Exhibit 10.6

 

IN THE UNITED STATES DISTRICT COURT

DISTRICT OF MASSACHUSETTS

 

UNITED STATES OF AMERICA,

 

 

 

Plaintiff,

 

 

 

v.

 

 

 

AEGERION PHARMACEUTICALS, INC.,

 

 

 

 

 

Civil Action No.

 

a corporation

 

 

 

and

 

 

 

DR. CHARLES M. GERRITS, an individual,

 

 

 

Defendants.

 

 

CONSENT DECREE OF PERMANENT INJUNCTION

 

Plaintiff, the United States of America, by its undersigned attorneys, having
filed a complaint for permanent injunctive relief against Aegerion
Pharmaceuticals, Inc. (“Aegerion”), a corporation, and Dr. Charles M. Gerrits
(who was hired by Aegerion and assumed his position as Senior Vice President for
Global Market Access, Patient Advocacy, and REMS in January 2017, after all the
investigations described in the Complaint were completed), an individual
(collectively, “Defendants”), and Defendants, having consented to entry of this
Decree without contest, without admitting or denying the allegations in the
Complaint, and disclaiming any liability in connection therewith except for
Aegerion as to the admissions Aegerion makes in the plea agreement in United
States v. Aegerion, Inc., Criminal Action No. (to be assigned) (D. Mass.), and
before any testimony has been taken, and the United States of America, having
consented to this Decree;

 

IT IS HEREBY ORDERED, ADJUDGED, AND DECREED as follows:

 

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1.                                      This Court has jurisdiction over the
subject matter of this action and personal jurisdiction over all parties to this
action pursuant to 28 U.S.C. § 1345 and 21 U.S.C. § 332(a).

 

2.                                      Venue is proper in this District under
28 U.S.C. § 1391(b) and (c).

 

3.                                      The Complaint for Permanent Injunction
states a cause of action against Defendants under the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. §§ 301 et seq. (the “Act”). This Decree is in accordance
with the Act and the Court’s inherent equitable authority.

 

4.                                      The government alleges that Aegerion
violated the Act, 21 U.S.C. § 331(a), by introducing or causing to be
introduced, or delivering or causing to be delivered for introduction into
interstate commerce articles of drug that were misbranded within the meaning of
21 U.S.C. § 352(f)(1) in that their labeling bore inadequate directions for use,
and 21 U.S.C. § 352(y) in that Defendants failed to comply with a Risk
Evaluation and Mitigation Strategy (“REMS”) pursuant to 21 § U.S.C. 355(p).

 

5.                                      The government also alleges that
Aegerion violated the Act, 21 U.S.C. § 331(k), by doing acts that resulted in
the misbranding of articles of drug, within the meaning of 21 U.S.C. §
352(f)(1) and 21 U.S.C. § 352(y), while such drugs were held for sale after the
shipment of one or more of their components in interstate commerce.

 

DEFINITIONS

 

6.                                      For purposes of this Decree, the
following definitions shall apply:

 

A.                                    “Associated Persons” means each and all of
Aegerion’s directors, officers, agents, employees, representatives, successors,
assigns, attorneys, and any and all persons in active concert or participation
with any of them who are engaged in the operation of the Juxtapid REMS Program
(including individuals, directors,

 

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partnerships, corporations, subsidiaries, and affiliates) and who receive actual
notice of this Decree by personal service or otherwise.

 

B.                                    “Days” refers to calendar days, including
all Saturdays, Sundays, and federal holidays.

 

C.                                    “Detailing,” in the context of this
Decree, means interaction by, or at the direction of, a Covered Person with a
healthcare provider, in person, by telephone, email, or other electronic media,
or by direct mail, for the purpose of promoting Juxtapid.

 

D.                                    “Drug(s)” shall have the meaning given the
term in 21 U.S.C. § 321(g)(1).

 

E.                                     “Covered Persons” includes:

 

i.                                          all Aegerion employees engaged in or
directly responsible for: (a) the selling, detailing, marketing, advertising,
promoting, or branding of Juxtapid; and (b) the preparation or external
dissemination of promotional materials or information about, or the provision of
promotional services relating to, Juxtapid, including those functions relating
to Aegerion’s review and approval processes for promotional materials and any
applicable review committee(s);

 

ii.                                       all Aegerion employees engaged in
activities related to compliance with or training on any REMS Program
requirements for Juxtapid; and

 

iii.                                    all contractors, agents and other
persons engaged in (a) the selling, detailing, marketing, advertising,
promoting, or branding of Juxtapid; (b) the preparation or external
dissemination of promotional materials or information about, or the provision of
promotional services relating to, Juxtapid, including those functions relating
to Aegerion’s review and

 

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approval processes for promotional materials and any applicable review
committee(s); or (c) activities related to compliance with or training on any
REMS Program requirements for Juxtapid.

 

F.                                      “Juxtapid” is the trade name of the
pharmaceutical drug, lomitapide mesylate, approved by the FDA as an adjunct to a
low-fat diet and other lipid-lowering treatments, including LDL apheresis where
available, to reduce low-density lipoprotein cholesterol (LDL-C), total
cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein
cholesterol (non-HDL-C) in patients with homozygous familial
hypercholesterolemia (HoFH).

 

G.                                    “Juxtapid REMS Program” means all elements
of the Risk Evaluation and Mitigation Strategy applicable to Juxtapid as of the
date this Decree is entered, including any modifications of the REMS, or any
changes to the Juxtapid REMS accepted by FDA during the term of this Decree.

 

INJUNCTION PROVISIONS

 

7.                                      Defendants and each and all of their
Associated Persons are permanently restrained and enjoined under 21 U.S.C. §
332(a) from directly or indirectly doing or causing to be done, at any location,
any act that:

 

A.                                    violates 21 U.S.C. § 331(a) by introducing
or delivering for introduction into interstate commerce, any article of drug
that is misbranded within the meaning of 21 U.S.C. §§ 352(f)(1) and 352(y); and,

 

B.                                    violates 21 U.S.C. § 331(k) by causing any
drug to become misbranded within the meaning of 21 U.S.C. §§ 352(f)(1) and
352(y), while such drug is held for sale after shipment in interstate commerce.

 

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8.                                      Upon entry of this Decree, Defendants
shall, consistent with the Juxtapid REMS Program:

 

A.                                    With respect to healthcare providers:

 

i.                                          provide mechanisms for healthcare
providers to complete the certification process for the Juxtapid REMS Program by
email and fax;

 

ii.                                       notify healthcare providers when they
are certified by the Juxtapid REMS Program;

 

iii.                                    maintain a validated, secure database of
healthcare providers who are certified to prescribe Juxtapid in the Juxtapid
REMS Program;

 

iv.                                   require that healthcare providers who
prescribe Juxtapid be certified in compliance with the Juxtapid REMS Program and
complete a Juxtapid REMS Program Prescription Authorization Form for each new
Juxtapid prescription;

 

v.                                      investigate all instances of healthcare
provider potential noncompliance with the Juxtapid REMS Program requirements;

 

vi.                                   de-certify any healthcare provider who has
demonstrated a pattern of noncompliant prescribing, defined as any healthcare
provider who Aegerion determines, after completing its investigation, has not
complied with the Juxtapid REMS Program requirements on two or more occasions;

 

vii.                                provide the Juxtapid REMS Program Fact
Sheet, Juxtapid REMS Program Prescriber Training Module, Juxtapid REMS Program
Patient Guide, Juxtapid REMS Program Patient-Prescriber Acknowledgement Form,
Juxtapid REMS Program Prescription Authorization Form and the

 

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Juxtapid Prescribing Information to healthcare providers who (1) attempt to
prescribe Juxtapid and are not yet certified, or (2) inquire about how to become
certified; and

 

viii.                             ensure that the REMS Letter for Healthcare
Providers that was sent on February 22, 2017 and made available on the Juxtapid
REMS Program Website (www.juxtapidREMSprogram.com) be available upon request
from the Juxtapid REMS Program by phone at 1-855- JUXTAPID (1-855-898-2743).

 

B.                                    With respect to pharmacies:

 

i.                                          require pharmacies that seek to
dispense Juxtapid to designate an authorized representative;

 

ii.                                       require such pharmacies’ authorized
representatives to complete and submit to Aegerion the Juxtapid REMS Program
Pharmacy Enrollment Form;

 

iii.                                    notify pharmacies when they are
certified by the Juxtapid REMS Program;

 

iv.                                   ensure that certified pharmacies are
provided access to a database of certified prescribers and patients who have a
completed Juxtapid REMS Program Patient-Prescriber Acknowledgement Form;

 

v.                                      verify every twelve (12) months that the
authorized representative’s name and contact information corresponds to that of
the current designated authorized representative for the certified pharmacy;

 

vi.                                   require certified pharmacies to recertify
in the Juxtapid REMS Program if a pharmacy designates a new authorized
representative;

 

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vii.                                require certified pharmacies to maintain,
and make available to Aegerion or a third party acting on behalf of Aegerion,
documentation, including prescription data and training and verification
records, to demonstrate that all processes and procedures are in place and are
being followed for the Juxtapid REMS Program; and,

 

viii.                             require certified pharmacies to comply with
audits by Aegerion, FDA, or a third party acting on behalf of Aegerion or FDA to
ensure that all processes and procedures are in place and are being followed for
the Juxtapid REMS Program.

 

C.                                    With respect to the evidence of safe-use
conditions for Juxtapid:

 

i.                                          require that patients or their
caregivers sign a Juxtapid REMS Program Patient-Prescriber Acknowledgement
Form indicating that the patient has: (a) received and read the Juxtapid REMS
Program Patient Guide; and (b) received counseling from his or her prescriber
regarding the risk of hepatotoxicity, the need for periodic liver function
monitoring, and appropriate patient selection for Juxtapid;

 

ii.                                       provide mechanisms for certified
prescribers to be able to submit completed Juxtapid REMS Program
Patient-Prescriber Acknowledgement Forms by email and fax;

 

iii.                                    require that, before dispensing
Juxtapid, pharmacies have: (a) reviewed the Prescribing Information and the
Juxtapid REMS Program Fact Sheet; (b) completed the Juxtapid REMS Program
Pharmacy Training Module and successfully completed the Knowledge Assessment;
and (c) trained all

 

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relevant staff on appropriate procedures for dispensing Juxtapid in accordance
with the Juxtapid REMS Program Pharmacy Training Module;

 

iv.                                   require that certified pharmacies dispense
Juxtapid to patients only if they can verify that, for each Juxtapid
prescription there is: (a) a completed Juxtapid REMS Program Patient-Prescriber
Acknowledgement Form; and (b) a prescription from a certified prescriber; and

 

v.                                      require that certified pharmacies only
fill new Juxtapid prescriptions if they can verify that there is a completed
Juxtapid REMS Program Prescription Authorization Forms for each new Juxtapid
prescription.

 

D.                                    Submit to FDA, at least ninety (90) days
before administering, any survey methodology and protocols to which Defendants
have made substantive changes (which methodology and protocols shall include at
least: the target sample size; precision estimates associated with that sample
size; a list of specific criteria that will be used to select participants in
the survey; a description of how and when the surveys will be administered; an
explanation of the design features and controls that will be included to
minimize bias and compensate for any limitations in the methodology; and a copy
of the survey questionnaire), for the following surveys:

 

i.                                          a “Knowledge, Attitudes, and
Behavior” (“KAB”) survey of a random sample of certified prescribers to
determine, for Juxtapid, prescribers’ awareness and understanding of: (a) the
indication for use; (b) the risk of hepatotoxicity, including appropriate
evaluation, monitoring and counseling to minimize this risk as described in the
Prescribing

 

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Information, the Fact Sheet, and the Prescriber Training Module; (c) the
Juxtapid REMS Program materials; and, (d) the Juxtapid REMS Program
requirements; and

 

ii.                                       a Patient Knowledge survey to evaluate
patient understanding of the Juxtapid REMS goals concerning the risk of
hepatotoxicity and the need for baseline and periodic monitoring.

 

E.                                     Receive written approval from FDA for the
KAB and Patient Knowledge protocols, including any amended protocols, before
administering either survey.

 

9.                                      Nothing in this Decree shall affect the
date by which prescribers and pharmacies must be recertified in accordance with
the Juxtapid REMS Program approved by FDA on January 3, 2017, and any changes
thereto approved by FDA or otherwise accepted by FDA.

 

10.                               Nothing in this Decree shall alter Defendants’
requirement under the Juxtapid REMS Program to submit written assessments to FDA
or FDA’s ability to change the timetable for such assessments under the Juxtapid
REMS Program, including by reducing the frequency of or eliminating the
requirement to submit such assessments. The requirements of this Decree are in
addition to, and not instead of, the Juxtapid REMS Program reporting
requirements.

 

11.                               Within ninety (90) days of entry of this
Decree, Defendants shall retain an independent person or persons (the “Auditor”)
at Aegerion’s expense to review and monitor Defendants’ activities related to
the Juxtapid REMS Program not less than once every twelve (12) months for a
period of five (5) years. The Auditor shall be qualified by education, training,
and experience to conduct such audits, and shall be without personal or
financial ties (other than a consulting agreement with Defendants) to
Defendants’

 

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officers or employees or their immediate families. Defendants shall notify FDA
in writing of the identity and qualifications of the Auditor as soon as they
retain such Auditor. The Auditor shall evaluate the Defendants’ REMS Assessment
Reports (“REMS Assessments”) for any non-compliance with the Juxtapid REMS
Program. Specifically, the Auditor shall, consistent with the Juxtapid REMS
Program:

 

A.                                    Evaluate Defendants’ implementation of the
KAB and Patient Knowledge Surveys and whether Defendants adhered to the
protocols and methodologies approved by FDA in Paragraph 8(E).

 

B.                                    Evaluate Defendants’ communications with
certified prescribers and certified pharmacies. The Auditor shall determine
whether each REMS Assessment includes, at a minimum:

 

i.                                          the date of mailing and number of
recipients of the REMS Letter for Healthcare Providers and REMS Letter for
Pharmacists;

 

ii.                                       the number of mailings returned;

 

iii.                                    a representative copy of all documents
included in each mailing;

 

iv.                                   a summary of issues and complaints
received by the Juxtapid REMS Program Call Center and a summary how these issues
and complaints were resolved; and

 

v.                                      a summary of the reasons (and numbers
per reason) for calls into the Juxtapid REMS Program Call Center.

 

C.                                    Evaluate Defendants’ compliance with the
prescriber certification requirements. The Auditor shall determine whether each
REMS Assessment includes, at a minimum:

 

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i.                                          the number of healthcare prescribers
certified or re-certified in the Juxtapid REMS Program during the reporting
period and cumulatively (stratified by prescriber degree, practice setting,
geographic location and specialty);

 

ii.                                       the volume of prescriptions for each
prescriber and each specialty, including a full breakdown of prescribing
specialties contained in the “other” category;

 

iii.                                    the specialties of any “high volume”
prescribers, i.e., those who write more than four (4) prescriptions in an
assessment period and cumulatively, including a full breakdown of prescribing
specialties contained in the “other” category;

 

iv.                                   a summary of the method prescribers used
to enroll during the reporting period and cumulatively; and

 

v.                                      the number of healthcare providers that
had their certification revoked during the reporting period and cumulatively and
the reason for the revocation.

 

D.                                    Evaluate Defendants’ compliance with the
wholesaler/distributor authorization requirements. The Auditor shall determine
whether each REMS Assessment includes, at a minimum:

 

i.                                          the number of
wholesalers/distributors that were authorized in the REMS program, during the
reporting period and cumulatively;

 

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ii.                                       the number of wholesalers/distributors
that had their authorization revoked during the reporting period and
cumulatively and the reason for the revocation;

 

iii.                                    the number of Juxtapid orders shipped to
pharmacies during the reporting period and cumulatively, including number of
bottles, bottle size, and dosage strength; and

 

iv.                                   the number of Juxtapid orders shipped to
non-certified pharmacies.

 

E.                                     Evaluate Defendants’ compliance with the
pharmacy enrollment and metrics requirements. The Auditor shall determine
whether each REMS Assessment includes, at a minimum:

 

i.                                          the number of pharmacies that were
certified or re-certified in the Juxtapid REMS Program during the reporting
period and cumulatively;

 

ii.                                       the number of pharmacies that had
their certification revoked during the reporting period and cumulatively and the
reason for the revocation;

 

iii.                                    the number of new Juxtapid prescriptions
received;

 

iv.                                   the total number of prescriptions
dispensed for Juxtapid, including quantity of capsules (mean, minimum, and
maximum) and dosage strength during the reporting period and cumulatively;

 

v.                                      the total number of Juxtapid
prescriptions that were: (a) received from certified and non-certified
healthcare providers; (b) dispensed without a signed attestation on the Juxtapid
REMS Program Prescription Authorization Form; or (c) dispensed without a
completed Juxtapid REMS Program Patient-Prescriber Acknowledgement Form;

 

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vi.                                   the number and details concerning any
prescribers that submitted an altered Juxtapid REMS Program Prescription
Authorization Form, and whether pharmacies dispensed Juxtapid in response to
such forms;

 

vii.                                the number and demographics (e.g., including
gender, age, geographic location) of unique patients who received Juxtapid
during the reporting period and cumulatively, calculated by reconciling orders
dispensed to unique patients;

 

viii.                             duration of therapy for patients (mean,
median, and range);

 

ix.                                   the number of prescriptions pending or
canceled, and an explanation for their status, including the specific criterion
used to classify a prescription as canceled;

 

x.                                      the number, length, and reasons for
shipment delays to patients and whether or not these reasons were related to the
REMS, and any additional information from insurance payers as to the reason for
delay/non-payment; and

 

xi.                                   the percentage of fill delays that involve
new prescriptions versus refills.

 

F.                                      Evaluate whether the Juxtapid REMS
Program and Defendants’ implementation thereof is meeting the goal to mitigate
the risk of hepatotoxicity associated with Juxtapid, and whether Defendants
have:

 

i.                                          included a detailed description of
root cause of any noncompliance with the REMS Program, and any corrective and/or
preventive actions taken to address the noncompliance;

 

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ii.                                       provided an analysis of the
post-marketing cases of specific hepatic adverse events reported in association
with Juxtapid during the reporting period and cumulatively, and the outcome of
such analysis;

 

iii.                                    specified measures that will be taken to
increase awareness if the KAB survey indicates inadequate prescriber awareness
of the risks associated with Juxtapid; and

 

iv.                                   assessed the extent to which each approved
strategy, including each element of each strategy, is meeting the goal or
whether one or more such strategies or such elements should be modified.

 

G.                                    Prepare a written audit report (the “Audit
Report”) at the conclusion of each Audit, synthesizing the Auditor’s
observations, analyzing whether Defendants’ operations are in compliance with
the Juxtapid REMS Program and this Decree with respect to the Juxtapid REMS
Program, and identifying in detail any deviations from the foregoing (“Audit
Report Observations”). Each Audit Report shall:

 

i.                                          list all records and information
reviewed by the Auditor in connection with the report, including, but not
limited to, call notes, emails, message recall studies, and prescription data,
and whether the Auditor requires additional information or materials to evaluate
compliance;

 

ii.                                       assess the adequacy of corrective
actions taken by Defendants to correct all previous Audit Report Observations;

 

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iii.                                    include the survey results and summaries
and analyses for all of the completed KAB and Patient Knowledge surveys, if not
included in Defendants’ REMS Assessment;

 

iv.                                   contain a written assessment of the
Defendants’ compliance with the requirements of the Act, its regulations, and
this Decree with respect to its operation of the Juxtapid REMS program,
including any adverse observations that indicate inconsistency with the Juxtapid
REMS Program and goals; and,

 

v.                                      be completed and delivered
contemporaneously to Defendants and FDA by courier service or overnight delivery
service, no later than sixty (60) days after Defendants submit each REMS
Assessment to FDA.

 

12.                               Defendants shall maintain complete Audit
Reports and all of their underlying data in readily accessible files at their
facilities and shall promptly make the Audit Reports and underlying data
available to FDA upon request. Additionally, if an Audit Report contains any
Audit Report Observations, Defendants shall, within forty-five (45) days after
receipt of the Audit Report, take action to correct those observations, unless
FDA notifies Defendants that a shorter time period is necessary. If, after
receiving the Audit Report, Defendants believe that any action it plans to take
to correct any Audit Report Observation will take longer than forty-five (45)
days, or any shorter period required by FDA, Defendants shall, within fifteen
(15) days after receipt of the Audit Report, propose a schedule for completing
such actions (“Action Schedule”) and provide justification for the additional
time. That Action Schedule must be reviewed and approved by FDA in writing.
Defendants shall complete all corrections according to the approved Action

 

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Schedule and notify the Auditor when such actions are complete. Within thirty
(30) days after being notified that Defendants have taken actions to correct the
Audit Report Observations, the Auditor shall review the actions taken by
Defendants to correct the Audit Report Observation(s). Within fifteen (15) days
of completing the review, the Auditor shall complete and deliver a written
report contemporaneously to Defendants and FDA by courier service or overnight
delivery service addressing whether each of the Audit Report Observations has
been corrected and, if not, which adverse Audit Report Observations remain
uncorrected; explaining the Auditor’s basis for such a determination; and
identifying the actions required by Defendants to correct each of the Audit
Report Observations.

 

13.                               In the event Defendants replace the Auditor
required by this Decree, Defendants shall notify FDA in writing of this change
within thirty (30) days after such replacement. In satisfying the requirements
of this Decree, any Auditor may review the previous Auditor’s work, and refer to
such work to satisfy the requirements of the Decree; however, when such work is
referenced by the new Auditor, he or she shall identify the specific prior work
referenced.

 

14.                               If, at any time after entry of this Decree,
FDA determines, based on the results of an inspection, a report submitted by
Defendants, the Auditor, or any other information, that Defendants have failed
to comply with any provision of this Decree, the Act, or its implementing
regulations with respect to the operation of the Juxtapid REMS Program, or that
additional corrective actions are necessary to achieve compliance with this
Decree, the Act, or its implementing regulations with respect to the operation
of the Juxtapid REMS Program, FDA may, as and when it deems necessary, notify
Defendants

 

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in writing of the noncompliance and order Defendants to take appropriate
corrective action, including, but not limited to, ordering Defendants to
immediately take one or more of the following actions:

 

A.                                    Cease selling, detailing, and/or
distributing Juxtapid;

 

B.                                    Revise, modify, expand, or continue to
submit any reports or plans prepared pursuant to this Decree;

 

C.                                    Submit additional reports or information
to FDA as requested;

 

D.                                    Issue a safety alert; and/or

 

E.                                     Take any other corrective actions as FDA,
in its discretion, deems necessary to bring Defendants into compliance with this
Decree, the Act, and its implementing regulations with respect to the Juxtapid
REMS Program, including instituting or re-implementing any of the requirements
set forth in this Decree.

 

The provisions of this Paragraph shall be apart from, and in addition to, all
other remedies available to FDA.

 

15.                               The following process and procedures shall
apply in the event that FDA issues an order under Paragraph 14:

 

A.                                    Upon receipt of any order issued by FDA
pursuant to Paragraph 14, Defendants shall, within ten (10) business days after
receiving such order, notify FDA in writing either that: (i) Defendants are
undertaking or have undertaken corrective action(s), in which event Defendants
shall describe the specific action(s) taken or proposed to be taken and the
proposed schedule for completing the action(s); or (ii) Defendants do not agree
with FDA’s order. If Defendants notify FDA that they do not agree with FDA’s
order, Defendants shall explain in writing the basis

 

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for their disagreement; in doing so, Defendants may also propose specific
alternative actions and specific time frames for achieving FDA’s objectives.

 

B.                                    If Defendants notify FDA that they do not
agree with FDA’s order, FDA will review Defendants’ notification and thereafter,
in writing, affirm, modify, or withdraw its order, as FDA deems appropriate. If
FDA affirms or modifies its order, it will explain the basis for its decision in
writing. The written notice of affirmation or modification shall constitute
final agency action.

 

C.                                    If FDA affirms or modifies its order,
Defendants shall, upon receipt of FDA’s notice of affirmation or modification,
immediately implement the order (as modified, if applicable), and, if they so
choose, bring the matter before this Court on an expedited basis. Defendants
shall continue to diligently implement FDA’s order, as modified if applicable,
unless the Court sets aside, stays, reverses, vacates, or modifies FDA’s order.
Any review of FDA’s order under this Paragraph shall be made in accordance with
the terms set forth in Paragraph 32.

 

D.                                    The procedures set forth in Paragraphs
15(A)-15(C) shall not apply to any order issued under Paragraph 14 if such order
states that it is based on FDA’s judgment that the matter raises significant
public health concerns, and FDA’s judgment and basis for such decision are
stated in the order. In such case, Defendants shall immediately and fully comply
with the terms of that order. If they so choose, Defendants may bring the matter
before this Court on an expedited basis. Defendants shall continue to diligently
implement FDA’s order, unless the Court sets aside, stays, reverses, vacates, or
modifies FDA’s order. Any review of

 

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FDA’s order under this Paragraph shall be made in accordance with the terms set
forth in Paragraph 32.

 

E.                                     Any cessation of operations or other
action described in Paragraphs 14 or 15 shall continue until Defendants receive
written notification from FDA that Defendants appear to be in compliance with
this Decree, the Act, and its implementing regulations with respect to the
operation of the Juxtapid REMS Program, and that Defendants may resume
operations. Defendants may at any time submit a request to FDA in writing to
discontinue any cessation of operations or other action described in Paragraph
14. After receiving Defendants’ written request to resume operations, FDA will
determine whether it needs to inspect any of Defendants’ facilities to determine
Defendants’ compliance with this Decree, the Act, and its implementing
regulations with respect to the operation of the Juxtapid REMS Program. If FDA
determines that an inspection is necessary, it shall conduct the inspection and
determine whether Defendants appear to be in compliance with this Decree, the
Act, and its implementing regulations with respect to the operation of the
Juxtapid REMS Program, and, if so, FDA will issue to Defendants a written
notification permitting resumption of operations. Irrespective of FDA’s decision
to conduct an inspection, FDA will decide within sixty (60) days after receipt
of the Defendants’ written request whether Defendants appear to be in compliance
and, if so, issue to Defendants a written notification permitting resumption of
actions described in Paragraph 14. The cost of FDA’s inspections, sampling,
testing, travel time, and subsistence expenses to

 

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implement the remedies set forth in Paragraphs 14 and 15 shall be borne by
Defendants at the rates specified in Paragraph 27.

 

16.                               Within thirty (30) days after entry of this
Decree, Defendants shall post a letter in a prominent place on the main page of
its company website and for a period of three years thereafter. This letter
shall be dated and shall be signed by Aegerion’s Board Chair and shall contain
the language set forth below:

 

As you may be aware, Aegerion Pharmaceuticals, Inc. (Aegerion) recently entered
into a global civil, criminal, and administrative settlement with the United
States and individual states in connection with Aegerion’s promotion and sales
of its product Juxtapid. This letter provides you with additional information
about the global settlement, explains Aegerion’s commitments going forward, and
provides you with access to information about those commitments.

 

In general terms, the Government alleges that Aegerion engaged in several types
of unlawful and improper conduct. More specifically, the Government alleges that
Aegerion unlawfully distributed Juxtapid for intended uses not approved by FDA
and failed to comply with a Risk Evaluation and Mitigation Strategy required by
the FDA for Juxtapid. The Government also alleges that certain Aegerion
employees made false and misleading statements about Juxtapid, that the company
violated certain patient privacy requirements, and that Aegerion made payments
to an independent charity for patient co-payment assistance that violated the
Anti-kickback Statute.

 

To address these issues, Aegerion pleaded guilty to violating the Federal Food,
Drug, and Cosmetic Act and agreed to pay approximately $7 million in criminal
fines and forfeiture. Aegerion also entered into a five-year Deferred
Prosecution Agreement to resolve claims that it violated the Health Insurance
Portability and Accountability Act of 1996 (HIPAA). Separately, Aegerion agreed
to enter into a civil Consent Decree of Permanent Injunction to be monitored by
the U.S. Food and Drug Administration (FDA).

 

In addition, the federal government and several individual states alleged that
Aegerion’s conduct violated the federal False Claims Act and equivalent state
statutes. To resolve those allegations, Aegerion entered into a separate civil
False Claims Act settlement whereby Aegerion agreed to reimburse federal and
state health care programs approximately $29 million.

 

Finally, the Securities and Exchange Commission alleged that Aegerion’s conduct
violated federal security statutes. To resolve those allegations, Aegerion
entered into a separate civil securities settlement whereby Aegerion agreed to
pay

 

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approximately $4 million. Copies of and more information about these settlements
may be found at the following website:

 

https://www.justice.gov/civil/current-and-recent-cases#_Pharm2

 

As part of the global settlement, Aegerion also entered into a five-year
corporate integrity agreement with the Office of Inspector General of the U.S.
Department of Health and Human Services. The corporate integrity agreement is
available at http://oig.hhs.gov/fraud/cia/index.html. Under this agreement,
Aegerion agreed to undertake certain obligations designed to promote compliance
with Federal health care program and FDA requirements. We also agreed to notify
healthcare providers about the settlement and inform them that they can report
any questionable practices by Aegerion’s representatives to Aegerion’s
Compliance organization or the FDA using the information set out below. Please
call Aegerion at 1-855-463-8974 or visit us at
http://novelion.com/about-novelion/aegerion-pharmaceuticals/aegerion-government-settlement
if you have questions about the settlement referenced above. Please call
Aegerion at 1-855-233-8089 or visit us at
https://novelioncompliance.tnwreports.com to report any instances in which you
believe that an Aegerion representative inappropriately promoted a product or
engaged in other questionable conduct. Alternatively, you may report any
improper conduct associated with prescription drug marketing committed by an
Aegerion Representative to the FDA’s Office of Prescription Drug Promotion at
301-796-1200.You should direct medical questions or concerns about Aegerion
products to 1-855-303-2347 or
http://www.novelion.com/physician-resources/global-medical-information.

 

Within thirty five (35) days after entry of this Decree, Defendants shall
provide to FDA an affidavit, from a person with personal knowledge of the facts
stated therein, stating the fact and manner of their compliance with this
Paragraph.

 

17.                               Within thirty (30) days after entry of this
Decree, Defendants shall communicate to all Covered Persons that Defendants have
entered into this Decree and describe the terms and obligations of this Decree.
Within thirty-five (35) days after entry of this Decree, Defendants shall
provide to FDA an affidavit, from a person with personal knowledge of the facts
stated therein, stating the fact and manner of their compliance with this
Paragraph and a copy of the communication(s) sent pursuant to this Paragraph.

 

18.                               Within fifteen (15) days after entry of this
Decree, Defendants shall provide a copy of the Decree by personal service,
electronic mail, or certified mail (return receipt requested) to

 

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each and all Covered Persons and Associated Persons. Within twenty (20) days
after entry of this Decree, Defendants shall provide to FDA an affidavit, from a
person with personal knowledge of the facts stated therein, stating the fact and
manner of Defendants’ compliance with this Paragraph, and identifying the names,
street or electronic mail addresses (as applicable), and positions of all
persons who have received a copy of this Decree in accordance with this
Paragraph.

 

19.                               In the event that any of the Defendants
becomes associated with additional Associated Persons at any time after entry of
this Decree, Defendants shall, within fifteen (15) days of the commencement of
such association, provide a copy of this Decree, by personal service, electronic
mail, or certified mail (restricted delivery, return receipt requested), to such
Associated Persons. Defendants shall, every twelve (12) months, provide FDA an
affidavit, from a person with personal knowledge of the facts stated therein,
stating the fact and manner of Defendants’ compliance with this Paragraph,
identifying the names, street or electronic mail addresses (as applicable), and
positions of all Associated Persons who received a copy of this Decree pursuant
to this Paragraph. Within ten (10) days of receiving a request from FDA for any
information or documentation FDA deems necessary to evaluate compliance with
this Paragraph, Defendants shall provide such information or documentation to
FDA.

 

20.                               Aegerion shall notify FDA, in writing, at the
address specified in Paragraph 29, at least ten (10) days before any change in
ownership, character, or name of their business, such as dissolution,
assignment, or sale resulting in the emergence of a successor corporation, the
creation or dissolution of subsidiaries, franchises, affiliates, or “doing
business as” entities that may affect the operations, assets, rights, or
liabilities of Aegerion in the

 

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United States, or any other change in the organizational structure of Aegerion
or in the sale or assignment of any business assets, such as buildings,
equipment, or inventory, that may affect compliance with this Decree. Aegerion
shall provide a copy of this Decree to any potential successor or assignee at
least fifteen (15) days before any sale or assignment. Aegerion shall furnish
FDA with an affidavit, from a person with personal knowledge of the facts stated
therein, stating the fact and manner of their compliance with this Paragraph no
later than ten (10) days prior to such assignment or change in ownership.

 

21.                               Should Aegerion intend to permanently transfer
all rights to Juxtapid, including the responsibilities related to its marketing,
compliance with the FDCA and its implementing regulations, and the Juxtapid
REMS, it must notify FDA as required by Paragraph 20, and provide FDA, within
ten (10) days, with any additional information about the transaction that the
agency may request. No sooner than sixty (60) days after providing FDA with any
additional information requested by the agency under this Paragraph, or if no
such information is requested within sixty (60) days of Aegerion providing
notice under Paragraph 20, Aegerion may petition the Court to substitute the
entity obtaining the rights to Juxtapid as the corporate Defendant under this
Consent Decree (“Substitute Corporate Defendant”). Aegerion shall remain bound
as the Corporate Defendant under this Decree unless and until the Substitute
Corporate Defendant agrees in writing to be bound by this Consent Decree and is
so ordered by the Court.

 

22.                               If Defendant Gerrits’s responsibilities are
materially reduced or altered, or his position is eliminated, Aegerion shall
petition the Court to substitute for him an individual Defendant that is either
his successor or the individual or individuals vested with the

 

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responsibility for the Juxtapid REMS program and regulatory compliance with the
Act, its regulations, and this Decree. If removing an individual Defendant would
result in no individual Defendant being subject to this Decree, Aegerion shall
designate an individual or individuals of similar position and responsibility to
be substituted as Defendant(s) (“Substitute Individual Defendant(s)”), and
provide FDA with the name(s), position description(s), and organizational
chart(s) demonstrating the position and responsibilities for the proposed
Substitute Individual Defendant(s). Aegerion shall petition the Court to
substitute the Substitute Individual Defendant(s) for Defendant Gerrits’s and
the United States will not oppose such a motion so long as FDA has sufficient
evidence or information regarding the position and responsibilities of the
proposed Substitute Individual Defendant(s).

 

23.                               FDA shall be permitted, without prior notice
and when FDA deems necessary, to make inspections of the Defendants’ place(s) of
business during reasonable times and within reasonable limits and in a
reasonable manner, and, without prior notice, take any other measures necessary
to monitor and ensure continuing compliance with the terms of this Decree, the
Act, and FDA regulations with respect to the Juxtapid REMS Program. During
inspections, FDA shall be permitted to have ready access to buildings,
equipment, products, labeling, and other materials therein; take photographs and
make video recordings; take samples of Defendants’ products, containers,
packaging material, labeling, and other materials; and examine and copy all
records relating to the importing, receiving, manufacturing, preparing,
processing, packing, labeling, holding, and/or distributing of any and all drugs
and their respective components. FDA will provide Defendants with a receipt for
any samples taken pursuant to 21 U.S.C. § 374 and with

 

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copies of any photographs and video recordings made, upon a written request by
Defendants and at Aegerion’s expense. The inspections shall be permitted upon
presentation of a copy of this Decree and appropriate credentials. The
inspection authority granted by this Decree is separate from, and in addition
to, the authority to make inspections under the Act, 21 U.S.C. § 374.

 

24.                               Defendants’ obligations under this Decree do
not modify or absolve them from any prospective obligation to comply with the
Act or its implementing regulations or any other federal statute or regulation.

 

25.                               Nothing in this Decree shall affect FDA’s
authority to suspend or revoke any applications pursuant to 21 U.S.C. §
355(e) or either party’s ability to take any other action authorized by the Act
or its implementing regulations, including any action related to the Juxtapid
REMS Program.

 

FINANCIAL PROVISIONS

 

26.                               Should Defendants fail to comply with any
provision of this Decree, the Act, or its implementing regulations with respect
to the operation of the Juxtapid REMS Program, Aegerion shall pay to the United
States of America ten thousand dollars ($10,000) in liquidated damages for each
such violation of this Decree, the Act, and/or its implementing regulations, and
an additional ten thousand dollars ($10,000) in liquidated damages per day, per
violation, for each violation of this Decree, the Act, and/or its implementing
regulations with respect to the operation of the Juxtapid REMS Program. The
total payments under this Paragraph shall not exceed one million dollars
($1,000,000). Defendants understand and agree that the liquidated damages
specified in this Paragraph are not punitive in nature and their imposition does
not in any way limit

 

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the ability of the United States to seek, and the Court to impose, additional
civil or criminal penalties based on conduct that may also be the basis for
payment of the liquidated damages.

 

27.                               Aegerion shall pay all costs of all FDA
inspections, investigations, analyses, examinations, sampling, reviews, document
preparation, testing, travel, and subsistence expenses that FDA deems necessary
to evaluate Defendants’ compliance with any part of this Decree, at the standard
rates prevailing at the time costs are incurred. For the purposes of this
Decree, inspections include, but are not limited to, FDA’s review and analysis
of Defendants’ claims for their products in the product labels, labeling,
promotional materials, and any and all websites or any other media owned or
controlled by or related to Aegerion or their articles of drug. As of the date
that this Decree is signed by the parties, these rates are: $90.65 per hour and
fraction thereof per representative for inspection or investigative work;
$108.83 per hour or fraction thereof per representative for analytical or review
work; $0.54 per mile for travel by automobile; government rate or the equivalent
for travel by air or other means; and the published government per diem rate or
the equivalent for the areas in which the inspections are performed per
representative and per day for subsistence expenses. FDA shall submit a
reasonably detailed bill of costs to Aegerion. In the event that the standard
rates applicable to FDA supervision of court-ordered compliance are modified,
these rates shall be increased or decreased without further order of the Court.

 

28.                               Should the United States bring and prevail in
a contempt action to enforce the terms of this Decree, Aegerion shall, in
addition to other remedies, reimburse the United States for its attorneys’ fees
and overhead, investigational and analytical expenses, expert witness

 

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fees, travel expenses incurred by attorneys and witnesses, and court costs
relating to such contempt proceedings.

 

GENERAL PROVISIONS

 

29.                               Defendants shall address all communications
required under this Decree to Director, Office of Compliance, CDER, Building 51,
Room 5270, 10903 New Hampshire Ave., Silver Spring, MD 20993, shall prominently
mark the envelope as “DECREE CORRESPONDENCE,” and shall reference this civil
action by case name and civil action number. Unless otherwise specified, all
notifications, certifications, reports, correspondence, and other communications
to Defendants required by the terms of this Decree shall be addressed to
Aegerion’s Chief Legal Officer with copy to Aegerion’s President, Aegerion
Pharmaceuticals, Inc., One Main Street, Cambridge, MA 02142.

 

30.                               If any deadline in this Decree falls on a
weekend or federal holiday, the deadline shall be continued to the next business
day.

 

31.                               The parties may at any time petition each
other in writing to modify any deadline provided herein, and if the parties
mutually agree in writing to modify a deadline, such extension may be granted
without seeking leave of Court.

 

32.                               All decisions conferred upon FDA in this
Decree or under the Act or its implementing regulations shall be vested in the
discretion of FDA. FDA’s decisions shall be final and, if challenged, shall be
reviewed by the Court under the arbitrary and capricious standard set forth in 5
U.S.C. § 706(2)(A). Review by the Court of any FDA decision rendered pursuant to
this Decree shall be based exclusively on the written record before FDA at the
time the decision was made. No discovery shall be taken by either party.

 

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33.                               In all instances where FDA is required to
provide written notification to Defendants under this Decree, FDA’s silence
shall not be construed as a substitute for written notification.

 

34.                               If, and for so long as, an individual
Defendant ceases to be employed by and to act on behalf of Aegerion or any of
its subsidiaries, franchises, affiliates, or “doing business as” entities, then
that individual shall not be subject to this Decree, except as to such
individual’s act(s) or failure(s) to act under this Decree prior to the time
such individual ceased to be employed by and to act on behalf of Aegerion or any
of its subsidiaries, franchises, affiliates, or “doing business as” entities.

 

35.                               If Defendants have maintained a state of
continuous compliance with the Juxtapid REMS Program, the Act, its implementing
regulations, and this Decree for at least 60 months after entry of this Decree,
Defendants may petition the Court for relief from this Decree, and the
Government will not oppose the petition.

 

36.                               This Court retains jurisdiction over this
action and the parties thereto for the purpose of enforcing and modifying this
Decree and for the purpose of granting such additional relief as may be
necessary or appropriate.

 

SO ORDERED, this        Day of           , 2017

 

 

 

 

UNITED STATES DISTRICT JUDGE

 

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The undersigned hereby consent to entry of the foregoing Decree:

 

FOR DEFENDANTS

 

FOR PLAINTIFF

 

 

 

/s/ Charles M. Gerrits

 

WILLIAM D. WEINREB

CHARLES M. GERRITS

 

Attorney for the United States

individually, and on behalf of AEGERION

 

Acting Under 28 U.S.C. § 515

PHARMACEUTICALS, INC.

 

 

 

 

 

/s/ Gregory H. Levine

 

/s/ Kriss Basil

GREGORY H. LEVINE

 

KRISS BASIL

Ropes & Gray LLP

 

Assistant United States Attorney

2099 Pennsylvania Avenue NW

 

John Joseph Moakley

Washington, DC 20006-6807

 

United States Federal Courthouse

T +1 202 508 4831

 

1 Courthouse Way, Suite 9200

F +1 202 383 9822

 

Boston, MA 02210

 

 

 

 

 

CHAD A. READLER

 

 

Acting Assistant Attorney General

 

 

 

/s/ Joshua S. Levy

 

JOSHUA I. WILKENFELD

JOSHUA S. LEVY

 

Acting Director, Consumer Protection Branch

Ropes & Gray LLP

 

 

Prudential Tower

 

 

800 Boylston Street

 

 

Boston, MA 02199-3600

 

 

T +1 617 951 7000

 

 

F +1 617 951 7050

 

 

Attorneys for Corporate Defendant

 

/s/ Matthew J. Lash

 

 

MATTHEW J. LASH

 

 

Trial Attorney

 

 

Consumer Protection Branch

 

 

450 Fifth Street, NW

 

 

Room 6400 - South

 

 

Washington, D.C. 20001

 

 

(202) 514-3764

 

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OF COUNSEL:

 

 

 

 

 

JEFFREY S. DAVIS

 

 

Acting General Counsel

/s/ Jennifer Zachary

 

 

JENNIFER ZACHARY

 

REBECCA K. WOOD

Covington & Burling LLP

 

Chief Counsel

One City Center

 

Food and Drug Division

850 Tenth Street, NW

 

 

Washington, DC 20001-4956

 

ANNAMARIE KEMPIC

T +1 202 662 5037

 

Deputy Chief Counsel, Litigation

Attorney for Charles M. Gerrits

 

 

 

 

SONIA W. NATH

 

 

Associate Chief Counsel for Enforcement

 

 

United States Department of

 

 

Health and Human Services

 

 

Office of the General Counsel

 

 

Food and Drug Administration

 

 

10903 New Hampshire Ave.

 

 

WO Bldg. 31, Rm. 4568

 

 

Silver Spring, MD 20993

 

 

(301) 796-8708

 

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