Document:

Exhibit 10.6

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

LICENSE AGREEMENT

 

Between:

 

Aventis Pharma S.A.

 

20 avenue Raymond Aron

 

92160 Antony

 

France

 

(hereinafter referred to as “AVENTIS”)

 

And,

 

Amsterdam Molecular Therapeutics B.V.

 

Meibergdreef 61

 

1105 BA Amsterdam

 

The Netherlands

 

(hereinafter referred to as “AMT”).

 

PREAMBLE

 

WHEREAS AVENTIS is the owner of the certain patents relating to the preparation and use of recombinant viruses in gene therapy.

 

WHEREAS the University of British Columbia (“UBC”) is co-owner or is entitled to be co-owner of such patents but AVENTIS is entitled to exploit the invention directly or indirectly through third parties.

 

WHEREAS AMT is interested to get a license in order to exploit the invention in the Field and in the Territory (as more fully described below), under the terms and conditions defined therein.

 

 

NOW, THEREFORE, the parties agree as follows:

 

1.                                      DEFINITIONS

 

1.1                               “Affiliate” shall mean, with respect to AVENTIS, any company which controls, is controlled by or is under common control with AVENTIS, and shall mean, with respect to AMT, any company which controls, is controlled by or is under common control with AMT.  Control shall mean the direct and/or indirect legal or beneficial ownership of more than fifty (50) percent of the voting stock of such company.

 

1.2                               “Effective Date” shall mean the date the License Agreement comes into force being the date that the last party signs the same.

 

1.3                               “Field of Use” shall mean indications of Lipoprotein Lipase (LPL) deficiency also referred to as Type I or V hyperlipoproteinemia.

 

1.4                               ““License Agreement” shall mean this license agreement between AVENTIS and AMT dated the Effective Date.

 

1.5                               “Net Sales” shall mean the gross sales invoiced for the Product by AMT and its Affiliates to third parties in the Territory less: (i) quantity and/or cash discounts, allowances actually allowed or given, and transportation and insurance costs for shipments to customers; (ii) credits or refunds actually allowed for returned Product; (iii) compulsory payments and rebates, accrued, paid or deducted pursuant to agreements (including but not limited to managed care agreements) or governmental regulations and (iv) sales and other excise taxes directly related to that sale, to the extent that such items are included in the gross invoice price (but not including taxes assessed against the income derived from such sale).

 

1.6                               “Patents” shall mean the patents or patent applications listed in Annex 1 hereto and their divisional, reexamination, continuation-in-part, or extension including supplemental protection certificate, which are or will be owned by AVENTIS and UBC and which relate to the preparation and use of recombinant viruses in gene therapy.

 

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1.7                               “Product” shall mean a gene therapy product containing a recombinant virus with a nucleic acid coding for a lipoprotein lipase (LPL) developed, used and/or commercialised by or for AMT or its affiliates where the activity in relation to such product occurs in one of the countries of the Territory and is covered in whole or in part by a Valid Claim within the Patents in that country.

 

1.8                               “Territory” shall mean the countries listed in Annex 1.

 

1.9                               “Valid Claim” means any claim of any issued or granted and unexpired Patent which has not been held unenforceable, unpatentable or invalid by a court or other governmental agency of competent jurisdiction in an unappealed or unappealable decision, and which has not been disclaimed or admitted to be invalid or unenforceable through reissue or disclaimer award in an interference proceeding, or final rejection in a re-examination or re-issue proceeding, and which has not lapsed, been withdrawn or otherwise gone abandoned.

 

2.                                      GRANT - CONDITION PRECENDENT

 

2.1                               AVENTIS hereby grants to AMT and AMT accepts from AVENTIS an exclusive license right under the Patents to develop, use, make, have made, sell or offer to sell Product in the Field of Use and in the Territory.

 

2.2                               The license shall be non-transferable and non-assignable except for Affiliates of AMT.

 

2.3                               The grant of rights hereunder is subject to, and shall only come into force upon the unconditional withdrawal by AMT of the opposition filed by AMT on June 3rd 2003 against [**].

 

3.                                      CONSIDERATION

 

3.1                               In consideration of the rights granted by AVENTIS to AMT under this License Agreement AMT undertakes to effect the following payments:

 

(a)                                 Ten thousand Euros (10.000 €) upon signature of the Agreement;

 

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(b)                                 Fifty thousand Euros (50.000 €) upon [**];

 

(c)                                  Seventy-five thousand Euros (75.000 €) at the [**];

 

(d)                                 Royalties of [**] percent ([**]%) of Net Sales of Product in the Territory as long as total cumulative Net Sales of Product are below [**] Euros ([**]€);

 

(e)                                  Royalties of [**] percent ([**]%) of Net Sales of Product in the Territory as soon as total cumulative Net Sales for Product in the Territory are equal to or exceed [**] Euros ([**]€).

 

The [**] percent royalty payment by AMT shall begin at the end of the first calendar year of sales in any country of the Territory.  For the sake of clarity, the “end of the first calendar year” means December 31 of the first year of sales in any country of the Territory and does not mean the end of the first consecutive twelve months of sales in a country of the Territory.

 

3.2                               All royalties payable under this Agreement in respect of a calendar year shall be due and payable in EURO within [**] days after December 31 in that calendar year.

 

3.3                               AMT shall pay the royalties annually in EURO.  Payment of the royalties and other sums described in Section 3.1 shall be made by wire transfer to AVENTIS’s bank account as will be indicated in writing to AMT from time to time provided that AVENTIS has indicated its bank account details to AMT prior to the royalties or any other sums under this Agreement becoming due and payable.  For the avoidance of doubt, the signature fee under Section 3.1(a) shall be due and payable following signature of the License Agreement by both parties and within [**] days after receipt of an invoice setting out AVENTIS’s bank account details.

 

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3.4                               If AMT fails to make a timely payment, interest shall accrue at a rate of [**] % per month independent of sending a reminder to AMT.

 

3.5                               AMT shall keep, and cause its Affiliates to keep, complete and correct records concerning the calculation of Net Sales and the royalties thereon.  AMT shall be obliged to keep such records for [**] years after the making of a royalty payment.  For any calendar year during the term hereof and within [**] days of the end of such calendar year, AMT shall send to AVENTIS a written report describing (i) the Net Sales of Product booked by AMT or its Affiliates by country and (ii) corresponding calculation of the royalties.  In those cases where the amount due is calculated based on a currency other than the EURO, the amount due in EURO shall be calculated using the average rate of exchange for such currency, as quoted in the Financial Times, on the last business day of each of the calendar year to which such payment pertains.

 

3.6                               AVENTIS shall have the right to have an independent accountant reasonably acceptable to AMT inspect AMT’s records and AMT Affiliates’ records of Net Sales and royalties.  Such accountant shall have access, during ordinary business hours, to such records of AMT and/or its Affiliates in order to verify the accuracy of royalty payments made or payable hereunder.  AVENTIS shall only have access to the report of the accountant as to whether or not the payments were accurate or inaccurate and to what extent, the accountant keeping all data and information of AMT confidential.  The costs and expenses of the accountant’s inspections shall be borne by AVENTIS except in the event of an underpayment of greater than [**]% of royalty payments payable hereunder, where the costs and expenses of the accountant’s inspections shall be borne by AMT.

 

4.                                      REPRESENTATIONS AND WARRANTIES

 

4.1                               REPRESENTATIONS AND WARRANTIES OF AVENTIS: AVENTIS represents and warrants that as at the Effective Date it is duly organized, validly existing and in good standing under the laws of France, that it has full corporate power and authority to enter into this Agreement and to carry out its provisions and more specifically the execution, delivery and performance by AVENTIS of this Agreement and its compliance with the terms and provisions hereof does not conflict with, or result in a breach of any of the

 

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terms and provisions of, or constitute a default under any agreement to which AVENTIS is a party.  AVENTIS further represents and warrants that it is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder and that the execution, delivery and performance of this Agreement by it does not require the consent, approval or authorization of or notice, filing or registration with any governmental or regulatory agency.

 

4.2                               REPRESENTATIONS AND WARRANTIES OF AMT: AMT represents and warrants that as at the Effective Date it is duly organized, validly existing and in good standing under the laws of the Netherlands, that it has full corporate power and authority to enter into this Agreement and to carry out its provisions and more specifically the execution, delivery and performance by AMT of this Agreement and its compliance with the terms and provisions hereof does not conflict with, or result in a breach of any of the terms and provisions of, or constitute a default under any agreement to which AMT is a party.  AMT further represents and warrants that it is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and that the execution, delivery and performance of this Agreement by it does not require the consent, approval or authorization of or notice, filing or registration with any governmental or regulatory agency.

 

5.                                      PATENT MAINTENANCE AND DEFENSE

 

5.1                               AVENTIS shall maintain the Patents in the Territory and shall bear all expenses in connection with the foregoing during the term of this License Agreement.

 

5.2                               If AVENTIS declines to maintain any Patents in any country in the Territory, then AVENTIS shall provide AMT with written notice thereof, and AMT shall have the right, subject, where applicable, to the preemptive right of UBC under any local patent law in the Territory, to have AVENTIS assign its share in such Patents to AMT free of charge and in a form approved by a patent attorney mutually agreed between the parties in the applicable country in the Territory (“Agreed Form”).  AVENTIS shall give such notice at least [**] days prior to the expiration of any official substantive deadline relating to the maintenance of the Patents in question.  In any such circumstances AMT shall have the

 

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right to decide that AMT should continue to maintain such Patents and in such case AMT shall give written notice to AVENTIS together with the Agreed Form.  AVENTIS shall upon receipt of any such notice from AMT transfer to AMT all its records and tiles relating to the relevant Patents and execute any documents in the Agreed Form to assign the Patents to AMT or otherwise transfer control of such maintenance to AMT and thereafter AMT shall be responsible for the cost and expense of maintaining such Patents.  Notwithstanding the operation of this Section 5.2, AMT’s payment obligations contained in Section 3.1 shall remain unaffected.

 

5.3                               In the event a third party, through the actual or proposed manufacture, import, use, sale or offer for sale of a product competitive with the Product, infringes or is reasonably likely to infringe any Patent, AMT shall have the right, at its sole cost and expense, to institute, prosecute and control any action or proceeding with respect to such infringement.  AVENTIS has the right to participate and be represented in such action by counsel of its own selection at its own expense, and also agrees to be joined as a party plaintiff, if necessary in any such action, and to give AMT reasonable assistance and needed authority to control, file and to prosecute such action.

 

6.                                      INDEMNIFICATION

 

6.1                               AVENTIS and/or its Affiliates shall indemnify and hold AMT and/or its Affiliates harmless from and against any and all claims, judgements, costs, awards, expenses (including, without limitation, reasonable attorney’s fees) attributable or alleged to be attributable to the breach by AVENTIS of its representations and warranties under this License Agreement.

 

6.2                               AMT and/or its Affiliates shall indemnify and hold AVENTIS and/or its Affiliates harmless from and against any and all claims, judgements, costs, awards, expenses (including, without limitation, reasonable attorney’s fees) or liability of any kind attributable or alleged to be attributable to (i) the manufacture and/or use of the Product or marketing, sale and/or distribution of the Product by AMT and/or its Affiliates in the Territory or (ii) the breach by AMT of its representations and warranties under this License Agreement.

 

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7.                                      CONFIDENTIALITY

 

7.1                               Each party undertakes to keep strictly confidential the substance contained in this License Agreement and any and all information received from the other party in connection with this License Agreement (collectively referred to hereinafter as “Confidential Information”) and to use it only for the purpose of this Agreement.

 

7.2                               The receiving party undertakes to make the Confidential Information available only to those of its employees or to those employees of its Affiliates who in advance have been committed to confidentiality under conditions at least as stringent as contained herein.

 

7.3                               The obligations to maintain confidentiality and to respect the restriction of the use shall not apply where, as properly evidenced by documentation:

 

(a)                                 the Confidential Information was previously known to the receiving party at the time of disclosure from sources other than the disclosing party and other than under an obligation of confidentiality; or

 

(b)                                 the Confidential Information was generally available to the public or otherwise part of the public domain at the time of its disclosure; or

 

(c)                                  the Confidential Information became generally available to the public or otherwise part of the public domain after its disclosure to the receiving party other than through any act or omission of the receiving party in breach of this License Agreement; or

 

(d)                                 the Confidential Information is acquired in good faith in the future by the receiving party from a third party who has a lawful right to disclose such information and who is not under an obligation of confidence to the disclosing party with respect to such information; or

 

(e)                                  the Confidential Information is subsequently developed by or on behalf of the receiving party without use of the disclosing party’s Confidential Information, as can be documented by reasonable proof.

 

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7.4                               The receiving party shall be entitled to disclose Confidential Information or parts thereof to authorities and/or courts to the extent required by law or order.

 

7.5                               The obligations to maintain confidentiality shall survive the termination of this Agreement for [**] years.

 

8.                                      TERM

 

This License Agreement shall become effective on the date on which this Agreement is signed by the last party to sign and, unless terminated early pursuant to Section 9 hereof, shall continue to be in full force and effect until the expiration of the last-to-expire Patent in the Territory.

 

9.                                      TERMINATION

 

9.1                               Either party shall have the right to terminate this License Agreement immediately by written notice in the event that the other party shall default in any of the substantial obligations hereunder and fails to cure such default, if possible of cure, within [**] days after receipt of a written notice from the party not being in default.  For the purpose of this provision, substantial obligations shall include, without limitation, the payment by AMT of the amounts mentioned in Article 3 hereto.

 

9.2                               AVENTIS shall have the right to terminate this License Agreement upon sixty (60) day prior written notice to AMT (i) in relation to France, Germany and the Netherlands in the event that AMT fails to launch the Product in France, Germany and the Netherlands within 4 years following the date on which this Agreement is signed by the last party to sign, (ii) on a country-by-country basis in the event that AMT fails to launch the Product in the remaining countries in the Territory (other than France, Germany and the Netherlands) 4 years following the date of launch of the Product in the last country of either France, Germany or the Netherlands and (iii) if there is a proceeding commenced against AMT under any bankruptcy act or under any present or future law for relief of debtors, or an action or proceeding is commenced to dissolve AMT, or AMT makes an assignment for the benefit of creditors or ceases to carry on business for any reason.

 

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10.                               EFFECTS UPON EXPIRATION OR TERMINATION

 

Expiration or termination shall not affect obligations which have accrued earlier.

 

11.                               NOTICES

 

Any notices required or provided for use in this License Agreement shall be in writing and shall be given by facsimile or by certified mail prepaid and properly addressed to the address of the party to be served as shown below.

 

If to AVENTIS:                                                          Aventis Pharma S. A.
 20 avenue Raymond Aron
 92160 Antony
 France

 

Attn: President Directeur General 
 Fax: +33.1.53.77.42.03

 

With a copy to Sanofi-Aventis, attn General Counsel, 174 avenue de France, 75013 Paris, France. Facsimile: +33.1.53.77.46.43.

 

If to AMT:                                                                                    Amsterdam Molecular Therapeutics B. V.
 Meibergdreef 61 
 1105 BA Amsterdam 
 The Netherlands

 

Attn: Prof. Sander J.van Deventer, MD, PhD, Chief Scientific Officer 
 Fax:+31 (0) 20 566 9272

 

12.                               FORCE MAJEURE

 

Neither party hereto shall be liable to the other party for any losses or damages attributable to a default in or breach of this License Agreement which is the result of any cause beyond the reasonable control of such party and in this case the performance of obligations hereunder shall be suspended during, but no longer than the existence of such cause.  The party affected by an event of force majeure shall inform the other party hereof without delay.  Furthermore, it shall endeavour to take up its performance under this Agreement again as soon as possible.

 

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13.                               MISCELLANEOUS

 

13.1                        The relationship of the parties of this License Agreement is that of independent contractors.  Neither party shall be the agent of the other and neither party is authorized to take any action binding on the other.

 

13.2                        This License Agreement shall be construed and interpreted pursuant to the laws of France.

 

13.3                        This License Agreement shall be binding upon the parties hereto and their respective legal successors.

 

13.4                        This License Agreement is personal to the parties hereto and neither party shall be entitled to assign any of its rights or obligations hereunder without the prior written consent of the other party hereto which consent shall not be unreasonably withheld.  It is expressly understood and agreed, however, that any permitted assignor of any rights or obligations hereunder shall remain bound by this License Agreement.

 

13.5                        Any amendment or supplement to this License Agreement shall be by written instrument signed by both parties hereto.

 

13.6                        The delay in or the omission to exercise any rights under this License Agreement shall not be deemed to be a waiver of such right.

 

13.7                        In the event that any provision of this License Agreement shall be or become invalid, then the parties shall agree on a valid provision which comes as close as possible to the commercial objectives of the invalid provision.  In the event that the parties cannot agree so the invalidity of such provision shall not affect the validity of this License Agreement as a whole, unless the invalid provision is of such essential importance that it is to be reasonably assumed that the parties would not have contracted this License Agreement without the invalid provision.

 

13.8                        All disputes between the parties arising out of the circumstances and relationships contemplated by this License Agreement including disputes relating to the validity, construction or interpretation of this License Agreement and including disputes relating

 

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to pre-contractual representations shall first be referred to the respective Chief Executive Officers of the parties for resolution, but if the Chief Executive Officers are unable to resolve the dispute within [**] days of its referral, the dispute shall be referred to and finally settled by arbitration carried out in accordance with the then current rules of the International Chamber of Commerce of Paris.  Arbitration shall take place in Paris.  All submissions and awards in relation to arbitration hereunder shall be made in English and all arbitration proceedings shall be conducted in English.

 

IN WITNESS WHEREOF, the parties hereto have executed this License Agreement by their duly authorized officers.

 

	
Date:   November 13, 2006
    	
Date:   December 20, 2006
    
	
Aventis   Pharma S. A.
    	
Amsterdam   Molecular Therapeutics B.V.
    
	
 
    	
 
    
	
 
    	
 
    
	
By:
    	
/s/   Jean-Luc Renard
    	
 
    	
By:
    	
/s/   Ronald Lorijn
    
	
Name:   Jean-Luc RENARD
    	
Name:   Ronald HW LORIJN, MD, PhD, MBA
    
	
Title:   Chairman & Chief Executive Officer
    	
Title:   Chief Executive Officer
    
	
 
    	
 
    
	
 
    	
 
    
	
By:
    	
/s/   Jean-Michel Demeure
    	
 
    	
 
    
	
Name:   Jean-Michel DEMEURE
    	
 
    
	
Title:   Finance Director
    	
 
    

 

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Annex 1

 

Patents

 

	
Country
    	
 
    	
Patent
   Application/Patent
   Number
    	
 
    	
Status
    
	
[**]
    	
 
    	
[**]
    	
 
    	
[**]
    
	
[**]
    	
 
    	
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[**]
    
	
[**]
    	
 
    	
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[**]
    
	
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[**]
    	
 
    	
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[**]
    	
 
    	
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[**]
    	
 
    	
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[**]
    	
 
    	
 
    	
 
    	
 
    
	
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[**]
    	
 
    	
 
    	
 
    	
[**]
    

 

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AVENTIS PHARMA S.A.

 

and

 

UNIQURE BIOPHARMA B.V.

 

 

AMENDMENT N°1 TO THE
 LICENSE AGREEMENT

 

 

 

AMENDMENT N°1 TO THE LICENSE AGREEMENT (the “Amendment”), with the effective date of June 28, 2013 (“Effective Date”),

 

BY AND BETWEEN:

 

AVENTIS PHARMA S.A., a company incorporated under the laws of the France, with offices at 20 Avenue Raymond Aron, 92160 Antony, France (“Aventis”);

 

and

 

uniQure biopharma B.V. (formerly: Amsterdam Molecular Therapeutics (AMT) B.V.), a company incorporated under the laws of the Netherlands, with offices at Meibergdreef 61, 1105 BA Amsterdam, The Netherlands (“uniQure”),

 

each, a “Party” and together the “Parties”,

 

BACKGROUND:

 

(A)                               The Parties have signed a License Agreement with an effective date of December 20, 2006 (hereinafter the “Agreement”);

 

(B)                               The Parties desire that the Agreement be amended as set forth below in order to:

 

I.                                        Change the name of uniQure from Amsterdam Molecular Therapeutics B.V. to uniQure biopharma B.V. This name change is the result of a transaction that took place on 30 March 2012, whereby Amsterdam Molecular Therapeutics (AMT)

II.                                   Holding N.V., a public company, was liquidated and all its operations and stocks were transferred to UniQure B.V., a privately held company;

II                                      Add language related to sublicensing, so that the possibility is created for uniQure to enter into sublicensing agreements under the patents licensed through the  Agreement;

III.                              Modify the financial terms associated with royalty payments;

IV.                               Create reporting obligations regarding pricing and reimbursement of uniQure’s gene therapy product Glybera® and its development milestones, and

V.                                    Add a Right of First Negotiation for Aventis.

 

IT IS NOW AGREED AS FOLLOWS:

 

1.                                      Modifications

 

I.                                        In the Agreement, all references to “Amsterdam Molecular Therapeutics B.V.” are changed to “uniQure biopharma B.V”.

 

II.                                   In the Agreement, all references to “AMT” are changed to “uniQure”.

 

III.                              Section 1.1 is deleted and replaced in its entirety with the following:

 

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1.1                               “Affiliate” shall mean any company which Controls, is Controlled by or is under common Control with AVENTIS, and shall mean, with respect to uniQure, any company which Controls, is Controlled by or is under common Control with uniQure and shall mean, with respect to the Commercialization Partner, any company which Controls, is Controlled by or is under common Control with the Commercialization Partner. “Control” shall mean the direct and/or indirect legal or beneficial ownership of fifty percent (50%) or more of the capital stock or the voting rights of such company.

 

IV.                               Section 1.5 is deleted and replaced in its entirety with the following:

 

1.5                               “Net Sales” shall mean the gross sales invoiced for the Product by uniQure and its Affiliates, or by the Commercialization Partner and its Affiliates, as applicable, to third parties in the Territory less: (i) quantity and/or cash discounts, allowances actually allowed or given, and transportation and insurance costs for shipments to customers; (ii) credits or refunds actually allowed for returned Product; (iii) compulsory payments and rebates, accrued, paid or deducted pursuant to agreements (including but not limited to managed care agreements) or governmental regulations and (iv) sales and other excise taxes directly related to that sale, to the extent that such items are included in the gross invoice price (but not including taxes assessed against the income derived from such sale).

 

V.                                    Section 1.7 is deleted and replaced in its entirety with the following:

 

1.7                               “Product” shall mean a gene therapy product containing a recombinant virus with a nucleic acid coding for a lipoprotein lipase (LPL) developed, used and/or commercialized by or for uniQure, the Commercialization Partner or their Affiliates where the activity in relation to such product occurs in one of the countries of the Territory and is covered in whole or in part by a Valid Claim within the Patents in that country.

 

VI.                               A new Section 1.10 is added to the Agreement that reads as follows:

 

1.10                        “Commercialization Partner” means uniQure’s partner for the commercialization of the Product.

 

VII.                          A new Section 1.11 is added to the Agreement that reads as follows:

 

1.11                        “Fully Loaded Cost of Goods” shall mean the fully loaded cost of goods of the Product as defined in Annex 2.

 

VIII.                     A new Section 1.12 is added to the Agreement that reads as follows:

 

1.12                        “Invoice Price” means the price invoiced by uniQure to the Commercialization Partner for the Products minus the Fully Loaded Cost of Goods.

 

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IX.                               New Sections 2.4 and 2.5 are added to the Agreement which read as follows:

 

2.4                               uniQure shall have the right to grant sublicenses under the Patents to third parties for the purpose of developing, using, marketing, selling, offering for sale, manufacturing, distributing or otherwise commercializing Products, and having such activities performed, without the written consent of Aventis, on terms that permit uniQure to comply with its obligations set out in the Agreement.

 

2.5                               Except for those expressly set forth in this Agreement, no other rights, licenses or sublicense rights are granted by Aventis or its Affiliates to uniQure.

 

X.                                    Section 3.1 is deleted and replaced in its entirety with the following:

 

3.1                               In consideration of the rights granted by Aventis to uniQure under this License Agreement, uniQure undertakes to effect the following payments:

 

(a)                                 Ten thousand Euros (10,000 €) upon signature of the Agreement;

 

(b)                                 Fifty thousand Euros (50,000 €) upon [**];

 

(c)                                  Seventy-five thousand Euros (75,000 €) at the [**];

 

(d)                                 Royalty payments the higher of:

 

Either

 

i                                             (x) [**] percent ([**]%) of UniQure’s Net Sales of Product in the Territory or (y) if Product is being sold by Commercialization Partner and not uniQure, then [**]percent ([**]%) of the royalties (or other revenue) uniQure receives from its Commercialization Partner for its Net Sales of Product in the Territory plus [**] percent ([**]%) of the Invoice Price of Product in the Territory, in each case (x) or (y), as long as total cumulative Net Sales of Product are below [**] Euros ([**] €), and

 

ii                                          (x) [**] percent ([**]%) of UniQure’s Net Sales of Product in the Territory or (y) if Product is being sold by Commercialization Partner and not uniQure, then [**] percent ([**]%) of the royalties (or other revenue) uniQure receives from its Commercialization Partner for its Net Sales of Product in the Territory plus [**] percent ([**]%) of the Invoice Price of Product in the Territory, in each case (x) or (y), as long as total cumulative Net Sales of Product are equal to or exceed [**] Euros ([**] €),

 

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or

 

iii                                       [**] percent ([**]%) of Net Sales by Commercialization Partner of Product in the Territory.

 

The royalty payments by uniQure to Aventis shall begin at the end of the first calendar year of sales in any country of the Territory. For the sake of clarity, the “end of the first calendar year” means December 31 of the first year of sales in any country of the Territory and does not mean the end of the first consecutive twelve months of sales in a country of the Territory.

 

XI.                               A new Section 3.7 is added to the Agreement that reads as follows:

 

3.7                               For a period of [**] years from [**], uniQure shall provide Aventis with written quarterly reports describing (i) the pricing and reimbursement status of Glybera®, including but not limited to, detailed minutes, transcripts or summaries (as available) of any communication, feedback, guidance or decisions from any reimbursement authority regarding Glybera®, as well as copies of any currently existing or future (during the [**] years) reimbursement reports or advice received from any external consultants and (ii) uniQure’s pipeline development milestones. For the sake of clarity, this means that Aventis shall receive a total number of eight of such reports on or before the following dates: [**].

 

XII.                          A new Section 3.8 is added to the Agreement that reads as follows:

 

3.8                               uniQure is developing its proprietary construct AMT-021 for the treatment of Acute Intermittent Porphyria (AIP) in humans (the “AIP Product”). If after completion of phase l/l1 clinical trials regarding the AIP Product or for a period of [**]months thereafter, uniQure contemplates entering into a partnership for the co-development and commercialization of the AIP Product, uniQure shall inform Aventis accordingly and offer Aventis a right of first negotiation to enter into a partnership agreement for such development and commercialization (the “Right of First Negotiation” or “ROFN”). uniQure shall provide Aventis with a summary of the existing clinical trial data regarding the AIP Product but any such summary shall not include any manufacturing information for the AIP Product unless specifically requested in writing by Aventis; in the event uniQure discloses manufacturing information to Aventis without its request, any such manufacturing information disclosed by or on behalf of uniQure shall not be treated as Confidential Information under the Agreement. Within [**] business days after having received such summary from uniQure, Aventis shall decide whether it wishes to exercise its ROFN. If Aventis remains silent after such period or informs uniQure it does not wish to enter into such negotiation, uniQure shall be free to further develop and commercialize the AIP Product as it deems fit and enter into a partnership agreement with any third party without any obligation to Aventis. If

 

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Aventis wishes to exercise its ROFN, Aventis will notify uniQure within the [**] day evaluation period and will then have [**] months from such notification date to negotiate a term sheet. Upon mutual agreement of the term sheet, the Parties shall then enter into good faith discussions, meeting and negotiating at reasonable times with willingness to reach agreement regarding the development and commercialization of the AIP Product using commercially reasonable terms. Such negotiations shall be consistent with the aim of achieving a final definitive agreement within [**] months from the start of said negotiations, and shall include, but not be limited to, responding promptly to proposals from the other Party and attending meetings at reasonable notice. If the Parties are unable to finalize the terms of a definitive agreement, uniQure shall be free to enter into an agreement with a third party. Aventis’s ROFN shall expire upon expiry of the Agreement pursuant to Section 8 or upon termination of this Agreement by uniQure pursuant to Section 9.1.

 

2.              Miscellaneous:  All the other provisions of the Agreement remain unchanged and in full force and effect between the Parties, and the terms and definitions used in the Agreement shall apply to this Amendment. To the extent any terms or provisions of this Amendment conflict with the terms and provisions of the Agreement, the terms and provisions of this Amendment shall prevail. This Amendment is made a part of the Agreement.

 

IN WITNESS WHEREOF, the Parties have caused this Amendment to be executed as of the Effective Date.

 

	
Aventis Pharma S.A.
    	
UniQure biopharma B.V.
    
	
By:
    	
/s/ Philippe Goupit
    	
 
    	
By:
    	
/s/ PJ Morgan
    
	
Name:
    	
Philippe Goupit
    	
 
    	
Name:
    	
PJ Morgan
    
	
Title:
    	
Vice President Business   Development
    	
 
    	
Title:
    	
CFO
    
	
Date:
    	
28/06/2013
    	
 
    	
Date:
    	
28 June 2013
    

 

19

 

Annex 2

 

Definition 
 Fully Loaded Cost of Goods

 

	
Item per 50 L 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 [**]
    

 

[**]

 

20Exhibit 10.7

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

NON-EXCLUSIVE LICENSE AGREEMENT

 

This License Agreement (the “Agreement”), effective as of September 3, 2010 (the “Effective Date”), is by and between Asklêpios Biopharmaceutical, Inc., an entity organized and existing under the laws of the State of North Carolina, with its registered office located at 45 N. Chatham Parkway, Chapel Hill, NC 27517 (the “AskBio”), and Amsterdam Molecular Therapeutics (AMI) B.V., with offices located at Meibergdreef 61, 1100 DA Amsterdam, The Netherlands (“AMT”).  AMT and AskBio may be hereinafter referred to individually as “Party” and jointly as “Parties”.

 

RECITALS

 

WHEREAS, AskBio is the exclusive licensee of the AskBio Patent Rights (as defined below) pursuant to the amended and restated license agreement made and entered into on June 1, 2009 between The University of North Carolina at Chapel Hill and AskBio;

 

WHEREAS, AskBio has the right to grant sublicenses under such AskBio Patent Rights; and

 

WHEREAS, AMT desires to obtain a non-exclusive license under the AskBio Patent Rights upon the terms and conditions set forth below.

 

NOW, THEREFORE, for and in consideration of the mutual covenants contained herein and of other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, AskBio and AMT hereby agree as follows:

 

AGREEMENT

 

1.              Definitions.

 

a.              “AskBio Patent Rights” means the patents and patent applications listed in Exhibit A hereto, including all provisionals, divisions, continuations, continuations-in-part, reissues, reexaminations, extensions, supplementary protection certificates, and foreign counterparts of any of the foregoing.

 

b.              “Field” means the treatment of lipoprotein lipase deficiency in humans.

 

c.               “Product” means GLYBERA® and/or any other pharmaceutical product which contains or consists of an AAV vector having an AAV genetic construct encoding LPL gene variant and which, in the absence of a license, would infringe any Valid Claim in the applicable country.

 

d.              “Territory” means worldwide.

 

e.               “Valid Claim” means any claim from an issued and unexpired AskBio Patent Right which has not been rejected, revoked or held unenforceable or invalid by a final, nonappealable decision of a court or other governmental authority of competent jurisdiction or unappealed within the time allowable for appeal, and which has not been explicitly disclaimed, or admitted to be invalid or unenforceable by AskBio through reissue, disclaimer or otherwise.

 

2.              Grant.  AskBio grants AMT a non-exclusive license (the “License”) to research, develop, make, have made, use, sell, offer for sale, have sold and import Products in the Field in the Territory.  AMT shall have the right to grant sublicenses to third parties, without the written consent of AskBio, under the AskBio Patent Rights, on terms permitting AMT to comply with its obligations set out in this Agreement.  AskBio does not grant AMT any other rights and all rights not granted to AMT hereunder are expressly reserved to AskBio.  The License granted hereunder does not constitute a transfer or sale of any ownership rights in the AskBio Patent Rights.

 

AskBio — AMT
 Non-Exclusive License Agreement
 September 30, 2010

1

 

3.              Payment.  In consideration of the rights granted hereunder, and subject to the terms and conditions of this Agreement, AMT shall pay to AskBio the following nonrefundable license fees:

 

a.              Signature Fee:  US$50,000 upon the Effective Date of this Agreement; and

 

b.              License Maintenance Fee:  US$[**] due within [**] days of each anniversary of the Effective Date of this Agreement.

 

4.              Warranties by AskBio and Disclaimer.  AskBio hereby represents and warrants to AMT that (i) to AskBio’s best knowledge, the University of North Carolina at Chapel Hill is the sole owner of the AskBio Patent Rights and at the Effective Date the license is in force; (ii) AskBio has obtained from the University of North Carolina at Chapel Hill the exclusive, world-wide, rights for all applications under the AskBio Patents Rights; (iii) AskBio is entitled to grant the License granted hereunder; (iv) AskBio has not granted any license to any third party that would be inconsistent with the license granted to AMT hereunder; and (v) to AskBio’s best knowledge, the exercise of the AskBio Patent Rights does not infringe any other intellectual property right of AskBio or any intellectual property right of any third party.  EXCEPT AS SET FORTH IN THIS SECTION 4, ASKBIO DISCLAIMS ANY AND ALL REPRESENTATION AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF NON-INFRINGEMENT, TITLE, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE.  THE ASKBIO PATENT RIGHTS ARE PROVIDED TO AMT “AS-IS”, WITH ANY ACCOMPANY SERVICES, REPRESENTATIONS, OR WARRANTIES FROM ASKBIO.

 

5.              Limitation of Liability.  AMT assumes all liability for damages that may arise from the practice of the AskBio Patent Rights by AMT.  AskBio will not be liable to AMT for any loss, claim, or demand made by AMT, or made against AMT by any third party, due to or arising from the practice of the AskBio Patent Rights by AMT, except to the extent permitted by law when caused by the gross negligence or willful misconduct of AskBio or breach of warranties by AskBio as set forth in Article 4 hereof.  IN NO EVENT SHALL AMT BE ENTITLED TO RECOVER FROM ASKBIO ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, INCLUDING BUT NOT LIMITED TO LOST PROFITS, ARISING OUT OF OR IN ANY WAY RELATED TO THIS AGREEMENT OR THE PRACTICE OF THE ASKBIO PATENT RIGHTS BY AMT, ITS AFFILIATES, PARENT COMPANY, OR JOINT VENTURERS, REGARDLESS OF THE NATURE OF THE CLAIM, WHETHER IN CONTRACT, TORT, INTELLECTUAL PROPERTY, INFRINGEMENT, OR OTHER ACTION, AND WHETHER AMT HAS INFORMED THE ASKBIO OF ANY POSSIBLE DAMAGES.

 

6.              Indemnification.  AMT agrees to indemnify, defend, and hold harmless AskBio, its officers, agents, and employees from and against any and all claims, liabilities, demands, damages, losses, costs and expenses (including costs and reasonable attorney’s fees) or claims for injury or damages arising out of or related to AMT’s performance hereunder, including those that are caused by or result from AMT’s practice of the AskBio Patent Rights, save for claims, liability, demands, damages, losses, costs and expenses that result from the gross negligence or willful misconduct of AskBio or from breach by AskBio of its warranties set forth in Article 4.

 

7.              Term and Termination.

 

7.1.                            Term.  The term of this Agreement shall begin on the Effective Date and shall, on a country-by-country basis, end on the earlier of June 5, 2016 or the last date on which Products are covered by a Valid Claim in such country.

 

7.2.                            Early Termination by AMT.  AMT may terminate this Agreement at any time upon thirty (30) days notice to AskBio.

 

2

 

7.3.                            Early Termination by AskBio.  AskBio may terminate this Agreement (i) upon a material breach that is not cured within ten (10) days of written notice thereof, or (ii) if AMT or any of its sublicensees challenges, or assists others challenging, the validity, patentability, enforceability and/or non-infringement of any of the AskBio Patent Rights or otherwise opposes any of the AskBio Patent Rights.

 

7.4.                            Effect of Early Termination.  Upon early termination of this Agreement, the license granted to AMT hereunder shall immediately terminate, and AMT shall immediately cease all use of the AskBio Patent Rights.

 

8.              Miscellaneous.

 

8.1.                            Relationship of the Parties.  For the purpose of this Agreement and all services to be provided hereunder, both parties shall be, and shall be deemed to be, independent contractors and not agents or employees of the other.  Neither party shall have authority to make any statements, representations or commitments of any kind, or to take any action, that will be binding on the other party.

 

8.2.                            Notices.  Any notice or other communication required or permitted to be given to either Party hereto shall be deemed to have been properly given provided it is delivered to the Party at the respective address set forth below, or as otherwise designated by prior written notice provided to the other Party.  Any such notice or communication shall be deemed to be effective on the date of delivery if delivered in person, or on the date of mailing if delivered by certified mail.

 

If to AskBio:                         Asklêpios Biopharmaceutical, Inc.
 45 N. Chatham Parkway 
 Chapel Hill, NC 27517 
 Attention:  Jade Samulski

 

If to AMT:                                    Amsterdam Molecular Therapeutics B.V.
 Meibergdreef 61 
 1100 DA Amsterdam, The Netherlands 
 Attention:  Piers Morgan

 

8.3.                            Publicity; Advertising.  Neither of the Parties will use the other Party’s name or the name of any member of that Party’s personnel in any publicity (including press releases) relating to this Agreement or in any advertising, packaging or other promotional material, without the prior written approval of the other Party, except as may be required by law, regulation or legal process.

 

8.4.                           No Modification/Amendments.  This Agreement, including the exhibits, may be changed only by written agreement of the Parties and in accordance with the terms of this Agreement; no amendment of any provision of this Agreement shall be valid unless the same shall be in writing and signed by the Parties.

 

8.5.                            No Waiver.  No waiver by a Party of any right or remedy hereunder shall be valid unless the same shall be in writing and signed by the Party giving such waiver.  No waiver by a Party with respect to any default, misrepresentation, or breach of warranty or covenant hereunder shall be deemed to extend to any prior or subsequent default, misrepresentation, or breach of warranty or covenant hereunder or affect in any way any rights arising by virtue of any prior or subsequent such occurrence.

 

8.6.                            Severability.  Any term or provision of this Agreement that is invalid or unenforceable in any situation in any jurisdiction shall not affect the validity or enforceability of the remaining terms and provisions hereof or the validity or enforceability of the offending term or provision in any other situation or in any other jurisdiction.  If the final judgment of a court of competent jurisdiction declares that any term or provision hereof is invalid or unenforceable, the Parties agree that the court making the determination of invalidity or 

 

3

 

unenforceability shall have the power to limit the term or provision, to delete specific words or phrases, or to replace any invalid or unenforceable term or provision with a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term or provision, and this Agreement shall be enforceable as so modified.

 

8.7.                            Assignment.  This Agreement, and the rights and obligations hereunder, may not be assigned or transferred, in whole or in part, by either Party and AskBio shall not assign its rights under the license agreement with University of North Carolina at Chapel Hill to any third party without the prior written consent of the other Party, except that each Party may assign this Agreement without the consent of the other Party in connection with the merger, consolidation or sale of all or substantially all of its assets, stock or business to which this Agreement relates.

 

8.8.                            Applicable Law.  This Agreement shall be governed by the laws of the state of New York, United States, without regard to conflicts of laws principles.

 

8.9.                            Counterparts.  This Agreement may be executed in two or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument.

 

8.10.                     Entire Agreement.  This Agreement, including all attachments hereto, constitutes the entire agreement of the Parties with regard to its subject matter, and supersedes all previous written or oral representations, agreements and understandings between the Parties.

 

IN WITNESS WHEREOF, AskBio and AMT have executed this Agreement by their respective officers hereunto duly authorized, on the day and year hereinafter written.

 

	
For Asklêpios Biopharmaceutical, Inc.
    	
For Amsterdam Molecular Therapeutics (AMT) B.V.
    
	
 
    	
 
    
	
By: 
    	
/s/ Jude Samulski
    	
 
    	
By: 
    	
/s/ P J Morgan
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name: 
    	
Jude Samulski
    	
 
    	
Name: 
    	
P J Morgan
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title: 
    	
President
    	
 
    	
Title: 
    	
CFO
    

 

4

 

Exhibit A
 AskBio Patent Rights

 

	
Patent Filing
    	
 
    	
Publication Date
    	
 
    	
Filing Date
    	
 
    	
Status as of the Effective Date
    
	
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