Council and the Taskforce or
Council shall be administratively housed in DCF.
(g) Meetings - The Taskforce or Council shall meet quarterly in person or virtually
using communications media technology as defined in section 120.54(5)(b)(2),
Florida Statutes.
(h) Reporting_- The Taskforce or Council shall provide and publish a report
annually no later than November 30th or the first business day after November 30th,
if November 30th falls on a weekend or is otherwise not a business day. The report
shall contain information on how monies were spent the previous fiscal year by the
State, each of the Qualified Counties, each of the Managing Entities, and each of the
Local Governments. It shall also contain recommendations to the Governor, the
Legislature, and Local Governments for priorities among the Approved Purposes or
similar such uses for how monies should be spent the coming fiscal year to respond to
the opioid epidemic. Prior to July I st of each year, the State and each of the Local
Governments shall provide information to DCF about how they intend to expend
Opioid Funds in the upcoming fiscal year.
(i) Accountability - The State and each of the Local Governments shall report its
expenditures to DCF no later than August 31 st for the previous fiscal year. The
Taskforce or Council will set other data sets that need to be reported to DCF to
demonstrate the effectiveness of expenditures on Approved Purposes. In setting those
requirements, the Taskforce or Council shall consider the Reporting Templates,
Deliverables, Performance Measures, and other already utilized and existing templates
and forms required by DCF from Managing Entities and suggest that similar
requirements be utilized by all Parties to this Agreement.
0) Conflict of Interest - All Members shall adhere to the rules, regulations and
laws of Florida including, but not limited to, Florida Statute § 112.311, concerning the
disclosure of conflicts of interest and recusal from discussions or votes on conflicted
matters.
7. Administrative Costs- The State may take no more than a 5% administrative fee
from the State Fund and any Regional Fund that it administers for counties that are not Qualified
Counties. Each Qualified County may take no more than a 5% administrative fee from its share of
the Regional Funds. Municipalities and Counties may take no more than a 5% administrative fee
from any funds that they receive or control from the City/County Fund.
7
8. Negotiation of Non -Multistate Settlements - If the State begins negotiations with a
Pharmaceutical Supply Chain Participant that is separate and apart from a multi -state negotiation,
the State shall include Local Governments that are a part of the Negotiating Committee in such
negotiations. No Settlement shall be recommended or accepted without the affirmative votes of
both the State and Local Government representatives of the Negotiating Committee.
9. Negotiation of Multistate or Local Government Settlements - To the extent
practicable and allowed by other parties to a negotiation, both Parties agree to communicate with
members of the Negotiation Committee regarding the terms of any other Pharmaceutical Supply
Chain Participant Settlement.
10. Program Requirements- DCF and Local Governments desire to make the most
efficient and effective use of the Opioid Funds. DCF and Local Governments will work to achieve
that goal by ensuring the following requirements will be minimally met by any governmental entity
or provider providing services pursuant to a contract or grant of Opioid Funds:
a. In either performing services under this Agreement or contracting with a
provider to provide services with the Opioid Funds under this Agreement, the State and
Local Governments shall be aware of and comply with all State and Federal laws, rules,
Children and Families Operating Procedures (CFOPs), and similar regulations relating
to the substance abuse and treatment services.
b. The State and Local Governments shall have and follow their existing policies
and practices for accounting and auditing, including policies relating to whistleblowers
and avoiding fraud, waste, and abuse. The State and Local Governments shall consider
additional policies and practices recommended by the Opioid Abatement Taskforce or
Council. c. In any award or grant to any provider, State and Local Governments shall
ensure that each provider acknowledges its awareness of its obligations under law and
shall audit, supervise, or review each provider's performance routinely, at least once
every year.
d. In contracting with a provider, the State and Local Governments shall set
performance measures in writing for a provider.
c. The State and Local Governments shall receive and report expenditures, service
utilization data, demographic information, and national outcome measures in a similar
fashion as required by the 42.U.S.C. s. 300x and 42 U.S.C. s. 300x-21.
f. The State and Local Governments, that implement evidenced based practice
models will participate in fidelity monitoring as prescribed and completed by the
originator of the model chosen..
g. The State and Local Governments shall ensure that each year, an evaluation of
the procedures and activities undertaken to comply with the requirements of this
Agreement are completed.
Q
h. The State and Local Governments shall implement a monitoring process that will
demonstrate oversight and corrective action in the case of non-compliance, for all
providers that receive Opioid Funds. Monitoring shall include:
(i) Oversight of the any contractual or grant requirements;
(ii) Develop and utilize standardized monitoring tools;
(iii) Provide DCF and the Opioid Abatement Taskforce or Council with
access to the monitoring reports; and
(iv) Develop and utilize the monitoring reports to create corrective action
plans for providers, where necessary.
11. Reporting and Records Requirements- The State and Local Governments shall
follow their existing reporting and records retention requirements along with considering any
additional recommendations from the Opioid Abatement Taskforce or Council. Local
Governments shall respond and provide documents to any reasonable requests from the State or
Opioid Abatement Taskforce or Council for data or information about programs receiving Opioid
Funds. The State and Local Governments shall ensure that any provider or sub -recipient of Opioid
Funds at a minimum does the following:
(a) Any provider shall establish and maintain books, records and documents
(including electronic storage media) sufficient to reflect all income and expenditures of
Opioid Funds. Upon demand, at no additional cost to the State or Local Government, any
provider will facilitate the duplication and transfer of any records or documents during the
term that it receives any Opioid Funds and the required retention period for the State or
Local Government. These records shall be made available at all reasonable times for
inspection, review, copying, or audit by Federal, State, or other personnel duly authorized
by the State or Local Government.
(b) Any provider shall retain and maintain all client records, financial records,
supporting documents, statistical records, and any other documents (including electronic
storage media) pertinent to the use of the Opioid Funds during the term of its receipt of
Opioid Funds and retained for a period of six (6) years after its ceases to receives Opioid
Funds or longer when required by law. In the event an audit is required by the State of
Local Governments, records shall be retained for a minimum period of six (6) years after
the audit report is issued or until resolution of any audit findings or litigation based on the
terms of any award or contract.
(c) At all reasonable times for as long as records are maintained, persons duly
authorized by State or Local Government auditors shall be allowed full access to and the
right to examine any of the contracts and related records and documents, regardless of the
form in which kept.
(d) A financial and compliance audit shall be performed annually and provided to
the State.
9
(e) All providers shall comply and cooperate immediately with any inspections,
reviews, investigations, or audits deemed necessary by The Office of the Inspector General
(section 20.055, F.S.) or the State.
(f) No record may be withheld nor may any provider attempt to limit the scope of
any of the foregoing inspections, reviews, copying, transfers or audits based on any claim
that any record is exempt from public inspection or is confidential, proprietary or trade
secret in nature; provided, however, that this provision does not limit any exemption to
public inspection or copying to any such record.
12. Expense Fund - The Parties agree that in any negotiation every effort shall be made
to cause Pharmaceutical Supply Chain Participants to pay costs of litigation, including attorneys'
fees, in addition to any agreed to Opioid Funds in the Settlement. To the extent that a fund
sufficient to pay the full contingent fees of Local Governments is not created as part of a Settlement
by a Pharmaceutical Supply Chain Participant, the Parties agree that an additional expense fund
for attorneys who represent Local Governments (herein "Expense Fund") shall be created out of
the City/County fund for the purpose of paying the hard costs of a litigating Local Government
and then paying attorneys' fees.
(a) The Source of Funds for the Expense Fund- Money for the Expense Fund
shall be sourced -e-i exclusively from the City/County Fund.
(b) The Amount of the Expense - The State recognizes the value litigating
Local Governments bring to the State in connection with the Settlement because their
participation increases the amount of Incentive Payments due from each Pharmaceutical
Supply Chain Participant. In recognition of that value, the amount of funds that shall be
deposited into the Expense Fund shall be contingent upon on the percentage of litigating
Local Government participation in the Settlement, according to the following table:
Litigating Local
Amount that shall be
Government Participation in
paid into the Expense Fund
the Settlement Cfrom
(and as a percentage
12�centa,-,e of the population) 1
off the City/County fund
96 to 100%10%
91 to 95%
- ----------
7.5%
86 to 90%
5%
85%
2.5%
Less than 85%
0%
If fewer than 85% percent of the litigating Local Governments (by population) participate,
then the Expense Fund shall not be funded, and this Section of the Agreement shall be null and
void.
(c) The Timing of Payments into the Ex )A.,epse Fnd- Although the amount of
.--
the Expense Fund shall be calculated based on the entirety of payments due to the
City/County fund over a ten -to -eighteen -year period, the Expense Fund shall be funded
entirely from payments made by Pharmaceutical Supply Chain Participants during the first
two payments of the Settlement. Accordingly, to offset the amounts being paid from the
Ulf,
City/County Fund to the Expense Fund in the first two years, Counties or Municipalities
may borrow from the Regional Fund during the first two years and pay the borrowed
amounts back to the Regional Fund during years three, four, and five.
For the avoidance of doubt, the following provides an illustrative example regarding the
calculation of payments and amounts that may be borrowed under the terms of this MOU,
consistent with the provisions of this Section:
Opioid Funds due to State of Florida and Local Governments (over 10
to 18 years):
Litigating Local Government Participation:
City/County Fund (over 10 to 18 years):
Expense Fund (paid over 2 years):
Amount Paid to Expense Fund in I st year:
Amount Paid to Expense Fund in 2nd year
Amount that may be borrowed from Regional Fund in I st year:
Amount that may be borrowed from Regional Fund in 2nd year:
Amount that must be paid back to Regional Fund in 3rd year:
Amount that must be paid back to Regional Fund in 4th year:
Amount that must be paid back to Regional Fund in 5th year:
$1,000
100%
$150
$15
$7.5
$7.5
$7.5
$7.5
$5
$5
$5
(d) Creation of and Jurisdiction over the Expense Fund- The Expense Fund
shall be established, consistent with the provisions of this Section of the Agreement, by
order of the Court. The Court shall have jurisdiction over the Expense Fund, including
authority to allocate and disburse amounts from the Expense Fund and to resolve any
disputes concerning the Expense Fund.
(e) Allocation of Payments to Counsel from the Expense Fund- As part of the
order establishing the Expense Fund, counsel for the litigating Local Governments shall
seek to have the Court appoint a third -neutral to serve as a special master for purposes of
allocating the Expense Fund. Within 30 days of entry of the order appointing a special
master for the Expense Fund, any counsel who intend to seek an award from the Expense
Fund shall provide the copies of their contingency fee contracts to the special master. The
special master shall then build a mathematical model, which shall be based on each
litigating Local Government's share under the Negotiation Class Metrics and the rate set
forth in their contingency contracts, to calculate a proposed award for each litigating Local
Government who timely provided a copy of its contingency contract.
13. Dispute resolution- Any one or more of the Local Governments or the State may
object to an allocation or expenditure of Opioid Funds solely on the basis that the allocation or
expenditure at issue (a) is inconsistent with the Approved Purposes; (b) is inconsistent with the
distribution scheme as provided in paragraph,; (c) violates the limitations set forth herein with
respect to administrative costs or the Expense Fund; or (d) to recover amounts advanced from the
Regional Fund for the Expense Fund. There shall be no other basis for bringing an objection to the
approval of an allocation or expenditure of Opioid Funds. In the event that there is a National
Settlement Administrator or similar entity, the Local Governments sole action for non-payment of
11
amounts due from the City/County Fund shall be against the particular settling defendant and/or
the National Settlement Administrator or similar entity.
C. Other Terms and Conditions
1. Governing Law and Venue: This Agreement will be governed by the laws of the
State of Florida. Any and all litigation arising under the Agreement, unless otherwise specified in
this Agreement, will be instituted in either: (a) the Court that enters the Order if the matter deals
with a matter covered by the Order and the Court retains jurisdiction; or (b) the appropriate State
court in Leon County, Florida.
2. Agreement Management and Notification: The Parties have identified the
following individuals as Agreement Managers and Administrators:
a. State of Florida Agreement Manager:
Greg Slemp
PL -01, The Capitol, Tallahassee, FL 32399
850-414-3300
Greg. slernp@myfloridalegal.com
b. State of Florida A!-,,rqqmeqt, Administrator
Janna Barineau
PL -01, The Capitol, Tallahassee, FL 32399
850-414-3300
Janna.barineau@myfloridalegal.com
C. Local Governments Agreement Managers and Administrators are listed on
Exhibit C to this Agreement.
Changes to either the Managers or Administrators may be made by notifying the other Party
in writing, without formal amendment to this Agreement.
3. Notices. All notices required under the Agreement will be delivered by certified
mail, return receipt requested, by reputable air courier, or by personal delivery to the designee
identified in paragraphs C.2., above. Either designated recipient may notify the other, in writing,
if someone else is designated to receive notice.
4. Cooperation with Inspector General: Pursuant to section 20.055, Florida Statutes,
the Parties, understand and will comply with their duty to cooperate with the Inspector General in
any investigation, audit, inspection, review, or hearing.
12
5. Public Records: The Parties will keep and maintain public records pursuant to
Chapter 119, Florida Statutes and will comply will all applicable provisions of that Chapter.
6. Modification: This Agreement may only be modified by a written amendment
between the appropriate parties. No promises or agreements made subsequent to the execution of this
Agreement shall be binding unless express, reduced to writing, and signed by the Parties.
7. Execution in Counterparts: This Agreement may be executed in any number of
counterparts, each of which shall be deemed to be an original, but all of which together shall
constitute one and the same instrument.
8. Assignment: The rights granted in this Agreement may not be assigned or
transferred by any party without the prior written approval of the other party. No party shall be
permitted to delegate its responsibilities or obligations under this Agreement without the prior
written approval of the other parties.
9. Additional Documents: The Parties agree to cooperate fully and execute any and
all supplementary documents and to take all additional actions which may be reasonably necessary
or appropriate to give full force and effect to the basic terms and intent of this Agreement.
10. Captions: The captions contained in this Agreement are for convenience only and
shall in no way define, limit, extend or describe the scope of this Agreement or any part of it.
11. Entire Agreement: This Agreement, including any attachments, embodies the entire
agreement of the parties. There are no other provisions, terms, conditions, or obligations. This
Agreement supersedes all previous oral or written communications, representations or agreements
on this subject.
12. Construction: The parties hereto hereby mutually acknowledge and represent that
they have been fully advised by their respective legal counsel of their rights and responsibilities
under this Agreement, that they have read, know, and understand completely the contents hereof,
and that they have voluntarily executed the same. The parties hereto further hereby mutually
acknowledge that they have had input into the drafting of this Agreement and that accordingly, in
any construction to be made of this Agreement, it shall not be construed for or against any party,
but rather shall be given a fair and reasonable interpretation, based on the plain language of the
Agreement and the expressed intent of the parties.
13. Capacity to Execute Agreement: The parties hereto hereby represent and warrant
that the individuals signing this Agreement on their behalf are duly authorized and fully competent
to do so.
13
14. Effectiveness: This Agreement shall become effective (in the date on which the last
required signature is affixed to this Agreement.
IN WITNESS THEREOF, the parties hereto have caused the Agreement to be executed by
their undersigned officials as duly authorized.
14
11/15/2021
DATED
4 NIMBI I I IV,
4 a -
Schedule A
Core Strategies
States and Qualifying Block Grantees shall choose from among the abatement strategies listed in
Schedule B. However, priority shall be given to the following core abatement strategies ("Core
Strategies")[, such that a minimum of _% of the [aggregate] state -level abatement distributions shall
be spent on [one or more of] them annually].'
A. Naloxone or other FDA -approved drug to reverse opioid overdoses
1. Expand training for first responders, schools, community support groups and families; and
2. Increase distribution to individuals who are uninsured or whose insurance does not cover the needed
service.
B. Medication -Assisted Treatment (`MAT") Distribution and other opioid -related treatment
1. Increase distribution of MAT to non -Medicaid eligible or uninsured individuals;
2. Provide education to school-based and youth -focused programs that discourage or prevent misuse;
3. Provide MAT education and awareness training to healthcare providers, EMTs, law enforcement,
and other first responders; and
4. Treatment and Recovery Support Services such as residential and inpatient treatment, intensive
outpatient treatment, outpatient therapy or counseling, and recovery housing that allow or integrate
medication with other support services.
C. Pregnant & Postpartum Women
1. Expand Screening, Brief Intervention, and Referral to Treatment (`SBIRT") services to non -
Medicaid eligible or uninsured pregnant women;
2. Expand comprehensive evidence -based treatment and recovery services, including MAT, for women
with co-occurring Opioid Use Disorder ("OUD") and other Substance Use Disorder (`SUD")/Mental
Health disorders for uninsured individuals for up to 12 months postpartum; and
3. Provide comprehensive wrap-around services to individuals with Opioid Use Disorder (OUD)
including housing, transportation, job placement/training, and childcare.
D. Expanding Treatment for Neonatal Abstinence Syndrome
1. Expand comprehensive evidence -based and recovery support for NAS babies;
2. Expand services for better continuum of care with infant -need dyad; and
3. Expand long-term treatment and services for medical monitoring of NAS babies and their families.
' As used in this Schedule A, words like "expand," "fund," "provide" or the like shall not indicate a preference for new or
existing programs. Priorities will be established through the mechanisms described in the Term Sheet.
E. Expansion of Warm Hand-off Programs and Recovery Services
1. Expand services such as navigators and on-call teams to begin MAT in hospital emergency
departments;
2. Expand warm hand-off services to transition to recovery services;
3. Broaden scope of recovery services to include co-occurring SUD or mental health conditions. ;
4. Provide comprehensive wrap-around services to individuals in recovery including housing,
transportation, job placement/training, and childcare; and
5. Hire additional social workers or other behavioral health workers to facilitate expansions above.
F. Treatment for Incarcerated Population
1. Provide evidence -based treatment and recovery support including MAT for persons with OUD and
co-occurring SUD/MH disorders within and transitioning out of the criminal justice system; and
2. Increase funding for jails to provide treatment to inmates with OUD.
G. Prevention Programs
1. Funding for media campaigns to prevent opioid use (similar to the FDA's "Real Cost" campaign to
prevent youth from misusing tobacco);
2. Funding for evidence -based prevention programs in schools.;
3. Funding for medical provider education and outreach regarding best prescribing practices for opioids
consistent with the 2016 CDC guidelines, including providers at hospitals (academic detailing);
4. Funding for community drug disposal programs; and
5. Funding and training for first responders to participate in pre -arrest diversion programs, post -
overdose response teams, or similar strategies that connect at -risk individuals to behavioral health
services and supports.
H. Expanding Syringe Service Programs
1. Provide comprehensive syringe services programs with more wrap-around services including linkage
to OUD treatment, access to sterile syringes, and linkage to care and treatment of infectious diseases.
I. Evidence -based data collection and research analyzing the effectiveness of the abatement strategies
within the State.
Schedule B
Approved Uses
PART ONE: TREATMENT
A. TREAT OPIOID USE DISORDER (OUD)
Support treatment of Opioid Use Disorder (OUD) and any co-occurring Substance Use Disorder or
Mental Health (SUD/MH) conditions through evidence -based or evidence -informed programs or
strategies that may include, but are not limited to, the following: 2
1. Expand availability of treatment for OUD and any co-occurring SUD/MH conditions, including all
forms of Medication -Assisted Treatment (MAT) approved by the U.S. Food and Drug Administration.
2. Support and reimburse evidence -based services that adhere to the American Society of Addiction
Medicine (ASAM) continuum of care for OUD and any co-occurring SUD/MH conditions
3. Expand telchealth to increase access to treatment for OUD and any co-occurring SUD/Ml-I
conditions, including MAT, as well as counseling, psychiatric support, and other treatment and
recovery support services.
4. Improve oversight of Opioid Treatment Programs (OTPs) to assure evidence -based or evidence -
informed practices such as adequate methadone dosing and low threshold approaches to treatment.
5. Support mobile intervention, treatment, and recovery services, offered by qualified professionals and
service providers, such as peer recovery coaches, for persons with OUD and any co-occurring
SUD/MH conditions and for persons who have experienced an opioid overdose.
6. Treatment of trauma for individuals with OUD (e.g., violence, sexual assault, human trafficking, or
adverse childhood experiences) and family members (e.g., surviving family members after an overdose
or overdose fatality), and training of health care personnel to identify and address such trauma.
7. Support evidence -based withdrawal management services for people with OUD and any co-
occurring mental health conditions.
8. Training on MAT for health care providers, first responders, students, or other supporting
professionals, such as peer recovery coaches or recovery outreach specialists, including telementoring
to assist community-based providers in rural or underserved areas.
9. Support workforce development for addiction professionals who work with persons with OUD and
any co-occurring SUD/MH conditions.
10. Fellowships for addiction medicine specialists for direct patient care, instructors, and clinical
research for treatments.
11. Scholarships and supports for behavioral health practitioners or workers involved in addressing
OUD and any co-occurring SUD or mental health conditions, including but not limited to training,
' As used in this Schedule B, words like "expand," "fund," "provide" or the like shall not indicate a preference for new or
existing pro. -rams. Priorities will be established through the mechanisms described in the Term Sheet.
scholarships, fellowships, loan repayment programs, or other incentives for providers to work in rural
or underserved areas.
12. [Intentionally Blank — to be cleaned up later for numbering]
13. Provide funding and training for clinicians to obtain a waiver under the federal Drug Addiction
Treatment Act of 2000 (DATA 2000) to prescribe MAT for OUD, and provide technical assistance and
professional support to clinicians who have obtained a DATA 2000 waiver.
14. Dissemination of web-based training curricula, such as the American Academy of Addiction
Psychiatry's Provider Clinical Support Service-Opioids web-based training curriculum and
motivational interviewing.
15. Development and dissemination of new curricula, such as the American Academy of Addiction
Psychiatry's Provider Clinical Support Service for Medication-Assisted Treatment.
B. SUPPORT PEOPLE IN TREATMENT AND RECOVERY
Support people in treatment for or recovery from OUD and any co-occurring SUD/MH conditions
through evidence-based or evidence-informed programs or strategies that may include, but are not
limited to, the following:
1. Provide comprehensive wrap-around services to individuals with OUD and any co-occurring
SUD/MH conditions, including housing, transportation, education, job placement, job training, or
childcare.
2. Provide the full continuum of care of treatment and recovery services for OUD and any co-occurring
SUD/MH conditions, including supportive housing, peer support services and counseling, community
navigators, case management, and connections to community-based services.
3. Provide counseling, peer-support, recovery case management and residential treatment with access to
medications for those who need it to persons with OUD and any co-occurring SUD/MH conditions.
4. Provide access to housing for people with OUD and any co-occurring SUD/MH conditions,
including supportive housing, recovery housing, housing assistance programs, training for housing
providers, or recovery housing programs that allow or integrate FDA-approved medication with other
support services.
5. Provide community support services, including social and legal services, to assist in
deinstitutionalizing persons with OUD and any co-occurring SUD/MH conditions.
6. Support or expand peer-recovery centers, which may include support groups, social events, computer
access, or other services for persons with OUD and any co-occurring SUD/MH conditions.
7. Provide or support transportation to treatment or recovery programs or services for persons with
OUD and any co-occurring SUD/MH conditions.
8. Provide employment training or educational services for persons in treatment for or recovery from
OUD and any co-occurring SUD/Ml-I conditions.
9. Identify successful recovery programs such as physician, pilot, and college recovery programs, and
provide support and technical assistance to increase the number and capacity of high-quality programs
to help those in recovery.
10. Engage non -profits, faith -based communities, and community coalitions to support people in
treatment and recovery and to support family members in their efforts to support the person with OUD
in the family.
11. Training and development of procedures for government staff to appropriately interact and provide
social and other services to individuals with or in recovery from OUD, including reducing stigma.
12. Support stigma reduction efforts regarding treatment and support for persons with OUD, including
reducing the stigma on effective treatment.
13. Create or support culturally appropriate services and programs for persons with OUD and any co-
occurring SUD/MH conditions, including new Americans.
14. Create and/or support recovery high schools.
15. Hire or train behavioral health workers to provide or expand any of the services or supports listed
above.
C. CONNECT PEOPLE WHO NEED HELP TO THE HELP THEY NEED (CONNECTIONS
TO CARE)
Provide connections to care for people who have — or at risk of developing — OUD and any co-
occurring SUDIMH conditions through evidence -based or evidence -informed programs or strategies
that may include, but are not limited to, the following:
1. Ensure that health care providers are screening for OUD and other risk factors and know how to
appropriately counsel and treat (or refer if necessary) a patient for OUD treatment.
2. Fund Screening, Brief Intervention and Referral to Treatment (SBIRT) programs to reduce the
transition from use to disorders, including SBIRT services to pregnant women who are uninsured or not
eligible for Medicaid.
3. Provide training and long-term implementation of SBIRT in key systems (health, schools, colleges,
criminal justice, and probation), with a focus on youth and young adults when transition from misuse to
opioid disorder is common.
4. Purchase automated versions of SBIRT and support ongoing costs of the technology.
5. Expand services such as navigators and on-call teams to begin MAT in hospital emergency
departments.
6. Training for emergency room personnel treating opioid overdose patients on post -discharge planning,
including community referrals for MAT, recovery case management or support services.
7. Support hospital programs that transition persons with OUD and any co-occurring SUD/MH
conditions, or persons who have experienced an opioid overdose, into clinically -appropriate follow-up
care through a bridge clinic or similar approach.
8. Support crisis stabilization centers that serve as an alternative to hospital emergency departments for
persons with OUD and any co-occurring SUD/MH conditions or persons that have experienced an
opioid overdose.
9. Support the work of Emergency Medical Systems, including peer support specialists, to connect
individuals to treatment or other appropriate services following an opioid overdose or other opioid -
related adverse event.
10. Provide funding for peer support specialists or recovery coaches in emergency departments, detox
facilities, recovery centers, recovery housing, or similar settings; offer services, supports, or
connections to care to persons with OUD and any co-occurring SUD/MH conditions or to persons who
have experienced an opioid overdose.
11. Expand warm hand-off services to transition to recovery services.
12. Create or support school-based contacts that parents can engage with to seek immediate treatment
services for their child, and support prevention, intervention, treatment, and recovery programs focused
on young people.
13. Develop and support best practices on addressing OUD in the workplace.
14. Support assistance programs for health care providers with OUD.
15. Engage non -profits and the faith community as a system to support outreach for treatment.
16. Support centralized call centers that provide information and connections to appropriate services
and supports for persons with OUD and any co-occurring SUD/MH conditions.
D. ADDRESS THE NEEDS OF CRIMINAL -JUSTICE -INVOLVED PERSONS
Address the needs of persons with OUD and any co-occurring SUD/MH conditions who are involved
in, are at risk of becoming involved in, or are transitioning out of the criminal justice system through
evidence -based or evidence -informed programs or strategies that may include, but are not limited to,
the following:
1. Support pre -arrest or pre -arraignment diversion and deflection strategies for persons with OUD and
any co-occurring SUD/MH conditions, including established strategies such as:
a. Self -referral strategies such as the Angel Programs or the Police Assisted Addiction Recovery
Initiative (PAARI);
b. Active outreach strategies such as the Drug Abuse Response Team (DART) model,
c. "Naloxone Plus" strategies, which work to ensure that individuals who have received
naloxone to reverse the effects of an overdose are then linked to treatment programs or other
appropriate services;
d. Officer prevention strategies, such as the Law Enforcement Assisted Diversion (LEAD)
model;
e. Officer intervention strategies such as the Leon County, Florida Adult Civil Citation Network
or the Chicago Westside Narcotics Diversion to Treatment Initiative: or
f. Co -responder and/or alternative responder models to address OUD-related 411 calls with
greater SUD expertise
2. Support pre-trial services that connect individuals with OUD and any co-occurring SUD/M1.1
conditions to evidence -informed treatment, including MAT, and related services.
3. Support treatment and recovery courts that provide evidence -based options for persons with OUD
and any co-occurring SUD/MH conditions
4. Provide evidence -informed treatment, including MAT, recovery support, harm reduction, or other
appropriate services to individuals with OUD and any co-occurring SUD/MH conditions who are
incarcerated in jail or prison.
S. Provide evidence -informed treatment, including MAT, recovery support, harm reduction, or other
appropriate services to individuals with OUD and any co-occurring SUD/MH conditions who are
leaving jail or prison have recently left jail or prison, are on probation or parole, are under community
corrections supervision, or are in re-entry programs or facilities.
6. Support critical time interventions (CTI), particularly for individuals living with dual -diagnosis
OUD/serious mental illness, and services for individuals who face immediate risks and service needs
and risks upon release from correctional settings.
7. Provide training on best practices for addressing the needs of criminal -justice -involved persons with
OUD and any co-occurring SUD/Mfl conditions to law enforcement, correctional, or judicial personnel
or to providers of treatment, recovery, harm reduction, case management, or other services offered in
connection with any of the strategies described in this section.
E. ADDRESS THE NEEDS OF PREGNANT OR PARENTING WOMEN AND THEIR
FAMILIES, INCLUDING BABIES WITH NEONATAL ABSTINENCE SYNDROME
Address the needs of pregnant or parenting women with OUD and any co-occurring SUD/MH
conditions, and the needs of their families, including babies with neonatal abstinence syndrome (NAS),
through evidence -based or evidence -informed programs or strategies that may include, but are not
limited to, the following:
1. Support evidence -based or evidence -informed treatment, including MAT, recovery services and
supports, and prevention services for pregnant women — or women who could become pregnant — who
have OUD and any co-occurring SUD/MH conditions, and other measures to educate and provide
support to families affected by Neonatal Abstinence Syndrome.
2. Expand comprehensive evidence -based treatment and recovery services, including MAT, for
uninsured women with OUD and any co-occurring SUD/MH conditions for up to 12 months
postpartum.
3. Training for obstetricians or other healthcare personnel that work with pregnant women and their
families regarding treatment of OUD and any co-occurring SUD/MH conditions.
4. Expand comprehensive evidence -based treatment and recovery support for NAS babies; expand
services for better continuum of care with infant -need dyad; expand long-term treatment and services
for medical monitoring of NAS babies and their families.
5. Provide training to health care providers who work with pregnant or parenting women on best
practices for compliance with federal requirements that children born with Neonatal Abstinence
Syndrome get referred to appropriate services and receive a plan of safe care,
6. Child and family supports for parenting women with OUD and any co-occurring SUD/MH
conditions.
7. Enhanced family supports and child care services for parents with OUD and any co-occurring
SUD/MH conditions.
8. Provide enhanced support for children and family members suffering trauma as a result of addiction
in the family; and offer trauma -informed behavioral health treatment for adverse childhood events.
9. Offer home-based wrap-around services to persons with OUD and any co-occurring SUD/MH
conditions, including but not limited to parent skills training.
10. Support for Children's Services — Fund additional positions and services, including supportive
housing and other residential services, relating to children being removed from the home and/or placed
in foster care due to custodial opioid use.
PART TWO: PREVENTION
F. PREVENT OVER -PRESCRIBING AND ENSURE APPROPRIATE PRESCRIBING AND
DISPENSING OF OPIOIDS
Support efforts to prevent over -prescribing and ensure appropriate prescribing and dispensing of
opioids through evidence -based or evidence -informed programs or strategies that may include, but are
not limited to, the following:
I. Fund medical provider education and outreach regarding best prescribing practices for opioids
consistent with Guidelines for Prescribing Opioids for Chronic Pain from the U.S. Centers for Disease
Control and Prevention, including providers at hospitals (academic detailing).
2. Training for health care providers regarding safe and responsible opioid prescribing, dosing, and
tapering patients off opioids.
3. Continuing Medical Education (CME) on appropriate prescribing of opioids.
4. Support for non -opioid pain treatment alternatives, including training providers to offer or refer to
multi -modal, evidence -informed treatment of pain.
5. Support enhancements or improvements to Prescription Drug Monitoring Programs (PDMPs),
including but not limited to improvements that:
a. Increase the number of prescribers using PDMPs;
b. Improve point -of -care decision-making by increasing the quantity, quality, or format of data
available to prescribers using PDMPs, by improving the interface that prescribers use to access
PDMP data, or both; or
c. Enable states to use PDMP data in support of surveillance or intervention strategies, including
MAT referrals and follow-up for individuals identified within PDMP data as likely to
experience OUD in a manner that complies with all relevant privacy and security laws and rules.
6. Ensuring PDMPs incorporate available overdose/naloxone deployment data, including the United
States Department of Transportation's Emergency Medical Technician overdose database in a manner
that complies with all relevant privacy and security laws and rules.
7. Increase electronic prescribing to prevent diversion or forgery.
8. Educate Dispensers on appropriate opioid dispensing.
G. PREVENT MISUSE OF OPIOIDS
Support efforts to discourage or prevent misuse of opioids through evidence -based or evidence -
informed programs or strategies that may include, but are not limited to, the following:
1. Fund media campaigns to prevent opioid misuse.
2. Corrective advertising or affirmative public education campaigns based on evidence.
3. Public education relating to drug disposal.
4. Drug take -back disposal or destruction programs.
5. Fund community anti-drug coalitions that engage in drug prevention efforts.
6. Support community coalitions in implementing evidence -informed prevention, such as reduced
social access and physical access, stigma reduction — including staffing, educational campaigns, support
for people in treatment or recovery, or training of coalitions in evidence -informed implementation,
including the Strategic Prevention Framework developed by the U.S. Substance Abuse and Mental
Health Services Administration (SAMHSA).
7. Engage non -profits and faith -based communities as systems to support prevention.
8. Fund evidence -based prevention programs in schools or evidence -informed school and community
education programs and campaigns for students, families, school employees, school athletic programs,
parent -teacher and student associations, and others.
9. School-based or youth -focused programs or strategies that have demonstrated effectiveness in
preventing drug misuse and seem likely to be effective in preventing the uptake and use of opioids.
10. Create of support community-based education or intervention services for families, youth, and
adolescents at risk for OUD and any co-occurring SUD/MH conditions.
11. Support evidence -informed programs or curricula to address mental health needs of young people
who may be at risk of misusing opioids or other drugs, including emotional modulation and resilience
skills.
12. Support greater access to mental health services and supports for young people, including services
and supports provided by school nurses, behavioral health workers or other school staff.. to address
mental health needs in young people that (when not properly addressed) increase the risk of opioid or
other drug misuse.
H. PREVENT OVERDOSE DEATHS AND OTHER HARMS (HARM REDUCTION)
Support efforts to prevent or reduce overdose deaths or other opioid-related harms through evidence-
based or evidence-informed programs or strategies that may include, but are not limited to, the
following:
1. Increase availability and distribution of naloxone and other drugs that treat overdoses for first
responders, overdose patients, individuals with OUD and their friends and family members, individuals
at high risk of overdose, schools, community navigators and outreach workers, persons being released
from jail or prison, or other members of the general public.
2. Public health entities provide free naloxone to anyone in the community
3. Training and education regarding naloxone and other drugs that treat overdoses for first responders,
overdose patients, patients taking opioids, families, schools, community support groups, and other
members of the general public.
4. Enable school nurses and other school staff to respond to opioid overdoses, and provide them with
naloxone, training, and support.
S. Expand, improve, or develop data tracking software and applications for overdoses/naloxone
revivals.
6. Public education relating to emergency responses to overdoses.
7. Public education relating to immunity and Good Samaritan laws.
8. Educate first responders regarding the existence and operation of immunity and Good Samaritan
laws.
9. Syringe service programs and other evidence-informed programs to reduce harms associated with
intravenous drug use, including supplies, staffing, space, peer support services, referrals to treatment,
fentanyl checking, connections to care, and the full range of harm reduction and treatment services
provided by these programs.
10. Expand access to testing and treatment for infectious diseases such as HIV and Hepatitis C resulting
from intravenous opioid use.
11. Support mobile units that offer or provide referrals to harm reduction services, treatment, recovery
supports, health care, or other appropriate services to persons that use opioids or persons with OUD and
any co-occurring SUD/MH conditions.
12. Provide training in harm reduction strategies to health care providers, students, peer recovery
coaches, recovery outreach specialists, or other professionals that provide care to persons who use
opioids or persons with OUD and any co-occurring SUD/MH conditions.
13. Support screening for fentanyl in routine clinical toxicology testing
PART THREE: OTHER STRATEGIES
I. FIRST RESPONDERS
In addition to items in sections C, D, and H relating to first responders, support the following:
1. Educate law enforcement or other first responders regarding appropriate practices and precautions
when dealing with fentanyl or other drugs.
2. Provision of wellness and support services for first responders and others who experience secondary
trauma associated with opioid -related emergency events.
J. LEADERSHIP, PLANNING AND COORDINATION
Support efforts to provide leadership, planning, coordination, facilitation, training and technical
assistance to abate the opioid epidemic through activities, programs, or strategies that may include, but
are not limited to, the following:
1. Statewide, regional, local, or community regional planning to identify root causes of addiction and
overdose, goals for reducing harms related to the opioid epidemic, and areas and populations with the
greatest needs for treatment intervention services; to support training and technical assistance; or to
support other strategies to abate the opioid epidemic described in this opioid abatement strategy list.
2. A dashboard to share reports, recommendations, or plans to spend opioid settlement funds; to show
how opioid settlement funds have been spent; to report program or strategy outcomes; or to track, share,
or visualize key opioid -related or health-related indicators and supports as identified through
collaborative statewide, regional, local, or community processes.
3. Invest in infrastructure or staffing at government or not-for-profit agencies to support collaborative,
cross -system coordination with the purpose of preventing overprescribing, opioid misuse, or opioid
overdoses, treating those with OUD and any co-occurring SUD/MH conditions, supporting them in
treatment or recovery, connecting them to care, or implementing other strategies to abate the opioid
epidemic described in this opioid abatement strategy list.
4. Provide resources to staff government oversight and management of opioid abatement programs.
K. TRAINING
In addition to the training referred to throughout this document, support training to abate the opioid
epidemic through activities, programs, or strategies that may include, but are not limited to, the
following:
1. Provide funding for staff training or networking programs and services to improve the capability of
government, community, and not-for-profit entities to abate the opioid crisis.
2. Support infrastructure and staffing for collaborative cross -system coordination to prevent opioid
misuse, prevent overdoses, and treat those with OUD and any co-occurring SUD/MH conditions, or
implement other strategies to abate the opioid epidemic described in this opioid abatement strategy list
(e.g., health care, primary care, pharmacies, PDMPs, etc.).
L. RESEARCH
Support opioid abatement research that may include, but is not limited to, the following:
1. Monitoring, surveillance, data collection, and evaluation of programs and strategies described in this
opioid abatement strategy list.
2. Research non -opioid treatment of chronic pain.
3. Research on improved service delivery for modalities such as SBIRT that demonstrate promising but
mixed results in populations vulnerable to opioid use disorders.
4. Research on novel harm reduction and prevention efforts such as the provision of fentanyl test strips.
5. Research on innovative supply-side enforcement efforts such as improved detection of mail -based
delivery of synthetic opioids.
6. Expanded research on swift/certain/fair models to reduce and deter opioid misuse within criminal
justice populations that build upon promising approaches used to address other substances (e.g. Hawaii
HOPE and Dakota 24/7).
7. Epidemiological surveillance of OUD-related behaviors in critical populations including individuals
entering the criminal justice system, including but not limited to approaches modeled on the Arrestee
Drug Abuse Monitoring (ADAM) system.
8. Qualitative and quantitative research regarding public health risks and harm reduction opportunities
within illicit drug markets, including surveys of market participants who sell or distribute illicit opioids.
9. Gcospatial analysis of access barriers to MAT and their association with treatment engagement and
treatment outcomes.
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