Item R7
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BOARD OF COUNTY COMMISSIONERS
C ounty of M onroe
Mayor David Rice, District 4
Mayor Pro Tem Craig Cates, District 1
The Florida Keys
Michelle Coldiron, District 2
Vacant, District 3
Holly Merrill Raschein, District 5
County Commission Meeting
March 16, 2022
Agenda Item Number: R.7
Agenda Item Summary #10357
BULK ITEM: Yes DEPARTMENT: County Attorney's Office
TIME APPROXIMATE: STAFF CONTACT: Cynthia Hall (305) 292-3470
No
AGENDA ITEM WORDING: Approval of a resolution ratifying the Monroe County Attorney's
signature on a Participation Form to resolve class action opioid litigation with Endo Health
Solutions, Inc. and Endo Pharmaceuticals, Inc. ("Endo") in the County's multi-district litigation
against opioid manufacturers and distributors, and authorizing the County Attorney to enter into
additional Participation Forms as necessary to resolve the opioid litigation against additional future
settling defendants.
ITEM BACKGROUND: This item seeks ratification of a Participation Form to settle Monroe
County's multi-district litigation as against opioid manufacturers and distributors, as to the next
settling defendant (Endo Health Solutions, Inc., and Endo Pharmaceuticals, Inc.). The agenda item
also asks for authority for the County Attorney to execute additional participation forms and related
documents to settle against additional defendants in the future.
Background: On April 3, 2019, Monroe County filed a lawsuit against manufacturers and
distributors, including several national retail pharmacy chains, in the federal district court for the
Southern District of Florida, for damages caused to the County by opioids manufactured and
distributed by the defendants. The lawsuit was later removed and consolidated with other cases filed
by other states and local governments, in multi district litigation (MDL) pending in Ohio. In
addition, some states, including Florida and other local governments, filed their own separate suits in
their respective state courts.
In September 2021, the Board of County Commissioners approved Monroe County Resolution No.
285-2021, approving in principle a settlement with settling defendants along the lines of the
Memorandum of Understanding ("MOU") attached to the Resolution. In broad terms, the MOU
established a formula showing how the State and local governments would share in settlement
proceeds (50% to the State, 35% to Regional Abatement Funds, 15% to individual cities and
counties). The MOU also showed percentage amounts that would go to counties and all cities within
the Regional Abatement Fund and the City/County Fund. Finally, the MOU showed the approved
uses for the settlement funds.
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Adoption of the MOUs by cities and counties was the first step in the settlement process. Resolution
No. 285-2021 said that individual settlements would be brought back to the BOCC for approval. In
December, the Florida Attorney General notified cities and counties of the first settlement, with 3
Distributors (McKesson, Cardinal Health, Amerisource Bergen) and one manufacturer (Janssen,
parent company of Johnson & Johnson). The Monroe County BOCC approved settlement with
those defendants in December 2021.
On February 8, 2022, the Florida AG sent notification of another settlement, with another
manufacturer: Endo Health Solutions, Inc. and Endo Pharmaceuticals, Inc. As explained more fully
in the attached memo, key deal points are as follows:
The overall amount of the settlement between Endo and the State of Florida is $65 million. Of
this, $55 goes into a Remediation Fund. The rest of set aside for attorneys' fees and costs.
The Endo Settlement will be divided into three funds: (a) 50% to State Fund, (b) 35% to
Regional Abatement Fund, and (c) 15% to City/County Fund. For Monroe County, the monies
from the Regional Fund or Abatement Fund will be paid through a "regional managing entity"
one of seven behavioral health networks in the State of Florida with whom the State has a
contract. In the case of Monroe County, it will come through the South Florida Behavioral
Health Network, Inc., d/b/a Thriving Minds, based in Miami.
Payout of this settlement will be within next 6 months, conditional upon approval by Florida
cities/counties.
The settlement will provide approximately $32,034.86 to Monroe County from the Regional
Abatement Fund, $104,805.52 to Monroe County from the Regional Abatement Fund.
$7,267.21 will also go to the City of Key West if the settlement is approved by the City. Endo
can apply to the court to receive back any settlement funds not approved by cities and counties,
so it is in the best interest of the County (and Key West) to approve the settlement.
More information about the settlement between the State of Florida and Endo is available on the
Florida Attorney General's website:
http://www.myfloridalegal.com/newsrel.nsf/newsreleases/DBE8B56810857CB3852587CE0077
6C03
PREVIOUS RELEVANT BOCC ACTION:
1/17/18: the BOCC approved issuance of an RFP for outside counsel.
4/19/18: BOCC approved selection of counsel and authorized the suit.
Sept. 2021: BOCC approval of Resolution No. 285-2021 approving settlement in principle.
December 2021: approval of settlements with 3 Distributors (Cardinal Health, McKesson,
Amerisource Bergen) and 1 manufacturer (J&J).
CONTRACT/AGREEMENT CHANGES:
N/A
STAFF RECOMMENDATION: Approval.
DOCUMENTATION:
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Resolution ratifying Endo and for future settlements
Exhibit A to resolution, Endo Participation Agreement - Monroe County
Resolution 285-2021
Executed Endo-Florida Agreement
Memo to Commissioners Opioid Case 2-28-2022-signed
FINANCIAL IMPACT:
Effective Date: Upon approval.
Expiration Date: N/A
Total Dollar Value of Contract: N/A
Total Cost to County:
Current Year Portion:
Budgeted:
Source of Funds:
CPI:
Indirect Costs:
Estimated Ongoing Costs Not Included in above dollar amounts:
Revenue Producing: Yes If yes, amount: TBD
Grant:
County Match:
Insurance Required: No
Additional Details:
REVIEWED BY:
Cynthia Hall Completed 03/01/2022 10:05 AM
Bob Shillinger Completed 03/01/2022 3:03 PM
Budget and Finance Completed 03/01/2022 3:05 PM
Lindsey Ballard Completed 03/01/2022 3:28 PM
Board of County Commissioners Pending 03/16/2022 9:00 AM
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RESOLUTION NO. ____ - 2022
A RESOLUTION OF THE BOARD OF COUNTY COMMISSIONERS OF MONROE
COUNTY, FLORIDA, RATIFYING THE EXECUTION OF A SUBDIVISION SETTLEMENT
PARTICIPATION FORM IN ORDER TO RESOLVE OPIOID LITIGATION WITH ENDO
HEALTH SOLUTIONS, INC. AND ENDO PHARMACEUTICALS, INC. IN MDL CASE
NO. 2804, AND AUTHORIZING THE COUNTY ATTONREY TO EXECUTE
ADDITIONAL PARTICIPATION FORMS AS NECESSARY IN ORDER TO SETTLE WITH
ADDITIONAL FUTURE DEFENDANTS IN MDL CASE NO. 2804.
XIFSFBT-!Monroe County, Florida, has suffered harm from the opioid epidemic; and
XIFSFBT-!on April 3, 2019, Monroe County filed a complaint against eight (8)
manufacturers and eight (8) distributors, including certain national retail pharmacy
chains, who have manufactured, distributed and sold opioid substances, alleging
various causes of action including violation of 18 U.S.C. § 1961, Racketeer Influenced
and Corrupt Organizations (RICO) Act, violation of the Florida Deceptive and Unfair
Trade Practices Act, and other causes of action, which action was subsequently
removed to and consolidated with lawsuits filed by numerous other states and local
governments as part of multi-district litigation ("MDL"), In re: National Prescription
Opiate Litigation, MDL Case number 2804 (N.D. Ohio) (the "Opioid Litigation"), in which
Monroe County is a litigating party; and
XIFSFBT- one of the manufacturers named in the County's complaint was Endo
Pharmaceuticals, Inc. and Endo Health Solutions, Inc. (collectively, Endo), which
actively marketed opioids to the public; and
XIFSFBT-!on May 15, 2018, the State of Florida filed its own complaint in the Circuit
Court for the Sixth Judicial Circuit in and for Pasco County, Case No. 2018-CA-001438-
CA, naming essentially the same distributor and manufacturer defendants, which case
is currently being litigated in that Circuit Court; and
XIFSFBT- lawyers representing the State of Florida and also Florida local
governments (including Monroe County) have been engaged with the defendants in the
MDL litigation as well as litigation brought by the State of Florida and other states and
local governments not part of the MDL litigation, to discuss potential settlement of the
various cases; and
XIFSFBT-!on September 15, 2021, the Monroe County Board of County
Commissioners adopted Resolution No. 285-2021, authorizing Monroe County to join
with the State of Florida and other local government units as a participant in a Florida
Memorandum of Understanding to resolve the opioid litigation on a statewide basis; and
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XIFSFBT, Exhibit 1 to the MOU, including Schedules A and B, showed agreed upon
uses of settlement proceeds from the opioid proceeds and also showed a formula for
distribution of settlement proceeds among the State of Florida, Florida counties, and
Florida cities; and
XIFSFBT, on December 8, 2021, the BOCC gave approval to execute settlement
agreements with the first three defendant distributors in the class action litigation
(Amerisource Bergen, Cardinal Health, and McKesson) and one manufacturer (Johnson
& Johnson); and
XIFSFBT- on January 15, 2022, the Florida Attorney General announced that the
State of Florida had achieved a settlement with another defendant (manufacturer Endo),
and the Attorney General requested that each Florida county and city execute a
Participation Form as to this defendant; and
XIFSFBT- resolution of Monroe County's claims against Endo will be beneficial to
Monroe County for numerous reasons: (a) Monroe County can expect to receive
approximately $32,034.86 in settlement funds from a Regional Abatement Fund and a
further $104,805.52 from a City/County settlement fund, all to be paid in one time
conditional upon finalization of the settlement between Florida local governments and
Endo; (b) the settlement funds can be used on substance abuse abatement problems;
(c) the proposed settlement amount is based on the distribution formula approved in
Resolution 285-2021, and is slightly higher than Monroe County would receive based on
population alone; and (d) the settlement will release all claims by Monroe County
against Endo and bring closure to the lawsuit as to this settling defendant; and
XIFSFBT- the County Attorney executed the Participation Form for the Endo
settlement on March 1, 20222 in light of (a) the benefit to Monroe County, (b) the fact
that the funds shown are consistent with the distribution formula shown in Resolution
No. 285-2021, and (c) the fact that the Attorney General requested an immediate
approval in order to finalize the settlement. This item therefore seeks ratification of the
approved Participation Form; and
XIFSFBT- in order to expedite the settlement process for future potential settlements
with settling defendants, staff is requesting that the BOCC authorize the County
Attorney to enter into future additional settlements with additional defendants on behalf
of Monroe County and to execute Participation Forms and related documents as
necessary to effect the settlements, provided the terms and conditions are consistent
with Resolution No. 285-2021 both in terms of the distribution formula and in terms of
approved uses for the settlement funds as shown in Schedules A and B to Exhibit 1 to
the MOU.
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1.The Board of County Commissioners for Monroe County, Floridaratifies the
Participation Form for Endo (Exhibit A to this Resolution).
2.The Board of County Commissioners for Monroe County, Florida, grants
authority to the County Attorney to execute Participation Forms and any other
related documents in order to effect similar settlements with other settling
defendants, provided the terms are consistent with the plan for the allocationand
use of opioid settlement proceeds as generally described in the MOU attached to
Resolution No. 285-2021, including Exhibit 1 andSchedule A (Core Strategies)
and Schedule B (Approved Uses)to the Resolution.
3.This Resolution shall become effective immediately upon adoption.
PASSED AND ADOPTED by the Board of County Commissioners of Monroe County,
Florida, at a regular meeting of the Board held on March 16, 2022.
Mayor David Rice_____
Mayor Pro Tem Craig Cates_____
Commissioner Michelle Coldiron_____
Commissioner District 3, Vacant_____
Commissioner Holly Merrill Raschein_____
(Attest)BOARD OF COUNTY COMMISSIONERS
OF MONROE COUNTY, FLORIDA
KEVIN MADOK, CLERK OF THE COURT
By: ______________________________By: ______________________________
As Deputy ClerkMayor
Approved as to form and legal sufficiency:
Assistant County Attorney March 1, 2022
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Exhibit D
Subdivision Settlement Participation Form
NpospfDpvouz
Governmental Entity:State:
Gmpsjeb
SpcfsuC/Tijmmjohfs-Ks/-DpvouzBuupsofz
Authorized Official:
222223uiTu/-Tvjuf519
Address 1:
Address 2:
LfzXftu-GM44151
City, State, Zip:
Phone:
tijmmjohfs.cpcAnpospfdpvouz.gm/hpw
Email:
The governmental entity identified above (“Governmental Entity”), in order to obtain and
in consideration for thebenefitsprovided to the GovernmentalEntitypursuantto the Settlement
Agreement dated(“Endo Settlement”), and acting through the undersigned
authorized official, herebyelects to participate in the Endo Settlement, release all Released
Claims against all Releasees, and agrees as follows.
1.The Governmental Entity is aware of and has reviewed the Endo Settlement, understands
that all terms in this Subdivision Settlement ParticipationForm have the meanings
defined therein, and agrees that by signing this Subdivision Settlement Participation
Form, the Governmental Entity elects to participate in the Endo Settlement and become a
Participating Subdivision as provided therein.
2.The Governmental Entity shall immediately cease any and all litigation activities as to the
Releasees and Released Claims and, within the later of 7 days following the entry of the
Consent Judgment or 7 days of the Execution Date of this Subdivision Settlement
Participation Form voluntarily dismiss with prejudice any Released Claims that it has
filed.
3.The Governmental Entity agrees to the terms of the Endo Settlement pertaining to
Subdivisions as defined therein.
4.By agreeing to the terms of the Endo Settlement and expressly agreeing to the releases
provided for therein, the Governmental Entity is entitled to the benefits provided therein,
including, if applicable, monetary payments beginning after the Effective Date of the
Agreement.
5.The Governmental Entity agrees to use any monies it receives through the Endo
Settlement solely for the purposes provided therein.
6.The Governmental Entity submits to the jurisdiction of the Court for purposes limited to
the Court’s role as provided in, and for resolving disputes to the extent provided in, the
Endo Settlement.
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7.The Governmental Entity has the right to enforce those rights given to them in the Endo
Settlement.
8.The Governmental Entity, as a Participating Subdivision, hereby becomes a Releasor for
all purposes in the Endo Settlement, including, but not limited to, all provisions of
Section D and E, and along with all departments, agencies, divisions, boards,
commissions, districts, instrumentalities of any kind and attorneys, and any person in
their official capacity elected or appointed to serve any of the foregoing and any agency,
person, or other entity claiming by or through any of the foregoing, and any other entity
identified in the definition of Releasor, provides for a release to the fullest extent of its
authority. As a Releasor, the Governmental Entity hereby absolutely, unconditionally,
and irrevocably covenants not to bring, file, or claim, or to cause, assist or permit to be
brought, filed, or claimed, or to otherwise seek to establish liability for any Released
Claims against any Releasee in any forum whatsoever. The releases provided for in the
Endo Settlement are intended by the Parties to be broad and shall be interpreted so as to
give the Releasees the broadest possible bar against any liability relating in any way to
Released Claims and extend to the full extent of the power of the Governmental Entity to
release Claims. The Endo Settlement shall be a complete bar to any Released Claim.
9.The Governmental Entity hereby takes on all rights and obligations of a Participating
Subdivision as set forth in the Endo Settlement.
10.In connection with the releases provided for in the Endo Settlement, each Governmental
Entity 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 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
he creditor or releasing party does not know or suspect to exist in his or
t
her favor at the time of executing the release, and 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 which it
knows, believes, or assumes to be true with respect to the Released Claims, but each
Governmental Entity hereby expressly waives and fully, finally, and forever settles,
releases and discharges, upon the Effective Date of the Release, any and all Released
Claims that may exist as of such date but which Releasors do not know or suspect to
exist, whether through ignorance, oversight, error, negligence or through no fault
whatsoever, and which, if known, would materially affect the Governmental Entities’
decision to participate in the Endo Settlement.
11.Nothing herein is intended to modify in any way the terms of the Endo Settlement, to
which the Governmental Entity hereby agrees. To the extent this Subdivision Settlement
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Participation Form is interpreted differently from the Endo Settlement in any respect, the
Endo Settlement controls.
I have all necessary power and authorization to execute this Subdivision Settlement Participation
Form on behalf of the Governmental Entity.
Ejhjubmmz!tjhofe!cz!Spcfsu!C/!Tijmmjohfs!
EO;!do>Spcfsu!C/!Tijmmjohfs-!p>Npospf!Dpvouz!CPDD-!pv>Npospf!
Dpvouz!Buupsofz-!fnbjm>tijmmjohfs.cpcAnpospfdpvouz.gm/hpw-!d>VT!
Spcfsu!C/!Tijmmjohfs
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Signature:_____________________________
SpcfsuC/Tijmmjohfs-Ks/
Name:_____________________________
DpvouzBuupsofz
Title:_____________________________
4.2.3133
Date:_____________________________
(the “Execution Date of this Subdivision
Settlement Participation Form”)
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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,
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
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;
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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
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 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
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
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
Action and any other Actions;
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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
y to bring and resolve litigation in which the State has an interest and
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 Actions; and
-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
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
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 S
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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) ActionsFlorida AG Action and any lawsuit by a Subdivision
asserting any Released Claim against any Releasee.
(b) Agreement, Settlement Settlement Agreement
Settlement Agreement, together with any exhibits attached hereto, which are incorporated
herein by reference.
(c) Bankruptcy Codeitle 11 of the United States Code, 11 U.S.C.
§ 101, et seq.
(d) Barall 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) Claimmeans 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
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
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-Overmeans 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 Judgmentmeans 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) CourtSixth Judicial Circuit Court in and for Pasco County,
State of Florida.
(i) Covered Conduct
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.
(j) Effective Date of the Agreement3 business days after the Initial
Participation Date, provided that either a Bar exists or a sufficient number of Subdivisions
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
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 Releasemeans the date on which the Court enters
the Consent Judgment.
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(l) Endo
(m) Execution Date
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 Subdivisionmeans 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
costs and expenses incurred in connection with Claims asserted against any Releasee in the
Action.
(q) Non-Joining Subdivision 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
Subdivision.
(s) Non-Participating Subdivision
yet a Participating Subdivision.
(t) Opioid Remediationmeans 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
1
reasonable related administrative expenses.
(u) Participating Subdivision means any Subdivision that executes a
subdivision settlement participation form attached as Exhibit D.
(v) PartiesSettling Parties, with each being
PartySettling Party.
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
1
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.
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(w) Post-Effective Date Sign-on Deadline
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: (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
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 combinati
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
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
1.468B-1.
(aa) Qualified Settlement Fund 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
responsibilities, including a detailed mechanism for paying the Qualified Settlement Fund
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
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
Agreement as Exhibit E.
(bb) Released Claimsany 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
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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
C
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
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) Releasorsmeans 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
each
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
in subsection A(gg) below. In addition to being a Releasor as
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
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
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
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 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) Subdivisionmeans (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.
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.
pond to categories of Special Districts recognized by the U.S. Census
Bureau.
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
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
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
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
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 Subdivisionagreement to implement an immediate cessation of any and all
litigation activities relating to such Litigating SubdivisionAction 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
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.
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
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
or by commencing a declaratory
judgment or other action that establishes a . 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
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
Subdivision unless and until Plaintiff has delivered to Endo a signed agreement from such
Subdivision providing for the Subdivisiond conditions of this
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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 Paymentllocated in accordance with subsection C.3 below; (b) five
accordance with subsection C.1(c) State Litigation Cost Payment
five million dollars ($5,000,000) to be available to reimburse the Litigation Costs of
Litigating Subdivisions in accordance with subsection C.1(b) Litigating
Subdivision Litigation Cost Payment
Litigating Subdivision Cost Payment shall collectively be referred to herein as the
Litigation Costs Payments
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
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
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.1(b)(3)
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 jurisdictio
professional conduct.
(c) Plaintiff shall file in the Court a motion for
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
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
Covered Conduct or Litigation Costs or this Settlement.
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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 I, 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
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
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-
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Effective Date Sign-on Deadline, (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 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.
request to the Qualified Settlement Fund Administrator, any Non-
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
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
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
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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
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
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
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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
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
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
discharged from all liability for contribution to any other alleged
tortfeasor in the Florida AG Action and in any other Action,
whenever filed.
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(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
Non-Party Covered Conduct
Claims 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-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 a judgment 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.
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
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
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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. I
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
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
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
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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.
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
2. Voluntary Settlement. This Settlement Agreement was negotiated in good faith
-length over several weeks, and the exchange of the Remediation Payment and
20
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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 Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdj
qbujpo!gpsn*
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.
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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 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
-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
and
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:
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
Geoffrey M. Wyatt
Skadden, Arps, Slate, Meagher & Flom LLP
1440 New York Avenue N.W.
22
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Washington, D.C. 20005
geoffrey.wyatt@skadden.com
and
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 B 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
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
or any portion thereof.
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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
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
instrument.
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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 , 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.
Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
20.!Most Favored Nations. If, after execution of this Agreement, there is a collective
resolutionthrough settlement, bankruptcy or other mechanismof substantially all claims
25
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Buubdinfou;!Fyfdvufe!Foep.Gmpsjeb!Bhsffnfou!!)Pqjpje!mjujhbujpo-!sftpmvujpo!sbujgzjoh!Foep!qbsujdjqbujpo!gpsn*
Qbdlfu!Qh/!3376
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Esblf!Nbsujo
2.26.3133
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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
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Seminole County
St. Johns County
St. Lucie County
Suwannee County
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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
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City of Palmetto
City of Panama City
City of Pembroke Pines
City of Pensacola
City of Pinellas Park
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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
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Exhibit B
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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,
2
Core Strategies
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-MAT
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.
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2
preference for new or existing programs.
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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:
PART ONE: TREATMENT
A.!TREAT OPIOID USE DISORDER (OUD)
OUD-occurring Substance Use
SUD/MH-based or evidence-
3
informed programs or strategies that may include, but are not limited to, those that:
1. Expand availability of treatment for OUD and any co-occurring SUD/MH
conditions, including all forms of Medication-MAT
approved by the U.S. Food and Drug Administration.
2. Support and reimburse evidence-based services that adhere to the American
ASAM-
occurring SUD/MH conditions.
3. 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. OTPs-
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.
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3
As used in this Schedule B, words
for new or existing programs.
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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
DATA 2000
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
Opioids web-based
training curriculum and motivational interviewing.
14. Develop and disseminate new curricula, such as the American Academy of
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:
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 with respect to 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.
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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.
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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)
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Provide connections to care for people who haveor are at risk of developingOUD
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:
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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 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,
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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.
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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:
1. Self-referral strategies such as the Angel Programs or the Police Assisted
PAARI
2. Active outreach strategies such as the Drug Abuse Response Team
DART
3.
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
LEAD
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.
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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.
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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. CTI
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
NASvidence-based or evidence-informed programs or
strategies that may include, but are not limited to, those that:
1. Support evidence-based or evidence-informed treatment, including MAT,
recovery services and supports, and prevention services for pregnant womenor
women who could become pregnantwho 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.
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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 NAS get referred to appropriate services and receive a plan of safe care.
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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. 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:
1. 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.
3. 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
PDMPs
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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
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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,
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 reductionincluding
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
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
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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.
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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:
1. 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.
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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,
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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.
PART THREE: OTHER STRATEGIES
I.!FIRST RESPONDERS
In addition to items in section C, D and H relating to first responders, support the
following:
1. 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:
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, 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
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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.
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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, those that:
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, Manufacturers, 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.
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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).
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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
ADAM
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. Geospatial analysis of access barriers to MAT and their association with
treatment engagement and treatment outcomes.
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Exhibit D
Subdivision Settlement Participation Form
Governmental Entity:State:
Authorized Official:
Address 1:
Address 2:
City, State, Zip:
Phone:
Email:
The governmental entity identified above (“Governmental Entity”), in order to obtain and
in consideration for the benefits provided to the Governmental Entity pursuant to the Settlement
Agreement dated January 15, 2022 (“Endo Settlement”), and acting through the undersigned
authorized official, hereby elects to participate in the Endo Settlement, release all Released
Claims against all Releasees, and agrees as follows.
1.The Governmental Entity is aware of and has reviewed the Endo Settlement, understands
that all terms in this Subdivision Settlement Participation Form have the meanings
defined therein, and agrees that by signing this Subdivision Settlement Participation
Form, the Governmental Entity elects to participate in the Endo Settlement and become a
Participating Subdivision as provided therein.
2.The Governmental Entity shall immediately cease any and all litigation activities as to the
Releasees and Released Claims and, within the later of 7 days following the entry of the
Consent Judgment or 7 days of the Execution Date of this Subdivision Settlement
Participation Form voluntarily dismiss with prejudice any Released Claims that it has
filed.
3.The Governmental Entity agrees to the terms of the Endo Settlement pertaining to
Subdivisions as defined therein.
4.By agreeing to the terms of the Endo Settlement and expressly agreeing to the releases
provided for therein, the Governmental Entity is entitled to the benefits provided therein,
including, if applicable, monetary payments beginning after the Effective Date of the
Agreement.
5.The Governmental Entity agrees to use any monies it receives through the Endo
Settlement solely for the purposes provided therein.
6.The Governmental Entity submits to the jurisdiction of the Court for purposes limited to
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the Court’s role as provided in, and for resolving disputes to the extent provided in, the
Endo Settlement.
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7. The Governmental Entity has the right to enforce those rights given to them in the Endo
Settlement.
8. The Governmental Entity, as a Participating Subdivision, hereby becomes a Releasor for
all purposes in the Endo Settlement, including, but not limited to, all provisions of
Section D and E, and along with all departments, agencies, divisions, boards,
commissions, districts, instrumentalities of any kind and attorneys, and any person in
their official capacity elected or appointed to serve any of the foregoing and any agency,
person, or other entity claiming by or through any of the foregoing, and any other entity
identified in the definition of Releasor, provides for a release to the fullest extent of its
authority. As a Releasor, the Governmental Entity hereby absolutely, unconditionally,
and irrevocably covenants not to bring, file, or claim, or to cause, assist or permit to be
brought, filed, or claimed, or to otherwise seek to establish liability for any Released
Claims against any Releasee in any forum whatsoever. The releases provided for in the
Endo Settlement are intended by the Parties to be broad and shall be interpreted so as to
give the Releasees the broadest possible bar against any liability relating in any way to
Released Claims and extend to the full extent of the power of the Governmental Entity to
release Claims. The Endo Settlement shall be a complete bar to any Released Claim.
9. The Governmental Entity hereby takes on all rights and obligations of a Participating
Subdivision as set forth in the Endo Settlement.
10. In connection with the releases provided for in the Endo Settlement, each Governmental
Entity 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 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, and 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 which it
knows, believes, or assumes to be true with respect to the Released Claims, but each
Governmental Entity hereby expressly waives and fully, finally, and forever settles,
releases and discharges, upon the Effective Date of the Release, any and all Released
Claims that may exist as of such date but which Releasors do not know or suspect to
exist, whether through ignorance, oversight, error, negligence or through no fault
whatsoever, and which, i
decision to participate in the Endo Settlement.
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11. Nothing herein is intended to modify in any way the terms of the Endo Settlement, to
which the Governmental Entity hereby agrees. To the extent this Subdivision Settlement
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Participation Form is interpreted differently from the Endo Settlement in any respect, the
Endo Settlement controls.
I have all necessary power and authorization to execute this Subdivision Settlement Participation
Form on behalf of the Governmental Entity.
Signature: _____________________________
Name: _____________________________
Title: _____________________________
Date: _____________________________
Execution Date of this Subdivision
Settlement Participation Form
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Exhibit E
QUALIFIED SETTLEMENT FUND ADMINISTRATOR
\[TO BE ADDED\]
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Exhibit F
INJUNCTIVE RELIEF
I.!Definitions Specific to this Exhibit
A. -
from a
provided during remission.
B.
ng
data.
C. -of-
for dying in the near future in hospice care, hospitals, long-term care settings, or at
home.
D.
ventures, divisions, assigns, officers, directors, agents, partners, principals, current
employees, and affiliates acting on behalf of EPI or PPI in the United States.
E. -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.
list or examples are illustrative instances only and shall not be read to be restrictive.
G. -Kind Supp
commodities, services, or anything else of value.
H.
U.S.C. § 1602 et
seq., and any analogous state or local provisions governing the person or entity
s or Third
Parties.
I. -synthetic, or synthetic chemicals that
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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.
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J.
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
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
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. Diagnostic and Statistical
Manual of Mental Disorders, Fifth Edition (DSM5), as updated or amended.
L. all 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.
research position at an institution of higher education, a research organization, a
nonprofit organization, or a government agency.
N.
Substances Act, 21 U.S.C. §§ 801-904, and the regulations promulgated thereunder
and analogous Florida state laws and regulations.
O.
entity.
P.
or reduce pain.
Q. does not identify a
specific branded or generic product(s).
II.!Injunctive Relief
A. General Provisions
1. Endo shall not make any written or oral statement about Opioids or any
Opioid Product that is false, misleading, deceptive, unfair or
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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.
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B. Ban on Promotion
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.1 directly above, Endo may:
a. Maintain a corporate website;
b. Maintain a website that contains principally the following content
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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;
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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.
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
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;
g. 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
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;
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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,
re
other descriptive information (including information set forth in a
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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
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
regulation applicable in the state where the program is provided
through an independent Third Party, which shall be responsible for
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
l. 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.
3. Endo shall not engage in the following specific Promotional activity relating
to any products indicated for the treatment of Opioid-induced side effects
-
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-
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Kind Support for advertisements that Promote products indicated for
the treatment of Opioid-induced side effects, including but not
limited to internet advertisements or similar content, and providing
hyperlinks or otherwise directing internet traffic to advertisements.
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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,
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.
c. 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
1. 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
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permitted by other sections of this Consent Judgment.
3.
this Consent Judgment.
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D. Ban on Funding/Grants to Third Parties
1. 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.
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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
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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
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 II.D 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,
s and
(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
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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
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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
1. 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;
g. Evidence-based treatment (such as using medication-assisted
treatment with buprenorphine or methadone in combination with
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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.
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3. Endo shall not Lobby against the enactment of any federal, state or local
legislative or regulatory provision expanding the operation or use of
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.1-3, 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;
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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
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i. 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
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 II.E 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.
F. Ban on Certain High Dose Opioids
1. Endo shall not commence manufacturing, Promoting, or distributing any
Opioid Product in strengths exceeding 30 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.
G. Ban on Prescription Savings Programs
1. Endo shall not directly or indirectly offer any discounts, coupons, rebates,
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
-payments or the cost of
prescriptions (e.g., free trial prescriptions) for any Opioid Product.
H. 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;
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c. Utilize all information Endo receives that bears upon a direct
diversion activity or
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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
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 En
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.
I. Miscellaneous Terms
1. To the extent that any provision in this Consent Judgment conflicts with
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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
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that Endo cannot comply with both the law or regulation and 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
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 30 days of the request:
a. Any litigation or civil or criminal law enforcement subpoenas or
and
b.
Opioid Product(s) and all correspondence between Endo and the
FDA related to such letters.
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.
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J. Compliance with State Laws and Regulations Relating to the Sale, Promotion, and
Distribution of Any Opioid Product
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1. Subject to subsection II.G.1 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.
III.!Clinical Data Transparency
A. Data to Be Shared
1. 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. --marketing clinical research
and post-
§ 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
-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;
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c. The full protocol(s) (including the initial version, final version, and
all amendments); and
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d. Full statistical analysis plan(s) (including all amendments and
documentation for additional work processes) and analytic code.
B. Third-Party Data Archive
1. 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
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
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.
5. Endo shall bear all costs for making data and/or information available to the
third-party data archive.
IV.!Compliance
A. Compliance Duration
1. Sections II 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
1. Endo must be in full compliance with the provisions included in this
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Consent Judgment by the date it is entered. Nothing herein shall be
construed as permitting Endo to avoid existing legal obligations.
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V.!Enforcement
A. If the State believes that Endo is not in compliance with any term of this Consent
Judgment, then the State shall:
1. 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-
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.
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Exhibit G
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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
PURDUE PHARMA L.P., et al.,
Defendants.
CONSENT JUDGMENT
Plaintiff, the State of Florida, Office of the Attorney General, Department of Legal
-captioned action against Defendants Endo Health
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)
Florida, its governmental subdivisions and its citizens.
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In addition, numerous governmental entities in Florida, including counties, cities, hospital
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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
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
ction
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
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
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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
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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. laims 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
xpire.
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
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JOINTLY APPROVED AND
SUBMITTED FOR ENTRY:
FOR STATE OF FLORIDA, OFFICE OF THE ATTORNEY GENERAL, DEPARTMENT OF
LEGAL AFFAIRS
ASHLEY MOODY
ATTORNEY GENERAL
By:
\[to come\]
Date:
\[Additional approvals on subsequent pages\]
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OUTSIDE LITIGATION COUNSEL FOR STATE OF FLORIDA, OFFICE OF THE
ATTORNEY GENERAL, DEPARTMENT OF LEGAL AFFAIRS
By:
\[to come\]
Date:
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DEFENDANT ENDO HEALTH SOLUTIONS INC.
By:
Matthew J. Maletta
Executive Vice President and Chief Legal Officer
Endo
1400 Atwater Drive
Malvern, Pennsylvania 19355
Date:
DEFENDANT ENDO PHARMACEUTICALS INC.
By:
Matthew J. Maletta
Executive Vice President and Chief Legal Officer
Endo
1400 Atwater Drive
Malvern, Pennsylvania 19355
Date:
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COUNSEL FOR DEFENDANTS ENDO HEALTH SOLUTIONS INC. AND ENDO
PHARMACEUTICALS INC.
By:
Geoffrey M. Wyatt
Skadden, Arps, Slate, Meagher & Flom LLP
1440 New York Avenue, N.W.
Washington, D.C. 20005
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Exhibit I
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Exhibit J
MECHANISM BY WHICH QUALIFIED SETTLEMENT FUND ADMINISTRATOR IS
TO ALLOCATE, APPORTION AND DISTRIBUTE PAYMENTS
\[TO BE ADDED\]
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MEMORANDUM
Office of the Monroe County Attorney
TO: Monroe County Board of County Commissioners
Roman Gastesi, County Administrator
THRU:Bob Shillinger, County Attorney
FROM: Cynthia L. Hall, Assistant County Attorney
!!!!!!!!!DI
DATE: February28, 2022
SUBJECT: Proposed Settlement of Opioid Litigationwith Endo Health Solutions Inc. and
Endo Pharmaceuticals, Inc.
Background
On 4/3/2019, Monroe Countyfiled suit in federal district for the Southern District of Florida
against opioid manufacturers, distributors, and pharmacies, for damages caused in Monroe
County by the opioid epidemic.Thesuit was later moved and made part of multi district
litigation (MDL) consisting of similar lawsuits bystates (including theState of Florida) and
manylocal governments.
In September 2021, the Board of County Commissioners (BOCC) adopted Resolution No. 285-
2021.Resolution No. 285-2021 authorized Monroe County to joinwith the State of Florida and
other local government units in a framework for settling all of theopioid cases, usinga
Memorandum of Understanding("MOU").The MOU contained a formulashowing how
Monroe County and the municipalities in Monroe Countywould share in the settlement proceeds
with other cities and counties in the State of Florida.
In December 2021, the BOCC approved the first settlements,withthree distributors (Cardinal
Health, McKesson and Amerisource Bergen Drug Corporation) and one manufacturer (Johnson
& Johnson).
The Endo Settlement
On January 15, 2022, the Florida AttorneyGeneralentered intoasettlement with another
manufacturer defendant (Endo Health Solutions,Inc. and Endo Pharmaceuticals,Inc., including
subsidiaries and related entities owned by these companies, collectively "Endo"). On February
22, 2022, the Florida Attorney General's Office sent to the County a Participation Form, and
asked for the County's signature to Endo settlement.
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KeyPoints of the Endo Settlement:
The total dollar amount settlement between the State of Florida and Endo is $65 million,
which includes $55 million for opioid remediation("Remediation Fund"), $5 million for
the State's litigationcosts, and $5 millionfor the litigation costs of Litigating
Subdivision.
The MOU between the State ofFlorida and all participating subdivisions,approved by
the BOCC in Resolution No. 285-2021 in September 2021,stated that all Remediation
Fund from any settlements wouldbe split into three parts: 50% to the State, 35% to a
Regional Abatement fund, and 15% to individual counties and cities.The amounts for
each city and county wereapportioned based on percentages related loosely to population
as well degree ofopioid problem withinthe political subdivision.Monroe County
receives more than its share based on population alone.
Becausethedollar amount of this Endo settlement islower than the settlement with the 3
Distributors and J&J, Monroe County and City of Key West will receivetheir direct
allocations(assumingthat both jurisdictions approve the settlements and return the
signed Participation Forms), but Monroe County will also receive the percentages that
would have been allocated to the other municipalities.
Thissettlement is expected to be paid in one lump sum amount, over the next year
(assumingapproval of the settlement agreement by all subdivisions).(The settlement
with the 3 Distributors and J&J was spread over 18years.)
The dollar amounts that Monroe County and the City of Key West can expect to receive
1
are as follows:
Monroe County, amount from Regional Abatement Fund$32,034.86
Monroe County, amount from City/County settlementfund$104,805.52
City of Key West, amount from City/County settlement fund$7,267.21
In order to settle the case as to this defendant, Monroe County must dismiss its current
litigation against Endo.
Settlement proceeds must be used for the same approved programs as outlined in the
September resolution.
The attorneys representing the County have agreed to limit their attorneys' fees and costs
to the $5 million set aside under the agreement. Therefore, the dollar figure recovery
shown above isthenet recovery.
1
This is an estimateprovided by the Florida AG's office, based on best information available at
this time.
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Why the Endo Settlement Is Good for Monroe County
1. The settlement will provide $136,000 to Monroe County and another $7,267 to the City
of Key West (if approved by both entities) which can be used on substance abuse
abatement problems. Monroe County receives a slightly higher share than its pro rata
share would be based on population.
2. Endo can apply to the court to receive the funds allocated to any entity that does not
approve the settlement.
3. Without this settlement, it is extremely likely that plaintiffs would receive less from these
defendants. It is also possible that other defendants would file for the protection of the
bankruptcy court, which would drag out potential settlements even further.
4. The State of Florida is behind this settlement formula.
Based on the Attorney General's request for immediate approval, and the fact that the settlement
is on the same terms as previously approved by the BOCC in Resolution No. 285-2021, the
County Attorney has executed the Participation Form on behalf of Monroe County. Thisitem
seeks ratification of that action.
The County expects that additional settlements will be achieved with other defendants.
Therefore, this agenda item also seeks authority for the County Attorney to execute additional
Participation Forms and related documents as additional settlements with settling defendants are
achieved, provided the allocation to Monroe County (from the Regional Abatement Fund and the
city/county fund) is in line with the percentages shown in Resolution No. 285-2021.
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