Document:

Exhibit 10.11

 

	
CONFIDENTIAL
    	
 
    	
 
    	
 
    	
EXECUTION COPY
    

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

CO-DEVELOPMENT AND LICENSE AGREEMENT

 

This Co-Development and License Agreement (this “Agreement”) is entered into as of 29 April 2013 (the “Effective Date”), by and between uniQure Biopharma B.V., formerly known as Amsterdam Molecular Therapeutics (AMT) B.V., a Dutch corporation, with its offices at Meibergdreef 61, 1105 BA Amsterdam, The Netherlands (“uniQure”), and Chiesi Farmaceutici S.p.A., an Italian corporation, with its offices at Via Palermo, 26/A, 43122 Parma, Italy (“Chiesi”). uniQure and Chiesi are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

 

WHEREAS, uniQure is a company engaged in the research and clinical development of human gene based therapies and uniQure Controls (as defined below) all relevant rights to a certain Gene Therapy Product for Hemophilia B, as more specifically described below;

 

WHEREAS, Chiesi is a pharmaceutical company engaged in the research, development, manufacture and commercialization of products for human diseases and disorders;

 

WHEREAS, Chiesi and uniQure are interested in collaborating in the co-development and future Commercialization (as defined below) of the Product, on the terms and conditions set forth herein.

 

NOW, THEREFORE, uniQure and Chiesi hereby agree as follows:

 

ARTICLE I
  DEFINITIONS; INTERPRETATION

 

Capitalized terms used herein shall have the meanings assigned to them as follows.

 

Section 1.1                                    “AAV5 Vector” shall mean a recombinant adeno-associated virus vector with the serotype 5 that is a non-pathogenic, replication defective, parvovirus engineered to deliver functional gene copies to humans.

 

Section 1.2                                    “Acquired Party” has the meaning set forth in Section 15.1.

 

Section 1.3                                    “Acquirer” has the meaning set forth in Section 15.1.

 

Section 1.4                                    “Additional Rights” has the meaning set forth in Section 7.6(a).

 

Section 1.5                                    “Additional Rights Agreement” shall mean a written agreement to which either or both Parties are a party and that conveys rights in Additional Rights that are included in Licensed Technology or the Chiesi Technology pursuant to Section 7.6(d).

 

Section 1.6                                    “Affiliate” shall mean, with respect to a Party, any Person Controlled by, in Control of, or under common Control with such Party.

 

Section 1.7                                    “Agreement” has the meaning set forth in the first and opening paragraph of this Agreement.

 

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Section 1.8                                    “Alliance Manager” has the meaning set forth in Section 2.2(f).

 

Section 1.9                                    “Applicable Laws” shall mean all applicable laws, rules and regulations, including any rules, regulations, guidelines or other requirements of any Regulatory Authority, that may be in effect from time to time.

 

Section 1.10                             “Approved Activities” shall mean those activities identified on Exhibit C.

 

Section 1.11                             “Arbitration Request” has the meaning set forth in Section 13.2(b)(i).

 

Section 1.12                             “Average Net Sales Price” shall mean the average net sales price of a particular Product in the Territory, calculated on a monthly basis, by dividing the Net Sales of the Product in the Territory effected in a particular calendar month by the number of patient doses of the Product accounting for the Net Sales in such calendar month.

 

Section 1.13                             “Breaching Party” has the meaning set forth in Section 12.3.

 

Section 1.14                             “Business Day” shall mean a day on which banking institutions in Amsterdam, The Netherlands and Parma, Italy, are open for business, excluding any Saturday or Sunday.

 

Section 1.15                             “Change of Control” shall mean, with respect to a Party, the acquisition by any Third Party, directly or indirectly, of the Control of such Party.

 

Section 1.16                             “Chiesi” has the meaning set forth in the first and opening paragraph of this Agreement.

 

Section 1.17                             “Chiesi Know-How” shall mean all Know-How Controlled by Chiesi as of the Effective Date or during the Term that is necessary or useful for the Development, use, Manufacture, having Manufactured, or Commercialization of the Product. Chiesi Know-How also includes any Joint Know-How to the extent Controlled by Chiesi, and such other Know-How included in the Chiesi Know-How pursuant to Section 7.6.

 

Section 1.18                             “Chiesi Patents” shall mean all Patent Rights Controlled by Chiesi as of the Effective Date or during the Term that are directed to any Chiesi Know-How or the Development, Manufacture, having Manufactured, use, or Commercialization of the Product. Chiesi Patents also include any Joint Patents to the extent Controlled by Chiesi, and such other Patent Rights included in the Chiesi Patents pursuant to Section 7.6.

 

Section 1.19                             “Chiesi Shared Costs” has the meaning set forth in Section 8.2(a).

 

Section 1.20                             “Chiesi Sole Costs” shall mean all costs incurred in connection with launch and pre-launch commercial activities for the Product in the Territory, including key opinion leader (KOL) development, market research, pricing and reimbursement studies.

 

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Section 1.21                             “Chiesi Technology” shall mean Chiesi Know-How and Chiesi Patents.

 

Section 1.22                             “Claims” has the meaning set forth in Section 14.1.

 

Section 1.23                             “CMC” shall mean the Chemistry, Manufacturing and Controls portion of any IMPD or Marketing Authorization Application.

 

Section 1.24                             “Collaboration” shall mean the relationship between and activities conducted by the Parties under this Agreement and all other agreements between the Parties referenced herein (other than the Confidentiality Agreement), including the Commercialization Agreement (collectively, the “Collaboration Agreements”).

 

Section 1.25                             “Collaboration Agreements” has the meaning set forth in Section 1.24.

 

Section 1.26                             “Commercialization Agreement” shall mean that certain Commercialization Agreement for Glybera concluded separately between the Parties on the date hereof.

 

Section 1.27                             “Commercialization” shall mean any and all activities, whether before or after Regulatory Approval, directed to the marketing, detailing and promotion of the Product and shall include pre-launch, launch and post-launch marketing, promoting, detailing, marketing research, medical affairs, managed markets, distributing, offering to commercially sell and commercially selling the Product, importing, exporting or transporting the Product for commercial sale and regulatory affairs with respect to the foregoing, including the filing and obtaining of Price and Reimbursement Approval for the Product, but shall not include Manufacturing nor any Development activities. When used as a verb, “Commercializing”, “Commercialize” and “Commercialized” shall mean to engage in Commercialization.

 

Section 1.28                             “Commercially Reasonable Efforts” shall mean, with respect to the efforts to be expended by a Party with respect to a goal, reasonable, diligent, good faith efforts to accomplish such goal as a similarly situated (with respect to size, stage of development, and assets) biotechnology or pharmaceutical company, as the case may be, would use to accomplish a similar goal under similar circumstances so as to achieve such goal as expeditiously as possible; provided that, with respect to the Development and Commercialization of the Product, such efforts shall be substantially equivalent to those efforts and resources that a similarly situated (with respect to size, stage of development, and assets) biotechnology or pharmaceutical company, as the case may be, would typically devote to its own internally discovered products of similar market potential at a similar stage in their development or product life so as to achieve such goal as expeditiously as possible (which, with respect to activities for which Chiesi is responsible, shall be without regard to any amounts paid or payable to uniQure with respect to the Product under this Agreement, the Commercialization Agreement, or the HemB Supply and Distribution Agreement).

 

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Section 1.29                             “Competing Product” shall mean any Gene Therapy product developed, manufactured or commercialized in the Field other than the Product Developed, Manufactured or Commercialized pursuant to this Agreement.

 

Section 1.30                             “Competitive Infringement” has the meaning set forth in Section 9.3(a).

 

Section 1.31                             “Confidential Information” shall mean all confidential or proprietary information of a Party, including information regarding such Party’s or its Affiliates’ or licensors’ technology, products, business, business plans, financial status, biological substances, chemical substances, formulations, techniques, methodology, equipment, sources of supply and patent positioning and information belonging to such Party’s Affiliate or a Third Party provided to the other Party under this Agreement. The status, prospects or objectives regarding the Development Program or any Product being developed hereunder, as well as the terms and conditions of this Agreement, shall be deemed “Confidential Information” of both Parties. All information disclosed by uniQure prior to the Effective Date pursuant to the Two Way Confidentiality Disclosure Agreement between Amsterdam Molecular Therapeutics (AMT) B.V. and Chiesi Farmaceutici S.p.A., dated 22 July 2010 (the “Confidentiality Agreement”) shall be deemed “Confidential Information” of uniQure hereunder.

 

Section 1.32                             “Confidentiality Agreement” has the meaning set forth in Section 1.31.

 

Section 1.33                             “Control” or “Controlled” shall mean (a) when used in reference to any Confidential Information, Know-How, Patent or other intellectual property rights, the possession (whether by ownership or license (other than solely pursuant to a license under this Agreement)) by such Party or any of its Affiliates, of the legal authority or right to grant to the other Party access or a license or sublicense to such Confidential Information, Know-How, Patent or other intellectual property rights as provided herein, without violating the terms of any agreement or arrangement with any Third Party, or (b) when used in reference to Section 1.6, Section 1.15 and Section 15.1, (i) the possession, directly or indirectly, of the power to direct the management or policies of a Person, whether through ownership of voting securities, by contract or otherwise; (ii) ownership of fifty percent (50%) or more of the voting securities entitled to vote for the election of directors in the case of a corporation, or fifty percent (50%) or more of the equity interest in the case of any other type of legal entity; or (iii) status as a general partner in any partnership, or any other arrangement whereby a Person controls or have the right to control the board of directors or equivalent governing body of a corporation or other Person. Notwithstanding the foregoing, any portfolio company of any stockholder of such Person (which stockholder is a venture capital fund or private equity fund) shall not be deemed to be “under common Control with” such Person.

 

Section 1.34                             “Controlling Party” has the meaning set forth in Section 7.6(b).

 

Section 1.35                             “Cover” or “Covered” shall mean, with respect to any Patent and the subject matter at issue, that, but for a license granted under a Valid Claim of such Patent, the manufacture, use, sale, offer for sale or importation of the subject matter at issue would infringe such Valid Claim, or, in the case of a Patent that is a 

 

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patent application, would infringe a Valid Claim in such patent application if it were to issue as a patent.

 

Section 1.36                             “Development” shall mean all non-clinical and clinical drug development activities, each to the extent reasonably relating to the development of the Product in the Territory.  Development shall include toxicology, pharmacology, and other non-clinical efforts, test method development and stability testing, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, the conduct of clinical trials or other activities, including regulatory activities, relating to obtaining Regulatory Approval.  When used as a verb, “Develop” means to engage in Development activities.

 

Section 1.37                             “Development Plan and Budget” shall mean a plan and budget setting forth the Development activities with respect to the Product and the budget therefor, as prepared, updated and amended from time to time in accordance with this Agreement. The Development Plan and Budget includes the Initial Development Plan and Budget.

 

Section 1.38                             “Development Program” shall mean the pre-clinical, CMC, clinical and other development, regulatory and other pre-Marketing Authorization commercial activities of the Parties directed to the Product and undertaken in accordance with the Development Plan and Budget.

 

Section 1.39                             “Effective Date” has the meaning set forth in the first and opening paragraph of this Agreement.

 

Section 1.40                             “EMA” shall mean the European Medicines Agency and any successor agency thereto.

 

Section 1.41                             “EPO” has the meaning set forth in Section 9.2(d)(iii).

 

Section 1.42                             “EU” shall mean the European Union.

 

Section 1.43                             “EU Member States” shall mean Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.

 

Section 1.44                             “Executive Officers” shall mean the Chief Executive Officer of Chiesi or a senior officer designated by Chiesi, and the Chief Executive Officer of uniQure or a senior officer designated by uniQure.

 

Section 1.45                             “Existing Third Party Licenses” shall mean the PHS Agreements, the PSC Agreement and the St. Jude Agreements.

 

Section 1.46                             “FDA” shall mean the US Food and Drug Administration and any successor agency thereto.

 

Section 1.47                             “Field” shall mean the treatment of Hemophilia B in humans.

 

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Section 1.48                             “First Commercial Sale” shall mean, the first sale by Chiesi, an Affiliate of Chiesi, or a Sub-distributor of Chiesi, as the case may be, of the Product to a Third Party in the Territory; provided, however, that neither (a) transfers of the Product between Chiesi and its Affiliates, or Sub-distributors nor (b) supply of the Product for clinical trial purposes, shall constitute a First Commercial Sale.

 

Section 1.49                             “FTE” shall mean a full time equivalent person year (consisting of a total of [**] hours per year) of work on or directly related to activities undertaken by uniQure hereunder and related management activities.

 

Section 1.50                             “FTE Rate” shall mean EUR [**] per FTE, which includes overhead expenses and bench fees (materials used during Development, but excluding expenses for materials and external costs for GMP manufacturing).

 

Section 1.51                             “Fully Loaded Cost of Goods” shall mean the fully loaded cost of goods of the Product as defined in Exhibit D.

 

Section 1.52                             “Gene Therapy” shall mean the introduction and expression of genetic material in cells of a person in order to cure a disease or to minimize disease symptoms.

 

Section 1.53                             “HemB Supply and Distribution Agreement” has the meaning set forth in Section 3.4.

 

Section 1.54                             “HHS” has the meaning set forth in Section 1.91.

 

Section 1.55                             “ICC” shall mean the International Chamber of Commerce.

 

Section 1.56                             “IMPD” shall mean an application submitted to a Regulatory Authority to initiate human clinical trials, including (a) an Investigational Medicinal Product Dossier required to be submitted to the EMA or other Regulatory Authorities in the EU Member States for Regulatory Approval of clinical trials in the EU Member States, as further defined in the Clinical Trials Directive (2001/20/EC), (b) any non-EU Member States equivalent of the foregoing in any other country, and (c) all supplements and amendments that may be filed with respect to the foregoing.

 

Section 1.57                             “Improvement” shall mean any invention, discovery, development or modification relating to the Licensed Technology or the Product or the development, manufacture or exploitation thereof, including any method or process of manufacturing or using the Product, and any formulation for the Product, whether or not patentable as well as packaging and labeling of the Product, in each case if and to the extent Controlled by uniQure during the Term.

 

Section 1.58                             “In-Person JDC Meetings” has the meaning set forth in Section 2.2(c)(i).

 

Section 1.59                             “Indemnified Party” has the meaning set forth in Section 14.3(a).

 

Section 1.60                             “Indemnifying Party” has the meaning set forth in Section 14.3(a).

 

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Section 1.61                             “Initial Development Plan and Budget” shall mean the activities and budget set forth on Exhibit A attached hereto.

 

Section 1.62                             “Invalidity Claim” has the meaning set forth in Section 9.5.

 

Section 1.63                             “JCC” has the meaning set forth in Section 2.3(a).

 

Section 1.64                             “JDC” has the meaning set forth in Section 2.2(a).

 

Section 1.65                             “Joint Know-How” has the meaning set forth in Section 9.1(c).

 

Section 1.66                             “Joint Patents” shall mean all Patent Rights that are directed to any Joint Know-How.

 

Section 1.67                             “JSC” has the meaning set forth in Section 2.1(a).

 

Section 1.68                             “Know-How” shall mean all technical, scientific, manufacturing, financial, commercial and other know-how, data, tangible materials, information, trade secrets, ideas, formulae, inventions, discoveries, processes, machines, compositions of matter, formulations, improvements, protocols, techniques, works of authorship, and results of experimentation and testing (whether or not patentable) in written, electronic, physical (including in the form of tangible compounds or cell lines), oral or any other form.

 

Section 1.69                             “License” has the meaning set forth in Section 7.1.

 

Section 1.70                             “Licensed Know-How” shall mean all Know-How Controlled by uniQure as of the Effective Date or during the Term that is necessary or useful to Develop, use, or Commercialize the Product in the Field in the Territory. Licensed Know-How also includes any Joint Know-How to the extent Controlled by uniQure, and such other Know-How included in the Licensed Know-How pursuant to Section 7.6(c).

 

Section 1.71                             “Licensed Patents” shall mean (a) all Patent Rights Controlled by uniQure as of the Effective Date or during the Term that are necessary or useful to Develop, use, or Commercialize the Product in the Field in the Territory, including those Patent Rights set forth in Exhibit E, which exhibit shall be updated or confirmed upon the date this Agreement has become effective pursuant to Section 12.1(b); (b) any Joint Patents to the extent Controlled by uniQure; and (c) such other Patent Rights included in the Licensed Patents pursuant to Section 7.6(c).

 

Section 1.72                             “Licensed Technology” shall mean Licensed Know-How and Licensed Patents.

 

Section 1.73                             “Losses” has the meaning set forth in Section 14.1.

 

Section 1.74                             “Major Country” shall mean any of the following countries: France, Germany, Italy, Spain and the United Kingdom.

 

Section 1.75                             “Manufacture” and “Manufacturing” shall mean all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, shipping and holding of the Product or any intermediate thereof, including 

 

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process development, process qualification and validation, scale up, pre-clinical, clinical and commercial manufacture and analytical development, product characterization, stability testing, quality assurance and quality control. When used as a verb, “Manufacture” shall mean to engage in Manufacturing activities.

 

Section 1.76                             “Marketing Authorization” or “MA” shall mean the authorization issued by the relevant Regulatory Authority necessary to place on the market the Product in any country or regulatory jurisdiction in the Territory (including the approval of a Marketing Authorization Application in the EU Member States). For clarity, a Marketing Authorization shall not include any applicable Price and Reimbursement Approvals.

 

Section 1.77                             “Marketing Authorization Application” or “MAA” shall mean an application submitted to a Regulatory Authority for marketing approval of a drug or biologic product, including (a) a Marketing Authorization Application in the EU Member States under Regulation (EC) No. 726/2004 or Directive 2001/83/EC, (b) any non-EU Member States equivalent of the foregoing in any other country in the Territory, and (c) all supplements and amendments that may be filed with respect to any of the foregoing.

 

Section 1.78                             “Net Sales” shall mean the total amount of invoiced sales of the Product in the Territory by or on behalf of Chiesi or its Affiliates or Sub-distributors to Third Parties (including wholesalers, hospitals, end users and others), in bona fide arm’s length transactions, less the following deductions, in each case related specifically to the Product and customary in the trade and actually allowed and taken by such Third Parties and not otherwise recovered by or reimbursed to Chiesi: (a) cash discounts; (b) taxes on sales (such as sales or use taxes) to the extent added to the sale price and set forth separately as such in the total amount invoiced; (c) freight and insurance to the extent added to the sale price and set forth separately as such in the total amount invoiced; (d) amounts repaid or credited by reason of rejections, defects, recalls, expirations, or returns; and (e) any governmental mandated charge backs, rebates, and discounts. No deductions shall be made for (x) commissions paid to individuals, whether they are with independent sales agencies or regularly employed by Chiesi or any of its Affiliates, and on its payroll, (y) the cost of collections, and (z) any advertising and promotional expenses.

 

Section 1.79                             “New Product” has the meaning set forth in Section 6.2(a).

 

Section 1.80                             “NIH” has the meaning set forth in Section 1.92.

 

Section 1.81                             “Non-Acquired Party” has the meaning set forth in Section 15.1.

 

Section 1.82                             “Non-Arbitrable Termination Dispute” has the meaning set forth in Section 13.1(a).

 

Section 1.83                             “Non-Breaching Party” has the meaning set forth in Section 12.3.

 

Section 1.84                             “Non-Controlling Party” has the meaning set forth in Section 7.6(b).

 

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Section 1.85                             “Party” and “Parties” has the meaning set forth in the first and opening paragraph of this Agreement.

 

Section 1.86                             “Patent Challenge” has the meaning set forth in Section 12.4.

 

Section 1.87                             “Patent Prosecution” shall mean the preparation, filing and prosecution of patent applications, and the maintenance of patents, included in Patent Rights.

 

Section 1.88                             “Patent Right(s)” shall mean any patent or patent application, including utility patents, utility models, design patents, provisional applications, certificates of invention, and all divisionals, continuations, continuations-in-part, substitutions, reissues, reexaminations, renewals, extensions (including any supplemental patent certificate) or additions to any patent or patent application.

 

Section 1.89                             “Paying Party” has the meaning set forth in Section 8.4.

 

Section 1.90                             “Person” shall mean any natural person or any corporation, company, partnership, limited liability company, joint venture, firm, agency or other entity, including a Party.

 

Section 1.91                             “Phase I/II Study” shall mean the first human clinical trial in which patients with Hemophilia B are dosed with the Product.

 

Section 1.92                             “PHS” shall mean The National Institutes of Health (“NIH”) or the FDA, agencies of the US Public Health Service within the Department of Health and Human Services (“HHS”).

 

Section 1.93                             “PHS Agreements” shall mean the PHS 2011 Agreement and the PHS 2007 Agreement.

 

Section 1.94                             “PHS 2007 Agreement” shall mean the Non-Exclusive Patent License Agreement, number L-107-2007/0, dated as of 25 April/2 May 2007, by and between uniQure and PHS, as amended from time to time.

 

Section 1.95                             “PHS 2011 Agreement” shall mean the Exclusive and Non-Exclusive Patent License Agreement, number L-116-2011/0, dated as of 5/10 August 2011, by and between uniQure and PHS, as amended from time to time.

 

Section 1.96                             “Pivotal Study” shall mean, with respect to the Product, a human clinical trial, the principal purpose of which is to establish safety and efficacy of such Product in patients with Hemophilia B as required under Regulation (EC) No. 726/2004 or Directive 2001/83/EC, or a similar clinical trial prescribed by the applicable Regulatory Authority in the Territory. A Pivotal Study also includes any other human clinical trial intended as a pivotal study of such Product regarding Hemophilia B, such as a phase II/III or phase IIb clinical trial, whether or not such study is a traditional phase III clinical trial.

 

Section 1.97                             “Pre-Existing Affiliate” has the meaning set forth in Section 15.1.

 

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Section 1.98                             “Price and Reimbursement Approval” shall mean any approval or authorization of any Regulatory Authority establishing a pricing- and payment scheme or a reimbursement scheme for the Product in any country or jurisdiction of the Territory.

 

Section 1.99                             “Product” shall mean a Gene Therapy product for the treatment of Hemophilia B in humans that includes an AAV5 Vector containing a functional copy of the codon-optimized human Factor IX gene or part thereof under the control of a liver-specific promoter.

 

Section 1.100                      “Product Data” shall mean all preclinical and clinical data, safety data and all other supporting data, including pharmacology and biology data, regulatory documentation (including IMPDs, MAAs and other Marketing Authorizations, Regulatory Approvals and regulatory filings in the Territory) and other Know-How generated under the Development Program that relate to the Product.

 

Section 1.101                      “Product Manufacturing Cost Reimbursement” has the meaning set forth on Exhibit D.

 

Section 1.102                      “Product Transfer Price” has the meaning set forth on Exhibit D.

 

Section 1.103                      “PSC” shall mean Protein Sciences Corporation.

 

Section 1.104                      “PSC Agreement” shall mean the License Agreement, dated as of 22 March 2007, by and between uniQure and PSC, as amended from time to time.

 

Section 1.105                      “Publishing Party” has the meaning set forth in Section 10.5(a).

 

Section 1.106                      “Receiving Party” has the meaning set forth in Section 8.4.

 

Section 1.107                      “Reconciliation Payment” has the meaning set forth in Section 8.2(d).

 

Section 1.108                      “Regular JDC Meeting” has the meaning set forth in Section 2.2(c)(i).

 

Section 1.109                      “Regulatory Approval” shall mean any and all approvals (including, where required, any applicable Price and Reimbursement Approvals), licenses, registrations or authorizations of any Regulatory Authority necessary for the Manufacture, use, and Commercialization of a Product in a country or jurisdiction, including IMPDs and Marketing Authorizations.

 

Section 1.110                      “Regulatory Authority” shall mean any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the testing, Regulatory Approval, manufacture, use, storage, import, promotion, marketing or sale of a drug or biologic product in a country or jurisdiction, including the EMA.

 

Section 1.111                      “SDEA” has the meaning set forth in Section 4.4.

 

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Section 1.112                      “SEC” has the meaning set forth in Section 10.1(e).

 

Section 1.113                      “Severed Clause” has the meaning set forth in Section 15.14.

 

Section 1.114                      “Shared Costs” shall mean, for a calendar quarter, (a) each Party’s duly documented out-of-pocket costs incurred during such calendar quarter pursuant to the Development Program, including costs associated with preclinical studies, clinical studies, CRO, CMC, clinical supply and other reasonable and customary development expenses, as set forth in the Development Plan and Budget; (b) uniQure’s FTE Rate for each uniQure FTE conducting activities during such calendar quarter pursuant to the Development Program (including any activities conducted in connection with the Development Plan and Budget during the period from the Effective Date until the date this Agreement has become effective pursuant to Section 12.1(b)); (c) each Party’s out-of-pocket costs and expenses incurred during such calendar quarter associated with Patent Prosecution of Joint Patents in the Territory as provided in Section 9.2 and enforcement of Joint Patents against Competitive Infringement in the Territory as provided in Section 9.3, including (i) out-of-pocket costs incurred in gathering information or making filings with any governmental authority, (ii) fees and expenses of counsel and consultants (including translators) and (iii) extraordinary employee costs; (d) actual costs associated with any Approved Activity, whether incurred before or after the Effective Date, including as set forth in Exhibit C; (e) development and regulatory milestone payments associated with the Existing Third Party Licenses and, if required, any costs associated with any Additional Rights Agreements, to the extent incurred in connection with Development Program activities performed during such calendar quarter; (f) all costs and expenses relating to the withdrawal or recall of any Product in a country in the Territory prior to, Marketing Approval in such country pursuant to Section 4.3 and (g) all costs related to Phase IV (a post approval study) if agreed between the Parties. Shared Costs shall exclude uniQure Sole Costs and Chiesi Sole Costs.

 

Section 1.115                      “St. Jude” shall mean St. Jude Children’s Research Hospital, Inc.

 

Section 1.116                      “St. Jude Agreements” shall mean the Exclusive License Agreement and the Sponsored Research Agreement, both dated as of 7 July 2008, between St. Jude and uniQure, as amended from time to time.

 

Section 1.117                      “Sub-distributor” shall mean a Third Party that is granted a sub-distribution or other Commercialization right in the Territory by Chiesi under this Agreement.

 

Section 1.118                      “Subject Disclosure” has the meaning set forth in Section 10.3(b).

 

Section 1.119                      “Supply Failure” has the meaning set forth in Section 3.5.

 

Section 1.120                      “Term” has the meaning set forth in Section 12.1.

 

Section 1.121                      “Territory” shall mean the EU Member States, Iceland, Liechtenstein and Norway as well as Albania, Algeria, Andorra, Bosnia, Brazil,

 

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Croatia, Egypt, Macedonia, Mexico, Monaco, Montenegro, Morocco, Pakistan, Republic of San Marino, Russia and ex-CIS countries (i.e. Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kirghizstan, Moldova, Tajikistan, Turkmenistan, Ukraine and Uzbekistan), Serbia (including Kosovo), Switzerland, Tunisia, Turkey, and Vatican City. For the avoidance of doubt, the Territory shall exclude China and the US.

 

Section 1.122                      “Third Party” shall mean any Person other than uniQure, Chiesi, or their respective Affiliates.

 

Section 1.123                      “uniQure” has the meaning set forth in the first and opening paragraph of this Agreement.

 

Section 1.124                      “uniQure Shared Costs” has the meaning set forth in Section 8.2(a).

 

Section 1.125                      “uniQure Sole Costs” shall mean (a) any expenses for extra patients in a clinical trial of the Product beyond the number required by Regulatory Authority guidelines, or through Regulatory Authority feedback, in the Territory, unless the inclusion of such extra patients is agreed to by the JDC, (b) post-Marketing Authorization Product Manufacturing costs unless specifically required by Chiesi, (c) any filing fees associated with CMC of the Product and (d) subject to Section 4.3, the costs of safety monitoring of the Product, including any filing fees associated with Pharmacovigliance.

 

Section 1.126                      “Upfront Payment” has the meaning set forth in Section 8.1.

 

Section 1.127                      “US” or “USA” shall mean the United States of America, including its territories and possessions.

 

Section 1.128                      “Valid Claim” shall mean any claim within an issued and unexpired Patent or pending Patent application that (i) is not expired, lapsed, or abandoned, (ii) is not dedicated to the public, disclaimed, or admitted to be unenforceable or invalid; and (iii) has not been invalidated, held unenforceable or cancelled by a court or administrative agency of competent jurisdiction in an order or decision from which no appeal has been or can be taken, including through opposition, re-examination, reissue, disclaimer or otherwise.

 

Section 1.129                      “WIPO” has the meaning set forth in Section 9.2(d)(iii).

 

Section 1.130                      Interpretation. Any reference in this Agreement to an Article, Section, subsection, paragraph, clause, or Exhibit shall be deemed to be a reference to any Article, Section, subsection, paragraph, clause, or Exhibit, of or to, as the case may be, this Agreement. Except where the context clearly otherwise requires, (a) wherever used, the use of any gender will be applicable to all genders, (b) the singular shall include the plural and vice versa, (c) any definition of or reference to any agreement, instrument or other document refers to such agreement, instrument 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 or therein), (d) any reference to any Applicable Laws refers to such Applicable Laws as from time to time enacted, repealed or amended, (e) the words

 

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“herein”, “hereof” and “hereunder”, and words of similar import, refer to this Agreement in its entirety and not to any particular provision hereof, (f) the words “include”, “includes” and “including” are deemed to be followed by the phrase “but not limited to”, “without limitation” or words of similar import, (g) the word “or” has the inclusive meaning (i.e., “and/or”), (h) the word “day” means a calendar day, the word “month” means a calendar month, and the word “year” means, and the word “annual” refers to, a calendar year, (i) the word “quarterly” refers to a calendar quarter, (j) each accounting term used herein that is not specifically defined herein has the meaning given to it under the International Financial Reporting Standards, and (k) the captions or headings of the Exhibits, Articles, Sections or other subdivisions hereof are inserted only as a matter of convenience or for reference and shall have no effect on the meaning of the provisions hereof.

 

ARTICLE II
  GOVERNANCE; DECISION MAKING

 

Section 2.1                                    Joint Steering Committee.

 

(a)                                 Formation and Membership. Within [**] days after the Effective Date, Chiesi and uniQure shall establish a joint steering committee (the “JSC”) to manage the Collaboration. The JSC to be established under this Agreement shall be identical to the one to be established under the Commercialization Agreement. The JSC shall be comprised of [**] executives or senior employees of Chiesi and [**] executives or senior employees of uniQure with appropriate experience and level of decision-making authority. From time to time, in addition to the JDC described below, the Parties may establish one or more subcommittees of the JSC to oversee particular projects or activities (e.g., activities under the Commercialization Agreement, financial reporting). Each such subcommittee shall be comprised of an equal number of representatives from each Party with appropriate experience and level of decision-making authority. Each subcommittee shall meet with a frequency to be agreed on by the Parties. Each Party may change any one or more of its representatives on the JSC or any subcommittee at any time upon written notice to the other Party.

 

(b)                                 Responsibilities.  The JSC shall be responsible for:

 

(i)                         providing overall direction of the Collaboration;

 

(ii)                      attempting to resolve disputes arising under the Collaboration Agreements; and

 

(iii)                   performing such other tasks and undertaking such other responsibilities as may be set forth in the Collaboration Agreements.

 

(c)                                  Meetings.

 

(i)                         The JSC shall meet at least [**], by tele- or video-conference or in person, with the meetings in approximately [**] to be held in-person. The location of in-person JSC meetings shall alternate between the headquarters offices of each Party, with the first meeting to take place at [**].

 

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(ii)                      Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JSC and any subcommittees. In addition, each Party may, at its discretion, invite a reasonable number of non-voting employees or officers, and, with the consent of the other Party, consultants or scientific advisors, to attend meetings of the JSC or any subcommittee, or the relevant portion thereof; provided that, its representatives and any such other employees, officers, consultants or scientific advisors are bound by written obligations of confidentiality that are at least as stringent as those set forth in this Agreement. Each Party shall bear all travel and living expenses of its representatives and other employees, officers, consultants or scientific advisors incurred to attend the meetings of the JSC or any subcommittee.

 

(iii)                   Either Party may also request, by providing written notice to the other Party, that a special meeting of the JSC be convened for the purpose of resolving disputes in connection with, or for the purpose of reviewing or making a decision pertaining to, any material matter within the purview of the JSC, the examination or resolution of which cannot reasonably be postponed until the next scheduled JSC meeting. Such meeting shall be convened at such time as may be mutually agreed upon by the Parties, but in any event shall be held within [**] days after the date of such notice.

 

(d)                                 Administrative Matters.  The right to appoint the chairperson of the JSC shall alternate on an annual basis between Chiesi and uniQure, with [**]having the right to appoint the chairperson for the first year of the Term. The Alliance Managers (defined below) shall work with the chairperson to develop JSC meeting agendas. The chairperson shall be responsible for calling meetings of the JSC and for leading the meetings. A JSC member of the chairing Party shall serve as secretary of such meetings. The secretary shall promptly prepare and distribute to all members of the JSC draft minutes of the meeting for review and comment, including a list of any actions or decisions approved by the JSC, with the goal of distributing final approved minutes of each JSC meeting within [**] days after the meeting. Neither the chairperson nor the secretary shall have any greater authority than any other representative on the JSC and the Party appointing the chairperson and the secretary shall not have any greater authority than the other Party by virtue of its right to make such appointments. The chairperson shall include on the agenda any items proposed by either Party.

 

(e)                                  Decision Making.  Each Party, through its representatives, shall have one (1) vote on the JSC and each subcommittee. Both Parties must vote in the affirmative to allow the JSC or a subcommittee to take any action that requires the approval of the JSC or the subcommittee. Decision on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement. If a subcommittee is unable to resolve any dispute, or to unanimously agree on any matter, within its responsibilities, such dispute or matter shall be referred to the JSC for resolution. Either Party may convene a special meeting of the JSC in accordance with Section 2.1(c)(iii) for the purpose of resolving any dispute within the JSC’s jurisdiction that represents a material issue the resolution of which cannot reasonably await until the next scheduled meeting of the JSC.

 

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(f)                                   Dispute Resolution by Executive Officers.

 

(i)                         If the JSC is unable to resolve any dispute within the responsibilities of the JSC specified in Section 2.1(b) within [**] days after a Party provides notice to the other Party of the existence of such dispute, such dispute or other matter shall be referred to the Executive Officers for resolution, pursuant to Section 13.2.

 

(ii)                      In resolving any disputes under this Section 2.1(f), each Party shall act in good faith, subject to the terms and conditions of the Collaboration Agreements, and in a commercially reasonable manner without favoring other products being developed or commercialized by or on behalf of such Party or its Affiliates outside of the Collaboration.

 

Section 2.2                                    Joint Development Committee.

 

(a)                                 Formation and Membership.  Within [**] days after the Effective Date, Chiesi and uniQure shall establish, as a subcommittee of the JSC, a joint development committee (the “JDC”) to manage the overall relationship between the Parties under this Agreement. The JDC shall be comprised of [**] executives or senior employees of Chiesi and [**] executives or senior employees of uniQure with appropriate experience and level of decision-making authority. From time to time, the Parties may establish one or more subcommittees of the JDC to oversee particular projects or activities (e.g., clinical/regulatory, CMC, development). Each such subcommittee shall be comprised of an equal number of representatives from each Party with appropriate experience and level of decision-making authority. Each subcommittee shall meet with a frequency to be agreed on by the Parties. Each Party may change any one or more of its representatives on the JDC or any subcommittee at any time upon written notice to the other Party.

 

(b)                                 Responsibilities.  The JDC shall be responsible for:

 

(i)                         periodically reviewing the Development Plan and Budget and suggesting or approving such updates or amendments to the Development Plan and Budget as the JDC deems appropriate, including all budgets relating to activities to be conducted hereunder and amendments thereto;

 

(ii)                      ensuring consistency and coordination between Development activities to be conducted by uniQure under the Development Plan and Budget and, if applicable, by Chiesi under the Development Plan and Budget;

 

(iii)                   providing overall strategic direction with respect to Development and regulatory activities for the Product, including activities conducted under the Development Plan and Budget;

 

(iv)                  overseeing Development and regulatory activities for the Product;

 

(v)                     discussing and addressing any supply chain or other delivery issues that have arisen or might arise relating to the Product;

 

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(vi)                  determining, managing and reviewing the Patent strategy relating to inventions made after the Effective Date covering the Product in the Territory;

 

(vii)               attempting to resolve disputes arising under this Agreement that are referred to the JDC by either Party or any subcommittee; and

 

(viii)            performing such other tasks and undertaking such other responsibilities as may be set forth in this Agreement or as may be delegated to it by the JSC.

 

(c)                                  Meetings.

 

(i)                         The JDC shall meet at least [**], by tele- or video-conference or in person, with the meetings in approximately [**] to be held in-person (such [**] regularly scheduled [**] in-person meetings shall be the “Regular JDC Meetings”, while all in-person meetings of the JDC, including the Regular JDC Meetings, shall be “In-Person JDC Meetings”). The location of In-Person JDC Meetings shall alternate between the headquarters offices of each Party, with the first meeting to take place at [**].

 

(ii)                      Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC and any subcommittees. In addition, each Party may, at its discretion, invite a reasonable number of non-voting employees or officers, and, with the consent of the other Party, consultants or scientific advisors, to attend meetings of the JDC or any subcommittee, or the relevant portion thereof; provided that, its representatives and any such other employees, officers, consultants or scientific advisors are bound by written obligations of confidentiality that are at least as stringent as those set forth in this Agreement. Each Party shall bear all travel and living expenses of its representatives and other employees, officers, consultants or scientific advisors incurred to attend the meetings of the JDC or any subcommittee.

 

(iii)                   Either Party may also request, by providing written notice to the other Party, that a special meeting of the JDC be convened for the purpose of resolving disputes in connection with, or for the purpose of reviewing or making a decision pertaining to, any material matter within the purview of the JDC, the examination or resolution of which cannot reasonably be postponed until the next scheduled JDC meeting. Such meeting shall be convened at such time as may be mutually agreed upon by the Parties, but in any event shall be held within [**] days after the date of such notice.

 

(d)                                 Administrative Matters.  [**] shall have the right to appoint the chairperson of the JDC. The Alliance Managers (defined below) shall work with the chairperson to develop JDC meeting agendas. The chairperson shall be responsible for calling meetings of the JDC and for leading the meetings. A [**] JDC member shall serve as secretary of such meetings. The secretary shall promptly prepare and distribute to all members of the JDC draft minutes of the meeting for review and comment, including a list of any actions or decisions approved by the JDC, with the goal of distributing final approved minutes of each JDC meeting within [**] days after the meeting. Neither the chairperson nor the secretary shall have any greater authority than any other representative on the JDC and [**] shall not have any greater

 

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authority than [**] by virtue of its right to make such appointments. The chairperson shall include on the agenda any items proposed by either Party.

 

(e)                                  Decision Making.  Each Party, through its representatives, shall have one (1) vote on the JDC and each subcommittee. Both Parties must vote in the affirmative to allow the JDC or a subcommittee to take any action that requires the approval of the JDC or the subcommittee. Decision on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement. If a subcommittee is unable to resolve any dispute, or to unanimously agree on any matter, within its responsibilities, such dispute or matter shall be referred to the JDC for resolution. Either Party may convene a special meeting of the JDC in accordance with Section 2.2(c)(iii) for the purpose of resolving any dispute within the JDC’s jurisdiction that represents a material issue the resolution of which cannot reasonably await until the next scheduled meeting of the JDC.

 

(f)                                   Dispute Resolution.  If the JDC is unable to resolve any dispute within the responsibilities of the JDC specified in Section 2.2(b), or to unanimously agree on any matter set forth in subsections (i)-(vi) below, within [**] days after a Party provides notice to the other Party of the existence of such dispute, then (A) uniQure shall have final decision-making authority (except as set forth below in this Section 2.2(f)) with respect to all research and Development activities with respect to the Product, with reasonable input from Chiesi taking into account Territory-specific matters, and (B) Chiesi shall have final decision-making authority with respect to all Commercialization activities with respect to the Product in the Territory, with reasonable input from uniQure taking into account uniQure’s global Product strategy; provided, however, that the following decisions must be decided unanimously (or, if not able to be decided unanimously, will be referred to the JSC for resolution pursuant to Section 2.1), in that neither Party shall have the right to exercise its final decision-making authority to unilaterally:

 

(i)                         increase the other Party’s obligations or reduce such other Party’s rights under this Agreement, including any obligation to conduct activities, or devote additional personnel to a specific activity to be conducted by such other Party, under the Development Plan and Budget, or require such other Party to conduct activities the costs of which are not reimbursed by such Party or included in Shared Costs;

 

(ii)                      expand such Party’s rights or reduce such Party’s obligations under this Agreement;

 

(iii)                   resolve disputes regarding the Parties’ rights and obligations under this Agreement;

 

(iv)                  make a decision that is expressly stated in this Agreement to require the other Party’s prior approval or consent, or the mutual agreement of the Parties, or that is not consistent with the terms and conditions of this Agreement;

 

(v)                     require the other Party to perform any act that such other Party reasonably believes to be inconsistent with Applicable Law; or

 

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(vi)                  make a decision in a manner that would cause a breach of any Existing Third Party License or Additional Rights Agreement, or to require any Third Party to take any actions not required to be performed by such Third Party under any Existing Third Party License or Additional Rights Agreement.

 

In addition, each Party shall exercise its final decision-making authority in good faith, subject to the terms and conditions of this Agreement, and in a commercially reasonable manner without favoring other products being developed or commercialized by or on behalf of such Party or its Affiliates outside the Collaboration. With respect to regulatory matters, both Parties agree that they will jointly work towards a regulatory strategy for the Product in the Territory, with an understanding that Chiesi (i) shall have the final decision right on the regulatory strategy for the Product in the Territory, including on all regulatory matters as described in Section 4.1 and Section 4.2 and (ii) shall support uniQure’s global regulatory strategy for the Product unless such support leads to a material increase in costs or time to market for Chiesi, in which case Chiesi shall have the final decision right, as to cause the Parties to maintain the regulatory strategy for the Product in the Territory, as included in the Initial Development Plan and Budget as amended due to any mandatory request of any Regulatory Authority or Applicable Laws in the Territory. For the avoidance of doubt, “material increase in costs” shall mean additional costs (i.e. costs not reimbursed by uniQure to Chiesi) in excess of EUR [**] and “material increase in time to market” shall mean an additional time for submission of a Marketing Authorization Application of more than [**] days, in each case to be determined by comparing such additional costs or additional time with the initial costs or time included in the Initial Development Plan and Budget, as such initial costs or time may have been adjusted due to any mandatory request of any Regulatory Authority or Applicable Laws in the Territory (in other words, any increase of costs or time due to such mandatory requests shall not be relevant for the calculation of the EUR [**] and [**] days thresholds, whereas any other adjustments to the costs or time included in the Initial Development Plan and Budget shall be credited against such thresholds).

 

Without prejudice to the foregoing, it is further understood and agreed that the above final decision-making authority can be exercised by the respective representative(s) of uniQure or Chiesi, as the case may be, also at the JSC level.

 

Section 2.3                                    Joint Commercialization Committee.  Within [**] days after the Effective Date, Chiesi and uniQure may also establish, as a subcommittee of the JSC, a joint commercialization committee (the “JCC”) to manage any specific matter not otherwise dealt with by the JDC hereunder. If a JCC is formed, the provisions of Sections 2.2(a) and 2.2(c) through (f) above shall apply to the JCC, mutatis mutandis.

 

Section 2.4                                    Alliance Managers.  Each Party shall appoint an employee (or an employee of its Affiliate) to serve as an alliance manager (“Alliance Manager”) with responsibility for overseeing that the Parties’ activities are conducted in accordance with the Collaboration Agreements, and for being the primary point of contact between the Parties with respect to all such activities. The Alliance Managers to be appointed under this Agreement shall be identical to the ones to be appointed under the Commercialization Agreement. The Alliance Managers are responsible for driving the Collaboration progress and the resolution of issues between the Parties. The Alliance Managers may be members, but in any event may attend the meetings,

 

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of the JSC, JDC, or any other JSC subcommittee, and be responsible for communicating with and reporting to the JSC, JDC, and any other JSC subcommittee, on all relevant matters.

 

ARTICLE III
  DEVELOPMENT; MANUFACTURE AND SUPPLY

 

Section 3.1                                    Overview; Development Plan and Budget.

 

(a)                                 Subject to and in accordance with the terms and conditions of this Agreement, the Parties shall collaborate on the Development of the Product for the Territory in accordance with the Development Plan and Budget. Each Party shall be responsible for, and shall use Commercially Reasonable Efforts to conduct, those activities assigned to it under the Development Plan and Budget. Unless the Parties otherwise mutually agree:

 

(i)                         uniQure shall be responsible for, and shall use Commercially Reasonable Efforts to conduct all activities to Develop the Product in the Territory, including all clinical Development activities that are required to obtain Marketing Authorization in the Territory (with particular emphasis on each Major Country). The Parties will jointly work towards a regulatory strategy for the Product in the Territory, including preparing, filing, obtaining and maintaining all Regulatory Approvals necessary to Develop and Commercialize the Product in each Major Country, subject to Section 2.2(f) and, provided, that all matters under this sub-paragraph (i) shall be included in the Initial Development Plan and Budget; and

 

(ii)                      Subject to Section 2.2(f), Chiesi shall be responsible for, and shall use Commercially Reasonable Efforts to conduct all launch and pre-launch activities for the Product in the Territory, including KOL development, market research, and conducting pricing and reimbursement studies.

 

(b)                                 Each successive Development Plan and Budget shall be prepared by uniQure in consultation with Chiesi, shall be reviewed and approved by the JDC, shall be consistent with the terms and conditions of the Agreement (including this Section 3.1) and shall specify among other things:

 

(i)                         Development objectives,

 

(ii)                      activities to be performed thereunder for at least the next [**] years,

 

(iii)                   associated budgets for the next year, and good faith projections for the [**] years thereafter, regarding such activities,

 

(iv)                  anticipated timelines for performance, and

 

(v)                     specific deliverables.

 

(c)                                  The Parties shall update the Development Plan and Budget [**] and otherwise as reasonably required, as determined by the JDC. uniQure shall propose updates to the Development Plan and Budget in writing to Chiesi at least [**] Business Days prior to each of the Regular JDC Meetings. Unless the Parties

 

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otherwise agree, the number of FTEs of each Party for a given year of the Development Plan and Budget shall not exceed the applicable number of FTEs set forth in Exhibit F.

 

Section 3.2                                    Development Reports. Each Party shall provide written reports to the other Party at least [**] Business Days before each Regular JDC Meeting, setting forth in reasonable detail such Party’s and its Affiliates’ activities and progress during the [**] month period ending on the last day of [**], as applicable, related to the Development of the Product.

 

Section 3.3                                    Development Program Costs.  The costs of conducting the Development Program shall be borne by the Parties as set forth in Section 8.2.

 

Section 3.4                                    Manufacture of Product. uniQure shall provide supplies of the Product as necessary for the activities under the Development Plan and Budget; provided, however, that uniQure shall provide commercial supply of the Product pursuant to a supply and distribution agreement (the “HemB Supply and Distribution Agreement”).

 

(a)                                 Prior to the first dosing of the first patient in a Pivotal Study, the Parties shall negotiate in good faith the HemB Supply and Distribution Agreement, with the terms set forth on Exhibit D and other terms expected to be substantially similar to the Commercialization Agreement; provided, however, that the terms of the HemB Supply and Distribution Agreement, including the “Net Sales” definition and related provisions, may vary from those in the Commercialization Agreement in order to conform to and comply with the Existing Third Party Licenses and any applicable Additional Rights Agreements.

 

(b)                                 uniQure may supply NIH with inert samples of the Product or its packaging for educational and display purposes.

 

Section 3.5                                    Failure to Supply.

 

(a)                                 In the event that it becomes apparent to uniQure that it will be unable to provide supplies of the Product as necessary for the activities under the then current Development Plan and Budget (“Supply Failure”), uniQure shall, immediately after learning of such event or circumstances, notify Chiesi in writing of uniQure’s Supply Failure, along with a reasonable explanation of the reason, to the extent then known to uniQure, for uniQure’s Supply Failure and with a specific indication of the quantity of Product affected by such Supply Failure and anticipated timing of delivery of the Product. Promptly after Chiesi’s receipt of any such notice, the Parties shall agree upon mutually acceptable revised quantities and delivery dates with respect to any ordered Product or, to the extent this is not possible in light of the specific or then unknown reason for uniQure’s Supply Failure, shall discuss in good faith measures to further investigate the root cause and, as the case may be, appropriate steps to overcome such Supply Failure.

 

(b)                                 Without prejudice to the foregoing paragraph (a), if

 

(i)                                     uniQure’s Supply Failure affects at least supplies for a period of no less than nine (9) months, and

 

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(ii)                                  the reason for uniQure’s Supply Failure could be established during the Parties’ discussion pursuant to paragraph (a) above, and such reason was specifically related to uniQure’s ability to Manufacture the Product at its current manufacturing site (i.e. the Supply Failure could reasonably be expected to be overcome if the Product was Manufactured at a different manufacturing site),

 

upon either Party’s request, the Manufacturing of the Product shall be transferred to (A) uniQure’s US manufacturing site, provided such site is operational at the relevant point in time, and further provided uniQure, within [**] following such request, does not opt against such transfer, and (B) otherwise (i.e. if uniQure opts against such transfer within the foregoing [**] period) to any other Third Party manufacturer mutually agreed to by uniQure and Chiesi. uniQure shall efficiently and promptly transfer to its US manufacturing site or, as the case may be, such Third Party manufacturer all information, licenses and rights controlled by uniQure and necessary to Manufacture the Product during the continuance of uniQure’s Supply Failure. Such transfer shall ensure uniQure’s ongoing control over the information, licenses and right so transferred, shall include the steps outlined in Exhibit G, and shall occur through email and videoconference interactions, as well as face-to-face meetings as required to ensure efficient transfer of technologies and capabilities.

 

If uniQure’s US manufacturing site or, as the case may be, such Third Party manufacturer is unable to Manufacture the Product within [**] months after uniQure has started the technology transfer to such person, Chiesi shall have the right to terminate this Agreement with three (3) month notice in writing, except if uniQure’s Supply Failure is caused as a result of Force Majeure pursuant to Section 15.7. Such termination shall not become effective if, during such three (3) month notice period, uniQure has notified Chiesi of the ability of its US manufacturing site or, as the case may be, such Third Party manufacturer to Manufacture the Product. Upon termination of this Agreement by Chiesi pursuant to this Section 3.5(b), the provisions of Section 12.6 shall apply.

 

(c)                                  Without prejudice to the foregoing paragraph (a), if

 

(i)                                     uniQure’s Supply Failure affects at least supplies for a period of no less than nine (9) months, and

 

(ii)                                  the reason for uniQure’s Supply Failure (A) could be established during the Parties’ discussion pursuant to paragraph (a) above, but such reason was not specifically related to uniQure’s ability to Manufacture the Product at its current manufacturing site (i.e. the Supply Failure could not reasonably be expected to be overcome if the Product was Manufactured at a different manufacturing site), or (B) could not be established during the Parties’ discussion pursuant to paragraph (a) above during at least the foregoing nine (9) months period, and

 

(iii)                               uniQure’s Supply Failure is not caused as a result of Force Majeure pursuant to Section 15.7,

 

Chiesi may terminate this Agreement with three (3) month notice in writing. Such termination shall not become effective if, during such three (3)

 

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month notice period, uniQure has notified Chiesi of the end of its Supply Failure and has provided to Chiesi at least [**] of the outstanding orders. Upon termination of this Agreement by Chiesi pursuant to this Section 3.5(c), the provisions of Section 12.6 shall apply.

 

ARTICLE IV
  REGULATORY MATTERS

 

Section 4.1                                    Regulatory Filings.  Following the Effective Date, except as may be set forth in the HemB Supply and Distribution Agreement, (a) Chiesi shall own, and shall be responsible for preparing (with input from and in collaboration with uniQure pursuant to Section 3.1 and subject to Section 2.2(f)), filing and maintaining, all regulatory filings and Regulatory Approvals that are required for the Development, use, Manufacture or Commercialization of the Product in the Territory, and (b) Chiesi shall be responsible for all communications and interactions with Regulatory Authorities in the Territory with respect to the Development, use, Manufacture and Commercialization of the Product; provided that, at Chiesi’s reasonable request, uniQure at its expense shall use Commercially Reasonable Efforts to provide assistance to Chiesi in the making of any such regulatory filings.

 

Section 4.2                                    Coordination. Subject to Section 2.2(f), the Parties shall coordinate their regulatory matters with respect to the Product in the Territory taking into account the framework of uniQure’s global regulatory strategy for the Product. In particular:

 

(a)                                 Each Party shall take such actions and otherwise cooperate with the other Party as may be reasonably requested by such other Party to enable such other Party to perform the activities assigned to it as set forth in the Development Plan and Budget, and any other Development or regulatory activities assigned to it under this Agreement, or to comply with any of such other Party’s obligations under the Existing Third Party Licenses or any Additional Rights Agreement.

 

(b)                                 Chiesi shall provide uniQure with electronic copies of all regulatory submissions to, and material communications with, Regulatory Authorities in the Territory and uniQure shall have the right to review and comment on such submissions and communications.

 

(c)                                  Chiesi shall keep uniQure promptly (or to the extent possible, in advance) informed regarding Chiesi’s (or its Affiliate’s) regulatory strategy, planned regulatory submissions and material communications with Regulatory Authorities in the Territory with respect to the Product, including any changes to such strategy, submissions or communications.

 

(d)                                 Chiesi shall provide uniQure with copies of any proposed regulatory submissions to, or material communications with, any Regulatory Authorities in the Territory with respect to the Product, at least [**] days prior to submission.

 

(e)                                  Chiesi shall promptly provide uniQure with copies of regulatory submissions to, and material communications with, any Regulatory Authorities in the Territory relating to the Product;

 

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(f)                                   uniQure shall have the right to have a senior employee of uniQure (expert for each relevant section of CTD) participate in all meetings or substantive teleconferences with the EMA and/or other Regulatory Authorities in the Territory with respect to the Product, as well as to participate in internal meetings or discussions of Chiesi occurring immediately before or after, and related to, such EMA and/or other Regulatory Authorities in the Territory meetings or teleconferences, and shall be provided with advance access to Chiesi’s materials prepared for such EMA and/or other Regulatory Authorities in the Territory meetings and teleconferences.

 

(g)                                  Chiesi shall provide uniQure, if feasible, with reasonable advance notice of any other meeting or substantive teleconference with Regulatory Authorities in the Territory relating to the Product.

 

(h)                                 Without limiting the generality of any of the foregoing in this Section 4.2, Chiesi shall also promptly provide uniQure with an electronic copy of all material correspondence that Chiesi (or its Affiliate) receives from, or submits to, any Regulatory Authority in any country of the Territory related to the Product, including contact reports concerning conversations or substantive meetings, contact reports of all Regulatory Authority interactions in the Territory concerning conversations or substantive meetings, all required periodic reports, and cover letters of all agency submissions (including copies of all attachments to any such cover letters) relating to the Product. Chiesi shall also provide uniQure with any meeting minutes that Chiesi prepares that reflect communications with any Regulatory Authority in any country of the Territory regarding the Product.

 

Section 4.3                                    Product Withdrawals and Recalls. If any Regulatory Authority prior to Marketing Authorization in a country in the Territory (a) threatens, initiates or advises any action to remove the Product from the market in such country, or (b) requires or advises either Party or such Party’s Affiliates to distribute a “Dear Doctor” letter or its equivalent regarding use of the Product in such country, then uniQure or Chiesi, as applicable, shall notify the other Party of such event within [**] Business Days (or sooner if required by Applicable Law) after such Party becomes aware of the action, threat, advice or requirement. The JDC will meet promptly, but in any case within [**] Business Days, to discuss and attempt to agree upon whether to recall or withdraw such Product in the Territory; provided, however, that if the Parties fail to agree within an appropriate time period or if the matter involves a safety issue that, in order to protect patient safety, does not allow for sufficient time for a discussion at the JDC level (in which event uniQure shall nonetheless provide advance notice and consultation with Chiesi to the maximum practical extent prior to making a decision), uniQure shall decide whether to recall or withdraw such Product in such country and shall undertake any such recall or withdrawal.

 

Section 4.4                                    Safety Monitoring; Pharmacovigilance.  uniQure shall be responsible for safety monitoring of the Product and for any other obligations imposed by any Regulatory Authority in connection with the conduct of any preclinical or clinical activities or the granting of the relevant Marketing Authorization. The Parties shall negotiate and execute a detailed safety data exchange agreement (the “SDEA”) prior to the start of clinical Development of the Product, to arrange any future pharmacovigilance exchange between the Parties when relevant. Each Party shall ensure, through its JDC representatives or designated personnel, that the competent pharmacovigilance or clinical groups or personnel from such Party

 

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begin to negotiate and establish the appropriate SDEA no later than [**] months before the start of clinical Development of the Product, or on reasonable request of either Party. The SDEA shall be negotiated in good faith between the pharmacovigilance or clinical groups or personnel of each Party.The SDEA shall define the roles and responsibilities of each Party in terms of pharmacovigilance and define the detailed safety exchange required to permit compliance by each Party with safety reporting requirements to Regulatory Authorities and other entities in the Territory and ensure worldwide safety surveillance. At a minimum, uniQure may share pharmacovigilance information with its licensors and licensees of the Licensed Technology. In the event of a conflict between the terms of this Agreement and the SDEA, the terms of this Agreement shall govern.

 

ARTICLE V
  COMMERCIALIZATION

 

Section 5.1                                    Overview.  Subject to the terms and conditions hereunder, including Exhibit D, and the HemB Supply and Distribution Agreement, Chiesi will have sole right and responsibility to Commercialize the Product in the Field in the Territory, including for pre-launch Commercialization activities, including KOL development, pricing and reimbursement studies, as well as for post-launch Commercialization of the Product in the Field in the Territory, including all Chiesi Sole Costs relating thereto, and for booking all sales of the Product throughout the Territory.

 

ARTICLE VI
  EXCLUSIVITY

 

Section 6.1                                    Exclusivity.  During the Term, to the fullest extent consistent with any Applicable Law, neither Party nor, subject to Section 15.1, any of such Party’s Affiliates, shall, by itself or through, with or on behalf of any Third Party, undertake the development, manufacture or commercialization anywhere in the Territory of any Competing Product.

 

ARTICLE VII
  GRANT OF LICENSES

 

Section 7.1                                    uniQure License Grants.  Subject to the Existing Third Party Licenses and the other terms and conditions of this Agreement, uniQure hereby grants to Chiesi and its Affiliates an exclusive right and license, with the right to grant sublicenses only to Sub-distributors, under the Licensed Technology, to co-Develop, use and Commercialize the Product in the Field in the Territory (the “License”). As used in the preceding sentence, “co-Develop” means that uniQure and its Affiliates may also exercise such Development rights in accordance with this Agreement, but that uniQure shall not grant any such rights to any Third Party in the Territory. Improvements that are (i) Controlled by uniQure or its Affiliates and (ii) necessary or useful to co-Develop, use or Commercialize the Product in the Field in the Territory, shall be deemed part of the Licensed Technology and included in the License. uniQure shall promptly disclose to Chiesi all Improvements that are Developed by uniQure or its Affiliates (alone or in collaboration with Chiesi or its Affiliates) during the Term and that are necessary or useful to co-Develop, use or Commercialize the Product in the Field in the Territory.

 

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Section 7.2                                    Chiesi License Grants.

 

(a)                                 Subject to the terms and conditions of this Agreement, Chiesi hereby grants to uniQure and its Affiliates a non-exclusive, royalty-free, fully paid-up, irrevocable and perpetual (subject to Article XII) license in the Territory, with the right to grant sublicenses, under the Chiesi Technology, for the purposes of conducting Development Program activities.

 

(b)                                 Subject to the terms and conditions of this Agreement, Chiesi hereby grants to uniQure a non-exclusive, worldwide, royalty-free, fully paid-up, irrevocable, perpetual (subject to Article XII) license, with the right to grant sublicenses, under the Chiesi Technology (including, subject to Section 7.3 any rights Chiesi may have in and to the Product Data), to Develop, Manufacture, having Manufactured, use, and Commercialize (outside the Territory) the Product in the Field.

 

Section 7.3                                    Use of Product Data Outside of Territory.  Chiesi shall provide uniQure, promptly following uniQure’s request, with any Product Data not otherwise in uniQure’s possession, and uniQure shall have the right to use such Product Data in connection with development and regulatory activities conducted by or on behalf of uniQure outside the Territory.

 

Section 7.4                                    Disclosure of and License under Chiesi Improvements.  Chiesi shall promptly disclose to uniQure all Improvements that are developed by Chiesi or its Affiliates (alone or in collaboration with uniQure or its Affiliates) during the Term. Chiesi shall, and hereby does, grant to uniQure a non-exclusive, worldwide, royalty-free, fully paid-up, irrevocable and perpetual (subject to Article XII) license, with the right to sublicense, under all Improvements Controlled by Chiesi and its Affiliates, to Develop, Manufacture, having Manufactured, use, and Commercialize (outside the Territory) the Product in the Field.

 

Section 7.5                                    Compliance with Third Party Agreements.

 

(a)                                 The grants by uniQure under Licensed Technology set forth in Section 7.1 include the sublicense of certain Licensed Technology that is not owned by uniQure. Chiesi’s rights and licenses under, or with respect to, Licensed Technology, including any Patent Prosecution or enforcement undertaken by the Parties pursuant to Article IX, are limited to the rights granted by Third Party licensors to uniQure under the Existing Third Party Licenses and are subject to all applicable restrictions, limitations and obligations imposed on uniQure or its sub-licensees in such Existing Third Party Licenses. Chiesi shall comply, and cause its Affiliates and Sub-distributors to comply, with all such restrictions, limitations and obligations mutatis mutandis (including Paragraphs 5.1-5.4, 8.1, 10.1, 10.2, 12.5, and 13.8-13.10 of the PHS 2011 Agreement, and Paragraphs 5.1, 5.2, 8.1, 10.1, 10.2, 12.5 and 13.6-13.8 of the PHS 2007 Agreement, a copy of which provisions is attached hereto as Exhibit B). To the extent there is a conflict between the terms of any Existing Third Party License and the rights granted to Chiesi hereunder, the terms of such Existing Third Party License shall control solely with respect to the Patent Rights and Know-How owned or controlled by the applicable Third Party licensor. Notwithstanding anything to the contrary in this Agreement, either Party may not exercise any of its rights under this Agreement (including any right to any cure period

 

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(including under Section 12.3) or to delay performance of an obligation (including under Article XIII or Section 15.7)) in any manner that would result in any licensor having a right to terminate an Existing Third Party License, or that would cause the other Party to be in breach of any of its obligations under any Existing Third Party License.

 

(b)                                 During the Term, uniQure shall comply with the Existing Third Party Licenses in effect which are then applicable to the activities under this Agreement with respect to the Product (and in particular shall not commit any breach that would entitle the Third Party licensor to terminate such an Existing Third Party License) and shall not terminate any such Existing Third Party License without Chiesi’s prior written consent. In addition, during the Term, uniQure shall promptly notify Chiesi of any written notice of breach or termination received by uniQure with respect to any such Existing Third Party License and, to the extent that uniQure does not cure such breach at least [**] Business Days before the date on which the relevant licensor could terminate such Existing Third Party License due to such breach by uniQure, Chiesi shall have the right (to the extent consistent with such Existing Third Party License) to cure any such breach on uniQure’s behalf and in such a case, Chiesi shall have the right to deduct (i) any and all arm’s length payments made on behalf of uniQure for the above purpose, from the next due payments to be made hereunder plus (ii) interest on such payments calculated pursuant to Section 8.5 below.

 

(c)                                  Any sublicensee obligations required by any Existing Third Party License to be included in a sublicense thereunder, including any required provision making the applicable Third Party licensor a third party beneficiary of any sublicense thereunder, shall be deemed to be included in this Agreement; provided that, a copy of the relevant agreement provisions has been attached hereto as Exhibit B.

 

(d)                                 The license granted by uniQure in Section 7.1 with respect to the Patent Rights licensed under the Existing Third Party Licenses are subject to rights reserved by the licensors and the US government as set forth in the Existing Third Party Licenses.

 

Section 7.6                                    Additional Rights Acquired after Effective Date.

 

(a)                                 During the Term, if either Party identifies the need for, or is otherwise offered, a license, covenant not to sue or similar rights to any Third Party Patent Right or Third Party Know-How that such Party in good faith believes is necessary or useful for the Development, use, Manufacture, having Manufactured, or Commercialization of the Product in the Field in the Territory (“Additional Rights”), then such Party shall promptly notify the other Party and, in any event, prior to commencing negotiation or entering into an agreement with respect to such Additional Rights, and the Parties’ rights to conduct such negotiations shall be subject to the remaining provisions of this Section 7.6. The Parties shall thereafter conduct good faith discussions regarding whether such Additional Rights are necessary or useful for the Development, use, Manufacture, having Manufactured, or Commercialization of the Product in the Field in the Territory or whether they otherwise agree that such Additional Rights should be acquired.

 

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(b)                                 uniQure shall have the first right (but not the obligation) to license or otherwise acquire rights to any Additional Rights. If uniQure provides written notice to Chiesi that uniQure declines to exercise such first right, then Chiesi shall have the right (but not the obligation) to pursue acquiring rights to any given Additional Rights. The Party pursuing any given Additional Rights (the “Controlling Party”) shall keep the other Party (the “Non-Controlling Party”) reasonably informed regarding the status thereof and shall use Commercially Reasonable Efforts to obtain from the applicable Third Party licensor the right to sublicense such Additional Rights under the licenses granted to the Non-Controlling Party hereunder.

 

(c)                                  If the Controlling Party acquires rights to any Additional Rights and has the right to grant a sublicense under such Additional Rights to the Non-Controlling Party, and the Non-Controlling Party wishes to include such Additional Rights in the licenses granted to the Non-Controlling Party hereunder (or under the HemB Supply and Distribution Agreement), the Non-Controlling Party shall notify the Controlling Party of its desire to do so and the Controlling Party shall provide the Non-Controlling Party a summary of all material restrictions on the scope of the licenses granted under, and all material payment obligations that would be owed by the Non-Controlling Party with respect to, any Third Party agreement applicable to such Additional Rights. The Non-Controlling Party may, upon written notice to the Controlling Party and subject to Section 7.6(d), Section 7.6(e) and Section 7.6(f), obtain a sublicense under such Additional Rights and include such Additional Rights under the licenses granted to the Non-Controlling Party hereunder.

 

(d)                                 Following such notice from the Non-Controlling Party that it desires to include any given Additional Rights under the license granted to the Non-Controlling Party hereunder (or under the HemB Supply and Distribution Agreement), (i) any such Additional Rights that do not carry financial or other obligations or restrictions shall be included automatically under the applicable license hereunder, and (ii) subject to Section 7.6(e) below, any such Additional Rights that carry financial or other obligations or restrictions shall be included under the applicable license hereunder only if the Non-Controlling Party agrees to share the costs of such Additional Rights (including any upfront payment or similar acquisition cost to access such Additional Rights) with the Controlling Party and to assume all other obligations to, and be subject to all restrictions imposed by, the Controlling Party’s licensor to the extent arising from the grant to the Non-Controlling Party under such Additional Rights (including, to the extent access to such terms have been made available to the Non-Controlling Party in unredacted form, all other terms of the Additional Rights Agreement that apply to the licenses granted to the Non-Controlling Party hereunder).

 

(e)                                  If the Parties are unable, after [**] Business Days, to agree as to whether any given Additional Rights are in fact necessary or useful for the Development, use, Manufacture, having Manufactured, or Commercialization of the Product in the Field in the Territory or if the Parties are unable to agree to the allocation of the costs (as specified above), then, notwithstanding Article XIII, the Parties shall jointly engage an expert panel consisting of patent attorney(s) or expert(s) in the development, manufacturing or commercialization of products comparable to the Product in question and other CMC matters, as applicable, not

 

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regularly employed by either Party to resolve such dispute. The decision of such expert panel shall be binding on the Parties as to such dispute.

 

(f)                                   Nothing in this Section 7.6 shall restrict either Party, at such Party’s sole cost and expense, from licensing or otherwise acquiring any additional rights that are not necessary or useful for the Development, use, Manufacture, having Manufactured, or Commercialization of the Product in the Field in the Territory.

 

Section 7.7                                    No Implied Licenses.  Except as explicitly set forth in this Agreement, neither Party grants to the other Party any license, express or implied, under its intellectual property rights.

 

ARTICLE VIII
  FINANCIAL PROVISIONS

 

Section 8.1                                    Upfront Payment.  Subject to the condition precedent pursuant to Section 12.1(b),

 

(a)                                 in recognition of uniQure’s past expenditure developing the Product, Chiesi shall pay uniQure a one-time, non-refundable, non-creditable fee of Five Million Euros (EUR 5,000,000);

 

(b)                                 as reimbursement of uniQure’s past expenditure setting up the Manufacturing site for the Product in The Netherlands, Chiesi shall pay uniQure a one-time, non-refundable, non-creditable amount of Seven Million Five Hundred Thousand Euros (EUR 7,500,000); and

 

(c)                                  in consideration of uniQure making available to Chiesi Manufacturing capacity at uniQure’s Manufacturing site for the Product under this Agreement, Chiesi shall pay uniQure a one-time, non-refundable, non-creditable fee of Two Million Five Hundred Thousand Euros (EUR 2,500,000);

 

(a) to (c), collectively, the “Upfront Payment”.

 

Chiesi shall pay the Upfront Payment to uniQure within [**] Business Days after this Agreement has become effective pursuant to Section 12.1(b), provided receipt of a proper invoice from uniQure for the Upfront Payment.

 

Section 8.2                                    Development Program Costs.

 

(a)                                 Shared Costs.

 

(i)                                     At the end of each calendar quarter, in accordance with paragraph (d) below, Chiesi shall pay to uniQure fifty percent (50%) of the actual Shared Costs incurred by uniQure during such calendar quarter (including, after the end of the first calendar quarter, the actual Shared Costs incurred by uniQure during the period prior to the date this Agreement has become effective pursuant to Section 12.1(b)), and uniQure shall pay to Chiesi fifty percent (50%) of the actual Shared Costs incurred by Chiesi during such calendar quarter. To this end, each Party shall provide to the other Party and to the JDC, within [**] days after the end of each calendar quarter, (A) a written report with an accounting of and copies of supporting invoices for Shared Costs actually incurred by such Party during such calendar quarter

 

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(including, after the end of the first calendar quarter, the actual Shared Costs incurred by uniQure during the period prior to the date this Agreement has become effective pursuant to Section 12.1(b)) or, with respect to Third Party invoices not timely received by a Party, for Shared Costs incurred with respect to previous calendar quarters (such amount, “uniQure Shared Cost” or “Chiesi Shared Cost”, as applicable), (B) an estimate of the Shared Costs to complete the current year of the Development Program (which shall be the estimated cost to complete the current year of the Initial or newly agreed Development Plan and Budget), and (C) an estimate of the Shared Costs to complete the Development Program (which shall be the estimated cost to complete the Initial or newly agreed Development Plan and Budget).

 

(ii)                                  In the case the estimated Shared Costs to complete the Development Program as set out in sub-paragraph (a)(i)(C) above is equal or within a [**] percent ([**]%) budget overrun of the Initial or newly agreed Development Plan and Budget, Chiesi or, as the case may be, uniQure agrees to make the quarterly payment pursuant to paragraph (i) in full. In case the estimated Shared Costs to complete the Development Program as set out in sub-paragraph (a)(i)(C) above is more than [**] percent ([**]%) higher than the Initial or newly agreed Development Plan and Budget, Chiesi and uniQure shall investigate the cause of this budget overrun and shall jointly agree to next steps (in the JDC). Any activity that is not budgeted in the Initial or newly agreed Development Plan and Budget shall be handled as a scope change and each scope change (incl. the budget of the scope change) must be agreed beforehand by both Parties and, when agreed, the Development Plan and Budget shall be deemed amended accordingly. Without prejudice to the foregoing provisions of this sub-paragraph (ii), any above budget overrun of the Initial or newly agreed Development Plan and Budget or any new activity not budgeted but agreed beforehand by both Parties, shall be calculated at the actual direct costs therefor (including costs for out-of-pocket expenses as well as costs for personnel at actual direct costs), without any reference to the FTE Rate.

 

(iii)                               Within [**] Business Days after this Agreement has become effective pursuant to Section 12.1(b), Chiesi agrees to pay EUR [**] as a first payment to prevent uniQure of pre-paying the activities of the Initial Development Plan and Budget. At the end of the Development Program, uniQure shall credit the last quarterly payment against such EUR [**] payment and pay any remaining amount, if any, to Chiesi within [**] days after the end of such last calendar quarter.

 

(b)                                 Chiesi Sole Costs.  uniQure shall provide to Chiesi and to the JDC, within [**] days after the end of each calendar quarter, a written report with an accounting of and copies of supporting invoices for Chiesi Sole Costs actually incurred by uniQure during such calendar quarter or, with respect to Third Party invoices not timely received by uniQure, for Chiesi Sole Costs incurred with respect to previous calendar quarters.

 

(c)                                  uniQure Sole Costs.  Chiesi shall provide to uniQure and to the JDC, within [**] days after the end of each calendar quarter, a written report with an accounting of and copies of supporting invoices for uniQure Sole Costs actually incurred by Chiesi during such calendar quarter or, with respect to Third Party invoices not timely received by Chiesi, for uniQure Sole Costs incurred with respect to previous calendar quarters.

 

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(d)                                 Reconciliation Payment. Within [**] days after receipt of Chiesi’s accountings of Chiesi Shared Cost pursuant to Section 8.2(a)(i) and of uniQure Sole Costs pursuant to Section 8.2(c), uniQure shall calculate the amount of a payment (the “Reconciliation Payment”) necessary to effect the Parties’ agreed allocation of costs as follows:

 

(i)                         each Party shall bear fifty percent (50%) of all Shared Costs;

 

(ii)                      Chiesi shall bear one hundred percent (100%) of all Chiesi Sole Costs; and

 

(iii)                   uniQure shall bear one hundred percent (100%) of all uniQure Sole Costs;

 

pursuant to the following calculation:

 

Reconciliation Payment =

 

(.5 × uniQure Shared Costs)
 – (.5 × Chiesi Shared Costs)
 + Chiesi Sole Costs reported by uniQure pursuant to Section 8.2(b)
 – uniQure Sole Costs reported by Chiesi pursuant to Section 8.2(c).

 

Promptly following such calculation, uniQure shall provide to Chiesi a written report thereof. Such report shall be accompanied, as applicable, by either an invoice (if the Reconciliation Payment is positive) or a credit memo (if the Reconciliation Payment is negative), which credit memo Chiesi may apply to any future payment due to uniQure under this Section 8.2. Chiesi shall pay any such invoice within [**] days after receipt.

 

Section 8.3                                    Recordkeeping; Audit Rights.  Each Party shall keep, and shall require its Affiliates to keep, complete and accurate records of the latest [**] years of costs incurred by such Party in the conduct of Development and regulatory activities under the Development Plan and Budget (including the activities set forth in the Initial Development Plan and Budget). For the sole purpose of verifying costs included in the reports provided pursuant to Section 8.2, each Party shall have the right [**] at such Party’s expense to retain an independent certified public accountant selected by such Party, and reasonably acceptable to the other Party, to review such records in the location(s) where such records are maintained by the other Party or its Affiliates upon reasonable notice and during regular business hours and under obligations of confidence. Results of such review shall be made available to both Parties. If the review indicates that there was an underpayment of any amount payable to the auditing Party, the amount of such underpayment shall be remitted to the auditing Party within [**] days after such review, together with interest calculated in the manner provided in Section 8.5.If the underpayment is equal to or greater than [**] percent ([**]%) of the amount that was otherwise due, the audited Party shall pay all of the auditing Party’s reasonable out-of-pocket expenses of such review. If the review indicates that there was an overpayment of any amounts by the audited Party,

 

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the audited Party may apply the amount of such overpayment to any future payment due to the auditing Party under Section 8.2.

 

Section 8.4                                    Method of Payment.  All amounts payable by a Party (the “Paying Party”) hereunder shall be paid by or on behalf of such Paying Party in Euros. Shared Costs, uniQure Sole Costs or Chiesi Sole Costs incurred in a currency other than Euros shall be expressed in their Euro equivalent, calculated on the last Business Day of the calendar quarter to which the applicable report relates using the currency converter at www.oanda.com. All payments due to a Party (the “Receiving Party”) hereunder shall be made by wire transfer directly to an account designated by the Receiving Party in writing. The Receiving Party shall be responsible for all charges from the receiving bank due to the receipt of the wire transfer. The Paying Party shall be responsible for all other bank costs.

 

Section 8.5                                    Late Payments.  Any payment under this Agreement that is not paid on or before the date such payment is due shall bear interest at the lesser of (a) [**] per year, or (b) the highest rate permitted by Applicable Laws, calculated on the number of days such payments are overdue.

 

Section 8.6                                    Tax Withholding.  To the extent that any payments hereunder by the Paying Party to the Receiving Party are subject to tax, the Paying Party shall pay such tax; provided, however, that, with respect to any payments subject to withholding tax, the Paying Party shall pay the applicable withholding tax amount to the relevant taxing authority and promptly provide the Receiving Party with all necessary documentation for the Receiving Party to recover such tax. The Paying Party will take all reasonable and lawful steps to minimize the amount of any such withholding tax obligation and the Receiving Party shall promptly provide all information and documentation in its possession necessary for doing so.

 

Section 8.7                                    Blocked Payments.  In the event that, by reason of Applicable Laws in any country, it becomes impossible or illegal for the Paying Party to transfer payments to the Receiving Party, the Paying Party shall, to the extent consistent with Applicable Laws, have such royalties or other payments paid to the Receiving Party by an Affiliate of the Paying Party. To the extent such payment is not consistent with Applicable Laws, the Paying Party shall deposit such payments in local currency in the relevant country to the credit of the Receiving Party in a recognized banking institution designated by the Receiving Party or, if none is designated by the Receiving Party within a period of [**] days after written request from the Paying Party, in a recognized banking institution selected by the Paying Party and identified in a notice in writing given to the Receiving Party.

 

ARTICLE IX
  INTELLECTUAL PROPERTY

 

Section 9.1                                    Ownership.

 

(a)                                 Existing Intellectual Property.  Except as expressly set forth in this Agreement and subject to the licenses granted under this Agreement, as between the Parties each Party shall retain all right, title and interest in and to the Patent Rights, Know-How and other intellectual property rights owned by or Controlled by such Party or its Affiliates as of the Effective Date.

 

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(b)                                 Solely Owned Know-How.  Except as expressly set forth in this Agreement and subject to the licenses granted by such Party under this Agreement, as between the Parties each Party or its Affiliate, as applicable, shall exclusively own all right, title and interest in and to all Know-How made or conceived solely by the employees, agents or consultants of such Party or its Affiliates in the course of performing its activities under this Agreement.

 

(c)                                  Joint Know-How.  All Know-How made or conceived jointly by employees, agents or consultants of uniQure or its Affiliates, on the one hand, and employees, agents or consultants of Chiesi or its Affiliates, on the other hand, shall be owned jointly on the basis of each Party having an undivided one-half (1⁄2) interest in the whole (“Joint Know-How”), and each Party hereby assigns to the other Party a sufficient interest in its rights in and to the Joint Know-How so as to effect such joint ownership. Subject to the licenses granted herein and each Party’s payment obligations hereunder, each Party shall have the right to exploit the Joint Know-How, or sell, license or otherwise transfer or grant rights under Joint Know-How, or any Joint Patents directed to the Joint Know-How, to its Affiliates or any Third Party, without any duty to account to the other Party; provided that, during the Term neither Party nor its Affiliates may use, sell, license or otherwise transfer or grant rights under Joint Know-How, or any Joint Patents directed to such Joint Know-How, to any Affiliate or Third Party in any manner which would conflict with, or limit the scope of, any of the rights or licenses granted to the other Party hereunder.

 

(d)                                 Inventorship.  For purposes of determining the Parties’ rights under this Agreement, the determination of inventorship shall be made in accordance with US patent laws.

 

Section 9.2                                    Prosecution and Maintenance of Patent Rights.

 

(a)                                 Licensed Patents.  Subject to any rights of and obligations to uniQure’s Third Party licensors, uniQure shall have the exclusive right and obligation to conduct Patent Prosecution for the Licensed Patents (other than any Joint Patent) in the Territory, in uniQure’s name, and to control any interference, derivation proceeding, reexamination, review, opposition and similar proceedings relating thereto. Subject to any rights of and obligations to uniQure’s Third Party licensors, uniQure shall promptly and regularly inform and consult with Chiesi regarding the Patent Prosecution, including any interference, derivation proceeding, reexamination, review, opposition and similar proceedings relating thereto, of all Licensed Patents in the Territory.

 

(b)                                 Chiesi Patents.  Chiesi shall have the exclusive right and obligation to conduct Patent Prosecution for the Chiesi Patents (other than any Joint Patents) in Chiesi’s name, and to control any interference, derivation proceeding, reexamination, review, opposition and similar proceedings relating thereto. Chiesi shall promptly and regularly inform and consult with uniQure regarding the Patent Prosecution, including any interference, derivation proceeding, reexamination, review, opposition and similar proceedings relating thereto, of all Chiesi Patents.

 

(c)                                  Joint Patents.  uniQure shall have the first right and option (but not the obligation) to conduct Patent Prosecution for the Joint Patents in uniQure’s name, and to control any interference, derivation proceeding, reexamination, review,

 

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opposition and similar proceedings relating thereto. In the event that uniQure elects to conduct Patent Prosecution according to the foregoing sentence, uniQure shall grant, and hereby grants, to Chiesi, subject to the terms and conditions of this Agreement, a non-exclusive, worldwide, royalty-free, fully paid-up, irrevocable, perpetual license, with the right to grant sublicenses, under the Joint Patents to Develop, use, Manufacture, have Manufactured, and Commercialize the Product in the Field. In the event that uniQure elects not to conduct Patent Prosecution for, or elects to abandon, any Joint Patent, or declines to control any related interference, derivation proceeding, reexamination, review, opposition or similar proceedings, uniQure shall give Chiesi reasonable written notice to this effect, sufficiently in advance to permit Chiesi, in its sole discretion, to undertake such Patent Prosecution, or to control such interference, derivation proceeding, reexamination, review, opposition or similar proceedings, without a loss of rights, and thereafter Chiesi may, upon written notice to uniQure and in Chiesi’s name, conduct Patent Prosecution for such Joint Patents and control such interference, derivation proceeding, reexamination, review, opposition or similar proceedings. If required under Applicable Laws in order for the prosecuting Party to control any interference, derivation proceeding, reexamination, review, opposition and similar proceedings relating to any Joint Patent, the other Party shall join as a party to such interference, derivation proceeding, reexamination, review, opposition and similar proceedings.

 

(d)                                 Cooperation.  Each Party agrees to cooperate with the other Party with respect to Patent Prosecution, including any interference, derivation proceeding, reexamination, review, opposition and similar proceedings relating thereto, of Joint Patents pursuant to Section 9.2(c), subject to any rights of, and obligations to, uniQure’s Third Party licensors, including by:

 

(i)                         executing all such documents and instruments and performing of such acts as may be reasonably necessary in order to permit the other Party to continue any Patent Prosecution that such Party has elected not to pursue, as provided for in Section 9.2(c);

 

(ii)                      making its employees, agents and consultants reasonably available to the other Party (or to the other Party’s authorized attorneys, agents or representatives), to the extent reasonably necessary to enable the prosecuting Party to undertake Patent Prosecution;

 

(iii)                   providing (itself or through patent counsel) the other Party with a copy of each proposed material correspondence pertaining to substantive Patent Prosecution on the merits with World Intellectual Property Office (“WIPO”) or the European Patent Office (“EPO”), as well as providing draft copies of patent applications to be submitted to the WIPO under the Patent Cooperation Treaty, or submitted to any patent office in the Territory in a form substantially different from that previously submitted to the WIPO, reasonably in advance of any applicable filing or response deadline to allow the other Party to review and comment on the content of such proposed correspondence and advise the prosecuting Party as to the conduct of such Patent Prosecution, which comments and advice the prosecuting Party will consider in good faith;

 

(iv)                  providing (itself or through patent counsel) the other Party with copies of all material correspondence pertaining to substantive Patent

 

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Prosecution on the merits with the WIPO or the EPO after its submission or receipt, as the case may be; and

 

(v)                     seeking patent term extensions, adjustments, and the like wherever available for the Product.

 

Section 9.3                                    Third Party Infringement.

 

(a)                                 Notice.  Each Party shall promptly report in writing to the other Party during the Term any known or suspected infringement of any Valid Claims within the Licensed Patents, Chiesi Patents or Joint Patents involving the use, manufacture or commercialization of a product or product candidate that is or would likely be a Competing Product (“Competitive Infringement”), and shall provide the other Party with all available evidence supporting such infringement or suspected infringement. Promptly after receipt of a notice of a Competitive Infringement in the Territory, the Parties shall discuss in good faith the infringement and appropriate actions that could be taken to cause such Competitive Infringement to cease.

 

(b)                                 Enforcement of Patents.  The Party with responsibility under Section 9.2 for Patent Prosecution of the Patent Right that is subject of the Competitive Infringement shall have the exclusive right to initiate a suit or take other appropriate action that it believes is reasonably required to prevent or abate actual or threatened infringement of, or otherwise enforce, in the best commercial interests of the Product, the applicable Patent Right. The Party filing any such suit or taking any such action shall control all decision making related to any such suit or action, subject to Section 9.3(c) below.

 

(c)                                  Conduct of Actions.  The Party initiating suit or action pursuant to Section 9.3(b) with respect to Competitive Infringement in the Territory shall have the sole and exclusive right to select counsel for such suit or action. At the initiating Party’s request and expense, the other Party shall join as a party to the suit or action. Such other Party shall offer reasonable assistance to the initiating Party in connection therewith. The initiating Party shall provide the other Party with an opportunity to make suggestions and comments regarding such suit or action. The initiating Party shall, to the extent permitted by Applicable Laws, keep the other Party promptly informed, and shall from time to time consult with such other Party, regarding the status of any such suit or action and shall provide such other Party with copies of all material documents (including complaints, answers, counterclaims, material motions, orders of the court, memoranda of law and legal briefs, interrogatory responses, depositions, material pre-trial filings, expert reports, affidavits filed in court, transcripts of hearings and trial testimony, trial exhibits and notices of appeal) filed in, or otherwise directly relating to, such suit or action. The Party not initiating such suit or action shall have the right to participate and be represented in any such suit by its own counsel at its own expense. Neither Party shall conduct any such suit or action in a manner that materially places at risk the scope or validity of any Joint Patent, and neither Party shall settle or compromise any claim or proceeding relating to any Joint Patent, without obtaining the prior written consent of the other Party. If Chiesi or any of its Affiliates conduct any such suit or action in a manner that materially places at risk the scope or validity of any Licensed Patent, uniQure may terminate this Agreement in accordance with the provisions of Section 12.4. If uniQure or any of its Affiliates conduct any such suit or action in a manner that materially places at risk the

 

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scope or validity of any Chiesi Patent, Chiesi may terminate this Agreement in accordance with the provisions of Section 12.4.

 

(d)                                 Recoveries.  With respect to any suit or action to protect any Joint Patent referred to in Section 9.3(b) above, any recovery obtained by a Party as a result of any such proceeding, by settlement or otherwise, shall be applied in the following order of priority:

 

(i)                         first, such Party shall pay to the applicable licensor any amount to which such licensor is entitled pursuant to the terms of any Existing Third Party License or Additional Rights Agreement; and

 

(ii)                      second, any remainder shall be allocated equally between the Parties.

 

Section 9.4                                    Claimed Infringement.  In the event that a Party becomes aware of any claim or threat of claim that the Development, use, Manufacture, have Manufactured or Commercialization hereunder of the Product infringes or misappropriates the intellectual property rights of any Third Party, such Party shall promptly notify the other Party. Each Party shall provide to the other Party copies of any notices such Party receives from Third Parties regarding any alleged infringement of Third Party Patent Rights or any alleged misappropriation of Third Party Know-How. Such notices shall be provided promptly, but in no event after more than [**] days following receipt thereof. In any such instance, the Parties shall cooperate in undertaking an appropriate course of action.

 

Section 9.5                                    Patent Invalidity Claim. If a Third Party at any time asserts a claim that any Licensed Patent (including a Joint Patent) or Chiesi Patent (including a Joint Patent) that covers the composition of matter of the Product or the method of use of the Product in the Field in the Territory is invalid or otherwise unenforceable (“Invalidity Claim”), either as a defense in an infringement action brought by Chiesi or uniQure pursuant to Section 9.3 or in an action brought against Chiesi or uniQure under Section 9.4, including any declaratory judgment action, the Parties shall cooperate with each other in (i) preparing and formulating a response to such Invalidity Claim and (ii) undertaking any further and appropriate course of action. Neither Party shall settle or compromise any Invalidity Claim without the consent of the other Party, which consent shall not be unreasonably withheld.

 

Section 9.6                                    Licensor Rights.  All obligations under Sections 9.2 through 9.5 are subject to the rights of the relevant licensor pursuant to the terms of any Existing Third Party License or Additional Rights Agreement.

 

ARTICLE X
  CONFIDENTIALITY

 

Section 10.1                             Confidential Information.  All Confidential Information disclosed by a Party or any of its Affiliates to the other Party or any of its Affiliates before or during the Term shall not be used by the receiving Party or any of its Affiliates except in connection with the activities contemplated by this Agreement, shall be maintained in confidence by the receiving Party and its Affiliates, and shall not otherwise be disclosed by the receiving Party or its Affiliates to any Third Party

 

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(except as set forth in the remainder of this Article X), without the prior written consent of the disclosing Party, except to the extent that the Confidential Information:

 

(a)                                 was known or used by the receiving Party or any of its Affiliates prior to its date of disclosure by the disclosing Party;

 

(b)                                 either before or after the date of the disclosure to the receiving Party hereunder or under the Confidentiality Agreement is lawfully disclosed to the receiving Party or any of its Affiliates by a Third Party rightfully in possession of and with the right to disclose such Confidential Information other than under an obligation of confidentiality;

 

(c)                                  either before or after the date of the disclosure to the receiving Party hereunder or under the Confidentiality Agreement becomes generally known to the public through no fault or omission on the part of the receiving Party or its Affiliates;

 

(d)                                 is independently developed by or for the receiving Party or any of its Affiliates without reference to or reliance upon any of the other Party’s Confidential Information; or

 

(e)                                  is required to be disclosed by the receiving Party or its Affiliates to comply with Applicable Laws, which may include the rules of Euronext, of the US Securities and Exchange Commission (“SEC”), or of any other stock exchange, or to defend or prosecute litigation or arbitration or to comply with legal process; provided that, the receiving Party provides prior written notice of such disclosure to the disclosing Party (to the extent feasible) and only discloses Confidential Information of the other Party to the extent necessary for such legal compliance or litigation purpose; and provided, further, that such information shall otherwise remain Confidential Information (subject to the exceptions in this Section 10.1).

 

Notwithstanding the foregoing, clauses (a), (b) and (d) shall not alter the requirement to keep the terms and conditions of this Agreement confidential, as set forth herein, subject to the remainder of this Article X.

 

Section 10.2                             Employee, Director, Consultant and Advisor Obligations.  Chiesi and uniQure each agrees that it and its Affiliates shall provide Confidential Information received from the other Party only to the receiving Party’s employees, directors, consultants, agents and advisors, and to the employees, directors, consultants, agents and advisors of the receiving Party’s Affiliates, who have a need to know such Confidential Information to assist the receiving Party in fulfilling its obligations under this Agreement and who are bound by obligations of confidentiality and non-use that are at least as restrictive as those set forth in this Agreement. Each Party shall remain responsible for any failure by any of its or its Affiliates’ employees, directors, consultants, agents and advisors to treat such Confidential Information as required under this Article X.

 

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Section 10.3                             Publicity.

 

(a)                                 Following execution of this Agreement, the Parties shall jointly or separately issue a press release, in a text to be agreed upon between the Parties in advance, announcing the execution of this Agreement and the Commercialization Agreement.

 

(b)                                 Thereafter, each Party shall only issue press releases (other than the press release pursuant to paragraph (a) above) or make other public disclosures regarding this Agreement or the Parties’ activities under this Agreement (each such press release or public disclosure, a “Subject Disclosure”):

 

(i)                                     that have been approved in writing in advance by the other Party (such approval not to be unreasonably withheld, conditioned or delayed);

 

(ii)                                  if advised by counsel to issue such Subject Disclosure in order to comply with Applicable Laws, which may include the disclosure rules of SEC or a similar regulatory agency in a country in the Territory or of Euronext or any other stock exchange of other securities trading institution (for clarity such issuance is also subject to Section 10.3(c));

 

(iii)                               subject to Section 10.3(c), if the contents of such Subject Disclosure have previously been made public other than through a breach of this Article X by a Party; or

 

(iv)                              subject to sub-paragraph (i) above, to the extent that such Subject Disclosure describes one or more of the following:

 

(A)                   preclinical results with respect to the Product;

 

(B)                   the commencement, completion or “top-line” results of clinical studies of the Product;

 

(C)                   the completion of patient enrollments for clinical studies of the Product;

 

(D)                   the filing for or receipt of Marketing Authorization with respect to the Product;

 

(E)                    the Patent Prosecution or enforcement of any of the Licensed Patents, including the issuance of any patent included in the Licensed Patents;

 

(F)                     the receipt of any regulatory exclusivity for the Product; or

 

(G)                   the first Party’s presence or participation at scientific, financial or investor forums.

 

(c)                                  Unless not feasible under the circumstances because of the need to comply with Applicable Laws or stock exchange rules, the Party making a Subject Disclosure shall provide the other Party with a draft Subject Disclosure at

 

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least [**] Business Days prior to its intended publication for the other Party’s review. Such other Party may provide the first Party with suggested modifications to the draft Subject Disclosure. The first Party shall consider in good faith the other Party’s suggestions in issuing such Subject Disclosure.

 

(d)                                 For clarity, nothing in this Agreement shall restrict each Party from issuing press releases or making other public disclosures regarding such Party’s development, manufacturing or commercialization activities with respect to any product other than the Product, or, with reference to uniQure only, with respect to any Product outside the Territory.

 

Section 10.4                             Other Disclosures.  Notwithstanding anything in this Agreement to the contrary, each Party shall have the right to disclose the other Party’s Confidential Information (including the terms of this Agreement) (as applicable):

 

(a)                                 to such Party’s then-current or potential investors, lenders, acquirers, investment bankers, and other Third Parties in connection with financing, partnering (to the extent consistent with this Agreement) and acquisition activities, solely on a need-to-know basis and under obligations of confidentiality and non-use that are at least as restrictive as those set forth in this Article X;

 

(b)                                 as required by the Existing Third Party Licenses or any Additional Rights Agreement;

 

(c)                                  to conduct Patent Prosecution or enforcement of Patent Rights for which such Party is responsible hereunder;

 

(d)                                 to such Party’s then-current or potential collaborators, and Third Party contractors (including contract manufacturers and Sub-distributors) for purposes of engaging in the Development, use, Manufacture or Commercialization of the Product as contemplated hereunder, solely on a need-to-know basis and under obligations of confidentiality and non-use that are at least as restrictive as those set forth in this Article X.

 

Section 10.5                             Publications.

 

(a)                                 Notwithstanding Section 10.3 and Section 10.4, a Party (the “Publishing Party”) which is, or whose Affiliates is, seeking to publish or publicly present scientific or technical data, results or other information with respect to the Product shall provide the other Party and the JDC with a copy of any proposed publication or presentation at least [**] days (or at least [**] days in the case of abstracts or oral public presentations) prior to submission for publication or presentation so as to provide such other Party with an opportunity to recommend any changes it reasonably believes are necessary to continue to maintain such other Party’s Confidential Information in accordance with the requirements of this Agreement or to not jeopardize the patentability of any results or data.

 

(b)                                 If the non-Publishing Party notifies the Publishing Party that such publication or presentation, in the non-Publishing Party’s reasonable judgment, (i) discloses an invention for which the non-Publishing Party desires to seek patent protection, or (ii) contains any Confidential Information of the non-Publishing Party,

 

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or could be expected to have an adverse effect on the commercial value of any Confidential Information disclosed by the non-Publishing Party to the Publishing Party, the Publishing Party shall delete such Confidential Information from the proposed publication or presentation and shall further delay such publication or presentation for a period reasonably sufficient to permit the timely preparation and filing of a patent application(s) on any invention disclosed in such publication or presentation (but no more than [**] days from the date of the non-Publishing Party’s notice thereof).

 

Section 10.6                             Use of Names.

 

(a)                                 Chiesi, its Affiliates and Third Party contractors shall not use the name “St. Jude Children’s Research Hospital” or any variation of that name, or any trademarks or logos belonging to St. Jude, or the names of any of St. Jude’s trustees, officers, faculty, student, employees, or agents, or any adaptation of such names, or any term of the St. Jude Agreement in any promotional material or other public announcement or disclosure or in connection with the Commercialization of the Product, without the prior written approval of St. Jude; except (i) in annual reports or as part of required regulatory or financial disclosures to the FDA, SEC or other US federal or foreign agencies; and (ii) where otherwise required by Applicable Laws, provided that, Chiesi shall notify St. Jude in advance of any disclosure to be made under these exceptions.

 

(b)                                 Chiesi, its Affiliates and Third Party contractors shall not state or imply that the PHS Agreements are an endorsement by the US government, PHS, any other US government organizational unit, or any US government employee. Additionally, Chiesi and its Affiliates shall not use the names of NIH, FDA, PHS, or HHS or the US government or their employees in any advertising, promotional, or sales literature without the prior written approval of PHS.

 

Section 10.7                             Term.  All obligations of confidentiality imposed under this Article X shall expire [**] years following termination or expiration of this Agreement, except to the extent any Existing Third Party License or Additional Rights Agreement extends such obligations; provided, however, that the receiving Party shall maintain the confidentiality of any of the other Party’s trade secrets indefinitely until such trade secret is no longer a trade secret.

 

ARTICLE XI
  REPRESENTATIONS, WARRANTIES AND COVENANTS

 

Section 11.1                             Representations and Warranties of Both Parties.  Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:

 

(a)                                 such Party is duly organized, validly existing and in good standing under the Applicable Laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;

 

(b)                                 such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;

 

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(c)                                  this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof; and

 

(d)                                 the execution, delivery and performance of this Agreement by such Party does not conflict with any agreement, instrument or binding understanding, oral or written, to which it is a party or by which it is bound, nor violate any Applicable Law of any court, governmental body or administrative or other agency having jurisdiction over such Party.

 

Section 11.2                             Representations and Warranties of uniQure.  uniQure hereby represents and warrants to Chiesi, as of the Effective Date that:

 

(a)                                 Exhibit E attached hereto is a complete and correct list of all Licensed Patents that claim the composition of matter, or method of use or manufacture, of the Product and are Controlled by uniQure and for which uniQure controls Patent Prosecution as of the Effective Date;

 

(b)                                 uniQure Controls the Licensed Technology and has the full right, power and authority to grant all rights and licenses to Chiesi with respect to the Licensed Technology under this Agreement;

 

(c)                                  To uniQure’s knowledge, it has not (i) employed or used any contractor or consultant that employs any individual or entity debarred by the FDA (or subject to a similar sanction of EMA), or (ii) employed any individual or entity that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMA), in each of clauses (i) and (ii), in the conduct of development activities directed to the Product;

 

(d)                                 To uniQure’s knowledge, the Development and Commercialization of the Product in the Territory, as anticipated hereunder, does not infringe upon any intellectual property rights of any Third Party

 

(e)                                  uniQure has not received any written allegation from a Third Party that any of the issued Licensed Patents is invalid or unenforceable and, except as disclosed in Exhibit H, to uniQure’s knowledge, none of such Licensed Patents is infringed by any Third Party;

 

(f)                                   uniQure has not received, with respect to the Product as Developed by uniQure, any written notice from a Third Party claiming infringement or misappropriation of any Patent Right or any Know-How owned by such Third Party; and

 

(g)                                  uniQure has provided Chiesi with a complete and correct copy of each of the Existing Third Party Licenses.

 

Section 11.3                             Representation and Warranty of Chiesi.  Chiesi hereby represents and warrants to uniQure, as of the Effective Date, that Chiesi Controls the Chiesi Technology and has the full right, power and authority to grant all rights and licenses to uniQure under this Agreement.

 

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Section 11.4                             Mutual Covenants.  Each Party hereby covenants to the other Party that:

 

(a)                                 All employees of such Party or its Affiliates working under this Agreement are and will be under the obligation to assign all right, title and interest in and to their inventions and discoveries arising in the performance of such work, whether or not patentable, to (i) such Party as the sole owner thereof or (ii) to one of such Party’s Affiliates as the sole owner thereof so that such Party Controls such inventions and discoveries;

 

(b)                                 To its knowledge, such Party will not, in the conduct of its activities under this Agreement, (i) employ or use any contractor or consultant that employs any individual or entity debarred by the FDA (or subject to a similar sanction of EMA), or (ii) employ any individual who or entity that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMA), in each of clauses (i) and (ii) in the conduct of its activities under this Agreement;

 

(c)                                  Such Party shall perform its activities pursuant to this Agreement in compliance in all material respects with Applicable Laws; and

 

(d)                                 Neither Party shall, during the Term, grant any right or license to any Third Party relating to any of the intellectual property rights it Controls which would conflict with, or limit the scope of, any of the rights or licenses granted or to be granted to the other Party hereunder.

 

Section 11.5                             DISCLAIMER.  EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY THAT ANY PATENT RIGHTS ARE VALID OR ENFORCEABLE, AND EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, EACH PARTY DISCLAIMS ANY WARRANTIES WITH REGARDS TO: (A) THE SUCCESS OF ANY STUDY OR CLINICAL TRIAL COMMENCED UNDER THIS AGREEMENT; (B) THE SAFETY, USEFULNESS FOR ANY PURPOSE OR NON-INFRINGEMENT OF ANY PRODUCT; OR (C) THE VALIDITY, ENFORCEABILITY OR NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OR TECHNOLOGY IT PROVIDES OR LICENSES TO THE OTHER PARTY UNDER THIS AGREEMENT.

 

ARTICLE XII
  TERM AND TERMINATION

 

Section 12.1                             Term.

 

(a)                                 General.  This Agreement shall become effective as of the Effective Date and shall remain in force, on a country-by-country basis, for the longer of (i) twelve (12) years from the First Commercial Sale of the Product in the relevant country of the Territory; (ii) expiry of any regulatory exclusivity granted by any Marketing Authorization or any other Regulatory Approval in the relevant country of

 

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the Territory; or (iii) expiry of the last Valid Claim Covering the Product in the relevant country of the Territory. Unless terminated by a Party with three (3) months written notice to the other Party to the end of the above initial or any subsequent term, this Agreement shall automatically be renewed for successive five (5) year terms (the initial and each subsequent term, the “Term”).

 

(b)                                 Condition Precedent.  This Agreement, and any ancillary agreement concluded between the Parties in connection herewith, including the SDEA, and the Commercialization Agreement and the agreement regarding the equity investment of Chiesi in uniQure concluded on the date hereof, shall become effective once the Parties have received consent from PHS as the Third Party licensor to the subcontracting of the rights and licenses licensed by uniQure as licensee under the PHS Agreements to Chiesi. uniQure shall use Commercially Reasonable Efforts to obtain such consent on or prior to [**]. If, despite uniQure’s Commercially Reasonable Efforts, such consent has not been obtained from PHS by the end of [**], this Agreement and all other agreements that are subject to the condition precedent pursuant to sentence 1 shall be deemed null and void as of the Effective Date, unless, prior to the end of such period, following a corresponding request of either Party, the Parties mutually agree in writing on an extension of such period. The Parties agree that (i) costs and expenses incurred in connection with the preparation and execution of this Agreement as well as obtaining of the aforementioned consent shall not be reimbursed, provided, however, that uniQure shall pay back to Chiesi any payments received in connection with this Agreement on or prior to [**] (or such extended period mutually agreed between the Parties in accordance with the foregoing), and (ii) Sections 10.1, 10.2 and 10.7 shall apply mutatis mutandis.

 

Section 12.2                             Termination for Convenience.  Chiesi may terminate this Agreement for convenience upon six (6) months’ prior written notice to uniQure at any time during the Term, following the first six (6) months of the Agreement.

 

Section 12.3                             Termination for Material Breach.  Upon any material breach of this Agreement by either Party (in such capacity, the “Breaching Party”), the other Party (in such capacity, the “Non-Breaching Party”) may terminate this Agreement by providing [**] days’ prior written notice to the Breaching Party, specifying the material breach. The termination shall become effective at the end of the [**] day period unless the Breaching Party cures such breach during such [**] day period.

 

In the event that either Party is the Breaching Party or that either Party, its Affiliates or Third Party contractors breach any of the requirements under any Existing Third Party Licenses or Additional Rights Agreements, such Party’s cure period described in the preceding paragraph shall be eliminated or reduced to the extent necessary to prevent the breach from giving a licensor a right to terminate an Existing Third Party License or any Additional Rights Agreement or from causing the other Party to be in breach of its obligations under any Existing Third Party License or any Additional Rights Agreement.

 

Section 12.4                             Termination for Patent Challenge.  If either Party or any of its Affiliates or Third Party contractors challenges the validity, enforceability, patentability or scope of any claim included in any Patent, (any of the foregoing, a “Patent Challenge”), the other Party shall have the right to terminate this Agreement immediately upon written notice to such Party.

 

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Section 12.5                             Effects of Termination by Chiesi for Convenience or by uniQure for Chiesi Uncured Breach or Patent Challenge.  Upon termination of this Agreement by Chiesi in its entirety pursuant to Section 12.2 (Termination for Convenience) or by uniQure pursuant to Section 12.3 (Termination for Material Breach) or pursuant to Section 12.4 (Termination for Patent Challenge):

 

(a)                                 All rights and licenses granted by uniQure to Chiesi shall terminate and revert to uniQure, and all rights and licenses granted by Chiesi to uniQure shall survive and become fully paid-up, irrevocable and perpetual;

 

(b)                                 Chiesi shall promptly provide to uniQure a fair and accurate description of the status of its Development Program activities through the effective date of termination;

 

(c)                                  Chiesi shall promptly assign to uniQure the entire right, title, and interest in and to, and transfer to uniQure all copies of, any Product Data in Chiesi’s or its Affiliates’ or Third Party contractors’ possession or control;

 

(d)                                 At uniQure’s option and upon uniQure’s request as to any or all of the following (in whole or in part), Chiesi (or its relevant Affiliate) shall promptly:

 

(i)                         assign or cause the assignment to uniQure of any and all applicable Third Party agreements for the Product, including agreements with contract research organizations and other agreements relating to the Development of the Product, in each case to the extent assignable; provided, however, that, to the extent such agreements are not specific to the Product, or are not assignable, Chiesi shall, at uniQure’s request, hold such agreements for the benefit of uniQure and Chiesi and its Affiliates shall take such actions as uniQure may reasonably request so as to provide uniQure with the benefits thereunder with respect to the Product;

 

(ii)                      Chiesi and its Affiliates shall waive any obligations of confidentiality, non-competition and exclusivity imposed on its Third Party service providers, in order to permit uniQure to negotiate agreements with such service providers to develop, import, export and use the Product; and

 

(iii)                   at uniQure’s request, on a clinical trial-by-clinical trial basis with respect to any on-going clinical trial with the Product being conducted by or under authority of Chiesi or its Affiliates as of the date of the termination notice, either:

 

(A)                   terminate any such clinical trial as of the date of the termination notice in a manner conforming to Applicable Laws and provide all related data to uniQure promptly following termination of such clinical trial,

 

(B)                   continue to conduct such clinical trial to completion, keeping uniQure fully informed of the status of such clinical trial, and provide all related data to uniQure promptly following its completion, or

 

(C)                   promptly transfer such clinical trial to uniQure or its designee and continue to conduct such clinical trial up to completion of such

 

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transfer, keeping uniQure fully informed of the status of such clinical trial, and provide all related data to uniQure promptly following completion of such transfer;

 

(e)                                  In accordance with uniQure’s request, Chiesi shall promptly return to uniQure, or promptly destroy and certify to uniQure in writing that it has destroyed, all materials and records in its possession or Control containing Confidential Information of uniQure, except for a single copy of such Confidential Information that may be retained confidentially for legal purposes only;

 

(f)                                   With respect to Chiesi Patents, (i) the provisions of Section 9.2(b), Section 9.3(b) and Section 9.5 shall apply to the Chiesi Patents with the respective roles of the Parties reversed, and (ii) if uniQure initiates suit pursuant to Section 9.3(b), uniQure may retain any damages, settlements, accounts of profits, or other financial compensation recovered from a Third Party based upon such suit;

 

(g)                                  uniQure shall have the sole right to conduct Patent Prosecution with respect to the Joint Patents, notwithstanding Section 9.2(c), and to enforce the Joint Patents, notwithstanding Section 9.3;

 

(h)                                 Neither Chiesi nor any of its Affiliates shall use or grant rights to any Affiliate or Third Party for Joint Know-How in relation to any Competing Product during the [**] following termination;

 

(i)                                     The restrictions on Chiesi and its Affiliates set forth in Section 6.1 shall survive for [**] following termination; and

 

(j)                                    Chiesi shall execute all documents and take all such further actions as may be reasonably requested by uniQure in order to give effect to the foregoing clauses (a) through (i).

 

Section 12.6                             Effects of Termination by Chiesi for uniQure Uncured Breach or Patent Challenge.  Upon termination of this Agreement by Chiesi pursuant to Section 12.3 (Termination for Material Breach) or pursuant to Section 12.4 (Termination for Patent Challenge), the consequences set forth in Section 12.5 shall apply, mutatis mutandis; provided that, the Parties shall negotiate in good faith appropriate consideration payable by uniQure to Chiesi in connection therewith reflecting the stage to which the Parties have Developed the Product prior to such termination.

 

Section 12.7                             Upon expiration of the Term with respect to this Agreement pursuant to Section 12.1:

 

(a)                                 all rights, privileges and licenses granted hereunder to Chiesi shall become fully paid-up, irrevocable and perpetual;

 

(b)                                 all rights, privileges and licenses granted hereunder to uniQure shall become fully paid-up, irrevocable and perpetual;

 

(c)                                  at any time upon written request of the disclosing Party, unless expressly set forth otherwise in this Agreement, the receiving Party shall cease use of and return or at the disclosing Party’s request destroy all Confidential Information of

 

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the disclosing Party and all copies thereof except for a single copy of such Confidential Information that may be retained confidentially for legal purposes only.

 

Section 12.8                             Survival.

 

(a)                                 Upon expiration or termination of this Agreement for any reason, all rights and obligations of each Party shall terminate hereunder, except as expressly set forth in Section 12.5, Section 12.6, Section 12.7 or this Section 12.8; provided, however, that nothing in this Agreement shall be construed to release either Party from any obligations or liabilities that matured prior to the effective date of expiration or termination, or which are attributable to a period prior to such expiration or termination.

 

(b)                                 Notwithstanding anything in this Agreement to the contrary, the following provisions shall expressly survive any expiration or termination of this Agreement in accordance with their terms: Article I, Section 6.2, Section 7.3, Article VIII (in each case, to the extent any amounts are due but unpaid as of the effective date of expiration or termination or thereafter pursuant to Section 12.5); Section 9.1; Article X; Section 11.5; Section 12.5; Section 12.6; Section 12.7; Section 12.8; Article XIII; Article XIV; and Article XV.

 

(c)                                  Termination of this Agreement shall be in addition to, and shall not prejudice, the Parties’ remedies at law or in equity, including the Parties’ ability to receive legal damages or equitable relief with respect to any breach of this Agreement, regardless of whether or not such breach was the reason for the termination.

 

ARTICLE XIII
  DISPUTE RESOLUTION

 

Section 13.1                             Resolution of Certain Disputes Other Than by Arbitration.

 

(a)                                 Either Party’s exercise of its right to terminate this Agreement for the other Party’s material breach in accordance with Section 12.3, to the extent necessary to prevent such breach (whether by the other Party or its Affiliate) or from giving a licensor a right to terminate an Existing Third Party License or an Additional Rights Agreement or from causing the first Party to be in breach of its obligations under any Existing Third Party License or any Additional Rights Agreement, (a “Non-Arbitrable Termination Dispute”) shall not be subject to the dispute resolution procedures of Article II or Section 13.2 prior to termination. The other Party shall not be entitled to injunctive relief to prevent or delay such termination, and shall only be entitled to monetary damages in the event that it thereafter disputes such termination pursuant to Section 13.2(b)(i) and the arbitrators determine that the first Party has not properly exercised its termination right hereunder.

 

(b)                                 Any dispute that could be resolved by the JSC under Section 2.1(e), if unresolved by the JSC, shall be finally resolved as set forth in Section 13.2.

 

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Section 13.2                             Resolution of Other Disputes by Executive Officers and Arbitration.

 

(a)                                 With the exception of Non-Arbitrable Termination Disputes, in the event any dispute arises out of or in relation to or in connection with any of the Collaboration Agreements, including any issue relating to the interpretation or application of the Collaboration Agreements, the Parties shall use good faith efforts to resolve such dispute within [**] days, through the JSC if the dispute is within the responsibilities of the JSC, or, if the dispute is not within the responsibilities of the JSC, through informal negotiations between the respective representatives of the Parties.  If the JSC or the applicable representatives are unable to resolve such dispute within such [**] day period, the Parties shall refer such dispute to the Executive Officers for resolution. If a dispute is referred to the Executive Officers for resolution pursuant to the preceding sentence (or pursuant to Section 2.1(f)), the Executive Officers shall attempt in good faith to resolve such dispute within [**] days.

 

(b)                                 If the Executive Officers are unable to resolve a given dispute referred to such Executive Officers pursuant to Section 13.2(a) (or pursuant to Section 2.1(f) (other than Non-Arbitrable Termination Disputes) within [**] days following such referral of such dispute to such Executive Officers, either Party may have the dispute settled by binding arbitration in the manner described below:

 

(i)                         Arbitration Request.  If a Party intends to begin an arbitration to resolve a dispute arising under a Collaboration Agreement, such Party shall provide written notice (the “Arbitration Request”) to the other Party of such intention and the issues for resolution.

 

(ii)                      Additional Issues.  Within [**] days after the receipt of the Arbitration Request, the other Party may, by written notice, add additional issues for resolution.

 

(iii)                   Arbitration Location; Rules.  Except as expressly provided herein, the sole mechanism for resolution of any claim, dispute or controversy arising out of or in connection with or relating to any Collaboration Agreement or the breach or alleged breach thereof shall be binding arbitration by ICC in London, England, pursuant to ICC’s Arbitration Rules and Procedures, except as provided herein.

 

(iv)                  English Language.  All proceedings shall be held in English and a transcribed record prepared in English. Documents submitted in the arbitration, the originals of which are not in English, shall be submitted together with a reasonably complete and accurate English translation.

 

(v)                     Selection of Arbitrators.  The Parties shall each select one arbitrator within [**] days after receipt of the Arbitration Request and the two (2) arbitrators so selected shall select by mutual agreement a third arbitrator within [**] days after they have been selected as arbitrators. If all three (3) arbitrators have not been selected within [**] days after receipt of the Arbitration Request or any extension of time that is mutually agreed on, ICC shall select such additional arbitrator(s) needed to complete the three (3) arbitrator panel within [**] days thereafter. If the issues in dispute involve scientific or technical matters, any arbitrators chosen hereunder shall have educational training or experience sufficient to demonstrate a reasonable level of knowledge in the pharmaceutical and biotechnology fields.

 

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(vi)                  Time Schedule.  Within [**] days after initiation of arbitration, the Parties shall reach agreement upon and thereafter follow procedures directed at assuring that the arbitration will be concluded and the award rendered within no more than [**] months after selection of the three (3) arbitrators. Failing such agreement, ICC will design, and the Parties will follow procedures, directed at meeting such a time schedule.

 

(vii)               Powers of Arbitrators.  The arbitrators:

 

(A)                   shall not have any power or authority to add to, alter, amend or modify the terms of any Collaboration Agreement;

 

(B)                   shall establish and enforce appropriate rules to allow reasonable discovery by the Parties and to ensure that the proceedings, including the decision, be kept confidential and that all Confidential Information of the Parties be kept confidential and be used for no purpose other than the arbitration (unless disclosure or use is otherwise expressly permitted by the applicable Collaboration Agreement);

 

(C)                   shall have the power to enforce specifically the applicable Collaboration Agreement and the terms and conditions thereof in addition to any other remedies at law or in equity; and

 

(D)                   shall issue all awards in writing.

 

(viii)            Costs; Exclusion from Award.  Awards rendered by the arbitrators shall not include costs of arbitration, attorneys’ fees or costs for expert and other witnesses, with respect to which each Party shall bear its own costs and expenses, except that the Parties shall share equally the fees of the arbitrators.

 

(ix)                  Injunctive Relief.  Nothing in this Agreement (except Section 13.1(a)) shall be deemed as preventing either Party from seeking injunctive relief (or any other provisional remedy such as temporary restraining order, preliminary injunction or other interim equitable relief) from the arbitrators or from any court having jurisdiction over the Parties (and prior to or during any arbitration if necessary to protect the interests of such Party in avoiding irreparable harm or to preserve the status quo pending the arbitration proceeding) and the subject matter of the dispute as necessary to protect either Party’s name, Confidential Information, trade secrets, Know-How or any other proprietary right or otherwise to avoid irreparable harm. In particular, the Parties agree that any breach by a Party of its obligations under Section 6.1, Section 7.5(a) or Article X, or any claim by either Party contrary to Section 13.1(a), will cause irreparable harm to the other Party for which an award of monetary damages would be an inadequate remedy and, accordingly, that the other Party shall be entitled to injunctive relief enjoining such breach without the requirement to post a bond.

 

(x)                     Judgment.  Judgment on any award rendered by the arbitrators may be entered in any court of competent jurisdiction.

 

47

 

ARTICLE XIV
  INDEMNIFICATION; INSURANCE

 

Section 14.1                             Indemnification by Chiesi.  Chiesi shall indemnify, defend and hold harmless uniQure and its Affiliates, and its and their respective directors, officers, employees and agents, from and against any and all liabilities, damages, losses, costs and expenses, including the reasonable fees of attorneys and other professional Third Parties (collectively, “Losses”), arising out of or resulting from any and all Third Party suits, claims, actions, proceedings or demands (“Claims”) to the extent based upon:

 

(a)                                 any breach of any representation, warranty or covenant made by, or any material obligation of, Chiesi under this Agreement;

 

(b)                                 Development Program activities conducted by or on behalf (other than by uniQure or any of its Affiliates, or a Third Party performing activities on their behalf) of Chiesi or its Affiliates; or

 

(c)                                  the gross negligence, recklessness or willful misconduct of Chiesi or its Affiliates and its or their respective directors, officers, employees and agents;

 

provided that Chiesi shall not be obligated pursuant to this Section 14.1 to the extent uniQure is required to indemnify Chiesi under Section 14.2 below.

 

Section 14.2                             Indemnification by uniQure.  uniQure shall indemnify, defend and hold harmless Chiesi and its Affiliates, and its and their respective directors, officers, employees and agents, from and against any and all Losses, arising out of or resulting from any and all Claims to the extent based upon:

 

(a)                                 any breach of any representation, warranty or covenant made by, or any material obligation of, uniQure under this Agreement;

 

(b)                                 Development Program activities conducted by or on behalf (other than by Chiesi or any of its Affiliates, or a Third Party performing activities on their behalf) of uniQure or its Affiliates;

 

(c)                                  the gross negligence, recklessness or willful misconduct of uniQure or its Affiliates and its or their respective directors, officers, employees and agents; or

 

(d)                                 Claims that the exercise of any rights or licenses granted to Chiesi and its Affiliates in accordance with this Agreement violates or infringes upon the Intellectual Property Rights of any Third Party;

 

provided that uniQure shall not be obligated pursuant to this Section 14.2 to the extent Chiesi is required to indemnify uniQure under Section 14.1above.

 

Section 14.3                             Procedure.

 

(a)                                 A Party entitled to indemnification under this Article XIV (an “Indemnified Party”) shall give prompt written notification to the Party from whom

 

48

 

indemnification is sought (the “Indemnifying Party”) of the commencement of any Claim for which indemnification may be sought or, if earlier, upon the assertion of any such Claim by a Third Party (it being understood and agreed, however, that the failure by an Indemnified Party to give notice of a Claim as provided in this Section 14.3(a) shall not relieve the Indemnifying Party of its indemnification obligation under this Agreement except and only to the extent that such Indemnifying Party is actually damaged as a result of such failure to give notice).

 

(b)                                 Within [**] days after delivery of such notification, the Indemnifying Party may, upon written notice thereof to the Indemnified Party, assume control of the defense of such Claim with counsel reasonably satisfactory to the Indemnified Party.

 

(c)                                  If the Indemnifying Party does not assume control of such defense, the Indemnified Party shall control such defense and, without limiting the Indemnifying Party’s indemnification obligations, the Indemnifying Party shall reimburse the Indemnified Party for all reasonable costs and expenses, including reasonable attorney’s fees, incurred by the Indemnified Party in defending itself, within [**] days after receipt of any invoice therefor from the Indemnified Party, such invoice to be issued no more often than quarterly.

 

(d)                                 The Party not controlling such defense may participate therein at its own expense; provided that, if the Indemnifying Party assumes control of such defense and the Indemnified Party in good faith concludes, based on advice from counsel, that the Indemnifying Party and the Indemnified Party have conflicting interests with respect to such Claim, the Indemnifying Party shall be responsible for the reasonable fees and expenses of counsel to the Indemnified Party in connection with its participation in the defense action.

 

(e)                                  The Party controlling such defense shall keep the other Party advised of the status of such Claim and the defense thereof and shall consider recommendations made by the other Party with respect thereto.

 

(f)                                   The Indemnified Party shall not agree to any settlement of any Claim without the prior written consent of the Indemnifying Party, which shall not be unreasonably withheld, delayed or conditioned. The Indemnifying Party shall not, without the prior written consent of the Indemnified Party, agree to any settlement of such Claim, or consent to any judgment in respect thereof, that does not include a complete and unconditional release of the Indemnified Party from all liability with respect thereto, that imposes any liability or obligation on the Indemnified Party or that acknowledges fault by the Indemnified Party.

 

Section 14.4                             Insurance.  Each Party shall procure and maintain insurance, including product liability insurance, adequate to cover its obligations hereunder and which are consistent with normal business practices of comparable companies with respect to similar obligations and liabilities, at all times during the Term. uniQure shall further procure and maintain, at uniQure’s cost, insurance adequate to cover its obligations under the St. Jude Agreements and Chiesi shall reasonably cooperate with uniQure in obtaining such insurance. It is understood that such insurance shall not be construed to create any limit of either Party’s obligations or liabilities with respect to

 

49

 

its indemnification obligations hereunder. Each Party shall provide the other, upon request, with evidence of such insurance.

 

Section 14.5                             Limitation of Liability.  EXCEPT WITH RESPECT TO ANY BREACH BY A PARTY OF ITS OBLIGATIONS UNDER ARTICLE X, EXCEPT FOR ANY DAMAGES ARISING FROM A PARTY’S WILLFUL MISCONDUCT AND EXCEPT TO THE EXTENT A PARTY MAY BE REQUIRED TO INDEMNIFY THE OTHER PARTY UNDER THIS ARTICLE XIV WITH RESPECT TO THIRD PARTY CLAIMS, NEITHER PARTY SHALL BE LIABLE FOR ANY (AND EACH PARTY HEREBY DISCLAIMS ALL) SPECIAL, EXEMPLARY, CONSEQUENTIAL, PUNITIVE OR OTHER INDIRECT DAMAGES, INCLUDING LOST REVENUE AND LOST PROFITS, WHETHER BASED UPON WARRANTY, CONTRACT, TORT, STRICT LIABILITY OR OTHER LEGAL THEORY.

 

ARTICLE XV
  MISCELLANEOUS

 

Section 15.1                             Change of Control.  Each Party agrees that, notwithstanding any provisions of this Agreement to the contrary, following the closing of a Change of Control of a Party (the “Acquired Party”), the other Party (the “Non-Acquired Party”) shall not obtain rights or access to the Patent Rights or Know-How of the Acquirer (as defined below) or of the Affiliates of such Acquirer (other than the Acquired Party and its Affiliates which exist immediately prior to the closing of such Change of Control (such Affiliates, the “Pre-Existing Affiliates”)); and the Acquirer and its Affiliates (other than the Acquired Party and its Pre-Existing Affiliates) shall not obtain rights or access to the Patent Rights or Know-How of the Non-Acquired Party or be bound by the restrictions set forth in Section 6.1; provided, however, that the Non-Acquired Party’s rights in all Patent Rights and Know-How of the Acquired Party and its Pre-Existing Affiliates, which Patent Rights and Know-How exist as of the date of the closing of such Change of Control and are then licensed hereunder to the Non-Acquired Party, shall remain licensed to such Non-Acquired Party after the date of the closing of such Change of Control in accordance with and subject to the terms and conditions of this Agreement and shall not be affected in any manner by virtue of such Change of Control. “Acquirer” means, with respect to the Acquired Party, the Third Party that acquires the Control of such Acquired Party.

 

Section 15.2                             Governing Law.  The validity and interpretation of this Agreement shall be governed by the laws of England without regard to its conflicts of laws principles and to the express exclusion of the United Nations Conventions on Contracts for the International Sale of Goods (CISG).

 

Section 15.3                             Assignment.  Except as expressly provided herein, neither this Agreement nor any rights and obligations hereunder shall be assignable by a Party without the prior written consent of the other Party; provided, however, that a Party may assign this Agreement to any Affiliate or to any successor in interest by way of merger, acquisition or sale of all or substantially all of its assets to which this Agreement relates, provided that such successor agrees in writing to be bound by the terms of this Agreement as if it were the assigning Party. This Agreement shall be binding upon the successors and permitted assigns of the Parties. Any assignment not in accordance with this Section 15.3 shall be void.

 

50

 

Section 15.4                             Entire Agreement; Amendments.  This Agreement and the attachments hereto contain the entire understanding and agreement of the Parties with respect to the subject matter hereof and cancel and supersede any and all prior negotiations, correspondence, understandings and agreements between the Parties, whether oral or written, regarding such subject matter, including the Memorandum of Understanding dated 21 December 2012 and the Confidentiality Agreement, but expressly excluding the Commercialization Agreement. Except for the rights expressly conferred on the JSC, JDC or JCC, this Agreement cannot be modified except by a written document bearing the signatures of both Parties. The same applies to any waiver of this written form requirement.

 

Section 15.5                             Notices.  Other than as expressly specified in this Agreement, all notices and consents required to be provided hereunder shall be in writing and provided by hand, by recorded delivery mail (return receipt requested), by facsimile, or by recognized overnight courier service to the other Party at its address or facsimile number shown below or such other address or facsimile number notified by such other Party from time to time.

 

If to uniQure, addressed to:

 

uniQure Biopharma B.V.

P.O. Box 22506

1100 DA Amsterdam

The Netherlands

Attention: CEO

Fax: +31 20 566 9272

 

If to Chiesi, addressed to:

 

Chiesi Farmaceutici S.p.A.

Via Palermo, 26/A

43122 Parma

Italy

Attention: CEO

Copy to: Corporate Development, Head and General Counsel

Fax: +39 0521 774468

 

Section 15.6                             Exports.  The Parties acknowledge that the export of technical data, materials or products is subject to the exporting Party receiving any necessary export licenses and that the Parties cannot be responsible for any delays attributable to export controls that are beyond the reasonable control of either Party. Chiesi and uniQure agree not to export or re-export, directly or indirectly, any Product (or any associated products, information, items, articles, computer software, media, technical data, the direct product of such data, samples or equipment received or generated under this Agreement) in violation of any Applicable Laws that may be applicable. Chiesi and uniQure agree to obtain similar covenants from their Affiliates and Third Party contractors with respect to the subject matter of this Section 15.6, to the extent applicable.

 

51

 

Section 15.7                             Force Majeure.  Neither Party shall lose any rights hereunder or be liable to the other Party for damages or losses on account of failure of performance by the defaulting Party if the failure is occasioned by war, civil insurrection, strike, fire, Act of God, earthquake, tempest, flood, epidemic, blackout, lockout, embargo, governmental acts or orders or restrictions, delays in delivery and non-supply by exclusive suppliers, where such delay or non-supply occurs as a result of such force majeure, or any other reason where failure to perform is beyond the reasonable control of such Party and such failure to perform is not caused by the negligence, intentional conduct or misconduct of the non-performing Party and such Party has exerted all Commercially Reasonable Efforts to avoid or remedy such force majeure event; provided, however, that in no event shall a Party be required to settle any labor dispute or disturbance.

 

Section 15.8                             Performance by Affiliates, Sub-distributors or Third Party Contractors.  To the extent that this Agreement imposes obligations on or permits the exercise of rights by Affiliates, Sub-distributors or Third Party contractors of a Party, such Party shall cause such Party’s Affiliates, Sub-distributors or Third Party contractors to perform such obligations (and all related obligations) and shall remain responsible for any breach of such obligations and for the exercise of rights by such Party’s Affiliates, Sub-distributors or Third Party Contractors.

 

Section 15.9                             Independent Contractors.  It is understood and agreed that the relationship between the Parties hereunder is that of independent contractors and that nothing in this Agreement shall be construed as authorization for either uniQure or Chiesi to act for, bind or commit the other in any way. Each Alliance Manager shall be considered the employee of Chiesi or uniQure, as the case may be, and shall not be deemed to be an employee of the other Party.

 

Section 15.10                      Costs.  Except as expressly provided in this Agreement or as separately agreed upon in writing between the Parties, each Party shall bear its own costs incurred in connection with the implementation of the obligations under this Agreement.

 

Section 15.11                      Construction.  Each Party agrees that this Agreement shall be interpreted without regard to any presumption or rule requiring construction against the Party causing this Agreement to be drafted.

 

Section 15.12                      English Language.  This Agreement was prepared and is established in the English language; any translation thereof shall be deemed for convenience only and shall never prevail against the original English version. All reports, notices and communications to be exchanged under this Agreement shall be in the English language; provided, however, that, neither Party shall be under any obligation to translate into English any document originally established and existing in another language, for the sole purpose of communicating such document to the other Party, it being agreed that such documents will be provided on an as-is basis.

 

Section 15.13                      No Implied Waivers; Rights Cumulative.  No failure on the part of a Party to exercise, and no delay in exercising, any right, power, remedy or privilege under this Agreement, or provided by statute or at law or in equity or otherwise, shall impair, prejudice or constitute a waiver of any such right, power, remedy or privilege or be construed as a waiver of any breach of this Agreement or as

 

52

 

an acquiescence therein, nor shall any single or partial waiver of any such right, power, remedy or privilege preclude any other or further exercise thereof or the exercise of any other right, power, remedy or privilege. Any Party may waive its rights hereunder in a writing signed by such Party.

 

Section 15.14                      Severability.  If, under Applicable Law, any provision of this Agreement is held to be invalid or unenforceable, or otherwise directly or indirectly affects the validity of any other material provision(s) of this Agreement (such invalid or unenforceable provision, a “Severed Clause”), this Agreement shall endure except for the Severed Clause. The Parties shall consult one another and use reasonable efforts to agree upon a valid and enforceable provision that is a reasonable substitute for the Severed Clause in view of the objectives contemplated by the Parties when entering into the Agreement and the general balance of the respective interests of the Parties as initially intended under the Agreement.

 

Section 15.15                      Counterparts.  This Agreement may be executed in two (2) or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument. A pdf file of this Agreement contained in an email, including the signed signature pages hereto, will be deemed to be an original.

 

[Signature Page Follows]

 

53

 

IN WITNESS WHEREOF, the Parties have executed this Co-Development and License Agreement as of the Effective Date.

 

	
UNIQURE   BIOPHARMA B.V.
    	
UNIQURE   BIOPHARMA B.V.
    
	
 
    	
 
    
	
 
    	
 
    
	
By:   
    	
/s/   Piers Morgan
    	
 
    	
By:   
    	
/s/   Hans Preusting
    
	
 
    	
Name:   Mr. Piers Morgan
    	
 
    	
 
    	
Name: Mr. Hans Preusting
    
	
 
    	
Title:   Chief Financial Officer
    	
 
    	
 
    	
Title:   Business Development, Vice President
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
CHIESI   FARMACEUTICI S.p.A.
    	
CHIESI FARMACEUTICI S.p.A.
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
By:   
    	
/s/   Alberto Chiesi
    	
 
    	
By:   
    	
/s/   Ugo Di Francsco
    
	
 
    	
Name:   Mr. Alberto Chiesi
    	
 
    	
 
    	
Name: Mr. Ugo Di Francesco
    
	
 
    	
Title:   President
    	
 
    	
 
    	
Title:   CEO
    

 

54

 

EXHIBIT A

 

Initial Development Plan and Budget

 

AMT-060 Key Development Activities to MAA

 

Foregrounds and assumptions to the Development Plan

 

·                  The present document is a high level overview and not an exhaustive list of all the work and activities involved in the development of AMT060.

 

·                  The timelines have been developed based on current knowledge and understanding of what is necessary in order to obtain marketing authorization.

 

·                  Plans and decisions may change depending on emerging data and information, according to the decisions taken by the JDC.

 

·                  The present plan does not include some tasks/ activities that are already foreseen, but which cannot be planned at the present stage due to missing information or for which decision making is expected to occur later on in development. Those activities include:

 

[**]

 

Tables 1 and 2 below highlight key activities in the AMT-060 development programme.

 

A-1

 

Table 1: Key activities needed to deliver Phase I

 

	
uniQure   Function
    	
 
    	
Activity
    	
 
    	
Start 
   Date (1)
    	
 
    	
Completion 
   Date (2)
    	
 
    	
Status
    
	
Regulatory   affairs
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Non-clinical
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Process   Development 
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Assay   Development
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Quality   control
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Manufacturing   
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Quality   Assurance
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Clinical   
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    

 

(1) “Start date” means the date when the activity is planned to start. For clinical studies, “start date” means the first patient enrolled in the study (i.e. [**]). For regulatory activities, it means the start of the window period in which the activity will occur.

 

(2) “Completion date” means the date by which the activity is planned to end. For clinical studies, “completion date” means the completion of the Clinical Study Report (i.e. CSR). For regulatory activities, it means the end of the window period in which the activity will occur.

 

(3) The planned “completion date” for the Phase I study assumes:[**].

 

[**]

 

A-2

 

Table 2: Key activities needed to deliver Phase II/III

 

	
uniQure Function
    	
 
    	
Activity
    	
 
    	
Start
   Date (1)
    	
 
    	
Completion 
   Date (2)
    	
 
    	
Status
    
	
Regulatory   affairs
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Non   clinical
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Process   Development
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Assay   Development
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Quality   control
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Manufacturing
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Quality   Assurance
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Clinical
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    

[**]

 

FTE requirements over the next [**]

 

Table 3 shows the maximum FTE required by UniQure per year over the next [**].  This timeline captures [**].

 

·                  These numbers include [**].

 

·                  The figures also include [**].

 

Table 4 indicates the maximum number of FTEs requirements for the time period [**] and Table 5 shows [**].

 

NOTE: FTEs and costs beyond [**] to be determined and agreed by the JDC.

 

Table 3: Maximum FTE number per year per Function

 

	
uniQure
   Function*
    	
 
    	
FTE AV.[**]
    	
 
    	
FTE AV.[**]
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
[**]
    	
 
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 

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

 

A-3

 

	
[**]
    	
 
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
 
    	
[**]
    	
 
    	
[**]
    
	
AV.   TOTAL
    	
 
    	
 
    	
[**]
    	
 
    	
[**]
    

 

[**]

 

A-4

 

Table 4: Maximum FTE requirement [**]:

 

	
Year
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Total FTE
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    

 

Table 5: AMT-060 total budget and costs [**]

 

	
 
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    
	
[**]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
[**]
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    
	
TOTAL BUDGET (€)
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    

 

[**]

 

NOTE: all external costs estimates and costs allocation per year are based on current knowledge and planning.

 

A-5

 

Outline of proposed clinical studies

 

Phase I study

 

	
Study
    	
 
    	
Phase   I, multicentre, open label, prospective, interventional, single dose,   dose-escalation clinical trial to investigate the safety and tolerability of   AAV5-hFIXco, an adeno-associated viral vector containing a codon-optimised   human factor IX gene in severe Haemophilia B (Study code: AMT-060-001)
    
	
 
    	
 
    	
 
    
	
Objectives   and end-points
    	
 
    	
Primary   objective:

 

To   assess the safety of systemic and determine the MTD of the gene therapy   vector AAV5-hFIXco for the treatment of the Severe Haemophila B, registering   and evaluating the occurrence of adverse events and serious adverse events at   the dose identified.

 

Main   secondary objectives:

 

·      To estimate the appropriate dose required to achieve stable expression of hFIX at or above 3% of normal

·      To evaluate kinetics (dose-related duration and magnitude) of   expression

·      To describe the immune response to hFIX transgene product

·      To describe the immune response to the AAV5 capsid proteins

·      To assess viral shedding in various body fluids (including   semen)

·      Assess the occurrence of FIX inhibitors

·      Evaluate coagulation   parameters

·      Assess need for FIX concomitant treatment
    
	
 
    	
 
    	
 
    
	
Study   design
    	
 
    	
[**]
    
	
 
    	
 
    	
 
    
	
Study   population (key eligibility criteria)
    	
 
    	
[**]
    
	
 
    	
 
    	
 
    
	
Treatments
    	
 
    	
[**]
    
	
 
    	
 
    	
 
    
	
Duration
    	
 
    	
The   trial will last [**]for each patient
    
	
 
    	
 
    	
 
    
	
Sample   size
    	
 
    	
[**]patients
    

 

Phase II/ III: [**].

 

A-6

 

EXHIBIT B

 

Certain Requirements under PHS Agreements

 

Each capitalized term used but not defined in this Exhibit B shall have the meaning ascribed to it in the applicable PHS Agreement.

 

PHS 2011 Requirements

 

4.2                               Licensee agrees that any sublicenses granted by it shall provide that the obligations to PHS of Paragraphs 5.1-5.4, 8.1, 10.1, 10.2, 12.5, and 13.8-13.10 of this Agreement shall be binding upon the sub-licensee as if it were a party to this Agreement. Licensee further agrees to attach copies of these Paragraphs to all sublicense agreements.

 

5.1                               (a)           PHS reserves on behalf of the Government an irrevocable, nonexclusive, nontransferable, royalty-free license for the practice of all inventions licensed under the Licensed Patent Rights throughout the world by or on behalf of the Government and on behalf of any foreign government or international organization pursuant to any existing or future treaty or agreement to which the Government is a signatory. Prior to the First Commercial Sale, Licensee agrees to provide PHS with reasonable quantities of Licensed Products or materials made through the Licensed Processes for PHS research use; and

 

(b)           In the event that the Licensed Patent Rights are Subject Inventions made under a Cooperative Research and Development Agreement (“CRADA”), Licensee grants to the Government, pursuant to 15 U.S.C. §3710a(b)(1)(A), a nonexclusive, nontransferable, irrevocable, paid-up license to practice Licensed Patent Rights or have Licensed Patent Rights practiced throughout the world by or on behalf of the Government. In the exercise of this license, the Government shall not publicly disclose trade secrets or commercial or financial information that is privileged or confidential within the meaning of 5 U.S.C. §552(b)(4) or which would be considered as such if it had been obtained from a non-Federal party. Prior to the First Commercial Sale, Licensee agrees to provide PHS reasonable quantities of Licensed Products or materials made through the Licensed Processes for PHS research use.

 

5.2                               Licensee agrees that products used or sold in the United States embodying Licensed Products or produced through use of Licensed Processes shall be manufactured substantially in the United States, unless a written waiver is obtained in advance from PHS.

 

5.3                               Licensee acknowledges that PHS may enter into future CRADAs under the Federal Technology Transfer Act of 1986 that relate to the subject matter of this Agreement. Licensee agrees not to unreasonably deny requests for a Research License from future collaborators with PHS when acquiring these rights is necessary in order to make a CRADA project feasible. Licensee may request an opportunity to join as a party to the proposed CRADA.

 

5.4                               (a)           In addition to the reserved license of Paragraph 5.1, PHS reserves the right to grant Research Licenses directly or to require Licensee to grant Research Licenses on reasonable terms. The purpose of these Research Licenses is to encourage basic 

 

B-1

 

research, whether conducted at an academic or corporate facility. In order to safeguard the Licensed Patent Rights, however, PHS shall consult with Licensee before granting to commercial entities a Research License or providing to them research samples of materials made through the Licensed Processes; and

 

(b)           In exceptional circumstances, and in the event that Licensed Patent Rights are Subject Inventions made under a CRADA, the Government, pursuant to 15 U.S.C. §3710a(b)(1)(B), retains the right to require the Licensee to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the Licensed Patent Rights in the Licensed Field of Use on terms that are reasonable under the circumstances, or if Licensee fails to grant this license, the Government retains the right to grant the license itself. The exercise of these rights by the Government shall only be in exceptional circumstances and only if the Government determines:

 

(i)                                     the action is necessary to meet health or safety needs that are not reasonably satisfied by Licensee;

 

(ii)                                  the action is necessary to meet requirements for public use specified by Federal regulations, and these requirements are not reasonably satisfied by the Licensee; or

 

(iii)                               the Licensee has failed to comply with an agreement containing provisions described in 15 U.S.C. §3710a(c)(4)(B); and

 

(c)           The determination made by the Government under this Paragraph 5.4 is subject to administrative appeal and judicial review under 35 U.S.C. §203(b).

 

10.1                        Licensee shall use its reasonable commercial efforts to bring the Licensed Products and Licensed Processes to Practical Application. “Reasonable commercial efforts” for the purposes of this provision shall include adherence to the Commercial Development Plan in Appendix E and performance of the Benchmarks in Appendix D. The efforts of a sub-licensee shall be considered the efforts of Licensee.

 

10.2                        Upon the First Commercial Sale, until the expiration or termination of this Agreement, Licensee shall use its reasonable commercial efforts to make Licensed Products and Licensed Processes reasonably accessible to the United States public.

 

12.5                        Licensee shall indemnify and hold PHS, its employees, students, fellows, agents, and consultants harmless from and against all liability, demands, damages, expenses, and losses, including but not limited to death, personal injury, illness, or property damage in connection with or arising out of:

 

(a)                                 the use by or on behalf of Licensee, its sub-licensees, directors, employees, or third parties of any Licensed Patent Rights; or

 

(b)                                 the design, manufacture, distribution, or use of any Licensed Products, Licensed Processes or materials by Licensee, or other products or processes developed in connection with or arising out of the Licensed Patent Rights.

 

13.8                        PHS reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that this action is necessary to meet the requirements for 

 

B-2

 

public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by Licensee.

 

13.9                        Within [**] days of receipt of written notice of PHS’ unilateral decision to modify or terminate this Agreement, Licensee may, consistent with the provisions of 37 C.F.R. §404.11, appeal the decision by written submission to the designated PHS official. The decision of the designated PHS official shall be the final agency decision. Licensee may thereafter exercise any and all administrative or judicial remedies that may be available.

 

13.10                 Within [**] days of expiration or termination of this Agreement under this Article 13, a final report shall be submitted by Licensee. Any royalty payments, including those incurred but not yet paid (such as the full minimum annual royalty), and those related to patent expense, due to PHS shall become immediately due and payable upon termination or expiration. If terminated under this Article 13, sub-licensees may elect to convert their sublicenses to direct licenses with PHS pursuant to Paragraph 4.3.Unless otherwise specifically provided for under this Agreement, upon termination or expiration of this Agreement, Licensee shall return all Licensed Products or other materials included within the Licensed Patent Rights to PHS or provide PHS with certification of the destruction thereof. Licensee may not be granted additional PHS licenses if the final reporting requirement is not fulfilled.

 

PHS 2007 Requirements

 

4.2                               Licensee agrees that any sublicenses granted by it shall provide that the obligations to PHS of Paragraphs 5.1, 5.2, 8.1, 10.1, 10.2, 12.5 and 13.6-13.8 of this Agreement shall be binding upon the sub-licensee as if it were a party to this Agreement. Licensee further agrees to attach copies of these Paragraphs to all sublicense Agreements.

 

5.1                               Prior to the First Commercial Sale, Licensee agrees to provide PHS with reasonable quantities of Licensed Products or New Products made through the Licensed Processes or Supplied Materials solely for PHS research use, if requested in writing.

 

5.2                               Licensee agrees that products used or sold in the United States embodying Licensed Products or New Products or produced through use of Licensed Processes shall be manufactured substantially in the United States, unless a written waiver is obtained in advance from PHS.

 

8.1                               Licensee agrees to keep accurate and correct records of Licensed Products or New Products made, used, sold, or imported and Licensed Processes practiced under this Agreement appropriate to determine the amount of royalties due PHS. These records shall be retained for at least [**] years following a given reporting period and shall be available during normal business hours for inspection, at the expense of PHS, by an accountant or other designated auditor selected by PHS for the sole purpose of verifying reports and royalty payments hereunder. The accountant or auditor shall only disclose to PHS information relating to the accuracy of reports and royalty payments made under this Agreement. If an inspection shows an underreporting or underpayment in excess of [**] percent ([**]%) for any twelve (12) month period, then Licensee shall reimburse PHS for the cost of the inspection at the time Licensee pays the unreported royalties, including any additional royalties as required by 

 

B-3

 

Paragraph 9.8, All royalty payments required under this Paragraph shall be due within [**] days of the date PHS provides Licensee notice of the payment due.

 

10.1                        Licensee shall use its reasonable commercial efforts to bring the Licensed Products or New Products and Licensed Processes to Practical Application. “Reasonable commercial efforts” for the purposes of this provision shall include adherence to the Commercial Development Plan in Appendix E and performance of the Benchmarks in Appendix D. The efforts of a sublicense shall be considered the efforts of Licensee.

 

10.2                        Upon the First Commercial Sale, until the expiration or termination of this Agreement, Licensee shall use its reasonable commercial efforts to make Licensed Products or New Products and Licensed Processes reasonably accessible to the United States public.

 

12.5                        Licensee shall indemnify and hold PHS, its employees, students, fellows, agents, and consultants harmless from and against all liability, demands, damages, expenses, and losses, including but not limited to death, personal injury, illness, or property damage in connection with or arising out of:

 

(a)                                 the use by or on behalf of Licensee, its sub-licensees, its directors, employees, or third parties of any Licensed Patent Rights or Supplied Materials; or

 

(b)                                 the design, manufacture, distribution, or use of any Licensed Products, Licensed Processes or New Products by Licensee, or other products or processes developed in connection with or arising out of the Licensed Patent Rights. Licensee agrees to maintain a liability insurance program consistent with sound business practice.

 

13.6                        In making the determination referenced in Paragraph 13.5, PHS shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, PHS shall give written notice to Licensee providing Licensee specific notice of, and a [**] day opportunity to respond to. PHS’ concerns as to the items referenced in 13.5(a)-13.5(g). If Licensee fails to alleviate PHS’ concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to PHS’ satisfaction, PHS may terminate this Agreement.

 

13.7                        PHS reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement if it is determined that the action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by Licensee.

 

13.8                        Within [**] days of receipt of written notice of PHS’ unilateral decision to modify or terminate this Agreement, Licensee may, consistent with the provisions of 37 CFR §404.11, appeal the decision by written submission to the designated PHS official. The decision of the designated PHS official shall be the final agency decision. Licensee may thereafter exercise any and all administrative or judicial remedies that maybe available.

 

B-4

 

EXHIBIT C

 

Approved Activities

 

1.      Estimated Product expenses for [**]:

 

	
 
    	
 
    	
Subtotal
    
	
Approved Activity
    	
 
    	
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TOTAL Product Development Costs (out-of-pocket) for [**]

 

C-1

 

EXHIBIT D

 

Certain Terms for HemB Supply and Distribution Agreement

 

Transfer Price: Chiesi shall purchase the Product for the greater of (a) [**] or (b) [**] (the “Product Transfer Price”). The Product Manufacturing Cost Reimbursement associated with each patient dose of the Product sold by Chiesi shall be credited against the Product Transfer Price.  The “Product Manufacturing Cost Reimbursement” for each patient dose of the Product shall be uniQure’s Fully Loaded Costs of Goods.

 

Commercial Supply: Prior to initiation of the Pivotal Study, the Parties shall negotiate in good faith the HemB Supply and Distribution Agreement for commercial material with the financial terms described above and other terms expected to be substantially similar to the Commercialization Agreement. For the avoidance of doubt, the provisions set forth in Section 2.6 of the Commercialization Agreement shall be included in the HemB Supply and Distribution Agreement.

 

“Fully Loaded Costs of Goods” shall be determined according to the principles applied in the Commercialization Agreement, in particular Schedule 2.3 thereof.

 

Indemnification:

 

Indemnification by Chiesi.  Chiesi shall indemnify, defend and hold harmless uniQure and its Affiliates, and its and their respective directors, officers, employees and agents, from and against any and all Losses, arising out of or resulting from any and all Third Party Claims to the extent based upon:

 

(a)           any breach of any representation, warranty or covenant made by, or any material obligation of, Chiesi under the HemB Supply and Distribution Agreement;

 

(b)           the gross negligence, recklessness or willful misconduct of Chiesi or its Affiliates and its or their respective directors, officers, employees and agents; or

 

(c)           any theory of product liability (including without limitation tort, warranty, or strict liability) that is applicable in the Territory with respect to the death, personal injury, or illness of any Person in the Territory, and arising directly from Chiesi’s or its Affiliates’ or Sub-distributors’ Commercialization of the Product in the Territory;

 

provided that Chiesi shall not be obligated to indemnify uniQureto the extent uniQure is required to indemnify Chiesi under the HemB Supply and Distribution Agreement.

 

Indemnification by uniQure.  uniQure shall indemnify, defend and hold harmless Chiesi and its Affiliates, and its and their respective directors, officers, employees and agents, from and against any and all Losses, arising out of or resulting from any and all Claims to the extent based upon:

 

(a)           any breach of any representation, warranty or covenant made by, or any material obligation of, uniQure under the HemB Supply and Distribution Agreement;

 

D-1

 

(b)           the gross negligence, recklessness or willful misconduct of uniQure or its Affiliates and its or their respective directors, officers, employees and agents;

 

(c)           any theory of product liability (including without limitation tort, warranty, or strict liability) that is applicable in the Territory with respect to the death, personal injury, or illness of any Person in the Territory, and arising directly from uniQure’s or its Affiliates’ design, Manufacture, storage, release and handling of the Product; or

 

(d)           Claims that the (i) Commercialization of the Product; or (ii) exercise of any rights or licenses granted to Chiesi and its Affiliates in accordance with the HemB Supply and Distribution Agreement; violates or infringes upon the Intellectual Property Rights of any Third Party;

 

provided that uniQure shall not be obligated to indemnify Chiesi to the extent Chiesi is required to indemnify uniQure under the HemB Supply and Distribution Agreement.

 

Trademark: The Product will be Commercialized by Chiesi in the Field in the Territory exclusively under a trademark mutually agreed between the Parties. Such trademark shall be owned by uniQure and shall be licensed to Chiesi for Commercialization of the Product in the Field in the Territory. Section 2.2(a) of the Commercialization Agreement shall apply mutatis mutandis.

 

D-2

 

 

EXHIBIT E

 

Licensed Patents

 

	
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E-1

 

Note:

 

[**]

 

E-2

 

EXHIBIT F

 

uniQure FTE Limits

 

Unless otherwise agreed in writing as part of the then current Development Plan and Budget, the number of uniQure FTEs will be no higher than:

 

[**]

 

Unless otherwise agreed in writing as part of the then current Development Plan and Budget, the number of Chiesi FTEs will be no higher than:

 

[**]

 

F-1

 

EXHIBIT G

 

Technology Transfer

 

The following is a non-exhaustive list describing key steps which the Parties would typically envisage for a transfer of the Manufacturing of the Product to another manufacturing site during Product Development:

 

	
Steps
    	
 
    	
Estimated Timelines
    
	
·   if transferred to a Third Party   manufacturer: select and contract manufacturer party
    	
 
    	
[**]
    
	
·   process transfer (on paper)
    	
 
    	
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·   obtain time slot
    	
 
    	
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·   process validation
    	
 
    	
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Total
    	
 
    	
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G-1

 

EXHIBIT H

 

Disclosure Schedule to Section 11.2(e)

 

[**].

 

G-1Exhibit 10.12

 

EXECUTION COPY

 

Confidential Materials omitted and filed separately with the Securities and Exchange Commission.  Double asterisks denote omissions.

 

COMMERCIALIZATION AGREEMENT

 

This Commercialization Agreement (this “Agreement”) is entered into as of 29 April 2013 (the “Effective Date”), by and between uniQure Biopharma B.V., formerly known as Amsterdam Molecular Therapeutics (AMT) B.V., a Dutch corporation, with its offices at Meibergdreef 61, 1105 BA Amsterdam, The Netherlands (“uniQure”), and Chiesi Farmaceutici S.p.A., an Italian corporation, with its offices at Via Palermo, 26/A, 43122 Parma, Italy (“Chiesi”). uniQure and Chiesi are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

 

WHEREAS, uniQure is a company engaged in the research and clinical development of human gene based therapies. Its lead product, “Glybera”, for the treatment of lipoprotein lipase deficiency was approved by the European Commission in November 2012;

 

WHEREAS, Chiesi is a pharmaceutical company engaged in the research, development, sales and marketing as well as distribution of ethical medicinal products;

 

WHEREAS, uniQure desires to appoint Chiesi, on an exclusive basis, to obtain and maintain the best possible Price and Reimbursement Approval (as defined below) and to Commercialize (as defined below) the Product (as defined below) in the Territory (as defined below), in accordance with the terms and conditions set forth below, and Chiesi desires to accept uniQure’s exclusive appointment.

 

NOW, THEREFORE, uniQure and Chiesi hereby agree as follows:

 

ARTICLE I

DEFINITIONS; INTERPRETATION

 

Capitalized terms used herein shall have the meanings assigned to them as follows.

 

1.1                               “Affiliate” shall mean, with respect to a Party, any Person Controlled by, in Control of, or under common Control with such Party.

 

1.2                               “Additional Rights” has the meaning set forth in Section 7.5(a).

 

1.3                               “Agreement” has the meaning set forth in the first and opening paragraph of this Agreement.

 

1.4                               “Alliance Manager” has the meaning set forth in Section 4.4.

 

1.5                               “Applicable Laws” shall mean all applicable laws, statutes, codes, rules and regulations, judgments, order and ordinances, including any rules, regulations, guidelines or other requirements of any Regulatory Authority within the Territory, that may be in effect from time to time.

 

1.6                               “Approved Activities” has the meaning set forth in Section 8.1(b).

 

 

CONFIDENTIAL

 

1.7                               “Average Net Sales Price” shall mean the average net sales price of a particular Product in the Territory, calculated on a monthly basis, by dividing the Net Sales of the Product in the Territory effected in a particular calendar month by the number of patient doses of the Product accounting for the Net Sales in such calendar month.

 

1.8                               “Business Day” shall mean a day on which banking institutions in Amsterdam, The Netherlands and Parma, Italy, are open for business, excluding any Saturday or Sunday.

 

1.9                               “Certificate of Analysis” shall mean the certificate substantially in the form attached hereto as Schedule 1.9 evidencing the analytical test conducted on a specific lot of Product and setting forth, among other items, the items tested, Specifications, and test results.

 

1.10                        “Certificate of Compliance” shall mean the certificate substantially in the form attached as Schedule 1.10 stating that a specific lot of Product complies with the warranties set forth in Section 5.2.

 

1.11                        “Chiesi” has the meaning set forth in the first and opening paragraph of this Agreement.

 

1.12                        “Claims” has the meaning set forth in Section 6.1.

 

1.13                        “Co-Development and License Agreement” shall mean that certain Co-Development and License Agreement for Hemophilia B concluded separately between the Parties on the date hereof.

 

1.14                        “Collaboration” shall mean the relationship between and activities conducted by the Parties under this Agreement and all other agreements between the Parties referenced herein (other than the Confidentiality Agreement), including the Co-Development and License Agreement (collectively, the “Collaboration Agreements”).

 

1.15                        “Collaboration Agreements” has the meaning set forth in Section 1.14.

 

1.16                        “Commercialization” shall mean any and all activities, whether before or after Regulatory Approval, directed to the marketing, detailing and promotion of the Product and shall include pre-launch, launch and post-launch marketing, promoting, detailing, marketing research, medical affairs, managed markets, distributing, offering to commercially sell and commercially selling the Product, importing, exporting or transporting the Product for commercial sale and regulatory affairs with respect to the foregoing, including the filing and obtaining of Price and Reimbursement Approval for the Product, but shall not include Manufacturing nor any development activities. When used as a verb, “Commercializing”, “Commercialize” and “Commercialized” shall mean to engage in Commercialization.

 

1.17                        “Commercially Reasonable Efforts” shall mean, with respect to the efforts to be expended by a Party with respect to a goal, reasonable, diligent, good faith efforts to accomplish such goal as a similarly situated (with respect to size and assets) pharmaceutical company would use to accomplish a similar goal under similar circumstances so as to achieve such goal as expeditiously as possible; provided that, with

 

2

 

respect to the Commercialization of the Product, such efforts shall be substantially equivalent to those efforts and resources that a similarly situated (with respect to size and assets) pharmaceutical company would typically devote to its own internally discovered products of similar market potential at a similar stage in their product life so as to achieve such goal as expeditiously as possible (which, with respect to activities for which Chiesi is responsible, shall be without regard to any amounts paid or payable to uniQure with respect to the Product under this Agreement or the Co-Development and License Agreement). Without prejudice to the foregoing and with respect to Chiesi, Commercially Reasonable Efforts shall at least include the efforts as further described in Schedule 8.1(a).

 

1.18                        “Confidential Information” shall mean all confidential or proprietary information of a Party, including information regarding such Party’s or its Affiliates’ or licensors’ products, business, business plans, financial status, biological substances, chemical substances, formulations, techniques, methodology, equipment, sources of supply and patent positioning and information belonging to such Party’s Affiliate or a Third Party and provided to the other Party under this Agreement. The terms and conditions of this Agreement shall be deemed “Confidential Information” of both Parties. All information disclosed by uniQure prior to the Effective Date pursuant to the Two Way Confidentiality Disclosure Agreement between Amsterdam Molecular Therapeutics (AMT) B.V. and Chiesi Farmaceutici S.p.A. dated 22 July 2010 (the “Confidentiality Agreement”) shall be deemed “Confidential Information” of uniQure hereunder.

 

1.19                        “Confidentiality Agreement” has the meaning set forth in Section 1.18.

 

1.20                        “Confirmed Firm Order” has the meaning set forth in Section 2.4(c).

 

1.21                        “Control” or “Controlled” shall mean, (a) when used in reference to any Confidential Information, Patent or other Intellectual Property Rights, the possession (whether by ownership or license (other than solely pursuant to a license under this Agreement)) by such Party or any of its Affiliates, of the legal authority or right to grant to the other Party access or a license or sublicense to such Confidential Information, Patent or other Intellectual Property Rights as provided herein, without violating the terms of any agreement or arrangement with any Third Party, or (b) when used in reference to Section 1.1, (i) the possession, directly or indirectly, of the power to direct the management or policies of a Person, whether through ownership of voting securities, by contract or otherwise; (ii) ownership of fifty percent (50%) or more of the voting securities entitled to vote for the election of directors in the case of a corporation, or fifty percent (50%) or more of the equity interest in the case of any other type of legal entity; or (iii) status as a general partner in any partnership, or any other arrangement whereby a Person controls or have the right to control the board of directors or equivalent governing body of a corporation or other Person. Notwithstanding the foregoing, any portfolio company of any stockholder of such Person (which stockholder is a venture capital fund or private equity fund) shall not be deemed to be “under common Control with” such Person.

 

1.22                        “Controlling Party” has the meaning set forth in Section 7.5(b).

 

1.23                        “Cover” or “Covered” shall mean, with respect to any Patent and the subject matter at issue, that, but for a license granted under a Valid Claim of such Patent, the manufacture, use, sale, offer for sale or importation of the subject matter at issue

 

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would infringe such Valid Claim, or, in the case of a Patent that is a patent application, would infringe a Valid Claim in such patent application if it were to issue as a patent.

 

1.24                        “Delivery Notification” has the meaning set forth in Section 2.5(b).

 

1.25                        “Discretionary Manufacturing Changes” has the meaning set forth in Section 3.4(b).

 

1.26                        “Effective Date” has the meaning set forth in the first and opening paragraph of this Agreement.

 

1.27                        “EMA” shall mean the European Medicines Agency and any successor agency thereto.

 

1.28                        “EU” shall mean the European Union.

 

1.29                        “EU Member States” shall mean Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.

 

1.30                        “Executive Officers” shall mean the Chief Executive Officer of Chiesi or a senior officer designated by Chiesi, and the Chief Executive Officer of uniQure or a senior officer designated by uniQure.

 

1.31                        “Existing Third Party Licenses” has the meaning set forth in Section 7.4.

 

1.32                        “EXW” shall mean “ex works” as defined by the International Chamber of Commerce (Incoterms 2010).

 

1.33                        “Failure to Supply” has the meaning set forth in Section 2.6(a).

 

1.34                        “FDA” shall mean the US Food and Drug Administration and any successor agency thereto.

 

1.35                        “Field” shall mean the treatment of lipoprotein lipase deficiency.

 

1.36                        “Firm Order” shall mean a written (including facsimile or email) irrevocable firm purchase order for the Product, which order shall include the precise name of the Product ordered and the quantity of the Product ordered (such quantity to be equal or above the Minimum Order Quantity).

 

1.37                        “First Commercial Sale” shall mean the first sale by Chiesi, an Affiliate of Chiesi, or a Sub-distributor of Chiesi, as the case may be, of the Product to a Third Party in the Territory; provided, however, that neither (a) transfers of the Product between Chiesi and its Affiliates or Sub-distributors nor (b) supply of the Product for clinical trial purposes, shall constitute a First Commercial Sale.

 

1.38                        “Force Majeure Event” has the meaning set forth in Section 11.6.

 

1.39                        “Forecast” has the meaning set forth in Section 2.4(a).

 

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1.40                        “FTE” shall mean an annual average of at least [**] hours allocated to one or more persons allocated to the Commercialization of the Product (including product specialists, KAMs, MSLs, medical, regulatory, pharmacovigilance, market access and marketing personnel) in the Territory (both at an headquarter and country level).

 

1.41                        “Fully Loaded Cost of Goods” shall mean the fully loaded cost of goods of the Product as defined in Schedule 2.3.

 

1.42                        “GDPs” shall mean the current good distribution practices promulgated by any Regulatory Authorities or Applicable Laws throughout the Territory that are applicable to the Product.

 

1.43                        “Gene Therapy” shall mean the introduction and expression of genetic material in cells of a person in order to cure a disease or to minimize disease symptoms.

 

1.44                        “Glybera Manufacturing Cost Reimbursement” has the meaning set forth in Section 2.3(c)(i).

 

1.45                        “GMPs” shall mean the current good manufacturing practices promulgated by any Regulatory Authorities or Applicable Laws throughout the Territory that are applicable to the Product.

 

1.46                        “Improvements” shall mean any improvements to the Product Controlled by uniQure during the Term, such as future formulations, dosages, dosage forms, delivery modes and line extensions of the Product, packaging of the Product, labeling of the Product, and developments in the Product itself.

 

1.47                        “Indemnified Party” has the meaning set forth in Section 6.3(i).

 

1.48                        “Indemnifying Party” has the meaning set forth in Section 6.3(i).

 

1.49                        “Intellectual Property Rights” shall mean all patents (including the Patents), trademarks (including the Trademark), trade names, service marks, trade dress, trade secrets and copyrights, including, without limitation, any renewal, extension or other rights therefor, and applications, provisionals, divisionals, reexaminations, continuations in part, divisions, continuations, reissues, additions, substitutions and registrations for any of the foregoing and all corresponding foreign patents and patent applications of each of the foregoing, technical information, devices, processes, procedures, discoveries, techniques, formulae, software, designs, drawings, data, methods, protocols, products, apparatuses and other materials, compositions, mask works, domain names, schematics, manufacturing processes, know-how, moral rights, software programs or applications, manufacturing and production processes and techniques, research and development information, drawings, specifications, designs, plans, proposals, technical data, results of experimentation and testing (whether or not patentable) in written, electronic, physical (including in the form of tangible compounds or cell lines), oral or any other form, financial and marketing plans, customer and supplier lists and information, and all other intellectual property or proprietary rights.

 

1.50                        “JCC” has the meaning set forth in Section 4.2(a).

 

1.51                        “JSC” has the meaning set forth in Section 4.1(a).

 

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1.52                        “Losses” has the meaning set forth in Section 6.1.

 

1.53                        “Lost Profit” has the meaning set forth in Section 2.6.

 

1.54                        “Manufacture” and “Manufacturing” shall mean all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, shipping and holding of the Product or any intermediate thereof, including process development, process qualification and validation, scale up, pre-clinical, clinical and commercial manufacture and analytical development, product characterization, stability testing, quality assurance and quality control. When used as a verb, “Manufacture” shall mean to engage in Manufacturing.

 

1.55                        “Marketing Authorization” shall mean the authorization issued by the relevant Regulatory Authority necessary to place on the market the Product in any country or regulatory jurisdiction in the Territory (including the centralized approval of a Marketing Authorization Application in the EU). For clarity, a Marketing Authorization shall not include any applicable Price and Reimbursement Approvals.

 

1.56                        “Marketing Authorization Application” shall mean an application submitted to a Regulatory Authority for marketing approval of a drug or biologic product, including (a) a Marketing Authorization Application in the EU under Regulation (EC) No. 726/2004 or Directive 2001/83/EC, (b) any non-EU equivalent of the foregoing in any other country in the Territory, and (c) all supplements and amendments that may be filed with respect to any of the foregoing.

 

1.57                        “Marketing Plan” has the meaning set forth in Schedule 8.1(a).

 

1.58                        “Minimum FTEs” has the meaning set forth in Schedule 8.1(a).

 

1.59                        “Minimum Order Quantity” has the meaning set forth in Section 2.4(d).

 

1.60                        “Net Sales” shall mean the total amount of invoiced sales of the Product in the Territory by or on behalf of Chiesi or its Affiliates or Sub-distributors to Third Parties (including wholesalers, hospitals, end users and others), in bona fide arm’s length transactions, less the following deductions, in each case related specifically to the Product and customary in the trade and actually allowed and taken by such Third Parties and not otherwise recovered by or reimbursed to Chiesi: (a) cash discounts allowed and actually taken; (b) taxes on sales (such as sales or use taxes) to the extent added to the sale price and set forth separately as such in the total amount invoiced; (c) freight and insurance to the extent added to the sale price and set forth separately as such in the total amount invoiced; (d) amounts repaid or credited by reason of rejections, defects, recalls, expirations, or returns; and (e) any governmental mandated charge backs, rebates, and discounts. No deductions shall be made for (x) commissions paid to individuals, whether they are with independent sales agencies or regularly employed by Chiesi or any of its Affiliates, and on its payroll, (y) the cost of collections, and (z) any advertising and promotional expenses. In no event shall Chiesi have a right to apply any discounts or deductions on the Product, resulting from Chiesi entering into “package deals” whereby Chiesi sells more than one product (in addition to the Product) to a customer and offers “package deal discounts”.

 

1.61                        “Non-Controlling Party” has the meaning set forth in Section 7.5(b).

 

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1.62                        “Party” and “Parties” has the meaning set forth in the first and opening paragraph of this Agreement.

 

1.63                        “Patents” shall mean any patent or patent application, including utility patents, utility models, design patents, provisional applications, certificates of invention, and all divisionals, continuations, continuations-in-part, substitutions, reissues, reexaminations, renewals, extensions (including any supplemental protection certificate) or additions to any patent or patent application that Cover the Product owned or Controlled by either of the Parties as of the Effective Date or during the Term. Schedule 1.63 sets forth a list of Patents that Cover the Product in the Territory owned or Controlled by uniQure as of the Effective Date, such list to be updated or confirmed upon the date this Agreement has become effective pursuant to Section 9.1(b).

 

1.64                        “Person” shall mean any natural person or any corporation, company, partnership, limited liability company, joint venture, firm, agency or other entity, including a Party.

 

1.65                        “Price and Reimbursement Approval” shall mean any approval or authorization of any Regulatory Authority establishing a pricing- and payment scheme or a reimbursement scheme for the Product in any country or jurisdiction of the Territory.

 

1.66                        “Product” shall mean the medicinal product set forth in Schedule 1.66, and any Improvements thereof.

 

1.67                        “Product Complaint” shall mean any oral or written communication of dissatisfaction issued by any Regulatory Authority regarding the identity, quality, durability, reliability or performance of any Product, including appearance, low fills, foreign materials, foreign product, defective packaging or defective labeling.

 

1.68                        “Profit” has the meaning set forth in Section 2.6.

 

1.69                        “Publishing Party” has the meaning set forth in Section 10.5(a).

 

1.70                        “Purchase Price” has the meaning set forth in Section 2.3(b).

 

1.71                        “Quality Agreement” has the meaning set forth in Section 3.3(a).

 

1.72                        “Registry” shall mean an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes and meets the requirements of the EMA.

 

1.73                        “Regulatory Approval” shall mean any and all approvals (including, where required, any applicable Price and Reimbursement Approvals), licenses, registrations or authorizations of any Regulatory Authority necessary for the Commercialization or use of a Product in a country or jurisdiction, including Marketing Authorizations.

 

1.74                        “Regulatory Authority” shall mean any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the testing, Regulatory Approval, manufacture, use, storage,

 

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import, promotion, marketing or sale of a drug or biologic product in a country or jurisdiction, including the EMA.

 

1.75                        “Regulatory Plan” has the meaning set forth in Section 3.2.

 

1.76                        “Required Manufacturing Changes” has the meaning set forth in Section 3.4(a).

 

1.77                        “SDEA” has the meaning set forth in Section 3.3(b).

 

1.78                        “Specifications” shall mean the composition, quality and specifications regarding the Product as may be amended, modified or supplemented from time to time in accordance with the terms hereof. The initial Specifications are annexed as Schedule 1.78.

 

1.79                        “Sub-distributor” shall mean a Third Party that is granted a sub-distribution or other Commercialization right in the Territory by Chiesi in accordance with this Agreement.

 

1.80                        “Subject Disclosure” has the meaning set forth in Section 10.3(b).

 

1.81                        “Target Price” has the meaning set forth in Schedule 8.1(a).

 

1.82                        “Term” has the meaning set forth in Section 9.1(a).

 

1.83                        “Territory” shall mean (i) the EU Member States, Iceland, Liechtenstein and Norway and (ii) Albania, Andorra, Bosnia, Croatia, Macedonia, Monaco, Montenegro, Republic of San Marino, Serbia (including Kosovo), Switzerland and Vatican City ((i) and (ii), collectively, “Territory A”) as well as (iii) Algeria, Brazil, China, Egypt, Mexico, Morocco, Pakistan, Russia and ex-CIS countries (i.e. Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kirghizstan, Moldova, Tajikistan, Turkmenistan, Ukraine and Uzbekistan), Tunisia and Turkey (“Territory B”).

 

1.84                        “Territory A” has the meaning set forth in Section 1.83.

 

1.85                        “Territory B” has the meaning set forth in Section 1.83.

 

1.86                        “Third Party” shall mean any Person other than uniQure, Chiesi, or their respective Affiliates.

 

1.87                        “Trademark” has the meaning set forth in Section 2.2(a)(i).

 

1.88                        “uniQure” has the meaning set forth in the first and opening paragraph of this Agreement.

 

1.89                        “uniQure Intellectual Property Rights” shall mean all Intellectual Property Rights Controlled by uniQure on the Effective Date or during the Term which would be infringed by the Commercialization of the Product as provided for in this Agreement.

 

1.90                        “Valid Claim” shall mean any claim within an issued and unexpired Patent or within a pending Patent application that (i) is not expired, lapsed, or abandoned, (ii) is not dedicated to the public, disclaimed, or admitted to be unenforceable or invalid; and (iii) has not been invalidated, held unenforceable or cancelled by a court or administrative

 

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agency of competent jurisdiction in an order or decision from which no appeal has been or can be taken, including through opposition, re-examination, reissue, disclaimer or otherwise.

 

1.91                        “Interpretation”. Any reference in this Agreement to an Article, Section, subsection, paragraph, clause, or Schedule shall be deemed to be a reference to any Article, Section, subsection, paragraph, clause, or Schedule, of or to, as the case may be, this Agreement. Except where the context clearly otherwise requires, (a) wherever used, the use of any gender will be applicable to all genders, (b) the singular shall include the plural and vice versa, (c) any definition of or reference to any agreement, instrument or other document refers to such agreement, instrument 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 or therein), (d) any reference to any Applicable Laws refers to such Applicable Laws as from time to time enacted, repealed or amended, (e) the words “herein”, “hereof” and “hereunder”, and words of similar import, refer to this Agreement in its entirety and not to any particular provision hereof, (f) the words “include”, “includes” and “including” are deemed to be followed by the phrase “but not limited to”, “without limitation” or words of similar import, (g) the word “or” has the inclusive meaning (i.e., “and/or”), (h) the word “day” means a calendar day, the word “month” means a calendar month, and the word “year” means, and the word “annual” refers to, a calendar year, (i) the word “quarterly” refers to a calendar quarter, (j) each accounting term used herein that is not specifically defined herein has the meaning given to it under the International Financial Reporting Standards, and (k) the captions or headings of the Schedule, Articles, Sections or other subdivisions hereof are inserted only as a matter of convenience or for reference and shall have no effect on the meaning of the provisions hereof.

 

ARTICLE II

APPOINTMENT, SUPPLY OF PRODUCTS

 

2.1                               Appointment, Consideration.

 

(a)                                 Subject to the terms hereof, uniQure hereby appoints Chiesi as its distributor with the exclusive right to Commercialize the Product solely in the Field in the Territory during the Term.

 

(b)                                 Chiesi shall be entitled to appoint any of its Affiliates or, subject to the prior written consent of uniQure, which shall not be unreasonably withheld, Third Parties as sub-distributor to the extent required for Commercialization of the Product in the Field in the Territory. In this event, Chiesi shall procure, and shall remain ultimately responsible for, compliance by such Affiliates or Sub-distributors with all the relevant obligations of Chiesi hereunder.

 

(c)(1)                   Subject to the condition precedent pursuant to Section 9.1(b), Chiesi shall pay to uniQure, after receipt of a proper invoice, a one-time, non-refundable fee of EUR 2,000,000.00 (in words: two million Euro) in recognition of uniQure’s past expenditure developing the Product, within [**] Business Days after this Agreement has become effective pursuant to Section 9.1(b).

 

(c)(2)                   In consideration of the licenses, rights and interest granted under this Agreement, and in addition to any other payments due hereunder, Chiesi shall pay to

 

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uniQure, after receipt of a proper invoice, the following commercial milestone payments, in each case within [**] days after the end of the corresponding calendar year:

 

(A)                               EUR [**] (in words: [**] Euro) when cumulated Net Sales of the Product achieve EUR [**] (in words: [**] Euro) in a calendar year;

 

(B)                               EUR [**] (in words: [**] Euro) when cumulated Net Sales of the Product achieve EUR [**] (in words: [**] Euro) in a calendar year;

 

(C)                               EUR [**] (in words: [**] Euro) when cumulated Net Sales of the Product achieve EUR [**] (in words: [**] Euro) in a calendar year;

 

(D)                               EUR [**] (in words: [**] Euro) when cumulated Net Sales of the Product achieve EUR [**] (in words: [**] Euro) in a calendar year.

 

Within [**] days after the end of each calendar year, Chiesi shall inform uniQure of the occurrence or, as the case may be, non-occurrence, of any such milestone event.

 

For the avoidance of doubt, each milestone is payable once, up to a maximum of EUR 42,000,000.00 (in words: forty two million Euro) in milestone payments and only one milestone is payable for any given calendar year. For clarity, the highest unpaid payment possible shall be paid with respect to a particular calendar year, and any payment not made because a higher payment was due shall be available for payment if the relevant Net Sales threshold is achieved in a subsequent year. For example, if, in calendar year 2014, Product sales of EUR [**] (in words: [**] Euro) are first achieved and Product sales had not achieved EUR [**] (in words: [**] Euro) in calendar year 2013, then EUR [**] (in words: [**] Euro) shall be due with respect to the sales in 2014 and if, in 2015, Product sales achieve at least EUR [**] (in words: [**] Euro), but less than EUR [**] (in words: [**] Euro), then the EUR [**] (in words: [**]  Euro) payment shall be due with respect to the sales in 2015.

 

(d)                                 Chiesi shall keep complete and accurate records of Product sold or otherwise made available as appropriate to determine the amount of commercial milestones and other payments to be paid to uniQure. These records shall be retained for at least [**] years after delivery of the Product pursuant to Section 2.5. uniQure shall have the right [**] at uniQure’s expense to retain an independent certified public accountant selected by uniQure, and reasonably acceptable to Chiesi, to review such records in the location(s) where such records are maintained by Chiesi upon reasonable notice and during regular business hours and under obligations of confidence. Results of such review shall be made available to both Parties. If the review indicates that there was an underpayment of any amount payable to uniQure, the amount of such underpayment shall be remitted to uniQure within [**] days after such review, together with interest calculated in the manner provided in paragraph (f) below. If the underpayment is equal to or greater than [**] percent ([**]%) of the amount that was otherwise due, Chiesi shall pay all of uniQure’s reasonable out-of-pocket expenses of such review. If the review

 

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indicates that there was an overpayment of any amounts by Chiesi, Chiesi may apply the amount of such overpayment to any future payment due to uniQure under Section 2.3.

 

(e)                                  All payments to be made under this Agreement shall be made in EUR by wire transfer to the account designated by uniQure in writing. If amounts (e.g. Average Net Sales Price or Fully Loaded Cost of Goods) relevant for the calculation of any payments to be made under this Agreement are in a currency other than Euros, such amounts shall be expressed in their Euro equivalent, calculated on the last Business Day of the calendar months to which the applicable amounts relate using the currency converter at www.oanda.com. Unless otherwise expressly set forth herein, all payments to uniQure are to be executed without any further deduction within [**] days after receipt by Chiesi of the invoice with respect thereto.

 

(f)                                   Any payment to uniQure under this Agreement that is not paid on or before the date such payment is due shall bear interest at the lesser of (i) [**] per year, or (ii) the highest rate permitted by Applicable Laws, calculated on the number of days such payments are overdue.

 

(g)                                  Any payment to be made under this Agreement shall be made plus value-added tax, if applicable.

 

(h)                                 To the extent that any payments hereunder by Chiesi to uniQure are subject to tax, Chiesi shall pay such tax; provided, however, that, with respect to any payments subject to withholding tax, Chiesi shall pay the applicable withholding tax amount to the relevant taxing authority and promptly provide uniQure with all necessary documentation for uniQure to recover such tax. Chiesi will take all reasonable and lawful steps to minimize the amount of any such withholding tax obligation and uniQure shall promptly provide all information and documentation in its possession necessary for doing so.

 

2.2                               Trademark, Labeling.

 

(a)                                 Trademark.

 

(i)                                     The Product will be Commercialized by Chiesi in the Field in the Territory exclusively under the trademark “Glybera” (as defined in Schedule 2.2(a)) or, subject to the prior written consent of uniQure, such alternative trademark identified by Chiesi (the “Trademark”). In the event that Chiesi provides sufficient written evidence to uniQure that the use of an alternative trademark is required under Applicable Laws to lawfully Commercialize the Product in any country or jurisdiction of the Territory and if Chiesi identifies any trademark other than “Glybera” for this purpose, then Chiesi shall be entitled to Commercialize the Product under such alternative trademark without the prior written consent of uniQure. In the event that Chiesi identifies any trademark other than “Glybera” for other material commercial reasons, Chiesi shall provide sufficient written evidence for such reasons to uniQure and shall not be entitled to Commercialize the Product under an alternative Trademark without the prior written consent of uniQure, such consent not to be unreasonably withheld. Chiesi shall inform uniQure promptly of the need of such alternative trademark, such notice to be accompanied by the aforementioned written evidence and a list of at least [**] alternative trademarks identified by Chiesi and suitable for Commercialization of the Product throughout the entire Territory.

 

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(ii)                                  In case the Product is Commercialized by Chiesi under the Trademark “Glybera”, uniQure hereby grants to Chiesi the exclusive, royalty-free, perpetual, irrevocable, right and license (subject to Section 9.3 below) to use the Trademark “Glybera” to Commercialize the Product solely in the Field in the Territory, with the right to grant sublicenses to Sub-distributors according to Section 2.1(b). Further, uniQure hereby grants to Chiesi the non-exclusive, royalty-free, right and license to use uniQure’s trade name (as defined in Schedule 2.2(a)) in each country of the Territory during the Term solely for the purpose of identifying uniQure as the manufacturer and Marketing Authorization holder of the Product as contemplated in this Agreement.

 

(iii)                               Chiesi acknowledges that, subject to the foregoing licenses, uniQure shall own all right, title and interest in and to the Trademark “Glybera” inside and outside the Field, whether inside or outside of the Territory as well as any goodwill associated with the Trademark “Glybera”. Chiesi shall ensure appropriate use of the trademark “Glybera” at all times in the entire Territory and observe the applicable trademark use guidelines issued by uniQure, as amended from time, attached in Schedule 2.2(b). Chiesi shall not, during the Term or thereafter, register, use, or attempt to obtain any right in and to (A) the trademarks “Glybera” and “uniQure”, or (B) any name, logo or trademark confusingly similar thereto. If Chiesi or any of its Affiliates or Sub-distributors challenges the validity of any such trademark during the Term, uniQure may terminate this Agreement in accordance with the provisions of Section 9.2(d). uniQure undertakes to maintain and defend the Trademark “Glybera” in each country inside the Territory during and, for as long as Chiesi retains licenses thereto, after the Term at its own cost. In the event that at any time during such term uniQure intends not to continue prosecution or maintenance of such Trademark anywhere inside the Territory, it shall inform Chiesi at least [**] days prior to doing so and shall, upon request of Chiesi transfer all right, title and interest in such Trademark in such country or jurisdiction to Chiesi for further prosecution and maintenance by Chiesi in Chiesi’s name and at Chiesi’s costs and Chiesi shall reimburse uniQure for any reasonable external costs incurred by uniQure for such transfer.

 

(iv)                              uniQure acknowledges that except as otherwise expressly provided in this Agreement, Chiesi shall own all right, title and interest in and to any Trademark other than the trademark “Glybera” as well as any goodwill associated therewith. In case the Product is Commercialized by Chiesi under such alternative Trademark, Chiesi hereby grants to uniQure an exclusive, royalty-free, perpetual, irrevocable, right and license (subject to Section 9.3 below) to use such Trademark to Manufacture and Commercialize the Product outside the Territory, with the right to grant sublicenses. uniQure shall not, during the Term or thereafter, register, use, or attempt to obtain any right in and to (A) such Trademark and the “Chiesi” trademark, or (B) any name, logo or trademark confusingly similar thereto. If uniQure or any of its Affiliates challenges the validity of any such trademark during the Term, Chiesi may terminate this Agreement in accordance with the provisions of Section 9.2(d). Chiesi undertakes to obtain, maintain and defend such Trademark in each country inside and, as requested by uniQure, outside of the Territory during and, for as long as uniQure retains licenses thereto, after the Term at its own cost. In the event that at any time during such term Chiesi intends not to continue prosecution or maintenance of such Trademark anywhere inside or outside of the Territory it shall inform uniQure at least [**] days prior to doing so and shall, upon request of uniQure transfer all right, title and interest in such Trademark in such country or jurisdiction to uniQure for further prosecution and 

 

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maintenance by uniQure in uniQure’s name and at uniQure’s costs and uniQure shall reimburse Chiesi for any reasonable external costs incurred by Chiesi for such transfer.

 

(b)                                 Labeling.

 

(i)                                     uniQure as Marketing Authorization holder of the Product in Territory A shall be ultimately responsible for the content and type of all labeling and packaging (and any changes or supplements thereto) for the Product to be Commercialized by Chiesi in the Field in Territory A. Notwithstanding the foregoing, the Parties agree that, subject to Section 3.1, (A) Chiesi shall provide all reasonable assistance to uniQure in connection with the labeling and packaging for the Product (e.g. use of Chiesi in-house capacity for the translation of package leaflets), and (B) the Product to be Commercialized by Chiesi in the Field in Territory A shall include, to the extent legally permitted, a reference to Chiesi as Commercialization partner, and shall take into account, to the extent legally permitted, Chiesi’s livery. Details shall be agreed upon between the Parties in the Regulatory Plan. Chiesi shall take out at its costs any necessary insurance required under Applicable Laws as a result of Chiesi being referred to as a Commercialization partner on the Product, and shall reimburse uniQure for any costs associated with changes to the labeling and packaging of the Product in accordance with the foregoing.

 

(ii)                                  Chiesi as Marketing Authorization holder of the Product in Territory B shall be ultimately responsible for the content and type of all labeling and packaging (and any changes or supplements thereto) for the Product to be Commercialized by Chiesi in the Field in Territory B. Notwithstanding the foregoing, the Parties agree that, subject to Section 3.1, (A) uniQure shall provide all reasonable assistance to Chiesi in connection with the labeling and packaging for the Product, and (B) the Product to be Commercialized by Chiesi in the Field in Territory B shall include, to the extent legally permitted, a reference to uniQure as originator and manufacturer of the Product, and shall take into account, to the extent legally permitted, uniQure’s livery. Details shall be agreed upon between the Parties in the Regulatory Plan. uniQure shall take out at its costs any necessary insurance required under Applicable Laws as a result of uniQure being referred to as originator and manufacturer on the Product, and shall reimburse Chiesi for any costs associated with changes to the labeling and packaging of the Product in accordance with the foregoing.

 

(iii)                               If, according to local mandatory regulatory requirements, uniQure is not eligible as Marketing Authorization holder of the Product in any country of Territory A, or Chiesi is not eligible as Marketing Authorization holder of the Product in any country of Territory B, Chiesi or, as the case may be, its Sub-distributor, or uniQure, shall become the Marketing Authorization holder of the Product in such country of the Territory. In such case, Chiesi or, as the case may be, its Sub-distributor, or uniQure, shall be ultimately responsible for the content and type of all labeling and packaging (and any changes or supplements thereto) for the Product to be Commercialized by Chiesi in the Field in such country of the Territory, and sentences 2 to 4 of paragraph (i) or (ii) above shall apply, respectively.

 

2.3                               Purchase of the Product.

 

(a)                                 Orders.  During the Term, Chiesi shall purchase from uniQure one hundred percent (100%) of Chiesi’s requirements for the Product for Commercialization 

 

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in the Field in the Territory. Purchase shall be made pursuant to Firm Orders submitted by Chiesi to uniQure from time to time in accordance with Section 2.4.

 

(b)                                 Purchase Price.  The purchase price for the individual Product ordered shall be the greater of (i) [**] and (ii) [**] (the “Purchase Price”).

 

(c)                                  Invoicing, Payment.  uniQure shall invoice Chiesi for all quantities of Product as follows:

 

(i)                                     As upfront payment to the Purchase Price, Chiesi shall pay to uniQure the Fully Loaded Cost of Goods, reduced by the cost items incurred by uniQure only after receipt of the corresponding Delivery Notification as identified in Schedule 2.3, for each patient dose of the Product delivered (i.e. through storage at uniQure’s warehouse) in accordance with Section 2.4 (“Glybera Manufacturing Cost Reimbursement”). uniQure shall promptly inform Chiesi of the occurrence of each such event.

 

(ii)                                  Chiesi shall pay the difference between the Purchase Price and the Glybera Manufacturing Cost Reimbursement within [**] days following the delivery of a particular patient dose of the Product in accordance with Section 2.5.

 

(iii)                               Section 2.1(e) to (h) shall apply.

 

2.4                               Forecasts; Firm Orders.

 

(a)                                 Forecasts.  Chiesi shall provide uniQure a non-binding forecast by [**], detailing the quantity of Product required for 2013. Every [**] months thereafter (i.e. no later than [**]) Chiesi shall provide uniQure a non-binding forecast detailing the quantity of Product per [**] required for the respective following [**] months period. Chiesi shall make all forecasts in good faith given market and other information available to Chiesi.

 

(b)                                 Firm Orders.  Chiesi shall purchase the Product solely by Firm Orders. Firm Orders consist of the number of patient doses for a period of [**] months specified per month. Chiesi shall submit each such Firm Order to uniQure at least [**] months in advance of the anticipated release date as specified in each Firm Order. Chiesi shall submit Firm Orders for the Product [**] times per calendar year no later than [**]. Notwithstanding the foregoing and the condition precedent set forth in Section 9.1(b), Chiesi shall submit the first Firm Order no later than [**] days after the Effective Date. Any terms or conditions contained in any Firm Order, acknowledgment, invoice, bill of lading, acceptance, or other writing or document issued by either Party, whether or not in conflict with the terms of this Agreement, shall be null and void without further notice required to be given by the other Party.

 

(c)                                  Order Processing.  In order to become effective, each Firm Order placed by Chiesi shall be confirmed by uniQure by facsimile or email showing the confirmed quantity indicated in each Firm Order and delivery (i.e. through storage at uniQure’s warehouse) date of the Product within [**] Business Days of receipt (the “Confirmed Firm Order”), provided that, if uniQure does not provide an acknowledgment of the Confirmed Firm Order within such period, uniQure shall be deemed to have confirmed the corresponding Firm Order. uniQure shall not be obliged to accept and 

 

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fulfill any Firm Orders which exceed [**] percent ([**]%) of the Product quantity indicated in each relevant forecast. uniQure shall ensure availability of confirmed quantities of the Product within [**] months after uniQure’s receipt of the corresponding Firm Order, provided, however, that in case a Firm Order exceeds [**] percent ([**]%) of the Product quantity indicated in each relevant forecast for the relevant period, and uniQure accepts such Firm Order, uniQure and Chiesi shall agree to a new release date and uniQure shall be entitled to release any amounts of Product exceeding the above threshold within [**] months after uniQure’s receipt of such Firm Order. uniQure shall store such Product at uniQure’s warehouse at uniQure’s cost.

 

(d)                                 Batch Sizes.  All quantities of Product ordered by Chiesi shall be consistent with uniQure’s current minimum batch sizes for the applicable Product (the “Minimum Order Quantity”), or multiples thereof, as set forth in Schedule 2.4(d). Notwithstanding the foregoing, uniQure agrees to support and cooperate with Chiesi to accept, fulfill and deliver order quantities at amounts less than the Minimum Order Quantity, in the event that Chiesi’s good faith internal evaluations or the requirements of customers for the Product support or require smaller quantity Firm Orders.

 

2.5                               Shipment and Delivery.

 

(a)                                 Terms.  Within [**] Business Days following receipt of a Delivery Notification from Chiesi, UniQure shall manufacture the finished dosage form of the Product for the quantities specified in the Delivery Notification (not to exceed the quantities in the respective Confirmed Firm Order), and ship such quantities of Product directly to the customers of Chiesi, together with a corresponding invoice to Chiesi. The Parties shall agree, after [**] the Effective Date, on a reduction of the [**] Business Day period set forth above. All quantities of Product shall be delivered EXW uniQure’s facility in Amsterdam. Chiesi shall obtain at its cost all necessary export or import licenses and permits to export or import the relevant quantities of the Product into the relevant country or jurisdiction of the Territory. Title and risk of loss and damage for any Product delivered pursuant to this Agreement shall pass to Chiesi at the time the same are tendered by uniQure to the carrier for delivery to Chiesi’s customers. uniQure shall pack Product for shipment in accordance with uniQure’s standard procedures and Applicable Laws, unless otherwise specified in writing by Chiesi within the scope of mandatory Applicable Laws [**] days prior to such shipment, in which event any extra costs incurred by uniQure on account of the packaging changes requested by Chiesi shall be promptly reimbursed by Chiesi.

 

(b)                                 Delivery Notification.  For each supply of Product to each of its customers, Chiesi shall ensure and confirm to uniQure in writing (each a “Delivery Notification”) that (i) the Product has obtained Price and Reimbursement Approval in the relevant part of the Territory, except for Germany until the relevant Price and Reimbursement Approval has been obtained, and (ii) the healthcare professionals involved in the treatment of a patient have received the educational pack and the patient to be treated with the supplied Product is included in the Registry.

 

(c)                                  Release.  uniQure shall perform release testing pursuant to the Specifications and in accordance with uniQure’s standard procedures regarding the Manufacturing of Product. After each shipment of Product, uniQure shall release the Product and provide to Chiesi a Certificate of Analysis and a Certificate of Compliance 

 

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and such other documents as may be required by Applicable Laws or mutually agreed by the Parties.

 

(d)                                 Minimum Remaining Shelf-life and Returns.  Product returns shall be the sole responsibility of Chiesi and uniQure shall have no obligation with respect to any such returned Product, provided that the releasing Qualified Person should be informed of return and final disposition and all Products supplied by uniQure hereunder shall have a minimum remaining shelf life upon delivery equal to no less than [**] months of the shelf-life set forth in the relevant Specifications or such longer period as required by a relevant customer in the Territory.

 

2.6                               Failure to Supply.

 

(a)                                 In the event that it becomes apparent to uniQure that it will be unable to fulfill any Confirmed Firm Order for the Product (“Failure to Supply”), uniQure shall, immediately after learning of such event or circumstances, notify Chiesi in writing of uniQure’s Failure to Supply, along with a reasonable explanation of the reason, to the extent then known to uniQure, for uniQure’s Failure to Supply and with a specific indication of the quantity of Product affected by such Failure to Supply and anticipated timing of delivery of the Product. Promptly after Chiesi’s receipt of any such notice, the Parties shall agree upon mutually acceptable revised quantities and delivery dates with respect to the Product subject to such Confirmed Firm Order or, to the extent this is not possible in light of the specific or then unknown reason for uniQure’s Failure to Supply, shall discuss in good faith measures to further investigate the root cause and, as the case may be, appropriate steps to overcome such Failure to Supply.

 

(b)                                 Notwithstanding paragraph (a), in the event that Chiesi cannot fulfill any firm orders for the Product received from any Third Parties as a consequence of uniQure’s Failure to Supply, except if such Failure to Supply is caused as a result of any Force Majeure Event, then Chiesi shall be entitled to an indemnification payment equal to Chiesi’s Lost Profit for the period during which Chiesi has been affected by the Failure to Supply. Any indemnification payment made to Chiesi under this paragraph for Failure to Supply shall be reimbursed in full to uniQure, in case any patient who suffered from the Failure to Supply is then subsequently treated. Such indemnification payments and reimbursements, if any, shall be calculated on a calendar year basis, such calculation to be made within [**] days after the end of the corresponding calendar year and any resulting amount to be paid within [**] days after such calculation has been made.  uniQure, in relying on the above Force Majeure Event exceptions, shall provide reasonably detailed particulars of the reasons underlying any such Force Majeure Event to Chiesi and shall allocate its existing stocks of the Product between uniQure, its Affiliates, Chiesi and other distributors of the Product, on a pro-rata basis, based upon order volumes for the Product for the prior [**]month period.

 

(c)                                  For the purpose of this Section 2.6, “Profit” shall be calculated, on a per Product basis, as the difference between (a) the relevant Average Net Sales Price that would have applied to the Product affected by the Failure to Supply and (b) the applicable Purchase Price for the Product affected by the Failure to Supply calculated as per Section 2.3 above, and “Lost Profit” shall mean the accumulated Profit for all quantities of Product affected by the Failure to Supply.

 

(d)                                 Without prejudice to the foregoing paragraphs (a) to (c), if

 

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(i)                                     uniQure’s Failure to Supply affects at least [**] consecutive Confirmed Firm Orders for a period of no less than nine (9) months, and

 

(ii)                                  the reason for uniQure’s Failure to Supply could be established during the Parties’ discussion pursuant to paragraph (a) above, and such reason was specifically related to uniQure’s ability to Manufacture the Product at its current manufacturing site (i.e. the Failure to Supply could reasonably be expected to be overcome if the Product was Manufactured at a different manufacturing site),

 

upon either Party’s request, the Manufacturing of the Product shall be transferred to (A) uniQure’s US manufacturing site, provided such site is operational at the relevant point in time, and further provided uniQure, within [**] following such request, does not opt against such transfer, and (B) otherwise (i.e. if uniQure opts against such transfer within the foregoing [**] period) to any other Third Party manufacturer mutually agreed to by uniQure and Chiesi. uniQure shall efficiently and promptly transfer to its US manufacturing site or, as the case may be, such Third Party manufacturer all information, licenses and rights controlled by uniQure and necessary to Manufacture and supply the Product to Chiesi hereunder during the continuance of uniQure’s Failure to Supply. Such transfer shall ensure uniQure’s ongoing control over the information, licenses and right so transferred, shall include the steps outlined in Schedule 2.6, and shall occur through email and videoconference interactions, as well as face-to-face meetings as required to ensure efficient transfer of technologies and capabilities.

 

If uniQure’s US manufacturing site or, as the case may be, such Third Party manufacturer is unable to Manufacture the Product within [**] months after uniQure has started the technology transfer to such person, Chiesi shall have the right to terminate this Agreement with three (3) month notice in writing, except if uniQure’s Failure to Supply is caused as a result of a Force Majeure Event. Such termination shall not become effective if, during such three (3) month notice period, uniQure has notified Chiesi of the ability of its US manufacturing site or, as the case may be, such Third Party manufacturer to Manufacture the Product. Upon termination of this Agreement by Chiesi pursuant to this Section 2.6(d), the provisions of Section 9.3(b) (i), (ii) and (iv) shall apply.

 

(e)                                  Without prejudice to the foregoing paragraphs (a) to (c), if

 

(i)                                     uniQure’s Failure to Supply affects at least [**] consecutive Confirmed Firm Orders for a period of no less than nine (9) months, and

 

(ii)                                  the reason for uniQure’s Failure to Supply (A) could be established during the Parties’ discussion pursuant to paragraph (a) above, but such reason was not specifically related to uniQure’s ability to Manufacture the Product at its current manufacturing site (i.e. the Failure to Supply could not reasonably be expected to be overcome if the Product was Manufactured at a different manufacturing site), or (B) could not be established during the Parties’ discussion pursuant to paragraph (a) above during at least the foregoing nine (9) months period, and

 

(iii)                               uniQure’s Failure to Supply is not caused as a result of a Force Majeure Event,

 

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Chiesi may terminate this Agreement with three (3) month notice in writing. Such termination shall not become effective if, during such three (3) month notice period, uniQure has notified Chiesi of the end of its Failure to Supply and has provided to Chiesi at least [**] of the outstanding Confirmed Firm Orders. Upon termination of this Agreement by Chiesi pursuant to this Section 2.6(e), the provisions of Section 9.3(b) (i), (ii) and (iv) shall apply.

 

(f)                                   Without prejudice to the foregoing paragraphs (a) to (e), if within [**] months after uniQure has notified Chiesi in writing of uniQure’s Failure to Supply, any Person is unable to Manufacture and supply the Product to Chiesi hereunder, then for any possible future supply of the Product to Chiesi hereunder, the percentage set out in Section 2.3(b)(i) above shall be reduced to [**] percent ([**]%) for any individual Product ordered after the end of uniQure’s Failure to Supply for a period equivalent to the duration of uniQure’s Failure to Supply (i.e. if uniQure’s Failure to Supply lasted for [**] months, the reduced percentage of [**] percent ([**]%) shall apply to any individual Product ordered during the [**] months period after the end of uniQure’s Failure to Supply).

 

ARTICLE III

QUALITY, REGULATORY AND PHARMACOVIGILANCE MATTERS

 

3.1                               Permits.

 

(a)                                 uniQure shall be responsible for any filing, holding and maintenance associated with all Marketing Authorizations for the Product in Territory A, and Chiesi shall be responsible for any filing, holding and maintenance associated with all Marketing Authorizations for the Product in Territory B. Notwithstanding the foregoing, if, according to local mandatory regulatory requirements, uniQure is not eligible as Marketing Authorization holder of the Product in any country of Territory A, or Chiesi is not eligible as Marketing Authorization holder of the Product in any country of Territory B, Chiesi or, as the case may be, its Sub-distributor, or uniQure, shall become the Marketing Authorization holder of the Product in such country of the Territory. Details regarding each Party’s responsibilities and obligations and the exchange of information in the process of filing, holding and maintaining any Marketing Authorizations for the Product in the Territory shall be agreed upon between the Parties in the Regulatory Plan. Notwithstanding the foregoing and except as otherwise set forth in this Agreement, including the Regulatory Plan, the Quality Agreement and the SDEA, each Party shall, at such Party’s sole cost and expense, maintain in full force and effect all other Regulatory Approvals required by Applicable Laws to carry out such Party’s duties and obligations under this Agreement.

 

(b)                                 Without prejudice to the generality of paragraph (a) above, (i) uniQure and Chiesi shall share equally the cost associated with the Registry in the EU, the PIP (Pediatric Investigation Plan) and any Phase IV clinical study regarding the Product mutually agreed between the Parties, (ii) uniQure shall be responsible for any filing, holding and maintenance fees associated with Marketing Authorizations and Marketing Authorization Applications in Territory A, including in the countries outside of the EU Member States, as further agreed between the Parties during the Term in accordance with Schedule 3.1, CMC (Chemistry, Manufacturing, and Controls), and pharmacovigilance regarding the Product in the Territory (except for the Registry), and (iii) Chiesi shall be responsible for any filing, holding and maintenance fees associated with Marketing 

 

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Authorizations and Marketing Authorization Applications in Territory B as further agreed between the Parties during the Term in accordance with Schedule 3.1, any changes (other than Required Manufacturing Changes and Discretionary Manufacturing Changes which are governed by Section 3.4 below) Chiesi shall request with respect to the Product, and reporting of safety data regarding the Product in Territory B.

 

3.2                               Regulatory Plan and Responsibility.  The Parties shall adopt a regulatory plan relating to the Product (the “Regulatory Plan”) a draft of which shall be attached as Schedule 3.2 and which shall be finalized by the Parties as soon as possible after the Effective Date, but in any event within [**] weeks thereafter. The Regulatory Plan shall be approved by the JCC and may be updated from time to time through the JSC or the JCC.

 

3.3                               Quality Agreement and Safety Data Exchange Agreement.

 

(a)                                 As soon as possible after the Effective Date, but in any event within [**] days after the Effective Date, the Parties shall enter into a quality agreement regarding the Product (the “Quality Agreement”), whereby the Parties shall define their respective responsibilities in relation to GDPs and quality matters, Specifications, release and supply of the Product. In the event of a conflict between the terms of this Agreement and the Quality Agreement, the terms of this Agreement shall govern.

 

(b)                                 Without prejudice to the generality of Section 3.1(b) above, as soon as possible after the Effective Date, but in any event within [**] days after the Effective Date, the Parties shall enter into a safety data exchange agreement (the “SDEA”) that defines the roles and responsibilities of each Party in terms of pharmacovigilance and the detailed safety exchange required to permit compliance by each Party with safety reporting requirements to Regulatory Authorities in the Territory. In the event of a conflict between the terms of this Agreement and the SDEA, the terms of this Agreement shall govern.

 

3.4                               Change Management.

 

(a)                                 For changes to the Specifications or Manufacture processes of the Product that are required by Applicable Laws in the Territory (collectively, “Required Manufacturing Changes”), uniQure and Chiesi shall cooperate in making such changes in a timely manner.

 

(b)                                 For changes to the Specifications or Manufacture processes of the Product that are not Required Manufacturing Changes (collectively, “Discretionary Manufacturing Changes”), uniQure and Chiesi must each agree in writing to any Discretionary Manufacturing Changes before such change is implemented, provided that neither Party shall unreasonably withhold its consent to such Discretionary Manufacturing Changes.

 

(c)                                  Unless otherwise agreed between the Parties, through the JSC or JCC, uniQure’s quality system, as further defined in the Quality Agreement, shall be utilized by the Parties in reviewing and implementing any changes under this Section 3.4.

 

(d)                                 The commercially reasonable costs, including obsolete raw materials, work-in-process, product packaging and labeling materials, (i) associated with 

 

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Required Manufacturing Changes shall be shared equally between uniQure and Chiesi, and (ii) associated with Discretionary Manufacturing Changes shall be borne by the Party initiating such changes.

 

3.5                               Stability Testing; Validation. uniQure shall perform stability testing, process validation or cleaning validations with respect to the Product in accordance with uniQure’s standard procedures, as further defined in the Quality Agreement, and Applicable Laws. Any additional testing reasonably requested by Chiesi shall be performed by uniQure at the expense of Chiesi.

 

3.6                               Recalls; Product Complaints.

 

(a)                                 uniQure shall have the sole authority and responsibility to respond to any Regulatory Authority, to respond to Product Complaints and to handle all recalls and market withdrawals of the Product in accordance with Applicable Laws, provided, that in all cases, unless otherwise required to comply with any Applicable Laws or any decision, order, request or directive of a Regulatory Authority, Chiesi shall release no communication into the marketplace regarding such Product Complaints, recalls or market withdrawals without first obtaining uniQure’s consent to such communication, which shall not be unreasonably withheld. Other complaints related to the Product, in particular complaints not related to regulatory matters, shall be managed solely by Chiesi.

 

(b)                                 Each Party shall promptly (but in any case, not later than [**] Business Days) notify the other Party in writing of any decision, order, request or directive of a Regulatory Authority to recall, withdraw or field correct any Product. UniQure shall promptly (but in any case, not later than [**] Business Days) notify Chiesi of any voluntary decision to recall, withdraw or field correct any Product. uniQure shall be solely responsible for determining whether to issue a recall, withdrawal, or field correction (but shall comply with all Applicable Laws in making such determination) and for the cost and expense of any such recall, withdrawal or field correction; provided, that uniQure shall give due consideration to all comments timely made by Chiesi relating to the Manufacture or testing of the Product and shall notify Chiesi in writing if uniQure declines to address any such comments, stating the reason therefor. If any recall, market withdrawal or field correction is not due to uniQure’s Manufacture of the Product, then uniQure shall be relieved of uniQure’s obligations to supply the Product hereunder until the cause of such recall, withdrawal or field correction has been resolved to the satisfaction of the Parties and the applicable Regulatory Authority, and during such period such relief shall be deemed a Force Majeure Event for the purposes of this Agreement.

 

(c)                                  Notwithstanding the foregoing paragraphs (a) and (b), but without prejudice to any obligations of uniQure under mandatory Applicable Laws, to the extent possible with view to any timelines applicable under Applicable Laws, the Parties, through the JSC or JCC, shall mutually discuss any of the foregoing events (i.e. response to any Regulatory Authority, response to Product Complaints, recalls, market withdrawals, field corrections) and agree on a joint communication in relation to such event both to any Regulatory Authority and the marketplace taking into account both the regulatory and commercial implications associated with such event and communication.

 

3.7                               Notice of Government Inspections.  Each Party agrees that, to the extent such Party becomes aware of the results, observations or outcome of any inspections or 

 

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audits of the facilities or operations involved in the Manufacture or Commercialization of the Product conducted by a Regulatory Authority, such Party will notify the other Party of any such information as it directly relates to the Product within [**] Business Days after obtaining the information and shall provide the other Party with a copy of any written materials provided by the Regulatory Authority in connection with such inspection or audit. Each Party will provide the other with copies of reports of quality audits conducted by such Party with respect to the Product and will apprise the other Party of material Manufacture, marketing, promotion, sales, or other issues affecting supply or Commercialization of the Product.

 

3.8                               Government Inquiries.  If either Party shall be contacted by any Regulatory Authority for any regulatory purpose pertaining specifically to this Agreement or to the Product, such Party shall immediately notify the other Party. Either Party may permit unannounced inspections of the Product or facilities by a Regulatory Authority with competent jurisdiction and may respond to the extent necessary to comply with such Party’s obligations under Applicable Laws.

 

3.9                               Inspections / Audit of Records and Facilities.  Unless otherwise required by Applicable Laws or any decision, order, request or directive of a Regulatory Authority, [**](or in case of uniQure’s facilities being inspected, up to [**] times a year [**]), for a period of no more than [**] Business Days and by no more than [**] designated personnel, each Party shall have reasonable access during normal business hours to the other Party’s regulatory files as they relate to the Manufacture and Commercialization of the Product in the Territory to (a) review all such records, correspondence, notices, documents, and other materials (including warning letters and letters of adverse findings) and (b) inspect the other Party’s facilities for compliance with this Agreement, in particular to inspect and audit uniQure’s standard procedures regarding the Manufacturing of Products. Any inspection shall not unreasonably disrupt the normal operations of the inspected Party and shall be announced with a notice period of at least [**] months prior to such audit.

 

3.10                        Price and Reimbursement Approvals.  Subject to Section 8.1(a) and(c) below, taking into account uniQure’s unique experience and understanding of Gene Therapy generally and the Product specifically, both Parties agree that Chiesi and uniQure shall jointly consult and prepare the pricing strategy for the Price and Reimbursement Approvals of the Product in the Field in the Territory to be filed and obtained by Chiesi. For the avoidance of doubt and in accordance with Section 8.1(c) below, such consultation shall not establish or create any obligation of Chiesi to set a certain or fixed price for the Product.

 

ARTICLE IV

GOVERNANCE; DECISION MAKING

 

4.1                               Joint Steering Committee.

 

(a)                                 Formation and Membership.  Within [**] days after the Effective Date, Chiesi and uniQure shall establish a joint steering committee (the “JSC”) to manage the Collaboration. The JSC to be established under this Agreement shall be identical to the one to be established under the Co-Development and License Agreement. The JSC shall be comprised of [**] executives or senior employees of Chiesi and [**] executives or senior employees of uniQure with appropriate experience and level of decision-making

 

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authority. From time to time, in addition to the JCC described below, the Parties may establish one or more subcommittees of the JSC to oversee particular projects or activities (e.g., activities under the Co-Development and License Agreement, financial reporting). Each such subcommittee shall be comprised of an equal number of representatives from each Party with appropriate experience and level of decision-making authority. Each subcommittee shall meet with a frequency to be agreed on by the Parties. Each Party may change any one or more of its representatives on the JSC or any subcommittee at any time upon written notice to the other Party.

 

(b)                                 Responsibilities.  The JSC shall be responsible for:

 

(i)                                     providing overall direction of the Collaboration;

 

(ii)                                  attempting to resolve disputes arising under the Collaboration Agreements; and

 

(iii)                               performing such other tasks and undertaking such other responsibilities as may be set forth in the Collaboration Agreements.

 

(c)                                  Meetings.

 

(i)                                     The JSC shall meet at least [**], by tele- or video-conference or in person, with the meetings in approximately [**] to be held in-person. The location of in-person JSC meetings shall alternate between the headquarters offices of each Party, with the first meeting to take place at [**] within [**] days after the Effective Date.

 

(ii)                                  Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JSC and any subcommittees. In addition, each Party may, at its discretion, invite a reasonable number of non-voting employees or officers, and, with the consent of the other Party, consultants or scientific advisors, to attend meetings of the JSC or any subcommittee, or the relevant portion thereof; provided that, its representatives and any such other employees, officers, consultants or scientific advisors are bound by written obligations of confidentiality that are at least as stringent as those set forth in this Agreement. Each Party shall bear all travel and living expenses of its representatives and other employees, officers, consultants or scientific advisors incurred to attend the meetings of the JSC or any subcommittee.

 

(iii)                               Either Party may also request, by providing written notice to the other Party, that a special meeting of the JSC be convened for the purpose of resolving disputes in connection with, or for the purpose of reviewing or making a decision pertaining to, any material matter within the purview of the JSC, the examination or resolution of which cannot reasonably be postponed until the next scheduled JSC meeting. Such meeting shall be convened at such time as may be mutually agreed upon by the Parties, but in any event shall be held within [**] days after the date of such notice.

 

(d)                                 Administrative Matters.  The right to appoint the chairperson of the JSC shall alternate on an annual basis between Chiesi and uniQure, with [**] having the right to appoint the chairperson for the first year of the Term. The Alliance Managers shall work with the chairperson to develop JSC meeting agendas. The chairperson shall be responsible for calling meetings of the JSC and for leading the meetings. A JSC

 

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member of the chairing Party shall serve as secretary of such meetings. The secretary shall promptly prepare and distribute to all members of the JSC draft minutes of the meeting for review and comment, including a list of any actions or decisions approved by the JSC, with the goal of distributing final approved minutes of each JSC meeting within [**] days after the meeting. Neither the chairperson nor the secretary shall have any greater authority than any other representative on the JSC and the Party appointing the chairperson and the secretary shall not have any greater authority than the other Party by virtue of its right to make such appointments. The chairperson shall include on the agenda any items proposed by either Party.

 

(e)                                  Decision Making.  Each Party, through its representatives, shall have one (1) vote on the JSC and each subcommittee. Both Parties must vote in the affirmative to allow the JSC or a subcommittee to take any action that requires the approval of the JSC or the subcommittee. Decision on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement. If a subcommittee is unable to resolve any dispute, or to unanimously agree on any matter, within its responsibilities, such dispute or matter shall be referred to the JSC for resolution. Either Party may convene a special meeting of the JSC in accordance with Section 4.1(c)(iii) for the purpose of resolving any dispute within the JSC’s jurisdiction that represents a material issue the resolution of which cannot reasonably await until the next scheduled meeting of the JSC.

 

(f)                                   Dispute Resolution by Executive Officers.

 

(i)                                     If the JSC is unable to resolve any dispute within the responsibilities of the JSC specified in Section 4.1(b) within [**] days after a Party provides notice to the other Party of the existence of such dispute, such dispute or other matter shall be referred to the Executive Officers for resolution. If a dispute is referred to the Executive Officers for resolution pursuant to the preceding sentence, the Executive Officers shall attempt in good faith to resolve such dispute within [**] days. In resolving any disputes under this Section 4.1(f), each Party shall act in good faith, subject to the terms and conditions of the Collaboration Agreements, and in a commercially reasonable manner without favoring other products being developed or commercialized by or on behalf of such Party or its Affiliates outside of the Collaboration.

 

(ii)                                  If the Executive Officers are unable to reach a consensus in accordance with paragraph (i) above, (A) uniQure shall have final decision-making authority with respect to all matters related to research or development in relation to the Product, with reasonable input from Chiesi taking into account Territory-specific matters, (B) Chiesi shall have final decision-making authority with respect to all matters related to Commercialization of the Product in the Territory, with reasonable input from uniQure taking into account uniQure’s global Product strategy, (C) subject to Sections 3.1 and 3.2, both Parties agree that on regulatory matters with respect to the Product they will jointly work towards a regulatory strategy for the Product in the countries of the Territory which are not EU Member States, and (D) any matter not falling within any of the foregoing categories (A) to (C) shall be decided by binding arbitration pursuant to Section 11.9 below.

 

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4.2                               Joint Commercialization Committee.

 

(a)                                 Formation and Membership.  Within [**] days after the Effective Date, Chiesi and uniQure shall establish, as a subcommittee of the JSC, a joint commercialization committee (the “JCC”) to manage the overall relationship between the Parties under this Agreement. The JCC shall be comprised of [**] executives or senior employees of Chiesi and [**] executives or senior employees of uniQure with appropriate experience and level of decision-making authority. From time to time, the Parties may establish one or more subcommittees of the JCC to oversee particular projects or activities (e.g., regulatory, supply, forecast, global brand integration). Each such subcommittee shall be comprised of an equal number of representatives from each Party with appropriate experience and level of decision-making authority. Each subcommittee shall meet with a frequency to be agreed on by the Parties. Each Party may change any one or more of its representatives on the JCC or any subcommittee at any time upon written notice to the other Party.

 

(b)                                 Responsibilities.  The JCC shall be responsible for:

 

(i)                                     periodically reviewing the Regulatory Plan and suggesting or approving such updates or amendments to the Regulatory Plan as the JCC deems appropriate, including all budgets relating to activities to be conducted hereunder and amendments thereto;

 

(ii)                                  ensuring consistency and coordination, to the maximum possible extent, between Commercialization activities to be conducted by uniQure in the Field outside the Territory and by Chiesi in the Field in the Territory;

 

(iii)                               providing overall strategic direction with respect to Commercialization and regulatory activities for the Product, including activities conducted under the Regulatory Plan;

 

(iv)                              overseeing Commercialization and regulatory activities for the Product;

 

(v)                                 discussing and addressing any supply chain or other delivery issues that have arisen or might arise relating to the Product;

 

(vi)                              attempting to resolve disputes arising under this Agreement that are referred to the JCC by either Party or any subcommittee; and

 

(vii)                           performing such other tasks and undertaking such other responsibilities as may be set forth in this Agreement or as may be delegated to it by the JCC.

 

(c)                                  Meetings.

 

(i)                                     The JCC shall meet at least [**], by tele- or video-conference or in person, with the meetings in approximately [**] to be held in-person. The location of in-person JCC meetings shall alternate between the headquarters offices of each Party, with the first meeting to take place at [**] within [**] days after the Effective Date.

 

(ii)                                  Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JCC and any subcommittees. In addition,

 

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each Party may, at its discretion, invite a reasonable number of non-voting employees or officers, and, with the consent of the other Party, consultants or scientific advisors, to attend meetings of the JCC or any subcommittee, or the relevant portion thereof; provided that, its representatives and any such other employees, officers, consultants or scientific advisors are bound by written obligations of confidentiality that are at least as stringent as those set forth in this Agreement. Each Party shall bear all travel and living expenses of its representatives and other employees, officers, consultants or scientific advisors incurred to attend the meetings of the JCC or any subcommittee.

 

(iii)                               Either Party may also request, by providing written notice to the other Party, that a special meeting of the JCC be convened for the purpose of resolving disputes in connection with, or for the purpose of reviewing or making a decision pertaining to, any material matter within the purview of the JCC, the examination or resolution of which cannot reasonably be postponed until the next scheduled JCC meeting. Such meeting shall be convened at such time as may be mutually agreed upon by the Parties, but in any event shall be held within [**] days after the date of such notice.

 

(d)                                 Administrative Matters.  [**] shall have the right to appoint the chairperson of the JCC. The Alliance Managers shall work with the chairperson to develop JCC meeting agendas. The chairperson shall be responsible for calling meetings of the JCC and for leading the meetings. A [**] JCC member shall serve as secretary of such meetings. The secretary shall promptly prepare and distribute to all members of the JCC draft minutes of the meeting for review and comment, including a list of any actions or decisions approved by the JCC, with the goal of distributing final approved minutes of each JCC meeting within [**] days after the meeting. Neither the chairperson nor the secretary shall have any greater authority than any other representative on the JCC and [**] shall not have any greater authority than [**] by virtue of its right to make such appointments. The chairperson shall include on the agenda any items proposed by either Party.

 

(e)                                  Decision Making.  Each Party, through its representatives, shall have one (1) vote on the JCC and each subcommittee. Both Parties must vote in the affirmative to allow the JCC or a subcommittee to take any action that requires the approval of the JCC or the subcommittee. Decision on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement. If a subcommittee is unable to resolve any dispute, or to unanimously agree on any matter, within its responsibilities, such dispute or matter shall be referred to the JCC for resolution. Either Party may convene a special meeting of the JCC in accordance with Section 4.2(c)(iii) for the purpose of resolving any dispute within the JCC’s jurisdiction that represents a material issue the resolution of which cannot reasonably await until the next scheduled meeting of the JCC.

 

(f)                                   Dispute Resolution.  If the JCC is unable to resolve any dispute within the responsibilities of the JCC specified in Section 4.2(b) within [**] days after a Party provides notice to the other Party of the existence of such dispute, then,(A) the respective representative(s) of each Party in the JCC may exercise the final decision-making authority of each Party pursuant to Section 4.1(f)(ii)(A) or, as the case may be, Section 4.1(f)(ii)(B) also at the JCC level or decide to refer such dispute to the JSC for decision, and (B) any matter not falling within any of the categories of Section

 

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4.1(f)(ii)(A) or, as the case may be, Section 4.1(f)(ii)(B) shall be referred to the JSC for decision.

 

4.3                               Alliance Managers.  Each Party shall appoint an employee (or an employee of its Affiliate) to serve as an alliance manager (“Alliance Manager”) with responsibility for overseeing that the Parties’ activities are conducted in accordance with the Collaboration Agreements, and for being the primary point of contact between the Parties with respect to all such activities. The Alliance Managers to be appointed under this Agreement shall be identical to the ones to be appointed under the Co-Development and License Agreement. The Alliance Managers are responsible for driving the Collaboration progress and the resolution of issues between the Parties. The Alliance Managers may be members, but in any event may attend the meetings of the JSC, JCC or any other JSC subcommittee, and be responsible for communicating with and reporting to the JSC, JCC and any other JSC subcommittee on all relevant matters.

 

ARTICLE V

REPRESENTATIONS, WARRANTIES AND COVENANTS

 

5.1                               Mutual Representations, Warranties and Covenants. Each Party hereby represents, warrants and covenants to the other Party, as of the Effective Date and, where expressly stated, at all times during the Term, as follows:

 

(a)                                 Such Party: (i) is duly formed and in good standing under the laws of the jurisdiction of its formation, (ii) has the power and authority and the legal right to enter into this Agreement and perform its obligations hereunder, and (iii) has taken all necessary action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;

 

(b)                                 Upon execution, this Agreement will have been duly executed and delivered on behalf of such Party and constitutes a legal, valid and binding obligation of such Party and is enforceable against it in accordance with its terms;

 

(c)                                  The execution and delivery of this Agreement and the performance of such Party’s obligations hereunder: (i) do not conflict with or violate any requirement of Applicable Laws or any provision of the articles of incorporation, bylaws or limited partnership agreement of such Party; and (ii) do not conflict with, violate, or breach, or constitute a default or require any further consent under, any contractual obligation or court or administrative order by which such Party is bound;

 

(d)                                 During the Term, to its knowledge, such Party will not, in the conduct of its activities under this Agreement, (i) employ or use any contractor or consultant that employs any individual or entity debarred by the FDA (or subject to a similar sanction of EMA), or (ii) employ any individual who or entity that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMA);

 

(e)                                  During the Term, such Party shall perform its activities pursuant to this Agreement in compliance in all material respects with Applicable Laws;

 

(f)                                   During the Term, neither Party shall grant any right or license to any Third Party relating to any of the Intellectual Property Rights it Controls which would

 

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conflict with, or limit the scope of, any of the rights or licenses granted or to be granted to the other Party hereunder.

 

5.2                               Additional Representations, Warranties and Covenants of uniQure. uniQure hereby represents, warrants and covenants as of the Effective Date, and, where expressly stated, at all times during the Term, that:

 

(a)                                 During the Term, at the time the same are tendered to the carrier for delivery to Chiesi’s customers, the Product sold to Chiesi pursuant to this Agreement (i) shall be Manufactured, stored, handled and released in compliance with all Applicable Laws, including GMPs; (ii) shall meet the applicable Specifications and (iii) shall not be adulterated or misbranded or otherwise defective within the meaning of any Applicable Laws;

 

(b)                                 Schedule 1.63 attached hereto is a complete and correct list of all Patents that Cover the Product in the Territory and, subject to Section 9.1(b), are Controlled by uniQure as of the Effective Date;

 

(c)                                  uniQure Controls all uniQure Intellectual Property and, subject to Section 9.1(b), has the full right, power and authority to grant to Chiesi the rights and licenses necessary to perform Chiesi’s activities under this Agreement in the Territory;

 

(d)                                 To uniQure’s knowledge, the Commercialization of the Product in the Territory, as anticipated hereunder, does not infringe upon any Intellectual Property Rights of any Third Party;

 

(e)                                  uniQure has not received any written allegation from a Third Party that any of the Patents issued on the Effective Date which is Controlled by UniQure and Covering the Product in the Territory is invalid or unenforceable and, to uniQure’s knowledge, none of such Patents is infringed by any Third Party.

 

5.3                               Additional Representations, Warranties and Covenants of Chiesi. Chiesi hereby represents, warrants and covenants as of the Effective Date, and, where expressly stated, at all times during the Term, that any and all Delivery Notification requirements set forth in Section 2.5(b) shall be fulfilled before any quantities of the Product are supplied to any of its customers.

 

5.4                               No Other Representations or Warranties.  EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY THAT ANY PATENT RIGHTS ARE VALID OR ENFORCEABLE, AND EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, EACH PARTY DISCLAIMS ANY WARRANTIES WITH REGARDS TO: (A) THE SAFETY, USEFULNESS FOR ANY PURPOSE OR NON-INFRINGEMENT OF ANY PRODUCT; OR (B) THE VALIDITY, ENFORCEABILITY OR NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS IT PROVIDES OR LICENSES TO THE OTHER PARTY UNDER THIS AGREEMENT.

 

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5.5                               No Reliance by Third Parties.  The representations and warranties of a Party set forth in this Article 5 are intended for the sole and exclusive benefit of the other Party hereto, and may not be relied upon by any Third Party.

 

ARTICLE VI

INDEMNIFICATION; INSURANCE

 

6.1                               Indemnification by Chiesi.  Chiesi shall indemnify, defend and hold harmless uniQure and its Affiliates, and its and their respective directors, officers, employees and agents, from and against any and all liabilities, damages, losses, costs and expenses, including the reasonable fees of attorneys and other professional Third Parties (collectively, “Losses”), arising out of or resulting from any and all Third Party suits, claims, actions, proceedings or demands (“Claims”) to the extent based upon:

 

(i)                                     any breach of any representation, warranty or covenant made by, or any material obligation of, Chiesi under this Agreement;

 

(ii)                                  the gross negligence, recklessness or willful misconduct of Chiesi or its Affiliates and its or their respective directors, officers, employees and agents;

 

(iii)                               any theory of product liability (including without limitation tort, warranty, or strict liability) that is applicable in the Territory with respect to the death, personal injury, or illness of any Person in the Territory, and arising directly from Chiesi’s or its Affiliates’ or Sub-distributors’ Commercialization of the Product in the Territory;

 

provided that Chiesi shall not be obligated pursuant to this Section 6.1 if and to the extent uniQure is required to indemnify Chiesi under Section 6.2 below.

 

6.2                               Indemnification by uniQure. uniQure shall indemnify, defend and hold harmless Chiesi and its Affiliates, and its and their respective directors, officers, employees and agents, from and against any and all Losses, arising out of or resulting from any and all Claims to the extent based upon:

 

(i)                                     any breach of any representation, warranty or covenant made by, or any material obligation of, uniQure under this Agreement;

 

(ii)                                  the gross negligence, recklessness or willful misconduct of uniQure or its Affiliates and its or their respective directors, officers, employees and agents;

 

(iii)                               any theory of product liability (including without limitation tort, warranty, or strict liability) that is applicable in the Territory with respect to the death, personal injury, or illness of any Person in the Territory, and arising directly from uniQure’s or its Affiliates’ development, design, Manufacture, storage, release and handling of the Product;

 

(iv)                              Claims that the (i) Commercialization of the Product; or (ii) exercise of any rights or licenses granted to Chiesi and its Affiliates in accordance with this Agreement; violates or infringes upon the Intellectual Property Rights of any Third Party;

 

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provided that uniQure shall not be obligated pursuant to this Section 6.2 if and to the extent Chiesi is required to indemnify uniQure under Section 6.1 above.

 

6.3                               Procedure.

 

(a)                                 A Party entitled to indemnification under this Article VI (an “Indemnified Party”) shall give prompt written notification to the Party from whom indemnification is sought (the “Indemnifying Party”) of the commencement of any Claim for which indemnification may be sought or, if earlier, upon the assertion of any such Claim by a Third Party (it being understood and agreed, however, that the failure by an Indemnified Party to give notice of a Claim as provided in this Section 6.3(i) shall not relieve the Indemnifying Party of its indemnification obligation under this Agreement except and only to the extent that such Indemnifying Party is actually damaged as a result of such failure to give notice).

 

(b)                                 Within [**] days after delivery of such notification, the Indemnifying Party may, upon written notice thereof to the Indemnified Party, assume control of the defense of such Claim with counsel reasonably satisfactory to the Indemnified Party.

 

(c)                                  If the Indemnifying Party does not assume control of such defense, the Indemnified Party shall control such defense and, without limiting the Indemnifying Party’s indemnification obligations, the Indemnifying Party shall reimburse the Indemnified Party for all reasonable costs and expenses, including reasonable attorney’s fees, incurred by the Indemnified Party in defending itself, within [**] days after receipt of any invoice therefor from the Indemnified Party, such invoice to be issued no more often than quarterly.

 

(d)                                 The Party not controlling such defense may participate therein at its own expense; provided that, if the Indemnifying Party assumes control of such defense and the Indemnified Party in good faith concludes, based on advice from counsel, that the Indemnifying Party and the Indemnified Party have conflicting interests with respect to such Claim, the Indemnifying Party shall be responsible for the reasonable fees and expenses of counsel to the Indemnified Party in connection with its participation in the defense action.

 

(e)                                  The Party controlling such defense shall keep the other Party advised of the status of such Claim and the defense thereof and shall consider recommendations made by the other Party with respect thereto.

 

(f)                                   The Indemnified Party shall not agree to any settlement of any Claim without the prior written consent of the Indemnifying Party, which shall not be unreasonably withheld, delayed or conditioned. The Indemnifying Party shall not, without the prior written consent of the Indemnified Party, agree to any settlement of such Claim, or consent to any judgment in respect thereof, that does not include a complete and unconditional release of the Indemnified Party from all liability with respect thereto, that imposes any liability or obligation on the Indemnified Party or that acknowledges fault by the Indemnified Party.

 

6.4                               Limitation of Liability.  EXCEPT WITH RESPECT TO ANY BREACH BY A PARTY OF ITS OBLIGATIONS UNDER ARTICLE X, EXCEPT AS

 

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PROVIDED FOR IN SECTION 2.6, EXCEPT FOR ANY DAMAGES ARISING FROM A PARTY’S WILLFUL MISCONDUCT AND EXCEPT TO THE EXTENT A PARTY MAY BE REQUIRED TO INDEMNIFY THE OTHER PARTY UNDER THIS ARTICLE VI WITH RESPECT TO THIRD PARTY CLAIMS, NEITHER PARTY SHALL BE LIABLE FOR ANY (AND EACH PARTY HEREBY DISCLAIMS ALL) SPECIAL, EXEMPLARY, CONSEQUENTIAL, PUNITIVE OR OTHER INDIRECT DAMAGES, INCLUDING LOST REVENUE AND LOST PROFITS, WHETHER BASED UPON WARRANTY, CONTRACT, TORT, STRICT LIABILITY OR OTHER LEGAL THEORY. EXCEPT WITH RESPECT TO ANY BREACH BY UNIQURE OF ITS OBLIGATIONS UNDER ARTICLE X, EXCEPT AS PROVIDED FOR IN SECTION 2.6, EXCEPT FOR ANY DAMAGES ARISING FROM UNIQURE’S WILLFUL MISCONDUCT AND EXCEPT TO THE EXTENT UNIQURE MAY BE REQUIRED TO INDEMNIFY CHIESI UNDER THIS ARTICLE VI WITH RESPECT TO THIRD PARTY CLAIMS, THE TOTAL LIABILITY OF UNIQURE, ITS AFFILIATES, AND THEIR RESPECTIVE OFFICERS, EMPLOYEES, AND AGENTS ARISING OUT OF OR IN RELATION TO THIS AGREEMENT, WHETHER BASED UPON WARRANTY, CONTRACT, TORT, STRICT LIABILITY OR OTHER LEGAL THEORY, SHALL FURTHER BE LIMITED TO AN AMOUNT OF EUR 10,000,000.00 (IN WORDS: TEN MILLION EURO) (REFLECTING THE AMOUNT PAYABLE UNDER UNIQURE’S INSURANCE PURSUANT TO SECTION 6.5) FOR THE CORRESPONDING DAMAGE EVENT. CHIESI SHALL REASONABLY COOPERATE WITH UNIQURE IN OBTAINING SUCH INSURANCE, AT UNIQURE’S COST.

 

6.5                               Insurance.  Each Party shall procure and maintain at its cost insurance, including product liability insurance, adequate to cover its obligations hereunder and which are consistent with normal business practices of comparable companies with respect to similar obligations and liabilities, at all times during the Term. In addition, uniQure shall further procure and maintain, at uniQure’s cost, insurance adequate to cover its obligations under the in-license agreement with Xenon Pharmaceuticals Inc. dated 18 June 2001 and Chiesi shall reasonably cooperate with uniQure in obtaining such insurance. It is understood that such insurance shall not be construed to create any limit of either Party’s obligations or liabilities with respect to its indemnification obligations hereunder. Each Party shall provide the other, upon request, with evidence of such insurance.

 

ARTICLE VII

INTELLECTUAL PROPERTY

 

7.1                               Ownership. uniQure shall own or otherwise Control all right, title and interest in and to any uniQure Intellectual Property Rights.

 

7.2                               Enforcement. uniQure shall have the exclusive right and the obligation, to institute infringement actions against any Third Parties (other than Sub-distributors) based on any Patents and other Intellectual Property Rights Covering the Product in the Territory. Chiesi shall execute all necessary and proper documents and take such actions as shall be appropriate to allow uniQure to institute and prosecute such infringement actions and shall otherwise cooperate, at uniQure’s expense, in the institution and prosecution of such actions. Upon reasonable request of Chiesi, uniQure (i) shall provide to Chiesi all reasonable information in connection with such infringement actions; (ii) shall allow a qualified representative of Chiesi to attend as an observer at relevant

 

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negotiations and hearings, if and to the extent such attendance is both legally permitted and reasonably acceptable for uniQure and (iii) shall consider any measures suggested by Chiesi in connection with such infringement actions, it being understood that uniQure, without any obligation to state reasons for its decision, shall not be obliged to accept, fulfill or maintain such measures.

 

7.3                               Right to Commercialize.

 

(a)                                 During the Term and subject to the terms of this Agreement, in particular Section 9.1(b), uniQure hereby grants to Chiesi and its Affiliates a royalty-free right and license, with the right to grant sublicenses only to Sub-distributors, in the Territory to uniQure Intellectual Property Rights that are required to Commercialize the Product in the Territory under and in accordance with the terms of this Agreement. Such right and license shall be exclusive except in cases where, based on agreements between uniQure and Third Parties existing on the Effective Date, uniQure is not capable of granting exclusive but only non-exclusive licenses (e.g. because uniQure itself has only obtained non-exclusive rights and licenses from Third Party licensors).

 

(b)                                 Chiesi shall not have the right to carry out any research or development with respect to the Product, or, subject to Sections 2.6, 9.3(b) and 9.3(c), to Manufacture the Product, or have the Product Manufactured by an Affiliate or Third Party.

 

7.4                               Compliance with Third Party Agreement.

 

(a)                                 The grants by uniQure under uniQure Intellectual Property Rights set forth in Section 7.3(a) include the sublicense of certain uniQure Intellectual Property Rights that are not owned by uniQure. Chiesi’s rights and licenses under, or with respect to, uniQure Intellectual Property Rights, including any Patent prosecution or enforcement undertaken by the Parties pursuant to Section 7.2, are limited to the rights granted by Third Party licensors to uniQure under the respective in-license agreements between such Third Party licensors and uniQure (“Existing Third Party Licenses”) and are subject to all applicable restrictions, limitations and obligations imposed on uniQure or its sub-licensees in such Existing Third Party Licenses, a copy of which agreements is attached hereto as Schedule 7.4. Chiesi shall comply, and cause its Affiliates and Sub-distributors to comply, with all such restrictions, limitations and obligations mutatis mutandis. To the extent there is a conflict between the terms of any Existing Third Party License and the rights granted to Chiesi hereunder, the terms of such Existing Third Party License shall control solely with respect to the Patents and know-how owned or controlled by the applicable Third Party licensor. Notwithstanding anything to the contrary in this Agreement, either Party may not exercise any of its rights under this Agreement (including any right to any cure period (including under Section 9.2(b)) or to delay performance of an obligation (including under Section 11.6)) in any manner that would result in any licensor having a right to terminate an Existing Third Party License, or that would cause the other Party to be in breach of any of its obligations under any Existing Third Party License.

 

(b)                                 During the Term, uniQure shall comply with the Existing Third Party Licenses in effect which are then applicable to the activities under this Agreement with respect to the Product (and in particular shall not commit any breach that would entitle the Third Party licensor to terminate such an Existing Third Party License) and

 

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shall not terminate any such Existing Third Party License without Chiesi’s prior written consent. In addition, during the Term, uniQure shall promptly notify Chiesi of any written notice of breach or termination received by uniQure with respect to any such Existing Third Party License and, to the extent that uniQure does not cure such breach at least [**] Business Days before the date on which the relevant licensor could terminate such Existing Third Party License due to such breach by uniQure, Chiesi shall have the right (to the extent consistent with such Existing Third Party License) to cure any such breach on uniQure’s behalf and in such a case, Chiesi shall have the right to deduct (i) any and all arm’s length payments made on behalf of uniQure for the above purpose, from the next due payments to be made hereunder plus (ii) interest on such payments calculated pursuant to Section 2.1(f) above.

 

(c)                                  The license granted by uniQure in Section 7.3(a) with respect to the Patents licensed under the Existing Third Party Licenses are subject to rights reserved by the licensors and the US government as set forth in the Existing Third Party Licenses.

 

7.5                               Additional Rights Acquired after Effective Date.

 

(a)                                 During the Term, if either Party identifies the need for, or is otherwise offered, a license, covenant not to sue or similar rights to any Third Party Intellectual Property Rights that such Party in good faith believes is necessary or useful for the Commercialization of the Product in the Field in the Territory (“Additional Rights”), then such Party shall promptly notify the other Party and, in any event, prior to commencing negotiation or entering into an agreement with respect to such Additional Rights, and the Parties’ rights to conduct such negotiations shall be subject to the remaining provisions of this Section 7.5. The Parties shall thereafter conduct good faith discussions regarding whether such Additional Rights are necessary or useful for the Commercialization of the Product in the Field in the Territory or whether they otherwise agree that such Additional Rights should be acquired.

 

(b)                                 uniQure shall have the first right (but not the obligation) to license or otherwise acquire rights to any Additional Rights. If uniQure provides written notice to Chiesi that uniQure declines to exercise such first right, then Chiesi shall have the right (but not the obligation) to pursue acquiring rights to any given Additional Rights. The Party pursuing any given Additional Rights (the “Controlling Party”) shall keep the other Party (the “Non-Controlling Party”) reasonably informed regarding the status thereof and shall use Commercially Reasonable Efforts to obtain from the applicable Third Party licensor the right to sublicense such Additional Rights under the licenses granted to the Non-Controlling Party hereunder.

 

(c)                                  If the Controlling Party acquires rights to any Additional Rights and has the right to grant a sublicense under such Additional Rights to the Non-Controlling Party, and the Non-Controlling Party wishes to include such Additional Rights in the licenses granted to the Non-Controlling Party hereunder, the Non-Controlling Party shall notify the Controlling Party of its desire to do so and the Controlling Party shall provide the Non-Controlling Party a summary of all material restrictions on the scope of the licenses granted under, and all material payment obligations that would be owed by the Non-Controlling Party with respect to, any Third Party agreement applicable to such Additional Rights. The Non-Controlling Party may, upon written notice to the Controlling Party and subject to Section 7.5(d), Section 7.5(e)

 

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and Section 7.5(f), obtain a sublicense under such Additional Rights and include such Additional Rights under the licenses granted to the Non-Controlling Party hereunder.

 

(d)                                 Following such notice from the Non-Controlling Party that it desires to include any given Additional Rights under the license granted to the Non-Controlling Party hereunder, (i) any such Additional Rights that do not carry financial or other obligations or restrictions shall be included automatically under the applicable license hereunder, and (ii) subject to Section 7.5(e) below, any such Additional Rights that carry financial or other obligations or restrictions shall be included under the applicable license hereunder only if the Non-Controlling Party agrees to share the costs of such Additional Rights (including any upfront payment or similar acquisition cost to access such Additional Rights) with the Controlling Party and to assume all other obligations to, and be subject to all restrictions imposed by, the Controlling Party’s licensor to the extent arising from the grant to the Non-Controlling Party under such Additional Rights (including, to the extent access to such terms have been made available to the Non-Controlling Party in unredacted form, all other terms of the Additional Rights Agreement that apply to the licenses granted to the Non-Controlling Party hereunder).

 

(e)                                  If the Parties are unable, after [**] Business Days, to agree as to whether any given Additional Rights are in fact necessary or useful for the Commercialization of the Product in the Field in the Territory or if the Parties are unable to agree to the allocation of the costs (as specified above), then the Parties shall jointly engage an expert panel consisting of patent attorney(s) or expert(s) in the development, manufacturing or commercialization of products comparable to the Product in question and other CMC matters, as applicable, not regularly employed by either Party to resolve such dispute. The decision of such expert panel shall be binding on the Parties as to such dispute.

 

(f)                                   Nothing in this Section 7.5 shall restrict either Party, at such Party’s sole cost and expense, from licensing or otherwise acquiring any additional rights that are not necessary or useful for the Commercialization of the Product in the Field in the Territory.

 

ARTICLE VIII

COMMERCIALIZATION

 

8.1                               Commercialization.

 

(a)                                 Chiesi shall have the sole right and responsibility, at its expense, to Commercialize the Product in the Field in the Territory, including for booking all sales of the Product throughout the Territory. At all times during the Term Chiesi shall in no event use less than Commercially Reasonable Efforts to Commercialize the Product, including compliance with marketing plan and budget, allocation of Minimum FTEs and setting of a Target Price (as defined in Schedule 8.1(a)) in Germany, as further described in Schedule 8.1(a). Notwithstanding the foregoing, Chiesi shall at least use Commercially Reasonable Efforts to achieve the First Commercial Sale of the Product in the Territory in the second half of 2013, provided that uniQure shall ensure availability of sufficient quantities of Product for supply to Chiesi’s customers for such purpose, prior to the First Commercial Sale. In the event Chiesi fails to meet (i) the allocation of Minimum FTEs or (ii) the timelines for submission of each relevant dossier for obtaining the Price and Reimbursement Approval for the Product, as further described in Schedule 8.1(a), and

 

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such failure is not caused by a Force Majeure Event or uniQure’s Failure to Supply, and Chiesi fails to cure such failure within [**] months after receiving written notice of such failure, uniQure shall have the right to terminate this Agreement in its entirety in the event of a failure as described in sub-paragraph (i) above or, at the sole discretion of uniQure, with respect to the particular countries to which such failure relates in the event of a failure as described in sub-paragraph (ii) above.

 

(b)                                 In order to prevent a substantial delay in achieving the First Commercial Sale of the Product in the Territory, certain commercial and development activities have been committed to by uniQure prior to the Effective Date (the “Approved Activities”) attached in Schedule 8.1(b). Such Approved Activities shall be reimbursed by Chiesi at uniQure’s actual cost.

 

(c)                                  Chiesi shall have the sole authority to determine the resale price of the Product in the Field in the Territory.

 

8.2                               Exclusivity.

 

(a)                                 During the Term, Chiesi shall not actively market, advertise for, canvas for or seek orders for the Product outside the Field or Territory or establish any branch, subsidiary, or depot for the supply of the Product outside the Field or Territory. The Parties shall inform each other promptly in case of any Commercialization activities of Third Parties in the Field in the Territory, or of any Commercialization activities of Chiesi or any of its Affiliates outside the Field or Territory to agree — within the limits of applicable competition laws — on any appropriate measures to be taken.

 

(b)                                 During the Term, uniQure shall not offer for sale, sell, license or otherwise Commercialize the Product in the Territory other than in compliance with the terms of this Agreement. uniQure shall be free, however, at any time during the Term, to Commercialize, directly or indirectly, the Product outside the Territory.

 

(c)                                  To the fullest extent consistent with any Applicable Laws, each Party shall, and shall procure that any of its Affiliates will, not directly or indirectly, itself or through or with or on behalf of any Third Party, develop, Manufacture or Commercialize in the Territory any Gene Therapy based product characterized to treat lipoprotein lipase deficiency, other than the Product in accordance with this Agreement. From time to time during the Term, the Parties may negotiate exceptions for Persons which will become Affiliates of a Party due to an acquisition of or by a Party or its Affiliates.

 

ARTICLE IX

TERM AND TERMINATION

 

9.1                               Term.

 

(a)                                 General.  This Agreement shall become effective as of the Effective Date and shall remain in force, on a country-by-country basis, for the longer of (i) twelve (12) years from the First Commercial Sale of the Product in the relevant country of the Territory; (ii) expiry of any regulatory exclusivity granted by any Marketing Authorization or any other Regulatory Approval in the relevant country of the Territory; or (iii) expiry of the last Valid Claim Covering the Product in the relevant

 

34

 

country of the Territory. Unless terminated by a Party with three (3) months written notice to the other Party to the end of the above initial or any subsequent term, this Agreement shall automatically be renewed for successive five (5) year terms (the initial and each subsequent term, the “Term”).

 

(b)                                 Condition Precedent.  This Agreement, except for the obligation to submit the first Firm Order in accordance with Section 2.4(b), and any ancillary agreement concluded between the Parties in connection herewith, including the Quality Agreement and the SDEA, and the Co-Development and License Agreement and the agreement regarding the equity investment of Chiesi in uniQure concluded on the date hereof, shall become effective once the Parties have received consent from or, as the case may be, entered into separate agreements with, the respective Third Party licensors to the subcontracting of the rights and licenses licensed by uniQure as licensee under the Existing Third Party Licenses listed in Schedule 9.1 to Chiesi. uniQure and, to the extent applicable, Chiesi, shall use Commercially Reasonable Efforts to obtain such consent or, as the case may be, enter into such agreements, on or prior to [**]. If, despite the Parties’ Commercially Reasonable Efforts, such consent has not been obtained from or, as the case may be, such agreements have not been entered into with, all such Third Party licensors by the end of [**], this Agreement and all other agreements that are subject to the condition precedent pursuant to sentence 1 shall be deemed null and void as of the Effective Date and the first Firm Order submitted by Chiesi in accordance with Section 2.4(b) shall be deemed withdrawn, unless, prior to the end of such period, following a corresponding request of either Party, the Parties mutually agree in writing on an extension of such period. The Parties agree that (i) costs and expenses incurred in connection with the preparation and execution of this Agreement as well as obtaining of the aforementioned consent or, as the case may be, enter into the aforementioned agreements, shall not be reimbursed, provided, however, that uniQure shall pay back to Chiesi any payments received in connection with this Agreement on or prior to [**] (or such extended period mutually agreed between the Parties in accordance with the foregoing), and (ii) Sections 10.1, 10.2 and 10.6 shall apply mutatis mutandis.

 

9.2                               Termination.  Without prejudice to any other termination rights set forth herein, the Parties shall have the following termination rights:

 

(a)                                 Mutual Agreement.  The Parties may terminate this Agreement at any time during the Term upon mutual agreement in writing.

 

(b)                                 Material Breach.  Either Party may immediately terminate this Agreement in writing if the other Party materially breaches this Agreement and fails to cure such breach within [**] days after receiving written notice of the breach.

 

(c)                                  Insolvency.  Either Party may immediately terminate this Agreement in writing if the other Party ceases to carry on business, is unable to pay its debts when they fall due, is declared bankrupt, or an order is made or a resolution passed for the winding up of that other Party or the appointment of an administrator, receiver, liquidator, or manager of that other Party.

 

(d)                                 IP Challenge.  Either Party may immediately terminate this Agreement in writing if the other Party or any of its Affiliates or, as the case may be, Sub-distributors challenges the validity of any trademark as set forth in Section 2.2(a) or if

 

35

 

Chiesi or any of its Affiliates or Sub-distributors challenges the validity, enforceability, patentability or scope of any Valid Claim included in any Patents.

 

9.3                               Effects of Expiration/Termination.

 

(a)                                 Upon termination of this Agreement by uniQure pursuant to Sections 8.1(a), 9.2(b), 9.2(c) or 9.2(d):

 

(i)                                     Chiesi shall purchase from uniQure any quantity of Product which has been included in a Confirmed Firm Order through the effective date of termination, unless otherwise elected by UniQure pursuant to Section 9.3(a)(ii) below;

 

(ii)                                  (A) all rights, privileges and licenses granted hereunder to Chiesi shall remain in full force and effect until all quantities of Product ordered and delivered hereunder, at the election of uniQure, (y) have been sold by Chiesi, or (z) have been redeemed by uniQure from Chiesi at the Purchase Price originally charged to Chiesi except for such portion of Product as is needed to fill orders then held by Chiesi; and (B) Chiesi shall thereafter not make any use whatsoever of any such rights, privileges and licenses and transfer to uniQure any Marketing Authorization then held by Chiesi or its Sub-distributor, unless required by Applicable Laws or expressly set forth otherwise in this Agreement;

 

(iii)                               save as required under the Quality Agreement or the SDEA, at any time upon written request of the disclosing Party, unless expressly set forth otherwise in this Agreement, the receiving Party shall cease use of and return or at the disclosing Party’s request destroy all Confidential Information of the disclosing Party and all copies thereof except for a single copy of such Confidential Information that may be retained confidentially for legal purposes only;

 

(iv)                              all rights, privileges and licenses granted hereunder to uniQure regarding any alternative Trademark identified by Chiesi and any other trademarks, logos or service marks of Chiesi shall become fully paid-up, irrevocable and perpetual.

 

(b)                                 Upon termination of this Agreement by Chiesi pursuant to Sections 9.2(b), 9.2(c) or 9.2(d):

 

(i)                                     all rights, privileges and licenses granted hereunder to Chiesi regarding the uniQure Intellectual Property Rights, including the rights granted under Section 2.2(a), shall become fully paid-up, irrevocable and perpetual;

 

(ii)                                  all rights, privileges and licenses granted hereunder to uniQure shall terminate and uniQure shall not make any use whatsoever of any alternative Trademark identified by Chiesi and any other trademarks, logos or service marks of Chiesi, unless required by Applicable Laws or expressly set forth otherwise in this Agreement;

 

(iii)                               uniQure shall furnish Chiesi with reasonable cooperation, and continue to supply Chiesi’s requirements of Product for the [**] month period following notice of termination in accordance with the terms and conditions of this Agreement, provided however, that the Purchase Price for the individual Product ordered

 

36

 

after the effective date of termination shall be the Fully Loaded Cost of Goods plus [**] percent ([**]%) markup for each patient dose sold of such particular Product. No later than [**] months prior to the expiration of such [**] month period the Parties shall enter into good faith negotiations regarding the supply of Chiesi’s requirements of Product after expiration of such [**] month period, taking into account a fair adjustment of the transfer price pursuant to Section 2.3(b) for the Product to be supplied to Chiesi after such expiration;

 

(iv)                              save as required under the Quality Agreement or the SDEA, at any time upon written request of the disclosing Party, unless expressly set forth otherwise in this Agreement, the receiving Party shall cease use of and return or at the disclosing Party’s request destroy all Confidential Information of the disclosing Party and all copies thereof except for a single copy of such Confidential Information that may be retained confidentially for legal purposes only.

 

(c)                                  Upon expiration of the Term with respect to this Agreement by a Party exercising its termination right pursuant to Section 9.1(a) or mutual termination pursuant to Section 9.2(a) (unless otherwise agreed between the Parties in such mutual termination agreement):

 

(i)                                     all rights, privileges and licenses granted hereunder to Chiesi shall become fully paid-up, irrevocable and perpetual;

 

(ii)                                  all rights, privileges and licenses granted hereunder to uniQure shall become fully paid-up, irrevocable and perpetual;

 

(iii)                               Chiesi shall purchase from uniQure any quantity of Product which has been included in a Confirmed Firm Order through the effective date of expiration;

 

(iv)                              save as required under the Quality Agreement or the SDEA, at any time upon written request of the disclosing Party, unless expressly set forth otherwise in this Agreement, the receiving Party shall cease use of and return or at the disclosing Party’s request destroy all Confidential Information of the disclosing Party and all copies thereof except for a single copy of such Confidential Information that may be retained confidentially for legal purposes only.

 

Upon expiration of the Term with respect to this Agreement by uniQure exercising its termination right pursuant to Section 9.1(a), uniQure shall continue to supply Chiesi’s requirements of Product for the [**] month period following notice of termination in accordance with the terms and conditions of this Agreement, provided however, that the Purchase Price for the individual Product ordered after the effective date of termination shall be the Fully Loaded Cost of Goods plus [**] percent ([**]%) markup for each patient dose sold of such particular Product. No later than [**] months prior to the expiration of such [**] month period the Parties shall enter into good faith negotiations regarding the supply of Chiesi’s requirements of Product after expiration of such [**] month period, taking into account a fair adjustment of the transfer price pursuant to Section 2.3(b) for the Product to be supplied to Chiesi after such expiration.

 

37

 

(d)                                 Accrued Rights; Surviving Provisions.

 

(i)                                     Notwithstanding the giving of any notice of termination pursuant to this Article 9, each Party shall continue to fulfill such Party’s obligations under this Agreement at all times until the effective date of any such termination.

 

(ii)                                  Termination or expiration of this Agreement for any reason shall be without prejudice to any rights which shall have accrued to the benefit of either Party prior to such termination or expiration.

 

(iii)                               Without prejudice to Section 11.7, to the extent legally permitted, any compensation claims by Chiesi resulting from a direct or analogous application of Article 17 of Council Directive 86/653/EEC, as amended, as transposed into the national laws of the EU Member States for undertaking the Commercialization of the Product in the Territory are expressly excluded and hereby expressly waived by Chiesi.

 

(iv)                              All those provisions which by their scope and nature extend beyond the Term, including Article I, Section 2.1(d) to (h), Article VI, Section 7.1, Section 9.3, Sections 10.1, 10.2 and 10.6, and Article XI, shall survive any expiration or termination of this Agreement, and remain in full force and effect.

 

ARTICLE X

CONFIDENTIALITY

 

10.1                        Confidential Information.  All Confidential Information disclosed by a Party or any of its Affiliates to the other Party or any of its Affiliates before or during the Term shall not be used by the receiving Party or any of its Affiliates except in connection with the activities contemplated by this Agreement, shall be maintained in confidence by the receiving Party and its Affiliates, and shall not otherwise be disclosed by the receiving Party or its Affiliates to any Third Party (except as set forth in the remainder of this Article X), without the prior written consent of the disclosing Party, except to the extent that the Confidential Information:

 

(a)                                 was known or used by the receiving Party or any of its Affiliates prior to its date of disclosure by the disclosing Party;

 

(b)                                 either before or after the date of the disclosure to the receiving Party hereunder or under the Confidentiality Agreement is lawfully disclosed to the receiving Party or any of its Affiliates by a Third Party rightfully in possession of and with the right to disclose such Confidential Information other than under an obligation of confidentiality;

 

(c)                                  either before or after the date of the disclosure to the receiving Party hereunder or under the Confidentiality Agreement becomes generally known to the public through no fault or omission on the part of the receiving Party or its Affiliates;

 

(d)                                 is independently developed by or for the receiving Party or any of its Affiliates without reference to or reliance upon any of the other Party’s Confidential Information; or

 

(e)                                  is required to be disclosed by the receiving Party or its Affiliates to comply with Applicable Laws, which may include the rules of Euronext, of the US

 

38

 

Securities and Exchange Commission, or of any other stock exchange, or to defend or prosecute litigation or arbitration or to comply with legal process; provided that, the receiving Party provides prior written notice of such disclosure to the disclosing Party (to the extent feasible) and only discloses Confidential Information of the other Party to the extent necessary for such legal compliance or litigation purpose; and provided, further, that (i) the receiving Party shall use, or shall cause its Affiliates, as the case may be, to use, reasonable efforts to obtain confidential treatment, or the equivalent, from Euronext, the US Securities and Exchange Commission, or other securities trading institution of any financial information or other information of a competitive or confidential nature, and shall include in such confidentiality request such provisions of this Agreement as may be reasonably requested by the disclosing Party, and (ii) such information shall otherwise remain Confidential Information (subject to the exceptions in this Section 10.1).

 

Notwithstanding the foregoing, paragraphs (a), (b) and (d) shall not alter the requirement to keep the terms and conditions of this Agreement confidential, as set forth herein, subject to the remainder of this Article X.

 

10.2                        Employee, Director, Consultant and Advisor Obligations.  Chiesi and uniQure each agrees that it and its Affiliates shall provide Confidential Information received from the other Party only to the receiving Party’s employees, directors, consultants, agents and advisors, and to the employees, directors, consultants, agents and advisors of the receiving Party’s Affiliates, who have a need to know such Confidential Information to assist the receiving Party in fulfilling its obligations under this Agreement and who are bound by obligations of confidentiality and non-use that are at least as restrictive as those set forth in this Agreement. Each Party shall remain responsible for any failure by any of its or its Affiliates’ employees, directors, consultants, agents and advisors to treat such Confidential Information as required under this Article X.

 

10.3                        Publicity.

 

(a)                                 Following execution of this Agreement, the Parties shall jointly or separately issue a press release, in a text to be agreed upon between the Parties in advance, announcing the execution of this Agreement and the Co-Development and License Agreement.

 

(b)                                 Each Party shall only issue press releases (other than the press release pursuant to paragraph (a) above) or make other public disclosures regarding this Agreement or the Parties’ activities under this Agreement (each such press release or public disclosure, a “Subject Disclosure”):

 

(i)                                     that have been approved in writing in advance by the other Party (such approval not to be unreasonably withheld, conditioned or delayed), including Subject Disclosures that describe one or more of the following:

 

(A)                               the filing for or receipt of Marketing Authorization with respect to the Product in the Territory;

 

(B)                               the receipt of Price and Reimbursement Approval for the Product in the Territory;

 

39

 

(C)                               the receipt of any regulatory exclusivity for the Product in the Territory;

 

(D)                               the achievement of any commercial milestone pursuant to Section 2.1(c)(ii); or

 

(E)                                the first Party’s presence or participation at scientific, financial or investor forums;

 

(ii)                                  subject to Section 10.3(c), if advised by counsel to issue such Subject Disclosure in order to comply with Applicable Laws, which may include the disclosure rules of the US Securities and Exchange Commission or a similar regulatory agency in a country in the Territory or of Euronext or any other stock exchange of other securities trading institution; or

 

(iii)                               subject to Section 10.3(c), if the contents of such Subject Disclosure have previously been made public other than through a breach of this Article X by a Party.

 

(c)                                  Unless not feasible under the circumstances because of the need to comply with Applicable Laws or stock exchange rules, the Party making a Subject Disclosure shall provide the other Party with a draft Subject Disclosure at least [**] Business Days prior to its intended publication for the other Party’s review. Such other Party may provide the first Party with suggested modifications to the draft Subject Disclosure. The first Party shall consider in good faith the other Party’s timely provided suggestions in issuing such Subject Disclosure.

 

(d)                                 For clarity, nothing in this Agreement shall restrict (i) each Party from issuing press releases or making other public disclosures regarding such Party’s development, manufacturing or commercialization activities with respect to any product other than the Product, or (ii) uniQure from issuing press releases or making other public disclosures regarding uniQure’s development, manufacturing or commercialization activities with respect to the Product outside the Field or Territory.

 

10.4                        Other Disclosures.  Notwithstanding anything in this Agreement to the contrary, each Party shall have the right to disclose the other Party’s Confidential Information (including the terms of this Agreement) (as applicable):

 

(a)                                 to such Party’s then-current or potential investors, lenders, acquirers, investment bankers, and other Third Parties in connection with financing, partnering (to the extent consistent with this Agreement) and acquisition activities, solely on a need-to-know basis and under obligations of confidentiality and non-use that are at least as restrictive as those set forth in this Article X;

 

(b)                                 as required by the existing license agreements between uniQure and its Third Party licensors;

 

(c)                                  to enforce Patents, Trademarks and other Intellectual Property Rights in accordance with Sections 2.2(a) and 7.2; or

 

(d)                                 to such Party’s then-current or potential collaborators, and Third Party contractors (including contract manufacturers and Sub-distributors) for purposes of

 

40

 

engaging in the Manufacture or Commercialization of the Product as contemplated hereunder, solely on a need-to-know basis and under obligations of confidentiality and non-use that are at least as restrictive as those set forth in this Article X.

 

10.5                        Publications.

 

(a)                                 Notwithstanding Section 10.3 and Section 10.4, a Party (the “Publishing Party”) which is, or whose Affiliates is, seeking to publish or publicly present scientific or technical data, results or other information with respect to the Product shall provide the other Party and the JCC with a copy of any proposed publication or presentation at least [**] days (or at least [**] days in the case of abstracts or oral public presentations) prior to submission for publication or presentation so as to provide such other Party with an opportunity to recommend any changes it reasonably believes are necessary to continue to maintain such other Party’s Confidential Information in accordance with the requirements of this Agreement or to not jeopardize the patentability of any results or data.

 

(b)                                 If the non-Publishing Party notifies the Publishing Party that such publication or presentation, in the non-Publishing Party’s reasonable judgment, (i) discloses an invention for which the non-Publishing Party desires to seek patent protection, or (ii) contains any Confidential Information of the non-Publishing Party, or could be expected to have an adverse effect on the commercial value of any Confidential Information disclosed by the non-Publishing Party to the Publishing Party, the Publishing Party shall delete such Confidential Information from the proposed publication or presentation and shall further delay such publication or presentation for a period reasonably sufficient to permit the timely preparation and filing of a patent application(s) on any invention disclosed in such publication or presentation (but no more than [**] days from the date of the non-Publishing Party’s notice thereof).

 

10.6                        Term.  All obligations of confidentiality imposed under this Article X shall expire [**] years following termination or expiration of this Agreement, except to the extent any Existing Third Party License between uniQure and its Third Party licensors extends such obligations; provided, however, that the receiving Party shall maintain the confidentiality of any of the other Party’s trade secrets indefinitely until such trade secret is no longer a trade secret.

 

ARTICLE XI

MISCELLANEOUS

 

11.1                        Entire Agreement, Amendments. This Agreement and the attachments hereto contain the entire understanding and agreement of the Parties with respect to the subject matter hereof and cancel and supersede any and all prior negotiations, correspondence, understandings and agreements between the Parties, whether oral or written, regarding such subject matter, including the Memorandum of Understanding dated 21 December 2012 and the Confidentiality Agreement, but expressly excluding the Co-Development and License Agreement. Except for the rights expressly conferred on the JSC or JCC, this Agreement cannot be modified except by a written document bearing the signatures of both Parties. The same applies to any waiver of this written form requirement.

 

41

 

11.2                        Assignments. Except as expressly provided herein, neither this Agreement nor any rights and obligations hereunder shall be assignable by a Party without the prior written consent of the other Party; provided, however, that a Party may assign this Agreement to any Affiliate or to any successor in interest by way of merger, acquisition or sale of all or substantially all of its assets to which this Agreement relates, provided that such successor agrees in writing to be bound by the terms of this Agreement as if it were the assigning Party. This Agreement shall be binding upon the successors and permitted assigns of the Parties. Any assignment not in accordance with this Section 11.2 shall be void.

 

11.3                        Severability. Should any provision of this Agreement be or become invalid, ineffective or unenforceable as a whole or in part, the validity, effectiveness and enforceability of the remaining provisions shall not be affected thereby. Any such invalid, ineffective or unenforceable provision shall be deemed replaced by such valid, effective and enforceable provision as comes closest to the economic intent and the purpose of such invalid, ineffective or unenforceable provision. The aforesaid shall apply mutatis mutandis to any gap in this Agreement.

 

11.4                        Notices. Other than as expressly specified in this Agreement, all notices and consents required to be provided hereunder shall be in writing and provided by hand, by recorded delivery mail (return receipt requested), by facsimile, or by recognized overnight courier service to the other Party at its address or facsimile number shown below or such other address or facsimile number notified by such other Party from time to time.

 

If to uniQure, addressed to:

 

uniQure Biopharma B.V.

P.O. Box 22506

1100 DA Amsterdam

The Netherlands

Attention: CEO

Fax: +31 20 566 9272

 

If to Chiesi, addressed to:

 

Chiesi Farmaceutici S.p.A.

Via Palermo, 26/A

43122 Parma

Italy

Attention: CEO

Copy to: Corporate Development, Head and General Counsel

Fax: +39 0521 774468

 

11.5                        Waiver. Any failure of either Party to enforce any provision hereof shall not constitute a waiver by that Party of its right subsequently to enforce the same or any other provision hereof. The waiver of any provision of this Agreement shall only be effective if in writing signed by the Party claimed to have waived such provision.

 

42

 

11.6                        Force Majeure. Neither Party shall lose any rights hereunder or be liable to the other Party for damages or losses on account of failure of performance by the defaulting Party if the failure is occasioned by war, civil insurrection, strike, fire, Act of God, earthquake, tempest, flood, epidemic, blackout, lockout, embargo, governmental acts or orders or restrictions, delays in delivery and non-supply by exclusive suppliers, where such delay or non-supply occurs as a result of such Force Majeure, or any other reason where failure to perform is beyond the reasonable control of such Party (each a “Force Majeure Event”) and such failure to perform is not caused by the negligence, intentional conduct or misconduct of the non-performing Party and such Party has exerted all reasonable efforts to avoid or remedy such Force Majeure Event; provided, however, that in no event shall a Party be required to settle any labor dispute or disturbance.

 

11.7                        Independence. The relationship between the Parties is that of independent contractors and neither Party shall have the power to bind or obligate the other Party in any manner. It is further understood and agreed that neither Party nor its Affiliates, nor its and their respective directors, officers and employees, shall be deemed an agent or employee of the other Party or its Affiliates.

 

11.8                        Third Party Beneficiaries.  All rights, benefits and remedies under this Agreement are solely intended for the benefit of uniQure and Chiesi. No Third Party shall have any rights whatsoever to (i) enforce any obligation contained in this Agreement; (ii) seek a benefit or remedy for any breach of this Agreement; or (iii) take any other action relating to this Agreement under any legal theory, including but not limited to, actions in contract, tort (including negligence, gross negligence and strict liability), or as a defense, setoff or counterclaim to any action or claim brought or made by the Parties.

 

11.9                        Governing Law, Dispute Resolution. The validity and interpretation of this Agreement shall be governed by the laws of England without regard to its conflicts of laws principles and to the express exclusion of the United Nations Conventions on Contracts for the International Sale of Goods (CISG). Any dispute arising under, out of or relating to this Agreement shall be referred to and finally determined under the Rules of Arbitration of the International Chamber of Commerce by three (3) arbitrators appointed in accordance with the said Rules. The place of arbitration shall be London, United Kingdom. The language to be used in said proceedings shall be English.

 

11.10                 Costs.  Except as expressly provided in this Agreement or as separately agreed upon in writing between the Parties, each Party shall bear its own costs incurred in connection with the implementation of the obligations under this Agreement.

 

11.11                 Construction.  Each Party agrees that this Agreement shall be interpreted without regard to any presumption or rule requiring construction against the Party causing this Agreement to be drafted.

 

11.12                 Language.  This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control.

 

11.13                 Counterparts.  This Agreement may be executed simultaneously in any number of counterparts, any one of which need not contain the signature of more than one

 

43

 

Party but all such counterparts taken together shall constitute one and the same agreement. A pdf file of this Agreement contained in an email, including the signed signature pages hereto, will be deemed to be an original.

 

[Signature Page Follows]

 

44

 

IN WITNESS WHEREOF, the Parties have executed this Commercialization Agreement as of the Effective Date.

 

	
UNIQURE BIOPHARMA B.V.
    	
UNIQURE BIOPHARMA B.V.
    
	
 
    	
 
    
	
 
    	
 
    
	
By:
    	
/s/ Piers Morgan
    	
 
    	
By:
    	
/s/ Hans Preusting
    
	
 
    	
Name:
    	
Mr. Piers Morgan 
    	
 
    	
Name:
    	
Mr. Hans Preusting 
    
	
 
    	
Title:
    	
Chief Financial Officer
    	
 
    	
Title:
    	
Business Development, Vice President
    
	
 
    	
 
    
	
 
    	
 
    
	
CHIESI FARMACEUTICA S.p.A.
    	
CHIESI FARMACEUTICI S.p.A.
    
	
 
    	
 
    
	
 
    	
 
    
	
By:
    	
/s/ Alberto Chiesi
    	
 
    	
By:
    	
/s/ Ugo Di Francesco
    
	
 
    	
Name:
    	
Mr. Alberto Chiesi 
    	
 
    	
Name:
    	
Mr. Ugo Di Francesco 
    
	
 
    	
Title:
    	
President
    	
 
    	
Title:
    	
CEO
    
							

 

45

 

SCHEDULE 1.9
 Certificate of Analysis

 

	
CONTROLLED DOCUMENT — CONFIDENTIAL
    	
 
    	

    

 

Certificate of Analysis

 

	
SMS number
    	
 
    	
 
    
	
Product
    	
 
    	
Glybera® Drug Product (Final Product)
    
	
Part number
    	
 
    	
C0114 rev.
    
	
Batch number
    	
 
    	
 
    
	
Production stage
    	
 
    	
Drug product
    
	
Expiry date
    	
 
    	
Page 1 of 1
    

 

	
Test, Method
    	
 
    	
Specification
    	
 
    	
Result
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
 
    

 

Remarks:

 

Conclusion

 

	
Authorized signature:
    	
 
    	
 
    
	
Name:
    	
 
    	
 
    
	
Date:
    	
 
    	
 
    
	
 
    	
 
    	
 
    

 

	
Visiting address
    	
 
    	
Postal address
    	
 
    	
 
    
	
Meibergdreef 61
    	
 
    	
P.O. Box 22506
    	
 
    	
tel +31 (0)20 566 7394
    
	
1105 BA Amsterdam
    	
 
    	
1100 DA Amsterdam
    	
 
    	
fax +31 (0)20 566 9272
    
	
The Netherlands
    	
 
    	
The Netherlands
    	
 
    	
info@uniqure.com
    

 

 

SCHEDULE 1.10
 Certificate of Compliance

 

	
Document No.: QA-SOP-XXX-0036-EX
    	
 
    	
 
    	
 
    	
 
    
	
Revision No.:

Page No.: 1 of 1

Effective date:
    	
 
    	
Preparation of   Certificates — 
   Exhibit X: Certificate of Release
    	
 
    	

    

 

	
Product name:
    	
 
    	
Date manufactured:
    
	
Quantity:
    	
 
    	
Expiry/retest date:
    
	
Batch number:
    	
 
    	
Storage conditions:
    

 

	
Manufacturer:
    	
 
    	
UniQure
    
	
Production Site:
    	
 
    	
Meibergdreef 61, 1105 BA Amsterdam, The   Netherlands
    

 

Release tests:

 

o:  All test results are within approved specifications.

 

Certification statement:

 

uniQure is certified by the Dutch Health Authorities (Ministerie van VWS), per manufacturing license number 108990F, to manufacture biological products (gene therapies).

 

I hereby certify that this batch has been manufactured at the above-stated site in full compliance with the EU GMP requirements, and meets the authorized quality specifications registered in uniQures’ quality systems.  The batch manufacturing and analytical records were reviewed and are found to be in compliance with GMP.

 

	
Name:
    	
 
    
	
Position:
    	
Qualified Person
    
	
Signature:
    	
 
    
	
 
    	
 
    
	
Date:
    	
 
    

 

47

 

SCHEDULE 1.63
  Patents

 

UniQure Patent Portfolio:  GLYBERA

 

	
UniQure Ref.
    	
 
    	
Country
    	
 
    	
Owners
    	
 
    	
Official No.
    	
 
    	
Case
   Status
    	
 
    	
Filing
   Date
    	
 
    	
Date
   Registration
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of four pages were omitted. [**]

 

48

 

In-licensed patent portfolio:  GLYBERA

 

	
Licensor
    	
 
    	
Owners
    	
 
    	
Official No.
    	
 
    	
Case Status
    	
 
    	
Filing Date
    	
 
    	
Date
   Registration
    
	
[**]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
[**]
    	
 
    	
[**]
    	
 
    	
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[**]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
[**]
    	
 
    	
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[**]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
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[**]
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
[**]
    	
 
    	
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[**]
    	
 
    	
 
    	
 
    	
 
    

 

Note:

 

[**]

 

49

 

SCHEDULE 1.66
 Product

 

Glybera: AAV1_LPLS447X

 

Marketing Authorization Numbers: EU/1/12/791/001

 

50

SCHEDULE 1.78

 

Initial Specifications

 

	
Module 3
   3.2.P.5
    	
 
    	
Glybera
   [alipogene tiparvovec]
    	
 
    	
uniQure
    

 

1.             SPECIFICATIONS

 

Before QC testing the samples taken from the drug product batch are stored at the same conditions and subjected to one freeze thaw cycle.

 

The proposed release and shelf life specifications for Glybera drug product are shown in Table 1 below:

 

Table 1:  Release and shelf life specifications for Glybera

 

	
Test parameter
    	
 
    	
Acceptance Criteria
    
	
General tests and test for contamination
    
	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
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[**]
    	
 
    	
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[**]
    	
 
    	
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[**]
    	
 
    	
[**]
    

 

51

 

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

 

[**]

 

52

 

SCHEDULE 2.2(a)
 Trademarks

 

uniQure’s Trademark Portfolio:  GLYBERA - uniQure

 

	
Catchword
    	
 
    	
Type
    	
 
    	
Country
    	
 
    	
Classes
    	
 
    	
Appl.No.
    	
 
    	
Appl.date
    	
 
    	
Reg.No.
    	
 
    	
Rcg.datc
    	
 
    	
Rcn.date
    	
 
    	
Applicant
    	
 
    	
Status
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	

   G device
    	
 
    	
Logotype
    	
 
    	
EU
    	
 
    	
05, 44
    	
 
    	
8640609
    	
 
    	
10/26/2009.
    	
 
    	
8640609
    	
 
    	
5/10/2010.
    	
 
    	
10/26/2019.
    	
 
    	
uniQure IP B.V.
    	
 
    	
Registered
    
	
GLYBERA
    	
 
    	
Wordmark
    	
 
    	
EU
    	
 
    	
05. 44
    	
 
    	
5901269
    	
 
    	
5/1/2007.
    	
 
    	
5901269
    	
 
    	
5/14/2009.
    	
 
    	
5/1/2017.
    	
 
    	
uniQure IP B.V.
    	
 
    	
Registered
    
	
GLYBERA
    	
 
    	
Wordmark
    	
 
    	
TR
    	
 
    	
05
    	
 
    	
2007026778
    	
 
    	
17.05.2007
    	
 
    	
2007026778
    	
 
    	
17.05.2007
    	
 
    	
17.05.2017
    	
 
    	
uniQure IP B.V.
    	
 
    	
Registered
    
	
GLYBERA
    	
 
    	
Wordmark
    	
 
    	
RU
    	
 
    	
05
    	
 
    	
2008707340
    	
 
    	
13.03.2008
    	
 
    	
377215
    	
 
    	
20.04.2009
    	
 
    	
13.03.2018
    	
 
    	
Amsterdam Molecular Therapeutics (AMT)   Holding N.V.
    	
 
    	
Registered
    
	
GLYBERA
    	
 
    	
Wordmark
    	
 
    	
CH
    	
 
    	
05
    	
 
    	
551392007
    	
 
    	
14.05.2007
    	
 
    	
562178
    	
 
    	
11.09.2007
    	
 
    	
14.05.2017
    	
 
    	
Amsterdam Molecular Therapeutics (AMT)   Holding N.V.
    	
 
    	
Registered
    
	
GLYBERA
    	
 
    	
Wordmark
    	
 
    	
IS
    	
 
    	
05
    	
 
    	
14642007
    	
 
    	
14.05.2007
    	
 
    	
8122007
    	
 
    	
04.07.2007
    	
 
    	
04.07.2017
    	
 
    	
Amsterdam Molecular Therapeutics (AMT)   Holding N.V.
    	
 
    	
Registered
    
	
GLYBERA
    	
 
    	
Wordmark
    	
 
    	
NO
    	
 
    	
05
    	
 
    	
200705606
    	
 
    	
15.05.2007
    	
 
    	
241553
    	
 
    	
19.10.2007
    	
 
    	
19.10.2017
    	
 
    	
Amsterdam Molecular Therapeutics (AMT)   Holding N.V.
    	
 
    	
Registered
    
	
GLYBERA
    	
 
    	
Wordmark
    	
 
    	
DZ
    	
 
    	
05
    	
 
    	
72791
    	
 
    	
24.10.2007
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Amsterdam Molecular Therapeutics (AMT)   Holding N.V.
    	
 
    	
Pending
    
	
GLYBERA
    	
 
    	
Wordmark
    	
 
    	
EG
    	
 
    	
05
    	
 
    	
208229
    	
 
    	
22.10.2007
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
Amsterdam Molecular Therapeutics (AMT)   Holding N.V.
    	
 
    	
Pending
    
	
GLYBERA
    	
 
    	
Wordmark
    	
 
    	
MA
    	
 
    	
05
    	
 
    	
113550
    	
 
    	
23.10.2007
    	
 
    	
113550
    	
 
    	
23.10.2007
    	
 
    	
23.10.2017
    	
 
    	
Amsterdam Molecular Therapeutics (AMT)   Holding N.V.
    	
 
    	
Registered
    
	
GLYBERA
    	
 
    	
Wordmark
    	
 
    	
TN
    	
 
    	
05
    	
 
    	
EE072667
    	
 
    	
24.10.2007
    	
 
    	
EE72667
    	
 
    	
19.05.2009
    	
 
    	
24.10.2017
    	
 
    	
Amsterdam Molecular Therapeutics (AMT)   Holding N.V.
    	
 
    	
Registered
    

 

53

 

	
 

GLYBERA device
    	
 
    	
Logotype
    	
 
    	
EU
    	
 
    	
05, 44
    	
 
    	
8640641
    	
 
    	
10/26/2009.
    	
 
    	
8640641
    	
 
    	
5/10/2010.
    	
 
    	
10/26/2019.
    	
 
    	
uniQure IP B.V.
    	
 
    	
Registered
    
	
UNIQURE
    	
 
    	
Wordmark
    	
 
    	
EU
    	
 
    	
01, 05, 42, 44
    	
 
    	
10431005
    	
 
    	
11/21/2011.
    	
 
    	
 
    	
 
    	
4/25/2012
    	
 
    	
11/21/2021.
    	
 
    	
uniQure IP B.V.
    	
 
    	
Registered
    

 

54

 

SCHEDULE 2.2(b)
 uniQure Trademark Guidelines

 

uniQure

 

TRADEMARK GUIDELINES

 

The trademarks of uniQureBiopharmaB.V. and its subsidiary uniQure IP B.V. -hereinafter “uniQure” or “Company” - are valuable and important intellectual property assets of the Company. It is crucial that you protect the value of our trademarks by using them properly. These guidelines, which are updated from time to time, set out our policies for your use of such assets.

 

If you are a licensee of uniQure trademarks, your license agreement will specify the trademarks that you are authorized to use and may provide additional special trademark usage guidelines. You may NOT use our trademarks in a manner that incorrectly suggests that uniQure sponsors or endorses or is otherwise associated with your activities, products, and services, except as set forth in your license agreement with us.

 

Registered trademarks:

 

UniQure is owner of the following trademark registrations in the European Union:

 

	
Trademark
    	
 
    	
Type
    	
 
    	
Country
    	
 
    	
goods/services
    	
 
    	
Reg. No.
    	
 
    	
Reg. Date
    
	
GLYBERA
    	
 
    	
Word
    	
 
    	
EU
    	
 
    	
Class 5: Pharmaceutical products; biological preparations for use in   medical and clinical gene therapy and cell therapy; clinical medical reagents   for use in gene therapy; gene diagnosis, and gene testing; pharmaceutical   preparations, vaccines for use in gene therapy: gene therapy and prophylaxis   products; all the aforementioned goods exclusively in the treatment of   metabolic disorders including such disorders which are single gene disorders   and disorders which are a result of one more mutations within the lipoprotein   lipase gene 

 

Class 44: Gene delivery, gene transfer, gene regulation and gene modulation   for the treatment of metabolic disorders, including such disorders which are   single gene disorders, and disorders which are a result of one more mutations   within in the lipoprotein lipase gene, ocular disorders
    	
 
    	
5901269
    	
 
    	
5/14/2009
    
	

    	
 
    	
word and device
    	
 
    	
EU
    	
 
    	
Class 5: Pharmaceutical products; biological preparations for use in   medical and clinical gene therapy and cell therapy; clinical medical
    	
 
    	
8640641
    	
 
    	
5/10/2010
    

 

 

	
Trademark
    	
 
    	
Type
    	
 
    	
Country
    	
 
    	
goods/services
    	
 
    	
Reg. No.
    	
 
    	
Reg. Date
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
reagents for use in gene therapy, gene   diagnosis, and gene testing; pharmaceutical preparations, vaccines for use in   gene therapy; gene therapy and prophylaxis products, all the aforementioned   goods exclusively in the treatment of metabolic disorders including such   disorders which are single gene disorders and disorders which are a result of   one more mutations within the lipoprotein lipase gene 

 

Class 44: Gene delivery, gene transfer, gene regulation and gene modulation   for the treatment of metabolic disorders, including such disorders which are   single gene disorders, and disorders which are a result of one more mutations   within the lipoprotein lipase gene and ocular disorders
    	
 
    	
 
    	
 
    	
 
    
	

    	
 
    	
device
    	
 
    	
EU
    	
 
    	
Class 5: Viral systems, gene therapy systems, nucleic acid delivery   systems, viral vectors, non-viral vectors, gene therapy vectors, nucleic acid   delivery vectors, and cells transformed by viral vectors, non-viral vectors,   gene therapy vectors or nucleic acid delivery vectors for medical purposes;   pharmaceutical products; biological preparations for use in medical and   clinical gene therapy, nucleic acid-based therapy and cell therapy; clinical   medical reagents for use in nucleic acid-based therapy, gene therapy, cell   therapy, gene diagnosis and gene testing; pharmaceutical preparations,   vaccines, prophylaxis products and other products for use in nucleic   acid-based therapy, gene therapy and cell therapy 

 

Class 44: Gene and nucleic acid delivery, gene and nucleic acid transfer,   gene and nucleic acid regulation and gene and nucleic acid modulation for the   treatment of metabolic disorders, ocular disorders, diseases of the nervous   system, blood disorders, liver disorders, muscular disorders, muscular   skeletal disorders, cancers, infectious diseases, inflammatory and   auto-immune diseases, vascular disorders, inherited disorders, genetic   disorders and single gene disorders.
    	
 
    	
8640609
    	
 
    	
5/10/2010
    

 

 

	
Trademark
    	
 
    	
Type
    	
 
    	
Country
    	
 
    	
goods/services
    	
 
    	
Reg. No.
    	
 
    	
Reg. Date
    
	
UNIQURE
    	
 
    	
Word
    	
 
    	
EU
    	
 
    	
Class 1: Viral systems, gene therapy systems, nucleic acid delivery   systems, viral vectors, non-viral vectors, gene therapy vectors, nucleic acid   delivery vectors, and cells transformed by viral vectors, non-viral vectors,   gene therapy vectors and nucleic acid delivery vectors for non-medical   research purposes

 

Class 5: Viral systems, gene therapy systems, nucleic acid delivery   systems, viral vectors, non-viral vectors, gene therapy vectors, nucleic acid   delivery vectors, and cells transformed by viral vectors, non-viral vectors,   gene therapy vectors or nucleic acid delivery vectors for medical purposes;   pharmaceutical products; biological preparations for use in medical and   clinical gene therapy, nucleic acid-based therapy and cell therapy; clinical   medical reagents for use in nucleic acid-based therapy, gene therapy, cell   therapy, gene diagnosis and gene testing; pharmaceutical preparations,   vaccines, prophylaxis products and other products for use in nucleic   acid-based therapy, gene therapy and cell therapy

 

Class 42: Research, product development and consultancy in the field of   biotechnology, biologics, pharmaceutics, medical science, chemistry and   biochemistry

 

Class 44: Gene and nucleic acid delivery, gene and nucleic acid transfer,   gene and nucleic acid regulation and gene and nucleic acid modulation for the   treatment of metabolic disorders, ocular disorders, diseases of the nervous   system, blood disorders, liver disorders, muscular disorders, muscular   skeletal disorders, cancers, infectious diseases, inflammatory and   auto-immune diseases, vascular disorders, inherited disorders, genetic   disorders and single gene disorders.
    	
 
    	
10431005
    	
 
    	
4/25/2012
    

 

UniQure is also the owner of the other trademark registrations and applications in the Territory identified in Schedule 2.2(a).

 

57

 

Basic Trademark Rules:

 

·                  The most prominent use (which is usually the first use of our registered trademarks in a title, heading, and text of a document) should have the superscripted registered trademark symbol ®.  If that symbol is not available, then use (R).

 

·                  Distinguish our trademarks. Visually set off our trademarks from the surrounding text.

 

·                  Our trademarks are never plural or possessive.

 

·                  Never modify the form of our trademarks, whether the trademarks are an acronym, word, words or graphic design.  Unless otherwise specifically permitted in writing, word trademarks should not be modified by abbreviations, translations or connections (e.g., by a hyphen or otherwise) to other words or trademarks.  Our trademarks should not be split over any lines.  All logos should be reproduced in strict compliance with the established graphical form.

 

·                  Colors of our trademarks. The preferred treatment for the company logo is as follows:

 

 

The logo has to be displayed in printed letters. Only the “Q” is in upper case.

 

·                  Attribute our trademarks by properly acknowledging our ownership interest in them (e.g., “Glybera is a trademark or registered trademark of uniQure IP B.V.”).  Such attribution statement may appear in any conventional location within a document or packaging (e.g., header, footer, footnote, etc.).

 

·                  Logo, size and proportion treatments. The “Glybera” word and device mark and the “G” device mark (logos) set forth in the table above must always be reproduced exactly as pictured in the table above, in the specific typefaces shown.  No other typefaces are permitted. The logos can be reproduced in color or black& white and may be proportionately enlarged or reduced so long as legibility is ensured. uniQure reserves the right to introduce specific requirements as to the color and font size of its trademarks and logos. The logos are independent trademarks and should not be incorporated into other trademarks, logos, and artwork. The logos may appear in proximity to a licensee’s trademarks and logos and other artwork, but with a clear visual separation.

 

·                  Inquiries regarding the Trademark Guidelines. In case of inquiries regarding these Trademark Guidelines uniQure may be contacted at the following address: Meibergdreef 61, 1105 BA Amsterdam, The Netherlands.

 

 

·                  Updates of the Trademark Guidelines. uniQure may at any time make changes to these Trademark Guidelines with a future effect. uniQure will give licensee no less than three (3) months prior written notice if changes are made to the Trademark Guidelines.

 

***

 

59

 

SCHEDULE 2.3
 Definition
 Fully Loaded Cost of Goods

 

	
Item per [**] batch
    	
 
    	
Costs* [EUR]
    
	
 
    	
 
    	
 
    
	
Clean room occupancy
    	
 
    	
[**]
    
	
Cell bank vial
    	
 
    	
[**]
    
	
Virus banks vials
    	
 
    	
[**]
    
	
Raw materials
    	
 
    	
[**]
    
	
External release assays (QC)
    	
 
    	
[**]
    
	
External QP
    	
 
    	
[**]
    
	
Personnel (MF, QC, QA)
    	
 
    	
[**]
    
	
Packaging (incl. release)
    	
 
    	
[**]
    
	
Stability study batch allocation
    	
 
    	
[**]
    
	
 
    	
 
    	
 
    
	
Total
    	
 
    	
[**]
    

 

Norms:

 

Number of patients per batch                           [**]

 

Batch success rate                                               [**]%

 

Result Fully loaded costs:

 

COG per patient                                                 EUR                 [**]*
 COG per batch                                                    EUR                 [**]*

 

COG relevant for Glybera Manufacturing Cost Reimbursement:

 

COG per patient                                                 EUR                 [**]*
 COG per batch                                                    EUR                 [**]*

 

* = as of the Effective Date

 

60

 

SCHEDULE 2.4(d)
 Minimum Order Quantity

 

The minimum Order Quantity is [**] patient doses.

 

61

 

SCHEDULE 2.6
 Technology Transfer

 

The following is a non-exhaustive list describing key steps which the Parties would typically envisage for a transfer of the Manufacturing of the Product to another manufacturing site:

 

	
Steps
    	
 
    	
Estimated Timelines
    
	
· if transferred to a Third Party manufacturer: select and contract   manufacturer party
    	
 
    	
[**]
    
	
· tech transfer (on paper)
    	
 
    	
[**]
    
	
· obtain time slot
    	
 
    	
[**]
    
	
· process validation at CMO
    	
 
    	
[**]
    
	
· file type II variation
    	
 
    	
[**]
    
	
· review and approval type II variation
    	
 
    	
[**]
    
	
Total
    	
 
    	
[**]
    

 

62

 

SCHEDULE 3.1
 MA/MAA Filing and Maintenance Activities and Fees Template

 

	
State
    	
 
    	
Activity
    	
 
    	
Fee
   Allocation
    	
 
    	
Responsible
   Party
    	
 
    	
Timeline
    
	
Albania
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Andorra
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Bosnia and Herzegovina
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Croatia
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Macedonia
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Monaco
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Montenegro
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Republic of San Marino
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Serbia
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Switzerland
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

63

 

	
State
    	
 
    	
Activity
    	
 
    	
Fee
   Allocation
    	
 
    	
Responsible
   Party
    	
 
    	
Timeline
    
	
Vatican City
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Algeria
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Armenia
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Azerbaijan
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Belarus
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Brazil
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
China
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Egypt
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Georgia
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Kazakhstan
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Kirghizstan
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

64

 

	
State
    	
 
    	
Activity
    	
 
    	
Fee
   Allocation
    	
 
    	
Responsible
   Party
    	
 
    	
Timeline
    
	
Mexico
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Moldova
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Morocco
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Pakistan
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Russia
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Tajikistan
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Tunisia
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Turkey
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Turkmenistan
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Ukraine
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Uzbekistan
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

65

 

	
State
    	
 
    	
Activity
    	
 
    	
Fee
   Allocation
    	
 
    	
Responsible
   Party
    	
 
    	
Timeline
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

66

 

SCHEDULE 3.2
 Regulatory Plan

 

A.            For the EU Member States:

 

1.             Quality

 

1.1          Specific Obligations

 

The following obligations were included in the Day 210 Assessment Report with the requirement to submit them as Type II variations prior to implementation.

 

	
Source
    	
 
    	
Name
    	
 
    	
Description
    	
 
    	
Due date
    	
 
    	
Status
    	
 
    	
Progress
    
	
D210   AR
    	
 
    	
Ii/003-SO1
    	
 
    	
Newly   developed release assay for cellular SF+ DNA submitted and approved by a Type   II variation.
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
D210   AR
    	
 
    	
II/004-SO2
    	
 
    	
An   improved or newly developed release assay for SF+ proteinor a combined   SF+/Baculovirus protein approved by a Type II variation
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
D210   AR
    	
 
    	
II/004-SO3
    	
 
    	
Assays   for Rep and Cap genes will be validated and acceptance criteria for accuracy   and precision will be justified in the validation report.
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
D210   AR
    	
 
    	
II/001-SO4
    	
 
    	
To   complete the validation of the residual infectious baculovirus assay ([**]   wells), the LOD should be experimentally confirmed, in addition the presented   risk assessment should be revised taking into account the experimentally   determined LOD.
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
D210   AR
    	
 
    	
II/002-SO5
    	
 
    	
An   improved release assay for replication competent AAV should be submitted and   approved via a Type II variation
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
D210   AR
    	
 
    	
II/Oxx—SO6
    	
 
    	
To   improve the virus safety profile of the product, an additional manufacturing   process step should be developed
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
 
    

 

67

 

	
Source
    	
 
    	
Name
    	
 
    	
Description
    	
 
    	
Due date
    	
 
    	
Status
    	
 
    	
Progress
    
	
D210   AR
    	
 
    	
II/Oxx-SO7
    	
 
    	
Additional   manufacturing process step validated to ensure that the process is capable,   of inactivating or removing at least the maximal baculovirus load used in   production.
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
 
    
	
D210   AR
    	
 
    	
II/Oxx—SO8
    	
 
    	
eCTD   update: Clarify the MOI to be used for any new WSV and qualification strategy   at the time of introduction of new WSV
    	
 
    	
[**]
    	
 
    	
[**]
    	
 
    	
 
    

 

The baseline eCTD Module 3 has been submitted on [**].

 

68

 

1.2          Commitments

 

The commitments listed below have been made during the review and authorisation procedure. For those commitments accompanied in the D120 or D180 responses by a planned date for completion, the definite completion and submission dates have to be submitted in a Letter of Undertaking. For some commitments no completion date was mentioned. Those will not be mentioned in the Letter of Undertaking and will be considered at a later stage during the yearly product quality review.

 

	
Source
    	
 
    	
Name
    	
 
    	
Description
    	
 
    	
Due date
    	
 
    	
Status
    
	
D120Q#60 and D180Q#20, 21
    	
 
    	
LU3
    	
 
    	
Stability study on the first batch of drug   substance stored in the new container is recommended to be performed prior to   product being released for patient treatment.
    	
 
    	
[**]
    	
 
    	
[**]
    
	
D120Q#2 and D180Q#1
    	
 
    	
LU5
    	
 
    	
Assess how long the baculovirus sequences   are persisting in vivo in mice
    	
 
    	
[**]
    	
 
    	
[**]
    
	
D120Q#2 and D180Q#1
    	
 
    	
LU6
    	
 
    	
Further characterization by N6S and analysis   of [**] new batches by NGS
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
D120Q#71 and D180Q#24
    	
 
    	
LU1
    	
 
    	
Review and revise the specification for the   ratio of full to infectious virus particles based on data from [**] batches   to allow meaningful specifications to be set.
    	
 
    	
[**]
    	
 
    	
[**]
    
	
D120Q#84 and D180Q#28
    	
 
    	
LU4
    	
 
    	
To provide details on the outcome of the   further development, validation and proposed implementation of the S2 cell   line that is non-permissive to baculovirus.
    	
 
    	
[**]
    	
 
    	
[**]
    
	
D120Q#59
    	
 
    	
LU7
    	
 
    	
Review specifications for protein impurity 2   when data of [**] batches are available
    	
 
    	
[**]
    	
 
    	
[**]
    

 

69

 

1.3          Other variations

 

	
Variation
    	
 
    	
Description
    	
 
    	
Planned submission
   date
    	
 
    	
Status
    
	
II/007
    	
 
    	
New test method for residual VHH
    	
 
    	
[**]
    	
 
    	
[**]
    
	
II/008
    	
 
    	
Improved test method for residual LPL
    	
 
    	
[**]
    	
 
    	
[**]
    
	
II/009
    	
 
    	
New test method for infectious vector titre
    	
 
    	
[**]
    	
 
    	
[**]
    
	
II/Oxx
    	
 
    	
Total to Full particles ratio specification   to be adapted (lower limit removed)
    	
 
    	
[**]
    	
 
    	
[**]
    
	
Tbd*
    	
 
    	
Changes to the stability protocol to remove   sterility testing at the end of shelf life. A new container closure study is   to be initiated
    	
 
    	
[**]
    	
 
    	
[**]
    

 

70

 

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of one page was omitted. [**]

 

B.            For the Territory outside of the EU Member States:

 

The Parties shall agree upon the Regulatory Plan for any remaining countries of the Territory outside of the EU Member States in the first meeting of the JCC after the Effective Date.

 

71

 

SCHEDULE 7.3
 Existing Third Party Licenses

 

Overview:

 

	
Licensor
    	
 
    	
Title of Agreement
    	
 
    	
Date
    	
 
    	
Relevant Intellectual Property Rights

(including quality of license, i.e. exclusive / non-exclusive rights)
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Xenon Pharmaceuticals Inc. (formerly Xenon Genetics   Inc.)
    	
 
    	
Sublicense and research agreement between   Xenon Genetics Inc. and Amsterdam Molecular Therapeutics BV
    	
 
    	
June 18, 2001
    	
 
    	
Exclusive sublicensable, not further   sublicensable without written consent
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
US Public Health   Service (PHS, NIH, HHS)
    	
 
    	
Public Health Service Patent License   Agreement - Nonexclusive
    	
 
    	
May 2, 2007
    	
 
    	
Non-exclusive, sub-licensable upon written   approval prior review
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Ampliphi Biosciences   Corporation (legal successor of Targeted Genetics)
    	
 
    	
License agreement 

 

Amendment No1 to the license agreement
    	
 
    	
December 5, 2006 

 

March 12, 2012
    	
 
    	
Non-exclusive, non-sublicensable
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Aventis Pharma S.A.
    	
 
    	
License agreement
    	
 
    	
December 20, 2006
    	
 
    	
Exclusive, non-transferable and   non-assignable
    

 

72

 

	
Salk Institute for   Biological Studies
    	
 
    	
License agreement between Salk Institute for   Biological Studies and Amsterdam Molecular Therapeutics BV, RNA export   element WPRE
    	
 
    	
February 8, 2008
    	
 
    	
Non-exclusive, non-transferable
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Asklepios Biopharmaceutical   Inc. (AskBio)
    	
 
    	
Non-exclusive license agreement
    	
 
    	
September 3, 2010
    	
 
    	
Non-exclusive, sublicensable
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
Protein Sciences   Corporation
    	
 
    	
License agreement — non-exclusive (expressSF+ cells) 
    	
 
    	
March 22, 2007 
    	
 
    	
Non-exclusive, non-sublicensable 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
License agreement — non-exclusive (expressSF+ cells) - AMENDMENT
    	
 
    	
June 13, 2012
    	
 
    	
Exclusive (with respect to Product),   sublicensable
    

 

Text of Agreements:

 

[full text of agreements to be provided to Chiesi on CD-ROM within [**] Business Days after signing of this Agreement]

 

73

 

SCHEDULE 8.1(a)
 Commercially Reasonable Efforts

 

At all times during the Term Chiesi shall in no event use less than Commercially Reasonable Efforts to Commercialize the Product as further described in this Schedule 8.1(a). Such efforts shall include:

 

Compliance with Marketing Plan and Budget

 

Chiesi shall perform all activities related to the Commercialization of the Product set forth in the marketing plan and budget to be agreed upon between the Parties annually (the “Marketing Plan”). The Marketing Plan shall require Chiesi to perform promotional activities typically applied in the pharmaceutical industry for orphan drugs, to draw the attention and interest to the Product and to render technical support to explain the efficacy of the Product, including detailing and training physicians, pharmacists or other prescribers. The detailing of the Products shall include: (a) regular visits and calls made to physicians and pharmacists by Chiesi’s marketing/detailing staff to provide Product information; and (b) activities implemented to call the attention of physicians, pharmacists and other prescribers such as organizing conferences, seminars, physicians- and pharmacists training sessions(including responsibility of the risk management plan (RMP) required with training materials in local language), lectures, mailings with announcements and product brochures, publications in professional magazines, and participation in trade exhibitions or symposia, subject to the requirements and limitations of any Applicable Laws.

 

The Marketing Plan shall further include details on the responsibility of Chiesi for (a) the provision and review of marketing materials, (b) training and maintaining a sufficient number of suitably qualified sales force, (c) training and maintaining a sufficient number of suitably qualified medical personnel, (d) collection and conveyance to uniQure of general market data (including customer requirements with respect to the Product; market analysis; and competition.

 

The Marketing Plan for the first year of the Agreement, attached hereto as Appendix A, sets forth the obligations of Chiesi in connection with the First Commercial Sale of the Product in the Territory.

 

Allocation of Minimum FTEs

 

Chiesi shall allocate a minimum number of FTEs in the Territory as follows (“Minimum FTEs”):

 

·                  1st anniversary after the Effective Date: [**] FTEs

 

·                  2nd anniversary after the Effective Date: [**] FTEs

 

·                  3rd anniversary after the Effective Date: [**] FTEs

 

·                  4th anniversary after the Effective Date: [**] FTEs

 

·                  5th  anniversary after the Effective Date: [**] FTEs

 

74

 

Beginning in 2013, prior to [**] of each year, Chiesi shall submit the Marketing Plan for any subsequent years to uniQure for its review and approval, which shall not be unreasonably withheld or delayed.

 

Setting of Target Price

 

First Submission (Germany) by uniQure

 

Notwithstanding the provisions hereunder, but without prejudice to Section 4.1(f)(ii), the Parties hereby agree that uniQure shall submit a dossier to the competent reimbursement body in Germany (GBA) before end 2013, which shall include a target manufacturer selling price (Herstellerabgabepreis) (the “Target Price”) of no less than EUR [**]. In case upon further investigation Chiesi is of the opinion that such Target Price in Germany can only be set at a lower level, Chiesi shall start consultations with uniQure on such lower Target Price at least [**] prior to uniQure submitting the dossier to the competent reimbursement body with the goal of both Parties agreeing to a lower Target Price mutually acceptable to the Parties. If the Parties cannot agree on such mutual lower Target Price before the end of such [**] period, uniQure shall submit the dossier to the competent reimbursement body with a Target Price of at least EUR [**]. The Target Price submitted to the German GBA is to be used as reference price in the other European countries mentioned below and hence such Target Price shall be used for all submissions by Chiesi in such other European countries.

 

In line with the Marketing Plan, Chiesi shall start with the Commercialization of the Product in Germany irrespective of the competent reimbursement body having rendered its final decision, provided all other requirements to start Commercializing the Product in Germany have been fulfilled.

 

Timelines for Price and Reimbursement Submissions in other European countries by Chiesi, unless otherwise agreed upon between the Parties in due course

 

[**]

 

75

 

Confidential Materials omitted and filed separately with the Securities and Exchange Commission.  A total of 42 pages were omitted. [**]

 

76

 

SCHEDULE 8.1(b)
 Approved Activities

 

[**]

 

77

 

SCHEDULE 9.1
 Upstream Licenses Relevant for Condition Precedent

 

	
Licensor
    	
 
    	
Title of Agreement
    	
 
    	
Date
    	
 
    	
Note
    
	
Xenon Pharmaceuticals Inc. (formerly Xenon   Genetics Inc.)
    	
 
    	
Sublicense and research agreement between   Xenon Genetics Inc. and Amsterdam Molecular Therapeutics BV
    	
 
    	
June 18, 2001
    	
 
    	
Exclusive sublicensable, not further   sublicensable without written consent
    
	
US Public Health Service (PHS, NIH, HHS)
    	
 
    	
Public Health Service Patent License   Agreement - Nonexclusive
    	
 
    	
May 2, 2007
    	
 
    	
Non-exclusive, sub-licensable upon written   approval prior review
    
	
Ampliphi Biosciences Corporation (legal   successor of Targeted Genetics)
    	
 
    	
License agreement 

 

Amendment No1 to the license agreement
    	
 
    	
December 5, 2006 

 

March 12, 2012
    	
 
    	
Non-exclusive, non-sublicensable
    
	
Aventis Pharma S.A.
    	
 
    	
License agreement
    	
 
    	
December 20, 2006
    	
 
    	
Exclusive, non-transferable and   non-assignable
    
	
Salk Institute for Biological Studies
    	
 
    	
License agreement between Salk Institute for   Biological Studies and Amsterdam Molecular Therapeutics BV, RNA export   element WPRE
    	
 
    	
February 8, 2008
    	
 
    	
Non-exclusive, non-transferable
    

 

78

 

Note:

 

The Parties agree that the condition precedent may be fulfilled not only by subcontracting of the rights and licenses licensed by uniQure as licensee under the Existing Third Party Licenses but also by equivalent arrangements mutually agreed between the Parties and the respective Third Party licensor (for instance in cases, where the Third Party licensor (such as the Salk Institute for Biological Studies) is of the opinion that a sublicense is not required for the activities performed by Chiesi, its Affiliates and Sub-distributors in connection with this Agreement).

 

79

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