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Portions of this Exhibit have been redacted because they are both (i) not
material and (ii) would be competitively harmful if publicly disclosed.
Information that was omitted has been noted in this document with a placeholder
identified by the mark “[***]”. EXECUTION COPY Exhibit 10.1 EXCLUSIVE LICENSE
AGREEMENT (JUXTAPID® JAPAN) THIS EXCLUSIVE LICENSE AGREEMENT (this “Agreement”)
is made and entered into effective as of February 5, 2019 (the “Effective
Date”), by and between AEGERION PHARMACEUTICALS, INC., a company organized under
the laws of Delaware with its registered office at One Main Street, Suite 800,
Cambridge, MA 02142 (“Aegerion”), and RECORDATI RARE DISEASES INC., a company
organized under the laws of Delaware with its registered office at c/o the
Prentice - Hall Corporation System, Inc., 2711 Centerville Road, Suite 400, in
the city of Wilmington, in the County of New Castle, Delaware (“Recordati”).
Aegerion and Recordati are sometimes referred to herein individually as a
“Party” and collectively as the “Parties”. RECITALS WHEREAS, Aegerion owns or
controls certain know-how, trademarks, and patent rights relating to the
Manufacture and Commercialization of the Product (as defined below); WHEREAS,
Recordati is engaged in the marketing and distribution of pharmaceutical
products used in treating or preventing human diseases and conditions; WHEREAS,
Aegerion wishes to out-license certain rights to the Product to Recordati for
Manufacture and Commercialization of the Product in the Field of Use and in the
Territory (each as defined below); and WHEREAS, Recordati now desires to obtain
such rights on the terms and conditions set forth herein. NOW THEREFORE, in
consideration of the foregoing premises and the mutual promises, covenants, and
conditions contained in this Agreement, the Parties agree as follows.
DEFINITIONS AND INTERPRETATION As used in this Agreement, the terms with initial
letters capitalized, whether used in the singular or plural form, shall have the
meanings set forth in this Article 1 or, if not listed below, the meaning
designated in places throughout this Agreement. 1.1 “Accounting Standards” means
with respect to a Person, IFRS or GAAP as generally and consistently applied
throughout such Person’s organization. 1.2 “Aegerion’s Group” means Aegerion and
its Affiliates. ACTIVE/99458941.1

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1.3 “Aegerion Indemnitees” has the meaning given in Section 14.1. 1.4 “Aegerion
Territory” means all countries of the World excluding the Territory. 1.5
“Affiliates” means, with respect to any Person, any other Person that directly
or indirectly (including through one or more intermediaries) controls, is
controlled by, or is under common control with, such first Person. For the
purposes of this definition, the word “control” (including, with correlative
meaning, the terms “controlled by” or “under the common control with”) as used
with respect to a Person, means that the Person has (i) direct or indirect
beneficial ownership of more than 50% of the voting share capital or other
equity interest in the controlled Person, or (ii) the actual power, either
directly or indirectly through one or more intermediaries, to direct or cause
the direction of the management and policies of such other Person. The Parties
acknowledge that in the case of certain entities organized under the laws of
certain countries outside the United States, the maximum percentage ownership
permitted by law for a foreign investor may be less than fifty percent (50%),
and that in such case such lower maximum percentage shall be substituted in the
preceding sentence, provided that such foreign investor has the power to direct
the management and policies of such entity. 1.6 “Anti-Bribery Law” means the
U.S. Foreign and Corrupt Practices Act 1977 and any other Applicable Laws to
which the relevant Party is subject for the prevention of fraud, corruption,
racketeering, money-laundering, or terrorism. 1.7 “Applicable Law” means all
applicable laws, statutes, ordinances, regulations, rules treaties or others of
any kind whatsoever of any Governmental Authority that may be in effect from
time to time during the Term with respect to the validity or enforceability of,
or activities under, this Agreement, including as applicable the Pharmaceutical
Affairs Law, U.S. Federal Food, Drug, and Cosmetic Act (21 U.S.C. §301 et seq.)
(“FFDCA”), Anti-Bribery Law, and environmental, health and safety laws. 1.8
“Assigned Contracts” means the Contracts to be assigned (pursuant to the
Transitional Services Agreement) to Recordati or its Affiliate (as Recordati may
designate) according to this Agreement and listed as “Assigned Contracts” in
Schedule 1 hereto. 1.9 “Breaching Party” has the meaning given in Section 17.2.
1.10 “Brite Stock” means bulk, unlabeled bottles, containing fourteen (14)
capsules of Product. 1.11 “Business Day” means a day other than a Saturday,
Sunday or a bank or other public holiday in Massachusetts and New Jersey, United
States, in Milan, Italy, or in Tokyo Japan. 1.12 “Calendar Quarter” means each
three (3)-month period ending on each of 31 March, 30 June, 30 September or 31
December; provided, however, that (a) the first Calendar Quarter of the Term
shall extend from the Effective Date to the end of the first full Calendar
Quarter thereafter, and (b) the last Calendar Quarter of the Term shall end upon
expiration or termination of the Agreement. 2 ACTIVE/99458941.1

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1.13 “Calendar Year” means a period of twelve (12) consecutive calendar months
commencing on 1 January and ending on the 31 December of the same year;
provided, however, that (a) the first Calendar Year of the Term shall commence
on the Effective Date and end on 31 December of the same year and (b) the last
Calendar Year of the Term shall commence on 1 January of the Calendar Year in
which this Agreement terminates or expires and end on the date of termination or
expiration of this Agreement. 1.14 “Commercially Reasonable Efforts” means the
efforts and resources typically used by companies with sizes and resources
similar to the respective Party and its Affiliates actually involved in the
performance of this Agreement to perform the obligation at issue, which efforts
shall be those efforts made with respect to its own products at a similar stage
of development or in a similar stage of product life, with similar developmental
risk profiles, of similar market and commercial potential, taking into account
the proprietary position of the products, the expected and actual
competitiveness of alternative products sold by Third Parties in the
marketplace, the regulatory structure involved (including regulatory or data
exclusivity), expected and actual Regulatory Authority approved labeling,
expected and actual product profile, the expected and actual profitability and
return on investment of the applicable product taking into consideration, among
other factors, issues of safety and efficacy, the likely timing of the product’s
entry into the market, the likelihood of receiving a Marketing Authorization
(including regulatory or data exclusivity), the expected and actual patent and
other proprietary position of the product, and other relevant scientific,
technical and commercial factors. 1.15 “Commercialize” or “Commercialization”
means any and all activities relating to the transporting, storage, marketing,
detailing, promotion, sale (and offer for sale or contract to sell),
distribution, importation, exportation or other commercial exploitation
(including pricing and reimbursement activities) for the Product in the
Territory, and seeking of pricing and reimbursement of such Product (if
applicable), and including sales force efforts, detailing, advertising,
promotional materials, market strategy, market research, market access
(including list price and reimbursement activities), and appropriate medical
education and information services, publication, and scientific and medical
affairs. For clarity, Commercialization excludes any Manufacturing or
Development activities. 1.16 “Competitive Product” means [***]. 1.17 “Completion
Date” means the date on which the Product Marketing Authorization is
successfully transferred to Recordati or its Affiliate. 1.18 “Confidential
Information” has the meaning given in Section 15.1. 1.19 “Contracts” means all
the contracts relating to the Product in the Territory entered into by or on
behalf of Aegerion or its Affiliates, including the agreements related to local
labeling and release testing ([***]), in each case, which are listed in Schedule
XI. 1.20 “Control or Controlled” means, with respect to any Know-How, Patent,
trademark or other intellectual property right, the possession (including
ownership) by a Party, or its Affiliates, of the ability (without taking into
account any rights granted by one Party to the other Party under the terms of
this Agreement) to grant access, a license or a sublicense to such 3
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Know-How, Patent, trademark, or other intellectual property right without
violating the terms of any agreement or other arrangement with, any Third Party.
1.21 “Controlling Party” in relation to an Enforcement Action, has the meaning
given in Section 16.3(e). 1.22 “Develop” or “Development” means, with respect to
a product, any and all activities that relate to seeking, expanding, or
obtaining marketing authorization for such product, including any and all
activities related to the design, research, discovery, generation,
identification, profiling, characterization, production, process development,
testing method development, pre-clinical development or non-clinical or
pre-clinical studies of such product, clinical drug development activities
conducted before or after obtaining marketing authorization for such product
that are reasonably related to or leading to the development, preparation, or
submission of data and information to a Regulatory Authority for the purpose of
obtaining, supporting or expanding marketing authorization of such product,
together with all activities related to pharmacokinetic profiling, design and
conduct of clinical studies (including post- marketing studies) of such product,
and regulatory affairs, statistical analysis, report writing, and regulatory
filing creation and submission related to the foregoing (including the services
of outside advisors and consultants in connection therewith). 1.23 “Disclosing
Party” has the meaning given in Section 15.1. 1.24 “Dollar” or “$” means the
legal tender of the United States of America. 1.25 “Effective Date” has the
meaning given in the Introductory Paragraph. 1.26 “Enforcement Action” has the
meaning given in Section 16.3(b). 1.27 “Executive Officer” means, for Aegerion,
its President or another senior executive designee with responsibilities and
seniority comparable thereto and, for Recordati, its Chief Executive Officer or
another senior executive designee with responsibilities and seniority comparable
thereto; provided, however, that any of the foregoing individuals may designate
the Chief Financial Officer as his/her designee for financial related matters.
In the event that the position of any of the Executive Officers identified in
this Section 1.27 no longer exists due to a change of control, corporate
reorganization, corporate restructuring or the like that results in the
elimination of the identified position, the applicable Executive Officer shall
be replaced with another executive officer with responsibilities and seniority
comparable to the eliminated Executive Officer. 1.28 “Field of Use” means the
Licensed Indication. 1.29 “GAAP” means generally accepted accounting principles
as practiced in the United States, consistently applied. 1.30 “Governmental
Authority” means any supra national, national or sub national authority,
commission, department, agency, court, tribunal, arbitrator, regulator,
reimbursement authority, legislative body, or other regulatory body in any
applicable jurisdiction. 4 ACTIVE/99458941.1

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1.31 “ICH” means the International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use. 1.32 “IFRS” means the
International Financial Reporting Standards, consistently applied. 1.33
“Indirect Tax” means any and all indirect taxes, including consumption tax,
value added tax, sales tax, and other similar taxes. 1.34 “Joint Steering
Committee” has the meaning given in Section 6.1. 1.35 “JPY” means Japanese Yen.
1.36 “Know-How” means any technology, specifications, trade secrets, business,
marketing and commercial information, technical information, know-how and
materials, records, techniques, processes, documentation, data, databases,
inventions, software, instrumentation, devices, compositions, formulas,
biological materials, assays, reagents, constructs, compounds, discoveries,
procedures, practices, protocols, methods, results of experimentation or
testing, knowledge, skill and experience, and other proprietary information that
is identified or identifiable in a tangible form, in each case whether or not
patentable or copyrightable. 1.37 “Liabilities” means all losses, costs
(including legal costs on an indemnity basis, other professional fees and
disbursements and associated Indirect Taxes), damages, expenses, compensation,
interest, charges, actions, proceedings, claims, demands and other liabilities
associated with or arising out of the relevant subject matter. 1.38 “Licensed
Indication” means homozygous familial hypercholesterolemia (HoFH). 1.39
“Licensed Know-How” means any and all Know-How, [***]. 1.40 “Licensed Patents”
means the Patents in the Territory that are Controlled by Aegerion or its
Affiliates as of the Effective Date or during the Term and which claim or cover
the Product in the Territory, to the extent set out at Schedule 3, as may be
amended from time-to- time by the Parties acting reasonably upon a finding that
a Patent not already included in Schedule 3 claims or covers the Product in the
Territory (a Party making such finding shall promptly inform the other Party of
such finding). 1.41 “Line Extension” means any new pack form for the Product and
formulation, dosage form, dosage strength or form of administration for the
Product. 1.42 “List Price” means the price (in JPY) for the Product established
by the National Health Insurance System of Japan and listed in the Territory.
1.43 “Lomitapide” means the active pharmaceutical ingredient lomitapide
mesylate. 1.44 “Material Breach” means a failure to [***]. 5 ACTIVE/99458941.1

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1.45 “Manufacturing” or “Manufacture” means, with respect to the Product, all
activities related to the manufacture of the Product, including manufacturing
supplies for Commercialization, packaging, in-process and finished product
testing, release of such Product or any component or ingredient thereof, quality
assurance and quality control activities related to manufacturing and release of
such Product, ongoing stability tests, storage, shipment, and regulatory
activities related to any of the foregoing. 1.46 “Marketing Authorization” means
marketing authorizations, licenses, consents and approvals of any Governmental
Authority (and any applications for the same) with respect to the promotion,
marketing, distribution, and sale and, where relevant, Manufacture, of the
Product in the Territory. 1.47 “Marketing Authorization Holder” means a local,
qualified entity that holds a license from a Regulatory Authority to market a
pharmaceutical product in the Territory pursuant to the requirements,
obligations, and guidelines of the MHLW, PMDA, and any other applicable
Regulatory Authority. 1.48 “MHLW” means the Japanese Ministry of Health, Labour
and Welfare, or any successor agency thereto. 1.49 “Net Sales” means, with
respect to the Royalty Payments, the aggregate gross invoiced sales prices from
sales of all units of the Product sold in the Territory by a member of
Recordati’s Group or any Sublicensee of Recordati to Third Parties after
deducting, if not previously deducted, from the amount invoiced or received: (a)
[***]; (b) [***]; (c) [***]; (d) [***]; (e) [***]; (f) [***]; (g) [***]; and (h)
[***]. Such amounts shall be determined from the books and records of Recordati
that are maintained in accordance with the applicable Accounting Standards. In
the case of any sale or other disposal for value, such as barter or
counter-trade, of the Product in the Territory, other than in an arm’s length
transaction exclusively for cash, Net Sales shall be calculated as above on the
value of the non-cash consideration received in relation to the 6
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sale of the Product in the Territory, as determined in accordance with the
applicable Accounting Standards. Notwithstanding the foregoing, sales between or
among Recordati and other members of Recordati’s Group shall not be included in
Net Sales (but Net Sales shall include sales to the first Third Party by
Recordati or other members of Recordati’s Group). The provision of Products for,
or use of Products in, clinical or pre-clinical trials, as samples or for
compassionate use free of charge and any other Products supplied free of charge
shall not give rise to any deemed sale under this definition and shall not be
included in the calculation of Net Sales. 1.50 “New Indication” means any
indication, [***]. 1.51 “Orphan Drug Designation” means the designation as an
orphan drug in the Territory as determined and granted by the MHLW in accordance
with Applicable Law. 1.52 “Patent” means all patents and patent applications and
all substitutions, divisions, continuations, continuations-in-part, any patent
issued with respect to any such patent applications, any reissue, reexamination,
utility models or designs, renewal or extension (including any patent term
extension and supplementary protection certificate) of any such patent, and any
confirmation patent or registration patent or patent of addition based on any
such patent, and all counterparts and equivalents of any of the foregoing in the
Territory. 1.53 “Patent Costs” means the direct out-of-pocket costs (including
the reasonable fees and expenses incurred to outside counsel and other Third
Parties, including application preparation, filing, prosecution and maintenance
expenses, and the fees related thereto incurred to Governmental Authorities)
incurred after the Effective Date and during the Term and pursuant to this
Agreement, in connection with the Prosecution and Maintenance of Patents,
including costs of Patent interference, appeal, opposition, reissue,
reexamination, inter partes review, post- grant review, revocation, petitions or
other administrative proceedings with respect to Patents and filing and
registration fees, and enforcing and defending any Patents, but excluding for
clarity any overhead, employee costs, or other internal costs or expenses. 1.54
“Person” means an individual, sole proprietorship, partnership, limited
partnership, limited liability partnership, corporation, limited liability
company, business trust, joint stock company, trust, unincorporated association,
joint venture or other similar entity or organization, including a governmental
authority or any department, agency or subdivision thereof. 1.55 “Pharmaceutical
Affairs Law” means the Act on Securing Quality, Efficacy and Safety of Products
including Pharmaceuticals and Medical Devices. 1.56 “PMDA” means Japan’s
Pharmaceuticals and Medical Devices Agency or any successor agency thereto. 7
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1.57 “Product” means the pharmaceutical product known as JUXTAPID® that contains
Lomitapide as the sole active ingredient in a capsule dosage form as approved
for marketing in the Territory as of the Effective Date and any Line Extensions
made by Aegerion following the Effective Date. 1.58 “Product Marketing
Authorization” means any and all Marketing Authorizations for the Product in the
Territory held by Aegerion or its Affiliates as of the Effective Date, including
the Marketing Authorizations listed in Schedule 1. 1.59 “Product Records” means
the records listed in Schedule 2, including the regulatory dossiers for the
Product in the Territory. 1.60 “Product Trademarks” means the trademarks listed
in Schedule 4. 1.61 “Prosecution and Maintenance” or “Prosecute and Maintain”
means, with regard to a particular Patent, the preparation, filing, prosecution
and maintenance of such Patent, as well as re-examinations, reissues and the
like with respect to that Patent. 1.62 “PV Agreement” means the
pharmacovigilance agreement to be entered into by the Parties in accordance with
Section 12.1. 1.63 “Quality Technical Agreement” means the quality technical
agreement to be entered into by the Parties or its Affiliates pursuant to the
Supply Agreement. 1.64 “Receiving Party” has the meaning given in Section 15.1.
1.65 “Recordati’s Group” means Recordati and its Affiliates. 1.66 “Regulatory
Authority” means any Governmental Authority that is concerned with the safety,
efficacy, reliability, manufacture, investigation, sale, or marketing of the
Product, including, in the Territory, the MHLW and the PMDA. 1.67 “Regulatory
Information” means all of the following, to the extent necessary or used as of
the Effective Date by or on behalf of Aegerion or its Affiliates and is
necessary, or reasonably useful (but only to the extent related to the Product
in the Territory), to Manufacture, have Manufactured or Commercialize, have
Commercialized the Product in the Territory (a) [***], (b) [***], and (c) [***].
1.68 “Regulatory Notification” means any notification by or from a Regulatory
Authority in relation to a Marketing Authorization. 1.69 “Regulatory Request”
means any written request by an applicable Regulatory Authority or other
Governmental Authority to amend, cancel, withdraw, or surrender any Marketing
Authorization, or to take any step in relation thereto. 1.70 “Safety Related
Information” means all adverse events, special situations (such as medication
errors or medication management), other documentation such as source data and
decisions related to individual case reports, minutes from safety meetings,
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activities, and raw data for periodic safety update reports, development safety
update reports, and risk management plans. 1.71 “SCLA” means the Settlement and
Cross-License Agreement, [***], made by and between UPenn and Aegerion on the
one hand, and Pfizer Inc. of New York, N.Y. (“Pfizer”) on the other, in the form
attached hereto in Schedule X, as may be amended from time-to-time only in
accordance with Section 11.2. 1.72 “Sublicense Revenues” means any and all
consideration, including upfront and milestone payments, received by Recordati
or any of its Affiliates under any agreement with a Sublicensee. [***]. 1.73
“Sublicensee” means a Third Party to which Recordati has granted rights, as
permitted under this Agreement, to Commercialize the Product for the Territory.
1.74 “Supply Agreement” means the supply agreement to be entered into between
Aegerion and Recordati or its Affiliate (as Recordati may designate) in relation
to the Product in the Territory. 1.75 “Term” has the meaning given in Section
17.1. 1.76 “Territory” means Japan and its territories and possessions. 1.77
“Third Parties” means any Person other than Aegerion and Aegerion’s Group,
Recordati and Recordati’s Group, and their respective permitted successors. 1.78
“Trademark Enforcement Action” has the meaning given in Section 16.4(c). 1.79
“Transaction Documents” means this Agreement, the Transitional Services
Agreement, the Supply Agreement, the PV Agreement and the Quality Technical
Agreement. 1.80 “Transitional Services Agreement” means the transitional
services agreement to be entered into between Aegerion and Recordati (or its
Affiliate) in relation to the Product in the Territory. 1.81 “University of
Pennsylvania” or “UPenn” means the Trustees of the University of Pennsylvania.
1.82 “University of Pennsylvania Agreement” means the patent license agreement
between the University of Pennsylvania and Aegerion Pharmaceuticals Inc., dated
May 19, 2006, in the form attached hereto in Schedule IX, as may be amended from
time-to-time only in accordance with Section 11.1(a). 1.83 “Valid Claim” means,
with respect to the Product in the Territory, any claim of a Licensed Patent
that: (a) has not been held permanently revoked, unenforceable or invalid by a
decision of a court or other governmental agency of competent jurisdiction,
which decision is un- appealable or un-appealed within the time allowed for
appeal; and (b) has not expired, lapsed, or 9 ACTIVE/99458941.1

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been cancelled, abandoned, dedicated to the public, disclaimed, denied or
admitted to be invalid or unenforceable, including through reissue,
reexamination, disclaimer, or otherwise. GRANT OF RIGHTS License Grant. Subject
to the terms and conditions of this Agreement, Aegerion hereby grants to
Recordati, and Recordati hereby, accepts: a non-transferable (except as provided
in Section 28), exclusive (including with respect to Aegerion and to Aegerion’s
Group) license (or sublicense), with the right to grant sublicenses in
accordance with Section 2.3, under the Licensed Patents and the Licensed Know-
How, to Manufacture, have Manufactured, Commercialize and have Commercialized
the Product in the Field of Use in the Territory; a non-transferable (except as
provided in Section 28), exclusive license, with the right to grant sublicenses
in accordance with Section 2.3, to use and display the Product Trademarks in the
form attached in Schedule 4 and solely to Manufacture or have Manufactured the
Product and to Commercialize the Product, in each case, in the Field of Use in
the Territory; and a non-transferable (except as provided in Section 28), fully
paid-up and royalty-free, non-exclusive license, with the right to grant
sublicenses in accordance with Section 2.3, in and to all rights Controlled by
Aegerion under [***] to (i) Manufacture and have Manufactured the Product
anywhere in the world in the Field of Use for the Territory and (ii)
Commercialize and have Commercialized the Product in the Field of Use in the
Territory. The license under this Section 2.1(c) is hereby granted by Aegerion
to Recordati and to its Affiliate operating the Product’s business in the
Territory, and shall be granted by Aegerion to any other entity in the Recordati
Group that operates the Product’s business in the Territory in the future, on
Recordati’s written request. Such license granted by Aegerion to Recordati’s
Affiliate under this Section 2.1(c) shall automatically terminate, with respect
to such Recordati’s Affiliate only, in the event such Recordati’s Affiliate
ceases to be an Affiliate of Recordati. University of Pennsylvania Agreement;
SCLA. University of Pennsylvania Agreement. The Parties acknowledge and agree
that, if the licenses granted by Aegerion in Section 2.1 include sublicenses
under the applicable license rights granted to Aegerion by the University of
Pennsylvania under the University of Pennsylvania Agreement, Recordati shall be
bound by, and shall comply with all applicable terms and conditions of the
University of Pennsylvania Agreement, as a sublicensee of the rights licensed to
Aegerion thereunder only to the extent applicable to the rights sublicensed to
Recordati hereunder. Recordati shall not willfully or knowingly, to [***], cause
Aegerion to breach the University of Pennsylvania Agreement; provided that
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be construed to require Recordati to expand its obligations under this
Agreement. Aegerion acknowledges that it is responsible for the fulfillment of
its obligations under the University of Pennsylvania Agreement and shall fulfill
the same, including any provisions necessary to maintain in full force and
effect any rights sublicensed to Recordati and its Affiliates and Sublicensees
hereunder and the exclusive nature of such rights, subject to Recordati’s
compliance with its obligations hereunder. Aegerion agrees to notify Recordati
in writing as soon as reasonably possible by giving reasonable details if a
dispute arises under the University of Pennsylvania Agreement that is relevant
to the rights granted to Recordati under this Agreement and shall keep Recordati
regularly updated with regard to the progress of any such dispute. Aegerion
shall also supply copies of any notices or other information that it receives
from the University of Pennsylvania under the University of Pennsylvania
Agreement and that are relevant to the rights granted to Recordati under this
Agreement. SCLA. [***]. [***]. [***]. Sublicensing. Recordati may sub-license
the rights granted in Section 2.1 to: [***]; or [***]; [***], provided that any
such sublicense shall be consistent with the terms and conditions of this
Agreement. The grant of any sublicense pursuant to Section 2.3 shall not relieve
Recordati of its obligations under this Agreement, except to the extent they are
performed by the relevant Affiliate or Third Party. Recordati shall ensure that
its Affiliates and Sublicensees comply with all applicable terms and conditions
of this Agreement as if such person were a party to this Agreement, and
Recordati shall be responsible for any failure of any such person to 11
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comply with such terms or conditions, with the further understanding that any
action or omission by any such person that, if committed by Recordati would be a
breach of this Agreement, shall be deemed a breach by Recordati of this
Agreement for which Recordati is responsible. Reservation of Rights. Recordati
acknowledges that Aegerion has reserved to itself the right to commercialize and
otherwise exploit the Product in the Aegerion Territory. To the extent permitted
by Applicable Law, neither Party shall, nor shall permit that any of its
Affiliates shall, and each Party shall use reasonable efforts to ensure that its
distributors and Sublicensees (or sublicensees, in the case of Aegerion) shall
not, distribute, market, promote, offer for sale or sell Products actively or
passively to any person in or for the Aegerion Territory, in the case of
Recordati, or in or for the Territory, in the case of Aegerion. To the extent
permitted by Applicable Law, each Party shall use its reasonable efforts to: (a)
include a similar provision in any new contracts that it enters with
distributors, wholesalers or sub-contractors following the Effective Date; and
(b) amend any continuing or renewed contracts with existing distributors,
wholesalers or subcontractors to include a similar provision when such contracts
first come up for renewal following the Effective Date. In addition, Aegerion
reserves for itself the right to Manufacture or have Manufactured the Product in
or for the Territory for the purposes of supplying Product to Recordati under
the Supply Agreement, or for the purposes of supplying product for sale in or
for the Aegerion Territory. In addition Aegerion shall have the right to carry
out, or have carried out, Development activities relating to the Product (for
example clinical trials) in the Territory for the Aegerion Territory; provided,
however, that Aegerion shall (i) promptly inform Recordati about such
Development activities in the JSC, and (ii) perform such activities in a manner
that does not impair Recordati’s rights under this Agreement. Restrictions.
Recordati shall not, and shall cause that its Affiliates and its or their
licensees, sublicensees or distributors shall not, do any act, or fail to do any
act, in connection with the Product in the Territory that would reasonably be
expected to: (i) cause the Product Marketing Authorization in the Territory, or
an equivalent approval in the Aegerion Territory, to be withdrawn or suspended;
or (ii) result in the Product having to be withdrawn from the Territory or the
Aegerion Territory; or (iii) [***]. Aegerion shall not, and shall cause that its
Affiliates and its or their licensees, sublicensees or distributors shall not,
do any act, or fail to do any act, in connection with the Product in the
Territory that would reasonably be expected to: (i) cause the Product Marketing
Authorization in the Territory to be withdrawn or suspended; or (ii) result in
the Product having to be withdrawn from the Territory; or (iii) [***]. Recordati
shall not, and shall cause that its Affiliates and shall use its reasonable
endeavours that its Sublicensees do not, engage in any Development activities
with respect to the Product or the Product Marketing Authorization during the
Term, and shall not grant or attempt to grant any Third Party any right or
license, or any option or other right to acquire a right or license, to engage
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Recordati shall not, and shall cause that its Affiliates and shall use its
reasonable endeavours that its Sublicensees do not, Develop or Commercialize a
Competitive Product in or for the Territory during the Term. Right of First
Negotiation for New Indications. [***]. TRANSFER OF MARKETING AUTHORIZATION,
CONTRACTS, DOCUMENTS In furtherance of the rights and license granted by
Aegerion to Recordati under this Agreement, (a) Aegerion shall: (i) [***],
initiate the transfer to Recordati or its Affiliate (as Recordati may designate)
of the Marketing Authorization and the Orphan Drug Designation identified on
Schedule 1 in accordance with Applicable Law and approval of each applicable
Regulatory Authority; (ii) [***], furnish to Recordati and/or its Affiliate (as
Recordati may designate) a copy of all Regulatory Information and Product
Records (with originals of documents which are required from a regulatory
perspective, and of any other documents that are mutually agreed by the Parties
to be furnished to Recordati, to be provided to Recordati after Completion
Date), and, pursuant to the terms of the Transition Services Agreement,
reasonable assistance necessary for the transfer of the Marketing Authorization
and Orphan Drug Designation; (iii) promptly after the Effective Date, transfer
the Licensed Know-How pursuant to the terms of the Transition Services
Agreement; and (iv) assign to Recordati or its Affiliate (as Recordati may
designate) all of Aegerion’s rights under the Assigned Contracts pursuant to the
Transitional Services Agreement; and (b) Recordati shall assume, discharge, and
perform all liabilities and obligations under the Product Marketing
Authorization for the Product in the Territory and under the Assigned Contracts
that arise from circumstances having their origin after the effective date of
such transfer and assignment. TRANSITION SERVICES In furtherance of the rights
and license granted by Aegerion to Recordati under this Agreement, Aegerion
shall provide any and all transition services to Recordati pursuant to the
Transitional Services Agreement as reasonably necessary for Recordati to enjoy
the economic benefit of the Commercialization of the Product in the Territory
following the Effective Date and prior to the Completion Date. PAYMENT Upfront
Payment. Upon the Effective Date, Recordati shall pay to Aegerion a one-time,
non-refundable, non-creditable payment of Twenty-Five Million Dollars
($25,000,000). Payment for Transfer of Product Marketing Authorization. No later
than forty- five (45) days after the Completion Date, Recordati shall pay to
Aegerion a one-time, non- refundable, non-creditable payment of Five Million
Dollars ($5,000,000). Royalty Payments. Recordati shall make non-refundable,
non-creditable royalty payments to Aegerion based on Net Sales of the Product in
the Field in the Territory by Recordati and its Affiliates and Sublicensees
during the Term at a rate of twenty two and a half 13 ACTIVE/99458941.1

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percent (22.5%) of Net Sales (“Royalty Payments”). Recordati shall pay Aegerion
any royalties due under this Section 5.3 within [***] days of the end of each
Calendar Quarter in respect of Net Sales made in that Calendar Quarter.
Sublicense Income. Recordati shall make non-refundable, non-creditable payments
to Aegerion at a rate of twenty percent (20.0%) of Sublicense Revenues
(“Sublicense Payments”). Recordati shall pay Aegerion any Sublicense Payments
due under this Section 5.4 within [***] days of the end of each Calendar Quarter
in respect of Sublicense Revenues made in that Calendar Quarter. For clarity,
the Sublicense Payments shall exclude royalties on Net Sales, which are payable
by Recordati to Aegerion pursuant to Section 5.3. Milestone Payments.
Milestones. Recordati shall make one-time, non-refundable, non- creditable
milestone payments to Aegerion (each a “Milestone Payment”) on the first
instance on which cumulative Net Sales during the Term by Recordati and its
Affiliates and Sublicensees of the Product in the Territory first reach the
Dollar threshold values indicated below (each, a “Milestone Event”): Milestone
Event Milestone Payment Cumulative Net Sales of Product in the Territory during
the $12,500,000 Term first equaling or exceeding $70,000,000 Cumulative Net
Sales of Product in the Territory during the $12,500,000 Term first equaling or
exceeding $140,000,000 Cumulative Net Sales of Products in the Territory during
the $12,500,000 Term first equaling or exceeding $210,000,000 Cumulative Net
Sales of Product in the Territory during the $12,500,000 Term first equaling or
exceeding $280,000,000 Cumulative Net Sales of Product in the Territory during
the $5,000,000 Term first equaling or exceeding $350,000,000 Cumulative Net
Sales of Product in the Territory during the $5,000,000 Term first equaling or
exceeding $420,000,000 Cumulative Net Sales of Product in the Territory during
the $5,000,000 Term first equaling or exceeding $490,000,000 Cumulative Net
Sales of Product in the Territory during the $5,000,000 Term first equaling or
exceeding $560,000,000 Cumulative Net Sales of Product in the Territory during
the $5,000,000 Term first equaling or exceeding $630,000,000 Cumulative Net
Sales of Product in the Territory during the $5,000,000 Term first equaling or
exceeding $700,000,000 For clarity, the Milestone Payments shall each be paid
only once, such that the maximum total amount potentially payable by Recordati
to Aegerion under this Section 5.5(a) is Eighty Million Dollars ($80,000,000)
(it being understood that the Milestone Payments shall be additive, such that,
if more than one Milestone Event set forth in the table above is achieved in the
same Calendar Quarter and no such Milestone Events have been achieved in any
prior Calendar Quarter, Recordati shall pay to Aegerion the total amount of the
Milestone Payments for such achieved Milestone Events in a single payment
(instead of separate payments for each 14 ACTIVE/99458941.1

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of the achieved Milestone Events) to be made in accordance with Section 5.5(b)
(e.g., if in one Calendar Quarter, the first four (4) Milestone Events are
achieved and no such Milestone Events has been achieved in any prior Calendar
Quarter, then Recordati would pay Aegerion [***] in one single payment in
accordance with Section 5.5(b)). Payment Terms for Milestone Payments. Recordati
shall notify Aegerion within [***] days of the first achievement of any
Milestone Event and shall pay to Aegerion the amount of the applicable Milestone
Payment no later than [***] days after the end of the Calendar Quarter in which
such Milestone Event was first achieved. Records. Recordati shall keep, and
shall procure that its Affiliates keep, proper records and books of account
showing Net Sales for the purpose of calculating the royalties and milestone
payments for the Product in the Territory as provided in the Agreement. Aegerion
shall be entitled, at its own expense, on [***] days’ prior written notice to
Recordati to appoint an independent accounting firm selected by Aegerion and
reasonably acceptable to Recordati to inspect and audit such records and books,
in all cases during normal business hours. Any auditor shall first enter into a
confidentiality agreement with Recordati agreeing to keep such records and books
confidential. There shall be no more than one (1) such audit in any Calendar
Year or with respect to any reporting period. [***]. Mode and Payment and
Interest. All payments under this Agreement shall be made by deposit of US
Dollars in the requisite amount in the account (in the USA) designated by
Aegerion. For the purpose of calculating any sums due under, or otherwise
reimbursable pursuant to, this Agreement (including the calculation of Net Sales
expressed in currencies other than US Dollars), any amounts expressed in a
currency other than US Dollars (where the relevant threshold or amount is
expressed in US Dollars) shall be converted into [***]. If Recordati fails to
make any Royalty Payment, Milestone Payment, or Sublicense Payment due under
this Agreement by the due date for payment, interest shall accrue on that amount
for the period beginning on the due date for payment and ending on the date of
actual payment (both before and after judgment) at the [***] plus the
then-applicable [***]. Interest shall be calculated on the basis of a year of
365 days and for the actual number of days elapsed, shall accrue from day to
day, and shall be compounded quarterly. Recordati shall have no right to offset,
set off or deduct any amounts from or against the amounts due to Aegerion
hereunder. Taxes. The payments payable by Recordati to Aegerion under this
Agreement shall be paid free and clear of any and all taxes (which, for clarity,
shall be the responsibility of Recordati), except for any withholding taxes
required by Applicable Law. Recordati shall 15 ACTIVE/99458941.1

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deduct or withhold from the Royalty Payments, Milestone Payments, and Sublicense
Payments any taxes that is required by Applicable Law to deduct or withhold,
provided that Recordati shall provide Aegerion with written notice promptly upon
learning of such withholding obligation. Notwithstanding the foregoing, if
Aegerion is entitled under any applicable tax treaty to a reduction of rate of,
or the elimination of, applicable withholding tax, it shall deliver to Recordati
or the appropriate governmental authority (with the assistance of Recordati to
the extent that this is reasonably required and is requested in writing) the
prescribed forms necessary to reduce the applicable rate of withholding or to
relieve Recordati of its obligation to withhold such tax and Recordati shall
apply the reduced rate of withholding or dispense with withholding, as the case
may be; provided, that Recordati has received evidence of Aegerion’s delivery of
all applicable forms (and, if necessary, its receipt of appropriate governmental
authorization) at least [***] days prior to the time that the relevant Royalty
Payments, Milestone Payments and Sublicense Payments are due. If, in accordance
with the foregoing, Recordati withholds any amount, it shall pay to Aegerion the
balance when due, make timely payment to the proper taxing authority of the
withheld amount and send to Aegerion proof of such payment within [***] days
following such payment. Notwithstanding anything contained in Section 5.8(a),
this Section 5.8(b) shall apply with respect to Indirect Taxes. All payments due
under this Agreement are exclusive of Indirect Taxes. If any Indirect Taxes are
chargeable in respect of any payments, including under the reverse charge
procedure as a result of the transfer of any right or asset under this
Agreement, Recordati shall be responsible for and shall pay all such Indirect
Taxes at the applicable rate in respect of any such payments or transfer. For
purposes of this Section 5.8, each Party undertakes to provide the other Party
with any Form 6166 (Certification of U.S. Tax Residency issued by the U.S.
Treasury Department) as promptly as practically possible after such Form 6166 is
issued by a competent Governmental Authority. JOINT STEERING COMMITTEE AND
ONGOING CO-OPERATION Promptly following the Effective Date (but in no event
later than [***] days thereafter) the Parties shall establish a committee to
manage the overall relationship between the Parties pursuant to the terms of
this Agreement and to facilitate the exchange of information regarding
regulatory, medical, pharmacovigilance and commercial matters related to the
Product in the Territory (“Joint Steering Committee” or “JSC”). In addition to
its overall responsibilities described in Section 6.1, the JSC shall, among
other things: [***]; [***]; [***]; and [***]. 16 ACTIVE/99458941.1

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Each Party shall each designate an equal number (up to a maximum of [***]
representatives of each Party) of representatives who are employees of such
Party, or of an Affiliate of such Party, with appropriate expertise and
seniority to serve as members of the JSC and to make the decisions delegated to
the JSC. Each Party may replace its JSC representatives at any time upon written
notice to the other Party, provided that the Parties shall use reasonable
endeavors to keep such replacements to a minimum. The JSC shall have a
chairperson selected from one of the members of the JSC. The chairperson of the
JSC shall be responsible for calling meetings, preparing and circulating an
agenda in advance of each meeting of the JSC, and preparing and issuing minutes
of each meeting within [***] days thereafter; provided, however, that a JSC
chairperson shall call a meeting of the JSC promptly upon the written request of
a representative of the other Party on the JSC to convene such a meeting. Such
minutes shall not be finalized until a representative of the other Party on the
JSC has reviewed and confirmed the accuracy of such minutes in writing. The JSC
shall hold meetings at such times as it elects to do so; provided, however, that
the JSC shall hold meetings no less frequently than once every Calendar Quarter.
Meetings of the JSC may be held by means of telecommunication (e.g., telephone,
video, or web conferences). Other employees of each Party, or of any of its
respective Affiliates involved in the Commercialization of the Product, may
attend meetings of the JSC as non-voting participants, and, with the consent of
each Party, consultants, representatives, or advisors involved in the
Commercialization of the Product may attend meetings of the JSC as non-voting
observers; provided, however, that such Third Party representatives are under
obligations of confidentiality and non-use applicable to the Confidential
Information of each Party and that are at least as stringent as those set forth
in Section 15 of this Agreement. Each Party shall be responsible for all of its
own expenses of participating in the JSC. Each Party shall disclose to the other
Party the proposed agenda items along with appropriate information at least
[***] Business Days in advance of each meeting of the JSC; provided, however,
that under exigent circumstances requiring JSC input, a Party may provide its
agenda items to the other Party within a lesser period of time in advance of the
meeting, or may propose that there not be a specific agenda for a particular
meeting, so long as such other Party consents to such later addition of such
agenda items or the absence of a specific agenda for such JSC meeting. The JSC
shall decide with the unanimous votes of its members. If the JSC is unable to
reach consensus regarding a matter within [***] Business Days after commencement
of good faith negotiations, the issue shall be escalated to the applicable
Executive Officers pursuant to Section 32.2 hereof; [***]. REGULATORY Subject to
the terms and conditions in this Agreement, Recordati or its Affiliate shall be
entitled in its sole discretion to discuss and agree with Governmental
Authorities in the Territory all decisions usually taken by a Marketing
Authorization Holder, [***]. Recordati shall inform Aegerion as soon as
reasonably practicable once a List Price has been agreed with the applicable
Governmental Authority in the Territory. 17 ACTIVE/99458941.1

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The following provisions shall apply to the Product Marketing Authorization:
subject to Section 7.2(j), with effect from the Effective Date, Recordati shall
bear any filing or maintenance fees required to be paid to the issuer of the
Product Marketing Authorization, and following the Completion Date shall
maintain in force the Product Marketing Authorization and the Orphan Drug
Designation; Recordati shall be responsible, at its own expense, for preparing
all translations from Japanese to English, or from English to Japanese (if not
already available to Aegerion), for all submissions, applications, filings and
correspondence in connection with the transfer and maintenance of the Product
Marketing Authorization and Orphan Drug Designation; each Party shall promptly
provide the other Party with copies of any material correspondence that could
have implications for the safety of the Product, or which could otherwise impact
on any Marketing Authorization for the Product received by such Party or any of
its Affiliates from any Governmental Authorities relating to the Product. To the
extent not prohibited by such applicable Regulatory Authority or Applicable Law
and reasonably practicable, Aegerion and Recordati shall use reasonable
endeavours to discuss said material correspondence from a Regulatory Authority
that is reasonably expected to have a material impact on the Product core safety
information, labeling, drug substance or drug product manufacturing, or quality
control, or that otherwise requires a change control assessment, reasonably in
advance of any deadline to submit such response, and Recordati or Aegerion shall
reasonably cooperate with the other Party in responding or taking steps relating
thereto; Recordati and Aegerion shall not amend, supplement, replace, cancel,
withdraw, or surrender the Product Marketing Authorization, or take any step in
relation thereto; subject to the other provisions of this Article 7, as between
the Parties, [***]; any Line Extension available to Aegerion, or planned by
Aegerion to be exploited in the Territory, shall be promptly communicated to
Recordati. [***]; the post-marketing commitments in existence as of the
Effective Date and listed in Schedule 5 shall be carried out [***]. [***]; and
Recordati and Aegerion shall ensure that all activities carried out by or on
behalf of Recordati or Aegerion, its Affiliates or its sublicensees in relation
to the Product Marketing Authorization or the Product in the Territory are
carried out in accordance with Applicable Law and any risk management plan or
similar requirements of any Regulatory Authority. Recordati hereby grants
Aegerion and its Affiliates a [***]. Aegerion or its Affiliates shall provide to
Recordati during the Term of this Agreement any data (including, for clarity,
pharmacovigilance data, PMS study data and quality data) that Aegerion or its
Affiliates Controls that relate to the Product and that Recordati may 18
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reasonably request or that is required by Recordati to comply with its
regulatory obligations relating to the Product in the Territory.
COMMERCIALIZATION IN THE TERRITORY Except to the extent otherwise provided in
any Transaction Document, from and after the Effective Date, Recordati or its
Affiliate shall, at its own cost and expense, be solely responsible for: (a) the
Commercialization of the Product in and for the Territory and shall
independently determine and set the selling prices for the Product in the
Territory, including the selling price, volume discounts, rebates, and similar
matters; (b) all marketing, advertising and promotional materials related to the
Product in the Territory; and (c) receiving and processing all orders,
undertaking all invoicing, collection and receivables, booking sales, and
providing all customer service related to the sale of the Product in the
Territory (including handling all returns or recalls of the Product in the
Territory). Recordati shall ensure that all of the foregoing activities are
carried out in accordance with the Product Marketing Authorization and
Applicable Law. For clarity, and without limiting or derogating from the terms
of the Transitional Services Agreement, Aegerion shall be responsible for
handling, and bearing all costs relating to, all returns or recalls of the
Product Manufactured before the Effective Date and sold by or on behalf of
Aegerion in the Territory before or after the Effective Date. Recordati shall
keep all discounts, rebates and other non-public pricing information for the
Product in the Territory confidential. Commercialization Plan. Recordati shall
within [***] days of the Effective Date submit to Aegerion a detailed business
and commercialization plan for the Product in the Territory (“Commercialization
Plan”) for Calendar Year 2019. Following the initial Commercialization Plan,
Recordati shall provide an updated Commercialization plan to the JSC by [***] of
each Calendar Year, which plan will cover immediately subsequent calendar year.
Recordati shall in good faith reasonably consider the JSC’s comments and notes
with respect to each such updated Commercialization plan. Diligence. During the
Term of this Agreement Recordati shall use [***] to Commercialize the Product in
the Territory, taking into account the annual Commercialization Plan. RECORDS
Prior to delivery of the Product Records and the Regulatory Information to
Recordati or to its Affiliate, as Recordati will instruct at its own discretion,
Aegerion shall be entitled to take and retain a copy of them and at any time to
use those copies for the following purposes: defending any claim against
Aegerion or any other member of Aegerion’s Group arising out of or relating to
the Product, its supply or any other actions taken by Aegerion or Aegerion’s
Group prior to the Effective Date in connection with the Product; responding to
any enquiries or audits carried out by or on behalf of any Regulatory Authority;
and 19 ACTIVE/99458941.1

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fulfilling its obligations under any Transaction Document. If Aegerion requires
access to the original copies of the Product Records or the Regulatory
Information transferred to Recordati or its Affiliate, Recordati shall provide
copies of or access to the same to Aegerion promptly upon request. MUTUAL
REPRESENTATIONS AND WARRANTIES Each Party hereby represents and warrants to the
other Party that, as of the Effective Date: such Party is validly existing and
is a company duly incorporated, registered, and in good standing under the laws
of the jurisdiction of its incorporation; such Party has the legal right, power
and authority and all necessary consents and authorizations to enter into and
perform its obligations pursuant to this Agreement; this Agreement constitutes,
or will when executed constitute, legal, valid and binding obligations on such
Party and will be enforceable against such Party in accordance with its terms
subject to applicable bankruptcy, insolvency, fraudulent transfer,
reorganization, moratorium and other laws affecting creditors’ rights generally
and general principles of equity; the entry into and performance of its
obligations under this Agreement by such Party shall not (i) conflict with or
breach any material agreement, instrument, or understanding, oral or written to
which it is a party or by which it is bound, (ii) violate any provision of its
constitutional documents, nor (iii) violate any Applicable Law; such Party or
its Affiliate is entering into each Transaction Document to which it is a party
on its own behalf and not on behalf of any Third Party; such Party has not
granted, and shall not grant, during the Term, any right to any Third Party that
would conflict with the rights granted or to be granted to the other Party under
this Agreement; all consents, approvals, and authorizations from all
Governmental Authorities and other third parties required to be obtained by such
Party in connection with the execution and delivery of this Agreement, with the
exception of those set forth on Schedule 7 attached hereto, have been obtained;
there is no claim, action, proceeding or suit by or before any Governmental
Authority or pending or, to such Party’s knowledge, threatened, which in any
such case would or would reasonably be expected to impair or delay such Party or
its Affiliate’s ability to perform its obligations under any Transaction
Document and to consummate the transactions contemplated thereby; and neither
such Party, nor any of its Affiliates, directors, officers, employees or
representatives, is a crime syndicate, member of a crime syndicate, crime
syndicate-related companies or association, corporate racketeer or any other
antisocial force (each an “Antisocial 20 ACTIVE/99458941.1

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Force”), and neither it, its parent company, nor any of its Affiliates,
directors, officers, employees or representatives is, nor shall be, involved in
any actions or activities using, or jointly associated with, any party that is
an Antisocial Force. ADDITIONAL REPRESENTATIONS, WARRANTIES AND UNDERTAKINGS OF
THE PARTIES Aegerion hereby represents and warrants the following to Recordati
as of the Effective Date. The Contracts listed in Schedule XI are all contracts
relating to the Product in the Territory entered into by or on behalf of
Aegerion or its Affiliates. Each such Contract and the SCLA is in effect and is
valid and binding on Aegerion (or its Affiliate, as applicable), enforceable in
accordance with its terms, and neither Aegerion nor any of its Affiliates, nor
to the knowledge of Aegerion, any other party thereto, is in material breach of,
or material default under, any such Contract or the SCLA. No event has occurred
that, with the giving of notice or lapse of time or both, would constitute a
material breach or material default by Aegerion or any of its Affiliates under
any such Contract or the SCLA. Aegerion shall comply with its obligations under
each such Contract and the SCLA and shall not amend, modify, waive, or
terminate, any of its rights under any such Contract, including the University
of Pennsylvania Agreement, or the SCLA, in a manner that would have an adverse
effect on the obligations or interests of Recordati hereunder without the prior
written consent of Recordati. Schedule 3 lists all Licensed Patents that (i) are
Controlled by Aegerion or its Affiliates and (ii) claim or cover the Product in
the Territory. Schedule 4 lists all the Product Trademarks relating to the
Product in the Territory that are Controlled by Aegerion or its Affiliates.
[***]. [***]. The Orphan Drug Designation and the Product Marketing
Authorizations have been validly obtained for the Territory and are currently in
force without any limitations (with the sole exception of the Post-marketing
commitments listed in Schedule 5). The Product Marketing Authorizations and
related regulatory dossiers for the Product in the Territory are updated. [***].
[***]. Aegerion or its Affiliates have the authority to grant the licenses and
sublicenses under Section 2.1 and Section 2.3 of this Agreement, and the right
to use and disclose and to enable Recordati to use and disclose the Licensed
Know-How in accordance with the terms and conditions of this Agreement to the
extent that Recordati is granted the right to use and disclose such Licensed
Know-How. [***]. [***]. 21 ACTIVE/99458941.1

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Neither Aegerion nor any of its Affiliates has made a claim against any Third
Party alleging that such Third Party is infringing the Licensed Patents or the
Product Trademarks in the Territory and, to Aegerion’s knowledge, no basis for
such a claim exists. All fees that are required to be paid as of the Effective
Date in order to maintain the Licensed Patents, the Product Trademarks, the
Orphan Drug Designation and the Product Marketing Authorizations in force for
the Product in the Territory have been paid on or before their due date.
Aegerion and its Affiliates, sublicensees, and subcontractors have conducted
Development, Manufacturing and Commercialization activities with respect to the
Product in the Territory in compliance with Applicable Law. Recordati undertakes
to Aegerion that it shall not and shall procure that no other member of
Recordati’s Group shall hold out or represent the Product as having any
continuing association with Aegerion or Aegerion’s Group except as expressly
allowed or provided for by the Transaction Documents. [***]. SAFETY AND ADVERSE
EVENT REPORTING The Parties (and/or their respective Affiliates) shall enter
into a pharmacovigilance agreement relating to the Product (“PV Agreement”)
promptly following the Effective Date, which agreement shall govern matters
relating to the exchange of information relating to the safety of the Product,
on terms no less stringent than those required by applicable ICH guidelines. The
Parties (and/or their respective Affiliates) shall exchange safety data relating
to the Product pursuant to the PV Agreement to ensure that they can comply with
their obligations to Regulatory Authorities under Applicable Law in their
respective territories. At its own cost, Aegerion shall maintain the global
pharmacovigilance safety database for the Product and shall continue to generate
annual reports (e.g., PSURs or PBRERs) for submission to Regulatory Authorities.
Recordati (or its Affiliate) shall be responsible at its cost for collating and
preparing all pharmacovigilance safety data reports including annual reports and
for complying with the applicable risk management plan as required by any
Regulatory Authority or Applicable Law in relation to the Product in the
Territory. Aegerion shall have the right to audit Recordati’s pharmacovigilance
operations, at Aegerion’s cost, to ensure compliance with applicable quality
standards in the Territory, and shall cooperate with Aegerion with respect to
safety signal detection and risk mitigation activities, all as further specified
in the PV Agreement. The Parties intend to utilize the services of a contract
safety organization (“CSO”) for the purposes of providing pharmacovigilance
services. Recordati shall consider retaining the services of the same CSO as
that utilized by Aegerion and, if so retained following the Completion date,
shall pay the costs of such CSO attributable to the safety data and risk
mitigation activities relating to the Product arising in the Territory.
Alternatively, Recordati may elect to contract with a separate independent CSO
to carry out its pharmacovigilance activities with regard to the Product in the
Territory and shall be responsible for all associated costs. SUPPLY AGREEMENT;
QUALITY TECHNICAL AGREEMENT 22 ACTIVE/99458941.1

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Aegerion shall supply Recordati (or its Affiliates) with full batches of Brite
Stock of the Product for the Territory in accordance with the terms and
conditions set forth in the Supply Agreement entered into by and between
Aegerion and Recordati as of the Effective Date. [***]. Aegerion undertakes to
supply the Brite Stock during the term of the Supply Agreement in accordance
with its terms. Following the Effective Date, and at least prior to the receipt
of the release of the first batch of saleable Product, Aegerion and Recordati or
their Affiliates shall establish a Quality Technical Agreement to outline to
required samples, audits, notifications and exchange of information to
facilitate batch release and maintain compliance. The Quality Technical
Agreement shall define a Joint Quality Committee to address significant
deviations, OOS results and potential recalls of Product in the Territory.
MUTUAL INDEMNITIES; LIMITATION OF LIABILITY Recordati agrees to defend,
indemnify and hold harmless Aegerion and its Affiliates, and each of their
respective directors, officers, employees, agents and representatives (each an
“Aegerion Indemnitee”) from and against any and all Liabilities incurred in
connection with Third Party claims to which any Aegerion Indemnitee may become
subject to the extent such Liabilities arise directly or indirectly out of
[***]. [***]. In the event of any such claim against any Aegerion Indemnitee or
Recordati Indemnitee (individually, an “Indemnitee”), the indemnified Party
shall promptly notify the other Party in writing of the claim and the
indemnifying Party shall manage and control, at its sole expense, the defense of
the claim and its settlement. The Indemnitee shall cooperate with the
indemnifying Party and may, at its option and expense, be represented in any
such action or proceeding. Subject to the Indemnifying Party’s performance of
its obligations under this Section 14, the indemnifying Party shall not be
liable for any settlements, litigation costs or expenses incurred by any
Indemnitee without the indemnifying Party’s written authorization.
Notwithstanding the foregoing, if the indemnifying Party believes that any of
the exceptions to its obligation of indemnification of the Indemnitees set forth
in this Section 14 may apply, the indemnifying Party shall promptly notify the
Indemnitees, which shall then have the right to be represented in any such
action or proceeding by separate counsel at their expense, provided, however,
that the indemnifying Party shall be responsible for payment of such expenses if
the Indemnitees are ultimately determined to be entitled to indemnification from
the indemnifying Party for the matters to which the indemnifying Party notified
the Indemnitees that such exception(s) may apply. NEITHER PARTY WILL BE LIABLE
UNDER THIS AGREEMENT (WHETHER IN AN ACTION IN NEGLIGENCE, CONTRACT OR TORT BASED
ON A WARRANTY OR OTHERWISE) FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR
PUNITIVE DAMAGES [***]. NOTHING IN THIS SECTION 14.4 IS INTENDED TO LIMIT OR
RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER SECTION
14.1 OR 14.2. 23 ACTIVE/99458941.1

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CONFIDENTIALITY As used in this Agreement, the term “Confidential Information”
means all secret, confidential or proprietary information or data, whether
provided in written, oral, graphic, video, computer, electronic or other form,
provided pursuant to this Agreement by one Party (or its Affiliates) (the
“Disclosing Party”) to the other Party (or its Affiliates) (the “Receiving
Party”), including information relating to the Disclosing Party’s existing or
proposed research, development efforts, Know-How, development data, published
and unpublished patent applications, business or products, and any other
materials that have not been made available by the Disclosing Party to the
general public. Without limitation to the foregoing, the Licensed Know-How shall
be deemed to be the Confidential Information of Aegerion. Notwithstanding the
foregoing sentence, Confidential Information shall not include any information
or materials that: were already known to the Receiving Party (other than under
an obligation of confidentiality), at the time of disclosure by the Disclosing
Party, to the extent such Receiving Party has documentary evidence to that
effect; were available to the public or otherwise part of the public domain at
the time of disclosure thereof to the Receiving Party; became generally
available to one or more Third Parties, or otherwise part of the public domain
other than through any act or omission of a Party in breach of such Party’s
confidentiality obligations under this Agreement; were disclosed to the
Receiving Party, other than under an obligation of confidentiality, by a Third
Party who had no obligation to the Disclosing Party not to disclose such
information to others; or were independently discovered or developed by or on
behalf of the Receiving Party without the use of the Confidential Information
belonging to the other Party. Each of Aegerion and Recordati shall keep all
Confidential Information received from the other Party with the same degree of
care it maintains the confidentiality of its own Confidential Information, but
in no event less than a reasonable degree of care. Neither Party shall use such
Confidential Information for any purpose other than in performance of or
exercise of its rights under this Agreement or the Transaction Documents, nor
disclose the same to any other Person other than to such of its and its
Affiliates or sub-licensees, directors, officers, managers, employees,
independent contractors, agents or consultants who have a need to know such
Confidential Information to implement the terms of this Agreement or the
Transaction Documents, or to exercise or enforce its rights under this Agreement
or the Transaction Documents; provided, however, that a Receiving Party shall
advise any of its and its Affiliates’, sub-licensees, directors, officers,
managers, employees, independent contractors, agents or consultants who receive
such Confidential Information of the confidential nature thereof and of the
obligations contained in this Agreement relating thereto, and the Receiving
Party shall ensure (including, in the case of a Third Party, by means of a
written agreement with such Third Party having terms at least as protective as
those contained in this Article 15) that all such directors, 24
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officers, managers, employees, independent contractors, agents or consultants
comply with such obligations as if they had been a party hereto. Upon
termination of this Agreement, the Receiving Party shall return or destroy all
documents, tapes or other media containing Confidential Information of the
Disclosing Party that remain in the possession of the Receiving Party or its
directors, managers, officers, employees, independent contractors, agents or
consultants, except that the Receiving Party may keep one copy of the
Confidential Information in the legal department files of the Receiving Party,
solely for archival purposes. Such archival copy shall be deemed to be the
property of the Disclosing Party, and shall continue to be subject to the
provisions of this Article 15. It is understood that receipt of Confidential
Information under this Agreement shall not limit the Receiving Party from
assigning its employees to any particular job or task in any way it may choose,
subject to the terms and conditions of this Agreement. Notwithstanding Section
15.2, each Party may disclose Confidential Information belonging to the other
Party to the extent such disclosure is reasonably necessary to: (a) obtain
regulatory approval of a Product to the extent such disclosure is made to a
Regulatory Authority; (b) comply with or enforce or exercise any rights under
any of the provisions of this Agreement; or (c) comply with Applicable Laws and
any regulations regarding a filing with the Securities and Exchange Commission
or other listing or financial authority; or (d) comply with the financial
reporting requirements for the applicable Accounting Standards. If a Party deems
it necessary to disclose Confidential Information of the other Party pursuant to
this Section 15.3, such Party shall, if reasonably possible, give reasonable
advance notice of such disclosure to the other Party to permit such other Party
sufficient opportunity to object to such disclosure or to take measures to
ensure confidential treatment of such information. Aegerion agrees that it shall
ensure that Aegerion shall not, and shall ensure that its Affiliates shall not,
make public any of the Licensed Know-How that is material to the Product in the
Territory without first obtaining the consent of Recordati. The Receiving Party
shall notify the Disclosing Party promptly upon discovery of any unauthorized
use or disclosure of the Disclosing Party’s Confidential Information, and shall
cooperate with the Disclosing Party in any reasonably requested fashion to
assist the Disclosing Party to regain possession of such Confidential
Information and to prevent its further unauthorized use or disclosure.
Notwithstanding anything to the contrary in this Article 15, the Parties agree
that the public announcement of the execution of this Agreement shall be in the
form of a press release agreed between the Parties prior to the Effective Date.
Recordati’s press release is attached hereto as Schedule 6-1 and Aegerion’s
press release is attached hereto as Schedule 6-2. Any other publication, news
release or other public announcement relating to this Agreement or to the
performance hereunder shall first be reviewed and approved by both Parties;
provided, however, that any disclosure which is required by Applicable Law or
which is permitted pursuant to Section 15.3 may be made without the prior
consent of the other Party. To the extent practicable, the Disclosing Party
shall be given at least [***] Business Days’ advance notice of any such legally
required disclosure, and the other Party shall provide any comments on the
proposed disclosure during such period, provided, however, that no such consent
shall be required for any disclosures that are substantially similar to any
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After release of a press release, each Party may disclose to Third Parties the
information contained in such press release without the need for further
approval by the other. To the extent that either Party determines that it or the
other Party is required to file or register this Agreement, or a notification
thereof, to comply with the requirements of an applicable stock exchange
regulation or any Governmental Authority, including without limitation the U.S.
Securities and Exchange Commission, the Competition Directorate of the
Commission of the European Communities, or the U.S. Federal Trade Commission,
such Party shall promptly inform the other Party thereof. Prior to making any
such filing, registration, or notification, the Parties shall agree on the
provisions of this Agreement for which the Parties shall seek confidential
treatment, it being understood that if one Party determines to seek confidential
treatment for a provision for which the other Party does not, then the Parties
shall use reasonable efforts in connection with such filing to seek the
confidential treatment of any such provision. The Parties shall cooperate, each
at its own expense, in such filing, registration, or notification, including
such confidential treatment request, and shall execute all documents reasonably
required in connection therewith. Neither Party shall use the name of the other
Party in relation to this transaction in any public announcement, press release,
or other public document, without the written consent of such other Party, which
consent shall not be unreasonably withheld, delayed, or denied; provided,
however, that: (a) either Party may use the name of the other Party in any
document filed with any regulatory agency or authority, including the Food and
Drug Administration, the PMDA, the MHLW, and the Securities and Exchange
Commission; (b) Recordati may identify Aegerion as the holder of the Marketing
Authorization for the Product in the Aegerion Territory in connection with the
Commercialization of the Product in the Territory; and (c) Aegerion may identify
Recordati as the holder of the Product Marketing Authorization in the Territory
in connection with the Commercialization of Products in the Aegerion Territory.
The terms of this Agreement shall be Confidential Information of each Party and,
as such, shall be subject to the provisions of this Article 15 provided that
[***]. Aegerion shall be entitled to provide a copy of this Agreement to
University of Pennsylvania. The obligations and prohibitions contained in this
Article 15 shall survive the expiration or termination of this Agreement. The
Parties agree to submit any publications that a Party or its Affiliate is
proposing to make relating to the Product to the JSC for review in advance of
publication, allowing the JSC a reasonable time to review and comment on such
draft publications. Each Party agrees to give reasonable consideration to any
comments of the other received via the JSC process but, for clarity, the JSC
shall not have a right of approval over any publications under this Section
15.11. Neither Party shall include the Confidential Information of the other
Party in a publication unless that other Party has given its prior written
consent. INTELLECTUAL PROPERTY Ownership. 26 ACTIVE/99458941.1

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All determinations of inventorship under this Agreement shall be made in
accordance with the applicable patent law. Background IP. As between the
Parties, and subject to the licenses granted under this Agreement, each Party
shall own and retain all rights, title, and interests in and to all Patents,
Know-How, and other intellectual property rights that: (i) such Party owns or
otherwise Controls as of the Effective Date; or (ii) such Party develops or
otherwise acquires after the Effective Date outside the performance of the
activities under this Agreement. Without limiting the foregoing, as between the
Parties, Aegerion shall solely and exclusively own and retain all right, title
and interest in and to all Licensed Patents, Licensed Know-How and Product
Trademarks. Arising IP. As between the Parties, [***]. Prosecution and
Maintenance of Licensed Patents. As between the Parties, Aegerion shall be
responsible for the Prosecution and Maintenance of the Licensed Patents and for
all Patent Costs associated with such Prosecution and Maintenance of the
Licensed Patents in the Territory. Aegerion shall keep Recordati informed of the
status of each Licensed Patent relating to the Product and shall give reasonable
consideration to any suggestions or recommendations of Recordati concerning the
Prosecution and Maintenance thereof. Before taking any steps regarding the
Prosecution and Maintenance of any Licensed Patent, Aegerion shall allow
Recordati to comment on the action proposed to be taken and Aegerion shall take
into account any reasonable comments and suggestions made by Recordati. If,
during the Term, Aegerion intends to allow any of the Licensed Patents in the
Territory to expire or otherwise be abandoned, Aegerion shall notify Recordati
of such intention at least [***] days prior to the date upon which such Licensed
Patent shall expire or be abandoned, and Recordati shall thereupon have the
right, but not the obligation, to assume responsibility for the Prosecution and
Maintenance thereof. Any such Licensed Patent shall, at Recordati’s request, be
assigned to Recordati, or at its direction one of Recordati’s Affiliates, for no
additional consideration. Litigation. In the event of any Third Party claim that
the Commercialization of the Product in the Territory infringes any Third Party
rights, the Party first having notice of the claim or assertion shall promptly
notify the other Party, and the Parties shall promptly confer to consider the
claim or assertion and the appropriate course of action. Unless the Parties
otherwise agree in writing, each Party shall have the right to defend itself
against a suit that names it as a defendant; provided, however, that, unless
prohibited by Applicable Law, [***]. In the event that either Party believes
that any Licensed Patent is being infringed by a Third Party, or is subject to a
declaratory judgment action arising from such infringement, such Party shall
promptly notify the other Party. In such event, Aegerion shall have the initial
right (but not the obligation) to enforce such Licensed Patents with respect to
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such infringement, or to defend any declaratory judgment action with respect
thereto at its own expense (an “Enforcement Action”). In the event that Aegerion
fails to initiate an Enforcement Action under Section 16.3(b) to enforce such
Licensed Patent against an infringement by a Third Party in the Territory,
within [***] days (or sooner if required by Applicable Law to preserve any
rights to defend the Enforcement Action) of a request by Recordati to initiate
such Enforcement Action, and unless prohibited by Applicable Law, Recordati may
initiate an Enforcement Action against such infringement at its own expense. In
such case, Aegerion shall cooperate with Recordati in such Enforcement Action,
[***]. The Party initiating or defending any such Enforcement Action shall keep
the other Party reasonably informed of the progress of any such Enforcement
Action, and such other Party shall have the right to participate with counsel of
its own choice. [***]. The Party assuming the lead role in the Enforcement
Action (“Controlling Party”) shall consult with the non-Controlling Party on all
material aspects of the enforcement. The non-Controlling Party shall have a
reasonable opportunity for meaningful participation in decision-making and
formulation of strategy. The Parties shall reasonably cooperate with each other
in all such actions or proceedings. Each Party agrees to be joined as a party
plaintiff if necessary and shall provide all reasonable cooperation (including
any necessary use of its name) required to prosecute such litigation provided
that the Controlling Party shall indemnify the non- Controlling Party in
relation to any costs awards made against it. The non-Controlling Party shall be
entitled to be represented by an independent counsel of its own choice at its
own expense. In the event that a judgment is entered against the Controlling
Party and an appeal is available, the Controlling Party shall have the first
right, but not the obligation, to file such appeal. In the event the Controlling
Party does not desire to file such an appeal, it shall promptly, in a reasonable
time period (i.e., with sufficient time for the non-Controlling Party to take
whatever action may be necessary) prior to the date on which such right to
appeal shall lapse or otherwise diminish, permit the non-Controlling Party to
pursue such appeal at such non- Controlling Party’s own cost. If the law
requires the Controlling Party’s involvement in such appeal, the Controlling
Party shall be a nominal party of the appeal and shall provide reasonable
cooperation with the other Party at the other Party’s expense. Trademarks. Each
Party and its Affiliates shall retain all right, title and interest in and to
its and their respective corporate names and logos. As between the Parties,
Aegerion shall be responsible for maintaining the Product Trademarks in the
Territory and for all costs associated with such maintenance of the Product
Trademarks in the Territory. If during the Term, [***] Aegerion shall notify
Recordati of such intention at least [***] days prior to the date [***]. Any
such Product Trademark and the associated goodwill, shall, at Recordati’s
request, be assigned to Recordati or at its discretion, one of Recordati’s
Affiliates for no additional consideration. 28 ACTIVE/99458941.1

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In the event that either Party becomes aware of any infringement of a Product
Trademark by a Third Party in the Territory, such Party shall promptly notify
the other Party. In such event of a Third Party infringement of a Product
Trademark, Aegerion shall have the initial right (but not the obligation) to
take legal action with respect to such infringement of such Product Trademark at
its own expense (“Trademark Enforcement Action”). In the event that Aegerion
fails to initiate a Trademark Enforcement Action to prevent infringement of such
Product Trademark by a Third Party in the Territory, within [***] days of a
request by Recordati to initiate such Trademark Enforcement Action, Recordati
may initiate a Trademark Enforcement Action against such Third Party at its own
expense. In each case, the other Party shall cooperate with such Party pursuing
a Trademark Enforcement Action at such Party’s expense. The Party initiating or
defending any such Trademark Enforcement Action shall keep the other Party
reasonably informed of the progress of any such Trademark Enforcement Action,
and such other Party shall have the right to participate with counsel of its own
choice. Any recovery received as a result of any Trademark Enforcement Action
shall be used first to reimburse the Parties for the costs and expenses
(including attorneys’ and professional fees) incurred in connection with such
Trademark Enforcement Action, and the remainder of the recovery shall be shared
equally between the Parties. TERM AND TERMINATION The initial term of this
Agreement shall commence as of the Effective Date and, unless sooner terminated
as provided herein, shall continue in effect until the latest of (a) expiration
of the last Valid Claim of a Licensed Patent covering the Product in the
Territory; (b) expiration of data or regulatory exclusivity (the relevant
Japanese regulatory re-examination period) in relation to the Product in the
Territory; or (c) ten (10) years from the Completion Date (“Initial Term”).
Thereafter, this Agreement shall automatically renew for an additional term of
five (5) years in the event Recordati has not breached any of its material
obligations of this Agreement (the “Additional Term”). Upon the expiration of
the Additional Term, this Agreement shall automatically renew for additional
terms of five (5) years each (each, a “Renewal Term,” and together with the
Initial Term and the Additional Term, the “Term”), unless written notice of
termination is given by either Party at least eighteen (18) months prior to the
end of any Renewal Term. Termination for Material Breach. Either Party may,
without prejudice to any other remedies available to it at law or in equity,
terminate this Agreement in the event that the other Party (the “Breaching
Party”) shall have committed a Material Breach of this Agreement. The Breaching
Party shall have [***] days ([***] days in the event of non-payment) after
written notice thereof was provided to the Breaching Party by the non-breaching
Party to remedy such Material Breach. Any such termination shall become
effective at the end of such [***] day period ([***] day period for non-payment)
unless the Breaching Party has cured any such breach or default prior to the
expiration of such [***] day or [***] day period; provided, however, that if
such Material Breach is capable of being cured but cannot be cured within such
cure period and the Breaching Party initiates all reasonable actions to cure
such Material Breach within such period and thereafter diligently pursues such
actions, the Breaching Party shall have an additional [***] days (for a 29
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[a101redactedrecordatilic030.jpg]
total of [***] days) to cure such Material Breach (except in the event of
non-payment, in which such case no additional time period shall apply). If the
Parties reasonably and in good faith disagree as to whether there has been a
Material Breach or a cure thereof, the Party that disputes whether there has
been a material breach or a cure may contest the allegation in accordance with
Article 32. Notwithstanding anything to the contrary contained in Section 17.2,
the [***] day cure period for any Material Breach that is the subject of a
Dispute shall run from the date of the resolution of such Dispute pursuant to
Article 32, and no termination pursuant to Section 17.2 shall become effective
during such period. During the pendency of such Dispute, all of the terms and
conditions of this Agreement shall remain in effect and the Parties shall
continue to perform all of their respective obligations under this Agreement.
Termination for Bankruptcy. Right to Terminate. Subject to automatic stay and
ipso facto provisions of sections 362, 365(e) and 541(c) of the U.S. Bankruptcy
Code, a Party may terminate this Agreement in its entirety by providing written
notice to the other Party on or after the time that such other Party makes a
general assignment for the benefit of creditors, files a voluntary petition in
bankruptcy, consents to an order for relief in connection with an involuntary
petition in bankruptcy filed against such Party (or an involuntary petition in
bankruptcy filed against such Party remains un-dismissed or un-stayed for a
period of more than [***] days), petitions for or acquiesces in the appointment
of any receiver, trustee or similar officer to liquidate or conserve its
business or any substantial part of its assets, commences under the laws of any
jurisdiction any proceeding involving its insolvency, bankruptcy,
reorganization, adjustment of debt, dissolution, liquidation or any other
similar proceeding for the release of financially distressed debtors, or becomes
the subject of any proceeding or action of the type described above (each, an
“Insolvency Event”). All rights and licenses (other than any rights in any
trademarks) granted under or pursuant to this Agreement from Aegerion to
Recordati with respect to the Licensed Patents and Licensed Know-How (but not
Product Trademarks) are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of the U.S. Bankruptcy Code or any non-U.S. equivalent thereof,
licenses of right to “intellectual property” as defined under Section 101 of the
U.S. Bankruptcy Code. [***]. Effects of Termination for Aegerion’s Material
Breach or Insolvency. [***]. Effects of Termination for Recordati’s Material
Breach or Insolvency. Without limiting any other legal or equitable remedies
that Aegerion may have, the following provisions shall apply on termination of
this Agreement by Aegerion pursuant to Sections 17.2 (Material Breach) or 17.3
(Insolvency Event). In such case, Recordati shall promptly (and in each case
within [***] days after receipt of Aegerion’s request or such longer period of
time required by Applicable Law or by a Regulatory Authority): upon Aegerion’s
request, [***]; [***]; and 30 ACTIVE/99458941.1

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[***]. Additional Effects of Expiration or Termination for any Reason. Without
limiting Sections 17.4 or 17.5, if this Agreement is terminated for any reason
or expires, then the provisions of this Section 17.6(a) shall apply. [***].
[***]. Expiration or termination of this Agreement for any reason shall be
without prejudice to any rights that shall have accrued or are accruing to the
benefit of a Party prior to the effective date of such expiration or
termination. Such termination or expiration shall not relieve a Party from
obligations that are expressly indicated to survive the termination or
expiration of this Agreement. [***]. The following Articles and Sections,
together with any definitions used or exhibits referenced therein, shall survive
any expiration or termination of this Agreement: 5.6, 5.7, 5.8, 14, 15, 16.1,
17.4, 17.5, 17.6, this Section 17.7, 19, 20, 21, 23, 25, 28, 29, 30, 31, 32, 33
and 34. ANTI-BRIBERY LAWS Both Parties shall ensure that in connection with the
Transaction Documents, they shall conduct their activities in a manner that is
consistent with the Anti-Bribery Laws. Each Party further undertakes that none
of its or its Affiliates’ employees, directors or officers shall, directly or
indirectly, engage in any activities that violate any Anti-Bribery Law (a) in
order to influence official action of any Government Official, or (b) with the
intention of or as a condition to inducing any person to carry out a duty or
function improperly or to reach a favorable decision on an improper basis, in
each case in connection with the activities contemplated under this Agreement
and the other Transaction Documents. Each Party shall promptly provide the other
Party with written notice of (a) becoming aware of a material Anti-Bribery Law
violation by it or any of its or its Affiliates’ employees, directors or
officers with respect to the subject matter of this Agreement and the other
Transaction Documents, or (b) upon receiving a formal notification that it or
any of its or its Affiliates’ employees, directors or officers is the target of
a formal investigation by any Governmental Authority for a material Anti-Bribery
Law violation with respect to the subject matter of this Agreement and the other
Transaction Documents. In addition, Recordati and its Affiliates shall take all
necessary actions to complete the compliance activities set forth in the
following table by the dates set forth next to each such activity in the table:
Compliance Activity Deadline for Completion Documentation required date [***]
[***] [***] [***] [***] [***] [***] [***] [***] 31 ACTIVE/99458941.1

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[***] [***] [***] Recordati shall cooperate with Aegerion’s requests for
meetings and documentation to assist Aegerion in determining the status of
Recordati’s efforts to meet the compliance requirements set forth above, and
shall permit Aegerion or its Affiliates to audit Recordati’s ongoing compliance
with such requirements. Recordati shall certify in writing on an annual basis,
in the first Calendar Quarter of each Calendar Year, that Recordati and its
Affiliates have complied, and continue to comply, with all Applicable Laws and
industry codes applicable to the performance of their obligations under this
Agreement. INSURANCE Each Party shall, at its own expense, procure and maintain
during the Term of this Agreement and for a period of [***] thereafter insurance
policies entered into with a reputable insurance company and for the
corresponding coverages which are commercially appropriate in relation to the
obligations of each Party under this Agreement Each Party shall provide the
other Party with written evidence of such insurance coverage upon request. Each
Party shall provide the other Party with at least [***] Business Days’ written
notice prior to any cancellation, non- renewal or material change in such
insurance. ANNOUNCEMENTS AND CONFIDENTIALITY Except as expressly required by
Applicable Law, all announcements and circulars by, for, or on behalf of,
Aegerion and relating to this Agreement shall be in a form approved in writing
by Recordati in advance of issue (which approval shall not be unreasonably
withheld). Subject to Article 15, each Party shall keep and procure to be kept
secret and confidential all Confidential Information belonging to the other
Party disclosed or obtained as a result of the discussions and negotiations
leading to the execution of, or the performance of, this Agreement, and shall
neither use nor disclose any such Confidential Information except so far as may
be required by Applicable Law and in such circumstances only after prior
consultation with the other Party or with the prior written consent of that
other Party (to that extent permissible by law). NOTICES All notices, delivery
or other communication that are required or permitted hereunder shall be in
writing, and sufficient if (a) delivered personally, (b) sent by nationally-
recognized overnight courier (with delivery tracking provided, signature
required and delivery prepaid) or (c) sent by registered or certified mail,
postage prepaid, return receipt requested, in each case to the other Party
addressed as follows: If to Aegerion, to: Aegerion Pharmaceuticals Inc. One Main
Street Suite 800 Cambridge, MA 02142 Attention: President 32 ACTIVE/99458941.1

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With a copy to (which Aegerion Pharmaceuticals Inc. shall not constitute One
Main Street notice): Suite 800 Cambridge, MA 02142 Attention: Legal Department
and Goodwin Procter LLP 100 Northern Avenue Boston, Massachusetts 02210
Attention: Robert M. Crawford Email: RCrawford@goodwinlaw.com If to Recordati,
to: Recordati Rare Diseases Inc. 100 Corporate Drive, Lebanon, NJ 08833
Attention: General Manager With a copy to (which Recordati S.p.A. shall not
constitute Via Matteo Civitali 1, 20148 Milan, Italy notice): Attention: Legal
Department and Orphan Europe Sarl Immeuble « Le Wilson », 70 avenue du Général
de Gaulle, 92800 Puteaux – France Attention: Mr. Bruno Parenti - Director New
Markets Email: bparenti@orphan-europe.com or to such other address as the Party
to whom notice is to be given may have furnished to the other Party in writing
in accordance herewith. Any such notice shall be deemed to have been given: (x)
when delivered if personally delivered on a Business Day (or if delivered or
sent on a non-Business Day, then on the next Business Day); (y) on the Business
Day of receipt if sent by overnight courier, facsimile or electronic mail; or
(z) on the Business Day of receipt if sent by mail (only in respect of
operational communications). FURTHER ASSURANCES Subject to the terms of this
Agreement, the Supply Agreement and the Transitional Services Agreement,
Aegerion shall, at the expense of Recordati, execute and deliver to Recordati
such instruments, documents and consents or further assurances as Recordati may
reasonably request in order to give effect to the transactions contemplated by
this Agreement. ENTIRE AGREEMENT 33 ACTIVE/99458941.1

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The Transaction Documents, in each case including any Schedules (but excluding
Schedule IX and X, i.e., the University of Pennsylvania Agreement and the SCLA)
or Exhibits thereto, constitute the entire agreement between the Parties in
relation to the matters covered by them and supersede any previous agreement,
arrangement or understanding between the Parties, whether written or oral, in
relation to those matters, which shall cease to have any further effect. The
Parties acknowledge that the Transaction Documents have not been entered into
wholly or partly in reliance on, nor has either Party been given, any warranty,
statement, promise, or representation (whether made innocently or negligently)
by the other or on its behalf other than as expressly set out in the Transaction
Documents. All warranties, conditions, statements, terms and representations not
set out in the Transaction Documents whether implied by statute or otherwise are
excluded to the extent permitted by Applicable Law. Nothing in this Article 23
excludes any remedy or liability for fraud. ALTERATIONS No purported alteration
or variation of this Agreement shall be effective unless it is in writing,
refers specifically to this Agreement, and is duly executed by each Party to
this Agreement. SEVERABILITY Each provision of this Agreement is severable and
distinct from the others. The Parties intend that each of those provisions shall
be, and remain, valid and enforceable to the fullest extent permitted by law. If
any such provision is held to be, or at any time becomes, to any extent invalid,
illegal, or unenforceable for any reason under any enactment or rule of law,
such invalidity, illegality, or unenforceability shall not affect any other
provision hereunder, and such invalid, illegal, or unenforceable provision shall
be deemed not to form part of this Agreement. The Parties shall in such an
instance use their reasonable efforts to replace the invalid, illegal, or
unenforceable provision with a valid and enforceable provision that
accomplishes, as nearly as possible, the same or similar intent of such original
provision, subject to the operation of this Section 25.1 not negating the
original commercial intent of the Parties under this Agreement. COUNTERPARTS
This Agreement may be executed in any number of counterparts (including by
facsimile or electronic transmission), each of which when executed shall
constitute an original of this Agreement, but all such counterparts together
shall constitute one and the same agreement. Signatures provided by facsimile
transmission or in Adobe™ Portable Document Format (PDF) sent by electronic mail
shall be deemed to be original signatures. No counterpart shall be effective
until each Party has duly executed at least one counterpart. PAYMENT OF COSTS 34
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Each Party shall (except to the extent, if any, expressly provided otherwise in
the Transaction Documents) be responsible for its respective legal and other
costs incurred in relation to the negotiation, preparation, and completion of
each of the Transaction Documents and all other relevant documents. SUCCESSORS
AND ASSIGNS Recordati may not assign this Agreement, or assign or transfer, in
whole or in part, any rights or obligations hereunder, without the prior written
consent of Aegerion, except that Recordati may make such an assignment or
transfer, in whole or in part, without the consent of Aegerion (i) to any
Affiliate of Recordati, or (ii) to any Third Party successor in interest or
purchaser of all or substantially all of the business or assets of Recordati to
which this Agreement relates (or if this Agreement is assigned in part, to which
such part of this Agreement relates), or (iii) pursuant to a merger,
combination, consolidation, reorganization, sale of stock, sale of assets or
other transaction of Recordati; provided, however, that in each case (i) through
(iii) Recordati provides written notice to Aegerion of such assignment and the
assignee shall have agreed in writing to be bound (or is otherwise required by
operation of Applicable Law to be bound) in the same manner as Recordati
hereunder. Aegerion may assign or transfer this Agreement, or any rights or
obligations hereunder, in whole or in part, without the prior written consent of
Recordati to (i) any Affiliate of Aegerion, or (ii) following the Completion
Date, to any Third Party, jointly with the Supply Agreement and the Transitional
Services Agreement, provided, however, that in each case (i) through (ii)
Aegerion provides written notice to Recordati of such assignment and the
assignee shall have agreed in writing to be bound (or is otherwise required by
operation of Applicable Law to be bound) in the same manner as Aegerion
hereunder. Notwithstanding the foregoing to the contrary, Aegerion may assign or
transfer its rights to receive payments under this Agreement to any Affiliate or
any Third Party. This Agreement shall be binding on the successors or heirs of
the assigning Party. Any assignment or attempted assignment by either Party in
violation of the terms of this Section 28.1 shall be null and void ab initio and
of no legal effect. RELATIONSHIP OF THE PARTIES It is expressly agreed that
Aegerion, on the one hand and Recordati, on the other hand, shall be independent
contractors and that the relationship between the two Parties to this Agreement
shall not constitute a partnership, joint venture, or agency. Neither Party
shall have the authority to make any statements, representations, or commitments
of any kind, nor to take any action that shall be binding on the other, without
the prior written consent of the other Party to do so. PERFORMANCE BY AFFILIATES
Subject to the terms and conditions of this Agreement, each Party may discharge
any obligations and exercise any rights (including granting or continuing
licenses and other rights) hereunder through one or more of its Affiliates.
Subject to an assignment to such Affiliate pursuant to Section 28.1, in any
event each Party shall remain responsible for the acts 35 ACTIVE/99458941.1

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and omissions, including financial liabilities, of its Affiliates. Each Party
hereby expressly waives any requirement that the other Party exhausts any right,
power, or remedy, or proceeds against any of the first Party’s Affiliates for
any obligation or performance hereunder, prior to proceeding directly against
such Party. GOVERNING LAW The law, including the statutes of limitation, of the
State of New York shall govern this Agreement, the interpretation and
enforcement of its terms, and any claim or cause of action (in law or equity),
controversy or dispute arising out of or related to it or its negotiation,
execution or performance, whether based on contract, tort, statutory or other
law, in each case without giving effect to any conflicts-of-law or other
principle requiring the application of the law of any other jurisdiction.
DISPUTE RESOLUTION; CONSENT TO JURISDICTION Disputes. Except as otherwise
expressly set forth in this Agreement, disputes of any nature arising under,
relating to, or in connection with this Agreement (“Disputes”) shall be resolved
pursuant to this Section 32. Dispute Escalation. In the event of a Dispute
between the Parties, the Parties shall first attempt to resolve such Dispute by
negotiation and consultation between themselves. In the event that such Dispute
is not resolved on an informal basis within [***] days from receipt of the
written notice of a Dispute, any Party may, by written notice to the other, have
such Dispute referred to the Executive Officers (or their designee, which
designee is required to have decision- making authority on behalf of such
Party), who shall attempt to resolve such Dispute by negotiation and
consultation for a thirty (30) day period following receipt of such written
notice. Non-Binding Mediation. Except as otherwise expressly set forth in this
Agreement, in the event the Parties have not resolved such Dispute within [***]
days of receipt of the written notice referring such Dispute to the Executive
Officers, then either Party may provide written notice to the other Party to
request mediation, and promptly upon receipt of such written notice, the Parties
shall enter into confidential non-binding mediation in New York, New York in
accordance with the Commercial Mediation Rules of the American Arbitration
Association (the “AAA”) in effect at the time of mediation request. The Parties
shall mutually approve a Third Party mediator who is neutral, disinterested, and
impartial, and who has the experience and qualifications relevant to the
specific subject matter of the Dispute. If the Parties are unable to mutually
approve a mediator, then a mediator having the requisite experience and
qualifications shall be appointed in accordance with the Commercial Mediation
Rules of the AAA. The mediation shall be held within [***] Business Days of the
selection of the mediator. The fees and expenses related to the services
provided by the mediator in connection with any mediation hereunder shall be
paid one-half by each Party. If the Parties are unable to resolve their Dispute
through mediation within [***] days after selection of the mediator, either
Party may seek appropriate resolution through an action or proceeding in the New
York Courts. Consent to Jurisdiction. All Actions that, directly or indirectly,
arise out of or relate to this Agreement shall be heard and determined
exclusively in the State and Federal 36 ACTIVE/99458941.1

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Courts in New York County, State of New York (such courts, “New York Courts”).
Each Party further agrees that service of any process, summons, notice, or
document by U.S. registered mail to such Party’s respective address set forth in
Section 21 shall be effective service of process for any action or proceeding in
the New York Courts with respect to any matters to which it has submitted to
jurisdiction in this Section 32.4. Consistent with the foregoing in this Section
32.4, each Party hereby (a) submits to the exclusive venue and jurisdiction of
the New York Courts for the purpose of any action or proceeding brought by any
Party hereto that, directly or indirectly, arises out of or relates to this
Agreement; (b) irrevocably waives and releases, and agrees not to assert by way
of motion, defense, or otherwise, in or with respect to any such action or
proceeding, any claim that (i) such action or proceeding is not subject to the
subject matter jurisdiction of at least one of the above-named courts; (ii) such
action or proceeding is brought in an inconvenient forum; or (iii) that the
venue of such action or proceeding is improper; and (c) agrees not to move to
transfer any such action or proceeding to a court other than any of the
above-named courts. Injunctive Relief. Notwithstanding the dispute resolution
procedures set forth in Section 32, and in addition to all other remedies, in
the event of an actual or threatened breach of this Agreement, the aggrieved
Party may seek provisional equitable relief (including restraining orders,
specific performance or other injunctive relief), without first submitting to
any dispute resolution procedures hereunder. Any claim for such equitable relief
shall be submitted exclusively to the New York Courts. Waiver of Jury Trial.
EACH PARTY HEREBY IRREVOCABLY WAIVES TO THE FULLEST EXTENT PERMITTED BY
APPLICABLE LAW ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY WITH RESPECT TO ANY
ACTION OR LIABILITY, DIRECTLY OR INDIRECTLY, ARISING OUT OF, RELATING TO, OR IN
CONNECTION WITH THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED BY THIS
AGREEMENT. INTERPRETATION The captions and headings to this Agreement are
included for convenience only, and are to be of no force or effect in construing
or interpreting any of the provisions of this Agreement. Unless specified to the
contrary, references to Articles, Sections or Schedules mean the particular
Articles, Sections or Schedules of this Agreement and references to this
Agreement include all Schedules hereto. Unless context otherwise clearly
requires, whenever used in this Agreement: (a) the words “include”, “includes”,
or “including” shall be construed as incorporating also the phrase “without
limitation” and shall not be interpreted to limit the provision to which it
relates; (b) the word “day”, “month”, or “quarter” means a calendar day, month,
or quarter, unless otherwise specified; (c) the word “notice” means notice in
writing (whether or not specifically stated) and shall include notices,
consents, approvals and other written communications contemplated under this
Agreement; (d) the words “hereof”, “herein”, “hereby” and derivative or similar
words refer to this Agreement (including any Schedules) and not any particular
provision hereof; (e) unless expressly set forth herein, provisions that require
that a Party, the Parties or the JSC hereunder “agree”, “consent”, or “approve”
or the like shall require that such agreement, 37 ACTIVE/99458941.1

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consent, or approval be specific and in writing, whether by written agreement,
letter, approved minutes or otherwise (but excluding e-mail and instant
messaging with the exception of operational communications); (f) words of any
gender include the other gender; (g) words using the singular or plural number
also include the plural or singular number, respectively; (h) references to any
specific law, rule or regulation, or article, Section or other division thereof,
shall be deemed to include the then-current amendments thereto or any
replacement law, rule or regulation thereof; (i) any definition of or reference
to any agreement, instrument or other document herein shall be construed as
referring to such agreement, instrument or other document as from time to time
amended, supplemented or otherwise modified (subject to any restrictions on such
amendments, supplements or modifications set forth herein); (j) any reference
herein to any Person shall be construed to include the Person’s successors and
assigns; (k) the word “will” shall be construed to have the same meaning and
effect as the word “shall”; and (l) the term “or” shall be interpreted in the
inclusive sense commonly associated with the term “and/or.” Ambiguities, if any,
in this Agreement shall not be construed against any Party, irrespective of
which Party may be deemed to have authored the ambiguous provision. The language
of this Agreement shall be deemed to be the language mutually chosen by the
Parties and no rule of strict construction shall be applied against either Party
hereto. This Agreement should be interpreted in its entirety and the fact that
certain provisions of this Agreement may be cross- referenced in a Section shall
not be deemed or construed to limit the application of other provisions of this
Agreement to such Section and vice versa. MISCELLANEOUS PROVISIONS Official
Language. English shall be the official language of this Agreement, and all
communications between the Parties hereto shall be conducted in that language.
For avoidance of doubt, neither Party shall be required to translate documents
originally prepared in other languages and required to be delivered under this
Agreement, but if a translation into English is available to and controlled by a
Party, the translation shall be delivered along with the original document.
Waiver. No provision of the Agreement may be waived except in writing by both
Parties hereto. No failure or delay by either Party hereto in exercising any
right or remedy hereunder or under applicable law shall operate as a waiver
thereof, or a waiver of a particular right or waiver of any right or remedy on
any subsequent occasion unless provided otherwise in this Agreement. Force
Majeure. Neither Party shall lose any rights hereunder or be held liable or
responsible to the other Party, nor be deemed to have defaulted under or
breached this Agreement, for any failure or delay in fulfilling or performing
any term of this Agreement, when such failure or delay is caused by or results
from fire, floods, embargoes, government regulations, prohibitions or
interventions, war, acts of war (whether war be declared or not), insurrections,
riots, civil commotions, strikes, lockouts, acts of God, or any other cause
beyond the reasonable control of the such Party (each a “Force Majeure”). If
either Party is affected by Force Majeure or is aware of the likelihood of a
situation constituting Force Majeure arising, it shall notify the other Party in
writing promptly of the cause and extent of such non-performance or likely
non-performance, the date or likely date of commencement thereof and the means
proposed to be adopted to remedy or abate the Force Majeure, and the Parties
shall consult with 38 ACTIVE/99458941.1

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each other with a view to taking such steps as may be appropriate to mitigate
the effects of such Force Majeure. During the pendency of a Force Majeure, the
affected Party shall use its commercially reasonable efforts to minimize the
effect of the Force Majeure on, and to resume the performance of its obligations
under, this Agreement. No Third-Party Beneficiaries. Except as expressly set
forth in Article 14 with respect to indemnified parties and Recordati’s
Affiliates, which shall be deemed an intended beneficiary hereunder and shall be
entitled to enforce the provisions of this Agreement and any other Transaction
Document: (a) no provision of this Agreement, or any Transaction Document, is
intended to confer any rights, benefits, remedies, obligations, or liabilities
hereunder upon any Person other than: (i) the Parties hereto; and (ii) the
Parties’ respective successors and assigns; (b) none of the provisions of this
Agreement, or any Transaction Document shall be enforceable by any Third Party,
including any creditor of either Party hereto, or the Aegerion’s Affiliates; and
(c) no such Third Party shall obtain any right under any provision of this
Agreement or any Transaction Document, including any right to make a claim, in
respect of any debt, liability or obligation (or otherwise) against any Party
hereto. No Brokerage. Each Party represents and warrants to the other that,
except to the extent any such payment is the sole responsibility of such Party,
no finder’s fee, brokerage fee, commission or other payment is due to any Third
Party claiming through such Party or its Affiliates with respect to the
execution of this Agreement or the consummation of the transactions contemplated
hereby. Registration of License. Each Party, may, at its expense, register the
license rights granted under this Agreement in the Territory or perform some
other comparable mechanism. Upon request by a Party, the other Party agrees
promptly to execute any “short form” license submitted to it by such Party and
any other necessary documents designated the requesting Party and to assist the
requesting Party in order to effect the foregoing registration in the Territory,
but such licenses shall in no way alter or affect the rights or obligations of
the Parties hereunder. [Signature page follows] 39 ACTIVE/99458941.1

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized representatives effective as of the Effective Date.
AEGERION PHARMACEUTICALS, INC. RECORDATI RARE DISEASES INC. By: /s/ Barbara Chan
By: /s/ Michael Waters Name: Barbara Chan Name: Michael Waters Title: President
Title: General Manager Signature Page to Exclusive License Agreement (Japan)
ACTIVE/99458941.1

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SCHEDULE 1 TRANSFERRED MATERIALS [***] ACTIVE/99458941.1

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SCHEDULE 2 PRODUCT RECORDS [***] ACTIVE/99458941.1

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SCHEDULE 3 LICENSED PATENTS [***] ACTIVE/99458941.1

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SCHEDULE 4 PRODUCT TRADEMARKS [***] ACTIVE/99458941.1

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SCHEDULE 5 POST-MARKETING COMMITMENTS [***] ACTIVE/99458941.1

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SCHEDULE 6-1 RECORDATI’S PRESS RELEASE [***] ACTIVE/99458941.1

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SCHEDULE 6-2 AEGERION’S PRESS RELEASE [***] ACTIVE/99458941.1

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SCHEDULE 7 REQUIRED CONSENTS [***] ACTIVE/99458941.1

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SCHEDULE 8 DEVELOPMENT ACTIVITIES RELATED TO LOMITAPIDE AND VARIATIONS TO THE
PRODUCT MARKETING AUTHORIZATIONS CURRENTLY ONGOING [***] ACTIVE/99458941.1

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SCHEDULE 9 COPY OF THE UNIVERSITY OF PENNSYLVANIA AGREEMENT [***]
ACTIVE/99458941.1

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SCHEDULE 10 COPY OF THE SETTLEMENT AND CROSS-LICENSE AGREEMENT [***]
ACTIVE/99458941.1

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SCHEDULE 11 CONTRACTS [***] ACTIVE/99458941.1

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