HomeMy WebLinkAboutContract1
JANSSEN WASHINGTON STATE-WIDE OPIOID SETTLEMENT AGREEMENT
I.Overview
This settlement agreement (the “Agreement”) sets forth the terms and conditions of a
settlement agreement between and among Janssen, the State of Washington, and Participating
Subdivisions (as those terms are defined below). Janssen has agreed to the below terms for the sole
purpose of settlement, and nothing herein 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 Janssen expressly denies. No part of this Agreement,
including its statements and commitments, shall constitute evidence of any liability, fault, or
wrongdoing by Janssen. Unless the contrary is expressly stated, this Agreement is not intended for
use by any third party for any purpose, including submission to any court for any purpose.
II.Definitions
Unless otherwise specified, the following definitions apply:
1.“Agreement” means this agreement as set forth above, inclusive of all exhibits.
2.“Alleged Harms” means the alleged past, present, and future financial, societal, and
related expenditures arising out of the alleged misuse and abuse of opioid products,
that have allegedly been caused by Janssen.
3.“Attorney” means any of the following retained through a legal contract: a solo
practitioner, multi-attorney law firm, or other legal representative of a Participating
Subdivision.
4.“Claim” means any past, present or future cause of action, claim for relief, cross-
claim or counterclaim, theory of liability, demand, derivative claim, request,
assessment, charge, covenant, damage, debt, lien, loss, penalty, judgment, right,
obligation, dispute, suit, contract, controversy, agreement, parens patriae claim,
promise, performance, warranty, omission, or grievance of any nature whatsoever,
whether legal, equitable, statutory, regulatory or administrative, whether arising
under federal, state or local common law, statute, regulation, guidance, ordinance or
principles of equity, whether filed or unfiled, whether asserted or unasserted,
whether known or unknown, whether accrued or unaccrued, whether foreseen,
unforeseen or unforeseeable, whether discovered or undiscovered, whether suspected
or unsuspected, whether fixed or contingent, and whether existing or hereafter
arising, in all such cases, including but not limited to any request for declaratory,
injunctive, or equitable relief, compensatory, punitive, or statutory damages, absolute
liability, strict liability, restitution, subrogation, contribution, indemnity,
apportionment, disgorgement, reimbursement, attorney fees, expert fees, consultant
fees, fines, penalties, expenses, costs or any other legal, equitable, civil,
administrative, or regulatory remedy whatsoever.
CAG-24-104
2
5.“Claim Over” means a Claim asserted by a Non-Released Entity against a Released
Entity on the basis of contribution, indemnity, or other claim-over on any theory
relating to a Non-Party Covered Conduct Claim asserted by a Releasor.
6.“Compensatory Restitution Amount” means the aggregate amount of payments by
Janssen hereunder other than amounts used for attorneys’ fees and costs.
7.“Consent Judgment” means a consent judgment in the form attached as Exhibit E.
8.“Court” means the court to which the Agreement and the Consent Judgment are
presented for approval and/or entry.
9.“Covered Conduct” means any actual or alleged act, failure to act, negligence,
statement, error, omission, breach of any duty, conduct, event, transaction,
agreement, misstatement, misleading statement or other activity of any kind
whatsoever from the beginning of time through the Effective Date (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) relating in any way to (a) 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; (b) the characteristics,
properties, risks, or benefits of any Product; (c) the reporting, disclosure, non-
reporting or non-disclosure to federal, state or other regulators of orders for any
Product placed with any Released Entity; (d) the selective breeding, harvesting,
extracting, purifying, exporting, importing, applying for quota for, procuring quota
for, handling, promoting, manufacturing, processing, packaging, supplying,
distributing, converting, or selling of, 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, finished active
pharmaceutical ingredients, drug substances, or any related intermediate Products; or
(e) diversion control programs or suspicious order monitoring related to any Product.
10.“Effective Date” means January 22, 2024.
11.“Janssen” means Johnson & Johnson, Johnson & Johnson Innovative Medicine,
Janssen Pharmaceuticals, Inc., Ortho-McNeil-Janssen Pharmaceuticals, Inc., and
Janssen Pharmaceutica, Inc.
12.“Litigating Subdivision” means a Subdivision (or Subdivision official asserting the
right of or for the Subdivision or the State to recover for alleged harms to the
Subdivision, the State, and/or the people thereof) that brought any Released Claims
against any Released Entity on or before the Effective Date that were not separately
3
resolved prior to that date. A list of all Litigating Subdivisions known to the Parties
is included in Exhibit F hereto.
13.“Net Settlement Amount” means the amount paid by Janssen into the Settlement
Fund under subsection V.C. For the avoidance of doubt, the Net Settlement Amount
does not include amounts paid for State Outside and Inside Counsel Fees and Costs
pursuant to subsection IX.A.
14.“Non-Litigating Subdivision” means a Subdivision that is not a Litigating
Subdivision.
15.“Non-Party Covered Conduct Claim” means a Claim against any Non-Released
Entity involving, arising out of, or related to Covered Conduct (or conduct that
would be Covered Conduct if engaged in by a Released Entity).
16.“Non-Party Settlement” means a settlement by any Releasor that settles any Non-
Party Covered Conduct Claim and includes a release of any Non-Released Entity.
17.“Non-Released Entity” means an entity that is not a Released Entity.
18.“Opioid Remediation” means care, treatment, and other programs and expenditures
(including reimbursement for past such programs or expenditures except where this
Agreement restricts the use of funds solely to future Opioid Remediation) designed
to (1) address the misuse and abuse of opioid products, (2) treat or mitigate opioid
use or related disorders, or (3) mitigate other alleged effects of the opioid abuse
crisis, including on those injured as a result of the opioid abuse crisis. Exhibit J
provides a non-exhaustive list of expenditures that qualify as being paid for Opioid
Remediation. Qualifying expenditures may include reasonable related administrative
expenses.
19.“Participating Subdivision” means a Subdivision that meets the requirements for
becoming a Participating Subdivision under Section VII.
20.“Parties” means Janssen and the State of Washington (each, a “Party”).
21.“Product” means any chemical substance, whether used for medicinal or non-
medicinal purposes, and whether natural, synthetic, or semi-synthetic, or any
finished pharmaceutical product made from or with such substance, that is an opioid
or opiate, as well as any product containing any such substance. It also includes: 1)
the following when used in combination with opioids or opiates: benzodiazepine,
carisoprodol, zolpidem, or gabapentin; and 2) a combination or “cocktail” of any
stimulant or other chemical substance prescribed, sold, bought, or dispensed to be
used together that includes opioids or opiates. For the avoidance of doubt, “Product”
does not include benzodiazepine, carisoprodol, zolpidem, or gabapentin when not
used in combination with opioids or opiates. “Product” includes but is not limited to
any substance consisting of or containing buprenorphine, codeine, fentanyl,
hydrocodone, hydromorphone, meperidine, methadone, morphine, naloxone,
4
naltrexone, oxycodone, oxymorphone, tapentadol, tramadol, opium, heroin,
carfentanil, any variant of these substances, or any similar substance. “Product” also
includes any natural, synthetic, semi-synthetic or chemical raw materials, starting
materials, finished active pharmaceutical ingredients, drug substances, and any
related intermediate products used or created in the manufacturing process for any of
the substances described in the preceding sentence.
22.“Released Claims” means any and all Claims that directly or indirectly are based on,
arise out of, or in any way relate to or concern the Covered Conduct occurring prior
to the Effective Date. Without limiting the foregoing, “Released Claims” include any
Claims that have been asserted against the Released Entities by the State or any of its
Litigating Subdivisions 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 the State, any of its Subdivisions, or any Releasors (whether
or not such State, Subdivision, or Releasor has brought such action or proceeding),
provided the Covered Conduct occurs prior to the Effective Date. Released Claims
also include all Claims asserted in any proceeding to be dismissed pursuant to the
Agreement, whether or not such claims relate to Covered Conduct, provided the
Covered Conduct occurs prior to the Effective Date. The Parties intend that
“Released Claims” be interpreted broadly. This Agreement does not release Claims
by private individuals. 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 by a Subdivision or other non-party Subdivision after the
Effective Date that would have been Released Claims if they had been brought by a
Releasor against a Released Entity.
23.“Released Entities” means Janssen and (1) all of Janssen’s past and present direct or
indirect parents, subsidiaries, divisions, predecessors, successors, assigns, including
Noramco, Inc. and Tasmanian Alkaloids PTY. LTD.; (2) the past and present direct
or indirect subsidiaries, divisions, and joint ventures, of any of the foregoing; (3) all
of Janssen’s insurers (solely in their role as insurers with respect to the Released
Claims); (4) all of Janssen’s, or of any entity described in subsection (1), past and
present joint ventures; and (5) the respective past and present officers, directors,
members, shareholders (solely in their capacity as shareholders of the foregoing
entities), partners, trustees, agents, and employees of any of the foregoing (for
actions that occurred during and related to their work for, or employment with,
Janssen). Any person or entity described in subsections (3)-(5) shall be a Released
Entity solely in the capacity described in such clause and shall not be a Released
Entity with respect to its conduct in any other capacity. For the avoidance of doubt,
the entities listed in Exhibit D are not Released Entities; and provided further that
any joint venture partner of Janssen or Janssen’s subsidiary is not a Released Entity
unless it falls within subsections (1)-(5) above. A list of Janssen’s present
subsidiaries and affiliates is attached as Exhibit G. Janssen’s predecessor entities
include but are not limited to those entities listed on Exhibit A. For the avoidance of
5
doubt, any entity acquired, or joint venture entered into, by Janssen after the
Effective Date is not a Released Entity.
24.“Releasors” means (1) the State; (2) each Participating Subdivision; and (3) without
limitation and to the maximum extent of the power of the State’s Attorney General
and/or Participating Subdivision to release the Claims, (a) the State’s and
Participating Subdivision’s departments, agencies, divisions, boards, commissions,
Subdivisions, districts, instrumentalities of any kind and attorneys, including its
Attorney General, and any person in their official capacity whether elected or
appointed to serve any of the foregoing and any agency, person, or other 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 Subdivisions in the
State, 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 or Subdivision in the State, whether or not any of them participate in the
Agreement. The inclusion of a specific reference to a type of entity in this definition
shall not be construed as meaning that the entity is not a Subdivision. In addition to
being a Releasor as provided herein, a Participating Subdivision shall also provide
the Settlement Participation Form referenced in Section VII providing for a release
to the fullest extent of the Participating Subdivision’s authority, which shall be
attached as an exhibit to the Agreement. The State’s Attorney General represents that
he or she has or has obtained the authority set forth in the Representation and
Warranty subsection of Section IV.
25.“Settlement Fund” means the interest-bearing fund established under the Agreement
into which all Net Settlement Amount payments by Janssen are made.
26.“Settlement Fund Administrator” means the entity that calculates the allocation of
payments under Section VI of this Agreement, and administers and distributes
amounts from the Settlement Fund. A detailed description of the Settlement Fund
Administrator’s duties, including a detailed mechanism for paying the Settlement
Fund Administrator’s fees and costs, shall be appended to the Agreement as Exhibit
I.
27.“Settlement Participation Form” means the form attached as Exhibit B that
Participating Subdivisions must execute and return to Janssen and the State of
Washington, and which shall (1) make such Participating Subdivisions signatories to
this Agreement, (2) include a full and complete release of any and of such
Subdivision’s claims, and (3) require the prompt dismissal with prejudice of any
Released Claims that have been filed by any such Participating Subdivision.
28.“Special District” means a formal and legally recognized sub-entity of the State that
is authorized by State law to provide one or a limited number of designated
6
functions, including but not limited to school districts, fire districts, healthcare &
hospital districts, and emergency services districts.
29.“State” means the State of Washington.
30.“State Outside and Inside Counsel Fees and Costs” means fees and costs of the
Washington Attorney General’s Office and State Outside Counsel.
31.“State Outside Counsel” means Nix Patterson, LLP and Whitten Burrage, who were
engaged by the Washington Attorney General’s Office for State of Washington v.
Johnson & Johnson, et al., King County Superior Court, Cause No. 20-2-00184-
8SEA.
32.“Subdivision” means a formal and legally recognized sub-entity of the State that
provides general governance for a defined area, including a county, city, town,
village, or similar entity. Unless otherwise specified, “Subdivision” includes all
functional counties and other functional levels of sub-entities of the State that
provide general governance for a defined area. Historic, non-functioning sub-entities
of the State are not Subdivisions, unless the entity has filed a lawsuit that includes a
Released Claim against a Released Entity in a direct, parens patriae, or any other
capacity. For purposes of this Agreement, the term Subdivision also includes Special
Districts.
III.Injunctive Relief
As part of the Consent Judgment, the Parties agree to the injunctive relief terms attached as
Exhibit C.
IV.Release
A.Scope. As of the Effective Date, the Released Entities will be released and forever
discharged from all of the Releasors’ Released Claims. The State of Washington (for itself
and its Releasors) and each Participating Subdivision (for itself and its Releasors) will, on or
before the Effective Date, absolutely, unconditionally, and irrevocably covenant not to
bring, file, or claim, or to cause, assist in bringing, or permit to be brought, filed, or claimed,
or to otherwise seek to establish liability for any Released Claims against any Released
Entity in any forum whatsoever. The releases provided for in the Agreement are intended by
the Parties to be broad and shall be interpreted so as to give the Released Entities 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 State and its Attorney General to release claims. The
Release shall be a complete bar to any Released Claim.
B.Claim Over and Non-Party Settlement.
1.Statement of Intent. It is the intent of the Parties that:
7
a.Released Entities should not seek contribution or indemnification (other than
pursuant to an insurance contract) from other parties for their payment
obligations under this Agreement;
b.The payments made under this Agreement shall be the sole payments made
by the Released Entities to the Releasors involving, arising out of, or related
to Covered Conduct (or conduct that would be Covered Conduct if engaged
in by a Released Entity);
c.Claims by Releasors against non-Parties should not result in additional
payments by Released Entities, whether through contribution,
indemnification or any other means; and
d.The Agreement meets the requirements of the Uniform Contribution Among
Joint Tortfeasors Act and any similar state law or doctrine that reduces or
discharges a released party’s liability to any other parties.
e.The provisions of this subsection IV.B are intended to be implemented
consistent with these principles. This Agreement and the releases and
dismissals provided for herein are made in good faith.
2.Contribution/Indemnity Prohibited. No Released Entity 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 Released Entity 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 Released Entity from recovering amounts owed
pursuant to insurance contracts.
3.Non-Party Settlement. To the extent that, on or after the Effective Date, any Releasor
enters into a Non-Party Settlement, including in any bankruptcy case or through any
plan of reorganization (whether individually or as a class of creditors), the Releasor
will 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 contribution or
indemnity of any kind substantially equivalent to that required from Janssen in
subsection IV.B.2, or a release from such Non-Released Entity in favor of the
Released Entities (in a form equivalent to the releases contained in this Agreement)
of any Claim-Over. The obligation to obtain the prohibition and/or release required
by this subsection is a material term of this Agreement.
4.Claim-Over. In the event that any Releasor obtains a judgment with respect to Non-
Party Covered Conduct against a Non-Released Entity that does not contain a
prohibition like that in subsection IV.B.3, 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
8
Settlement as provided in subsection IV.B.3, and such Non-Released Entity asserts a
Claim-Over against a Released Entity, that Releasor and Janssen shall take the
following actions to ensure that the Released Entities do not pay more with respect to
Covered Conduct to Releasors or to Non-Released Entities than the amounts owed
under this Agreement by Janssen:
a.Janssen shall notify that Releasor of the Claim-Over within thirty (30) days
of the assertion of the Claim-Over or thirty (30) days of the Effective Date of
this Agreement, whichever is later;
b.Janssen and that Releasor shall meet and confer concerning the means to hold
Released Entities harmless and ensure that it is not required to pay more with
respect to Covered Conduct than the amounts owed by Janssen under this
Agreement;
c.That Releasor and Janssen shall take steps sufficient and permissible under
the law of the State of the Releasor to hold Released Entities harmless from
the Claim-Over and ensure Released Entities are not required to pay more
with respect to Covered Conduct than the amounts owed by Janssen under
this Settlement Agreement. Such steps may include, where permissible:
(1)Filing of motions to dismiss or such other appropriate motion by
Janssen or Released Entities, and supported by Releasors, in response
to any claim filed in litigation or arbitration;
(2)Reduction of that Releasor’s Claim and any judgment it has obtained
or may obtain against such Non-Released Entity by whatever amount
or percentage is necessary to extinguish such Claim-Over under
applicable law, up to the amount that Releasor has obtained, may
obtain, or has authority to control from such Non-Released Entity;
(3)Placement into escrow of funds paid by the Non-Released Entities
such that those funds are available to satisfy the Claim-Over;
(4)Return of monies paid by Janssen to that Releasor under this
Settlement Agreement to permit satisfaction of a judgment against or
settlement with the Non-Released Entity to satisfy the Claim-Over;
(5)Payment of monies to Janssen by that Releasor to ensure it is held
harmless from such Claim-Over, up to the amount that Releasor has
obtained, may obtain, or has authority to control from such Non-
Released Entity;
(6)Credit to Janssen under this Settlement Agreement to reduce the
overall amounts to be paid under the Settlement Agreement such that
it is held harmless from the Claim-Over; and
9
(7)Such other actions as that Releasor and Janssen may devise to hold
Janssen harmless from the Claim Over.
d.The actions of that Releasor and Janssen taken pursuant to paragraph (c)
must, in combination, ensure Janssen is not required to pay more with respect
to Covered Conduct than the amounts owed by Janssen under this Settlement
Agreement.
e.In the event of any dispute over the sufficiency of the actions taken pursuant
to paragraph (c), that Releasor and Janssen may seek review by the court that
enters the Consent Judgment pursuant to Section X.
5.To the extent that the Claim-Over is based on a contractual indemnity, the
obligations under subsection IV.B.4 shall extend solely to a Non-Party Covered
Conduct Claim against a pharmacy, clinic, hospital or other purchaser or dispenser of
Products, a manufacturer that sold Products, a consultant, and/or a pharmacy benefit
manager or other third-party payor. Janssen shall notify the State, to the extent
permitted by applicable law, in the event that any of these types of Non-Released
Entities asserts a Claim-Over arising out of contractual indemnity against it.
C.General Release. In connection with the releases provided for in the Agreement, the State
(for itself and its Releasors) and each Participating Subdivision (for itself and its Releasors)
will expressly waive, release, and forever discharge 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 that, if known by
him or her, would have materially affected his or her settlement with
the debtor or released party.
A Releasor may thereafter discover facts other than or different from those which it knows,
believes, or assumes to be true with respect to the Released Claims, but the State (for itself
and its Releasors) and each Participating Subdivision (for itself and its Releasors) will
expressly waive and fully, finally, and forever settle, release and discharge, upon the
Effective Date, 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
State’s decision to enter into the Agreement or the Participating Subdivisions’ decision to
participate in the Agreement.
D.Res Judicata. Nothing in the Agreement shall be deemed to reduce the scope of the res
judicata or claim preclusive effect that the settlement memorialized in the Agreement, and/or
any Consent Judgment or other judgment entered on the Agreement, gives rise to under
applicable law.
10
E.Representation and Warranty. The signatories hereto on behalf of the State expressly
represent and warrant that they will obtain on or before the Effective Date (or have obtained)
the authority to settle and release, to the maximum extent of the State’s power, all Released
Claims of (1) the State; (2) all past and present executive departments, state agencies,
divisions, boards, commissions and instrumentalities with the regulatory authority to enforce
state and federal controlled substances acts; (3) any of the State’s past and present executive
departments, agencies, divisions, boards, commissions and instrumentalities that have the
authority to bring Claims related to Covered Conduct seeking money (including abatement
and/or remediation) or revocation of a pharmaceutical distribution license; and (4) any
Participating Subdivisions. For the purposes of clause (3) above, executive departments,
agencies, divisions, boards, commissions, and instrumentalities are those that are under the
executive authority or direct control of the State’s Governor. Also, for the purposes of clause
(3), a release from the State’s Governor is sufficient to demonstrate that the appropriate
releases have been obtained.
F.Effectiveness. The releases set forth in the Agreement shall not be impacted in any way by
any dispute that exists, has existed, or may later exist between or among the Releasors. Nor
shall such releases be impacted in any way by any current or future law, regulation,
ordinance, or court or agency order limiting, seizing, or controlling the distribution or use of
the settlement funds or any portion thereof, or by the enactment of future laws, or by any
seizure of the settlement funds or any portion thereof.
G.Cooperation. Releasors (i) will not encourage any person or entity to bring or maintain any
Released Claim against any Released Entity and (ii) will reasonably cooperate with and not
oppose any effort by a Released Entity to secure the prompt dismissal of any and all
Released Claims.
H.Non-Released Claims. Notwithstanding the foregoing or anything in the definition of
Released Claims, the Agreement does not waive, release or limit any criminal liability,
Claims for any outstanding liability under any tax or securities law, Claims against parties
who are not Released Entities, Claims by private individuals and any claims arising under
the Agreement for enforcement of the Agreement.
V.Monetary Relief and Payments
A.Participation. As consideration for the releases from the State and Participating
Subdivisions provided in Section IV above and the Settlement Participation Forms specified
in Section VII and Exhibit B below, the State represents and warrants that, subject to the
holdback provision in subsection V.D below, it will obtain and deliver (or cause to be
obtained and delivered) to Janssen, within one hundred ten (110) days after the Effective
Date or such later date as the parties may agree, executed Settlement Participation Forms for
all Litigating Subdivisions and all Non-Litigating Subdivisions listed on Exhibit F.
B.Conditions to Effectiveness of Agreement . If the State is able to obtain and deliver executed
Settlement Participation Forms for all Litigating Subdivisions listed on Exhibit F to Janssen
within one hundred ten (110) days after the Effective Date or such later date as the parties
may agree, this Agreement shall become effective. If the State is unable to obtain and
11
deliver executed Settlement Participation Forms for all Litigating Subdivisions listed on
Exhibit F to Janssen within one hundred ten (110) days after the Effective Date or such later
date as the parties may agree, this Agreement will have no further effect and all releases and
other commitments or obligations contained herein will be void.
C.Remediation and Restitution Payments. Within twenty-one (21) days after the effectiveness
of this Agreement as provided for in subsection V.B above, Janssen shall pay into the
Settlement Fund a Net Settlement Amount of $123,340,000, plus fees and costs payable to
the Washington Attorney General set forth in subsection IX.A, subject to any holdback
under subsection V.D below.
D.Holdback for Non-Litigating Subdivisions . If, by the date this Agreement becomes effective
as provided for in subsection V.B, any Non-Litigating Subdivision listed on Exhibit F has
not executed a Settlement Participation Form or has not provided Janssen an
acknowledgement that the Subdivision has no intention to file a lawsuit asserting Released
Claims against Released Entities, then Janssen will hold back $6,167,000 from the Net
Settlement Amount payment described in subsection V.B above, which Janssen will not pay
to the Settlement Fund; provided, however, Janssen will pay the $6,167,000 to the
Settlement Fund (1) within thirty (30) days of the date all remaining Non-Litigating
Subdivision(s) listed on Exhibit F have executed a Settlement Participation Form and those
Forms have been delivered to Janssen; or (2) within (30) days after the two-year anniversary
of the Effective Date, if all such Non-Litigating Subdivisions on Exhibit F have not executed
Settlement Participation Forms, and no such Non-Litigating Subdivision listed on Exhibit F
has filed litigation asserting Released Claims within two years after the Effective Date.
VI.Intra-State Allocation
A.Janssen’s Net Settlement Amount payments to the Settlement Fund shall be allocated as
follows:
1.Fifty percent (50%) to the State of Washington.
2.Fifty percent (50%) to the Participating Local Governments (“LG Share”).
B.The LG Share remainder shall be distributed to Participating Local Governments pursuant to
the One Washington Memorandum of Understanding Between Washington Municipalities
(“One Washington MOU”), which is attached as Exhibit H.
C.BrownGreer PLC shall be the Settlement Fund Administrator and shall allocate and
distribute payments in accordance with the terms of the One Washington MOU and this
Agreement, including the detailed description of the Settlement Fund Administrator’s duties
attached as Exhibit I. As set forth in Exhibit I, the Settlement Fund Administrator’s fees and
costs shall be paid from the interest on the LG Share portion of the funds in the Settlement
Fund between the date of Janssen’s payment and the date of disbursement to the
Subdivisions. If the aforementioned interest is insufficient to pay the full amount of the
Settlement Fund Administrator’s fees and costs, the remainder shall be paid by Janssen.
12
D.Use of Net Settlement Amount.
1.It is the intent of the Parties that the payments disbursed from the Settlement
Fund to the State and Participating Subdivisions listed in Exhibit F be for Opioid
Remediation, subject to limited exceptions that must be documented in
accordance with subsection VI.D.2. In no event may less than 85% of Janssen’s
Net Settlement Amount payment be spent on Opioid Remediation.
2.While disfavored by the Parties, the State or a Participating Subdivision listed on
Exhibit F may use monies from the Settlement Fund for purposes that do not
qualify as Opioid Remediation. If, at any time, the State or a Participating
Subdivision listed on Exhibit F uses any monies from the Settlement Fund for a
purpose that does not qualify as Opioid Remediation, the State or Participating
Subdivision shall identify such amounts and report to the Settlement Fund
Administrator and Janssen how such funds were used, including if used to pay
attorneys’ fees other than those provided for in subsection IX.B which shall be
identified by BrownGreer, investigation costs, litigation costs, or costs related to
the operation and enforcement of this Agreement. It is the intent of the Parties
that the reporting under this subsection VI.D.2 shall be available to the public.
For the avoidance of doubt, (a) any amounts not identified under this subsection
VI.D.2 as used to pay attorneys’ fees other than those provided for in subsection
IX.A, investigation costs, or litigation costs shall be included in the
“Compensatory Restitution Amount” for purposes of subsection XI.B and (b)
Participating Subdivisions not listed on Exhibit F that receive monies from the
Settlement Fund indirectly may only use such monies from the Settlement Fund
for purposes that qualify as Opioid Remediation.
VII.Participation by Subdivisions
A Subdivision may become a Participating Subdivision by returning an executed Settlement
Participation Form to Janssen and the State and upon prompt dismissal of its legal action pursuant
to the terms of this Agreement and the Settlement Participation Form.
VIII.Filing of Consent Judgment and Dismissals with Prejudice
No later than 15 days from delivery to Janssen of Settlement Participation Forms for all
Subdivisions listed on Exhibit F, the State and Janssen will proceed to file the Consent Judgment.
No later than 30 days after receipt of Janssen’s payments under Section V, the State and the
Participating Subdivisions shall dismiss all actions asserting Released claims with prejudice.
IX.Attorney Fee and Cost Payments
A.State Outside and Inside Counsel Fees and Costs. Janssen will pay the Washington Attorney
General’s Office $26,160,000.00 within twenty-one (21) days after the date this Agreement
becomes effective as provided for in subsection V.B to reimburse the State for State Outside
13
and Inside Counsel Fees and Costs, which shall be used for any lawful purpose in the
discharge of the Attorney General’s duties at the sole discretion of the Attorney General.
B.Fees and Costs for Participating Litigating Subdivisions’ Attorneys . From the LG Share of
the Settlement Fund, the Settlement Fund Administrator shall pay the Participating
Litigating Subdivisions’ attorneys their fees and costs pursuant to Paragraph D of the One
Washington MOU and this Agreement.
C.An Attorney for a Participating Litigating Subdivision may not receive any payment for
attorney fees unless the Attorney represents that s/he has no present intent to represent or
participate in the representation of any Subdivision or any Releasor with respect to Released
Claims against Released Entities brought after the Effective Date.
X.Enforcement and Dispute Resolution
A.The terms of the Agreement and Consent Judgment applicable to the State will be
enforceable solely by the State and Janssen.
B.Janssen consents to the jurisdiction of the Court in which the Consent Judgment is filed,
limited to resolution of disputes identified in subsection X.D for resolution in the Court in
which the Consent Judgment is filed.
C.The parties to a dispute shall promptly meet and confer in good faith to resolve any dispute.
If the parties cannot resolve the dispute informally, and unless otherwise agreed in writing,
they shall follow the remaining provisions of this section to resolve the dispute.
D.Disputes not resolved informally shall be resolved in the Court that entered the Consent
Judgment.
XI.Miscellaneous
A.No Admission. Janssen does not admit liability or wrongdoing. Neither this Agreement nor
the Consent Judgment shall be considered, construed, or represented to be (1) an admission,
concession, or evidence of liability or wrongdoing or (2) a waiver or any limitation of any
defense otherwise available to Janssen.
B.Nature of Payment. Janssen, the State, and the Participating Subdivisions acknowledge and
agree that notwithstanding anything to the contrary in this Agreement, including, but not
limited to, the scope of the Released Claims:
1.Janssen has entered into this Agreement to avoid the delay, expense, inconvenience,
and uncertainty of further litigation;
2.The State and the Participating Subdivisions sought compensatory restitution (within
the meaning of 26 U.S.C. § 162(f)(2)(A)) for the Alleged Harms allegedly suffered
by the State and Participating Subdivisions;
14
3.By executing this Agreement the State and the Participating Subdivisions certify
that: (a) the Compensatory Restitution Amount is no greater than the amount, in the
aggregate, of the Alleged Harms allegedly suffered by the State and Participating
Subdivisions; and (b) the portion of the Compensatory Restitution Amount received
by the State or Participating Subdivision is no greater than the amount of the Alleged
Harms allegedly suffered by the State or Participating Subdivision;
4.The payment of the Compensatory Restitution Amount by Janssen constitutes, and is
paid for, compensatory restitution (within the meaning of 26 U.S.C. § 162(f)(2)(A))
for Alleged Harms allegedly caused by Janssen;
5.The Compensatory Restitution Amount is being paid as compensatory restitution
(within the meaning of 26 U.S.C. § 162(f)(2)(A)) in order to restore, in whole or in
part, the State and Participating Subdivisions to the same position or condition that
they would be in had the State and Participating Subdivisions not suffered the
Alleged Harms;
6.For the avoidance of doubt: (a) no portion of the Compensatory Restitution Amount
represents reimbursement to the State, any Participating Subdivision, or other person
or entity for the costs of any investigation or litigation, (b) the entire Compensatory
Restitution Amount is properly characterized as described in this subsection XI.B,
and (c) no portion of the Compensatory Restitution Amount constitutes
disgorgement or is properly characterized as the payment of statutory or other fines,
penalties, punitive damages, other punitive assessments, or attorneys’ fees; and
7.The State, on behalf of all itself and Participating Subdivisions (the “Form 1098-F
Filer”) shall complete and file Form 1098-F with the Internal Revenue Service on or
before February 28 (March 31 if filed electronically) of the year following the
calendar year in which the order entering this Agreement becomes binding. On the
Form 1098-F, the Form 1098-F Filer shall identify the entire Compensatory
Restitution Amount received by the Form 1098-F Filer as remediation/restitution.
The Form 1098-F Filer shall also, on or before January 31 of the year following the
calendar year in which the order entering this Agreement becomes binding, furnish
Copy B of such Form 1098-F (or an acceptable substitute statement) to Janssen.
C.Tax Reporting and Cooperation.
1.Upon request by Janssen, the State and Participating Subdivisions agree to perform
such further acts and to execute and deliver such further documents as may be
reasonably necessary for Janssen to establish the statements set forth in subsection
XI.B to the satisfaction of their tax advisors, their independent financial auditors, the
Internal Revenue Service, or any other governmental authority, including as
contemplated by Treasury Regulations Section 1.162-21(b)(3)(ii) and any
subsequently proposed or finalized relevant regulations or administrative guidance.
2.Without limiting the generality of this subsection XI.C, the State and each
Participating Subdivision shall cooperate in good faith with Janssen with respect to
15
any tax claim, dispute, investigation, audit, examination, contest, litigation, or other
proceeding relating to this Agreement.
3.The State, on behalf of itself and Participating Subdivisions, shall designate one of
its officers or employees to act as the “appropriate official” within the meaning of
Treasury Regulations Section 1.6050X-1(f)(1)(ii)(B) (the “Appropriate Official”).
4.For the avoidance of doubt, neither Janssen nor the State and Participating
Subdivisions make any warranty or representation to any Settling jurisdiction or
Releasor as to the tax consequences of the payment of the Compensatory Restitution
Amount (or any portion thereof).
D.No Third-Party Beneficiaries. Except as expressly provided in this Agreement, no portion of
this Agreement shall provide any rights to, or be enforceable by, any person or entity that is
not the State or a Released Entity. The State may not assign or otherwise convey any right to
enforce any provision of this Agreement.
E.Calculation. Any figure or percentage referred to in this Agreement shall be carried to seven
decimal places.
F.Construction. None of the Parties and no Participating Subdivision shall be considered to be
the drafter of this Agreement or of any of its provisions 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 of this Agreement. The headings of the provisions of this
Agreement are not binding and are for reference only and do not limit, expand, or otherwise
affect the contents or meaning of this Agreement.
G.Cooperation. Each Party and each Participating Subdivision agrees to use its best efforts and
to cooperate with the other Parties and Participating Subdivisions to cause this Agreement
and the Consent Judgment to become effective, to obtain all necessary approvals, consents
and authorizations, if any, and to execute all documents and to take such other action as may
be appropriate in connection herewith. Consistent with the foregoing, each Party and each
Participating Subdivision agrees that it will not directly or indirectly assist or encourage any
challenge to this Agreement or the Consent Judgment by any other person, and will support
the integrity and enforcement of the terms of this Agreement and the Consent Judgment.
H.Entire Agreement. This Agreement, its exhibits and any other attachments embodies the
entire agreement and understanding between and among the Parties and Participating
Subdivisions relating to the subject matter hereof and supersedes (1) all prior agreements
and understandings relating to such subject matter, whether written or oral and (2) all
purportedly contemporaneous oral agreements and understandings relating to such subject
matter.
I.Execution. This Agreement may be executed in counterparts and by different signatories on
separate counterparts, each of which shall be deemed an original, but all of which shall
together be one and the same Agreement. One or more counterparts of this Agreement may
be delivered by facsimile or electronic transmission with the intent that it or they shall
16
constitute an original counterpart hereof. One or more counterparts of this Agreement may
be signed by electronic signature.
J.Good Faith and Voluntary Entry. Each Party warrants and represents that it negotiated the
terms of this Agreement in good faith. Each of the Parties and signatories to this Agreement
warrants and represents that it freely and voluntarily entered into this Agreement without
any degree of duress or compulsion. The Parties state that no promise of any kind or nature
whatsoever (other than the written terms of this Agreement) was made to them to induce
them to enter into this Agreement.
K.No Prevailing Party. The Parties each agree that they are not the prevailing party in this
action, for purposes of any claim for fees, costs, or expenses as prevailing parties arising
under common law or under the terms of any statute, because the Parties have reached a
good faith settlement. The Parties each further waive any right to challenge or contest the
validity of this Agreement on any ground, including, without limitation, that any term is
unconstitutional or is preempted by, or in conflict with, any current or future law.
L.Non-Admissibility. The settlement negotiations resulting in this Agreement have been
undertaken by the Parties and by certain representatives of the Participating Subdivisions in
good faith and for settlement purposes only, and no evidence of negotiations or discussions
underlying this Agreement shall be offered or received in evidence in any action or
proceeding for any purpose. This Agreement shall not be offered or received in evidence in
any action or proceeding for any purpose other than in an action or proceeding arising under
or relating to this Agreement.
M.Severability. If any provision of this Agreement—excepting Section IV (Release), Section V
(Monetary Relief and Payments), Section VII (Participation by Local Governments), Section
IX (Attorney Fee and Cost Payments), Section XI.B (Nature of Payment), and Section XI.C
(Tax Reporting and Cooperation)—were for any reason held to be invalid, illegal, or
unenforceable in any respect, such invalidity, illegality, or unenforceability shall not affect
any other provision of this Agreement.
N.Notices. All notices or other communications under this Agreement shall be in writing
(including but not limited to electronic communications) and shall be given to the recipients
indicated below:
For Janssen:
Charles C. Lifland
Daniel R. Suvor
O’Melveny & Myers LLP
400 South Hope Street, 18th Floor Los Angeles, CA 90071
Phone: (213) 430-6000
clifland@omm.com
dsuvor@omm.com
17
For the Attorney General:
Jeffrey G. Rupert
Martha Rodríguez López
Susan Llorens
Office of the Washington Attorney General
800 Fifth Avenue, Suite 2000
Seattle, WA 98104
Jeffrey.Rupert@atg.wa.gov
Martha.RodriguezLopez@atg.wa.gov
Susan.Llorens@atg.wa.gov
and
Brad Beckworth
Drew Pate
Nix Patterson LLP
8701 Bee Caves Road, Building 1, Suite 500
Austin, Texas 78746
bbeckworth@nixlaw.com
dpate@nixlaw.com
Any Party may change or add the contact information of the persons designated to receive
notice on its behalf by notice given (effective upon the giving of such notice) as provided in
this subsection.
O.No Waiver. The waiver of any rights conferred hereunder shall be effective only if made by
written instrument executed by the waiving Party or Parties. The waiver by any Party of any
breach of this Agreement shall not be deemed to be or construed as a waiver of any other
breach, whether prior, subsequent, or contemporaneous, nor shall such waiver be deemed to
be or construed as a waiver by any other Party.
P.Preservation of Privilege. Nothing contained in this Agreement or any Consent Judgment,
and no act required to be performed pursuant to this Agreement or any Consent Judgment, is
intended to constitute, cause, or effect any waiver (in whole or in part) of any attorney-client
privilege, work product protection, or common interest/joint defense privilege, and each
Party agrees that it shall not make or cause to be made in any forum any assertion to the
contrary.
Q.Successors. This Agreement shall be binding upon, and inure to the benefit of, Janssen and
its respective successors and assigns. Janssen shall not sell the majority of its voting stock or
substantially all its assets without obtaining the acquiror’s agreement that it will constitute a
successor with respect to Janssen’s obligations under this Agreement.
R.Modification, Amendment, Alteration. This Agreement may be modified, amended, or
altered by a written agreement of the Parties or, in the case of the Consent Judgment, by
18
court proceedings resulting in a modified judgment of the Court. For purposes of modifying
this Agreement or the Consent Judgment, Janssen may contact the Washington Attorney
General to coordinate this process.
S.Termination.
1.Unless otherwise agreed to by Janssen and the State, this Agreement and all of its
terms (except subsection XI.L and any other non-admissibility provisions, which
shall continue in full force and effect) shall be canceled and terminated with respect
to the State, and the Agreement and all orders issued by the Court pursuant to the
Agreement shall become null and void and of no effect if one or more of the
following conditions applies:
a.A Consent Judgment approving this Agreement without modification of any
of the Agreement’s terms has not been entered as to the State by a court of
competent jurisdiction on or before one hundred eighty (180) days after
Janssen’s payment under Section V; or
b.This Agreement or the Consent Judgment has been disapproved by a court of
competent jurisdiction to which it was presented for approval and/or entry
(or, in the event of an appeal from or review of a decision of such a court to
approve this Agreement and the Consent Judgment, by the court hearing such
appeal or conducting such review), and the time to appeal from such
disapproval has expired, or, in the event of an appeal from such disapproval,
the appeal has been dismissed or the disapproval has been affirmed by the
court of last resort to which such appeal has been taken and such dismissal or
disapproval has become no longer subject to further appeal (including,
without limitation, review by the United States Supreme Court).
2.If this Agreement is terminated with respect to the State and its Participating
Subdivisions for whatever reason pursuant to subsection XI.S.1, then:
a.An applicable statute of limitation or any similar time requirement (excluding
any statute of repose) shall be tolled from the date the State signed this
Agreement until the later of the time permitted by applicable law or for one
year from the date of such termination, with the effect that Janssen and the
State in question shall be in the same position with respect to the statute of
limitation as they were at the time the State filed its action; and
b.Janssen and the State and its Participating Subdivisions shall jointly move the
relevant court of competent jurisdiction for an order reinstating the actions
and claims dismissed pursuant to the terms of this Agreement governing
dismissal, with the effect that Janssen and the State and its Participating
Subdivisions shall be in the same position with respect to those actions and
claims as they were at the time the action or claim was stayed or dismissed.
A-1
EXHIBIT A
Janssen Predecessors and Former Affiliates
The following includes a non-exclusive list of Janssen’s predecessors and former affiliates:
1.Janssen Pharmaceutica, Inc.
2.Janssen Pharmaceutica N.V.
3.Janssen-Cilag Manufacturing, LLC
4.Janssen Global Services, LLC
5.Janssen Ortho LLC
6.Janssen Products, LP
7.Janssen Research & Development, LLC
8.Janssen Supply Group, LLC
9.Janssen Scientific Affairs, LLC
10.JOM Pharmaceutical Services, Inc.
11.OMJ Pharmaceuticals, Inc.
12.Ortho-McNeil Finance Co.
13.Ortho-McNeil Pharmaceutical
14.Ortho-McNeil-Janssen Pharmaceuticals
15.Ortho-McNeil Pharmaceutical Services Division
16.Ortho-McNeil Neurologic
17.Patriot Pharmaceuticals, LLC
18.Pricara, Ortho-McNeil-Janssen Pharmaceuticals
19.Alza Corp.
20.Alza Development Corp.
21.Janssen Supply Chain, Alza Corp.
22.Noramco, Inc.
23.Tasmanian Alkaloids PTY LTD.
B-1
EXHIBIT B
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 Janssen
Washington State-Wide Opioid Settlement Agreement dated January 22, 2024 (“Janssen
Settlement”), and acting through the undersigned authorized official, hereby elects to participate in
the Janssen Settlement, release all Released Claims against all Released Entities, and agrees as
follows.
1.The Governmental Entity is aware of and has reviewed the Janssen Settlement, understands
that all terms in this Election and Release have the meanings defined therein, and agrees that
by this Election, the Governmental Entity elects to participate in the Janssen Settlement and
become a Participating Subdivision as provided therein.
2.The Governmental Entity shall, within 30 days of the filing of the Consent Judgment, secure
the dismissal with prejudice of any Released Claims that it has filed.
3.The Governmental Entity agrees to the terms of the Janssen Settlement pertaining to
Subdivisions as defined therein.
4.By agreeing to the terms of the Janssen Settlement and becoming a Releasor, the
Governmental Entity is entitled to the benefits provided therein, including, if applicable,
monetary payments beginning after the Effective Date.
5.The Governmental Entity agrees to use any monies it receives through the Janssen
Settlement solely for the purposes provided therein.
6.The Governmental Entity submits to the jurisdiction of the court where the Consent
Judgment is filed for purposes limited to that court’s role as provided in, and for resolving
disputes to the extent provided in, the Janssen Settlement.
7.The Governmental Entity, as a Participating Subdivision, hereby becomes a Releasor for all
purposes in the Janssen Settlement, including but not limited to all provisions of Section IV
(Release), and along with all departments, agencies, divisions, boards, commissions,
districts, instrumentalities of any kind and attorneys, and any person in their official capacity
B-2
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 Released Entity in
any forum whatsoever. The releases provided for in the Janssen Settlement are intended by
the Parties to be broad and shall be interpreted so as to give the Released Entities 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 Janssen
Settlement shall be a complete bar to any Released Claim.
8.In connection with the releases provided for in the Janssen 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 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, 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 Janssen
Settlement.
9.This Settlement Participation Form shall be deemed effective as of the Effective Date of the
Janssen Settlement.
10.Nothing herein is intended to modify in any way the terms of the Janssen Settlement, to
which Governmental Entity hereby agrees. To the extent this Election and Release is
interpreted differently from the Janssen Settlement in any respect, the Janssen Settlement
controls.
B-3
I have all necessary power and authorization to execute this Election and Release on behalf of the
Governmental Entity.
Signature:
Name:
ATTEST:
Date:
_____________________________
_____________________________
_____________________________
_____________________________
Mayor Armondo Pavone
Jason A. Seth, City Clerk
4/26/2024
C-1
EXHIBIT C
Injunctive Relief
A.Definitions Specific to this Exhibit
1.“Cancer-Related Pain Care” means care that provides relief from pain resulting
from a patient’s active cancer or cancer treatment as distinguished from treatment
provided during remission.
2.“Janssen” means Johnson & Johnson, Johnson & Johnson Innovative Medicine,
Janssen Pharmaceuticals, Inc., Ortho-McNeil-Janssen Pharmaceuticals, Inc., and
Janssen Pharmaceutica, Inc. (collectively, “Janssen”), including all of their
subsidiaries, predecessors, successors, current officers, directors, employees,
representatives, agents, affiliates, parents, and assigns acting on behalf of Janssen in
the United States.
3.“End-of-Life Care” means care for persons with a terminal illness or at high risk for
dying in the near future in hospice care, hospitals, long-term care settings, or at
home.
4.“Health Care Provider” means any U.S.-based physician or other health care
practitioner who is licensed to provide health care services or to prescribe
pharmaceutical products and any medical facility, practice, hospital, clinic, or
pharmacy.
5.“In-Kind Support” means payment or assistance in the form of goods, commodities,
services, or anything else of value.
6.“Lobby” and “Lobbying” shall have the same meaning as “lobbying activities” and
“lobbying contacts” under the federal lobbying disclosure act, 2 U.S.C. § 1602 et
seq., and any analogous state or local provisions governing the person or entity being
lobbied. As used in this document, “Lobby” and “Lobbying” include Lobbying
directly or indirectly, through grantees or Third Parties.
7.“Opioid(s)” means all naturally occurring, synthetic, or semisynthetic substances that
interact with opioid receptors and act like opium. For the avoidance of doubt, the
term “Opioid(s)” does not include Imodium.
8.“Opioid Product(s)” means all current and future medications containing Opioids
approved by the U.S. Food & Drug Administration (FDA) and listed by the DEA as
Schedule II, III, or IV drugs pursuant to the federal Controlled Substances Act
(including but not limited to buprenorphine, codeine, fentanyl, hydrocodone,
hydromorphone, meperidine, methadone, morphine, oxycodone, oxymorphone,
tapentadol, and tramadol). The term “Opioid Products(s)” shall not include (i)
methadone and other substances when used exclusively to treat opioid abuse,
addiction, or overdose; or (ii) raw materials, immediate precursors, and/or active
C-2
pharmaceutical ingredients (APIs) used in the manufacture or study of Opioids or
Opioid Products, but only when such materials, immediate precursors, and/or APIs
are sold or marketed exclusively to DEA-licensed manufacturers or DEA-licensed
researchers.
9.“OUD” means opioid use disorder defined in the Diagnostic and Statistical Manual
of Mental Disorders, Fifth Edition (DSM–5), as updated or amended.
10.“Product(s) for the Treatment of Opioid-Induced Side Effects ” means any over-the-
counter or prescription remedy used to treat those side effects identified on the FDA
label for any Opioid Product, except that, for purposes of the Agreement, Product(s)
for the Treatment of Opioid-Induced Side Effects shall not include products that treat
OUD or respiratory depression.
11.“Promote,” “Promoting,” “Promotion,” and “Promotional” means dissemination of
information or other practices intended or reasonably anticipated to increase sales,
prescriptions, or that attempts to influence prescribing practices in the United States.
These terms shall not include the provision of scientific information or data in
response to unsolicited requests from Health Care Providers or payors as allowed in
subsection C.2.e-h.
12.“Third Party(ies)” means any person or entity other than Janssen or a government
entity.
13.“Treatment of Pain” means the provision of therapeutic modalities to alleviate or
reduce pain.
14.“Unbranded Information” means any information that does not identify a specific
branded or generic product.
B.Ban on Selling and Manufacturing Opioids
1.Janssen shall not manufacture or sell any Opioids or Opioid Products for distribution
in the State of Washington. Janssen represents that prior to the Effective Date, it de-
listed all of its Opioid Products and no longer ships any of them to or within the
United States.
C.Ban on Promotion
1.Janssen 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 or patients, or
to persons involved in determining the Opioid Products included in
formularies;
C-3
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 for Promotion of 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;
and
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 C.1 directly above, Janssen may:
a.Maintain a corporate website;
b.Maintain a website for any Opioid Product that contains principally the
following content: the FDA-approved package insert, medication guide, and
labeling, and a statement directing patients or caregivers to speak with a
licensed Health Care Provider;
c.Provide information or support the provision of information as expressly
required by law or any state or federal government agency with jurisdiction
in Washington;
d.Provide the following by mail, electronic mail, on or through Janssen’s
corporate or product websites or through other electronic or digital methods:
FDA-approved package insert, medication guide, approved labeling for
Opioid Products, or other prescribing information for Opioid Products that
are published by a state or federal government agency with jurisdiction in
Washington;
e.Provide scientific and/or medical information in response to an unsolicited
request by a Health Care Provider consistent with the standards set forth in
C-4
the FDA’s Draft Guidance for Industry, Responding to Unsolicited Requests
for Off-Label Information About Prescription Drugs and Medical Devices
(Dec. 2011) as updated or amended by the FDA, and Guidance for Industry,
Good Reprint Practices for the Distribution of Medical Journal Articles and
Medical or Scientific Reference Publications on Unapproved New Uses of
Approved Drugs and Approved or Cleared Medical Devices (Jan. 2009) as
updated or amended by the FDA;
f.Provide a response to any unsolicited question or request from a patient or
caregiver, directing the patient or caregiver to the FDA-approved labeling or
to speak with a licensed Health Care Provider without describing the safety
or effectiveness of Opioids or any Opioid Product or naming any specific
provider or healthcare institution; or directing the patient or caregiver to
speak with their insurance carrier regarding coverage of an Opioid Product;
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 forth in the FDA’s Draft Questions and Answers Guidance for
Industry and Review Staff, Drug and Device Manufacturer Communications
With Payors, Formulary Committees, and Similar Entities (Jan. 2018), as
updated or amended by the FDA;
h.Provide information relating solely to the pricing of any Opioid Product;
i.Sponsor or provide financial support or In-Kind Support for an accredited or
approved continuing medical education program required by either an FDA-
approved Risk Evaluation and Mitigation Strategy (REMS) program or other
federal or state law or regulation applicable in Washington through an
independent Third Party, which shall be responsible for the program’s
content without the participation of Janssen; and
j.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 Janssen as the source of the information.
3.Janssen shall not engage in the Promotion of Products for the Treatment of Opioid-
induced Side Effects, including but not limited to:
a.Employing or contracting with sales representatives or other persons to
Promote Products 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 for the Treatment of Opioid induced
Side Effects;
C-5
c.Sponsoring, or otherwise providing financial support or In-Kind Support to
medical education programs that Promote Products for the Treatment of
Opioid-induced Side Effects;
d.Creating, sponsoring, or otherwise providing financial support or In-Kind
Support for advertisements that Promote Products 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.
4.Notwithstanding subsection C, Janssen may Promote Products for the Treatment of
Opioid-induced Side Effects so long as such Promotion does not associate the
product with Opioids or Opioid Products.
5.Treatment of Pain
a.Janssen shall not, either through Janssen or through Third Parties, engage in
any conduct that Promotes the Treatment of Pain, except that Janssen may
continue to Promote the Treatment of Pain with branded non-Opioids,
including Tylenol and Motrin.
b.Janssen shall not, either through Janssen or through Third Parties, engage in
any conduct that Promotes the concept that pain is undertreated, except in
connection with Promoting the use of branded non-Opioids, including
Tylenol and Motrin, for the Treatment of Pain.
c.Janssen 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 that otherwise Promotes
Opioids or Opioid Products.
6.Notwithstanding subsection C.5 above:
a.Janssen may Promote or provide educational information about the Treatment
of Pain with non-Opioids or therapies such as acetaminophen or non-steroidal
anti-inflammatory drugs (NSAIDS), including Promoting or providing
educational information about such non-Opioids 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.
b.Janssen may provide educational information about the Treatment of Pain
related to medical procedures involving devices manufactured or sold by
Janssen, including educational information about Opioids or Opioid Products,
so long as such information does not Promote Opioids or Opioid Products.
C-6
7.The Promotional conduct prohibited in subsection C is not prohibited insofar as it
relates to the Promotion of Opioids or Opioid Products for Cancer-Related Pain Care
or End-of-Life Care only, and so long as Janssen is identified as the sponsor or
source of such Promotional conduct.
D.No Financial Reward or Discipline Based on Volume of Opioid Sales
1.Janssen 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;
2.Janssen shall not offer or pay any remuneration (including any kickback, bribe, or
rebate) directly or indirectly, to any person in return for the prescribing, sale, use, or
distribution of an Opioid Product; and
3.Janssen’s compensation policies and procedures shall ensure compliance with the
Agreement.
E.Ban on Funding/Grants to Third Parties
1.Janssen shall not directly or indirectly provide financial support or In-Kind Support
to any Third Party that primarily engages in conduct that Promotes Opioids, Opioid
Products, or Products for the Treatment of Opioid-induced Side Effects (subject to
subsections C.2, 4, and 6), including educational programs or websites that Promote
Opioids, Opioid Products, or products for the treatment of Opioid-induced side
effects, excluding financial support otherwise required by the Agreement, a court
order, or by a federal or state agency.
2.Janssen 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, Opioid Products, or products
for the treatment of Opioid-induced side effects.
3.Janssen 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 intended for the treatment of Opioid-induced side
effects (subject to subsections C.2, 4, and 6).
4.Janssen shall not use, assist, or employ any Third Party to engage in any activity that
Janssen itself would be prohibited from engaging in pursuant to the Agreement. To
the extent Janssen supports trade groups engaged in Lobbying, Janssen shall stipulate
that such support not be used for any purpose prohibited by the Agreement.
5.Janssen 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 foreseeable effect of limiting the dissemination of information regarding
the risks and side effects of using Opioids.
C-7
6.Janssen shall not compensate or support Health Care Providers or organizations to
advocate for formulary access or treatment guideline changes for the purpose of
increasing access to any Opioid Product through third-party payors, 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.
7.No officer or management-level employee of Janssen may concurrently serve as a
director, board member, employee, agent, or officer of any entity that primarily
engages in conduct that Promotes Opioids, Opioid Products, or products for the
treatment of Opioid-induced side effects. For the avoidance of doubt, nothing in this
provision shall preclude an officer or management-level employee of Janssen from
concurrently serving on the board of a hospital.
8.Janssen 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 for the treatment of Opioid-induced side effects. For avoidance
of doubt, nothing in this paragraph shall prohibit Janssen from fully and accurately
responding to unsolicited requests or inquiries about a person’s fitness to serve as an
employee or Board member at any such entity.
F.Lobbying Restrictions
1.Janssen 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;
b.Has the effect of limiting access to any non-Opioid alternative pain
treatments; or
c.Pertains to the classification of any Opioid or Opioid Product as a scheduled
drug under the Controlled Substances Act.
2.Janssen 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-8
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 behavioral therapies) for
OUD, including but not limited to third party reimbursement or payment for
such treatment; or
h.The implementation or use of Opioid drug disposal systems.
3.Janssen shall not Lobby against the enactment of any federal, state or local
legislative or regulatory provision expanding the operation or use of PDMPs,
including but not limited to provisions requiring Health Care Providers to review
PDMPs when Opioid use is initiated and with every prescription thereafter.
4.Notwithstanding the foregoing restrictions in subsections F.1-3, the following
conduct is not restricted:
a.Challenging the enforcement of or suing for declaratory or injunctive relief
with respect to legislation, rules, or regulations referred to in subsection F.1;
b.Communications made by Janssen in response to a statute, rule, regulation, or
order requiring such communication;
c.Communications by a Janssen representative appearing before a federal or
state legislative or administrative body, committee, or subcommittee as result
of a mandatory order or subpoena commanding that person to testify;
d.Responding, in a manner consistent with the Agreement, 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
Janssen from a government entity directly involved in the passage of that
legislation or promulgation of that rule or regulation; or
e.Lobbying for or against provisions of legislation or regulation that address
other subjects in addition to those identified in subsections F.1-3, so long as
the company does not support specific portions of such legislation or
C-9
regulation covered by subsection F.1 or oppose specific portions of such
legislation or regulation covered by subsections F.2-3.
5.Janssen shall provide notice of the prohibitions in subsection F to all employees
engaged in Lobbying; shall incorporate the prohibitions in subsection F into trainings
provided to Janssen employees engaged in Lobbying; and certify to the State of
Washington that it has provided such notice and trainings to Janssen employees
engaged in Lobbying.
G.Ban on Prescription Savings Programs
1.Janssen shall not directly or indirectly offer any discounts, coupons, rebates, or other
methods which have the effect of reducing or eliminating a patient’s co-payments or
the cost of prescriptions (e.g., free trial prescriptions) for any Opioid Product.
2.Janssen shall not directly or indirectly provide financial support to any Third Party
for discounts, coupons, rebates, or other methods which have the effect of reducing
or eliminating a patient’s co-payments or the cost of prescriptions (e.g., free trial
prescriptions) for any Opioid Product.
3.Janssen shall not directly or indirectly assist patients, Health Care Providers, or
pharmacies with the claims and/or prior authorization process required for third-
party payors to approve payment for any Opioid Product.
H.General Terms
1.Janssen shall not make any written or oral statement about Opioids or any Opioid
Product that is unfair, false, misleading, or deceptive as defined under the law of
Washington. For purposes of this paragraph, “Opioid Product” shall also include
methadone and other substances when used exclusively to treat opioid abuse,
addiction, or overdose.
2.Janssen shall not represent that Opioids or any Opioid Product(s) have approvals,
characteristics, uses, benefits, or qualities that they do not have. For purposes of this
paragraph, “Opioid Product” shall also include methadone and other substances
when used exclusively to treat opioid abuse, addiction, or overdose.
3.For the avoidance of doubt, the Agreement shall not be construed or used as a waiver
or limitation of any defense otherwise available to Janssen in any action, and nothing
in the Agreement is intended to or shall be construed to prohibit Janssen in any way
whatsoever from taking legal or factual positions with regard to any Opioid
Product(s) in defense of litigation or other legal proceedings.
4.Upon the request of the State of Washington Attorney General, Janssen shall provide
the Washington Attorney General with copies of the following, within thirty (30)
days of the request:
C-10
a. Any litigation or civil or criminal law enforcement subpoenas or Civil
Investigative Demands relating to Janssen’s Opioid Product(s); and
b. Warning or untitled letters issued by the FDA regarding Janssen’s Opioid
Product(s) and all correspondence between Janssen and the FDA related to
such letters.
5. The Agreement applies to conduct that results in the Promotion of Opioids or Opioid
Products, or the Treatment of Pain inside the United States.
6. Janssen will enter into the Agreement 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 Janssen expressly denies. No
part of the Agreement, including its statements and commitments, shall constitute
evidence of any liability, fault, or wrongdoing by Janssen. The Agreement is not
intended for use by any third party for any purpose, including submission to any
court for any purpose.
7. Nothing in the Agreement shall be construed to limit or impair Janssen’s ability to:
a. Communicate its positions and respond to media inquiries concerning
litigation, investigations, reports or other documents or proceedings relating
to Janssen or its Opioid Products.
b. Maintain a website explaining its litigation positions and responding to
allegations concerning its Opioid Products, including the website,
www.factsaboutourprescriptionopioids.com.
I. Compliance with All State Laws and Regulations Relating to the Sale, Promotion, and
Distribution of Any Opioid Product
1. Janssen shall comply with all applicable state laws and regulations that relate to the
sale, promotion, distribution, and disposal of Opioids or Opioid Products, including
conduct permitted by subsection B.2, provided that nothing in this paragraph requires
Janssen to violate federal law or regulations, including but not limited to:
a. Washington’s Uniform Controlled Substances Act, including all guidance
issued by the applicable state regulator(s);
b. Washington’s Consumer Protection Act; and
c. Washington State laws, regulations, and guidelines related to opioid
prescribing, distribution, and disposal.
J. Clinical Data Transparency
C-11
1. Janssen agrees to continue sharing clinical trial data under the Yale University Open
Data Access (YODA) Project to allow researchers qualified under the program to
access the company’s propriety data under the terms of the project.
2. In the event Yale University discontinues or withdraws from the YODA Project
agreement with Janssen, Janssen shall make its clinical research data regarding
Opioids and Opioid Products, and any additional clinical research data that Janssen
sponsors and controls regarding Opioids and Opioid Products, available to an
independent entity that is the functional equivalent of the YODA Project under
functionally equivalent terms.
K. Enforcement
1. For the purposes of resolving disputes with respect to compliance with this Exhibit,
should the State of Washington have a reasonable basis to believe that Janssen has
engaged in a practice that violates a provision of this Exhibit subsequent to the
Effective Date, the State of Washington shall notify Janssen in writing of the specific
objection, identify with particularity the provision of the Agreement that the practice
appears to violate, and give Janssen thirty (30) days to respond in writing to the
notification; provided, however, that the State of Washington may take any action if
the State believes that, because of the specific practice, a threat to health or safety of
the public requires immediate action.
2. Upon receipt of written notice, Janssen shall provide a good faith written response to
the State’s notification, containing either a statement explaining why Janssen
believes it is in compliance with the provisions of this Exhibit of the Agreement, or a
detailed explanation of how the alleged violation occurred and a statement
explaining how Janssen intends to remedy the alleged breach. Nothing in this section
shall be interpreted to limit the State of Washington’s civil investigative demand
(“CID”) or investigative subpoena authority, to the extent such authority exists under
applicable law, and Janssen reserves all of its rights in responding to a CID or
investigative subpoena issued pursuant to such authority.
3. The State of Washington may agree, in writing, to provide Janssen with additional
time beyond thirty (30) days to respond to a notice provided under subsection L.1,
above, without Court approval.
4. Upon giving Janssen thirty (30) days to respond to the notification described above,
the State shall also be permitted reasonable access to inspect and copy relevant, non-
privileged, non-work product records and documents in possession, custody, or
control of Janssen that relate to Janssen’s compliance with each provision of the
Agreement pursuant to the State of Washington’s CID or investigative subpoena
authority.
5. The State of Washington may assert any claim that Janssen has violated the
Agreement in a separate civil action to enforce compliance with the Agreement, or
may seek any other relief afforded by law for violations of the Agreement, but only
C-12
after providing Janssen an opportunity to respond to the notification described in
subsection L.1, above; provided, however, the State of Washington may take any
action if the State believes that, because of the specific practice, a threat to the health
or safety of the public requires immediate action.
6. In the event of a conflict between the requirements of the Agreement and any other
law, regulation, or requirement such that Janssen cannot comply with the law
without violating the terms of the Agreement or being subject to adverse action,
including fines and penalties, Janssen shall document such conflicts and notify the
State of the extent to which it will comply with the Agreement in order to eliminate
the conflict within thirty (30) days of Janssen’s discovery of the conflict. Janssen
shall comply with the terms of the Agreement to the fullest extent possible without
violating the law.
7. Janssen or the State may request that Janssen and the State meet and confer
regarding the resolution of an actual or potential conflict between the Agreement and
any other law, or between interpretations of the Agreement by different courts.
Nothing herein is intended to modify or extend the jurisdiction of any single judicial
authority as provided by law.
L. Compliance Duration
1. Subsections B-J of this Exhibit shall be effective for 8 years from the Effective Date.
2. Nothing in this Agreement shall relieve Janssen of its independent obligation to fully
comply with the laws of the State of Washington after expiration of the 8-year period
specified in this subsection.
M. Compliance Deadlines
1. Janssen must be in full compliance with the provisions included this Agreement by
the Effective Date. Nothing herein shall be construed as permitting Janssen to avoid
existing legal obligations.
D-1
EXHIBIT D
Non-Released Entities
The following includes a non-exclusive list of non-Released Entities:
1. Actavis LLC
2. Actavis Pharma, Inc.
3. Allergan PLC
4. Allergan Finance, LLC
5. AmerisourceBergen Corporation
6. AmerisourceBergen Drug Corporation
7. Anda, Inc.
8. Cardinal Health, Inc.
9. Cephalon, Inc.
10. Collegium Pharmaceuticals
11. CVS Health Corp.
12. CVS Pharmacy, Inc.
13. Endo Pharmaceuticals Inc.
14. Endo Health Solutions Inc.
15. Mallinckrodt LLC
16. McKesson Corporation
17. McKinsey & Company Inc.
18. Par Pharmaceutical, Inc.
19. Par Pharmaceutical Companies, Inc.
20. Purdue Pharma L.P.
21. Purdue Pharma Inc.
22. SpecGx LLC
23. Teva Pharmaceuticals USA, Inc.
24. The Purdue Frederick Company
25. Walgreen Co.
26. Walgreens Boots Alliance, Inc.
27. Walmart Inc.
28. Watson Laboratories, Inc.
E-1
EXHIBIT E
Template Consent Judgment
[CASE]
[COURT]
C.A. NO.:
FINAL CONSENT JUDGMENT AND DISMISSAL WITH PREJUDICE
The State of Washington (“State”) and Johnson & Johnson, Johnson & Johnson Innovative
Medicine, Janssen Pharmaceuticals, Inc., Ortho-McNeil-Janssen Pharmaceuticals, Inc., and Janssen
Pharmaceutica, Inc. (collectively, “Janssen” or “Defendants”) (together with the State, the
“Parties,” and each a “Party”) have entered into a consensual resolution of the above-captioned
litigation (the “Action”) pursuant to a settlement agreement entitled Janssen Washington State-Wide
Opioid Settlement Agreement, dated as of January 22, 2024 (the “Agreement”), a copy of which is
attached hereto as Exhibit A. The entry of this Final Consent Judgment (the “Judgment”) by the
Court is made without trial or adjudication of any contested issue of fact or law, and without finding
or admission of wrongdoing or liability of any kind.
RECITALS:
1. Each Party warrants and represents that it engaged in arm’s-length negotiations in
good faith. In hereby executing the Agreement, the Parties intend to effect a good-faith settlement.
2. The State has determined that the Agreement is in the public interest.
3. Janssen denies the allegations against it and that it has any liability whatsoever to the
State, its Subdivisions, and/or (a) any of the State’s or Subdivisions’ departments, agencies, divisions,
E-2
boards, commissions, districts, instrumentalities of any kind and attorneys, including its Attorney
General and any person in his or her official capacity whether elected or appointed to serve any of the
foregoing and any agency, person, or other entity claiming by or through any of the foregoing, (b)
any public entities, public instrumentalities, public educational institutions, unincorporated districts,
fire districts, irrigation districts, and other Subdivisions, 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.
4. The Parties recognize that the outcome of the Action is uncertain and a final resolution
through the adversarial process likely will require protracted litigation.
5. The Parties agree to the entry of the injunctive relief terms pursuant to Exhibit C of
the Agreement.
6. Therefore, without any admission of liability or wrongdoing by Janssen or any other
Released Entities (as defined in the Agreement), the Parties now mutually consent to the entry of this
Judgment and agree to dismissal of the claims with prejudice pursuant to the terms of the Agreement
to avoid the delay, expense, inconvenience, and uncertainty of protracted litigation.
NOW THEREFORE, IT IS HEREBY ORDERED, ADJUDGED AND DECREED THAT:
In consideration of the mutual promises, terms, and conditions set forth in the Agreement,
the adequacy of which is hereby acknowledged by all Parties, it is agreed by and between
Defendants and the State, and adjudicated by the Court, as follows:
1. The foregoing Recitals are incorporated herein and constitute an express term of this
Judgment.
E-3
2. The Parties have entered into a full and final settlement of all Released Claims of
Releasors against Janssen (including but not limited to the State) and the Released Entities pursuant
to the terms and conditions set forth in the Agreement.
3. The “Definitions” set forth in Section II of the Agreement are incorporated by
reference into this Judgment. Unless otherwise defined herein, capitalized terms in this Judgment
shall have the same meaning given to them in the Agreement.
4. The Parties agree that the Court has jurisdiction over the subject matter of the Action
and over the Parties with respect to the Action and this Judgment. This Judgment shall not be
construed or used as a waiver of any jurisdictional defense Janssen or any other Released Entity may
raise in any other proceeding.
5. The Court finds that the Agreement was entered into in good faith.
6. The Court finds that entry of this Judgment is in the public interest and reflects a
negotiated settlement agreed to by the Parties. The Action is dismissed with prejudice, subject to a
retention of jurisdiction by the Court as provided herein and in the Agreement.
7. By this Judgment, the Agreement is hereby approved by the Court, and the Court
hereby adopts the Agreement’s terms as its own determination of this matter and the Parties’
respective rights and obligations.
8. The Court shall have authority to resolve disputes identified in Section X of the
Agreement, governed by the rules and procedures of the Court.
9. [By this Judgment, [the State-Subdivision Agreement] [name of state’s agreement], a
copy of which is attached hereto as Exhibit [X] and as incorporated into the Agreement, is hereby
approved by the Court as the means by which relevant funds paid pursuant to the Agreement will be
divided within the State, subject to the full acceptance by any Subdivision receiving such funds of the
E-4
terms of the Agreement, including the releases provided therein. [Add any state-specific language
necessary for the effectiveness of the state-subdivision agreement.]]
10. The Parties have satisfied all conditions to effectiveness of the Agreement.
11. Release. The Parties acknowledge that the Release in Section IV of the Agreement,
which is incorporated by reference herein, is an integral part of this Judgment. Pursuant to the
Agreement and the Release and without limitation and to the maximum extent of the power of the
State’s Attorney General, Janssen and the other Released Entities are, as of the Effective Date, hereby
released from any and all Released Claims of (a) the State and its Participating Subdivisions and any
of their departments, agencies, divisions, boards, commissions, Subdivisions, districts,
instrumentalities of any kind and attorneys, including the State’s Attorney General, and any person
in his or her official capacity whether elected or appointed to serve any of the foregoing, and any
agency, person, or other 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 Subdivisions in the State, 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 or any Subdivision in the State, whether or not any of them participate in the Agreement.
Pursuant to the Agreement and the Release and to the maximum extent of the State’s power, Janssen
and the other Released Entities are, as of the Effective Date, hereby released from any and all Released
Claims of (1) the State, (2) all past and present executive departments, state agencies, divisions,
boards, commissions and instrumentalities with the regulatory authority to enforce state and federal
controlled substances acts, (3) any of the State’s past and present executive departments, agencies,
E-5
divisions, boards, commissions and instrumentalities that have the authority to bring Claims related
to Covered Conduct seeking money (including abatement and/or remediation) or revocation of a
pharmaceutical distribution license, and (4) any Participating Subdivision. For the purposes of clause
(3) above, executive departments, agencies, divisions, boards, commissions, and instrumentalities are
those that are under the executive authority or direct control of the State’s Governor. The Parties
acknowledge, and the Court finds, that those provisions are an integral part of the Agreement and this
Judgment, and shall govern the rights and obligations of all participants in the settlement. Any
modification of those rights and obligations may be made based only on a writing signed by all
affected parties and approved by the Court.
12. Release of Unknown Claims. The State 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 that, if known by him or her, would have materially affected his or her settlement
with the debtor or released party.
13. The State 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 the State expressly
waived and fully, finally, and forever settled, released and discharged, through the Agreement and
Release, any and all Released Claims that may exist as of the Effective Date but which the State does
not know or suspect to exist, whether through ignorance, oversight, error, negligence or through no
fault whatsoever, and which, if known, would have materially affected the State’s decision to enter
into the Agreement.
E-6
14. Costs and Fees. The Parties will bear their own costs and attorneys’ fees except as
otherwise provided in the Agreement.
15. No Admission of Liability. Defendants are consenting to this Judgment solely for the
purpose of effectuating the Agreement, and nothing contained herein 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 Defendants expressly deny. No Defendant
or Released Entity admits that it caused or contributed to any public nuisance, and no Defendant or
Released Entity admits any wrongdoing that was or could have been alleged by the State, its
Participating Subdivisions, or any other person or entity. No part of this Judgment shall constitute
evidence of any liability, fault, or wrongdoing by Defendants or any other Released Entity. The
Parties acknowledge that payments made under the Agreement are not a fine, penalty, or payment in
lieu thereof.
16. No Waiver. This Judgment is entered based on the Agreement without trial or
adjudication of any contested issue of fact or law or finding of liability of any kind. This Judgment
shall not be construed or used as a waiver of Janssen’s right, or any other Released Entity’s right, to
defend itself from, or make any arguments in, any other regulatory, governmental, private individual,
or class claims or suits relating to the subject matter or terms of this Judgment. Notwithstanding the
foregoing, the State may enforce the terms of this Judgment as expressly provided in the Agreement.
17. No Private Right of Action. This Judgment is not intended for use by any third party
for any purpose, including submission to any court for any purpose, except pursuant to Section X of
the Agreement. Except as expressly provided in the Agreement, no portion of the Agreement or this
Judgment shall provide any rights to, or be enforceable by, any person or entity that is not the State
or Released Entity. The State shall allow Participating Subdivisions in the State to notify it of any
E-7
perceived violations of the Agreement or this Judgment. The State may not assign or otherwise
convey any right to enforce any provision of the Agreement.
18. Admissibility. It is the intent of the Parties that this Judgment not be admissible in
other cases against Defendants or binding on Defendants in any respect other than in connection with
the enforcement of this Judgment or the Agreement. For the avoidance of doubt, nothing herein shall
prohibit Defendants from entering this Judgment or the Agreement into evidence in any litigation or
arbitration concerning (1) Defendants’ right to coverage under an insurance contract or (2) the
enforcement of the releases provided for by the Agreement and this Judgment.
19. Preservation of Privilege. Nothing contained in the Agreement or this Judgment, and
no act required to be performed pursuant to the Agreement or this Judgment, is intended to constitute,
cause, or effect any waiver (in whole or in part) of any attorney-client privilege, work product
protection, or common interest/joint defense privilege, and each Party agrees that it shall not make or
cause to be made in any forum any assertion to the contrary.
20. Mutual Interpretation. The Parties agree and stipulate that the Agreement was
negotiated on an arm’s-length basis between parties of equal bargaining power and was drafted jointly
by counsel for each Party. Accordingly, the Agreement is incorporated herein by reference and shall
be mutually interpreted and not construed in favor of or against any Party, except as expressly
provided for in the Agreement.
21. Retention of Jurisdiction. The Court shall retain jurisdiction of the Parties for the
limited purpose of the resolution of disputes identified in Section X of the Agreement. The Court
shall have jurisdiction over Participating Subdivisions in the State for the limited purposes identified
in the Agreement.
E-8
22. Successors and Assigns. This Judgment is binding on Defendants’ successors and
assigns.
23. Modification. This Judgment shall not be modified (by the Court, by any other court,
or by any other means) without the consent of the State and Defendants, or as provided for in Section
XI.R of the Agreement.
E-9
So ORDERED this _____ day of [[*]], 2024.
Enter: By Order:
_____________________________ _____________________________
APPROVED, AGREED TO AND PRESENTED BY:
[[SIGNATURE BLOCKS]]
F-1
EXHIBIT F
Litigating Subdivisions:
1.Anacortes City
2.Bainbridge Island City
3.Burlington City
4.Chelan County
5.Clallam County
6.Clark County
7.Everett City
8.Franklin County
9.Island County
10.Jefferson County
11.Kent City
12.King County
13.Kirkland City
14.Kitsap County
15.Kittitas County
16.La Conner School District
17.Lakewood City
18.Lewis County
19.Lincoln County
20.Mount Vernon City
21.Mount Vernon School District
22.Olympia City
23.Pierce County
24.San Juan County
25.Seattle City
26.Sedro-Woolley City
27.Sedro-Woolley School District
28.Skagit County
29.Snohomish County
30.Spokane City
31.Spokane County
32.Tacoma City
33.Thurston County
34.Vancouver City
35.Walla Walla County
36.Whatcom County
37.Whitman County
F-2
Non-litigating Subdivisions:
1.Aberdeen City
2.Adams County
3.Arlington City
4.Asotin County
5.Auburn City
6.Battle Ground City
7.Bellevue City
8.Bellingham City
9.Benton County
10.Bonney Lake City
11.Bothell City
12.Bremerton City
13.Burien City
14.Camas City
15.Centralia City
16.Cheney City
17.Covington City
18.Cowlitz County
19.Des Moines City
20.Douglas County
21.East Wenatchee City
22.Edgewood City
23.Edmonds City
24.Ellensburg City
25.Enumclaw City
26.Federal Way City
27.Ferndale City
28.Fife City
29.Gig Harbor City
30.Grandview City
31.Grant County
32.Grays Harbor County
33.Issaquah City
34.Kelso City
35.Kenmore City
36.Kennewick City
37.Klickitat County
38.Lacey City
39.Lake Forest Park City
40.Lake Stevens City
41.Liberty Lake City
42.Longview City
43.Lynden City
44.Lynnwood City
F-3
45.Maple Valley City
46.Marysville City
47.Mason County
48.Mercer Island City
49.Mill Creek City
50.Monroe City
51.Moses Lake City
52.Mountlake Terrace City
53.Mukilteo City
54.Newcastle City
55.Oak Harbor City
56.Okanogan County
57.Pacific County
58.Pasco City
59.Pend Oreille County
60.Port Angeles City
61.Port Orchard City
62.Poulsbo City
63.Pullman City
64.Puyallup City
65.Redmond City
66.Renton City
67.Richland City
68.Sammamish City
69.Seatac City
70.Shelton City
71.Shoreline City
72.Skamania County
73.Snohomish City
74.Snoqualmie City
75.Spokane Valley City
76.Stevens County
77.Sumner City
78.Sunnyside City
79.Tukwila City
80.Tumwater City
81.University Place City
82.Walla Walla City
83.Washougal City
84.Wenatchee City
85.West Richland City
86.Woodinville City
87.Yakima City
88.Yakima County
G-1
EXHIBIT G
List of Johnson & Johnson Subsidiaries
Johnson & Johnson, a New Jersey corporation, had the U.S. and international subsidiaries shown below as of
January 1, 2023. Johnson & Johnson is not a subsidiary of any other entity.
Name of Subsidiary Jurisdiction
U.S. Subsidiaries:
ABD Holding Company, Inc. Delaware
ABIOMED R&D, Inc. Delaware
ABIOMED, Inc. Delaware
Acclarent, Inc. Delaware
Actelion Pharmaceuticals US, Inc. Delaware
Albany Street LLC New Jersey
ALZA Corporation Delaware
Alza Land Management, Inc. Delaware
AMO Development, LLC Delaware
AMO Manufacturing USA, LLC Delaware
AMO Nominee Holdings, LLC Delaware
AMO Sales and Service, Inc. Delaware
AMO Spain Holdings, LLC Delaware
Anakuria Therapeutics, Inc. Delaware
AorTx, Inc. Delaware
Aragon Pharmaceuticals, Inc. Delaware
Asia Pacific Holdings, LLC New Jersey
Atrionix, Inc. California
AUB Holdings LLC Delaware
Auris Health, Inc. Delaware
BeneVir BioPharm, Inc. Delaware
BioMedical Enterprises, Inc. Texas
Biosense Webster, Inc. California
Breethe, Inc. Delaware
Centocor Biologics, LLC Pennsylvania
Centocor Research & Development, Inc. Pennsylvania
Cerenovus, Inc. New Jersey
Coherex Medical, Inc. Delaware
CoTherix Inc. Delaware
CRES Holdings, Inc. Delaware
CrossRoads Extremity Systems, LLC Tennessee
G-2
CSATS, Inc. Washington
DePuy Mitek, LLC Massachusetts
DePuy Orthopaedics, Inc. Indiana
DePuy Products, Inc. Indiana
DePuy Spine, LLC Ohio
DePuy Synthes Institute, LLC Delaware
DePuy Synthes Products, Inc. Delaware
DePuy Synthes Sales, Inc. Massachusetts
DePuy Synthes, Inc. Delaware
Dutch Holding LLC Delaware
ECL7, LLC Delaware
Ethicon Endo-Surgery, Inc. Ohio
Ethicon Endo-Surgery, LLC Delaware
Ethicon LLC Delaware
Ethicon US, LLC Texas
Ethicon, Inc. New Jersey
Hansen Medical International, Inc. Delaware
Hansen Medical, Inc. Delaware
I.D. Acquisition Corp.New Jersey
Janssen BioPharma, LLC Delaware
Janssen Biotech, Inc. Pennsylvania
Janssen Global Services, LLC New Jersey
Janssen Oncology, Inc. Delaware
Janssen Ortho LLC Delaware
Janssen Pharmaceuticals, Inc. Pennsylvania
Janssen Products, LP New Jersey
Janssen Research & Development, LLC New Jersey
Janssen Scientific Affairs, LLC New Jersey
Janssen Supply Group, LLC Pennsylvania
Janssen-Cilag Manufacturing, LLC Delaware
Jevco Holding, Inc. New Jersey
JJHC, LLC Delaware
JNJ International Investment LLC Delaware
JNTL (APAC) HoldCo 2 LLC Delaware
JNTL (APAC) HoldCo LLC Delaware
G-3
JNTL (Japan) HoldCo Inc. Delaware
JNTL (Middle East) HoldCo LLC Delaware
JNTL (Thailand) HoldCo LLC Delaware
JNTL Consumer Health (Services) LLC Delaware
JNTL HoldCo 2 LLC Delaware
JNTL HoldCo 3 LLC Delaware
JNTL HoldCo 4 LLC Delaware
JNTL HoldCo 5 LLC Delaware
JNTL HoldCo 6 LLC Delaware
JNTL HoldCo 7 LLC Delaware
JNTL HoldCo 8 LLC Delaware
JNTL HoldCo LLC Delaware
JNTL Holdings 2, Inc. Delaware
JNTL Holdings 3, Inc. Delaware
JNTL Holdings, Inc. Delaware
Johnson & Johnson New Jersey
Johnson & Johnson (Middle East) Inc. New Jersey
Johnson & Johnson (Singapore) Holdco LLC Delaware
Johnson & Johnson Consumer Inc. Nevada
Johnson & Johnson Consumer Inc. New Jersey
Johnson & Johnson Enterprise Innovation Inc. Delaware
Johnson & Johnson Finance Corporation New Jersey
Johnson & Johnson Gateway, LLC New Jersey
Johnson & Johnson Health and Wellness Solutions, Inc. Michigan
Johnson & Johnson Health Care Systems Inc. New Jersey
Johnson & Johnson Innovation - JJDC, Inc. New Jersey
Johnson & Johnson Innovation LLC Delaware
Johnson & Johnson International New Jersey
Johnson & Johnson Medical Devices & Diagnostics Group - Latin America, L.L.C. Florida
Johnson & Johnson S.E., Inc. New Jersey
Johnson & Johnson Services, Inc. New Jersey
Johnson & Johnson Surgical Vision, Inc. Delaware
Johnson & Johnson Urban Renewal Associates New Jersey
G-4
Johnson & Johnson Vision Care, Inc. Florida
JOM Pharmaceutical Services, Inc. Delaware
Kenvue Inc. Delaware
LTL Management LLC North Carolina
McNeil Consumer Pharmaceuticals Co. New Jersey
McNeil Healthcare LLC Delaware
McNeil LA LLC Delaware
McNEIL MMP, LLC New Jersey
McNeil Nutritionals, LLC Delaware
Medical Device Business Services, Inc. Indiana
Medical Devices & Diagnostics Global Services, LLC Delaware
Medical Devices International LLC Delaware
MegaDyne Medical Products, Inc. Utah
Mentor Partnership Holding Company I, LLC Delaware
Mentor Texas GP LLC Delaware
Mentor Texas L.P. Delaware
Mentor Worldwide LLC Delaware
Middlesex Assurance Company Limited Vermont
Momenta Pharmaceuticals, Inc. Delaware
NeoStrata Company, Inc. Delaware
Netherlands Holding Company Delaware
NeuWave Medical, Inc. Delaware
Novira Therapeutics, LLC Delaware
NuVera Medical, Inc. Delaware
OMJ Pharmaceuticals, Inc. Delaware
Omrix Biopharmaceuticals, Inc. Delaware
Ortho Biologics LLC Delaware
Ortho Biotech Holding LLC Delaware
G-5
Patriot Pharmaceuticals, LLC Pennsylvania
Peninsula Pharmaceuticals, LLC Delaware
Percivia LLC Delaware
preCARDIA, Inc. Delaware
Princeton Laboratories, Inc. Delaware
Prosidyan, Inc. Delaware
Pulsar Vascular, Inc. Delaware
Regency Urban Renewal Associates New Jersey
Royalty A&M LLC North Carolina
Rutan Realty LLC New Jersey
Scios LLC Delaware
SterilMed, Inc. Minnesota
Synthes USA Products, LLC Delaware
Synthes USA, LLC Delaware
Synthes, Inc. Delaware
TARIS Biomedical LLC Delaware
TearScience, Inc. Delaware
The Anspach Effort, LLC Florida
The Vision Care Institute, LLC Florida
Tibotec, LLC Delaware
Torax Medical, Inc. Delaware
Verb Surgical Inc. Delaware
Vogue International LLC Delaware
WH4110 Development Company, L.L.C. Georgia
Zarbee's, Inc. Delaware
International Subsidiaries:
3Dintegrated ApS Denmark
Actelion Ltd Switzerland
Actelion Pharmaceuticals Ltd Switzerland
Actelion Pharmaceuticals Trading (Shanghai) Co., Ltd. China
Actelion Treasury Unlimited Company Ireland
G-6
AMO (Hangzhou) Co., Ltd. China
AMO (Shanghai) Medical Devices Trading Co., Ltd. China
AMO ASIA LIMITED Hong Kong
AMO Australia Pty Limited Australia
AMO Canada Company Canada
AMO Denmark ApS Denmark
AMO France France
AMO Germany GmbH Germany
AMO Groningen B.V. Netherlands
AMO International Holdings Unlimited Company Ireland
AMO Ireland Cayman Islands
AMO Italy SRL Italy
AMO Japan K.K. Japan
AMO Netherlands BV Netherlands
AMO Norway AS Norway
AMO Puerto Rico Manufacturing, Inc. Cayman Islands
AMO Singapore Pte. Ltd. Singapore
AMO Switzerland GmbH Switzerland
AMO United Kingdom, Ltd. United Kingdom
AMO Uppsala AB Sweden
Apsis France
Backsvalan 6 Handelsbolag Sweden
Beijing Dabao Cosmetics Co., Ltd. China
Berna Rhein B.V. Netherlands
Biosense Webster (Israel) Ltd. Israel
C Consumer Products Denmark ApS Denmark
Carlo Erba OTC S.r.l. Italy
ChromaGenics B.V. Netherlands
G-7
Ci:z. Labo Co., Ltd. Japan
Cilag AG Switzerland
Cilag GmbH International Switzerland
Cilag Holding AG Switzerland
Cilag Holding Treasury Unlimited Company Ireland
Cilag-Biotech, S.L. Spain
ColBar LifeScience Ltd. Israel
Cordis de Mexico, S.A. de C.V. Mexico
Corimmun GmbH Germany
Debs-Vogue Corporation (Proprietary) Limited South Africa
DePuy Hellas SA Greece
DePuy International Limited United Kingdom
DePuy Ireland Unlimited Company Ireland
DePuy Mexico, S.A. de C.V. Mexico
EES Holdings de Mexico, S. de R.L. de C.V. Mexico
EES, S.A. de C.V. Mexico
EIT Emerging Implant Technologies GmbH Germany
Ethicon Endo-Surgery (Europe) GmbH Germany
Ethicon Sarl Switzerland
Ethicon Women's Health & Urology Sarl Switzerland
Ethnor (Proprietary) Limited South Africa
Ethnor del Istmo S.A. Panama
Ethnor Farmaceutica, S.A.
Venezuela, Bolivarian Republic
of
Finsbury (Development) Limited United Kingdom
Finsbury (Instruments) Limited United Kingdom
Finsbury Medical Limited United Kingdom
Finsbury Orthopaedics International Limited United Kingdom
Finsbury Orthopaedics Limited United Kingdom
G-8
FMS Future Medical System SA Switzerland
GATT Technologies B.V. Netherlands
GH Biotech Holdings Limited Ireland
Global Investment Participation B.V. Netherlands
GMED Healthcare BV Belgium
Guangzhou Bioseal Biotech Co., Ltd. China
Hansen Medical Deutschland GmbH Germany
Hansen Medical UK Limited United Kingdom
Healthcare Services (Shanghai) Ltd. China
Innomedic Gesellschaft für innovative Medizintechnik und Informatik mbH Germany
J & J Company West Africa Limited Nigeria
J&J Argentina S.A. Argentina
J&J Pension Trustees Limited United Kingdom
J&J Productos Medicos & Farmaceuticos del Peru S.A. Peru
J.C. General Services BV Belgium
Janssen Biologics (Ireland) Limited Ireland
Janssen Biologics B.V. Netherlands
Janssen Cilag Farmaceutica S.A. Argentina
Janssen Cilag S.p.A. Italy
Janssen Cilag SPA Algeria
Janssen Cilag, C.A.
Venezuela, Bolivarian Republic
of
Janssen Development Finance Unlimited Company Ireland
Janssen Egypt LLC Egypt
Janssen Farmaceutica Portugal Lda Portugal
Janssen France Treasury Unlimited Company France
Janssen Holding GmbH Switzerland
Janssen Inc. Canada
Janssen Irish Finance Unlimited Company Ireland
G-9
Janssen Japan Treasury Unlimited Company Japan
Janssen Korea Ltd. Korea, Republic of
Janssen Mexico Treasury Unlimited Company Ireland
Janssen Pharmaceutica (Proprietary) Limited South Africa
Janssen Pharmaceutica NV Belgium
Janssen Pharmaceutica S.A. Peru
Janssen Pharmaceutical K.K. Japan
Janssen Pharmaceutical Sciences Unlimited Company Ireland
Janssen Pharmaceutical Unlimited Company Ireland
Janssen R&D Ireland Unlimited Company Ireland
Janssen Sciences Ireland Unlimited Company Ireland
Janssen Vaccines & Prevention B.V. Netherlands
Janssen Vaccines Corp. Korea, Republic of
Janssen-Cilag France
Janssen-Cilag (New Zealand) Limited New Zealand
Janssen-Cilag A/S Denmark
Janssen-Cilag AG Switzerland
Janssen-Cilag Aktiebolag Sweden
Janssen-Cilag AS Norway
Janssen-Cilag B.V. Netherlands
Janssen-Cilag d.o.o. Beograd Serbia
Janssen-Cilag de Mexico S. de R.L. de C.V. Mexico
Janssen-Cilag Farmaceutica Lda. Portugal
Janssen-Cilag Farmaceutica Ltda. Brazil
Janssen-Cilag GmbH Germany
Janssen-Cilag International NV Belgium
Janssen-Cilag Kft. Hungary
Janssen-Cilag Limited United Kingdom
G-10
Janssen-Cilag Limited Thailand
Janssen-Cilag NV Belgium
Janssen-Cilag OY Finland
Janssen-Cilag Pharma GmbH Austria
Janssen-Cilag Pharmaceutical S.A.C.I. Greece
Janssen-Cilag Polska, Sp. z o.o. Poland
Janssen-Cilag Pty Ltd Australia
Janssen-Cilag S.A. Colombia
Janssen-Cilag s.r.o. Czech Republic
Janssen-Cilag, S.A. Spain
Janssen-Cilag, S.A. de C.V. Mexico
Janssen-Pharma, S.L. Spain
J-C Health Care Ltd.Israel
JJ Surgical Vision Spain, S.L. Spain
JJC Acquisition Company B.V. Netherlands
JJSV Belgium BV Belgium
JJSV Manufacturing Malaysia SDN. BHD. Malaysia
JJSV Norden AB Sweden
JJSV Produtos Oticos Ltda. Brazil
JNJ Global Business Services s.r.o. Czech Republic
JNJ Holding EMEA B.V. Netherlands
JNTL (APAC) HoldCo 3 Pte. Ltd. Singapore
JNTL (APAC) HoldCo Pte. Ltd. Singapore
JNTL (Malaysia) Sdn. Bhd. Malaysia
JNTL (Puerto Rico) HoldCo GmbH Switzerland
JNTL (Shanghai) Investment Co., Ltd. China
JNTL (Switzerland) HoldCo GmbH Switzerland
JNTL (UK) HoldCo Limited United Kingdom
G-11
JNTL Consumer Health (Vietnam) Co. Ltd. Vietnam
JNTL Consumer Health (Belgium) BV Belgium
JNTL Consumer Health (Brazil) Ltda. Brazil
JNTL Consumer Health (Czech Republic) s.r.o. Czech Republic
JNTL Consumer Health (Dominican Republic), S.A.S. Dominican Republic
JNTL Consumer Health (Finland) Oy Finland
JNTL Consumer Health (France) SAS France
JNTL Consumer Health (Hungary) Kft Hungary
JNTL Consumer Health (India) Private Limited India
JNTL Consumer Health (New Zealand) Limited New Zealand
JNTL Consumer Health (Norway) AS Norway
JNTL Consumer Health (Philippines) Inc. Philippines
JNTL Consumer Health (Poland) sp. z o.o. Poland
JNTL Consumer Health (Portugal) Limitada Portugal
JNTL Consumer Health (Slovakia), s.r.o. Slovakia
JNTL Consumer Health (Spain), S.L. Spain
JNTL Consumer Health (Taiwan) Limited Taiwan (Province of China)
JNTL Consumer Health General Services BV Belgium
JNTL Consumer Health I (Ireland) Limited Ireland
JNTL Consumer Health I (Switzerland) GmbH Switzerland
JNTL Consumer Health II (Switzerland) GmbH Switzerland
JNTL Consumer Health LLC Egypt
JNTL Consumer Health Mexico, S. de R.L. de C.V. Mexico
JNTL Consumer Health Middle East FZ-LLC United Arab Emirates
G-12
JNTL Holdings B.V. Netherlands
JNTL Ireland HoldCo 2 B.V. Netherlands
JNTL Netherlands HoldCo B.V. Netherlands
JNTL Turkey Tüketici Sağlığı Limited Şirketi Turkey
Johnson & Johnson - Societa' Per Azioni Italy
Johnson & Johnson (Angola), Limitada Angola
Johnson & Johnson (Australia) Pty Ltd Australia
Johnson & Johnson (Canada) Inc. Canada
Johnson & Johnson (China) Investment Ltd. China
Johnson & Johnson (Ecuador) S.A. Ecuador
Johnson & Johnson (Egypt) S.A.E. Egypt
Johnson & Johnson (Hong Kong) Limited Hong Kong
Johnson & Johnson (Ireland) Limited Ireland
Johnson & Johnson (Jamaica) Limited Jamaica
Johnson & Johnson (Kenya) Limited Kenya
Johnson & Johnson (Mozambique), Limitada Mozambique
Johnson & Johnson (Namibia) (Proprietary) Limited Namibia
Johnson & Johnson (New Zealand) Limited New Zealand
G-13
Johnson & Johnson (Philippines), Inc. Philippines
Johnson & Johnson (Private) Limited Zimbabwe
Johnson & Johnson (Thailand) Ltd. Thailand
Johnson & Johnson (Trinidad) Limited Trinidad and Tobago
Johnson & Johnson (Vietnam) Co., Ltd Vietnam
Johnson & Johnson AB Sweden
Johnson & Johnson AG Switzerland
Johnson & Johnson Bulgaria EOOD Bulgaria
Johnson & Johnson China Ltd. China
Johnson & Johnson Consumer (Hong Kong) Limited Hong Kong
Johnson & Johnson Consumer (Thailand) Limited Thailand
Johnson & Johnson Consumer B.V. Netherlands
Johnson & Johnson Consumer Holdings France France
Johnson & Johnson Consumer NV Belgium
Johnson & Johnson Consumer Saudi Arabia Limited Saudi Arabia
Johnson & Johnson Consumer Services EAME Ltd. United Kingdom
Johnson & Johnson d.o.o. Slovenia
Johnson & Johnson de Argentina S.A.C. e. I. Argentina
Johnson & Johnson de Chile S.A. Chile
Johnson & Johnson de Colombia S.A. Colombia
Johnson & Johnson de Mexico, S.A. de C.V. Mexico
Johnson & Johnson de Uruguay S.A. Uruguay
Johnson & Johnson de Venezuela, S.A.
Venezuela, Bolivarian Republic
of
Johnson & Johnson del Ecuador, S.A. Ecuador
Johnson & Johnson Del Paraguay, S.A. Paraguay
Johnson & Johnson del Peru S.A. Peru
Johnson & Johnson do Brasil Industria E Comercio de Produtos Para Saude Ltda. Brazil
Johnson & Johnson Dominicana, S.A.S. Dominican Republic
Johnson & Johnson European Treasury Unlimited Company Ireland
G-14
Johnson & Johnson Finance Limited United Kingdom
Johnson & Johnson Financial Services GmbH Germany
Johnson & Johnson for Export and Import LLC Egypt
Johnson & Johnson Gesellschaft m.b.H. Austria
Johnson & Johnson GmbH Germany
Johnson & Johnson GT, Sociedad Anónima Guatemala
Johnson & Johnson Guatemala, S.A. Guatemala
Johnson & Johnson Hellas Commercial and Industrial S.A. Greece
Johnson & Johnson Hellas Consumer Products Commercial Societe Anonyme Greece
Johnson & Johnson Hemisferica S.A. Puerto Rico
Johnson & Johnson Holding GmbH Germany
Johnson & Johnson Holdings (Austria) GmbH Austria
Johnson & Johnson Inc. Canada
Johnson & Johnson Industrial Ltda. Brazil
Johnson & Johnson Innovation Limited United Kingdom
G-15
Johnson & Johnson International (Singapore) Pte. Ltd. Singapore
Johnson & Johnson International Financial Services Unlimited Company Ireland
Johnson & Johnson Irish Finance Company Limited Ireland
Johnson & Johnson K.K. Japan
Johnson & Johnson Kft. Hungary
Johnson & Johnson Korea Selling & Distribution LLC Korea, Republic of
Johnson & Johnson Korea, Ltd. Korea, Republic of
Johnson & Johnson Limited United Kingdom
Johnson & Johnson LLC Russian Federation
Johnson & Johnson Luxembourg Finance Company Sarl Luxembourg
Johnson & Johnson Management Limited United Kingdom
Johnson & Johnson Medical (China) Ltd. China
Johnson & Johnson Medical (Proprietary) Ltd South Africa
Johnson & Johnson Medical (Shanghai) Ltd. China
Johnson & Johnson Medical (Suzhou) Ltd. China
Johnson & Johnson Medical B.V. Netherlands
Johnson & Johnson Medical GmbH Germany
G-16
Johnson & Johnson Medical Greece Single Member S.A. Greece
Johnson & Johnson Medical Korea Ltd. Korea, Republic of
Johnson & Johnson Medical Limited United Kingdom
Johnson & Johnson Medical Mexico, S.A. de C.V. Mexico
Johnson & Johnson Medical NV Belgium
Johnson & Johnson Medical Products GmbH Austria
Johnson & Johnson Medical Pty Ltd Australia
Johnson & Johnson Medical S.A. Argentina
Johnson & Johnson Medical S.p.A. Italy
Johnson & Johnson Medical SAS France
Johnson & Johnson Medical Saudi Arabia Limited Saudi Arabia
Johnson & Johnson Medical Taiwan Ltd. Taiwan (Province of China)
Johnson & Johnson Medical, S.C.S.
Venezuela, Bolivarian Republic
of
Johnson & Johnson Medikal Sanayi ve Ticaret Limited Sirketi Turkey
Johnson & Johnson MedTech (Thailand) Ltd. Thailand
Johnson & Johnson Medtech Colombia S.A.S. Colombia
Johnson & Johnson Middle East FZ-LLC United Arab Emirates
Johnson & Johnson Morocco Societe Anonyme Morocco
Johnson & Johnson Nordic AB Sweden
Johnson & Johnson Pacific Pty Limited Australia
Johnson & Johnson Pakistan (Private) Limited Pakistan
Johnson & Johnson Panama, S.A. Panama
Johnson & Johnson Personal Care (Chile) S.A. Chile
Johnson & Johnson Pharmaceutical Ltd. China
Johnson & Johnson Poland Sp. z o.o. Poland
Johnson & Johnson Private Limited India
Johnson & Johnson Pte. Ltd. Singapore
G-17
Johnson & Johnson Pty. Limited Australia
Johnson & Johnson Romania S.R.L. Romania
Johnson & Johnson S.E. d.o.o. Croatia
Johnson & Johnson Sante Beaute France France
Johnson & Johnson SDN. BHD. Malaysia
Johnson & Johnson Surgical Vision India Private Limited India
Johnson & Johnson Taiwan Ltd. Taiwan (Province of China)
Johnson & Johnson UK Treasury Company Limited United Kingdom
Johnson & Johnson Ukraine LLC Ukraine
Johnson & Johnson Vision Care (Australia) Pty Ltd Australia
Johnson & Johnson Vision Care (Shanghai) Ltd. China
Johnson & Johnson Vision Care Ireland Unlimited Company Ireland
Johnson & Johnson Vision Korea, Ltd. Korea, Republic of
Johnson & Johnson, Lda Portugal
Johnson & Johnson, S.A. Spain
Johnson & Johnson, S.A. de C.V. Mexico
Johnson & Johnson, s.r.o. Slovakia
Johnson & Johnson, s.r.o. Czech Republic
G-18
Johnson and Johnson (Proprietary) Limited South Africa
Johnson and Johnson Sihhi Malzeme Sanayi Ve Ticaret Limited Sirketi Turkey
Johnson Y Johnson de Costa Rica, S.A. Costa Rica
La Concha Land Investment Corporation Philippines
McNeil AB Sweden
McNeil Denmark ApS Denmark
McNeil Healthcare (Ireland) Limited Ireland
McNeil Healthcare (UK) Limited United Kingdom
McNeil Iberica S.L.U. Spain
McNeil Panama, LLC Panama
McNeil Products Limited United Kingdom
McNeil Sweden AB Sweden
Medos International Sarl Switzerland
Medos Sarl Switzerland
Menlo Care De Mexico, S.A. de C.V. Mexico
Mentor B.V. Netherlands
Mentor Deutschland GmbH Germany
Mentor Medical Systems B.V. Netherlands
Momenta Ireland Limited Ireland
NeoStrata UG (haftungsbeschränkt) Germany
Neuravi Limited Ireland
Obtech Medical Mexico, S.A. de C.V. Mexico
OBTECH Medical Sarl Switzerland
OGX Beauty Limited United Kingdom
OMJ Holding GmbH Switzerland
Omrix Biopharmaceuticals Ltd. Israel
Omrix Biopharmaceuticals NV Belgium
Orthospin Ltd. Israel
Orthotaxy France
Pharmadirect Ltd. Canada
Pharmedica Laboratories (Proprietary) Limited South Africa
Productos de Cuidado Personal y de La Salud de Bolivia S.R.L. Bolivia
Proleader S.A. Uruguay
G-19
PT Integrated Healthcare Indonesia Indonesia
PT Johnson & Johnson Indonesia Indonesia
PT Johnson and Johnson Indonesia Two Indonesia
RespiVert Ltd. United Kingdom
Review Manager Test Entity 2 France
Serhum S.A. de C.V. Mexico
Shanghai Elsker Mother & Baby Co., Ltd China
Shanghai Johnson & Johnson Ltd. China
Shanghai Johnson & Johnson Pharmaceuticals Ltd. China
Sodiac ESV Belgium
Spectrum Vision Limited Liability Company Russian Federation
Spectrum Vision Limited Liability Company Ukraine
Spectrum Vision Limited Liability Partnership Kazakhstan
Surgical Process Institute Deutschland GmbH Germany
Synthes Costa Rica S.C.R., Limitada Costa Rica
SYNTHES GmbH Germany
Synthes GmbH Switzerland
Synthes Holding AG Switzerland
Synthes Holding Limited United Arab Emirates
SYNTHES Medical Immobilien GmbH Germany
Synthes Medical Surgical Equipment & Instruments Trading LLC United Arab Emirates
Synthes Produktions GmbH Switzerland
Synthes Proprietary Limited South Africa
Synthes S.M.P., S. de R.L. de C.V. Mexico
Synthes Tuttlingen GmbH Germany
UAB "Johnson & Johnson" Lithuania
Vania Expansion France
Vision Care Finance Unlimited Company Ireland
Xian Janssen Pharmaceutical Ltd. China
XO1 Limited United Kingdom
H-1
EXHIBIT H
One Washington Memorandum of Understanding between the Washington Municipalities
H-2
H-3
H-4
H-5
H-6
H-7
H-8
H-9
H-10
H-11
H-12
H-13
H-14
H-15
H-16
H-17
H-18
H-19
H-20
H-21
H-22
H-23
H-2 4
H-25
H-26
H-27
H-28
H-29
H-30
H-31
H-32
H-33
H-34
H-35
H-36
H-37
H-38
H-39
I-1
EXHIBIT I
Settlement Fund Administrator Terms
I.Definitions
A.This Settlement Fund Administrator Terms incorporates all defined terms in the
Janssen Washington State-Wide Opioid Settlement Agreement (“Janssen
Settlement Agreement”), unless otherwise defined herein, and shall be interpreted
in a manner consistent with the Janssen Settlement Agreement.
II.Establishment of the Settlement Fund Administrator
A.Selection of the Settlement Fund Administrator.
i.Subject to the removal provisions under Section II.C below, BrownGreer
PLC is hereby selected as the Settlement Fund Administrator.
ii.Within thirty (30) calendar days of the Effective Date of the Janssen
Settlement Agreement, unless such time is extended by written agreement
of Janssen and the State, a contract shall be negotiated and finalized with
BrownGreer PLC.
iii.The terms of the Settlement Fund Administrator shall be for the duration
of the Janssen Settlement Agreement or as otherwise specified in the
contract executed with such entity, unless the Settlement Fund
Administrator is removed pursuant to Section II.C below.
B.Governance of the Settlement Fund Administrator.
i.The Settlement Fund Administrator will act as an independent and neutral
third party to determine the allocation of payments under Section VI.C of
the Janssen Settlement Agreement; administer and disburse funds from the
Settlement Fund; and perform other duties as described below and in the
Janssen Settlement Agreement.
ii.All parties to the Janssen Settlement Agreement are entitled to rely upon
information received from the Settlement Fund Administrator, whether in
oral, written, or other form. No Party to the Janssen Settlement
Agreement shall have any liability (whether direct or indirect, in contract
or tort or otherwise) to any party for or in connection with any action
taken or not taken by the Settlement Fund Administrator. In addition, no
Party to the Janssen Settlement Agreement shall have any liability
(whether direct or indirect, in contract or tort or otherwise) to any party for
or in connection with any action taken or not taken by Janssen based on
incorrect, inaccurate, incomplete or otherwise erroneous information or
data provided by the Settlement Fund Administrator. For the avoidance of
doubt, nothing in this paragraph alters Sections I to XI of the Janssen
Settlement Agreement or any of the exhibits thereto.
I-2
C. Removal of the Settlement Fund Administrator .
i. The Settlement Fund Administrator may be removed for cause. The
contract with each entity shall describe the standards for removing that
entity for cause.
ii. Disputes regarding the performance and/or removal of the Settlement
Fund Administrator will be resolved in accordance with Section X of the
Janssen Settlement Agreement.
D. Funding of the Settlement Fund Administrator.
i. The costs and fees associated with or arising out of the duties of the
Settlement Fund Administrator shall be paid from the interest accrued on
the LG Share portion of the funds in the Settlement Fund between the date
of Janssen’s payment and the date of disbursement to the Subdivisions.
Should such interest prove insufficient, the remaining costs and fees of the
Settlement Fund Administrator shall be paid by Janssen. Payments will be
made to the Settlement Fund Administrator within thirty (30) days after
the initial disbursements to the State and the Subdivisions are completed,
and if applicable, thirty (30) days after any holdback disbursement under
Section V.D of the Janssen Settlement Agreement.
ii. There will be a cap on the costs and fees of the Settlement Fund
Administrator, which shall be dependent on the scope of services, the
number and timing of distributions from the Settlement Fund, and the
Settlement Fund Administrator’s reporting requirements. The cap on fees
and costs shall be specified in the contract executed with the Settlement
Fund Administrator.
III. Calculation and Allocation of Payments
A. General Principles.
i. This Section III is intended to implement the relevant provisions of
Sections VI and IX.B of the Janssen Settlement Agreement, the exhibits
thereto, and the One Washington Memorandum of Understanding
Between Washington Municipalities (the “One Washington MOU”). To
the extent this Section III conflicts with the Janssen Settlement Agreement
and/or the exhibits thereto, the Janssen Settlement Agreement shall
control.
ii. The Settlement Fund Administrator is entitled to rely upon information
received from the Parties to the Janssen Settlement Agreement, whether in
oral, written, or other form, for the purpose for which it was submitted,
provided that such information is not disputed by another Party.
B. Establishment of Settlement Fund.
i. The Settlement Fund Administrator shall establish a Settlement Fund, as
defined in Section II.25 of the Janssen Settlement Agreement and subject
to Section IV.B below.
I-3
C. Calculation of Allocations and Disbursement of Amounts from Settlement Fund.
i. The Settlement Fund Administrator shall be responsible for calculating the
allocation of Net Settlement Amount payments under Section VI of the
Janssen Settlement Agreement and the One Washington MOU, as well as
Participating Litigating Subdivisions’ attorneys’ fees and costs under
Section IX.B of the Janssen Settlement Agreement and the One
Washington MOU.
ii. If the Janssen Settlement Agreement becomes effective and Janssen pays
the Net Settlement Amount into the Settlement Fund pursuant to Sections
V.B and V.C of the Janssen Settlement Agreement (subject to any
holdback under Section V.D of the Janssen Settlement Agreement), the
Settlement Fund Administrator shall:
1. disburse or cause to be disbursed 50% of the Net Settlement
Amount to the State, pursuant to Section VI.A.1 of the Janssen
Settlement Agreement;
2. deposit 15% of the 50% LG Share of the Net Settlement Amount
into a government fee subfund, pursuant to Section D of the One
Washington MOU; and
3. allocate and disburse or cause to be disbursed the remainder of the
LG Share of the Net Settlement Amount to Participating
Subdivisions in accordance with Sections B.3 and B.4 of the One
Washington MOU.
iii. The Settlement Fund Administrator, in cooperation with the Opioid Fee
and Expense Committee as defined in the One Washington MOU, shall
disburse or cause to be disbursed the monies in the government fee
subfund according to the procedures set forth in Section D of the One
Washington MOU.
iv. If Janssen pays the $6,167,000 holdback amount into the Settlement Fund
pursuant to Section V.D of the Janssen Settlement Agreement, the
Settlement Fund Administrator shall allocate, deposite, and disburse or
cause to be disbursed such holdback payment according to the principles
stated in Sections III.C.ii and III.C.iii above.
IV. Reporting Obligations
A. Reporting of Non-Opioid Remediation Uses.
i. The Settlement Fund Administrator shall set up a system to receive and
preserve reports from the State States and Participating Subdivisions that
have used monies from the Settlement Fund for purposes that do not
qualify as Opioid Remediation, pursuant to Section VI.D of the Janssen
Settlement Agreement. The Settlement Fund Administrator will not
require the State and Participating Subdivisions without any such uses of
money to submit a report, and the Settlement Fund Administrator may
I-4
treat the failure to submit a report as confirmation that the State or
Participating Subdivision had no such uses of money.
ii. The State and Participating Subdivisions shall report to the Settlement
Fund Administrator and Janssen the amount of funds received from the
Settlement Fund used for purposes that do not qualify as Opioid
Remediation (pursuant to Section VI.D of the Janssen Settlement
Agreement). Such reports to the Settlement Fund Administrator and
Janssen shall identify how such funds were used, including if used to pay
attorneys’ fees, investigation costs, litigation costs, or costs related to the
operation and enforcement of the Janssen Settlement Agreement,
respectively. Such State or Participating Subdivision shall make such
reports to the Settlement Fund Administrator and Janssen with respect to
each six-month period ending on June 30 or December 31 of any year in
which funds are received from the Settlement Fund. Such State or
Participating Subdivision shall make each such report within ninety (90)
days of the end of the applicable six-month period.
iii. The Settlement Fund Administrator shall make the reporting under this
Section IV.A available to the public.
iv. The Settlement Fund Administrator shall track and assist in the report of
the amount of remediation disbursed or applied during each fiscal year,
broken down by primary funded strategy category listed in Exhibit J of the
Janssen Settlement Agreement (with any permissible common costs
prorated among strategies).
v. Upon request by Janssen, the Settlement Fund Administrator shall agree to
perform such further acts and to execute and deliver such further
documents as may be reasonably necessary for Janssen to establish the
statements set forth in Section XI.B of the Janssen Settlement Agreement
to the satisfaction of their tax advisors, their independent financial
auditors, the Internal Revenue Service, or any other governmental
authority, including as contemplated by Treasury Regulations Section
1.162-21(b)(3)(ii) and any subsequently proposed or finalized relevant
regulations or administrative guidance. Nothing herein shall be read to
conflict with or limit the Parties’ obligations under Sections XI.B and
XI.C of the Janssen Settlement Agreement.
B. Qualified Settlement Fund Treatment.
i. Janssen and the Settlement Fund Administrator shall agree that the
Settlement Fund is intended to be classified as a “qualified settlement
fund” within the meaning of Treasury regulations Section 1.468B-1, et
seq. (and corresponding or similar provisions of state, local, or foreign
law, as applicable). The Settlement Fund Administrator or any
independent certified public accounting firm selected by Janssen to serve
as administrator of the Settlement Fund for tax purposes (the “Tax
Administrator”) shall not take any action or tax position inconsistent with
such treatment. The Settlement Fund shall be treated as a qualified
I-5
settlement fund from the earliest date possible, and Janssen and the
Settlement Fund Administrator shall agree to any relation-back election
required to treat the Settlement Fund as a qualified settlement fund from
the earliest date possible.
ii. The Settlement Fund Administrator or the Tax Administrator shall serve
as administrator of the Settlement Fund for tax purposes. The Settlement
Fund Administrator or Tax Administrator shall (i) obtain federal and state
taxpayer identification numbers for the Settlement Fund and provide the
same to Janssen and the Settlement Fund Administrator, (ii) be responsible
for all tax reporting, withholding and filing requirements for the
Settlement Fund, (iii) provide instructions to Janssen and the Settlement
Fund Administrator for the release of sufficient funds from the Settlement
Fund to pay all taxes owed by the Settlement Fund in accordance with
Treasury regulations Section 1.468B-2 and any applicable state, local or
other tax laws, and (iv) send copies of all such tax filings and returns to
Janssen and the Settlement Fund Administrator. Janssen and the
Settlement Fund Administrator shall provide such cooperation and
information as the Tax Administrator may reasonably request in
performing the responsibilities set forth in this Section IV.
J-1
EXHIBIT J
List of Opioid Remediation Uses
Schedule A
Core Strategies
States and Qualifying Block Grantees shall choose from among the abatement strategies listed in
Schedule B. However, priority shall be given to the following core abatement strategies (“Core
Strategies”).1
A. NALOXONE OR OTHER FDA-APPROVED DRUG TO
REVERSE OPIOID OVERDOSES
Expand training for first responders, schools, community support
groups and families; and
Increase distribution to individuals who are uninsured or whose
insurance does not cover the needed service.
B. MEDICATION-ASSISTED TREATMENT (“MAT”)
DISTRIBUTION AND OTHER OPIOID-RELATED
TREATMENT
1. Increase distribution of MAT to 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.
1 As used in this Schedule A, words like “expand,” “fund,” “provide” or the like shall not indicate a preference for
new or existing programs.
J-2
C.PREGNANT & POSTPARTUM WOMEN
1.Expand Screening, Brief Intervention, and Referral to
Treatment (“SBIRT”) services to non-Medicaid eligible or
uninsured pregnant women;
2.Expand comprehensive evidence-based treatment and
recovery services, including MAT, for women with co-
occurring Opioid Use Disorder (“OUD”) and other
Substance Use Disorder (“SUD”)/Mental Health disorders
for uninsured individuals for up to 12 months postpartum;
and
3.Provide comprehensive wrap-around services to individuals
with OUD, including housing, transportation, job
placement/training, and childcare.
D.EXPANDING TREATMENT FOR NEONATAL
ABSTINENCE SYNDROME (“NAS”)
1.Expand comprehensive evidence-based and recovery
support for NAS babies;
2.Expand services for better continuum of care with infant-
need dyad; and
3.Expand long-term treatment and services for medical
monitoring of NAS babies and their families.
E.EXPANSION OF WARM HAND-OFF PROGRAMS AND
RECOVERY SERVICES
1.Expand services such as navigators and on-call teams to
begin MAT in hospital emergency departments;
2.Expand warm hand-off services to transition to recovery
services;
3.Broaden scope of recovery services to include co-occurring
SUD or mental health conditions;
4.Provide comprehensive wrap-around services to individuals
in recovery, including housing, transportation, job
placement/training, and childcare; and
5.Hire additional social workers or other behavioral health
workers to facilitate expansions above.
J-3
F.TREATMENT FOR INCARCERATED POPULATION
1.Provide evidence-based treatment and recovery support,
including MAT for persons with OUD and co-occurring
SUD/MH disorders within and transitioning out of the
criminal justice system; and
2.Increase funding for jails to provide treatment to inmates
with OUD.
G.PREVENTION PROGRAMS
1.Funding for media campaigns to prevent opioid use (similar
to the FDA’s “Real Cost” campaign to prevent youth from
misusing tobacco);
2.Funding for evidence-based prevention programs in
schools;
3.Funding for medical provider education and outreach
regarding best prescribing practices for opioids consistent
with the 2016 CDC guidelines, including providers at
hospitals (academic detailing);
4.Funding for community drug disposal programs; and
5.Funding and training for first responders to participate in
pre-arrest diversion programs, post-overdose response
teams, or similar strategies that connect at-risk individuals
to behavioral health services and supports.
H.EXPANDING SYRINGE SERVICE PROGRAMS
1.Provide comprehensive syringe services programs with
more wrap-around services, including linkage to OUD
treatment, access to sterile syringes and linkage to care and
treatment of infectious diseases.
I.EVIDENCE-BASED DATA COLLECTION AND
RESEARCH ANALYZING THE EFFECTIVENESS OF THE
ABATEMENT STRATEGIES WITHIN THE STATE
J-4
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)
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, those that:2
1. Expand availability of treatment for OUD and any co-occurring SUD/MH conditions,
including all forms of Medication-Assisted Treatment (“MAT”) approved by the U.S.
Food and Drug Administration.
2. Support and reimburse evidence-based services that adhere to the American Society
of Addiction Medicine (“ASAM”) continuum of care for OUD and any co-occurring
SUD/MH conditions.
3. Expand telehealth to increase access to treatment for OUD and any co-occurring
SUD/MH conditions, including MAT, as well as counseling, psychiatric support, and
other treatment and recovery support services.
4. Improve oversight of Opioid Treatment Programs (“OTPs”) to assure evidence-based
or evidence-informed practices such as adequate methadone dosing and low threshold
approaches to treatment.
5. Support mobile intervention, treatment, and recovery services, offered by qualified
professionals and service providers, such as peer recovery coaches, for persons with
OUD and any co-occurring SUD/MH conditions and for persons who have
experienced an opioid overdose.
6. Provide treatment of trauma for individuals with OUD (e.g., violence, sexual assault,
human trafficking, or adverse childhood experiences) and family members (e.g.,
surviving family members after an overdose or overdose fatality), and training of
health care personnel to identify and address such trauma.
7. Support evidence-based withdrawal management services for people with OUD and
any co-occurring mental health conditions.
2 As used in this Schedule B, words like “expand,” “fund,” “provide” or the like shall not indicate a preference for
new or existing programs.
J-5
8. Provide training on MAT for health care providers, first responders, students, or other
supporting professionals, such as peer recovery coaches or recovery outreach
specialists, including telementoring to assist community-based providers in rural or
underserved areas.
9. Support workforce development for addiction professionals who work with persons
with OUD and any co-occurring SUD/MH conditions.
10. Offer fellowships for addiction medicine specialists for direct patient care, instructors,
and clinical research for treatments.
11. Offer scholarships and supports for behavioral health practitioners or workers
involved in addressing OUD and any co-occurring SUD/MH or mental health
conditions, including, but not limited to, training, scholarships, fellowships, loan
repayment programs, or other incentives for providers to work in rural or underserved
areas.
12. Provide funding and training for clinicians to obtain a waiver under the federal Drug
Addiction Treatment Act of 2000 (“DATA 2000”) to prescribe MAT for OUD, and
provide technical assistance and professional support to clinicians who have obtained
a DATA 2000 waiver.
13. Disseminate web-based training curricula, such as the American Academy of
Addiction Psychiatry’s Provider Clinical Support Service–Opioids web-based
training curriculum and motivational interviewing.
14. Develop and disseminate new curricula, such as the American Academy of Addiction
Psychiatry’s Provider Clinical Support Service for Medication–Assisted Treatment.
B. SUPPORT PEOPLE IN TREATMENT AND RECOVERY
Support people in recovery from OUD and any co-occurring SUD/MH conditions
through evidence-based or evidence-informed programs or strategies that may include,
but are not limited to, the 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 of treatment and recovery services for OUD and
any co-occurring SUD/MH conditions, including supportive housing, peer support
services and counseling, community navigators, case management, and connections
to community-based services.
3. Provide counseling, peer-support, recovery case management and residential
treatment with access to medications for those who need it to persons with OUD and
any co-occurring SUD/MH conditions.
J-6
4. Provide access to housing for people with OUD and any co-occurring SUD/MH
conditions, including supportive housing, recovery housing, housing assistance
programs, training for housing providers, or recovery housing programs that allow or
integrate FDA-approved mediation with other support services.
5. Provide community support services, including social and legal services, to assist in
deinstitutionalizing persons with OUD and any co-occurring SUD/MH conditions.
6. Support or expand peer-recovery centers, which may include support groups, social
events, computer access, or other services for persons with OUD and any co-
occurring SUD/MH conditions.
7. Provide or support transportation to treatment or recovery programs or services for
persons with OUD and any co-occurring SUD/MH conditions.
8. Provide employment training or educational services for persons in treatment for or
recovery from OUD and any co-occurring SUD/MH conditions.
9. Identify successful recovery programs such as physician, pilot, and college recovery
programs, and provide support and technical assistance to increase the number and
capacity of high-quality programs to help those in recovery.
10. Engage non-profits, faith-based communities, and community coalitions to support
people in treatment and recovery and to support family members in their efforts to
support the person with OUD in the family.
11. Provide training and development of procedures for government staff to appropriately
interact and provide social and other services to individuals with or in recovery from
OUD, including reducing stigma.
12. Support stigma reduction efforts regarding treatment and support for persons with
OUD, including reducing the stigma on effective treatment.
13. Create or support culturally appropriate services and programs for persons with OUD
and any co-occurring SUD/MH conditions, including new Americans.
14. Create and/or support recovery high schools.
15. Hire or train behavioral health workers to provide or expand any of the services or
supports listed above.
C. CONNECT PEOPLE WHO NEED HELP TO THE HELP THEY NEED
(CONNECTIONS TO CARE)
Provide connections to care for people who have—or are at risk of developing—OUD
and any co-occurring SUD/MH conditions through evidence-based or evidence-informed
programs or strategies that may include, but are not limited to, those that:
J-7
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,
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.
J-8
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
Addiction Recovery Initiative (“PAARI”);
2. Active outreach strategies such as the Drug Abuse Response Team (“DART”)
model;
3. “Naloxone Plus” strategies, which work to ensure that individuals who have
received naloxone to reverse the effects of an overdose are then linked to
treatment programs or other appropriate services;
4. Officer prevention strategies, such as the Law Enforcement Assisted
Diversion (“LEAD”) model;
5. Officer intervention strategies such as the Leon County, Florida Adult Civil
Citation Network or the Chicago Westside Narcotics Diversion to Treatment
Initiative; or
6. Co-responder and/or alternative responder models to address OUD-related
911 calls with greater SUD expertise.
2. Support pre-trial services that connect individuals with OUD and any co-occurring
SUD/MH conditions to evidence-informed treatment, including MAT, and related
services.
3. Support treatment and recovery courts that provide evidence-based options for
persons with OUD and any co-occurring SUD/MH conditions.
4. Provide evidence-informed treatment, including MAT, recovery support, harm
reduction, or other appropriate services to individuals with OUD and any co-
occurring SUD/MH conditions who are incarcerated in jail or prison.
J-9
5. Provide evidence-informed treatment, including MAT, recovery support, harm
reduction, or other appropriate services to individuals with OUD and any co-
occurring SUD/MH conditions who are leaving jail or prison or have recently left jail
or prison, are on probation or parole, are under community corrections supervision, or
are in re-entry programs or facilities.
6. Support critical time interventions (“CTI”), particularly for individuals living with
dual-diagnosis OUD/serious mental illness, and services for individuals who face
immediate risks and service needs and risks upon release from correctional settings.
7. Provide training on best practices for addressing the needs of criminal justice-
involved persons with OUD and any co-occurring SUD/MH conditions to law
enforcement, correctional, or judicial personnel or to providers of treatment, recovery,
harm reduction, case management, or other services offered in connection with any of
the strategies described in this section.
E. ADDRESS THE NEEDS OF PREGNANT OR PARENTING WOMEN AND
THEIR FAMILIES, INCLUDING BABIES WITH NEONATAL ABSTINENCE
SYNDROME
Address the needs of pregnant or parenting women with OUD and any co-occurring
SUD/MH conditions, and the needs of their families, including babies with neonatal
abstinence syndrome (“NAS”), through evidence-based or evidence-informed programs
or strategies that may include, but are not limited to, those that:
1. Support evidence-based or evidence-informed treatment, including MAT, recovery
services and supports, and prevention services for pregnant women—or women who
could become pregnant—who have OUD and any co-occurring SUD/MH conditions,
and other measures to educate and provide support to families affected by Neonatal
Abstinence Syndrome.
2. Expand comprehensive evidence-based treatment and recovery services, including
MAT, for uninsured women with OUD and any co-occurring SUD/MH conditions for
up to 12 months postpartum.
3. Provide training for obstetricians or other healthcare personnel who work with
pregnant women and their families regarding treatment of OUD and any co-occurring
SUD/MH conditions.
4. Expand comprehensive evidence-based treatment and recovery support for NAS
babies; expand services for better continuum of care with infant-need dyad; and
expand long-term treatment and services for medical monitoring of NAS babies and
their families.
5. Provide training to health care providers who work with pregnant or parenting women
on best practices for compliance with federal requirements that children born with
NAS get referred to appropriate services and receive a plan of safe care.
J-10
6. Provide child and family supports for parenting women with OUD and any co-
occurring SUD/MH conditions.
7. Provide enhanced family support and child care services for parents with OUD and
any co-occurring SUD/MH conditions.
8. Provide enhanced support for children and family members suffering trauma as a
result of addiction in the family; and offer trauma-informed behavioral health
treatment for adverse childhood events.
9. Offer home-based wrap-around services to persons with OUD and any co-occurring
SUD/MH conditions, including, but not limited to, parent skills training.
10. Provide support for Children’s Services—Fund additional positions and services,
including supportive housing and other residential services, relating to children being
removed from the home and/or placed in foster care due to custodial opioid use.
PART TWO: PREVENTION
F. PREVENT OVER-PRESCRIBING AND ENSURE APPROPRIATE
PRESCRIBING AND DISPENSING OF OPIOIDS
Support efforts to prevent over-prescribing and ensure appropriate prescribing and
dispensing of opioids through evidence-based or evidence-informed programs or
strategies that may include, but are not limited to, the following:
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
Programs (“PDMPs”), including, but not limited to, improvements that:
1. Increase the number of prescribers using PDMPs;
2. Improve point-of-care decision-making by increasing the quantity, quality, or
format of data available to prescribers using PDMPs, by improving the
interface that prescribers use to access PDMP data, or both; or
J-11
3. Enable states to use PDMP data in support of surveillance or intervention
strategies, including MAT referrals and follow-up for individuals identified
within PDMP data as likely to experience OUD in a manner that complies
with all relevant privacy and security laws and rules.
6. Ensuring PDMPs incorporate available overdose/naloxone deployment data,
including the United States Department of Transportation’s Emergency Medical
Technician overdose database in a manner that complies with all relevant privacy and
security laws and rules.
7. Increasing electronic prescribing to prevent diversion or forgery.
8. Educating dispensers on appropriate opioid dispensing.
G. PREVENT MISUSE OF OPIOIDS
Support efforts to discourage or prevent misuse of opioids through evidence-based or
evidence-informed programs or strategies that may include, but are not limited to, the
following:
1. Funding media campaigns to prevent opioid misuse.
2. Corrective advertising or affirmative public education campaigns based on evidence.
3. Public education relating to drug disposal.
4. Drug take-back disposal or destruction programs.
5. Funding community anti-drug coalitions that engage in drug prevention efforts.
6. Supporting community coalitions in implementing evidence-informed prevention,
such as reduced social access and physical access, stigma reduction—including
staffing, educational campaigns, support for people in treatment or recovery, or
training of coalitions in evidence-informed implementation, including the Strategic
Prevention Framework developed by the U.S. Substance Abuse and Mental Health
Services Administration (“SAMHSA”).
7. Engaging non-profits and faith-based communities as systems to support prevention.
8. Funding evidence-based prevention programs in schools or evidence-informed school
and community education programs and campaigns for students, families, school
employees, school athletic programs, parent-teacher and student associations, and
others.
9. School-based or youth-focused programs or strategies that have demonstrated
effectiveness in preventing drug misuse and seem likely to be effective in preventing
the uptake and use of opioids.
J-12
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 drugs, including
emotional modulation and resilience skills.
12. Support greater access to mental health services and supports for young people,
including services and supports provided by school nurses, behavioral health workers
or other school staff, to address mental health needs in young people that (when not
properly addressed) increase the risk of opioid or another drug misuse.
H. PREVENT OVERDOSE DEATHS AND OTHER HARMS (HARM REDUCTION)
Support efforts to prevent or reduce overdose deaths or other opioid-related harms
through evidence-based or evidence-informed programs or strategies that may include,
but are not limited to, the following:
1. Increased availability and distribution of naloxone and other drugs that treat
overdoses for first responders, overdose patients, individuals with OUD and their
friends and family members, 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 drugs that treat overdoses for
first responders, overdose patients, patients taking opioids, families, schools,
community support groups, and other members of the general public.
4. Enabling school nurses and other school staff to respond to opioid overdoses, and
provide them with naloxone, training, and support.
5. Expanding, improving, or developing data tracking software and applications for
overdoses/naloxone revivals.
6. Public education relating to emergency responses to overdoses.
7. Public education relating to immunity and Good Samaritan laws.
8. Educating first responders regarding the existence and operation of immunity and
Good Samaritan laws.
9. Syringe service programs and other evidence-informed programs to reduce harms
associated with intravenous drug use, including supplies, staffing, space, peer support
services, referrals to treatment, fentanyl checking, connections to care, and the full
range of harm reduction and treatment services provided by these programs.
J-13
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 drugs.
2. Provision of wellness and support services for first responders and others who
experience secondary trauma associated with opioid-related emergency events.
J. LEADERSHIP, PLANNING AND COORDINATION
Support efforts to provide leadership, planning, coordination, 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
settlement funds; (b) to show how opioid settlement funds have been spent; (c) to
report program or strategy outcomes; or (d) to track, share or visualize key opioid- or
health-related indicators and supports as identified through collaborative statewide,
regional, local or community processes.
3. Invest in infrastructure or staffing at government or not-for-profit agencies to support
collaborative, cross-system coordination with the purpose of preventing
J-14
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, pharmacies, PDMPs, etc.).
L. RESEARCH
Support opioid abatement research that may include, but is not limited to, the following:
1. Monitoring, surveillance, data collection and evaluation of programs and strategies
described in this opioid abatement strategy list.
2. Research non-opioid treatment of chronic pain.
3. Research on improved service delivery for modalities such as SBIRT that
demonstrate promising but mixed results in populations vulnerable to opioid use
disorders.
4. Research on novel harm reduction and prevention efforts such as the provision of
fentanyl test strips.
5. Research on innovative supply-side enforcement efforts such as improved detection
of mail-based delivery of synthetic opioids.
6. Expanded research on swift/certain/fair models to reduce and deter opioid misuse
within criminal justice populations that build upon promising approaches used to
address other substances (e.g., Hawaii HOPE and Dakota 24/7).
J-15
7.Epidemiological surveillance of OUD-related behaviors in critical populations,
including individuals entering the criminal justice system, including, but not limited
to approaches modeled on the Arrestee Drug Abuse Monitoring (“ADAM”) system.
8.Qualitative and quantitative research regarding public health risks and harm reduction
opportunities within illicit drug markets, including surveys of market participants
who sell or distribute illicit opioids.
9.Geospatial analysis of access barriers to MAT and their association with treatment
engagement and treatment outcomes.