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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  

 

       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  

 

       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   ACTIVE/99458941.1  

 

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  

 

       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  

 

       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   ACTIVE/99458941.1  

 

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  ACTIVE/99458941.1  

 

       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, signal detection                                          8   ACTIVE/99458941.1  

 

 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  

 

 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 compliance with the foregoing shall not                                          10   ACTIVE/99458941.1  

 

                        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  ACTIVE/99458941.1  

 

 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 in any such activities during the Term.                                           12   ACTIVE/99458941.1  

 

                   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  

 

 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  

 

 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  

 

 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  

 

            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  

 

             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   ACTIVE/99458941.1  

 

 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  

 

                   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  

 

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  

 

                  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  

 

             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  

 

       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   ACTIVE/99458941.1  

 

 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 previously approved disclosure.                                           25   ACTIVE/99458941.1  

 

 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  

 

                   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                                          27   ACTIVE/99458941.1  

 

 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  

 

                   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   ACTIVE/99458941.1  

 

 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  

 

                   [***].                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  

 

 [***]                       [***]                  [***]                  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  

 

                   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  

 

            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 AdobeTM 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  ACTIVE/99458941.1  

 

             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  

 

 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  

 

 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  

 

 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  

 

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  

 

         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  

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

                                   SCHEDULE 11                                  CONTRACTS   [***]             ACTIVE/99458941.1a102keipplandocument

                                                                                                                                                      Exhibit 10.2                           NOVELION THERAPEUTICS INC.            AMENDED AND RESTATED KEY EXECUTIVE INCENTIVE PLAN    ARTICLE 1.  Introduction.  The purpose of the Plan is to provide incentives for Participants to   promote exceptional performance by Novelion Therapeutics Inc. (the “Company”), to reinforce   restructuring objectives that maximize value to all stakeholders, and to maintain and reinforce the   importance of financial and operational milestones of the Company.  Capitalized terms shall have   the meaning set forth in Article 8.          This Plan was adopted as of November 19, 2018, and was amended and restated in its   current form with the consent of Participants in accordance with Article 6 as of March 22, 2019.    ARTICLE 2.  Participation.  The individuals who are eligible to participate in the Plan shall be   those key members of the senior management team of the Company or its subsidiaries (other than   Aegerion Pharmaceuticals, Inc. and its subsidiaries) who are expected to play significant roles in   achieving the objectives of the Company identified in the Plan, as designated by the Administrator.   Participants who are designated by the Administrator to participate in the Plan shall receive a  Participation Letter setting forth the amount of their KEIP Bonus opportunities under the Plan.   ARTICLE 3.  KEIP Bonuses.          (a)   Aggregate KEIP Bonus Metrics.  The amounts of KEIP Bonus payments are based   on the levels of achievement by the Company of a financial performance target tied to the NOCF   of the Company (the “NOCF Target”) during the First NOCF Performance Period, the Second   NOCF Performance Period and the Third NOCF Performance Period, and a restructuring or sale   transaction target (the “Restructuring/Transaction Target”) during the Restructuring/Transaction   Performance Period.  Payment of KEIP Bonuses shall be determined pursuant to this Article 3   based on (i) with respect to the NOCF Target, for the First NOCF Performance Period, at the target   NOCF Performance level, as set forth on Appendix A, for the Second NOCF Performance Period,   by comparing the Company’s actual NOCF during the Second NOCF Performance Period to the   threshold, target and maximum NOCF performance levels, as set forth on Appendix A, for the   Second NOCF Performance Period, and for the Third NOCF Performance Period, by comparing   the Company’s actual NOCF during the Third NOCF Performance Period to the threshold, target   and maximum NOCF   performance levels, as set forth on Appendix A, for the Third NOCF   Performance Period, and (ii) with respect to the Restructuring/Transaction Target, the occurrence   of the Completion Date, as modified by the “Award Modifier,” as set forth on Appendix B.  The   tables set forth on Appendices A and B reflect aggregate performance metrics under the Plan.    Individual KEIP Bonus payout amounts will be set forth in a Participant’s Participation Letter, and   calculated as described in Article 3(b) below.  Achievement of each Performance Target shall be   determined separately and shall not affect the level of payment under the other Performance   Target.  All determinations of levels of achievement of the Performance Targets shall be made by   the Administrator in its sole discretion.          (b)   Individual KEIP Bonus Amounts.  The Participation Letter for each Participant   shall set forth the KEIP Bonus amounts such Participant shall be eligible to earn at each applicable  

 

   performance level.  The KEIP Bonus amounts payable to a Participant shall be calculated by  determining such Participant’s individual payout amounts (as set forth in such Participant’s  Participation Letter) based on the level of achievement of the NOCF Target or the achievement of  the Restructuring/Transaction Target, as applicable, and, in the case of the  Restructuring/Transaction Target, multiplying such amount by the Award Modifier.         (c)   Notwithstanding anything herein to the contrary, the KEIP Bonus amount payable  in respect of the First NOCF Performance Period shall be determined assuming achievement of  the target level of performance, as acknowledged and agreed by each Participant in such  Participant’s Supplemental Participation Letter, and all references to “actual performance,” “level  of achievement,” and similar references relating to performance during the First NOCF  Performance Period contained in the Plan shall be deemed to refer to achievement at the target  level of performance.   ARTICLE 4.  Time of Payment.         (a)   Payment of KEIP Bonuses.  Subject to Sections 4(b), and 4(c) and 4(d) below:               (1)   KEIP Bonus amounts earned by a Participant (if any) in respect of the                   NOCF Target (“NOCF KEIP Bonus Amounts”) shall be measured as of the                    end of the applicable NOCF Performance Period, and shall be paid in a cash                   lump sum on the first regularly scheduled payroll date following the                   Administrator’s determination of the level of achievement of the NOCF                   Target as of the end of the applicable NOCF Performance Period, or as soon                   as reasonably practicable thereafter, which determination shall be made                   within thirty (30) days following the end of each such NOCF Performance                   Period; provided, that, (i) if the Completion Date occurs prior to the end of                   the Second NOCF Performance Period, the achievement of the NOCF                   Target shall be determined as of the end of the last completed calendar                   month preceding the Completion Date, (ii) upon the occurrence of the                   Completion Date and the conclusion of the Third NOCF Performance                   Period, the achievement of the NOCF Target shall be determined as of the                   end of the last completed calendar month preceding the Completion Date,                   and (iii) if the Completion Date occurs prior to the commencement of the                   Third NOCF Performance Period, a Participant shall be eligible to earn the                   NOCF KEIP Bonus Amounts allocated to both the Second and Third NOCF                   Performance Periods, as set forth in such Participant’s Participation Letter,                   based on the level of achievement of the NOCF Target determined as of the                   end of the last completed calendar month preceding the Completion Date.                    For the avoidance of doubt, following the Completion Date, the Company                   shall have no further obligations to, and a Participant shall have no further                   entitlement to, NOCF KEIP Bonus Amounts, other than any such amounts                   earned by a Participant through the end of the NOCF Performance                   Period(s).                 (2)   KEIP Bonus amounts earned by a Participant (if any) in respect of the                    Restructuring/Transaction Target (“Restructuring/Transaction KEIP Bonus                                          2  

 

                       Amounts”) shall be measured as of the Completion Date and shall be paid                     in a cash lump sum on the first regularly scheduled payroll date following                     the Completion Date, or as soon as reasonably practicable thereafter, based                     on the Award Modifier as of the Completion Date.          (b)   Termination of Employment.  A Participant’s right to a KEIP Bonus shall be   forfeited upon termination of employment of the Participant prior to the date on which such KEIP   Bonus amount is paid.  However, if a Participant’s employment is terminated by reason of death,   Disability, by a Participant for Good Reason or by the Company or its affiliates without Cause, in   each case, prior to the applicable payment date, such Participant (or the Participant’s estate) shall   receive the KEIP Bonus he or she would otherwise have been entitled to receive had he or she not   been so terminated, based on actual performance through the end of the NOCF Performance Period   or the Restructuring/Transaction Performance Period, as applicable, in each case, multiplied by a  fraction, (i) the numerator of which is the number of complete calendar months that the Participant  was actively employed during the applicable performance period, and (ii) the denominator of  which is the total number of complete calendar months in such performance period; provided, that  with respect to the Second NOCF Performance Period and the Third NOCF Performance Period,  for purposes of determining the number of complete calendar months to include in the numerator  and denominator of such fraction, such performance periods shall be deemed to have commenced  on March 1, 2019 and July 1, 2019, respectively.  Such KEIP Bonus shall be paid at the same time  as paid to other Participants.            (c)   Release.  Notwithstanding anything herein to the contrary, the Administrator may   condition payment of a KEIP Bonus upon the Participant’s timely execution of a general release   of claims in favor of the Company and its affiliates (with customary carve-outs for (i) rights to  accrued obligations; (ii) indemnification under any agreement with, policy or governing document  of the Company or its affiliates; and (iii) rights and remedies under any employment or services  agreement between the Participant and the Company or any of its affiliates that are intended to  survive termination of employment) in a form acceptable to the Administrator.  If any portion of a  KEIP Bonus is conditioned upon the Participant’s execution of a release of claims, any amount  that would have been payable prior to the effective date of the release pursuant to Article 4 hereof   will not be paid until the first regular payroll date following the effective date of the release, or as   soon as reasonably practicable thereafter (provided, that if any KEIP Bonus payment(s) constitute   “nonqualified deferred compensation” for purposes of Section 409A of the Code, and if the first   and the last day of the applicable release consideration/revocation period could fall in two (2)   separate taxable years, regardless of when the Participant actually executes the release, such KEIP   Bonus payment(s) will not be paid until the later taxable year).          (d)   Clawback.  Notwithstanding anything herein to the contrary, if a Participant   voluntarily resigns without Good Reason, or if a Participant’s employment is terminated by the   Company for Cause, in each case, within ninety (90) days following his or her receipt of any KEIP   Bonus payment (the “Clawback Period”), such Participant will be required to repay to the   Company any KEIP Bonus amounts he or she received (post-tax) during the Clawback Period.  If  a Participant is required to repay any portion of the KEIP Bonus due upon to the termination of  his or her employment, as provided above, such Participant shall be required to make such  repayment to the Company within fifteen (15) days following the date of such termination of  employment, whether or not the Company makes a demand for payment.  If a Participant does not                                           3  

 

     timely make such repayment, the Company will be entitled to recover from such Participant   collection costs and damages, including reasonable legal fees, expenses and court costs, arising   from the enforcement of this obligation, to the fullest extent permitted by law.  Notwithstanding   anything herein to the contrary, a Participant will not be required to repay any portion of his or her   KEIP Bonus if such Participant’s employment is terminated during the Clawback Period by reason   of his or her death or Disability, by such Participant for Good Reason or by the Company or its   affiliate without Cause.    ARTICLE 5.  Administration of the Plan.  The Plan shall be administered by the Administrator.    The Administrator shall have full power and discretionary authority to administer the Plan,   including, without limitation, to: (a) interpret and construe the Plan, apply the terms of the Plan,   interpret and resolve all questions of fact under the Plan, including with respect to the evaluation   of the Performance Targets under the Plan, (b) determine the rights of any person under the Plan,   or the meaning of requirements imposed by the terms of the Plan or an award, or any rule or   procedure established by the Administrator, and to resolve all disputes under the Plan, (c) adopt,   amend, and rescind administrative guidelines and other rules and regulations relating to the Plan,   (d) correct any defect or omission or reconcile any unintentional inconsistency in the Plan, and  (e) make all other determinations and take all other actions necessary or advisable for the  implementation and administration of the Plan, subject to the such limitations as may be imposed  by the Code or other applicable law.  The Administrator may delegate administrative duties under  the Plan to one or more agents as it shall deem necessary or advisable.  Any decision or action  taken by the Administrator with respect to the authorities under the Plan shall be conclusive and  binding upon all persons.  The Administrator shall not be personally liable for any action or  determination made in good faith with respect to the Plan or as to any settlement of any dispute  between a Participant and the Company.   ARTICLE 6.  Term of the Plan.  The Plan shall continue in effect until the payment of all KEIP  Bonuses earned under the Plan, if any.  The Plan may not be terminated prior to the payment of all  KEIP Bonuses earned under the Plan, if any, and may not be not amended in any manner that shall  adversely affect the rights of a Participant without the consent of the Participant; provided, that  any amendment of the Plan that adversely affects the rights of all Participants equally shall require  the consent of Participants that have a KEIP Bonus opportunity that is a majority of total KEIP  Bonus opportunity under the Plan.   ARTICLE 7.  Section 409A.  It is intended that the rights of Participants under the Plan will either  be exempt from or compliant with Section 409A of the Code.  The Plan shall be construed in a  manner that effects such intent.  Nevertheless, the tax treatment of the benefits provided under the  Plan is not warranted or guaranteed.  Neither the Company, its affiliates nor their respective  directors, officers or employees shall be held liable for any taxes, interest, penalties or other  monetary amounts owed by any Participant or other taxpayer as a result of the Plan.   ARTICLE 8.  Definitions.  For purposes of the Plan, the following terms shall have the meanings  set forth below.         “Administrator” means the Board of Directors of the Company or any authorized   committee or delegatee thereof.                                           4  

 

         “Cause”, with respect to a Participant, has the meaning ascribed thereto in any employment  or similar services agreement to which such Participant is a party with the Company or any parent  or subsidiary thereof.  To the extent a Participant is not party to any such agreement with the  Company or any parent or subsidiary thereof, “Cause” means (i) such Participant’s conviction of  or plea of guilty or nolo contendere to a felony or a crime involving moral turpitude, (ii) such  Participant’s engaging in conduct that constitutes fraud, gross negligence or willful misconduct in  connection with his or her employment duties or responsibilities, (iii) such Participant’s  contravention, in any material respect, of specific lawful directions related to such Participant’s  duties or responsibilities which is directed to be undertaken from the person to whom such  Participant reports consistent with such Participant’s position, (iv) any acts by such Participant  which constitute embezzlement, misappropriation or breach of fiduciary duty resulting or  intending to result in such Participant’s personal gain or enrichment at the expense of the Company  or any parent or subsidiary thereof, or (v) such Participant’s continued failure to comply with a  material policy of the Company or any parent or subsidiary thereof after receiving notice of failure  to comply from the person to whom such Participant reports.         “Code” means the Internal Revenue Code of 1986, as amended from time to time, and the  rules and regulations promulgated thereunder.         “Completion Date” means the earlier of (i) the consummation of any out of court  restructuring transaction involving all or substantially all of the outstanding indebtedness of the  Company, its parent (if any) and its subsidiaries, taken as a whole (ii) the emergence by the  Company, its parent (if any) or any of its subsidiaries from any case filed by or against the  Company, its parent (if any) or its subsidiary, as the case may be, under chapter 11 of the  Bankruptcy Code or analogous domestic or foreign law, in a case that implicates all or substantially  all of the assets, liabilities and operations of the Company, its parent (if any) and its subsidiaries,  taken as a whole, (iii) the consummation of the sale of all or substantially all of the assets of the  Company, its parent (if any) and its subsidiaries, taken as a whole, or the acquisition by any person  or persons of at least a majority of the outstanding capital stock of the Company (or its parent  company, if any) and its subsidiaries, taken as a whole, in one transaction or a series of related  transactions (including in connection with a debt for equity swap), in each case whether under  section 363 of the Bankruptcy Code or otherwise, or (iv) the occurrence of the Completion Date  (as defined in the Aegerion Pharmaceuticals, Inc. Key Executive Incentive Plan).         “Disability” means, with respect to a Participant, such Participant’s permanent disability  as determined under the long-term disability plan of the Company or any parent or subsidiary  thereof as in effect on the date of the termination of his or her employment.         “First NOCF Performance Period” means the period from the effective date of the Plan and  which concluded as of February 28, 2019.         “Good Reason”, with respect to a Participant, has the meaning ascribed thereto in any  employment or similar services agreement to which a Participant is a party with the Company or  any parent or subsidiary thereof.  To the extent a Participant is not party to any such agreement  with the Company or any parent or subsidiary thereof, “Good Reason” means, without his or her  consent, and to the extent not cured by the Company or any parent or subsidiary thereof within  ten (10) days after receipt of such Participant’s resignation notice specifying the event(s) that                                          5  

 

     constitute Good Reason, which such Participant must give to the Company within thirty (30) days   of the occurrence of such event(s), (i) a material diminution in such Participant’s title, duties, or   responsibilities, (ii) a material reduction in such Participant’s base salary, or (iii) a relocation of   such Participant’s principal place of employment more than fifty (50) miles from its current   location.          “KEIP Bonus” means the bonus opportunity set forth in a Participant’s Participation Letter   at each applicable performance level.          “NOCF” means the cumulative net operating cash flow of the Company, before any   projected disbursements to be made by the Company under the Plan, the Key Employee Retention   Plan, or in respect of any annual bonus payments made to certain key employees and managers   located in Europe, as defined in AlixPartners’ cash flow model and described on Appendix A.  The   Administrator shall determine NOCF for purposes of the Plan in its discretion.          “NOCF Performance Period” means the First NOCF Performance Period, the Second   NOCF Performance Period, or the Third NOCF Performance Period, as applicable.           “Participant” means an individual designated by the Administrator as a Participant in the   Plan and who has received a Participation Letter under the Plan.          “Participation Letter” means the letter granting the KEIP Bonus to a Participant.          “Performance Targets” means (a) the NOCF Target and (b) the Restructuring/Transaction   Target.          “Plan” means this Novelion Therapeutics Inc. Key Executive Incentive Plan, as amended   from time to time.          “Restructuring/Transaction Performance Period” means the period from the effective date   of the Plan and which shall conclude as of the Completion Date.          “Second NOCF Performance Period” means the period from the effective date of this Plan   through June 30, 2019.          “Supplemental Participation Letter” means the supplemental letter between the Company   and each Participant regarding their KEIP Bonus and their consent to the amendment and  restatement of this Plan.          “Third NOCF Performance Period” means the period from the effective date of this Plan   through the Completion Date.    ARTICLE 9. Miscellaneous.          (a)   Funding of Plan.  The Plan shall be unfunded and any payments shall be made from   the general assets of the Company.                                           6  

 

           (b)   Nature of Payments.  Any amounts paid to a Participant under the Plan shall not be   taken into account in determining the amount of the Participant’s benefits under any benefit plan   or program of the Company.          (c)   Withholding Tax.  Amounts payable under the Plan shall be subject to withholding   for federal, state, local or foreign taxes (including, but not limited to, any social security   contributions) as shall be required to be withheld pursuant to any applicable law or regulation.          (d)   Rights Non-Transferable.  A Participant’s rights to benefits under the Plan may not   be pledged, encumbered, or hypothecated to or in favor of any party, and shall not be subject to   any lien, obligation, or liability of the Participant to any other party, and are not assignable or   transferable by a Participant other than by will or the laws of descent and distribution.          (e)   Liability.  The Company shall be responsible for payment of any KEIP Bonus   payments earned by such Participant pursuant to the Plan.          (f)   Limitation of Rights.  Participation under the Plan shall not in any way impose any   obligation on the Company to continue the employment of any Participant or provide future rights  to payments to any Participant or others.          (g)   Plan Binding.  The Plan and any Participation Letter shall be binding upon and   inure to the benefit of the Company and its successors and permitted assigns, and upon the   Participant, and the Participant’s heirs, successors, legal representatives and permitted assigns.            (h)   Bankruptcy Court Approval.  Notwithstanding anything herein to the contrary, in   the event the Company or any parent or subsidiary thereof becomes subject to a case under the   Bankruptcy Code, the Plan, and each Participant’s right to receive any KEIP Bonus hereunder,   shall be subject to, and contingent upon, approval of the Plan by the Bankruptcy Court to the extent   required by law or deemed advisable by the Company.          (i)   Governing Law.  The Plan is governed by and to be construed in accordance with   the laws of the State of Delaware, without regard to conflicts of laws principles thereof.  Each of  the Company and each Participant, by accepting a KEIP Bonus award hereunder, irrevocably  submits to the exclusive jurisdiction of the federal and state courts sitting in the State of Delaware   in any action or proceeding arising out of or relating to the Plan.                                    *     *     *                                           7  

 

                                     Appendix A   First NOCF Performance Period                                           Cumulative Targets                            Threshold            Target            Maximum   November 2018           (11,247,000)        (9,173,000)        (8,641,000)   December 2018           (11,056,000)        (7,700,000)        (6,600,000)   January 2019            (12,652,000)        (7,688,000)        (5,596,000)   February 2019           (14,254,000)        (8,646,000)        (5,903,000)     Second NOCF Performance Period                                           Cumulative Targets                            Threshold            Target            Maximum   November 2018           (11,247,000)        (9,173,000)        (8,641,000)   December 2018           (11,056,000)        (7,700,000)        (6,600,000)   January 2019            (12,652,000)        (7,688,000)        (5,596,000)   February 2019           (14,254,000)        (8,646,000)        (5,903,000)   March 2019              (14,351,000)        (7,291,000)        (4,120,000)   April 2019              (10,897,000)        (2,024,000)         2,666,000   May 2019                (13,135,000)        (3,285,000)         1,882,000   June 2019               (11,466,000)         (128,000)          5,516,000     Third NOCF Performance Period                                           Cumulative Targets                            Threshold            Target            Maximum   November 2018           (11,247,000)        (9,173,000)        (8,641,000)   December 2018           (11,056,000)        (7,700,000)        (6,600,000)                                          8  

 

   January 2019            (12,652,000)        (7,688,000)        (5,596,000)   February 2019           (14,254,000)        (8,646,000)        (5,903,000)   March 2019              (14,351,000)        (7,291,000)        (4,120,000)   April 2019              (10,897,000)        (2,024,000)         2,666,000   May 2019                (13,135,000)        (3,285,000)         1,882,000   June 2019               (11,466,000)         (128,000)          5,516,000   July 2019               (8,347,000)          1,991,000          8,135,000   August 2019             (11,894,000)        (3,056,000)         3,838,000   September 2019          (9,206,000)         (1,868,000)         5,776,000        •  Performance for the First NOCF Performance period was determined to be at target level,        as acknowledged and agreed by each Participant in such Participant’s Supplemental        Participation Letter.      •  The NOCF Targets for the Second NOCF Performance Period and the Third NOCF        Performance Period set forth above are cumulative, and the Company’s level of        achievement relative to the threshold, target and maximum performance levels shall be        measured as of the end of the Second NOCF Performance Period or the Third NOCF        Performance Period, as applicable, in accordance with Section 4(a)(1) of the Plan.  In the        event that the Completion Date occurs prior to the end of the Second NOCF Performance        Period, or upon the occurrence of the Completion Date and the conclusion of the Third        NOCF Performance Period, Section 4(a)(1) of the Plan will apply.      •  If actual performance is between the threshold and target performance levels or the target        and maximum performance levels, then the amount of the KEIP Bonus in respect of the        NOCF Target for the Second NOCF Performance Period or the Third NOCF Performance        Period, as applicable, shall be determined by linear interpolation.      •  No payments shall be made for performance below the threshold performance level.      •  If the Third NOCF  Performance Period continues beyond September 2019, the        Administrator shall have the discretion to set NOCF Targets for any subsequent months.                                          9  

 

                                               Appendix B                            Restructuring/Transaction Award Modifier (1)                                                          Award Modifier           Out-of-Court                                   125%              120%              110%              100%    Restructuring/Transaction            In-Court                                   115%              110%              105%              100%    Restructuring/Transaction                                On or before      On or before      On or before         After                                 7/31/2019,        8/31/2019,        9/30/2019,        9/30/2019,                                except if the     except if the     except if the     except if the                              Completion Date   Completion Date   Completion Date   Completion Date                                  occurs in         occurs in        occurs in         occurs in        Completion Date        connection with   connection with   connection with  connection with                               an out-of-court   an out-of-court   an out-of-court   an out-of-court                              restructuring that restructuring that restructuring that restructuring that                               does not involve does not involve  does not involve  does not involve                               M&A, this date    M&A, this date    M&A, this date    M&A, this date                              shall be 5/31/2019 shall be 6/30/2019 shall be 7/31/2019 shall be 7/31/2019    (1) The KEIP Bonus in respect of the Restructuring/Transaction Target shall be earned upon the occurrence of the  Completion Date, and the amount of the KEIP Bonus payable to Participants in respect thereof will be determined by  multiplying the target KEIP Bonus amount in respect of the Restructuring/Transaction Target (which will be set out  for each Participant in his or her Participation Letter) by the applicable Award Modifier.                                                    10

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