Exhibit 10.1

 

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U.S. Department of Justice

 

William D. Weinreb

Acting United States Attorney

District of Massachusetts

 

 

Main Reception: (617) 748-3100

John Joseph Moakley United States Courthouse

1 Courthouse Way

Suite 9200

Boston, Massachusetts 02210

 

September 22, 2017

 

Joshua S. Levy

Ropes & Gray

Prudential Tower

800 Boylston Street

Boston, MA 02199-3600

 

Re: United States v. Aegerion Pharmaceuticals, Inc.

 

Dear Mr. Levy:

 

The Acting United States Attorney for the District of Massachusetts and the
United States Department of Justice, Consumer Protection Branch (jointly, “the
United States”) and your client, Aegerion Pharmaceuticals, Inc. (“Aegerion” or
“Defendant”) agree as follows with respect to the above-referenced case:

 

1.                                      Pleas

 

At the earliest practicable date, Defendant shall waive indictment and plead
guilty to the Information attached to this Plea Agreement as Exhibit A charging
it with two misdemeanor violations of the Federal Food, Drug, and Cosmetic Act,
21 U.S.C. §§ 331(a), 333(a)(1), 352(f)(1), and 352(y). Defendant expressly and
unequivocally admits that it committed the crimes charged in the Information and
is in fact guilty of those offenses. Defendant also agrees to waive venue, to
waive any applicable statute of limitations, and to waive any legal or
procedural defects in the Information.

 

2.                                      Penalties

 

Defendant faces the following mandatory minimum and maximum penalties:

 

a.                   A fine of $400,000 ($200,000 per count), or twice the gross
gain/loss, whichever is greater. See 18 U.S.C. § 3571(c), (d). The gross gain
resulting from the offense is $15,451,827. Thus, the maximum fine is
$30,903,653;

 

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b.                   A term of probation of not more than five (5) years. See 18
U.S.C. § 3561(c)(2);

 

c.                    A mandatory special assessment of $250 ($125 per count).
See 18 U.S.C. § 3013;

 

d.                   Restitution to any victims of the offense; and

 

e.                    Forfeiture to the extent charged in the Information.

 

3.                                      Fed. R. Crim. P. 11(c)(1)(C) Plea

 

This Plea Agreement is made under Fed. R. Crim. P. 11(c)(1)(C), and Defendant’s
guilty pleas will be tendered pursuant to that provision. In accordance with
Rule 11(c)(1)(C), if the District Court (“Court”) accepts this Plea Agreement,
the Court must include the agreed disposition in the judgment. If the Court
rejects any aspect of this Plea Agreement, either the United States or Defendant
may deem the Plea Agreement null and void. Defendant understands and
acknowledges that it may not withdraw its pleas of guilty unless the Court
rejects this Plea Agreement under Fed. R. Crim. P. 11(c)(5).

 

Defendant may seek sentencing by the Court immediately following the Rule 11
plea hearing. The United States does not object to the Court proceeding to
sentence Defendant immediately following the Rule 11 plea hearing or in the
absence of a Presentence Report in this case. Defendant understands that the
decision whether to proceed immediately with the sentencing proceeding following
the plea hearing, and to do so without a Presentence Report, is exclusively that
of the Court.

 

4.                                      Sentencing Guidelines

 

The parties agree jointly to take the following positions at sentencing under
the United States Sentencing Guidelines (“USSG” or “Guidelines”). The parties
also agree that while the fine provisions of the Guidelines do not apply to
organizational defendants for misdemeanor violations of the Federal Food, Drug,
and Cosmetic Act, see USSG § 8C2.1, the following is consonant with the
Guidelines and takes into account Aegerion’s conduct under 18 U.S.C. §§ 3553 and
3572 and USSG § 8C2.10, as follows:

 

·                       The base fine is $15,451,827, because this was the
reasonably estimated pecuniary gain to Defendant from the offenses. See USSG
§8C2.4(a)(2);

 

·                       Under USSC § 8C2.5, the culpability score is six (6),
determined as follows:

 

(a)              The base culpability score is five (5), under USSG § 8C2.5(a);

 

(b)              Three (3) points are added because the organization had 200 or
more employees and an individual within high-level personnel of the organization
participated in,

 

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condoned, or was willfully ignorant of the offenses, under USSG §
8C2.5(b)(3)(A); and

 

(c)               Two (2) points are deducted because the organization fully
cooperated in the investigation and clearly demonstrated recognition and
affirmative acceptance of responsibility for its criminal conduct, under USSG §
8C2.5(g)(2);

 

·                       Under USSG § 8C2.6, the appropriate multiplier range
associated with a culpability score of six is 1.2 to 2.4;

 

·                       Thus, under USSG § 8C2.7, the Guidelines fine range is
$18,542,192 to $30,903,653.

 

·                       Disgorgement under USSG § 8C2.9 is not necessary.

 

The parties further agree that under USSG § 8C3.3(b), there is a basis for a
reduction in the fine otherwise required by USSG § 8C2.7, in that Aegerion is
not able and, even with the use of a reasonable installment schedule, is not
likely to become able to pay the minimum Guidelines fine, and that a fine below
the Guidelines fine range will result in a reasonable sentence, taking into
consideration all of the factors set forth in 18 U.S.C. §§ 3553(a) and 3572.

 

The United States may, at its sole option, be released from its commitments
under this Plea Agreement, including, but not limited to, its agreement that
Paragraph 5 constitutes the appropriate disposition of this case, if at any time
between Defendant’s execution of this Plea Agreement and sentencing, Defendant:

 

(a)              Fails to complete a factual basis for the pleas;

 

(b)              Fails to truthfully admit Defendant’s conduct in the offenses
of conviction;

 

(c)               Falsely denies, or frivolously contests, relevant conduct for
which Defendant is accountable under USSG § 1B1.3;

 

(d)              Gives false or misleading testimony in any proceeding relating
to the criminal conduct charged in this case and any relevant conduct for which
Defendant is accountable under USSG § 1B1.3;

 

(e)               Engages in acts that form a basis for finding that Defendant
has obstructed or impeded the administration of justice under USSG § 3C1.1;

 

(f)                Commits a crime; or

 

(g)               Attempts to withdraw Defendant’s guilty plea.

 

Nothing in this Plea Agreement affects the United States’ obligation to provide
the Court and the U.S. Probation Office with accurate and complete information
regarding this case.

 

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5.                                      Agreed Disposition

 

Under Fed. R. Crim. P. 11(c)(1)(C), the United States and Defendant agree that
the following is a reasonable and appropriate disposition of this case, taking
into consideration all of the factors set forth in 18 U.S.C. §§ 3553(a) and
3572:

 

a.                   a criminal fine in the amount of $6,200,000, to be paid in
twelve quarterly installments over three years, with the first quarterly payment
to occur within ninety calendar days of the date of sentencing and the remaining
eleven payments due every ninety days thereafter. Payment of interest from the
first payment date on the unpaid principal balance at the rate of 1.75 percent
per annum is payable with each quarterly installment of principal, as follows:

 

Quarter

 

Payment

 

Interest

 

Principal

 

Balance

 

 

 

 

 

 

 

 

 

$

6,200,000.00

 

1

 

$

654,902.78

 

$

27,125.00

 

$

627,777.78

 

$

5,572,222.22

 

2

 

$

652,156.25

 

$

24,378.47

 

$

627,777.78

 

$

4,944,444.44

 

3

 

$

649,409.72

 

$

21,631.94

 

$

627,777.78

 

$

4,316,666.66

 

4

 

$

646,663.20

 

$

18,885.42

 

$

627,777.78

 

$

3,688,888.88

 

5

 

$

477,250.00

 

$

16,138.89

 

$

461,111.11

 

$

3,227,777.77

 

6

 

$

475,232.64

 

$

14,121.53

 

$

461,111.11

 

$

2,766,666.66

 

7

 

$

473,215.28

 

$

12,104.17

 

$

461,111.11

 

$

2,305,555.55

 

8

 

$

471,197.92

 

$

10,086.81

 

$

461,111.11

 

$

1,844,444.44

 

9

 

$

469,180.55

 

$

8,069.44

 

$

461,111.11

 

$

1,383,333.33

 

10

 

$

467,163.19

 

$

6,052.08

 

$

461,111.11

 

$

922,222.22

 

11

 

$

465,145.83

 

$

4,034.72

 

$

461,111.11

 

$

461,111.11

 

12

 

$

463,128.47

 

$

2,017.36

 

$

461,111.11

 

$

0.00

 

 

In accordance with 18 U.S.C. § 3572(d)(3), Defendant will notify the Court of
any material change in Defendant’s economic circumstances that might affect
Defendant’s ability to pay the fine. Upon receipt of such notice, the Court may,
on its own motion or the motion of any party, adjust the payment schedule, or
require immediate payment in full, as the interests of justice require.

 

b.                   a mandatory special assessment in the amount of $250,
payable to the Clerk of the Court on or before the date of sentencing;

 

c.                    forfeiture in the amount of $1,000,000, to be paid within
three business days of the date of sentencing;

 

d.                   in light of the Civil False Claims Act Settlement Agreement
in the pending civil action captioned United States ex rel. Michelle Clarke et
al. v. Aegerion Pharmaceuticals, Inc., et al., No. 13-CV-11785-RWZ (D. Mass.)
and Aegerion’s inability to pay, the parties agree that no restitution shall be

 

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awarded in this criminal case, 18 U.S.C. § 3663(a)(3); and that the complication
and prolongation of the sentencing process that would result from an attempt to
fashion a proper restitution order under 18 U.S.C. § 3663 outweighs the need to
provide restitution to any non-governmental victims in this case, 18 U.S.C. §
3663(a)(1)(B)(ii); and

 

e.                    in light of Aegerion’s commitment to make certain
certifications and resolutions to the United States as provided in Paragraph 10
below; enter into the attached three-year Deferred Prosecution Agreement
(Exhibit B) with the United States concerning additional criminal liability;
enter into a five-year Corporate Integrity Agreement with the Department of
Health and Human Services, Office of Inspector General; and enter into a Civil
Consent Decree of Permanent Injunction to be monitored by the Food and Drug
Administration, Aegerion will not be placed on probation.

 

6.                                      No Further Prosecution of Aegerion

 

Under Fed. R. Crim. P. 11(c)(1)(A), the United States agrees that, other than
the charges in the attached Information, the charges described in the parties’
separate Deferred Prosecution Agreement, and potential charges resulting from
any investigations of Aegerion regarding possible violations of the Foreign
Corrupt Practices Act and related offenses in connection with the sales and
marketing of Aegerion products to foreign customers, it shall not further
prosecute Aegerion for any additional federal criminal charges with respect to
the conduct: (a) covered by the Information; (b) that was the subject of the
investigation of Aegerion by the U.S. Attorney’s Office for the District of
Massachusetts into the sales, promotion, and marketing and patient on-boarding
practices in connection with Aegerion’s product, Juxtapid; or (c) currently
known to the United States regarding sales, promotion, and marketing and patient
on-boarding practices in connection with Aegerion’s product, Juxtapid.

 

This declination is expressly contingent on (i) the guilty pleas of Aegerion to
the attached Information being accepted by the Court and not withdrawn or
otherwise challenged by Aegerion; and (ii) Aegerion’s performance of all of its
obligations, including without limitation its cooperation obligations, as set
forth in this Plea Agreement. If Aegerion’s guilty pleas are not accepted by the
Court or are withdrawn for any reason, or if Aegerion should fail to perform an
obligation under this Plea Agreement or the attached Civil False Claims Act
Settlement Agreement (Exhibit C), this declination of prosecution shall be null
and void.

 

The United States reserves the right to prosecute any individual, including but
not limited to present and former officers, directors, employees, and other
agents of Aegerion, in connection with the conduct encompassed by this Plea
Agreement, within the scope of the grand jury investigation, or known to the
United States.

 

7.                                      Waiver of Right to Appeal and to Bring
Future Challenge

 

a.                   Defendant has conferred with its attorney and understands
that it has the right to challenge its conviction in the United States Court of
Appeals for the First

 

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Circuit (“direct appeal”). Defendant also understand that, in some
circumstances, Defendant may be able to challenge its conviction in a future
proceeding (collateral or otherwise), such as pursuant to a motion under 28
U.S.C. § 2255 or 28 U.S.C. § 2241. Defendant waives any right to challenge
Defendant’s conviction on direct appeal or in any future proceeding (collateral
or otherwise).

 

b.                   Defendant has conferred with its attorney and understands
that defendants ordinarily have a right to challenge in a direct appeal their
sentences (including any orders relating to the terms and conditions of
supervised release, fines, forfeiture, and restitution) and may sometimes
challenge their sentences (including any orders relating to the terms and
conditions of supervised release, fines, forfeiture, and restitution) in a
future proceeding (collateral or otherwise), such as under 28 U.S.C. § 2255, 28
U.S.C. § 2241, or 18 U.S.C. § 3582. The rights that are ordinarily available to
a defendant are limited when a defendant enters into a
Rule 11(c)(1)(C) agreement. In this case, Defendant waives any rights Defendant
may have to challenge the agreed-upon sentence (including any agreement relating
to the terms and conditions of supervised release, fines, forfeiture, and
restitution) on direct appeal and in a future proceeding (collateral or
otherwise), such as under 28 U.S.C. § 2255 and 28 U.S.C. § 2241. Defendant also
waives any right Defendant may have under 18 U.S.C. § 3582 to ask the Court to
modify the sentence, even if the USSG are later amended in a way that appears
favorable to Defendant. Defendant also agrees not to challenge the sentence in
an appeal or future proceeding (collateral or otherwise) even if the Court
rejects one or more positions advocated by any party at sentencing. In sum,
Defendant understands and agrees that in entering into this Plea Agreement, the
parties intend that Defendant will receive the benefits of the Plea Agreement
and that the sentence will be final.

 

c.                    The United States agrees that it will not appeal the
imposition by the Court of the sentence agreed to by the parties as set out in
Paragraph 5, even if the Court rejects one or more provisions advocated by
either party at sentencing.

 

d.                   Regardless of the previous subparagraphs, Defendant
reserves the right to claim that: (i) Defendant’s lawyer rendered ineffective
assistance of counsel under Strickland v. Washington; or (ii) the prosecutors in
this case engaged in misconduct that entitles Defendant to relief from
Defendant’s conviction or sentence.

 

8.                                      Cooperation

 

Aegerion acknowledges that its prior, ongoing, and future cooperation is
important and a material factor underlying the decision by the United States to
enter into this Plea Agreement. Aegerion therefore agrees to continue to
cooperate fully and actively with the United States, and any other agency of the
federal government designed by the United States regarding any matter

 

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about which Aegerion has knowledge or information in any ongoing investigation,
trial, or other proceeding arising out of any ongoing federal investigation on
the subject matter identified in paragraphs 6(a) to 6(b) above. Aegerion shall
use reasonable best efforts to cooperate with respect to the subject matter
identified in paragraphs 6(a) to 6(b) above and such cooperation shall include,
but not be limited to the following:

 

a.                   Completely and truthfully disclosing all non-privileged
information in its possession about which the United States may reasonably
inquire, including but not limited to all information about activities of
Aegerion and present and former officers, directors, employees, and agents of
Aegerion;

 

b.                   Assembling, organizing, and providing all non-privileged
documents, records, and other evidence in Aegerion’s possession, custody, or
control as may reasonably be requested by the United States;

 

c.                    Using its reasonable best efforts to make available its
present and former officers, directors, and employees to provide information
and/or testimony as requested by the United States, including testimony before a
grand jury, a trial court, other court proceeding, as well as interviews with
law enforcement authorities. Cooperation under this paragraph shall include
identification of witnesses who have material information concerning any
criminal prosecution and/or trial, civil trial, or other legal proceedings
brought by the United States against any present or former officer, director, or
employee of Aegerion;

 

d.                   Providing testimony or information necessary to identify or
establish the original location, authenticity, or other basis for admission into
evidence of documents or physical evidence in any criminal or other proceeding
as requested by the United States; and

 

e.                    Providing active assistance, including assistance by
current counsel and/or successor counsel, internal or external, in connection
with any investigation, criminal prosecution, and/or trial, civil trial, or
other legal proceeding brought by the United States against any present or
former officer, director, or employee of Aegerion.

 

However, notwithstanding any provision of this Plea Agreement, Aegerion is not
required to: (1) request of its current or former officers, agents, or employees
that they forego seeking the advice of an attorney or that they act contrary to
that advice; (2) take any action against its officers, agents, or employees for
following their attorney’s advice; or (3) waive any claim of privilege or work
product protection.

 

9.                                      Forfeiture

 

Defendant understands that the Court will, upon acceptance of Defendant’s guilty
pleas, enter an order of forfeiture as part of Defendant’s sentence, and that
the order of forfeiture may

 

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include assets directly or indirectly traceable to Defendant’s offense,
substitute assets, and/or a money judgment equal to the value of the property
derived from the offense.

 

The assets to be forfeited specifically include, without limitation, $1,000,000
in United States currency. Defendant admits that $1,000,000 in United States
currency is subject to forfeiture on the grounds that it constitutes, or is
derived from, gross proceeds traceable to the commission of Counts One and Two
of the Information. Defendant agrees to consent to the entry of orders of
forfeiture for such property, including the entry of an order of forfeiture for
a money judgment in the amount of $1,000,000, and Defendant waives the
requirements of Federal Rules of Criminal Procedure 11(b)(1)(J), 32.2, and
43(a) regarding notice of the forfeiture in the charging instrument, advice
regarding the forfeiture at the plea hearing, announcement of the forfeiture at
sentencing, and incorporation of the forfeiture in the judgment. Defendant
understands and agrees that forfeiture shall not satisfy or affect any fine,
lien, penalty, restitution, or any other debt owed to the United States.
Defendant understands and agrees that forfeiture shall not satisfy or affect any
fine, lien, penalty, restitution, cost of imprisonment, tax liability or any
other debt owed to the United States. Defendant further agrees that, no later
than three business days after sentencing, the Defendant shall deliver to the
U.S. Attorney’s Office, Asset Forfeiture Unit, a cashier’s check for $1,000,000
in United States currency, made payable to the United States Marshals Service.

 

Defendant agrees to assist fully in the forfeiture of the foregoing assets.
Defendant also agrees to waive all constitutional, legal, and equitable
challenges (including direct appeal, habeas corpus, or any other means) to any
forfeiture carried out in accordance with this Plea Agreement. Defendant agrees
not to challenge or seek review of any civil or administrative forfeiture of any
property subject to forfeiture under this Plea Agreement, and will not assist
any third party with regard to such challenge or review.

 

Defendant hereby waives and releases any claims Defendant may have to any
vehicles, currency, or other personal property seized by the United States, or
seized by any state or local law enforcement agency and turned over to the
United States, during the investigation and prosecution of this case, and
consents to the forfeiture of all such assets.

 

10.                               Certifications and Resolutions

 

Aegerion agrees to make certain certifications and resolutions to the United
States as follows:(1)

 

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(1) Consistent with the U.S. Department of Justice’s Freedom of Information Act
(“FOIA”) procedures, the United States shall make reasonable efforts to notify
Aegerion prior to any release by the Department of Justice of information
submitted by Aegerion pursuant to its obligations under this Plea Agreement and
identified upon submission of Aegerion as trade secrets, or information that is
commercial or financial and privileged or confidential, under the FOIA rules.
With respect to such releases, Aegerion shall have the rights set forth under
said procedures.

 

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a.                   Aegerion will conduct the reviews described in this
Paragraph for each of three (3) Review Periods. The duration of the first and
second Review Periods each will be one year, beginning with the first one-year
period following the entry of the guilty pleas in this matter. The duration of
the third Review Period will be nine months. Aegerion will provide the
certifications and resolutions described in this Paragraph to the Government
within one hundred twenty (120) days following the end of each of the first and
second Review Periods, and within sixty (60) days following the end of the third
Review Period.

 

b.                   Following the end of each Review Period, the President of
Aegerion shall conduct a review of Aegerion’s compliance with its obligations
under this Plea Agreement and the Civil Consent Decree of Permanent Injunction
referred to in Paragraph 5(e) above for the preceding Review Period. Based on
his or her review, the President shall submit to the United States a signed
certification stating that, to the best of his or her knowledge based on a
reasonable inquiry, during the preceding Review Period, Aegerion (1) complied
with all its obligations under this Plea Agreement, including its obligations to
cooperate with and make reports to the United States; and (2) complied with all
its obligations under the Civil Consent Decree of Permanent Injunction. The
certification shall summarize the review described above. If the President of
Aegerion is unable to provide any part of this certification as specified
herein, he or she shall provide a detailed explanation of why he or she is
unable to provide such certification. The certification and detailed explanation
shall be sworn to under the pains and penalty of perjury and shall set forth
that the representations contained therein may be provided to, relied upon, and
material to the United States, and that a knowing false statement could result
in criminal or civil liability for the signatory.

 

c.                    Following the end of each Review Period, the Board of
Directors of Novelion Therapeutics Inc. (or any future parent company of
Aegerion), or a designated Committee thereof (the “Board”), shall conduct a
review of Aegerion’s compliance with its obligations under this Plea Agreement
and the Civil Consent Decree of Permanent Injunction referred to in Paragraph
5(e) above for the preceding Review Period. The Board shall evaluate Aegerion’s
compliance by, at a minimum, receiving updates about the activities of
management employees responsible for ensuring compliance with this Plea
Agreement and the Civil Consent Decree of Permanent Injunction, and updates
about the adoption and implementation of policies, procedures, and practices as
it relates to such compliance. Based on its review, the Board shall submit to
the United States a resolution that summarizes its review and oversight as set
forth above and that includes, at a minimum, the following language:

 

The Board of Directors of Novelion Therapeutics Inc. [or any future parent
company of Aegerion] (or a designated Committee of the Board)

 

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has made a reasonable inquiry as described in Paragraph 10 of the Plea Agreement
with Aegerion concerning Aegerion’s compliance with its obligations under the
Plea Agreement and the Civil Consent Decree of Permanent Injunction for the
preceding Review Period, [insert date range], including the performance of
management employees responsible for ensuring such compliance. Based on its
reasonable inquiry and review, the Board has concluded that, to the best of its
knowledge, Aegerion has complied with all of its obligations under the Plea
Agreement and the Civil Consent Decree of Permanent Injunction.

 

If the Board is unable to provide any part of this statement, it shall include
in the resolution a written explanation of the reasons why it is unable to
provide such a statement.

 

d.                   The certifications and resolutions referenced in this
Paragraph shall be given by personal delivery, overnight delivery by a
recognized delivery service, or registered or certified mail, addressed to:

 

Chief, Health Care Fraud Unit

U.S. Attorney’s Office for the District of Massachusetts

John Joseph Moakley Federal Courthouse

One Courthouse Way

Boston, MA 02210

 

and

 

Director, Consumer Protection Branch

U.S. Department of Justice

450 5th Street, NW

Washington, DC 20530

 

e.                    The United States’ acceptance of delivery of any
certification or resolution referenced in this Paragraph, or the absence of any
response thereto, is not, and shall not be construed as, evidence of compliance
with this Plea Agreement; the Civil Consent Decree of Permanent Injunction; the
Federal Food, Drug, and Cosmetic Act; or any other applicable laws, policies, or
procedures. The certifications and resolutions referenced in this Paragraph are
in addition to, and not in lieu of, any obligation Aegerion may have under the
Civil Consent Decree of Permanent Injunction.

 

11.          Civil Liability

 

By entering into this Plea Agreement, the United States does not compromise any
civil or administrative liability, including but not limited to any tax
liability, Defendant may have incurred or may incur as a result of Defendant’s
conduct and pleas of guilty to the charges specified in Paragraph 1 of this Plea
Agreement.

 

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Defendant’s civil liability to the United States in connection with certain of
the matters under investigation by the United States is resolved in the attached
Civil False Claims Act Settlement Agreement (Exhibit C) according to the terms
of that Agreement.

 

12.          Waiver of Defenses

 

Should Defendant move to withdraw or otherwise challenge its guilty plea at any
time, should Defendant breach this Plea Agreement, or should the Court reject
the parties’ agreed-upon disposition in this case or any other aspect of this
Plea Agreement, Defendant agrees to waive any defenses based upon the statute of
limitations, the constitutional protection against pre-indictment delay, and the
Speedy Trial Act with respect to any and all charges that could have been timely
brought or pursued as of the date of this Plea Agreement.

 

13.          Breach of Plea Agreement

 

If the United States determines that Aegerion has failed to comply with any
material provision of this Plea Agreement, the United States may, at its sole
option, be released from its commitments under this Plea Agreement in its
entirety by notifying Aegerion, through counsel or otherwise, in writing. The
United States may also pursue all remedies available under the law, even if it
elects not to be released from its commitments under this Plea Agreement.
Aegerion recognizes that no such breach by Aegerion of an obligation under this
Plea Agreement shall be grounds for withdrawal of its guilty plea. Aegerion
understands that should it breach any provision of this Plea Agreement, the
United States will have the right to use against Aegerion before any grand jury,
at any trial or hearing, or for sentencing purposes, any statements that may be
made by Aegerion, and any information, materials, documents, or objects that may
be provided by it to the government subsequent to this Plea Agreement, without
any limitation.

 

In the event Aegerion at any time hereafter breaches any provision of this Plea
Agreement, Aegerion understands that (1) the United States will, as of the date
of that breach, be relieved of any obligations it may have in this Plea
Agreement and the attached Civil False Claims Act Settlement Agreement,
including but not limited to the promise not to further prosecute Aegerion as
set forth in this Plea Agreement; and (2) Aegerion will not be relieved of its
obligation to make the payments set forth in this Plea Agreement and the
attached Civil False Claims Act Settlement Agreement, nor will it be entitled to
return of any monies already paid. Moreover, in the event of a material breach
of this Plea Agreement, Aegerion understands and agrees that the United States
may pursue any and all charges that might otherwise have been brought but for
this Plea Agreement, and Aegerion hereby waives, and agrees it will not
interpose, any defense to any charges brought against it that it might otherwise
have under the Constitution for pre-indictment delay, any statute of
limitations, or the Speedy Trial Act.

 

14.          Who Is Bound by Plea Agreement

 

On the matters set forth in Paragraph 6 above, this Plea Agreement is binding
upon Aegerion, the United States Attorney for the District of Massachusetts, and
the Consumer Protection Branch of the United States Department of Justice.
Aegerion understands that this

 

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Plea Agreement does not bind any state or local prosecutive authorities, the
Fraud Section of the Civil Division of the U.S. Department of Justice, the Tax
Division of the U.S. Department of Justice, or the Internal Revenue Service of
the U.S. Department of the Treasury.

 

15.          Corporate Authorization

 

Aegerion’s acknowledgement of this Plea Agreement and execution of this Plea
Agreement is attached as Exhibit D.

 

16.          Complete Plea Agreement

 

This Plea Agreement and the attachments hereto set forth the complete and only
agreement between the parties relating to the disposition of the Information
described in Paragraph 1. No promises, representations, or agreements have been
made other than those set forth in this Plea Agreement and its attachments. This
Plea Agreement supersedes prior understandings, if any, of the parties, whether
written or oral. This Plea Agreement can be modified or supplemented only in a
written memorandum signed by the parties or on the record in Court.

 

If this letter accurately reflects the agreement between the United States and
your client, Aegerion, please have the authorized representative of Aegerion
sign the Corporate Acknowledgment of Plea Agreement, and please sign the
certification (Exhibit D). Return the original of the Corporate Acknowledgment
of Plea Agreement to Assistant U.S. Attorney Kriss Basil.

 

 

 

Very truly yours,

 

 

 

 

 

William D. Weinreb

 

 

Acting United States Attorney

 

 

 

 

 

 

 

By:

/s/ K. Nathaniel Yeager

 

 

K. Nathaniel Yeager

 

 

Chief, Health Care Fraud Unit

 

 

 

 

 

/s/ Kriss Basil

 

 

Kriss Basil

 

 

Young Paik

 

 

Assistant U.S. Attorneys

 

 

 

 

 

 

 

By:

/s/ Shannon Pedersen

 

 

Shannon Pedersen

 

 

Trial Attorney

 

 

Consumer Protection Branch

 

 

U.S. Department of Justice

 

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EXHIBIT D

 

Corporate Acknowledgement of Plea Agreement

 

The Board of Directors (“Board”) has authorized me to execute this Plea
Agreement on behalf of Aegerion Pharmaceuticals, Inc. (“Aegerion”) and to take
all such actions as may be necessary to effectuate this Plea Agreement. The
Board has read this Plea Agreement and all attached exhibits in their entirety
and has discussed them fully in consultation with Aegerion’s counsel. The Board
acknowledges that this Plea Agreement and attached exhibits fully set form
Aegerion’s agreement with the United States as it relates to the charges in the
Information. The Board further states that no additional promises or
representations have been made to the Board by any official of the Unites States
in connection with the charges in the Information.

 

 

Dated:

9-18-17

 

/s/ Jennifer Fitzpatrick

 

 

 

Aegerion Pharmaceuticals, Inc.

 

 

 

 

 

 

 

/s/ Joshua S. Levy

 

 

 

Joshua S. Levy

 

 

 

Ropes & Gray

 

 

 

Attorney for Defendant Aegerion

 

 

 

Pharmaceuticals, Inc.

 

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