Exhibit 10.1

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;

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,

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.

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:

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

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

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

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

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)

(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.

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)

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.

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

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.

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.

Exhibit 10.2

SETTLEMENT AGREEMENT

This Settlement Agreement (“Agreement”) is entered into among the following Parties (“Parties”): the United States of America, acting through the United States Department of Justice and on behalf of the Office of Inspector General (“OIG-HHS”) of the Department of Health and Human Services (“HHS”); the Defense Health Agency (“DHA”), acting on behalf of the TRICARE Program (collectively, the “United States”); Aegerion Pharmaceuticals, Inc. (“Aegerion”); and Michele Clark, Tricia Mullins, and Kristi Winger Szudlo (collectively, “Relators”), through their authorized representatives.

RECITALS

A.                                     Aegerion is a Delaware corporation with its principal place of business in Cambridge, MA. Aegerion manufactures and distributes the drug sold under the trade name Juxtapid (generic reference lomitapide). Aegerion is an indirect, wholly-owned subsidiary of Novelion Therapeutics Inc.

B.                                     The Food and Drug Administration (FDA) approved Juxtapid on December 21, 2012, to treat patients with homozygous familial hypercholesterolemia (HoFH). Juxtapid is indicated as an adjunct to a low-fat diet and other lipid-lowering treatments to reduce cholesterol in patients with HoFH. The FDA designated Juxtapid an orphan drug because HoFH is a rare disorder that meets the requirements of the Orphan Drug Designation program, which encourages the development of medical products intended to treat rare diseases and conditions affecting fewer than 200,000 people in the United States.

C.                                     HoFH is a genetic disorder, inherited from both parents, that prevents the removal of LDL-C, often called the “bad” cholesterol, from the blood, causing abnormally high levels of circulating LDL-C. Persons with HoFH develop dramatically early and severe atherosclerotic

cardiovascular disease (“CVD”). Symptomatic CVD typically presents during the first two decades of life, often leading to heart attack, stroke, and death. If untreated, most HoFH patients do not survive past age 30 due to death from CVD.

D.                                     Consistent with the orphan drug designation, when seeking approval for Juxtapid, Aegerion represented to the FDA that the prevalence of HoFH in the United States was 1 in 1 million persons. Aegerion made similar representations about the prevalence of HoFH to Federal health care programs (defined in Paragraph M below) to obtain formulary placement for Juxtapid.

E.                                      A boxed warning on the FDA-approved label cautions prescribers about the risk of hepatotoxicity (liver toxicity) when taking Juxtapid including elevations in transaminases (enzymes indicative of liver damage) and hepatic steatosis (the accumulation of fat in the liver), which can lead to liver disease, including steatohepatitis and cirrhosis.

F.                                       As a condition of approval of Juxtapid, a Risk Evaluation and Mitigation Strategy (“REMS”) was necessary to ensure that the benefits of the drug outweigh the risk of hepatotoxicity. During the relevant period, from December 24, 2012 through December 31, 2015, the purpose of the Juxtapid REMS Program was “to educate prescribers about the risks of hepatotoxicity associated with the use of Juxtapid and the need to monitor patients during treatment with Juxtapid as per product labeling,” and “to restrict access to therapy with Juxtapid to patients with a clinical or laboratory diagnosis consistent with HoFH.”

G.                                     During the relevant period, Juxtapid was only available through the Juxtapid REMS Program if the following requirements were met:

1.                                       Prescribers had to be trained on the risk of hepatotoxicity associated with the use of Juxtapid, appropriate patient selection and monitoring, and

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REMS requirements, and upon completion of the training, prescribers enrolled in the REMS Program and had to become specially certified to prescribe Juxtapid;

2.                                       Prescribers had to complete a Prescription Authorization Form for each new prescription stating that Juxtapid is indicated as an adjunct treatment for HoFH and that the patient had “a clinical or laboratory diagnosis consistent with HoFH,” among other attestations; and

3.                                       Only specially certified pharmacies could dispense Juxtapid.

H.                                    The Juxtapid REMS Program further required Aegerion to be responsible for the implementation, maintenance, monitoring, evaluation, and improvement of the implementation of the REMS elements to assure safe use. The FDA required Aegerion to submit REMS Assessments to the FDA at six months and then twelve months after the initial approval of the REMS, and then annually thereafter.

I.                                         On July 26, 2013, Relators filed a qui tam complaint in the United States District Court for the District of Massachusetts captioned United States, et al., ex rel. Michele Clarke, Tricia Mullins, and Kristi Winger Szudlo v. Aegerion Pharmaceuticals, Inc., Case No. 13-cv-11785, under the qui tam provisions of the False Claims Act, 31 U.S.C. § 3730(b), and amended that complaint on March 14, 2014 (“the Civil Action”).

J.                                         On such date as may be determined by the Court, Aegerion will plead guilty pursuant to Fed. R. Crim. P. 11(c)(1)(C) to an Information to be filed by the United States in United States v. Aegerion Pharmaceuticals, Inc., Criminal Action No. [to be assigned] (D. Mass.) (the “Criminal Action”), that will allege that Aegerion management and sales personnel distributed Juxtapid for the treatment of high cholesterol generally, without adequate directions

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for such use, in violation of 21 U.S.C. §§ 331, 333, and 352(f), and that Aegerion did not comply with pertinent provisions of the Juxtapid REMS Program relating to safe use of Juxtapid, in violation of 21 U.S.C. §§ 331, 333, and 352(y). Separately, Aegerion and the United States will enter into a Deferred Prosecution Agreement in which Aegerion will admit that Aegerion obtained patients’ personally identifiable health information for commercial gain, in violation of 42 U.S.C. §§ 1320d-6(a)(2) and (b)(3).

K.                                     Aegerion has entered into or will be entering into separate settlement agreements (hereinafter, referred to as the “Medicaid State Settlement Agreements”) with certain states in settlement of the Covered Conduct, defined in Paragraph N, below. States with which Aegerion executes a Medicaid State Settlement Agreement in the form to which Aegerion and the National Association of Medicaid Fraud Control Units Negotiating Team (“State Team”) have agreed, or in a form otherwise agreed to by Aegerion and an individual State, shall be defined as “Medicaid Participating States.”

L.                                      In addition, Aegerion has entered into or will be entering into a separate civil consent decree with the FDA to resolve civil liability under the Federal Food, Drug and Cosmetic Act (“FDCA”) (hereinafter, referred to as the “Civil FDCA Consent Decree”).

M.                                  The United States contends that Aegerion submitted or caused to be submitted claims for payment to the Medicare Program, Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395kkk-1 (“Medicare”); the Medicaid Program, 42 U.S.C. §§ 1396-1396w-5 (“Medicaid”); and the TRICARE Program, 10 U.S.C. §§ 1071-1110b (“TRICARE”) (collectively, “the Federal health care programs”).

N.                                     The United States alleges that it and the Medicaid Participating States have certain civil claims, as specified in the following sub-paragraphs, against Aegerion, for engaging

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in the following conduct during the period from December 24, 2012 through December 31, 2015 (hereinafter referred to as the “Covered Conduct”):

1.                    Aegerion distributed Juxtapid for patients without a laboratory or clinical diagnosis of, or consistent with, HoFH. In particular, Aegerion distributed the drug with the intention that it be used to treat patients who had high cholesterol but did not respond adequately to other lipid lowering treatments including, but not limited to, patients with heterozygous familial hypercholesterolemia, a more common condition than HoFH, and as a monotherapy to treat patients not receiving other lipid lowering therapies. Such usage is unapproved, is not a “medically accepted indication,” 42 U.S.C. § 1396r-8(k)(6), and is not covered by the Federal health care programs.

2.                    To circumvent the elements to assure safe use in the REMS and cause distribution of Juxtapid for unapproved uses, certain employees, including senior managers, at Aegerion made false and misleading statements to doctors that the use of Juxtapid was appropriate in patients with symptoms including high cholesterol, lack of response to statins, and coronary artery disease, irrespective of whether such patients had a diagnosis of HoFH and despite counter-indications to a diagnosis of HoFH, such as statin intolerance, statin resistance, lack of prior treatment of maximally tolerated dosages of other lipid lowering therapies, advanced age, diabetes, and lack of a history of early onset cardiac disease or abnormally elevated cholesterol levels in both parents.

3.                    Aegerion employees instructed doctors on the type of information to include in statements of medical necessity, and at times altered or falsified statements of

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medical necessity or instructed doctors and their office staff to include incorrect diagnostic and clinical information in statements of medical necessity. Aegerion employees falsified prior authorizations by providing false cholesterol levels, medication history, and clinical history to Federal health care program payors.

4.                    Aegerion induced purchases of Juxtapid by defraying patients’ co-payment obligations for Juxtapid, in violation of the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b)(2). Aegerion paid for patients’ co-payments through a fund created at Aegerion’s request, funded with Aegerion’s donations, by Patient Services, Inc. (“PSI”), an entity that claims 501(c)(3) status with the Internal Revenue Service. PSI represented to Aegerion that “it makes more sense to have industry provide a very small amount of funding [in the form of donations for co-payment coverage] to gain a reimbursement vehicle rather than give compassionate product.” Aegerion paid for patients’ copayments through PSI to eliminate any price sensitivity to physicians prescribing and patients taking Juxtapid. Aegerion participated in establishing the patient eligibility criteria the fund used to cover the co-payment obligations of patients taking Juxtapid.

5.                    As a result of the foregoing conduct in this Paragraph N, the United States and Medicaid Participating States allege that Aegerion knowingly caused false or fraudulent claims for Juxtapid to be submitted to the Federal health care programs.

O.                                     Relators claim entitlement under 31 U.S.C. § 3730(d) to a share of the proceeds of this Agreement and to Relators’ reasonable expenses and attorneys’ fees and costs.

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In consideration of the mutual promises and obligations of this Agreement, the Parties agree and covenant as follows:

TERMS AND CONDITIONS

1.                                       Aegerion shall pay to the United States and the Medicaid Participating States collectively, the total amount of twenty-eight million eight hundred thousand dollars ($28,800,000), plus accrued interest at the rate of 1.75% per annum from May 12, 2016 (“Settlement Amount”), consistent with the Payment Schedule appended as Attachment A and as follows:

a.                                       $26,103,387.86 (plus accrued interest) shall be paid to the United States (“Federal Settlement Amount”) pursuant to instructions from the United States Department of Justice; and

b.                                       $2,696,612.14 (plus accrued interest) shall be paid to the Medicaid Participating States (“State Settlement Amount”) pursuant to instructions from the State Team.

c.                                        Aegerion shall make the initial up-front payments, as identified in Attachment A (“Initial Payments”), by electronic funds transfer seven (7) business days after (1) the Effective Date of this Agreement (as defined in Paragraph 37, below); or (2) the Court accepts a Fed. R. Crim P. 11(c)(1)(C) guilty plea as described in Paragraph J from the Recitals in connection with the Criminal Action and imposes the agreed upon sentence, whichever occurs later.

d.                                       Aegerion shall make the first quarterly payments, as identified in Attachment A, by electronic funds transfer on or before 90 days after the Initial Payments.

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e.                                        Aegerion shall make the subsequent quarterly payments, as identified in Attachment A, by electronic funds transfer in subsequent 90-day intervals after the first quarterly payments.

f.                                         The entire balance of the Settlement Amount, or any portion thereof, may be prepaid without penalty. If Aegerion elects to pre-pay the Settlement Amount or any portion thereof, interest shall be accrued through the date on which Aegerion makes said pre-payment.

g.                                        The United States and the Participating Medicaid States will provide written instructions to Aegerion concerning the transfers of funds described in this Paragraph.

h.                                       If Aegerion’s agreed-upon guilty plea pursuant to Fed. R. Crim. P. 11 in the Criminal Action described in Recital Paragraph J is not accepted by the Court or the Court does not impose the agreed-upon sentence for whatever reason, or the Court does not accept the Deferred Prosecution Agreement, this Agreement shall be null and void at the option of either the United States or Aegerion. If either the United States or Aegerion exercises this option, which option shall be exercised by notifying all Parties, through counsel, in writing within ten (10) business days of the Court’s order, the Parties will not object and this Agreement will be rescinded. If this Agreement is rescinded, Aegerion will not plead, argue or otherwise raise any defenses under the theories of statute of limitations, laches, estoppel or similar theories, to any civil or administrative claims, actions or proceedings arising from the Covered Conduct that are brought by the United States within 90 calendar days of rescission, except to the extent such defenses were available on July 26, 2013.

2.                                            While any payment amounts remain outstanding as reflected in Attachment A (“Payment Period”), Aegerion shall provide written notice to the Department of Justice prior to the occurrence of a Fundamental Transaction or Qualifying Asset Sale, defined in Attachment B.

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a.                                       Unless waived by the Department of Justice, upon the consummation of a Fundamental Transaction during the Payment Period, any outstanding amount due from the Settlement Amount (including interest accrued but unpaid as of the day prior to the date of the consummation of such Fundamental Transaction), will become due, and Aegerion, within fifteen (15) business days of such consummation, shall pay such amount in satisfaction in full of its monetary obligations hereunder.

b.                                       Upon a Qualifying Asset Sale during the Payment Period, Aegerion will pay within fifteen (15) business days of the consummation of such Qualifying Asset Sale an amount equal to the lower of (1) 54% of the net proceeds it receives from such transaction or (2) the aggregate amount equal to the sum of any outstanding Settlement Amounts (including interest accrued but unpaid as of the day prior to the date of the consummation of such Qualifying Asset Sale) (with either (1) or (2) being the “Accelerated Amount”). Any such Accelerated Amount shall be deducted from the outstanding balance of the amounts payable by Aegerion first from the last quarterly payment due under this Agreement and thereafter for each quarterly payment due based on descending due dates.

3.                                       Conditioned upon the United States receiving each payment from Aegerion as set forth in Attachment A, the United States agrees that it shall make each corresponding payment to Relators according to the schedule set forth as Attachment C, by electronic funds transfer, as soon as feasible after receipt of each payment from Aegerion.

4.                                       Aegerion, Relators and Relators’ counsel have entered into a separate agreement with respect to the payment by Aegerion of Relators’ attorneys’ fees, costs, and expenses pursuant to 31 U.S.C. § 3730(d)(1) and applicable state False Claims acts.

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5.                                       Subject to the exceptions in Paragraph 9 (concerning excluded claims) below, and conditioned upon Aegerion’s full payment of the Settlement Amount and subject to Paragraph 25, below (concerning bankruptcy proceedings commenced within 91 days of the Effective Date of this Agreement or any payment made under this Agreement), the United States releases Aegerion, together with its parent corporation and direct and indirect subsidiaries, from any civil or administrative monetary claim the United States has for the Covered Conduct under the False Claims Act, 31 U.S.C. §§ 3729-3733; the Civil Monetary Penalties Law, 42 U.S.C. § 1320a-7a; the Program Fraud Civil Remedies Act, 31 U.S.C. §§ 3801-3812; any statutory provision creating a cause of action for civil damages or civil penalties which the Civil Division of the Department of Justice has actual or present authority to assert or compromise pursuant to 20 C.F.R. Part 0, Subpart I, 0.45(d); or the common law theories of payment by mistake, unjust enrichment, and fraud.

6.                                       Subject to the exceptions in Paragraph 9 below, and conditioned upon Aegerion’s full payment of the Settlement Amount, and subject to Paragraph 25, below (concerning bankruptcy proceedings commenced within 91 days of the Effective Date of this Agreement or any payment made under this Agreement), Relators, for themselves and for their heirs, successors, attorneys, agents, and assigns, releases Aegerion, together with its parent corporation and direct and indirect subsidiaries, from any civil monetary claim the Relators have on behalf of the United States for the Covered Conduct under the False Claims Act, 31 U.S.C. §§ 3729-3733, and further agrees to generally release, acquit, waive, and forever discharge Aegerion, together with its parent corporation and direct and indirect subsidiaries, and their current officers, directors, agents, and employees, from any and all rights, claims, expenses, debts, liabilities, demands, obligations, costs, attorneys’ fees, damages, injuries, actions, and causes of action of

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every nature, whether known or unknown, suspected or unsuspected, in law or in equity but not limited to those Relators advanced or could have advanced in the Civil Action. The foregoing release does not affect the separate agreement between Aegerion, Relators and Relators’ counsel that is referenced above in Paragraph 4.

7.                                       In consideration of the obligations of Aegerion in this Agreement and the Corporate Integrity Agreement (CIA), entered into between OIG-HHS and Aegerion, and conditioned upon Aegerion’s full payment of the Settlement Amount, the OIG-HHS agrees to release and refrain from instituting, directing, or maintaining any administrative action seeking exclusion from Medicare, Medicaid, and other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(f)) against Aegerion under 42 U.S.C. § 1320a-7a (Civil Monetary Penalties Law) or 42 U.S.C. § 1320a-7(b)(7) (permissive exclusion for fraud, kickbacks, and other prohibited activities) for the Covered Conduct, except as reserved in this Paragraph and in Paragraph 9 (concerning excluded claims), below. The OIG-HHS expressly reserves all rights to comply with any statutory obligations to exclude Aegerion from Medicare, Medicaid, and other Federal health care programs under 42 U.S.C. § 1320a-7(a) (mandatory exclusion) based upon the Covered Conduct. Nothing in this Paragraph precludes the OIG-HHS from taking action against entities or persons, or for conduct and practices, for which claims have been reserved in Paragraph 9, below.

8.                                       In consideration of the obligations of Aegerion set forth in this Agreement, and conditioned upon Aegerion’s full payment of the Settlement Amount, DHA agrees to release and refrain from instituting, directing, or maintaining any administrative action seeking exclusion from the TRICARE Program against Aegerion under 32 C.F.R. § 199.9 for the Covered Conduct, except as reserved in this Paragraph and in Paragraph 9 (concerning excluded claims),

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below. DHA expressly reserves authority to exclude Aegerion from the TRICARE Program under 32 C.F.R. §§ 199.9 (f)(1)(i)(A), (f)(1)(i)(B), and (f)(1)(iii) (mandatory exclusion), based upon the Covered Conduct. Nothing in this Paragraph precludes DHA or the TRICARE Program from taking action against entities or persons, or for conduct and practices, for which claims have been reserved in Paragraph 9, below.

9.                                  Notwithstanding the releases given in Paragraphs 5-8 of this Agreement, or any other term of this Agreement, the following claims of the United States specifically are reserved and are not released:

a.                                       Any liability arising under Title 26, U.S. Code (Internal Revenue Code);

b.                                       Any criminal liability;

c.                                        Except as explicitly stated in this Agreement, any administrative liability, including mandatory exclusion from Federal health care programs;

d.                                       Any liability under the Civil FDCA Consent Decree;

e.                                        Any liability to the United States (or its agencies) for any conduct other than the Covered Conduct;

f.                                         Any liability based upon obligations created by this Agreement;

g.                                        Any liability of individuals;

h.                                       Any liability for express or implied warranty claims or other claims for defective or deficient products or services, including quality of goods and services;

i.                                           Any liability for failure to deliver goods or services due; and

j.                                          Any liability for personal injury or property damage or for other consequential damages arising from the Covered Conduct.

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10.                           Relators and their heirs, successors, attorneys, agents, and assigns shall not object to this Agreement but agree and confirm that this Agreement is fair, adequate, and reasonable under all the circumstances, pursuant to 31 U.S.C. § 3730(c)(2)(B), and expressly waive the opportunity for a hearing on any objection to this Agreement. Conditioned upon Relators’ receipt of the payments described in Paragraph 3, Relators and their heirs, successors, attorneys, agents, and assigns fully and finally release, waive, and forever discharge the United States, its agencies, officers, agents, employees, and servants, from any claims arising from the filing of the Civil Action against Aegerion, including claims under 31 U.S.C. § 3730, and from any claims to a share of the proceeds of this Agreement and/or damages against Aegerion in the Civil Action.

11.                           Aegerion has provided sworn financial disclosure statements (Financial Statements) to the United States and the United States has relied on the accuracy and completeness of those Financial Statements in reaching this Agreement. Aegerion warrants that the Financial Statements are complete and accurate. If the United States learns of asset(s) in which Aegerion had an interest at the time of this Agreement that were not disclosed in the Financial Statements, or if the United States learns of any misrepresentation by Aegerion on, or in connection with, the Financial Statements, and if such nondisclosure or misrepresentation changes the estimated net worth (defined as total assets less total liabilities) set forth in the Financial Statements by two million dollars ($2,000,000) or more, the United States may at its option: (a) rescind this Agreement and file a complaint based on the Covered Conduct, or (b) let the Agreement stand and collect the full Settlement Amount plus one hundred percent (100%) of the value of the net worth of Aegerion previously undisclosed. Aegerion agrees not to contest any collection action undertaken by the United States pursuant to this provision, and immediately to pay the United States all reasonable costs incurred in such an action, including attorneys’ fees

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and expenses. If the United States elects to pursue option (b) above, and if the United States thereafter recovers funds from Aegerion that are in addition to the Settlement Amount, then the United States will pay Relators a share of such additional funds calculated in the same proportion as the share of the Settlement Amount paid to Relators pursuant to Paragraph 3 and Attachment C.

12.                                In the event that the United States, pursuant to Paragraph 11 (concerning disclosure of assets), above, opts to rescind this Agreement, Aegerion agrees not to plead, argue, or otherwise raise any defenses under the theories of statute of limitations, laches, estoppel, or similar theories, to any civil or administrative claims that (a) are filed by the United States within fourteen (14) calendar days of written notification to Aegerion that this Agreement has been rescinded, and (b) relate to the Covered Conduct, except to the extent these defenses were available on July 26, 2013.

13.                                In the event that Aegerion fails to pay any quarterly payment due pursuant to Paragraph 1 and the Payment Schedule in Attachment A, Aegerion shall be in Default of its payment obligations (“Default”). In the event of Default, the United States will provide written notice of the Default (“Notice of Default”) to Aegerion, and Aegerion shall have an opportunity to cure the Default within ten (10) business days from the date the Notice of Default (“Cure Period”) is delivered. Notice of Default will be delivered pursuant to Paragraph 36, with a courtesy copy emailed to Joshua Levy at Joshua.Levy@ropesgray.com. If Aegerion fails to cure the Default within the Cure Period as described in this Paragraph, the remaining unpaid balance of the Settlement Amount (“Remaining Settlement Amount”) shall, at the election of the United States, become immediately due and payable, and interest shall accrue at the rate of 12% per annum compounded daily (“Remaining Settlement Amount and Default Interest Balance”) from

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the date of Default until all amounts due have been paid in full. Aegerion shall consent to a Consent Judgment in the amount of the Remaining Settlement Amount and Default Interest Balance (“Aegerion Consent Judgment”), and the United States, at its sole option, may: (a) offset the Aegerion Consent Judgment from any amounts due and owing to Aegerion by any department, agency, or agent of the United States; (b) collect the entire Remaining Settlement Amount and Default Interest Balance, and all other amounts due upon the event of Default as specified in this Paragraph; or (c) exercise any other rights granted by law or in equity, including but not limited to referring such matters for private collection. Aegerion agrees not to contest any consent judgment or offset imposed and Aegerion agrees not to contest, and hereby waives and discharges any defenses to, any collection action undertaken by the United States or its agents or contractors pursuant to this Paragraph, either administratively or in any state or federal court. Aegerion shall pay the United States all reasonable costs of collection and enforcement under this Paragraph applicable to them, respectively, including attorneys’ fees and expenses (“Collection Costs”).

14.                           In the event of Default, the United States may also, at its sole option, rescind this Settlement Agreement after the expiration of the Cure Period if the Default is not cured (“Rescindment”). Rescindment shall be automatically effective upon the United States’ bringing any civil and/or administrative claim, action, or proceeding against Aegerion for the Covered Conduct. In the event of Rescindment, Aegerion shall not plead, argue, or otherwise raise, and hereby waives and discharges, any defenses under the theories of statute of limitations, laches, estoppel, or similar theories, to any such civil or administrative claims, actions, or proceeding that are brought by the United States within one hundred-twenty (120) calendar days of Default, except to the extent such defenses were available as of the effective date of this

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Agreement. Aegerion agrees that, in the event of Rescindment, it shall not plead, argue, or otherwise raise any defenses that any amounts paid to the United States pursuant to Paragraph 1 and the Payment Schedule should be used to reduce the determination of single damages for purposes of calculating treble damages or penalties under the FCA. The option for Rescindment identified in this Paragraph is in addition to, and not in lieu of, other options identified in this Agreement or otherwise available. In the event of Rescindment, whatever rights Relators could have asserted in connection with the Civil Action prior to its dismissal will be restored to Relators in connection with whatever claim, action, or proceeding the United States chooses to pursue.

15.                                Notwithstanding the foregoing, in the event of Default and after the expiration of the Cure Period as defined in Paragraph 13, above, OIG-HHS may exclude Aegerion from participating in all Federal health care programs until Aegerion pays the Remaining Settlement Amount and Default Interest Balance and Collection Costs, as set forth in Paragraph 13 above. OIG-HHS will provide written notice of any such exclusion to Aegerion. Aegerion waives any further notice of exclusion under 42 U.S.C. § 1320a-7(b)(7), and agrees not to contest exclusion either administratively or in any state or federal court. Reinstatement to program participation is not automatic. If at the end of the period of exclusion Aegerion wishes to apply for reinstatement, Aegerion must submit a written request for reinstatement to OIG-HHS in accordance with the provisions of 42 C.F.R. §§ 1001.3001-3005. Aegerion will not be reinstated unless and until OIG-HHS approves such request for reinstatement. The option for Exclusion for Default as defined in this Paragraph is in addition to, and not in lieu of, the options identified in this Agreement or otherwise available.

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16.                                Aegerion waives and shall not assert any defenses Aegerion may have to any criminal prosecution or administrative action relating to the Covered Conduct that may be based in whole or in part on a contention that, under the Double Jeopardy Clause in the Fifth Amendment of the Constitution, or under the Excessive Fines Clause in the Eighth Amendment of the Constitution, this Agreement bars a remedy sought in such criminal prosecution or administrative action. Nothing in this Paragraph or any other provision of this Agreement constitutes an agreement by the United States concerning the characterization of the Settlement Amount for purposes of the Internal Revenue laws, Title 26 of the United States Code.

17.                                Aegerion fully and finally releases the United States, its agencies, officers, agents, employees, and servants, from any claims (including attorneys’ fees, costs, and expenses of every kind and however denominated) that Aegerion has asserted, could have asserted, or may assert in the future against the United States, its agencies, officers, agents, employees, and servants, related to the Covered Conduct and the United States’ investigation and prosecution.

18.                                Aegerion fully and finally releases the Relators from any claims (including attorneys’ fees, costs, and expenses of every kind and however denominated) that Aegerion has asserted, could have asserted, or may assert in the future against the Relators, related to the Covered Conduct and the Relators’ investigation and prosecution thereof; provided, however, Aegerion reserves any defenses or claims as to Relators’ unresolved claims in the Civil Action or Relators’ counsel’s claims for reasonable attorneys fees, expenses, and costs resulting from the Civil Action pursuant to 31 U.S.C. § 3730(d) or other action brought by Relators against Aegerion.

19.                                The Settlement Amount shall not be decreased as a result of the denial of claims for payment now being withheld from payment by any Medicare contractor (e.g., Medicare

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Administrative Contractor, fiscal intermediary, carrier or any state payer) related to the Covered Conduct; and Aegerion agrees not to resubmit to any Medicare contractor or any state payer any previously denied claims related to the Covered Conduct, agrees not to appeal any such denials of claims, and agrees to withdraw any such pending appeals.

20.                                Aegerion agrees to the following:

a.                                       Unallowable Costs Defined: All costs (as defined in the Federal Acquisition Regulation, 48 C.F.R. § 31.205-47; and in Titles XVIII and XIX of the Social Security Act, 42 U.S.C. §§ 1395-1395kkk-1 and 1396-1396w-5; and the regulations and official program directives promulgated thereunder) incurred by or on behalf of Aegerion, its present or former officers, directors, employees, shareholders, and agents in connection with:

(1)                                  the matters covered by this Agreement and the related Plea Agreement;

(2)                                  the United States’ audit(s) and civil and any criminal investigation(s) of the matters covered by this Agreement;

(3)                                  Aegerion’s investigation, defense, and corrective actions undertaken in response to the United States’ audit(s) and civil and any criminal investigation(s) in connection with the matters covered by this Agreement (including attorneys’ fees);

(4)                                  the negotiation and performance of this Agreement and the Plea Agreement;

(5)                                  the payments Aegerion makes to the United States pursuant to this Agreement and any payments that Aegerion may make to Relators, including costs and attorneys’ fees; and

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(6)                             the negotiation of, and obligations undertaken pursuant to the CIA to: (i) retain an independent review organization to perform annual reviews as described in Section III of the CIA; and (ii) prepare and submit reports to the OIG-HHS

are unallowable costs for government contracting purposes and under the Medicare Program, Medicaid Program, TRICARE Program, and Federal Employees Health Benefits Program (FEHBP) (hereinafter referred to as Unallowable Costs). However, nothing in paragraph 20.a.(6) that may apply to the obligations undertaken pursuant to the CIA affects the status of costs that are not allowable based on any other authority applicable to Aegerion.

b.                                       Future Treatment of Unallowable Costs: Unallowable Costs shall be separately determined and accounted for by Aegerion, and Aegerion shall not charge such Unallowable Costs directly or indirectly to any contracts with the United States or any State Medicaid program, or seek payment for such Unallowable Costs through any cost report, cost statement, information statement, or payment request submitted by Aegerion or any of its subsidiaries or affiliates to the Medicare, Medicaid, TRICARE, or FEHBP Programs.

c.                                        Treatment of Unallowable Costs Previously Submitted for Payment: Aegerion further agrees that within 90 days of the Effective Date of this Agreement it shall identify to applicable Medicare and TRICARE fiscal intermediaries, carriers, and/or contractors, and Medicaid and FEHBP fiscal agents, any Unallowable Costs (as defined in this Paragraph) included in payments previously sought from the United States, or any State Medicaid program, including, but not limited to, payments sought in any cost reports, cost statements, information reports, or payment requests already submitted by Aegerion or any of its subsidiaries or affiliates, and shall request, and agree, that such cost reports, cost statements, information

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reports, or payment requests, even if already settled, be adjusted to account for the effect of the inclusion of the Unallowable Costs. Aegerion agrees that the United States, at a minimum, shall be entitled to recoup from Aegerion any overpayment plus applicable interest and penalties as a result of the inclusion of such Unallowable Costs on previously-submitted cost reports, information reports, cost statements, or requests for payment.

Any payments due after the adjustments have been made shall be paid to the United States pursuant to the direction of the Department of Justice and/or the affected agencies. The United States reserves its rights to disagree with any calculations submitted by Aegerion or any of its subsidiaries or affiliates on the effect of inclusion of Unallowable Costs (as defined in this Paragraph) on Aegerion or any of its subsidiaries or affiliates’ cost reports, cost statements, or information reports.

d.                                       Nothing in this Agreement shall constitute a waiver of the rights of the United States to audit, examine, or re-examine Aegerion’s books and records to determine that no Unallowable Costs have been claimed in accordance with the provisions of this Paragraph.

21.                                Aegerion agrees to cooperate fully and truthfully with the United States’ investigation of individuals and entities not released in this Agreement. Upon reasonable notice, Aegerion shall encourage, and agrees not to impair, the cooperation of its directors, officers, and employees, and shall use its best efforts to make available, and encourage, the cooperation of former directors, officers, and employees for interviews and testimony, consistent with the rights and privileges of such individuals. Aegerion further agrees to furnish to the United States, upon request, complete and unredacted copies of all non-privileged documents, reports, memoranda of interviews, and records in its possession, custody, or control concerning the Covered Conduct.

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22.           This Agreement is intended to be for the benefit of the Parties only. The Parties do not release any claims against any other person or entity, except to the extent provided for in Paragraphs 5-8, 10, and 17-18.

23.           Aegerion agrees that it waives and shall not seek payment for any of the health care billings covered by this Agreement from any health care beneficiaries or their parents, sponsors, legally responsible individuals, or third party payors based upon the claims arising from the Covered Conduct.

24.           Aegerion warrants that it has reviewed its financial situation and that it currently is solvent within the meaning of 11 U.S.C. §§ 547(b)(3) and 548(a)(1)(B)(ii)(I), and expects to remain solvent following payment to the United States of the Settlement Amount. Further, the Parties warrant that, in evaluating whether to execute this Agreement, they (a) have intended that the mutual promises, covenants, and obligations set forth constitute a contemporaneous exchange for new value given to Aegerion, within the meaning of 11 U.S.C. § 547(c)(1), and (b) conclude that these mutual promises, covenants, and obligations do, in fact, constitute such a contemporaneous exchange. Further, the Parties warrant that the mutual promises, covenants, and obligations set forth herein are intended to and do, in fact, represent a reasonably equivalent exchange of value that is not intended to hinder, delay, or defraud any entity to which Aegerion was or became indebted to on or after the date of this transfer, within the meaning of 11 U.S.C. § 548(a)(1).

25.           If within 91 days of the Effective Date of this Agreement or of any payment made under this Agreement, Aegerion commences, or a third party commences, any case, proceeding, or other action under any law relating to bankruptcy, insolvency, reorganization, or relief of debtors (a) seeking to have any order for relief of Aegerion’s debts, or seeking to adjudicate

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Aegerion as bankrupt or insolvent; or (b) seeking appointment of a receiver, trustee, custodian, or other similar official for Aegerion or for all or any substantial part of Aegerion’s assets, Aegerion agrees as follows:

(1)            Aegerion’s obligations under this Agreement may not be avoided pursuant to 11 U.S.C. § 547, and Aegerion shall not argue or otherwise take the position in any such case, proceeding, or action that: (a) Aegerion’s obligations under this Agreement may be avoided under 11 U.S.C. § 547; (b) Aegerion was insolvent at the time this Agreement was entered into, or became insolvent as a result of the payment made to the United States; or (c) the mutual promises, covenants, and obligations set forth in this Agreement do not constitute a contemporaneous exchange for new value given to Aegerion.

(2)            If, in the event that (a) Aegerion defaults on any of its obligations under this Agreement, after being given an opportunity to cure the default within ten (10) business days from the date of notice of default, prior to payment of the Settlement Amount, or (b) any portion of the Settlement Amount is avoided for any reason, including, but not limited to, through the exercise of powers granted under 11 U.S.C. § 544, 547, 548, or 550, or any other Bankruptcy Code provision or state law provision, by entry of judgment or settlement, the United States, at its sole option, may by written notice rescind the releases in this Agreement and bring any civil and/or administrative claim, action, or proceeding against Aegerion for the claims that would otherwise be covered by the releases provided in the above Paragraphs. Aegerion agrees that (a) any such claims, actions, or proceedings brought by the United States are not subject to an “automatic stay” pursuant to 11 U.S.C. § 362(a) as a result of the action, case, or proceedings described in the first clause of this Paragraph, and Aegerion shall not argue or otherwise contend that the United States’ claims, actions, or proceedings are subject to an automatic stay; (b)

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Aegerion shall not plead, argue, or otherwise raise any defenses under the theories of statute of limitations, laches, estoppel, or similar theories, to any such civil or administrative claims, actions, or proceeding that are brought by the United States within fourteen (14) calendar days of written notification to Aegerion that the releases have been rescinded pursuant to this Paragraph, except to the extent such defenses were available on July 26, 2013; and (c) the United States has a valid claim against Aegerion in the amount of $52,676,682 plus penalties of $5,500 to $11,000 for each false claim, and the United States may pursue its claim in the case, action, or proceeding referenced in the first clause of this Paragraph, as well as in any other case, action, or proceeding.

(3)         Aegerion acknowledges that its agreements in this Paragraph are provided in exchange for valuable consideration provided in this Agreement.

26.        Upon receipt of the Initial Payments, the United States and Relators shall file a Joint Stipulation of Dismissal in the Civil Action as follows:

a.            dismissal shall be with prejudice as to the United States’ and Relators’ claims against Aegerion as to the Covered Conduct in the Civil Action subject to and consistent with the terms and conditions of this Agreement;

b.            dismissal shall be without prejudice to the United States as to all other claims against Aegerion in the Civil Action; and

c.            dismissal shall be with prejudice to the Relators as to all claims against Aegerion in the Civil Action.

27.        Except for the separate agreement set forth in Paragraph 4 above, each Party shall bear its own legal and other costs incurred in connection with this matter, including the preparation and performance of this Agreement.

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28.           Each party and signatory to this Agreement represents that it freely and voluntarily enters in to this Agreement without any degree of duress or compulsion.

29.           This Agreement is governed by the laws of the United States. The exclusive jurisdiction and venue for any dispute relating to this Agreement is the United States District Court for the District of Massachusetts. For purposes of construing this Agreement, this Agreement shall be deemed to have been drafted by all Parties to this Agreement and shall not, therefore, be construed against any Party for that reason in any subsequent dispute.

30.           This Agreement constitutes the complete agreement between the Parties to resolve the Civil Action. This Agreement may not be amended except by written consent of the Parties.

31.           The undersigned counsel represent and warrant that they are fully authorized to execute this Agreement on behalf of the persons and entities indicated below.

32.           This Agreement may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same Agreement.

33.           This Agreement is binding on Aegerion’s successors, transferees, heirs, and assigns.

34.           This Agreement is binding on Relators’ successors, transferees, heirs, and assigns.

35.           All parties consent to the United States’ disclosure of this Agreement, and information about this Agreement, to the public.

36.           Notice to Aegerion, as referenced in this agreement, shall be in writing and delivered by via hand-delivery, overnight mail, or by registered or certified mail (return receipt requested) to:

Legal Department

Aegerion Pharmaceuticals, Inc.

One Main Street

Suite 800

Cambridge, MA 02142

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Courtesy copies of any Notice shall be provided to Aegerion’s counsel by hand-delivery, overnight mail, or email, to:

Joshua Levy

Ropes & Gray LLP
800 Boylston St.
Boston, MA 02199

37.          This Agreement is effective on the date of signature of the last signatory to the Agreement (Effective Date of this Agreement). Facsimiles and electronic transmissions of signatures shall constitute acceptable, binding signatures for purposes of this Agreement.

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THE UNITED STATES OF AMERICA

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AEGERION PHARMACEUTICALS, INC.

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RELATORS

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(1) Handshake interest is applicable and will be paid with the up front payments.

Attachment B

For purposes of this global settlement, a “ Fundamental Transaction ” means:

(a) any individual, corporation, partnership, limited liability company, joint venture, association, joint-stock company, trust, unincorporated organization or any other entity (“ Person ”) acquires beneficial ownership, directly or indirectly, through a purchase, merger or other acquisition transaction or series of transactions, of shares of the Company’s capital stock entitling the Person to exercise 50% or more of the total voting power of all shares of the Company’s capital stock entitled to vote generally in elections of directors, other than an acquisition by the Company, any of its wholly-owned subsidiaries and any of its employee benefit plans;

(b) the Company merges or consolidates with or into any other Person (other than one of its wholly-owned subsidiaries), another Person merges or consolidates with or into the Company, or the Company conveys, sells, transfers or leases all or substantially all of its assets to another Person in one transaction or a series of related transactions, other than any transaction:

(i) that does not result in a reclassification, conversion, exchange or cancellation of the outstanding Company common stock; or

(ii)   pursuant to which the Company’s parent company, Novelion Therapeutics, Inc., continues to hold 50% or more of the total voting power of all shares of capital stock of the surviving entity; or

(c) the Company’s shareholders approve any plan or proposal for the liquidation or dissolution of the Company;

provided, however, that a transaction or transactions described in clause (a) or (b) above shall not constitute a Fundamental Transaction if at least 90% of the consideration paid for the Company’s capital stock (excluding cash payments for fractional shares and cash payments made pursuant to dissenters’ or appraisal rights) in connection with such transaction or transactions consists of shares of common stock that are listed or quoted on any of The New York Stock Exchange, The NASDAQ Global Select Market or The NASDAQ Global Market (or any of their respective successors) or will be so traded or quoted immediately following such transaction or transactions. For purposes of clause (a) , whether a Person is a “beneficial owner” will be determined in accordance with Rule 13d-3 under the Securities Exchange Act of 1934, and “Person” includes any syndicate or group that would be deemed to be a “person” under Section 13(d)(3) of the Exchange Act.

For purposes of this global settlement, a “ Qualifying Asset Sale ” means any sale, license, exchange, transfer or disposition by the Company, in a single transaction or in a series of transactions, of all or substantially all of its ownership interests in or commercialization rights associated with JUXTAPID or MYALEPT.

Exhibit 10.3

UNITED STATES DISTRICT COURT

DISTRICT OF MASSACHUSETTS

SECURITIES AND EXCHANGE COMMISSION,

Plaintiff,

C.A. No.   -     ( )

v.

AEGERION PHARMACEUTICALS, INC.,

Defendant.

FINAL JUDGMENT AS TO DEFENDANT AEGERION PHARMACEUTICALS, INC.

The Securities and Exchange Commission having filed a Complaint and Defendant Aegerion Pharmaceuticals, Inc. (“Aegerion”) having entered a general appearance; consented to the Court’s jurisdiction over Defendant and the subject matter of this action; consented to entry of this Final Judgment without admitting or denying the allegations of the Complaint (except as to jurisdiction); waived findings of fact and conclusions of law; and waived any right to appeal from this Final Judgment:

I.

IT IS HEREBY FURTHER ORDERED, ADJUDGED, AND DECREED that Defendant is permanently restrained and enjoined from violating Section 17(a)(2) and (3) of the Securities Act of 1933 (the “Securities Act”) [15 U.S.C. § 77q(a)(2) and (3)] in the offer or sale of any security by the use of any means or instruments of transportation or communication in interstate commerce or by use of the mails, directly or indirectly:

(a)                          to obtain money or property by means of any untrue statement of a material fact or any omission of a material fact necessary in order to make the statements

made, in light of the circumstances under which they were made, not misleading; or

(b)                                  to engage in any transaction, practice, or course of business which operates or would operate as a fraud or deceit upon the purchaser.

IT IS FURTHER ORDERED, ADJUDGED, AND DECREED that, as provided in Federal Rule of Civil Procedure 65(d)(2), the foregoing paragraph also binds the following who receive actual notice of this Final Judgment by personal service or otherwise: (a) Defendant’s officers, agents, servants, employees, and attorneys; and (b) other persons in active concert or participation with Defendant or with anyone described in (a).

II.

IT IS FURTHER ORDERED, ADJUDGED, AND DECREED that Defendant shall pay a civil penalty in the amount of $4,100,000 (the “Settlement Amount”) to the Securities and Exchange Commission pursuant to Section 20(d) of the Securities Act [15 U.S.C. §77t(d)]. Defendant shall make this payment pursuant to the terms of the payment schedule set forth in paragraph III below after entry of this Final Judgment.

Defendant may transmit payment electronically to the Commission, which will provide detailed ACH transfer/Fedwire instructions upon request. Payment may also be made directly from a bank account via Pay.gov through the SEC website at http://www.sec.gov/about/offices/ofm.htm. Defendant may also pay by certified check, bank cashier’s check, or United States postal money order payable to the Securities and Exchange Commission, which shall be delivered or mailed to

Enterprise Services Center

Accounts Receivable Branch

6500 South MacArthur Boulevard

Oklahoma City, OK 73169

and shall be accompanied by a letter identifying the case title, civil action number, and name of this Court; identifying Aegerion Pharmaceuticals, Inc. as a defendant in this action; and specifying that payment is made pursuant to this Final Judgment.

Defendant shall simultaneously transmit photocopies of evidence of payment and case identifying information to the Commission’s counsel in this action. By making this payment, Defendant relinquishes all legal and equitable right, title, and interest in such funds and no part of the funds shall be returned to Defendant. The Commission shall send the funds paid pursuant to this Final Judgment to the United States Treasury. Defendant shall pay post-judgment interest on any delinquent amounts pursuant to 28 USC § 1961, but at a rate of 1.75%, as negotiated by the parties.

III.

The Settlement Amount consists of a penalty of $4,100,000, which Aegerion shall pay in 13 installments to the Commission according to the following schedule (the “Payment Period”): (1) $1,000,000, within 14 days of entry of this Final Judgment; and then in the following installments:

Payments shall be deemed made on the date they are received by the Commission and shall be applied first to post judgment interest, which accrues pursuant to 28 U.S.C. § 1961 on

any unpaid amounts due after 14 days of the entry of Final Judgment, but at a rate of 1.75%, as negotiated by the parties. Prior to making the final payment set forth herein, Aegerion shall contact the staff of the Commission for the amount due for the final payment.

If Aegerion fails to make any payment by the date agreed and/or in the amount agreed according to the schedule set forth above, all outstanding payments under this Final Judgment, including post-judgment interest, minus any payments made, shall become due and payable immediately at the discretion of the staff of the Commission without further application to the Court.

While any payment amounts remain outstanding during the Payment Period, Aegerion shall provide written notice to the Commission prior to the occurrence of a “Fundamental Transaction” or “Qualifying Asset Sale.”

A “Fundamental Transaction” shall mean (a) any individual, corporation, partnership, limited liability company, joint venture, association, joint-stock company, trust, unincorporated organization or any other entity (“Person”) acquires beneficial ownership, directly or indirectly, through a purchase, merger or other acquisition transaction or series of transactions, of shares of Aegerion’s capital stock entitling the Person to exercise 50% or more of the total voting power of all shares of Aegerion’s capital stock entitled to vote generally in elections of directors, other than an acquisition by Aegerion, any of its wholly-owned subsidiaries and any of its employee benefit plans; (b) Aegerion merges or consolidates with or into any other Person (other than one of its wholly-owned subsidiaries), another Person merges or consolidates with or into Aegerion, or Aegerion conveys, sells, transfers or leases all or substantially all of its assets to another Person in one transaction or a series of related transactions, other than any transaction: (i) that does not result in a reclassification, conversion, exchange or cancellation of the outstanding

Aegerion common stock; or (ii) pursuant to which Aegerion’s parent company, Novelion Therapeutics, Inc., continues to hold 50% or more of the total voting power of all shares of capital stock of the surviving entity; or (c) Aegerion’s shareholders approve any plan or proposal for the liquidation or dissolution of the Company; provided, however, that a transaction or transactions described in clause (a) or (b) above shall not constitute a Fundamental Transaction if at least 90% of the consideration paid for Aegerion’s capital stock (excluding cash payments for fractional shares and cash payments made pursuant to dissenters’ or appraisal rights) in connection with such transaction or transactions consists of shares of common stock that are listed or quoted on any of The New York Stock Exchange, The NASDAQ Global Select Market or The NASDAQ Global Market (or any of their respective successors) or will be so traded or quoted immediately following such transaction or transactions. For purposes of clause (a), whether a Person is a “beneficial owner” will be determined in accordance with Rule 13d-3 under the Securities Exchange Act of 1934, and “Person” includes any syndicate or group that would be deemed to be a “person” under Section 13(d)(3) of the Exchange Act.

A “Qualifying Asset Sale” means any sale, license, exchange, transfer or disposition by Aegerion, in a single transaction or in a series of transactions, of all or substantially all of its ownership interests in or commercialization rights associated with JUXTAPID or MYALEPT.

Unless waived by the Commission, upon the consummation of a Fundamental Transaction during the Payment Period, any outstanding Settlement Amounts, along with interest accrued but unpaid as of the day prior to the date of the consummation of such Fundamental Transaction, will become due, and Aegerion shall pay, within fifteen (15) business days of such consummation, such amount in satisfaction in full of its monetary obligations hereunder.

Unless waived by the Commission, upon a Qualifying Asset Sale during the Payment Period, Aegerion shall pay, within fifteen (15) business days of the consummation of such Qualifying Asset Sale, and in full or partial satisfaction of its monetary obligations hereunder, an amount equal to the lower of (a) 7.5% of the net proceeds it receives from such transaction, or (b) the aggregate amount equal to the sum of any outstanding Settlement Amount and interest accrued but unpaid as of the day prior to the date of the consummation of such transaction. Any Settlement Amounts and accrued but unpaid interest that remain outstanding following such payment shall remain due and payable on a quarterly basis using the above schedule, adjusted as necessary for the final payment, until the total Settlement Amount and appropriate interest is paid.

IV.

IT IS FURTHER ORDERED, ADJUDGED, AND DECREED that the Consent is incorporated herein with the same force and effect as if fully set forth herein, and that Defendant shall comply with all of the undertakings and agreements set forth therein.

V.

IT IS FURTHER ORDERED, ADJUDGED, AND DECREED that this Court shall retain jurisdiction of this matter for the purposes of enforcing the terms of this Final Judgment.

DEFERRED PROSECUTION AGREEMENT

1.                                       William D. Weinreb, Acting United States Attorney for the District of Massachusetts (by Assistant U.S. Attorneys Young Paik and Kriss Basil) (the “Office”); the United States Department of Justice, Consumer Protection Branch (by Trial Attorney Shannon L. Pedersen); and defendant Aegerion Pharmaceuticals, Inc. (“Aegerion”) (by defense counsel Joshua S. Levy, Esq., Ropes & Gray LLP and Aegerion’s current Board Chair, Mary T. Szela, pursuant to authority granted by Aegerion’s Board of Directors), hereby enter into the following Deferred Prosecution Agreement (“Agreement”).

2.                                       Aegerion consents to the filing, in United States District Court for the District of Massachusetts, of an information charging Aegerion with conspiring to violate the patient privacy provisions of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). This Information (hereinafter, “the HIPAA Information”) charges a violation of Title 18, United States Code, Section 371, to wit: conspiracy to violate Title 42, United States Code, Sections 1320d-6(a) and 6(b)(3), using or causing to be used unique health identifiers, obtaining individually identifiable health information relating to individuals, and disclosing individually identifiable health information to another person, with the intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain, or

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malicious harm. Aegerion knowingly waives its right to indictment on this charge and agrees to venue of the case in the District of Massachusetts. Aegerion further waives any legal or procedural defects in the Information.

3.                                       This Agreement is effective for a period beginning on the date on which the HIPAA Information is filed (“Effective Date”) and ending thirty-six (36) months from that date (the “Term”). However, the United States Attorney’s Office for the District of Massachusetts and the Consumer Protection Branch of the United States Department of Justice (jointly, the “Government”) agree that, in their sole discretion, the Term of this Agreement may be shortened by no more than twelve (12) months. However, Aegerion agrees that, in the event that the Government determines, in its sole discretion, that Aegerion has knowingly and materially violated any provision of this Agreement, an extension of the Term of the Agreement may be imposed by the Government, in its sole discretion, for up to a total additional time period of one year, without prejudice to the Government’s right to proceed as provided in Paragraphs 14 to 19 below. Any extension of the Agreement extends all terms of this Agreement.

4.                                       The Government enters into this Agreement based upon the individual facts and circumstances of this case, including:

a.                                       Aegerion’s acknowledgement of its conduct and acceptance of responsibility for that conduct;

b.                                       Aegerion’s cooperation in the investigation of this matter and Aegerion’s commitment to continue cooperation with the Government’s investigation of violations of federal health care laws, securities laws, and other criminal statutes, by individuals associated with Aegerion;

c.                                        Aegerion’s commitment to enhanced compliance measures;

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d.                                       Remedial measures undertaken by Aegerion and Aegerion’s commitment to undertake additional remediation as identified herein;

e.                                        Aegerion’s guilty plea to two misdemeanor violations of the Food, Drug, and Cosmetic Act (“FDCA”), Title 21, United States Code, Sections 331, 333, 352(f) and 352(y), as charged in an information (“FDCA Information”) filed by the Government in this matter, and payment of $7,200,000 in criminal fines and forfeiture;

f.                                         Aegerion’s entry into a Civil Settlement Agreement with the Office and the United States Department of Justice’s Civil Division, Fraud Section, to settle certain civil claims related, but not identical to the conduct that is the subject of the FDCA Information and the payment by Aegerion of $28,800,000, plus interest, to resolve those claims;

g.                                        Aegerion’s entry into a corporate integrity agreement with the United States Department of Health and Human Services, Office of Inspector General (“HHS-OIG”), in connection with the same conduct that is the subject of the FDCA Information, to implement certain specified compliance measures, which are related to those compliance measures specified in Attachment B of this Agreement;

h.                                       Aegerion’s entry into a civil consent decree, to be monitored by the United States Food and Drug Administration (“FDA”), in connection with the same conduct that is the subject of the FDCA Information;

i.                                           Aegerion’s commitment to full compliance with the FDCA and HIPAA; and

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j.                                          Aegerion’s commitment to fulfill all of the terms of this Agreement.

5.                                       The Government will recommend to the Court that prosecution of Aegerion on the HIPAA Information be deferred for the duration of the Term of this Agreement. Aegerion waives its right to a speedy trial pursuant to the Sixth Amendment to the United States Constitution, Title 18, United States Code, Section 3161, and Federal Criminal Procedure 48(b), and Aegerion and the Government agree that, under 18 U.S.C. § 3161(h)(2), the period of delay during which prosecution is deferred is excluded from the time within which trial of the offense charged must commence. If the Court declines to defer prosecution or exclude the deferral Term from the time within which trial on the HIPAA Information must be commenced, this Agreement shall be null and void, except for the tolling provisions described below in Paragraph 14.

AEGERION’S OBLIGATIONS

6.                                       Aegerion admits that it is responsible for the acts of its employees, directors, officers, and agents, as set forth in the Statement of Facts, attached hereto as Attachment A (“DPA Statement of Facts”). Aegerion further admits that the DPA Statement of Facts is true and accurate and agrees that, should the prosecution deferred pursuant to this Agreement be initiated, Aegerion will neither contest the admissibility of the DPA Statement of Facts nor contradict the DPA Statement of Facts in any such proceeding, including any trial, guilty plea or sentencing proceeding.

7.                                       Aegerion shall not, through its present or future attorneys, Board of Directors, officers, employees, agents, or any other person authorized to speak for Aegerion, make any public statement, in litigation or otherwise, contradicting in whole or in part the acceptance of responsibility by Aegerion set forth above or any fact contained in the DPA Statement of Facts, subject to the following provisions:

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a.                                       The Government shall have the sole discretion to decide whether any public statement contradicting a fact contained in the DPA Statement of Facts will be imputed to Aegerion.

b.                                       If the Government determines that Aegerion has made a public statement contradicting its acceptance of responsibility or any fact contained in the DPA Statement of Facts, the Government shall so notify Aegerion. Thereafter, Aegerion may avoid a breach by publicly repudiating the statement within five days after such notification. Any such contradictory public statement, if not repudiated by Aegerion, will constitute a breach of this Agreement as governed by Paragraphs 14 and 19 of this Agreement, and Aegerion thereafter will be subject to prosecution pursuant to the terms of this Agreement.

c.                                        This Paragraph does not apply to any statement made by any present or former officer, director, employee, or agent of Aegerion in the course of any criminal, regulatory, or civil case initiated against such individual, unless such individual is speaking on behalf of Aegerion.

d.                                       Aegerion shall be permitted to raise defenses and to assert affirmative claims in civil, regulatory, and other proceedings related to the matters set forth in the DPA Statement of Facts provided that such defenses and claims do not contradict, in whole or in part, a statement contained in the DPA Statement of Facts.

8.                                       Aegerion will comply in a timely manner with all of the terms of this Agreement.

If Aegerion sells, merges, or transfers all or substantially all of its business operations as they

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exist as of the date of this Agreement (whether structured as a sale, asset sale, merger, or transfer), unless otherwise agreed to in writing by the Government, Aegerion will maintain its existence and its ability to fulfill and complete all of its obligations under this Agreement, or include in any contract for sale, merger, or transfer a provision binding the purchaser, or any successor in interest to Aegerion, to fulfill and complete all of Aegerion’s obligations under this Agreement.

9.                                       Aegerion agrees to provide complete, truthful cooperation with the Government and any other agency designated by the Government in any investigation or prosecution of Aegerion and/or any of its current or former directors, officers, employees, agents, consultants, contractors, subcontractors, and subsidiaries, or any other party, concerning the conduct covered by the HIPAA Information or the FDCA Information and any related plea agreement as well as conduct related to matters covered by the subpoena issued by the United States Attorney’s Office for the District of Massachusetts in November 2013, until the date upon which all investigations and prosecutions arising out of such conduct are concluded, whether or not those investigations and prosecutions are concluded within the Term of this Agreement, as follows:

a.                                       Aegerion will truthfully disclose all factual information that is not protected by any applicable privilege or protection with respect to its activities or those of any of its current, former, or future directors, officers, employees, agents, consultants, contractors, subcontractors, and subsidiaries, or any others, including any evidence or allegations and internal or external investigations, concerning all matters about which Aegerion has any knowledge or about which the Government or other law enforcement agencies designated by the Government, may inquire.

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b.                                       Aegerion will provide documents, records, and/or other tangible evidence not protected by any applicable privilege or protection regarding matters about which the Government may inquire and identify knowledgeable directors, officers, employees, agents, and/or representatives to provide information, materials, and testimony. Aegerion will maintain and expeditiously produce any non-privileged documents, records, and/or other tangible evidence responsive to the subpoena issued by the United States Attorney’s Office for the District of Massachusetts in November 2013. Documents subject to production include documents in the custody, possession, and control of the pharmacy associated with the Juxtapid REMS program during the relevant time period.

c.                                        Aegerion will use its best efforts to ensure that its directors, officers, employees, agents, and representatives testify truthfully before the grand jury and/or at any trial or other proceeding with respect to any matters about which they may be questioned provided that the testimony sought is not protected by any applicable privilege or protection. Aegerion (and its directors, officers, employees, agents, and representatives) will at all times give complete, truthful, and accurate information and testimony provided that the information and testimony sought is not protected by any applicable privilege or protection, including the attorney-client privilege and the Fifth Amendment. Aegerion (and its directors, officers, employees, agents, and representatives) will neither attempt to protect any

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person who has been involved in criminal activity, nor falsely implicate anyone in criminal activity.

d.                                       With respect to any information, testimony, documents, records, or other tangible evidence provided to the Government pursuant to this Agreement, Aegerion consents to any and all disclosures, subject to applicable law and regulations, to other governmental authorities of such materials that the Government, in its sole discretion, shall deem appropriate.

10.                                Within thirty (30) days of the Effective Date of this Agreement, Aegerion will (a) make this executed Agreement and its attachments, including the DPA Statement of Facts, conspicuously available to the public on its website for the duration of this Agreement; and (b) communicate to all Aegerion employees that Aegerion has entered into this Agreement and make available this Agreement and its attachments to all such employees.

11.                                Aegerion will implement and maintain internal controls, policies, and procedures designed to prevent and detect violations of HIPAA, including at a minimum, the elements set forth in Attachment B, which is incorporated by reference into this Agreement.

GOVERNMENT’S OBLIGATIONS AND RIGHTS

12.                                If Aegerion fully complies with all of its obligations under this Agreement, the Government will not continue the criminal prosecution against Aegerion described in Paragraph 2 and as described in the DPA Statement of Facts. Within thirty (30) days after the expiration of the Term of this Agreement, the Government will seek dismissal with prejudice of the HIPAA Information filed against Aegerion, and agrees not to file charges in the future against Aegerion relating to the conduct described in the HIPAA Information and the DPA Statement of Facts.

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13.                                The Government will not use, in any criminal or civil case, any self-incriminating information provided by Aegerion pursuant to its cooperation that was not previously known to the United States, or any information directly or indirectly derived therefrom, except in (i) a prosecution or other proceeding for perjury, making a false statement, or obstruction of justice; (ii) a prosecution or other proceeding for any act of violence or act of terrorism; (iii) a prosecution or other proceeding relating to any violation of the Internal Revenue Code; or (iv) any prosecution or other proceeding permitted herein as a result of failure by Aegerion to comply with the terms of this Agreement.

14.                                If, during the Term of this Agreement, Aegerion (1) commits any felony under U.S. federal law; (2) gives deliberately false, incomplete, or misleading testimony or information; (3) fails to cooperate as set forth in Paragraph 9 of this Agreement; (4) fails to implement compliance measures as set forth in Attachment B of this Agreement; or (5) otherwise fails to perform or fulfill each of Aegerion’s obligations under this Agreement or any supplemental agreements with the Government, Aegerion shall thereafter be subject to prosecution for any federal criminal violation of which the Government has knowledge, including, but not limited to, the charge in the HIPAA Information described in Paragraph 2, which may be pursued by the Government in the United States District Court for the District of Massachusetts or any other appropriate venue. The decision whether conduct or statements of any present or future director, officer, or employee, or any person acting on behalf of, or at the direction of, Aegerion, will be imputed to Aegerion for the purposes of determining whether Aegerion has violated any provision of this Agreement shall be in the sole discretion of the Government. Determination of whether Aegerion has breached the Agreement and whether to pursue prosecution of Aegerion shall be in the Government’s sole discretion and is not subject to

9

review in any court or tribunal. Any such prosecution may be premised on information provided by Aegerion. Any such prosecution relating to conduct known by the Government before the date on which this Agreement was signed that is not time-barred by the applicable statute of limitation on the date of the signing of this Agreement may be commenced against Aegerion, notwithstanding the expiration of the statute of limitation, between the signing of this Agreement and the expiration of the Term plus one year. Thus, by signing this Agreement, Aegerion agrees that the statute of limitation with respect to any such prosecution that is not time barred on the date of the signing of this Agreement shall be tolled for the Term plus one year.

15.                                In the event the Government determines that Aegerion has breached this Agreement, the Government agrees to provide Aegerion with written notice of such breach prior to instituting any prosecution resulting from such breach. Within fourteen (14) days of receipt of such notice, Aegerion shall have the opportunity to respond to the Government in writing to explain the nature and circumstances of such breach, as well as the actions Aegerion has taken to address and remediate the situation, including whether Aegerion believes a breach occurred, whether such breach was material, and whether such breach was knowingly or willfully committed. The Government agrees to consider such explanation in determining whether to institute a prosecution of Aegerion.

16.                                As a contractual remedy, Aegerion and the Government agree that, in the Government’s sole discretion, any breach of this Agreement may lead to the imposition of a monetary payment of up to $15,000 per day for each day Aegerion is in breach of this Agreement (“Stipulated Penalties”). The imposition of Stipulated Penalties will be alternative to instituting a prosecution due to a breach of this Agreement. The Government shall notify Aegerion in writing of Aegerion’s failure to comply and the Government’s exercise of its

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contractual right to demand payment of the Stipulated Penalties (the “Demand Letter”). The Demand Letter shall set forth: (a) the provision(s) breached; (b) the approximate date of the breach; (c) a description of the breach sufficient to permit Aegerion to cure (as described below); and (d) the amount of Stipulated Penalties claimed by the Government as of the date of the Demand Letter. Within fourteen (14) days after receipt of the Demand Letter, or such other period as the Government may agree in writing, Aegerion will cure the breach to the Government’s reasonable satisfaction (the “Cure Period”). If Aegerion cures the breach within the Cure Period, no Stipulated Penalties shall be due. If Aegerion fails to cure the breach during the Cure Period, Stipulated Penalties calculated from the date of breach to the date of payment shall be payable to the United States within fourteen (14) days. The Stipulated Penalties shall be paid by electronic fund transfer according to wire instructions that will be provided by the Government. A joint reasonable determination by the United States Attorney’s Office for the District of Massachusetts and the United States Department of Justice’s Consumer Protection Branch as to whether Aegerion has failed to cure any breach will be final and non-appealable. Aegerion agrees that the United States District Court for the District of Massachusetts shall have jurisdiction over any action to collect such a penalty. If Aegerion fails to timely make a payment required in this Paragraph, interest (at the rate specified in Title 28, United States Code, Section 1961) shall accrue on the unpaid balance through the date of payment.

17.          The absence of a Demand Letter from the Government is not, and shall not be construed as, evidence of compliance with this Agreement, federal health care program requirements, HIPAA or its associated privacy regulations, or any other applicable laws, policies, or procedures.

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18.          In the event the Government institutes a prosecution due to Aegerion’s breach of this Agreement: (a) all statements made by or on behalf of Aegerion to the Government or to the Court, including the attached DPA Statement of Facts, and any testimony given by Aegerion before a grand jury, a court, or any tribunal, or at any legislative hearings, whether before or after this Agreement, and any leads derived from such statements or testimony, shall be admissible in evidence in any and all criminal proceedings brought by the Government against Aegerion; and (b) Aegerion shall not assert any claim under the United States Constitution; Rule 11(f) of the Federal Rules of Criminal Procedure; Rule 410 of the Federal Rules of Evidence; or any other federal rule that any such statements or testimony made by or on behalf of Aegerion before or after this Agreement, or any leads derived therefrom, should be suppressed or are otherwise inadmissible.

19.          Aegerion acknowledges that the Government has made no representations, assurances, or promises concerning what sentence may be imposed by the Court if Aegerion breached this Agreement and this matter proceeds to judgment. Aegerion further acknowledges that any such sentence is solely within the discretion of the Court and that nothing in this Agreement binds or restricts the Court in the exercise of such discretion.

20.          This Agreement is between Aegerion and the United States Attorney’s Office for the District of Massachusetts and the Consumer Protection Branch of the United States Department of Justice. This Agreement does not bind any other federal, state, or local prosecuting authorities. Furthermore, this Agreement does not prohibit the United States, any agency thereof, or any third party from initiating or prosecuting any civil or administrative proceedings directly or indirectly involving Aegerion, including, but not limited to, proceedings by the Internal Revenue Service relating to potential civil tax liability.

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21.          Any notice, certification, resolution, or report to the Government under this Agreement 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

Director, Consumer Protection Branch

U.S. Department of Justice

450 5th Street, NW

Washington, DC 20530

22.          Any notice to Aegerion under this Agreement shall be given by personal delivery, overnight delivery by a recognized delivery service, or registered or certified mail, addressed to:

Legal Department

Aegerion Pharmaceuticals, Inc.

One Main Street

Suite 800

Cambridge, MA 02142

Joshua S. Levy

Ropes & Gray LLP

Prudential Tower

800 Boylston Street

Boston, MA 02199-3600

23.          Notice shall be effective upon actual receipt by the Government or Aegerion.

24.          The Government’s acceptance of delivery of any notice, certification, resolution, or report referenced in this Agreement, or the absence of any response thereto, is not, and shall not be construed as, evidence of compliance with this Agreement, federal health care program requirements, HIPAA and associated privacy regulations, or any other applicable laws, policies, or procedures.

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25.          This Agreement, to become effective, must be signed by all of the parties listed below. No promises, agreements, terms, or conditions other than those set forth in this Agreement will be effective unless memorialized in writing and signed by all parties or confirmed on the record before the Court.

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ATTACHMENT A: DPA STATEMENT OF FACTS

The following DPA Statement of Facts is incorporated by reference as part of the Deferred Prosecution Agreement (this “Agreement”) between the United States Attorney’s Office for the District of Massachusetts and the United States Department of Justice, Consumer Protection Branch (collectively, the “Government”) and AEGERION PHARMACEUTICALS, INC. (“AEGERION”). AEGERION hereby agrees and stipulates that the following information is true and accurate. AEGERION admits, accepts, and acknowledges that it is responsible for the acts of its officers, directors, employees, and agents as set forth below. Should the Government pursue the prosecution that is deferred by this Agreement, AEGERION agrees that it will neither contest the admissibility of, nor contradict, this DPA Statement of Facts in any such proceeding. The following facts establish beyond a reasonable doubt the charge set forth in the HIPAA Information deferred by this Agreement:

1.             From at least January 2013, and continuing through in or about 2015, within the District of Massachusetts, and elsewhere, AEGERION PHARMACEUTICALS, INC. (“AEGERION acting by and through certain of its officers and employees in concert with certain non-AEGERION health professionals, known and unknown, did knowingly conspire, confederate, and agree to violate the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), Title 42, United States Code, Sections 1320d-6(a) and 6(b)(3), by knowingly using and causing to be used unique health identifiers, obtaining individually identifiable health information relating to individuals, and disclosing individually identifiable health information to another person, without patient authorization required by 45 C.F.R. § 164.508(a)(3), with the intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain, or malicious harm.

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2.             At all relevant times, the defendant, AEGERION, was a Delaware corporation with a principal place of business in Cambridge, Massachusetts, and from 2013 to 2015 manufactured and sold the drug Juxtapid (generic name: lomitapide).

3.             The U.S. Food and Drug Administration (“FDA”) approved Juxtapid with an indication for use as an adjunct to a low-fat diet and other lipid-lowering treatments to reduce cholesterol in patients with a rare genetic disorder called homozygous familial hypercholesterolemia, or “HoFH.”

4.             HIPAA was enacted, among other things, to limit the circumstances in which patients’ confidential medical information (“individually identifiable health information” or “protected health information”) could be used or disclosed. HIPAA regulations specifically forbid disclosure or use of individually identifiable health information for marketing without written patient authorization. 45 C.F.R. § 164.508(a)(3). HIPAA and the privacy regulations apply to health plans, health care clearinghouses, and health care providers who transmit any health information in electronic form in connection with a transaction covered by the law and privacy regulations. See 45 C.F.R. §§ 160.102(a) and 103 (defining “covered entity”).

5.             AEGERION officers and sales employees frequently called on physicians, attempting to convince them to prescribe Juxtapid. These physicians maintained records for patients which contained protected health information. Because these physicians were health care providers who transmitted patients’ protected health information in electronic form, they were covered by HIPAA and associated privacy regulations.

6.             At all times relevant to this DPA Statement of Facts, AEGERION officers and sales employees knew that they could not access HIPAA-protected patient information held by physicians without written patient authorizations.

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7.             AEGERION’s sales employees were not trained medical professionals and were at no time relevant to this DPA Statement of Facts qualified or able to provide medical treatment to patients or to assist physicians in providing medical treatment.

8.             Nevertheless, to market Juxtapid to doctors with patients not previously diagnosed with HoFH, non-medical AEGERION officers and sales employees involved in the sales and marketing of Juxtapid sought to obtain and did obtain and use patients’ protected health information possessed by physicians and their medical staff, without patient authorizations required by HIPAA regulations, for the purpose of marketing Juxtapid to physicians and, at times, directly to patients.

9.             Without obtaining required HIPAA authorizations, many AEGERION sales employees gained access to physicians’ electronic medical record (“EMR”) systems to perform searches to identify patients for whose treatment they could market Juxtapid to physicians and, at times, directly to patients.

10.          Many AEGERION sales employees gained access to protected health information without patient authorization to complete or to assist with the completion of statements of medical necessity to support insurance coverage of prescriptions for Juxtapid.

11.          Many AEGERION sales employees used protected health information obtained from physicians without patient authorization to contact patients to convince them to start Juxtapid therapy.

12.          Many AEGERION sales employees also used protected health information obtained from physicians without patient authorization to contact patients in order to obtain authorization from patients to allow AEGERION customer service personnel to access those patients’ protected health information.

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13.          Several AEGERION sales employees forged signatures on patient authorizations.

14.          One AEGERION sales representative obtained patient signatures on HIPAA authorizations, written in English, from non-English speaking patients who did not understand the nature of the HIPAA release.

15.          AEGERION sales employees gained access to patients’ HIPAA-protected health information without patient authorization for sales and marketing purposes at the direction of and with the approval of AEGERION’s senior management.

16.          One AEGERION sales executive encouraged AEGERION sales employees to wear surgical scrubs instead of business attire when visiting physicians’ offices in order to facilitate access to HIPAA-protected health information and to patients.

17.          In February 2013, certain AEGERION managers paired with AEGERION sales employees in a competition for the most new prescriptions in a single day. During the competition, AEGERION managers and employees obtained and used patients’ protected health information without patient authorization, including prescriptions for identified patients; one senior AEGERION manager sent a picture of two prescriptions (for pediatric patients without any patient authorization for access to HIPAA-protected health information) and of an EMR query report from a physician’s office including approximately 250 identifiable patients (without any patient authorizations) to the AEGERION sales teams to show his success with his sales representative partner in marketing Juxtapid.

18.          In May 2013, an AEGERION manager told the AEGERION sales force to contact patients who had not authorized direct contact in order to obtain HIPAA releases.

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19.          AEGERION also conducted “kickers” or bonus sales commission incentive programs for its sales employees, with one of the success criteria being the conversion of non-consented patients to consented patients within five days of obtaining a prescription for Juxtapid.

20.          Some AEGERION sales employees also gave gifts or provided benefits to medical staff in exchange for access to patient data, all in furtherance of marketing Juxtapid to physicians.

21.          As a result of AEGERION’s efforts to obtain and success in obtaining HIPAA-protected health information from physicians without patient authorization for hundreds of individuals, including patients under 18 years of age, AEGERION marketed Juxtapid to numerous physicians and patients, all for the purpose of commercial gain to AEGERION.

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ATTACHMENT B: COMPLIANCE PROGRAM AND CERTIFICATIONS

Aegerion Pharmaceuticals, Inc. (“Aegerion”) agrees to the provisions set forth in this Attachment, which is incorporated by reference as part of the Deferred Prosecution Agreement (the “Agreement”) between the United States Attorney’s Office for the District of Massachusetts and the United States Department of Justice, Consumer Protection Branch (collectively, “the Government”) and Aegerion. Aegerion recognizes that each of the terms in this Attachment constitutes a material term of the Deferred Prosecution Agreement.

Compliance and Ethics Program

1.             Aegerion will maintain a Compliance and Ethics Program that governs Aegerion’s business operations. The purpose of the Compliance and Ethics Program is to (a) prevent, detect, and correct violations of law and company policy and procedures; (b) assure the continuation of compliance-related policies and procedures for business operations; (c) assure the continued development of training and other programs designed to educate employees regarding applicable policies, procedures, and standards; (d) conduct auditing and monitoring of the effectiveness of applicable policies, procedures, and standards; (e) assure that there is a mechanism for internal reporting of questionable or inappropriate activities to enable timely investigation and resolution; and (f) assure that appropriate corrective action is taken to prevent recurrence of misconduct.

2.             Aegerion’s Compliance and Ethics Program will consist of a Vice President Ethics and Compliance (“Compliance Officer”) who reports to the President of Aegerion and the Global Chief Compliance Officer of Novelion Therapeutics Inc.; a Compliance Committee composed of Aegerion management (e.g., executives of relevant departments) that meets at least quarterly; a comprehensive set of written compliance policies and procedures governing the

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conduct of its employees; a training program focused on the company’s compliance policies and procedures; a disclosure program to allow employees to report potential violations of law or the company’s compliance policies and procedures; a non-retaliation policy; and a monitoring and auditing program designed to deter and detect compliance issues. The Compliance Officer is responsible for overseeing the administration and implementation of the Compliance and Ethics Program. The Compliance Officer reports at least quarterly on the Compliance and Ethics Program to the Compliance Committee. The Compliance Officer has direct access to senior executives vested with the authority to direct and implement compliance-related changes in Aegerion as necessary. The Compliance Officer has the authority to exercise independent judgment in assessing compliance-related matters. The Compliance Officer has authority to seek advice from outside legal counsel or other outside experts when appropriate. The Compliance Officer is authorized to report issues of any kind directly to the Board of Directors of Novelion Therapeutics Inc. (or a Committee thereof).

3.                                       The Compliance and Ethics Program will include and maintain compliance policies and procedures designed to prevent, detect, and correct violations of HIPAA and its associated privacy regulations, including, but not limited to, the following subjects:

a.                                       Impermissible Access to Patient Information : Aegerion will implement and maintain a policy prohibiting its sales agents from accessing and reviewing patient information (or otherwise consulting with health care providers) to identify potential patients for treatment with Aegerion’s products without patient consent as required by HIPAA or otherwise permitted under HIPAA.

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b.                                       Sales Compensation and Incentives : Aegerion will establish and maintain policies and procedures that shall require that financial incentives do not improperly motivate field-facing sales representatives or their direct managers to engage in improper promotion, sales, and marketing of Aegerion’s products (including accessing protected health information or representing themselves to be involved in the diagnosis and treatment of patients). Aegerion shall exclude from incentive compensation any sales under circumstances indicating that improper promotion of Aegerion’s products occurred, such as the impermissible accessing of protected patient information, and shall not offer or provide any other financial reward to its sales representatives or their managers based upon or involving patient authorization of Aegerion’s access to protected health information.

Notice to Health Care Providers and Entities

4.                                       Within sixty (60) days after the Effective Date of this Agreement, Aegerion shall send, by first class mail, postage prepaid with delivery confirmation, a notice containing the language set forth below to all health care providers (a) who are or who have previously been certified to prescribe Juxtapid under the Juxtapid REMS program, (b) who submitted a prescription for Juxtapid, (c) who made a medical information request concerning Juxtapid, (d) who participated in an Aegerion-sponsored speaker program concerning Juxtapid, or (e) who submitted a grant proposal concerning Juxtapid. This notice shall be dated and shall be signed by Aegerion’s Board Chair. The body of the notice shall state the following:

As you may be aware, Aegerion Pharmaceuticals, Inc. recently entered into civil, criminal, and administrative settlements with the United States

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of America and individual states in connection with Aegerion’s promotion of its product Juxtapid. This letter provides you with additional information about the global settlement, explains Aegerion’s commitments going forward, and tells you how to obtain more information about those commitments.

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 three-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. As part of the 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.

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 approximately $4 million.

More information about these settlements may be found at the following websites:

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

http://oig.hhs.gov/fraud/cia/index.html

Please call Aegerion at 1-855-463-8974 or visit us at http://novelion.com/about-novelion/aegerion-pharmaceuticals/aegeriongovernment-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.

5.                                       The Compliance Officer (or a designee) shall maintain a log (the “Log”) of all calls and messages received by the Compliance and Ethics Program through its disclosure

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program that report questionable practices by Aegerion employees concerning HIPAA and associated privacy regulations, including any such calls or messages made in response to the notice above. The Log shall include a record and summary of each call and message received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. Aegerion shall produce the Log to the United States within fourteen (14) days of a written request for such production.

Certifications and Board Resolution

6.                                       Aegerion will conduct the reviews described in Paragraphs 7 through 9 below 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 Effective Date of this Agreement. The duration of the third Review Period will be nine months. Aegerion will provide the certifications and resolutions described in Paragraphs 7 through 9 below 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.

7.                                       Following the end of each Review Period, the Compliance Officer shall conduct a review of the Log described in Paragraph 5 above for the preceding Review Period. Based on his or her review, the Compliance Officer shall submit to the Government a signed certification (the “Log Certification”) (a) stating that, to the best of his or her knowledge, during the preceding Review Period, Aegerion maintained the Log pursuant to this Agreement; and (b) stating the total number of calls and messages received by the Compliance and Ethics Program through its disclosure program, including any such calls or messages made in response to the notice in Paragraph 4, and the number of those calls and messages that relate to HIPAA and its associated privacy regulations for each month of the preceding Review Period.

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8.                                       Following the end of each Review Period, the President of Aegerion shall conduct a review of the effectiveness of the Compliance and Ethics Program for the preceding Review Period. Based on his or her review, the President of Aegerion shall submit to the Government a signed certification stating that, to the best of his or her knowledge based on a reasonable inquiry, during the preceding Review Period, the Compliance and Ethics Program was effective in identifying and preventing violations of federal health care program requirements, HIPAA, and associated privacy regulations. The certification shall summarize the review described above. If the President of Aegerion is unable to certify that the Compliance and Ethics Program was effective in preventing violations of federal health care program requirements, HIPAA, and associated privacy regulations, he or she shall provide a detailed explanation of why the Compliance and Ethics Program was not effective, and will state the steps Aegerion is taking to ensure the effectiveness of the Compliance and Ethics program.

9.                                       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 the effectiveness of the Compliance and Ethics Program for the preceding Review Period. This review shall include, but not be limited to, updates and reports by the Compliance Officer and other personnel regarding compliance matters. The Board shall evaluate the effectiveness of the Compliance and Ethics Program, including, at a minimum, by receiving updates about the activities of the Compliance Officer and Compliance Committee and updates about the adoption and implementation of policies, procedures, and practices to ensure compliance with applicable federal health care program requirements, HIPAA, and associated privacy regulations. Based on its review, the Board shall

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submit to the Government 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) has made a reasonable inquiry as described in Attachment B of the Deferred Prosecution Agreement with Aegerion into the operations of the Compliance and Ethics Program for the preceding Review Period, [insert date range], including the performance of the Compliance Officer and the Compliance Committee. Based on its reasonable inquiry and review, the Board has concluded that, to the best of its knowledge, Aegerion has implemented an effective compliance program, as defined in the United States Sentencing Commission Guidelines Manual, Chapter 8: Sentencing of Organizations, to meet the requirements of federal health care programs, the Health Insurance Portability and Accountability Act of 1996 and its associated privacy regulations, and as set forth in the Deferred Prosecution Agreement.

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.

10.                                Aegerion agrees that, in the event that the Government shortens or extends the Term of this Agreement pursuant to Paragraph 3 of the Deferred Prosecution Agreement, an increase or decrease in the duration of the Review Periods described in Paragraph 6 above, and an increase or decrease in the total number of reviews required by Paragraphs 7 through 9 above, may be required by the Government, in its sole discretion, and upon notice to Aegerion.

Additional Reporting Obligations

11.                                Fifteen (15) days after the end of each calendar quarter (that is, by January 15 for the calendar quarter ending December 31, April 15 for the calendar quarter ending March 31, July 15 for the calendar quarter ending June 30, and October 15 for the calendar quarter ending September 30), excepting any calendar quarter that ends within sixty (60) days of the end of the Term of this Agreement, Aegerion shall submit a report to the Government in writing stating whether any Reportable Events have been determined to have occurred during the preceding

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calendar quarter, and providing updated information about Reportable Events that Aegerion determined to have occurred during any prior calendar quarter, as may be necessary in the reasonable determination of Aegerion or at the Government’s request. A Reportable Event is any matter that, after a reasonable opportunity to conduct an appropriate review or investigation of the allegations, a reasonable person would consider a probable violation of HIPAA, 42 U.S.C. § 1320d-6, and its associated privacy regulations. A Reportable Event may be the result of an isolated event or a series of occurrences. The written report to the Government shall include: (a) a description of the Reportable Event, including the relevant facts, the positions of the persons involved, and the legal authorities implicated; (b) a description of Aegerion’s actions taken to investigate and correct the Reportable Event; and (c) a description of any further steps Aegerion plans to take to address the Reportable Event and prevent it from recurring. The Compliance Officer shall promptly report to the President of Aegerion any Reportable Event determined to have occurred by Aegerion. The Compliance Officer shall directly and promptly report to the Board (or a designated Committee of the Board), and record in writing, any allegation concerning a Reportable Event that involves any Aegerion employee with senior managerial responsibilities.

Filing of Certifications, Resolutions, and Reports(1)

12.                                The certifications referenced above in Paragraphs 7 and 8 above shall be sworn to under penalty of perjury and shall set forth that the representations contained therein may be

(1) Consistent with the U.S. Department of Justice’s Freedom of Information Act (“FOIA”) procedures, the Government shall make reasonable effort 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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provided to, relied upon, and material to the government of the United States, and that a knowing false statement could result in criminal or civil liability for the signatory.

13.                                Aegerion may submit a timely written request for an extension of time to provide the certifications, resolutions, or reports required by Paragraphs 6 through 9 and Paragraph 11 above. A written request is timely if it is received by the U.S. Attorney’s Office for the District of Massachusetts and the Consumer Protection Branch, U.S. Department of Justice, at least five business days prior to the date by which the certification, resolution or report is due. Timely requests for extension will not be unreasonably denied. If an extension of time is granted in writing, Stipulated Penalties as described in Paragraph 16 of the Deferred Prosecution Agreement shall not accrue until one day after Aegerion fails to meet the revised deadline. If not granted, Stipulated Penalties shall not begin to accrue until three (3) business days after Aegerion received the Government’s written denial of such request or the original deadline, whichever is later.

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ATTACHMENT C: CERTIFICATE OF CORPORATE RESOLUTIONS

WHEREAS, Aegerion Pharmaceuticals, Inc. (“Aegerion”) has been engaged in discussions with the United States Attorney’s Office for the District of Massachusetts and the United States Department of Justice, Consumer Protection Branch (collectively, the “United States”) regarding issues arising in relation to its sale and distribution of the drug, Juxtapid; and

WHEREAS, in order to resolve such discussions, it is proposed that Aegerion enter into a certain agreement with the Government; and

WHEREAS, outside counsel for Aegerion has advised the Board of Directors of Aegerion of its rights, possible defenses, the U.S. Sentencing Guidelines’ provisions, and the consequences of entering into such agreement with the United States;

Therefore, the Board of Directors has RESOLVED that:

1.                                       Aegerion (a) acknowledges the filing of the one-count Information charging Aegerion with conspiracy to violate Title 42, United States Code, Sections 1320d-6(a) and 6(b)(3), in violation of Title 18, United States Code, Section 371; and (b) waives indictment on such charges and enters into a deferred prosecution agreement with the United States.

2.                                       Aegerion accepts the terms and conditions of this Agreement, including, but not limited to, (a) a knowing waiver of its rights to a speedy trial pursuant to the Sixth Amendment to the United States Constitution, Title 18, United States Code, Section 3161, and Federal Rule of Criminal Procedure 48(b); (b) a knowing waiver for purposes of this Agreement and any charges by the United States arising out of the conduct described in the attached Statement of Facts of any objection with respect to venue and consent to the filing of the Information, as provided under the terms of this Agreement, in the United States District Court for the District of Massachusetts; and (c) a knowing waiver of any defenses based on the statute of limitations for

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any prosecution relating to the conduct described in the attached Statement of Facts or relating to conduct known to the United States prior to the date on which this Agreement was signed that is not time-barred by the applicable statute of limitations on the date of the signing of this Agreement;

3.                                       The Vice President, Corporate Counsel of Aegerion, Jennifer Fitzpatrick, is hereby authorized, empowered and directed, on behalf of Aegerion to execute the Deferred Prosecution Agreement substantially in such form as reviewed by this Board of Directors at this meeting with such changes as the Vice President, Corporate Counsel of Aegerion, Jennifer Fitzpatrick, may approve;

4.                                       The Vice President, Corporate Counsel of Aegerion, Jennifer Fitzpatrick, is hereby authorized, empowered and directed to take any and all actions as may be necessary or appropriate and to approve the forms, terms or provisions of any agreement or other documents as may be necessary or appropriate, to carry out and effectuate the purpose and intent of the foregoing resolutions; and

5.                                       All of the actions of the Vice President, Corporate Counsel of Aegerion, Jennifer Fitzpatrick, which actions would have been authorized by the foregoing resolutions except that such actions were taken prior to the adoption of such resolutions, are hereby severally ratified, confirmed, approved, and adopted as actions on behalf of Aegerion.

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Exhibit 10.5

CORPORATE INTEGRITY AGREEMENT

BETWEEN THE

OFFICE OF INSPECTOR GENERAL

OF THE

DEPARTMENT OF HEALTH AND HUMAN SERVICES

AND

AEGERION PHARMACEUTICALS, INC.

I.                                         PREAMBLE

Aegerion Pharmaceuticals, Inc. (Aegerion) hereby enters into this Corporate Integrity Agreement (CIA) with the Office of Inspector General (OIG) of the United States Department of Health and Human Services (HHS) to promote compliance with the statutes, regulations, and written directives of Medicare, Medicaid, and all other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(f)) (Federal health care program requirements) and with the statutes, regulations, and written directives of the Food and Drug Administration (FDA requirements).

Contemporaneously with this CIA, Aegerion is entering into a Settlement Agreement with the United States. Aegerion is also entering settlement agreements with various states (State Settlement Agreements) and Aegerion’s agreement to this CIA is a condition precedent to those agreements.

Aegerion represents that, prior to the Effective Date (as defined below), it implemented a compliance program that includes the following elements with regard to its business operations in the United States: a compliance officer, a compliance committee, training and education, policies and procedures, a hotline for reporting compliance issues, and monitoring and auditing activities (the “Compliance Program”). Aegerion shall continue its Compliance Program throughout the term of this CIA and shall do so in accordance with the terms set forth below. Aegerion may modify its Compliance Program as appropriate but, at a minimum, Aegerion shall ensure that during the term of this CIA, it shall comply with the obligations set forth herein.

Corporate Integrity Agreement

Aegerion Pharmaceuticals, Inc.

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II.                                    TERM AND SCOPE OF THE CIA

A.                                     The period of the compliance obligations assumed by Aegerion under this CIA shall be five years from the effective date of this CIA. The “Effective Date” shall be the date on which the final signatory of this CIA executes this CIA. Each one-year period, beginning with the one-year period following the Effective Date, shall be referred to as a “Reporting Period.”

B.                                     Sections VII, X, and XI shall expire no later than 120 days after OIG=s receipt of: (1) Aegerion’s final Annual Report; or (2) any additional materials submitted by Aegerion pursuant to OIG=s request, whichever is later.

C.                                     The scope of this CIA shall be governed by the following definitions:

1.                                       “Covered Persons” includes:

a.                                       all owners of Aegerion who are natural persons (other than shareholders who: (i) have an ownership interest of less than 5% and (ii) acquired the ownership interest through public trading) and all directors of Aegerion and Novelion Therapeutics Inc.;

b.                                       all officers and employees of Aegerion and all officers and employees of Novelion Therapeutics Inc. and Novelion Services USA, Inc. who are engaged in or who supervise personnel who are engaged in Covered Functions (as defined below in Section II.C.7); and

c.                                        all contractors, subcontractors, agents, and other persons (including contract sales personnel) who perform any of the Covered Functions on behalf of Aegerion, and in that capacity either: (i) interact directly with healthcare professionals (HCPs), healthcare institutions (HCIs), Payors (as defined below in Section II.C.6) or consumers; or (ii)

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perform activities, provide services, or create materials relating to the Covered Functions and those activities, services, or materials are not reviewed or supervised by an Aegerion employee who is a Covered Person prior to execution or dissemination.

Notwithstanding the above, the term Covered Persons does not include part-time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work more than 160 hours during a Reporting Period, except that any such individuals shall become “Covered Persons” at the point when they work more than 160 hours during the Reporting Period.

2.                                       “Relevant Covered Persons” includes all Covered Persons who engage in any of the Covered Functions and all individuals who supervise Covered Persons who engage in any of the Covered Functions.

3.                                       “Government Reimbursed Products” refers to all Aegerion products that are: (a) marketed or sold by Aegerion in the United States (or pursuant to contracts with the United States) and (b) reimbursed by Federal health care programs.

4.                                       The term “Promotional Functions” includes: (a) the selling, detailing, marketing, advertising, promoting, or branding of Government Reimbursed Products; and (b) the preparation or external dissemination of promotional materials or information about, or the provision of promotional services relating to, Government Reimbursed Products, including those functions relating to Aegerion’s review and approval processes for promotional materials and any applicable review committee(s).

5.                                       The term “Product Related Functions” includes: (a) the preparation or external dissemination of non-promotional materials that are governed by Federal healthcare program and/or FDA requirements and distributed to HCPs, HCIs, and Payors about Government Reimbursed Products, including those functions relating to any applicable review committees and those functions relating to Medical Affairs; (b) contracting with HCPs licensed to practice medicine in the United States or with U.S. HCIs, including for the purposes of conducting post-marketing clinical trials, Investigator-Initiated Studies (IISs) about Government Reimbursed Products, and any

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other types of post-marketing studies relating to Government Reimbursed Products; (c) authorship, publication, and disclosure of articles or study results relating to Government Reimbursed Products; (d) to the extent applicable to Aegerion, activities related to the submission of information about Government Reimbursed Products to compendia (such as Drugdex or other compendia of information about Government Reimbursed Products); and (e) activities relating to the provision of instructions or advice to HCPs and HCIs regarding the preparation or submission of claims, statements of medical necessity, or other related documents or information in order to obtain coverage or reimbursement for Government Reimbursed Products.

6.                                       The term “Payor Related Functions” refers to Promotional Functions and Product Related Functions as they relate to interactions (including contracting functions) between Aegerion and entities that provide a drug health benefit program for Government Reimbursed Products, including but not limited to government payors ( e.g. , Medicaid and Medicare) or individuals or entities under contract with or acting on behalf of government payors (such as PBMs) and commercial health plans (collectively referred to as “Payors”). Payor Related Functions also includes interactions with Payors related to formulary placement, contracting, and rebate activities involving Government Reimbursed Products, including those involving supplemental rebate agreements, and other types of rebate agreements.

7.                                       The term “Covered Functions” refers to “Promotional Functions,” “Product Related Functions,” and/or “Payor Related Functions” collectively.

8.                                       The term “Third Party Educational Activity” shall mean any scientific, educational, or professional program, meeting, or event for HCPs that are intended to be independent of Aegerion’s control or influence conducted by a third party and supported by Aegerion, including but not limited to, continuing medical education (CME), disease awareness, or sponsorship of symposia at medical conferences.

III.                               CORPORATE INTEGRITY OBLIGATIONS

Aegerion shall establish and maintain a Compliance Program that includes the following elements:

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A.                                     Compliance Officer and Committee, Board of Directors, and Management Compliance Obligations .

1.                                       Compliance Officer . Within 90 days after the Effective Date, Aegerion shall appoint an individual to serve as its Vice President Ethics and Compliance (Compliance Officer). Aegerion shall maintain a Compliance Officer for the term of the CIA. The Compliance Officer shall be responsible for developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health care program and FDA requirements. The Compliance Officer shall be an employee and a member of senior management of Aegerion and shall report directly to the President of Aegerion. The Compliance Officer shall also report to the Global Chief Compliance Officer who, in turn, reports to the Chief Executive Officer of Novelion Therapeutics Inc. The Compliance Officer shall make periodic (at least quarterly) reports regarding compliance matters directly to the Board of Directors of Novelion Therapeutics Inc. or a committee thereof (hereafter “Board”) and shall be authorized to report on such matters to the Board at any time. Written documentation of the Compliance Officer’s reports to the Board shall be made available to OIG upon request.

The Compliance Officer shall not be, or be subordinate to, the General Counsel or the Chief Financial and Administration Officer of Novelion Therapeutics Inc. or the Vice President Corporate Counsel of Aegerion. The Compliance Officer shall not have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for Aegerion, Novelion Therapeutics Inc., or Novelion Services USA, Inc. The Compliance Officer shall be responsible for monitoring the day-to-day compliance activities engaged in by Aegerion as well as for any reporting obligations created under this CIA. Any job responsibilities of the Compliance Officer unrelated to compliance shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA.

Aegerion shall report to OIG, in writing, any changes in the identity of the Compliance Officer or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.

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