Exhibit 10.3
STATE SETTLEMENT AGREEMENT AND
RELEASE
I.
PARTIES
This Settlement Agreement and
Release (“Agreement”) is entered into between the State
of
(“State”), and Cephalon, Inc.
(“Cephalon”), a Delaware corporation with its principal
place of business in Frazer, Pennsylvania, hereinafter collectively
referred to as “the Parties”.
II.
PREAMBLE
As a preamble to this Agreement, the
Parties agree to the following:
A.
At all relevant times, Cephalon
distributed, marketed and sold pharmaceutical products in the
United States, including drugs sold under the trade names of Actiq,
Gabitril and Provigil.
B.
Cephalon has entered into a plea
agreement with the United States Attorney for the Eastern District
of Pennsylvania and has agreed to plead guilty, pursuant to Fed. R.
Crim. P. 11, to a one count Information to be filed in United
States v. Cephalon, Inc . (the “Federal Criminal
Action”) that will allege that between January 2001
through October 1, 2001, Cephalon introduced into interstate
commerce and caused the introduction into interstate commerce of
drugs (Actiq, Gabitril, and Provigil) that were misbranded through
off-label promotion, a misdemeanor, in violation of 21 U.S. C.
§§ 331(a), 333(a)(1) and 352(f)(1).
C.
Cephalon has entered into a separate
settlement agreement (the “Federal Settlement Agreement and
Release”) with the United States (as that term is defined in
the Federal Settlement Agreement and Release), which will be
receiving settlement funds from
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Cephalon pursuant to Paragraph 1
below for the Covered Conduct described in Paragraph D
below.
D.
The State contends that it has
certain civil and administrative claims against Cephalon for
engaging in the following alleged conduct (“the Covered
Conduct”):
(i)
Between January 1, 2001 and
December 31, 2006 for Actiq and Provigil and between
January 1, 2001 and February 18, 2005 for Gabitril,
Cephalon knowingly and willfully promoted the sale and use of
Actiq, Gabitril and Provigil for certain uses which the Food and
Drug Administration had not approved (i.e. “unapproved
uses”). The promotion of Actiq, Gabitril and Provigil for
these unapproved uses violated the Food Drug and Cosmetic Act 21
U.S.C. § 331(a), 21 U.S.C. § 352(f). In addition, certain
of these unapproved uses were not medically accepted indications
for which the United States and State Medicaid programs approved
reimbursement. As a result of Cephalon’s conduct, Cephalon
knowingly caused false and/or fraudulent claims to be submitted to
the United States and the State Medicaid programs.
(ii)
Cephalon has entered into a plea
agreement with the United States Attorney for the Eastern District
of Pennsylvania and has agreed to plead guilty, pursuant to Fed. R.
Crim. P. 11, to a one Count Information to be filed in United
States v. Cephalon, Inc . (the “Federal Criminal
Action”) that will allege that between January 2001
through October 1, 2001, Cephalon introduced into interstate
commerce and caused the introduction into interstate commerce of
drugs (Actiq, Gabitril, and Provigil) that were
misbranded
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through off-label promotion, a
misdemeanor, in violation of 21 U.S. C. §§ 331(a),
333(a)(1) and 352(f)(1).
E. Cephalon has cooperated fully and completely
with the State throughout the course of its investigation and
continues to do so.
F. This Agreement is made in compromise of disputed
claims. This Agreement is neither an admission of facts or
liability by Cephalon nor a concession by the State that its claims
are not well founded. Neither this Settlement, its execution,
nor the performance of any obligation under it, including any
payment, nor the fact of the settlement, is intended to be or shall
be understood as an admission of liability or wrongdoing or other
expression reflecting upon the merits of the dispute by
Cephalon.
G. To avoid the delay, expense, inconvenience, and
uncertainty of protracted litigation of these claims, the Parties
mutually desire to reach a full and final settlement as set forth
below.
III. TERMS AND
CONDITIONS
NOW, THEREFORE, in reliance on the
representations contained herein and in consideration of the mutual
promises, covenants, and obligations set forth below in this
Agreement, and for good and valuable consideration as stated
herein, the Parties agree as follows:
1.
Cephalon agrees to pay to the United
States and the States that will be receiving settlement funds
pursuant to this paragraph (the “Medicaid Participating
States”) collectively the sum of three hundred seventy-five
million dollars ($375,000.000.00) plus interest in an
amount
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of 4.0% per annum from
January 1, 2008, and continuing until and including the day
before complete payment is made (the “Settlement
Amount”). Of this sum,
($ )
represents payment to Medicaid, which shall constitute a debt
immediately due and owing to the United States and the Medicaid
Participating States on the Effective Date of this Agreement
subject to the terms of the Federal Settlement Agreement and
Release and this Agreement. This debt is to be discharged by
payments to the United States and the Medicaid Participating States
under the following conditions:
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A.
Cephalon
and the United States separately have agreed that the sum of
($ ),
plus interest in an amount of 4.0% per annum from January 1,
2008, and continuing until and including the day before complete
payment is made represents the federal share (the “Federal
Settlement Amount”). The Federal Settlement Amount
shall be paid pursuant to the terms of the Federal Settlement
Agreement and Release.
B.
Cephalon and the
Medicaid Participating States agree that the sum of
($ ),
plus interest in an amount of 4.0% per annum from
January 1, 2008, until and including the day before complete
payment is made represents the States’ share (the
“Medicaid State Settlement Amount”).
This Medicaid State Settlement Amount shall be paid
into an interest bearing account no later than thirty (30) business
days after the Federal Settlement Agreement and Release’s
Effective Date pursuant to written payment instructions from the
National Association of Medicaid Fraud Control Units’
Negotiating Team (“NAMFCU”) for the Medicaid
Participating States.
C.
The total portion of the Settlement
Amount paid by Cephalon in settlement for the Covered Conduct to
the State is
$ ,
consisting of a portion paid to the State under this Agreement and
another portion paid to the Federal government as part of the
Federal Settlement Agreement and Release. The individual
portion of the Medicaid State Settlement Amount allocable to the
State under this Agreement is the sum of
$ ,
plus applicable interest. NAMFCU shall disburse to the State
the individual portion of the Medicaid State Settlement Amount
allocable to the State after the Effective Date of this
Agreement. If the State does not
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execute this Agreement within 180
days of the Effective Date of the Federal Settlement Agreement and
Release, the total portion of the Settlement Amount paid by
Cephalon in settlement for the Covered Conduct to the State plus
the interest accrued on that amount shall revert to
Cephalon.
2.
Contingent upon the Medicaid
Participating States receiving the Medicaid State Settlement
Amount, the Medicaid Participating States agree to pay, as soon as
feasible after receipt, the agreed upon amounts with
Relators.
3.
Subject to the exceptions in
Paragraph 4 below, and in consideration of the obligations of
Cephalon set forth in this Agreement, conditioned upon
Cephalon’s payment in full of the Settlement Amount, and
subject to Paragraph 13 below (concerning bankruptcy proceedings
commenced within 91 days of the Effective Date of this Agreement or
any payment under this Agreement), the State, on behalf of itself,
and its officers, agents, agencies, political subdivisions and
departments, agrees to release Cephalon, its predecessors, and its
current and former parents, affiliates, divisions, subsidiaries,
successors and assigns, and their current and former directors,
officers, and employees (collectively, “Cephalon Released
Entities”), from any civil or administrative liability or
monetary claim that the State or any of its political subdivisions
has or may have for any claims submitted or caused to be submitted
to the State Medicaid Program for the Covered Conduct. The
payment of the Settlement Amount fully discharges the Cephalon
Released Entities from any obligations to pay Medicaid related
restitution, damages, and/or any civil fine or civil penalty to the
State for the Covered Conduct.
4.
Notwithstanding any term of this
Agreement, the State specifically does not release any person or
entity from any of the following claims or liabilities:
(a) any criminal, civil, or administrative claims arising
under state revenue codes; (b) any criminal liability
not
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specifically released by this
Agreement; (c) any civil liability that Cephalon has or may
have under any state stat