STAINES-UPON-THAMES, United
Kingdom, Sept. 30, 2019
/PRNewswire/ -- Mallinckrodt
plc (NYSE: MNK), along with its wholly owned subsidiaries
Mallinckrodt LLC and SpecGx LLC, today announced that it has
executed a definitive settlement agreement and release (the
"Settlement Agreement") with Cuyahoga and Summit Counties in Ohio in connection with lawsuits pending in
multidistrict opioid litigation (MDL) in the U.S. District Court
for the Northern District of Ohio:
The County of Cuyahoga, et al. v.
Purdue Pharma, L.P., et al., Case No. 17-OP-45004; and The County
of Summit, et al. v. Purdue
Pharma, L.P., et al., Case No. 18-OP-45090 (collectively, the
"Track 1 Cases").
The settlement fully resolves the Track 1 Cases against all
named Mallinckrodt entities that are
currently scheduled to go to trial in October, 2019, in the MDL.
The Track 1 Cases assert various claims related to the opioid
business operated by SpecGx LLC.
Under the agreement, Mallinckrodt
will pay $24 million in cash and
provide $6 million in generic
products, including addiction treatment products. It also will
provide a $500,000 payment in two
years in recognition of the counties' time and expenses.
Further, in the event of a comprehensive resolution of
government-related opioid claims, Mallinckrodt has agreed that the two plaintiff
counties will receive the value they would have received under such
a resolution, less the payments described above. All named
Mallinckrodt entities will be dismissed
with prejudice from the lawsuit. The value of the settlement should
not be extrapolated to any other opioid-related cases or
claims.
"Mallinckrodt is pleased to finalize
this settlement agreement with the Cuyahoga and Summit Counties," said Mark Casey, Executive Vice President and Chief
Legal Officer of Mallinckrodt.
"With the Track 1 Cases resolved, we look forward to focusing our
efforts on achieving a global resolution of all the opioid
lawsuits."
For more information on Mallinckrodt's work to combat prescription drug
abuse and misuse, please visit www.mallinckrodt.com/solutions.
ABOUT MALLINCKRODT
Mallinckrodt is a global
business consisting of multiple wholly owned subsidiaries that
develop, manufacture, market and distribute specialty
pharmaceutical products and therapies. The company's Specialty
Brands reportable segment's areas of focus include autoimmune and
rare diseases in specialty areas like neurology, rheumatology,
nephrology, pulmonology and ophthalmology; immunotherapy and
neonatal respiratory critical care therapies; analgesics and
gastrointestinal products. Its Specialty Generics reportable
segment includes specialty generic drugs and active pharmaceutical
ingredients. To learn more about Mallinckrodt,
visit www.mallinckrodt.com.
Mallinckrodt uses its website as a channel of distribution
of important company information, such as press releases, investor
presentations and other financial information. It also uses its
website to expedite public access to time-critical information
regarding the company in advance of or in lieu of distributing a
press release or a filing with the U.S. Securities and
Exchange Commission (SEC) disclosing the same information.
Therefore, investors should look to the Investor Relations page of
the website for important and time-critical information. Visitors
to the website can also register to receive automatic e-mail and
other notifications alerting them when new information is made
available on the Investor Relations page of the website.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING
STATEMENTS
Statements in this document that are not strictly
historical, including statements regarding the terms of the
proposed settlement, statements regarding the ongoing lawsuits
against Mallinckrodt plc and its
subsidiaries, and any other statements regarding events or
developments that the company believes or anticipates will or may
occur in the future, may be "forward-looking" statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
and involve a number of risks and uncertainties.
There are a number of important factors that could cause actual
events to differ materially from those suggested or indicated by
such forward-looking statements and you should not place undue
reliance on any such forward-looking statements. These factors
include risks and uncertainties related to, among other things:
general economic conditions and conditions affecting the industries
in which Mallinckrodt operates; the
commercial success of Mallinckrodt's
products; Mallinckrodt's ability to
realize anticipated growth, synergies and cost savings from
acquisitions; conditions that could necessitate an evaluation of
Mallinckrodt's goodwill and/or
intangible assets for possible impairment; changes in laws and
regulations; Mallinckrodt's ability to
successfully integrate acquisitions of operations, technology,
products and businesses generally and to realize anticipated
growth, synergies and cost savings; Mallinckrodt's and Mallinckrodt's licensers' ability to successfully
develop or commercialize new products; Mallinckrodt's and Mallinckrodt's licensers' ability to protect
intellectual property rights; Mallinckrodt's ability to receive procurement and
production quotas granted by the U.S. Drug Enforcement
Administration; customer concentration; Mallinckrodt's reliance on certain individual
products that are material to its financial performance; cost
containment efforts of customers, purchasing groups, third-party
payers and governmental organizations; the reimbursement practices
of a small number of public or private insurers; pricing pressure
on certain of Mallinckrodt's products
due to legal changes or changes in insurers' reimbursement
practices resulting from recent increased public scrutiny of
healthcare and pharmaceutical costs; limited clinical trial data
for Acthar Gel; complex reporting and payment obligations under
healthcare rebate programs; Mallinckrodt's ability to navigate price
fluctuations; future changes to U.S. and foreign tax laws;
Mallinckrodt's ability to achieve
expected benefits from restructuring activities; complex
manufacturing processes; competition; product liability losses and
other litigation liability; ongoing governmental investigations;
material health, safety and environmental liabilities; retention of
key personnel; conducting business internationally; the
effectiveness of information technology infrastructure; and
cybersecurity and data leakage risks; Mallinckrodt's substantial indebtedness and its
ability to generate sufficient cash to reduce its indebtedness; and
any future actions taken with respect to the Specialty Generics
business.
These and other factors are identified and described in more
detail in the "Risk Factors" section of Mallinckrodt's Annual Report on Form 10-K for the
fiscal year ended December 28, 2018.
The forward-looking statements made herein speak only as of the
date hereof and Mallinckrodt does not
assume any obligation to update or revise any forward-looking
statement, whether as a result of new information, future events
and developments or otherwise, except as required by law.
CONTACTS
Investor Relations
Daniel J. Speciale, CPA
Vice President, Investor Relations and IRO
314-654-3638
daniel.speciale@mnk.com
Media
Daniel Yunger
Kekst CNC
212-521-4879
mallinckrodt@kekstcnc.com
Mallinckrodt, the "M" brand mark and
the Mallinckrodt Pharmaceuticals logo are trademarks of a
Mallinckrodt company. Other brands are
trademarks of a Mallinckrodt company or
their respective owners. © 2019 Mallinckrodt. 9/19
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SOURCE Mallinckrodt plc