Document:

Exhibit 10.9

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

LICENSE AGREEMENT

 

THIS AGREEMENT (the “Agreement”) is made and is effective December 5, 2006, (the “Effective Date”) by and between Targeted Genetics Corporation, a corporation having a principal place of business at 1100 Olive Way, Suite 100, Seattle, Washington 98101 (“TGC”), and Amsterdam Molecular Therapeutics B.V. (“AMT”), a corporation having a principal place of business at Meibergdreef 61, 1100 DA Amsterdam, The Netherlands.

 

RECITALS

 

WHEREAS, TGC has exclusively licensed the Licensed Patent Rights (relating to an AAV1 Vector gene delivery system) from the University of Pennsylvania as part of a license agreement entered into between TGC and the University of Pennsylvania (“UPenn”) with the effective date of June 1, 2002 (“UPenn Agreement”).

 

WHEREAS, AMT is developing an AAV1 product to treat LPL type 1 and LPL type 5 deficiency that requires a license to the Licensed Patent Rights and therefore seeks a license to the Licensed Patent Rights in the Field, as such terms are defined herein; and

 

WHEREAS, TGC is willing to grant such a license on the terms set forth herein and the University of Pennsylvania is willing to acknowledge such grant of a sublicense.

 

NOW THEREFORE, the parties agree as follows:

 

1.  DEFINITIONS

 

1.1                               “AAV1 Vector” means the adeno-associated virus serotype 1 vector technology which includes without limitation the AAV serotype 1 rep, cap, and ITR sequences and proteins whether utilized in whole or in part to deliver therapeutic genes into cells, and which is the subject of the Licensed Patent Rights

 

1.2                               “Affiliate” means any company or other legal entity other than AMT in whatever country organized, controlling, controlled by or under common control with AMT.  The term “control” means possession, direct or indirect, of the powers to direct, cause or significantly influence the direction of the management and policies of the company or entity in question, whether through the ownership of voting securities, by contract or otherwise.

 

1.3                               “Federal Government Interest” means the rights of the United States Government under Public Laws 96-517, 97-256 and 98-620, codified at 35 U.S.C. 200-212, and any regulations issued thereunder, as such statute or regulations may be amended from time to time hereafter.

 

1.4                               “Field” means treatment of LPL deficiency type 1 and LPL deficiency type 5 by in vivo gene therapy utilizing an AAV1 Vector encoding the LPL gene.

 

1.5                               “Included CIPs” has the meaning given in Paragraph 1.9.

 

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1.6                               “License” has the meaning given in Paragraph 2.1.

 

1.7                               “LPL” means Lipoprotein Lipase.

 

1.8                               “Licensed Patent Rights” means rights to any subject matter described or claimed in U.S. Patent Nos. [**]; and all foreign counterparts including all continuations, divisional, and any continuation-in-part applications, to the extent that such continuation-in- part (or any continuation or divisional thereof) has claims directed to subject matter enabled and described in U.S. Patent Nos. [**] and such claims are necessary or relevant for the Field ( collectively, “Included CIPs”); any patents issuing on said applications, continuing applications, divisional applications, including reissues and reexaminations thereof, and any foreign applications or patents corresponding directly thereto.

 

1.9                               “Licensed Product” means a product in the Field that, absent the License, would in the country of sale infringe any Valid Claim within the Licensed Patent Rights in such country.

 

1.10                        “Net Sales” means (a) the actual gross invoice price of Licensed Products sold by AMT or its Affiliates to any Third Party, less, to the extent included therein, the total of (i) ordinary and customary trade discounts; (ii) sales and excise taxes, and other similar taxes, customs duty and compulsory payments to governmental authorities actually paid or deducted and related to the sale (excluding what is commonly known as income taxes); and (iii) credits given to customers for rejects or returns of the product.  For purposes hereof, Net Sales shall not include sales of a Licensed Product from AMT to an Affiliate of AMT; it being intended that Net Sales shall only include sales to unrelated third-parties.

 

1.11                        “Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture, or other similar entity or organization, including without limitation, a government or political subdivision, department or agency of a government.

 

1.12                        “Royalties” has the meaning given in Paragraph 4.1.

 

1.13                        ‘Third Party” means any Person other than AMT, TGC or any of their respective Affiliates.

 

1.14                        “Valid Claim” means

 

i)                                         a claim of an issued and unexpired patent included within Licensed Patent Rights, which has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or un-appealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise; or

 

ii)                                      a claim of a pending patent application included within Licensed Patent Rights which claim was filed and is being prosecuted in good faith and has not been abandoned

 

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or finally disallowed without the possibility of appeal or refiling of the application, provided that no more than [**] years have passed since the earliest priority date for such application.

 

2.  GRANT

 

2.1                               TGC grants to AMT a non-exclusive, non-sublicensable license under the Licensed Patent Rights in each country of the world where there are Valid Claims of Licensed Patent Rights, to make, have made, develop, use, sell, offer to sell and import Licensed Products (the “License”).

 

2.2                               AMT acknowledges that in accordance with the Federal Government Interest, the United States government retains certain rights in intellectual property funded in whole or part under any contract, grant or similar agreement with a Federal agency, including but not limited to the requirement that Licensed Products subject to sale in the United States must be substantially manufactured in the United States.  The license grant of this Article 2 is expressly subject to all of such rights.

 

2.3                               UPenn retains the reserved right to use, and to permit other for-profit or nonprofit organizations to use, the Licensed Patent Rights strictly for educational and for research purposes.  Any such rights of UPenn or a third party to practice the Licensed Patent Rights for educational or research purposes shall be royalty-free.

 

3.  CONSIDERATION AND MAINTENANCE FEES

 

3.1                               Upon signing this Agreement, AMT shall pay to TGC a $1,750,000 fee in consideration of the License.

 

3.2                               Upon the first anniversary of the Effective Date and upon each anniversary during the Term thereafter, AMT shall pay to TGC a $100,000 maintenance fee for maintenance of the License.

 

4.  ROYALTIES AND PAYMENTS

 

4.1                               AMT shall pay to TGC earned royalties based on Net Sales (“Royalties”) in the amount of: (i) [**] percent ([**]%) of the Net Sales of Licensed Products if cumulative Net Sales are less than $[**], or (ii) [**] percent ([**]%) of the Net Sales of Licensed Products if cumulative Net Sales are equal to or greater than $[**] but less than $[**], or (iii) [**] percent ([**]%) of Net Sales of Licensed Products if cumulative Net Sales are $[**] or more.  In the case other third party royalties are paid by AMT to Third Party licensors of intellectual property that is required for the composition of AAV1 , then [**] percent ([**]%) of such royalty actually paid to Third Parties shall be deducted from the royalty in 4.l(i), (ii) or (iii), with a minimum due to TGC of [**] percent ([**]%) if cumulative Net Sales of Licensed Products are less than $[**] or, [**] percent ([**]%) if the cumulative Net Sales of Licensed Products are greater than or equal to $[**] but less than $[**] or, [**]percent ([**]%) if the cumulative Net Sales of Licensed Products are greater than or equal to $[**].  The Net Sales thresholds in such section (i)-(iii) will be applied separately to each distinct Licensed Product, but where the same Licensed Product is packaged or labeled differently in different nations, or otherwise to accommodate the same to

 

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different markets or indications, the Net Sales thereof in all such nations, markets and indications shall be aggregated.

 

4.2                               In addition to the Royalties and other payments set forth herein, AMT shall pay TGC the following “Milestone Payments.” For the purposes of this Agreement, the [**].  For the purpose of clarity, the total payments for milestones achieved assuming both the LPL type 1 and 5 deficiency proceed through regulatory approval for marketing would be four million nine hundred and fifty thousand U.S. Dollars ($4,950,000):

 

	
Section
    	
 
    	
Milestone
    	
 
    	
Milestone
   Payments
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
4.2.1
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
4.2.2
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
4.2.3
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
4.2.4
    	
 
    	
[**]
    	
 
    	
[**]
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
4.2.5
    	
 
    	
Upon first regulatory approval (BLA or   other) for each indication
    	
 
    	
[**]
    

 

4.3                               Royalties accruing to TGC shall be paid to TGC on a quarterly basis.  Each such payment will be for royalties which accrued within the most recently completed calendar quarter and payment shall be made by AMT within [**] days of the end of such calendar quarter.

 

4.4                               Milestone Payments shall be paid to TGC within [**] days of achievement.

 

4.5                               Royalty or Milestone Amounts that are not paid when due shall accrue interest from the due date until paid, at a rate equal to [**] percent ([**]%) per month (or the maximum allowed by law, if less).

 

4.6                               AMT must maintain complete and accurate books and records which enable the Royalties, fees, and payments payable under this Agreement to be verified.  The records for each calendar quarter must be maintained for [**] years after the submission of each report under Article 4.  Upon reasonable prior written notice to AMT from TGC, AMT shall permit a certified public accountant or a person possessing similar professional status and associated with an independent accounting firm reasonably acceptable to AMT to inspect all books and records relating to the sales of Licensed Products by AMT as necessary to verify the same.  Access to these books and records pertaining to Net Sales must be made available no more than [**] for each Licensed Product, during normal business hours, and [**] for each Licensed Product during each of the [**] years after expiration or termination of this Agreement.  The accounting firm shall enter into appropriate obligations with AMT to treat all information it receives during its inspection in confidence.  The accounting firm shall disclose to the parties only whether such books and records are correct and details concerning any discrepancies, but no other information shall be disclosed to TGC.  The charges of the accounting firm shall be paid by TCG, except if a review or audit of such books and records of AMT determines that AMT has underpaid royalties

 

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on Licensed Products by [**] percent ([**]%) or more then AMT must pay the charges of the accounting firm in connection with such review or audit.  Notwithstanding the foregoing, AMT agrees to conduct, at its expense, an independent audit of sales and Royalties with respect to a Licensed Product at least every [**] years once annual sales of such Licensed Product are greater than [**] dollars ($[**]) per annum.  The audit shall address, at a minimum, the amount of gross sales by or on behalf of AMT during the audit period, the amount of funds owed to TGC under this Agreement, and whether the amount owed has been paid to TGC and is reflected in the records of the AMT.  A report by the auditors shall be submitted promptly to TGC upon completion.

 

4.7                               In the event that any patent or any claim thereof included within the Licensed Patent Rights shall be held invalid or unenforceable in a final decision by a court of competent jurisdiction from which no appeal has or can be taken, any and all obligation to pay Royalties based solely on such patent or claim shall cease as of the date of such final decision.

 

4.8                               Any component of Net Sales denominated in currencies other than U.S. Dollars shall be converted into U.S. Dollars in accordance with the provisions of this paragraph, and reported in U.S. Dollars.  All payments required under this Agreement from time to time shall be made in U.S. Dollars.  Any currency conversions shall be made using the average quarterly exchange rates published regularly by Citibank, New York, or its successor.  The average will be calculated by summing the exchange rates for the final business day of each of the three (3) months in the applicable calendar quarter and dividing by three (3).  All currency conversions will be calculated to an accuracy of three (3) digits after the decimal point.

 

5.  PATENT FILING, PROSECUTION AND MAINTENANCE

 

5.1                               As between the parties, TGC shall have the responsibility for the preparation, filing, prosecution and maintenance of the Licensed Patent Rights in the United States and foreign countries for which patent protection has been sought.  TGC shall maintain the Licensed Patent Rights in all territories for the maximum time period permitted by applicable law, including by timely paying all applicable maintenance fees and diligently prosecuting any patent applications and diligently defending any Third Party challenges to validity or enforceability.

 

6.  PATENT INFRINGEMENT

 

6.1                               In the event that AMT learns of the infringement of any Licensed Patent Rights by the manufacture, use or sale of a product in the Field, AMT shall so inform TGC in writing and shall provide TGC with reasonable evidence of such infringement.

 

6.2                               As between the parties, TGC shall have the first right but not the obligation to prosecute such infringement of the Licensed Patent Rights.  In the event such infringement relates specifically to the manufacture, use or sale of a product in the Field, AMT shall have the right but not the obligation to participate in such infringement litigation and be represented by counsel of its choice at its own expense.  In the event TGC notifies AMT that it will not bring such action as it relates specifically to the manufacture, use or sale of a product in the Field, AMT at it is own expense shall have the right to bring such action and shall cause TGC to be

 

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joined in such action in jurisdictions where it is necessary for TGC to be named in order for AMT to have standing in such infringement litigations; provided, however, that AMT shall allow TGC to participate and be represented by counsel of its own choice at AMT’s sole expense.  AMT shall not nor shall AMT cause TGC to settle or compromise any such suit in a manner that imposes any obligations or restrictions on TGC or grants any License Patent Rights without TGC’s written permission.

 

6.3                               Each party shall, at the request and expense of the party initiating such suit, cooperate in all respects, including being joined as a named party, and, to the extent possible, have its employees testify when requested and make available relevant records, papers, information, samples, specimens, and the like.  No such suit shall be settled by a party in any manner which diminishes the rights of the other party hereto under this Agreement without the written agreement of both parties.

 

6.4                               Any legal action against a third party under this Section 6 shall be at the expense of the party on account of whom suit is brought and recoveries recovered thereby shall first be allocated to reimburse the expenses of the parties on a pro rata basis, after which, when the infringement relates to the manufacture, use or sale of a product in the Field,, any remaining recoveries shall belong to AMT and AMT shall pay TGC royalty amounts set forth in Section 4 on such remaining recoveries as if such recoveries were Net Sales.

 

7.  REPORTING

 

7.1                               AMT will make quarterly royalty reports to TGC on or before each [**] of each year (i.e., within [**] days from the end of each calendar quarter) and certified by the chief financial officer of AMT.  Each such royalty report will cover AMT’s most recently completed calendar quarter and will show: (a) the gross sales and Net Sales of Licensed Products sold by AMT during the most recently completed calendar quarter, including (i) all amounts invoiced, billed, or received; and (ii) the number of units and the country of sale; and (b) the Royalties payable hereunder with respect to such.  If no sales of Licensed Products have been made during any reporting period, a statement to this effect shall be provided by AMT to TGC.

 

7.2                               Progress Reports.

 

7.2.1                     AMT will provide TGC with a written plan relating to AMT’s development in the Field (the “Development Plan”) within [**] days after the signing of this Agreement by both parties.  The Development Plan will outline the disease indications, patient populations to be addressed, publicly available information on competition and estimates of development timelines for AMT’s products in the Field.  The Development Plan will separately address activities applicable to each Licensed Product.

 

7.2.2                     At or within [**] days following each anniversary of the Effective Date, AMT will provide TGC with a written progress report that describes any progress made against the Development Plan (as supplemented by progress reports, where applicable) submitted a year earlier and plans for development in the coming year.  AMT shall also notify TGC within [**] days of the first commercial sale of any Licensed Product.

 

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7.2.3                     AMT will provide TGC with audited financial statements, produced by a certified public accounting firm, [**] days following the end of each of AMT’s fiscal years, as well as a copy of any management letter recommendations submitted by the auditors.

 

7.2.4                     Where applicable AMT will provide TGC with copies of reports such as Form 10-K and Form 10-Q filings made to the United States Securities and Exchange Commission or other similar regulatory agency outside of the United States.

 

7.2.5                     TGC shall keep the Development Plan, all such progress reports, financial statements and any other information AMT provided to TCG under this Section 7 confidential, other than the provision of such reports to the University of Pennsylvania as required under the UPenn Agreement, for five (5) years or until the time, if any, of the first commercial sale of any Licensed Product(s).

 

8.  TERM OF THE AGREEMENT

 

8.1                               Unless otherwise terminated in accordance with the terms of this Agreement, this Agreement shall be in force from the Effective Date until the last to expire Valid Claim of Licensed Patent Rights (the “Term”).

 

8.2                               Any termination of this Agreement shall not affect the rights and obligations set forth in the following Articles:

 

Article 6.4 Allocation of Patent Infringement Recovery
 Article 11.2 Disposition of Licensed Products on Hand upon Termination
 Article 13 Use of Names and Trademarks
 Article 15 Limitation of Liability
 Article 16 Indemnification
 Article 19 Failure to Perform
 Article 20 Governing Law

 

9.  TERMINATION BY TGC

 

9.1                               If AMT violates or fails to pay Royalties, Milestone Payments or fees under Articles 3 or 4, or (ii) breaches or fails to perform, or has any other default, under any contractual obligation of AMT to TGC and fails to repair any default in Sections 9.1(i) or 9.1(ii) within [**] days after receipt of such notice of breach, TGC shall have the right to terminate this Agreement by a second written notice (“Notice of Termination”) to AMT.  If a Notice of Termination is sent to AMT, this Agreement shall terminate fifteen (15) days after receipt of such notice unless other terms are mutually agreed upon.

 

9.2                               If AMT shall cease its operations other than in connection with a reorganization of its business in connection with a redomociliation or other corporate event unrelated to the solvency of AMT, become bankrupt or insolvent, apply for or consent to the appointment of a trustee, receiver or liquidator of its assets or seek relief under any law for the aid of debtors then TGC shall have the right to terminate the License.

 

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10.  TERMINATION BY AMT

 

10.1                        AMT shall have the right to terminate this Agreement at any time, effective sixty (60) days after receipt by TGC of a written notice of termination delivered pursuant to this section.

 

10.2                        AMT may terminate this Agreement with immediate effect by giving written notice to TGC, if TGC ceases its operations, becomes insolvent, applies for or consents to the appointment of a trustee, receiver or liquidator of its assets, or seeks relief under any law for the aid of debtors.  If TGC violates or fails to perform any material term or covenant of this Agreement, then AMT may give written notice of such default (“Notice of Default”) to TGC.  If TGC fails to repair such default within [**] days after receipt of such Notice of Default, AMT shall have the right to terminate this Agreement by a Notice of Termination to TGC, effective immediately.

 

11.  EFFECT OF TERMINATION, DISPOSITION OF LICENSED
 PRODUCTS UPON TERMINATION

 

11.1                        Effect of Termination.  Upon the termination of this Agreement, except pursuant to Paragraph 10.2, the License granted by TGC to AMT hereunder shall revert to TGC.

 

11.2                        Upon termination of this Agreement for any reason, except pursuant to Paragraph 10.2, AMT shall have the right to dispose of all previously made or partially made Licensed Products, within a period of [**] months; provided, however, that the sale of such Licensed Products shall be subject to the terms of this Agreement including, but not limited to, the payment of Royalties at the rate and at the time provided herein and the rendering of reports.

 

11.3                        Upon termination of this Agreement for any reason, except pursuant to Paragraph 10.2, AMT shall pay, within [**] days to TGC, pursuant to Section 3 and 4, any and all amounts due within [**] days of receipt by TGC of a notice of termination from AMT.

 

11.4                        Upon the termination of this Agreement pursuant to Paragraph 10.2 or the termination of the UPenn Agreement, TGC’s rights hereunder shall be assigned directly to UPenn and shall remain in full force and effect under the terms hereof; and, provided that AMT is not in material breach of this Agreement, the rights and obligations of AMT herein (including but not limited to the License) shall continue in full force and effect without expansion, restriction, inhibition or diminution; provided that UPenn will require execution of an amended and restated license with AMT that will (i) restate Article 6, Patent Infringement, to reflect the corresponding provisions of UPenn’s then standard non-exclusive patent license agreement, (ii) limit any representations or warranties by UPenn under Article 14 of this Agreement to the representations made in Section 9.5 of the UPenn Agreement, (iii) omit Article 23 of this Agreement, and (iv) include Sections 12.1, 12.9 and 12.10 of the UPenn Agreement, substituting “AMT” in place of “Targeted” in each instance, see attachment A.  For clarity, the financial terms of this Agreement will remain unaltered.

 

11.5                        Nothing herein shall constitute a waiver of either party’s right to seek damages in the event of a material breach of this Agreement by the other party.

 

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12.  PATENT MARKING

 

12.1                        AMT agrees to mark all Licensed Products made, used or sold under the terms of this Agreement, or their containers, in accordance with the applicable patent marking laws.

 

13.  USE OF NAMES AND TRADEMARKS

 

13.1                        Unless required by law, nothing contained in this Agreement shall be construed as conferring any right to use in advertising, publicity, or other promotional activities any name, trade name, trademark, or other designation of either party hereto or the UPenn (including any contraction or abbreviation of the foregoing).

 

13.2                        Unless required by law, neither party shall disclose, at any time, the financial terms or events upon which financial obligations are triggered in the License, save that TGC and AMT shall have the right to do so (i) to the extent such disclosure is required in publicly filed financial statements or other public statements under rules governing a stock exchange (e.g., the rules of the United States Securities and Exchange Commission, NASDAQ, NYSE, Amsterdam, UKLA or any other stock exchange on which securities issued by either Party may be listed); and (ii) to its actual or potential investment bankers; (iii) to existing and potential investors in connection with an offering or placement of securities for purposes of obtaining financing for its business and to actual and prospective lenders for the purpose of obtaining financing for its business; and (iv) to a bona fide potential acquiror or merger partner for the purposes of evaluating entering into a merger or acquisition, provided, however, any such persons must be obligated to hold in confidence and not make use of such confidential information for any purpose.  A press release acknowledging the grant of the License by TGC to AMT shall be publicly disclosed by either or both parties, only upon mutual agreement of the text of such release by both parties.

 

14.  REPRESENTATIONS, WARRANTIES AND COVENANTS

 

14.1                        Each party hereby represents, warrants, and covenants to the other party as of the Effective Date as follows:

 

i)                                         such party (i) has the power and authority and the legal right to enter into this Agreement and perform its obligations hereunder, and (ii) 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.  This Agreement has been duly executed and delivered on behalf of such party and constitutes a legal, valid, binding obligation of such party and is enforceable against it in accordance with its terms;

 

ii)                                      such party is not aware of any pending or threatened litigation (and has not received any communication) that alleges that such party’s activities related to this Agreement have violated, or that by conducting the activities as contemplated herein such party would violate, any of the intellectual property rights of any other Person;

 

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iii)                                   all necessary consents, approvals and authorizations of all governmental authorities and other Persons or entities required to be obtained by such party in connection with this Agreement have been obtained; and

 

14.2                        TGC hereby represents, warrants, and covenants to AMT as of the Effective Date that TGC is the exclusive licensee of the Licensed Patent Rights.  During the term of this Agreement, TGC shall use its best efforts not to encumber or diminish the rights granted to AMT hereunder, including, without limitation, by not committing any acts or permitting the occurrence of any omissions that would cause the breach or termination of the UPenn Agreement.  TGC shall promptly provide AMT with notice of any alleged breach or termination of the UPenn Agreement.  As of the date hereof, TGC is not in breach of the UPenn Agreement, and it is in full force and effect.

 

15.  DISCLAIMER OF WARRANTY; INDEMNIFICATION

 

15.1                        THE LICENSED PATENT RIGHTS AND LICENSED PRODUCTS ARE PROVIDED ON AN “AS IS” BASIS AND TGC MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT THERETO.  BY WAY OF EXAMPLE BUT NOT OF LIMITATION, TGC MAKES NO REPRESENTATION OR WARRANTY; (i) OF COMMERCIAL UTILITY; (ii) OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE; OR (iii) THAT THE USE OF THE LICENSED PATENT RIGHTS AND LICENSED PRODUCTS UNDER THIS AGREEMENT WILL NOT INFRINGE ANY PATENT, COPYRIGHT OR TRADEMARK OR OTHER PROPRIETARY OR PROPERTY RIGHTS OF OTHERS.  TGC SHALL NOT BE LIABLE TO AMT OR ANY THIRD PARTY WITH RESPECT TO: ANY CLAIM ARISING FROM THE USE OF THE LICENSED PATENT RIGHTS AND LICENSED PRODUCTS LICENSED UNDER THIS AGREEMENT OR FROM THE MANUFACTURE, USE OR SALE OF LICENSED PRODUCTS; OR ANY CLAIM FOR LOSS OF PROFITS, LOSS OR INTERRUPTION OF BUSINESS, OR FOR INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES OF ANY KIND.

 

15.2                        AMT will defend, indemnify and hold harmless TGC and its trustees, officers, agents and employees and UPenn and its trustees, officers, agents and employees both collectively and severally (individually, an “Indemnified Party”, and collectively, the “Indemnified Parties”), from and against any and all liability, loss, damage, action, claim or expense suffered or incurred by the Indemnified Parties (including attorney’s fees) (individually, a “Liability”, and collectively, the “Liabilities”) that results from or arises out of (a) the development, use, manufacture, promotion, sale or other disposition of any Licensed Product by AMT or its collaborators or distributors; and (b) any breach by AMT of any covenant or agreement contained in this Agreement; and (c) the enforcement by an Indemnified Party of its rights under this Section.  Without limiting the foregoing, AMT will defend, indemnify and hold harmless the Indemnified Parties from and against any Liabilities resulting from:

 

15.2.1              any product liability or other claim of any kind related to the use by a third party of a Licensed Product that was manufactured, sold or otherwise disposed of by AMT, or its collaborators or distributors, pursuant to and within the scope of such relationships;

 

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15.2.2              a claim by a third party that the use by AMT or its collaborators or distributors, pursuant to and within the scope of such relationships, of Licensed Patent Rights or the design, composition, manufacture, use, sale or other disposition of any Licensed Product by AMT infringes or violates any patent, copyright, trademark or other intellectual property rights of such third party; and

 

15.2.3              clinical trials or studies conducted by or on behalf of AMT, or its collaborators or distributors, pursuant to and within the scope of such relationships, relating to the Licensed Products and Licensed Patent Rights, including, without limitation, any claim by or on behalf of a human subject of any such clinical trial or study, any claim arising from the procedures specified in any protocol used in any such clinical trial or study, any claim of deviation, authorized or unauthorized, from the protocols of any such clinical trial or study, and any claim resulting from or arising out of the manufacture or quality control by a third party of any substance administered in any clinical trial or study.

 

Notwithstanding the foregoing, however, the Liabilities shall not include, and in no instance shall AMT be required to indemnify any Indemnified Party with respect to, any liability, claims, lawsuits, losses, damages, costs or expenses to the extent the same are determined to be the result of any Indemnified Party’s gross negligence or willful misconduct.

 

15.3                        The Indemnified Party shall promptly notify AMT of any claim or action giving rise to Liabilities subject to the provisions of the foregoing Section.  AMT shall have the right to defend or to cause to be defended any such claim or action, at its cost and expense.  AMT shall not settle or compromise any such claim or action in a manner that imposes any restrictions or obligations on TGC or grants any rights to Licensed Patent Rights or Licensed Products (other than to the extent AMT has the right to grant such rights under this Agreement) without TGC’s prior written consent.  If AMT fails or declines to assume the defense of any such claim or action within [**] days after notice thereof, TGC may assume the defense of such claim or action for the account and at the risk of AMT, and any Liabilities related thereto shall be conclusively deemed a liability of AMT; provided however, that TGC shall not settle such claim or action if such settlement affects Licensed Patent Rights other than those specifically at issue in such claim or action without AMT’s written permission, which shall not be unreasonably withheld.  AMT shall pay promptly to the Indemnified Party any Liabilities to which the foregoing indemnity relates, as incurred.  The indemnification rights of TGC or other Indemnified Party contained herein are in addition to all other rights which such Indemnified Party may have at law or in equity or otherwise.

 

16.  INSURANCE

 

16.1                        AMT shall procure and maintain a policy or policies of commercial general liability insurance, including broad form and contractual liability, in a minimum amount of $[**] combined single limit per occurrence and in the aggregate as respects personal injury, bodily injury and property damage arising out of AMT’s performance of this Agreement.

 

16.2                        AMT shall, upon commencement of clinical trials involving Licensed Products, procure and maintain a policy or policies of product liability insurance in a minimum amount of

 

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$[**] combined single limit per occurrence and in the aggregate as respects bodily injury and property damage arising out of AMT’s performance of this Agreement.

 

16.3                        AMT shall provide TGC with certificates evidencing the insurance coverage required herein and all subsequent renewals thereof.  Such certificates shall provide that AMT’s insurance carrier(s) notify TGC in writing at least [**] days prior to cancellation or material change in coverage.  TGC will retain such certificates and notices from AMT’s insurance carrier.

 

16.4                        TGC shall periodically review the adequacy of the minimum limits of liability specified herein.  Further, TGC reserves the right to require AMT to adjust such coverage limits in accordance with prevailing industry norms, to the extent TGC is required to do the same by UPenn pursuant to the UPenn Agreement.  The specified minimum insurance amounts shall not constitute a limitation on AMT’s obligation to indemnify TGC under this Agreement.

 

17.  NOTICES

 

17.1                        Any notice or payment required to be given to either party shall be deemed to have been properly given and to be effective (a) on the date of delivery if delivered in person or (b) five (5) days after mailing if mailed by a nationally recognized courier or by first-class certified mail, postage paid, to the respective addresses given below, or to such other address designated by written notice, or sent via facsimile transmission to the number specified below.

 

	
For AMT:
    	
 
    	
Meibergdreef 61 
    
	
 
    	
 
    	
P.O.Box 22506 
    
	
 
    	
 
    	
1100 DA Amsterdam 
    
	
 
    	
 
    	
The Netherlands 
    
	
 
    	
 
    	
Fax: 31 (0) 20 566 92 72 
    
	
 
    	
 
    	
Attention: CFO
    
	
 
    	
 
    	
 
    
	
For TGC:
    	
 
    	
1100 Olive Way, Suite 100 
    
	
 
    	
 
    	
Seattle, Washington 98101 
    
	
 
    	
 
    	
Fax:+1 206 223-0288 
    
	
 
    	
 
    	
Attention: Chief Executive Officer
    

 

18.  ASSIGNABILITY

 

18.1                        This Agreement is binding upon and shall inure to the benefit of the parties and their successors and assigns.

 

18.2                        This Agreement may not be assigned by AMT without first obtaining the express written consent of TGC.  TGC shall not unreasonably withhold consent for AMT to assign this Agreement to a Third Party in the event that AMT transfers all or substantially all of the business of AMT to which the License relates to a Third Party.  Such Third Party shall assume all royalty obligations to TGC hereunder.  TGC further acknowledges that it shall not be entitled to any Royalty or other compensation from the transaction pursuant to which the transfer to a Third Party of all or substantially all of the business of AMT to which the License relates took place.

 

12

 

19.  WAIVER

 

19.1                        It is agreed that no waiver by either party hereto of any breach or default of any of the covenants or agreements herein set forth shall be deemed a waiver as to any subsequent and/or similar breach or default.

 

19.2                        UPenn, by its signature on this Agreement, expressly acknowledges and agrees (1) to the terms of this sublicense; (2) to the extent that any term of this sublicense is in conflict with the UPenn Agreement, the terms of this Agreement shall govern as to the rights and obligations of AMT to TGC and AMT to UPenn pursuant to this Agreement; and (3) to the extent any term of this sublicense is in conflict with the UPenn Agreement, other than the UPenn Agreement terms of Section 4.1.2 and 4.1.5, 4.3.2 and 4.3.3, the terms of this Agreement shall govern as to the obligation of TGC to UPenn as they relate to this specific Agreement.  TGC shall be obligated to comply with Sections 4.1.2, 4.1.5, 4.3.2 and 4.3.3 of the UPenn Agreement as they relate to the financial obligations of TGC to UPenn arising from the grant of this sublicense to AMT, unless mutually agreed otherwise between TGC and UPenn.

 

20.  FAILURE TO PERFORM

 

20.1                        In the event of a failure of performance due under the terms of this Agreement and if it becomes necessary for either party to undertake legal action against the other on account thereof, then the prevailing party shall be entitled to reasonable attorney’s fees in addition to costs and necessary disbursements.

 

21.  GOVERNING LAW

 

21.1                        This Agreement shall be interpreted and construed in accordance with the laws of the Commonwealth of Pennsylvania without regard to the principles of conflicts of laws, but the scope and validity of any patent or patent application shall be governed by the applicable laws of the country of such patent or patent application.  Each party hereby submits itself to the non-exclusive jurisdiction of the federal or state courts located in the Commonwealth of Pennsylvania, and any courts of appeal therefrom, and waives any objection (on grounds of lack of jurisdiction, or forum non conveniens or otherwise) to the exercise of such jurisdiction over it by any such courts, in connection with any action that may be brought in such courts.

 

22.  FORCE MAJEURE

 

22.1                        For a period of ninety (90) days, the parties to this Agreement shall be excused from any performance required hereunder if such performance is rendered impossible or unfeasible due to any catastrophe or other major event beyond their reasonable control, including, without limitation, war, riot, and insurrection; laws, proclamations, edicts, ordinances or regulations; strikes, lockouts or other serious labor disputes; and floods, fires, explosions, or other natural disasters.  When such events have abated, the parties’ respective obligations hereunder shall resume.

 

23.  RIGHTS IN BANKRUPTCY

 

23.1                        All rights and licenses (including but not limited to the License) granted under or pursuant to this Agreement by TGC to AMT are, and shall otherwise be deemed to be, for

 

13

 

purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to “intellectual property” as defined under Section 101 of the U.S. Banckruptcy Code.  The parties agree that AMT, as licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the U.S. Bankruptcy Code and to the fullest extent permitted by law.

 

24.  MISCELLANEOUS

 

24.1                        The headings of the several sections are inserted for convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement.  The English language is the official language of this Agreement and that text of the Agreement shall prevail over any translation thereof.

 

24.2                        This Agreement will not be binding upon the parties until it has been signed below on behalf of each party, in which event, it shall be effective as of the dated recited on page one.

 

24.3                        No amendment or modification hereof shall be valid or binding upon the parties unless made in writing and signed on behalf of each party.

 

24.4                        This Agreement embodies the entire understanding of the parties and shall supersede all previous communications, representations or understandings, either oral or written, between the parties relating to the subject matter hereof.

 

24.5                        If any provisions contained in this Agreement are or become invalid, are ruled illegal by any court of competent jurisdiction or are deemed unenforceable under then current applicable law from time to time in effect during the term hereof, it is the intention of the parties that the remainder of this Agreement shall not be affected thereby, provided that a party’s rights under this Agreement are not materially affected.  It is further the intention of the parties that in lieu of each such provision which is invalid, illegal, or unenforceable, there be substituted or added as part of this Agreement a provision which shall be as similar as possible in economic and business objectives as intended by the parties to such invalid, illegal or unenforceable, provision, but shall be valid, legal and enforceable.

 

14

 

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

 

	
Amsterdam Molecular   Therapeutics, B.V.
    	
 
    	
Targeted Genetics   Corporation
    
	
 
    	
 
    	
 
    
	
By
    	
/s/ Ronald HW. Lorijn
    	
 
    	
By
    	
/s/ H. Stewart Parker
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name
    	
Ronald H.W. Lorijn
    	
 
    	
Name
    	
H. Stewart Parker
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title
    	
CEO
    	
 
    	
Title
    	
President and CEO
    
	
 
    	
 
    	
 
    
	
Acknowledged and accepted by:
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
The Trustees of the University of   Pennsylvania
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By
    	
/s/ John S. Zawad, Ph.D.
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
Name
    	
John S. Zawad, Ph.D.
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
Title
    	
Managing Director
    	
 
    	
 
    

 

15

 

ATTACHMENT 1

 

Articles from the UPenn Agreement which would be added to this Agreement, pursuant to Section 11.4 of this Agreement.

 

9.5- Penn hereby represents that (i) to its knowledge it has the lawful right to grant the licenses granted herein, and (ii) all actions necessary with respect to due authorization, execution and performance of this Agreement to make it legal, valid, binding and enforceable with regard to Penn have been taken.

 

12.1        Targeted shall comply with all prevailing laws, rules and regulations pertaining to the development, testing, manufacture, marketing, sale, use, import or export of products.  Without limiting the foregoing, it is understood that this Agreement may be subject to United States laws and regulations controlling the export of technical data, computer software, laboratory prototypes and other commodities, articles and information, including the Arms Export Control Act as amended in the Export Administration Act of 1979, and that the parties’ obligations hereunder are contingent upon compliance with applicable United States export laws and regulations.  The transfer of certain technical data and commodities may require a license from the cognizant agency of the United States Government and/or written assurances by Targeted that Targeted shall not export data or commodities to certain foreign countries without prior approval of such agency.  Penn neither represents that a license is not required nor that, if required, it will issue.

 

12.9        Nothing in this Agreement, express or implied, is intended to confer on any person, other than the parties hereto, the Covered Affiliates, or their permitted assigns, any benefits, rights or remedies.

 

12.10      Penn and Targeted shall not discriminate against any employee or applicant for employment because of race, color, sex, sexual or affectional preference, age, religion, national or ethnic origin, or handicap.

 

16

 

EXECUTION

 

UNIVERSITY of PENNSYLVANIA

 

First Amendment to License Agreement

 

This First Amendment to the License Agreement (as defined below) effective as of June 28, 2013 (this “Amendment”), is made by and between AmpliPhi Biosciences, Inc., successor in interest to Targeted Genetics, Inc., having a principal place of business at 4870 Sadler Road, Suite 300, Glen Allen, VA 23060 (“AmpliPhi”) and uniQure Biopharma B.V., formerly known as Amsterdam Molecular Therapeutics B.V., a Dutch limited liability company having a principal place of business at Meibergdreef 61, 1105 BA Amsterdam, The Netherlands (“uniQure”) and amends the License Agreement dated December 5, 2006 by and between AmpliPhi and uniQure (the “Agreement” or “License Agreement”).

 

Recitals

 

WHEREAS, AmpliPhi has exclusively licensed the Licensed Patent Rights (relating to an AAVI Vector gene delivery system) from the Trustees of the University of Pennsylvania (“Penn”) as part of a license agreement entered into between AmpliPhi and Penn with the effective date of June 1, 2002 and as subsequently amended and restated (“Penn Agreement”);

 

WHEREAS, uniQure has developed and is commercializing an AAVI product to treat LPL type 1 and LPL type 5 deficiencies that requires a license to the Licensed Patent Rights;

 

WHEREAS, AmpliPhi granted to uniQure a non-exclusive sublicense under the Licensed Patent Rights pursuant to the License Agreement, which does not permit further downstream sublicensing by uniQure; and

 

WHEREAS, uniQure desires to sub-sublicense certain of the Licensed Patent Rights to Chiesi Farmaceutici, S.p.A, an Italian Corporation (“Chiesi”) under a certain Commercialization Agreement between uniQure and Chiesi dated April 29, 2013, a complete and accurate copy of which has been provided to AmpliPhi and Penn, in order to more widely market and distribute the Licensed Products (the “Commercialization Agreement”).

 

NOW, THEREFORE, the parties hereto hereby agree as follows:

 

1)                                     Unless otherwise defined herein, capitalized terms will have the meanings given them in the License Agreement.  Section references are to the License Agreement, unless otherwise stated.

 

2)                                     The purported Amendment No. 1 dated March 12, 2012 to the License Agreement entered into between AmpliPhi and uniQure was not executed by, agreed to, or consented to by Penn and therefore was not properly executed.  For clarity, such Amendment No. 1 is hereby declared void in its entirety, ab initio, and is of no force or effect.  All terms of the original License Agreement, including the terms purported to be modified by Amendment No. 1, remain in full force and effect, except as expressly modified by this Amendment.

 

3)                                     Section 1.10 is hereby amended and restated in its entirety:

 

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1.10        “Net Sales” means (a) the actual gross invoice price of Licensed Products sold by uniQure, its Affiliates or its sublicensees to any Third Party, less, to the extent included therein, the total of (i) ordinary and customary trade discounts; (ii) sales and excise taxes, and other similar taxes, customs duty and compulsory payments to governmental authorities actually paid or deducted and related to the sale (excluding what is commonly known as income taxes); and (iii) credits given to customers for rejects or returns of the product.  For purposes hereof, Net Sales shall not include sales of a Licensed Product from uniQure, an Affiliate of uniQure or a sublicensee to another of these entities; it being intended that Net Sales shall only include sales to Third Parties.

 

4)                                     Section 1.13 is hereby amended and restated in its entirety:

 

1.13        “Third Party” means any Person, other than: (i) uniQure or its respective Affiliates, successors or assigns, (ii) AmpliPhi or its respective affiliates, successors or assigns, or (iii) sublicensees of uniQure, including Chiesi, or their respective affiliates, sublicensees, distributors, successors or assigns, or (iv) collaborators or distributors of uniQure or any of their respective affiliates, sublicensees, successors or assigns.

 

5)                                     New Section 1.15 is hereby added to the License Agreement immediately following Section 1.14:

 

1.15        “Restricted Sublicensing Rights” means a non-exclusive sublicense under the Licensed Patent Rights from uniQure to sublicensees of uniQure, including Chiesi, pursuant to the sublicensing conditions contained in this Agreement.

 

6)                                     Section 2.1 is hereby amended and restated in its entirety:

 

2.1          AmpliPhi grants to uniQure a non-exclusive license under the Licensed Patent Rights in each country of the world where there are Valid Claims of Licensed Patent Rights, to make, develop, use, sell offer to sell, and import Licensed Products, with Restricted Sublicensing Rights (the “License”).

 

7)                                     New Section 2.4 is hereby added to the License Agreement immediately following Section 2.3:

 

2.4          The Restricted Sublicensing Rights conferred upon uniQure shall be subject to the following terms and conditions:

 

a.                                      uniQure must obtain the prior written consent of AmpliPhi and Penn to any sublicense or to any amendment modification or waiver thereto, which consent shall not be unreasonably withheld.

 

b.                                      AmpliPhi and Penn hereby consent to the Commercialization Agreement in effect as of the date hereof, provided that (a) in the event of a conflict between the terms of the Commercialization Agreement and this Agreement, this Agreement shall control and (b) for clarity, Chiesi agrees

 

2

 

to comply with the obligations of sublicensees hereunder, including but not limited to the obligations under this Section 2.4 and Sections 4.6, 16.2, 17, and that Penn is a third party beneficiary under the Commercialization Agreement to the extent relevant for or applicable to the sublicenses hereunder.

 

c.                                       Any sublicense shall be subject to the terms and conditions granted to uniQure under this Agreement.

 

d.                                      No sublicensee shall have the power to grant further sublicenses without the express approval of AmpliPhi and consent of Penn, which approval and consent shall not be unreasonably withheld, except that Chiesi may further sublicense its rights to sub-distributors ( each a “sub-sublicensee”) as provided in the Commericalization Agreement on condition that any such downstream sublicense agreement (“sub-sublicense”) requires the sub-sublicensee to comply with the applicable terms of this Agreement and prohibits further sublicensing.  For clarity, the sub-sublicensee shall be prohibited from further sublicensing.  Except when used in Section 1.15 and this Section 2.4 d. the term sublicense includes any sub-sublicense and the term sublicensee includes any sub-sublicensee.

 

e.                                       uniQure shall forward to AmpliPhi and Penn, within [**] days of execution, a complete and accurate copy written in the English language of any sublicense granted hereunder and any amendment, modification or waiver thereto.  AmpliPhi’s and Penn’s receipt of such sublicense shall not constitute an approval of such sublicense or a waiver of any of Penn’s or AmpliPhi’s rights or uniQure’s obligations hereunder.

 

f.                                        Notwithstanding any such sublicense, uniQure shall remain primarily liable to AmpliPhi for all of uniQure’s duties and obligations contained in this Agreement, and any act or omission of an Affiliate or sublicensee of uniQure which would be a breach of this Agreement if performed by uniQure shall be deemed to be a breach by uniQure of this Agreement.

 

8)                                     Section 4.1 is hereby amended and restated in its entirety:

 

4.1          uniQure shall pay to AmpliPhi earned royalties based on Net Sales (“Royalties”) in the amount of: (i) [**] percent ([**]%) of Net Sales of Licensed Products if cumulative annual Net Sales are less than or equal to $[**] US Dollars), (ii) [**] percent ([**]%) of Net Sales of Licensed Products if cumulative annual Net Sales are greater than $[**] US Dollars) but less than or equal to $[**] US Dollars), (iii) [**] percent ([**]%) of Net Sales of Licensed Products if cumulative annual Net Sales are greater than $[**] US Dollars) but less than or equal to $[**] US Dollars), and (iv) [**] percent ([**]%) of Net Sales of Licensed Products if cumulative annual Net Sales are greater than $[**] US Dollars).  The Net Sales thresholds in sections (i) - (iv) above will be applied separately to each distinct Licensed Product, but where the same Licensed Product is packaged or

 

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labeled differently in different nations, or otherwise to accommodate the same for different markets or indications, the Net Sales thereof in all such nations, markets and indications shall be aggregated.

 

9)                                     It is recognized and accepted by the parties that a Milestone as stated under Section 4.2.5 of the License Agreement was achieved on November 2, 2012 upon European regulatory approval for marketing authorization of Glybera indicated for treatment of LPL deficiency Type 1 (the “2012 Milestone”).  It is also recognized by the parties that a Milestone Payment for the 2012 Milestone (the “2012 Milestone Payment”) has not been made by uniQure to AmpliPhi.  Pursuant to Section 4.1.8 of the Penn Agreement, Penn is entitled to receive [**]% of said 2012 Milestone Payment from AmpliPhi, amounting to $[**] US Dollars).  As a negotiated settlement, not being construed to alter or set precedent for this milestone or the resulting Milestone Payments as they relate to regulatory approvals for future indications, and as full and final settlement for any obligation to uniQure that might remain to pay the 2012 Milestone Payment, uniQure shall pay the amount of USD [**] and AmpliPhi shall pay the amount of USD [**] due to Penn within [**] days after execution of this Amendment as a negotiated settlement for the 2012 Milestone Payment.  Further, AmpliPhi and uniQure agree to negotiate in good faith over the next [**] days concerning the license of additional rights from AmpliPhi, subject to existing license obligations and any consents required by Penn.  Penn shall be entitled to be part of these discussions between AmpliPhi and uniQure.

 

10)                              Section 4.6 is hereby amended and restated in its entirety:

 

4.6          uniQure, its Affiliates and sublicensees must maintain, complete and accurate books and records which enable the Royalties, fees, and payments payable under this Agreement to be verified.  The records for each calendar quarter must be maintained for [**] years after the submission of each report under Article 4.  Upon reasonable prior written notice to uniQure, uniQure must provide Penn and/or AmpliPhi with access to all of its books and records relating to the Sales of Licensed Products by uniQure, its Affiliates, and sublicensees in order to conduct a review or audit of those books and records.  Access to these books and records pertaining to Net Sales must be made available no more than [**] for each Licensed Product, during normal business hours, and [**] for each Licensed Product during each of the [**] years after expiration or termination of this Agreement.  If a review or audit of the books of uniQure determines that any of uniQure, its Affiliates, or sublicensees has underpaid royalties on a Licensed Product by [**] percent ([**]%) or more, uniQure must pay the documented costs and expenses of Penn and/or AmpliPhi and their accountants in connection with such review or audit.  Further, uniQure agrees to conduct, at Penn’s expense (except in the case of an underpayment, as provided in the preceding sentence), an independent audit of Sales and Royalties with respect to a Licensed Product at least every [**] years once annual Sales of such Licensed Product are greater than [**] US Dollars ($[**]) per annum.  The audit shall address, at a minimum, the amount of gross sales by or on behalf of uniQure, its Affiliates, or sublicensees

 

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during the audit period, the amount of funds owed to uniQure under this Agreement, and whether the amount owed has been paid to uniQure and is reflected in the records of uniQure.  A report by the auditors shall be submitted promptly to Penn and AmpliPhi upon completion.

 

11)                              Section 15.2 is hereby amended to require that any sublicensees indemnify Penn and its Trustees, officers, agents, and employees, both collectively and severally, to the same extent that uniQure indemnifies Penn under the current Section 15.2.

 

12)                              Section 16 is hereby amended to require that any sublicensees maintain insurance commensurate with the insurance that uniQure is required to maintain thereunder.

 

13)                              Section 17.1 is hereby amended and restated in its entirety as follows:

 

17.1        Any notice or payment required to be given to either party shall be deemed to have been properly given and to be effective (a) on the date of delivery if delivered in person or (b) five (5) days after mailing if mailed by a nationally recognized courier or by first-class certified mail, postage paid, to the respective addresses given below, or to such other address designated by written notice, or sent via facsimile transmission to the number specified below:

 

For uniQure:                                                                            Meibergdreef 61, 
 1105 BA Amsterdam 
 The Netherlands 
 Attn:
 Fax:

 

For AmpliPhi:                                                                     4870 Sadler Road,
 Suite 300
 Glen Allen, VA 23060
 Attn:
 Fax:

 

A copy of each notice shall be delivered to Penn as follows:

 

Center for Technology Transfer
 3160 Chestnut Street 
 Suite 200
 Philadelphia, PA 19104 
 Attn: Executive Director 
 Fax: 215-898-9519

 

14)                              Section 24.3 is hereby amended and restated in its entirety as follows:

 

24.3        No amendment or modification hereof or waiver of obligations hereunder shall be valid or binding upon the parties unless made in writing and signed on behalf of each party, including, for clarity, Penn.

 

5

 

15)                              This Amendment, together with the License Agreement, constitutes the entire agreement between the parties.

 

16)                              This Amendment may be executed in two or more counterparts, each of which shall be deemed an original and together shall be deemed one and the same instrument.

 

IN WITNESS WHEREOF, the parties, intending to be legally bound, have caused this Amendment to be executed by their duly authorized representatives.

 

	
AMPLIPHI   BIOSCIENCES, INC.
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
By:
    	
/s/ Philip Young
    	
 
    	
 
    
	
Name:
    	
Philip Young
    	
 
    	
 
    
	
Title:
    	
CEO
    	
 
    	
 
    
	
Date:
    	
17, July 2013
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
UNIQURE BIOPHARMA   B.V.
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
By:
    	
/s/ PJ Morgan
    	
 
    	
 
    
	
Name:
    	
PJ Morgan
    	
 
    	
 
    
	
Title:
    	
CFO
    	
 
    	
 
    
	
Date:
    	
15, July 2013
    	
 
    	
 
    

 

6

 

Acknowledged and Agreed:

 

THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA

 

	
By:
    	
/s/ John S. Swartley
    	
 
    	
 
    
	
Name:
    	
John S. Swartley, PhD
    	
 
    	
 
    
	
Title:
    	
Executive Director, Center for Technology   Transfer
    	
 
    	
 
    
	
Date:
    	
June 28, 2013
    	
 
    	
 
    

 

7Exhibit 10.10

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

EXCLUSIVE LICENSE AGREEMENT

 

THIS Exclusive License Agreement (“Agreement”), effective as of 07 July 2008 (“Effective Date”), is entered into by and between St. Jude Children’s Research Hospital, Inc., a Tennessee not-for-profit corporation located at 262 Danny Thomas Place, Memphis, Tennessee 38105 (“ST. JUDE”) and Amsterdam Molecular Therapeutics B.V., a closed limited liability company organized and existing under the laws of the Netherlands, with registered offices at Meibergdreef 61, 1105 BA Amsterdam, the Netherlands, (each a “Party” and together the “Parties”).

 

RECITALS

 

WHEREAS, ST. JUDE is the owner by assignment from Dr. John Gray of his entire right, title and interest in the Patent Rights and in the inventions described and claimed therein; and

 

WHEREAS, the Patent Rights relate to mechanisms for improving the expression of Factor IX in gene therapy vectors, including, the use of a specific Factor IX polynucleotide coding sequence designed for optimal expression, and, the use of transcriptional regulatory regions minimized in size so that they can be used to express Factor IX, as well as any other gene of interest, in a size-constrained environment such as in a self complementary gene therapy vector system; and

 

WHEREAS, under a separate agreement being entered into between the Parties on the same date as this Exclusive License Agreement (“Sponsored Research Agreement”), AMT engages ST. JUDE to develop a gene therapy vector incorporating certain features of the invention described in the Patent Rights but combined with certain technologies controlled by AMT (the “Vector”); and

 

WHEREAS, in order to carry out the work anticipated under the Sponsored Research Agreement, ST. JUDE will require access to technologies owned by AMT and AMT is willing to grant this access under a separate agreement being entered into between the Parties on the same date as this Exclusive License Agreement (“AMT Technology License Agreement”); and

 

SIGNATURE VERSION

 

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WHEREAS, the Vector will be further developed and commercialized by AMT and so AMT require a license under the Patent Rights; and

 

WHEREAS, AMT wishes to enter into an agreement with ST. JUDE to obtain a license under the Patent Rights and ST. JUDE is willing to grant such a license to AMT under the terms and conditions set forth in this Agreement.

 

NOW, THEREFORE, in consideration of the mutual promises contained herein and other good and valuable considerations, the Parties do hereby agree as follows:

 

1.                                      DEFINITIONS

 

1.1                               “Affiliate” shall mean any company, partnership or other business entity which Controls, is Controlled by or is under common Control with either Party.  For the purposes of this definition “Control” means any of the following: (i) the possession, directly or indirectly, of the power to direct the management or policies of an entity, 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 of fifty percent (50%) or more of the equity interest in the case of any other type of legal entity; (iii) status as a general partner in any partnership, or any other arrangement whereby a Party controls or has the right to control the board of directors or equivalent governing body of a corporation or other entity.

 

1.2                               “AMT” shall mean Amsterdam Molecular Therapeutics B.V. and any Affiliates of Amsterdam Molecular Therapeutics B.V.

 

1.3                               “Confidential Information” shall mean any confidential or proprietary non-public information furnished by one Party (the “Disclosing Party”) to the other Party (the “Receiving Party”) in connection with this Agreement.

 

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1.4                               “Commercialise”, “Commercialisation” or “Commercialising” shall mean all activities relating to the import, advertising, promotion and other marketing, pricing and reimbursement, detailing, distribution, storage, handling, offering for sale and selling, customer service and support or post regulatory approval regulatory activities in relation to Licensed Product.

 

1.5                               “Commercially Reasonable Efforts” shall mean efforts and resources commonly used by biotechnology companies of a similar size to AMT based on funds raised to Develop and Commercialise a product owned by such a company or to which it has rights, which product is at a similar stage in its development or product life and is of similar market potential to the Licensed Product in question and taking into account the patent and other proprietary position of the product.

 

1.6                               “Development (and the corresponding verb “to Develop”)” shall mean all pre-regulatory approval development and regulatory activities regarding a product in a country conducted with the aim of obtaining such regulatory approval including:

 

(a)                                 studies on the toxicological, pharmacological, metabolical or clinical aspects of a product conducted internally or by individual investigators or consultants; and

 

(b)                                 process development, process improvement, scale-up and recovery, the manufacture of clinical supplies of product, including failed batches, manufacture of qualification lots; and

 

(c)                                  preparing, submitting, reviewing or developing data or information for the purpose of submission to a regulatory authority to obtain, maintain and/or expand manufacturing and/or regulatory approval of a product including data management, statistical designs and studies, document preparation, and other administration; and

 

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(d)                                 all post regulatory approval regulatory activities and adverse event reporting in relation to products.

 

1.7                               “Field” shall mean gene therapy for the therapy or prophylaxis of Haemophilia B.

 

1.8                               “Investigational New Drug Application (“INDA”) shall mean an application submitted to the FDA or a foreign equivalent requesting permission to conduct human clinical studies with an investigational new drug or to conduct human clinical studies with an existing drug for a new use.

 

1.9                               “Licensed Product” shall mean all products containing Factor IX that are covered by Valid Claims of the Patent Rights to any extent.

 

1.10                        “Net Sales” shall mean the sum of all amounts actually invoiced by AMT (or Sublicensees as appropriate) from persons or entities for sales of Licensed Products, less the following deductions and offsets, to the extent such sums are actually incurred, paid or credited by AMT (or Sublicensees as appropriate) and not otherwise reimbursed:

 

(a)                                 normal and customary trade, cash and quantity discounts actually given, credits, price adjustments or allowances for damaged products, returns or rejections of products;

 

(b)                                 chargeback payments and rebates (or the equivalent thereof) for product granted on a customary trade basis to group purchasing organisations, managed health care organisations or to federal, state/provincial, local and other governments, including their agencies, or to trade customers;

 

(c)                                  reasonable and customary freight, shipping insurance and other transportation expenses directly related to the sale of product (if actually borne by AMT or Sublicensees without reimbursement from any third party);

 

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(d)                                 required distribution commissions/fees payable to any third party providing distribution services to AMT or Sublicensees;

 

(e)                                  sales, value-added, excise taxes, tariffs and duties, and other taxes and government charges directly related to the sale, to the extent that such items are included in the gross invoice price of product and are actually borne by AMT or its Sublicensees without reimbursement from any third party (but not including taxes assessed against the income derived from such sale); and

 

(f)                                   actual uncollectible amounts for product where collectibility is determined in accordance with IFRS consistently applied to all AMT products.

 

Sales of products intended for resale to third parties, and made internally amongst AMT and Sublicensees shall not be deemed sales for purposes of calculating “Net Sales” (however, sales to a third party other than a Sublicensee or Affiliate shall be included in the calculation of “Net Sales”).

 

1.11                        “Patent Rights” shall mean (i) U.S. Provisional Patent Application No. 60/612,135 filed September 22, 2004 entitled “Improved Expression of Factor IX in Gene Therapy Vectors” (ST. JUDE reference no. SJ-04-0024); (ii) all patent applications filed claiming priority from the above including all provisional patent applications and all national, regional and international patents and patent applications; (iii) all patent applications filed claiming priority from any of the above including any divisional, continuation, or continuation-in-part; (iv) any patent issued on any of the foregoing; (v) any reissue or extension of such patent; and (vi) any foreign counterparts to such patents and patent applications and applications and/or patents or the equivalent thereof claiming priority to or from any of the above.

 

1.12                        “Phase I Clinical Trial” shall mean a human clinical trial, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients as required in 21

 

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C.F.R. §312, or a similar clinical study prescribed by the regulatory authorities in a country other than the United States.

 

1.13                        “Phase II Clinical Trial” shall mean (i) a human clinical trial, for which a primary endpoint is a preliminary determination of efficacy or dose ranges in patients with the disease target being studied as required in 21 C.F.R. §312.21(b), as maybe amended from time to time, or a similar clinical study prescribed by the regulatory authorities in a country other than the United States, or (ii) a combined Phase II and Phase III Clinical Trial which enrolls at least forty (40) patients, or any Phase III Clinical Trial performed in lieu of a Phase II study.

 

1.14                        “Phase III Clinical Trial” shall mean a human clinical trial, the principal purpose of which is to establish safety and efficacy in patients with the disease target being studied as required in 21 C.F.R. §312, or similar clinical study prescribed by the regulatory authorities in a country other than the United States.  A Phase III Clinical Trial shall also include any other human clinical trial intended as a pivotal study, whether or not such study is a traditional Phase III study.

 

1.15                        “Royalty Reporting Period” shall mean the partial calendar half year commencing on the date on which a Licensed Product is first sold and every complete or partial calendar half year thereafter during which royalty payment obligations under this Agreement remain in effect.

 

1.16                        “Sublicensee” shall mean any sublicensee of the rights granted to AMT under this Agreement, as further described in Section 2.1(i).

 

1.17                        “ST. JUDE Improvements” shall mean any improvement or enhancement (whether patentable or not) to the inventions of a Valid Claim of the Patent Rights in the Field that is discovered, developed or otherwise acquired by ST. JUDE after the Effective Date

 

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pursuant to Section 2.1(v) (but, for clarity, outside the scope of the Sponsored Research Agreement) and in relation to which a patent application is filed by ST. JUDE.

 

1.18                        “Valid Claim” shall mean a claim of an issued and unexpired patent or pending published patent application included within Patent Rights, which has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or un-appealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise.

 

2.                                      GRANT

 

2.1                               License Grant

 

(i)                                     ST. JUDE hereby grants to AMT and AMT accepts, subject to the terms and conditions herein, an exclusive worldwide license under the Patent Rights to research, have researched, Develop, have Developed, make, have made, import, distribute, use and Commercialise Licensed Products in the Field.  Such license shall include the right to grant sublicenses provided that AMT shall remain responsible for compliance by Sublicensees with the terms and conditions of this Agreement.  Within [**] days of the grant of each sublicense under this Agreement, AMT shall inform ST. JUDE in writing of the identity of the Sublicensee and provide a copy of the sublicense agreement but showing only those terms directly pertaining to the sublicense itself, with all other terms including financial terms redacted.

 

(ii)                                  The license granted herein is subject to the rights, conditions and limitations imposed by U.S. law on inventions and discoveries conceived or first actually reduced to practice during the course of research funded by a U.S. federal agency that are relevant to the Patent Rights.  The words “exclusive license” as used herein

 

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shall mean exclusive except for the royalty-free non-exclusive license granted to the U.S. government by ST. JUDE pursuant to 35 USC Section 202 (c) (4) for any Patent Rights claiming any invention subject to such license as defined under 35 USC Section 201 and any other federal laws and applicable regulations.

 

(iii)                               To the extent that Licensed Products embody Patent Rights conceived or first actually reduced to practice during the course of research funded by a U.S. federal agency, AMT agrees that such Licensed Products shall be manufactured substantially in the United States in accordance with 35 U.S.C. Section 204.

 

(iv)                              Title to the Patent Rights shall remain with ST. JUDE and ST. JUDE retains the right to license the Patent Rights to other entities outside the Field and to use the Patent Rights for internal and collaborative research outside the Field.

 

(v)                                 The license granted under Section 2.1(i) of this Agreement is subject to the non-transferable right of ST. JUDE under the Patent Rights solely to perform internal and collaborative research and education in the Field with academic collaborators.  To the extent that such research involves pre-clinical or clinical research the data and other results of such research, including any IND package and a copy of any interim or final clinical research report shall be made available by ST. JUDE to AMT and AMT shall be permitted to utilise the same only for lawful purposes in its dealings with the FDA.  ST. JUDE will at its own cost procure that this is possible under the terms of any agreement between it and such academic collaborations.

 

2.2                               ST. JUDE Improvements.  If any ST. JUDE Improvements are made by ST. JUDE during the term of this Agreement, AMT shall have the first right of refusal to such ST. JUDE Improvements.  ST. JUDE will disclose any such ST. JUDE Improvement to AMT by notice in writing.  AMT shall treat any such disclosure as Confidential Information and

 

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shall only use such disclosure to consider its licensing interest.   AMT shall have [**] days from the date of such disclosure in which to indicate to ST. JUDE by notice in writing whether it wishes to negotiate a license with grant terms the same as those set out in Section 2.1.  If AMT does so indicate that it wishes to take a license within the notice period, the Parties shall negotiate in good faith the financial and other terms of such license during the subsequent period of [**] days.  If the Parties cannot reach agreement during the negotiation period, ST. JUDE will be free to deal with third parties in respect of the said ST. JUDE Improvements in the Field.  During the period from first notification by ST. JUDE of the ST. JUDE Improvement to AMT until the expiration of the aforesaid [**] day period, the ST. JUDE shall not enter into arrangements or agreements with any third party concerning the ST. JUDE Improvements in the Field.

 

3.                                      DILIGENCE OBLIGATIONS AND ANNUAL PROGRESS REPORT

 

3.1                               Use of Commercially Reasonable Efforts.  With effect from completion or termination of the Research Program under the Sponsored Research Agreement (“Commencement Date”) AMT  shall  use  Commercially  Reasonable  Efforts  to  diligently  Develop and Commercialize Licensed Products whether by itself or through its Sublicensee(s).

 

3.2                               Annual Progress Reports.  Within [**] days after each anniversary of the Commencement Date, AMT shall furnish ST. JUDE with a written report summarizing efforts and achievements toward Developing and Commercializing Licensed Products, including the status of any regulatory submissions, clinical trials and sublicensing activities.  This report shall also include a statement regarding insurance coverage in accordance with Section 8.1 (iii) below.

 

4.                                      PAYMENTS

 

4.1                               License Fee.  In partial consideration of the rights granted to AMT under this Agreement and to reimburse ST. JUDE for patent expenses already incurred in pursuing the Patent

 

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Rights, AMT shall pay [**] U.S. dollars to ST. JUDE within [**] days of the full execution of this Agreement.  This license fee payment is nonrefundable and not creditable against any other payments due to ST. JUDE under this Agreement.

 

4.2                               Annual Maintenance Fee.  AMT shall pay ST. JUDE an annual fee of [**] U.S. dollars within [**] days of January 1.  This fee shall be creditable to royalties and milestones which are due in the same calendar year.

 

4.3                               Milestone Payments.  AMT shall pay ST. JUDE the following milestone payments on the first occurrence of the following milestone events:

 

(i)                                     [**] U.S. dollars upon [**];

 

(ii)                                  [**] U.S. dollars upon [**]; and

 

(iii)                               [**] U.S. dollars upon [**].

 

Each of the milestone payments the subject of this Section shall only be payable by AMT upon the first occurrence of the applicable event whenever it occurs.

 

4.4                               Royalties.  AMT shall pay ST. JUDE [**] percent ([**]%) of Net Sales of Licensed Products sold by AMT itself or Sublicensees on a country by country basis until expiry of the Valid Claims of the Patent Rights in the country of sale that cover the product and render it a Licensed Product.

 

4.5                               Sublicense Consideration.  In addition to the royalty obligation as set forth under Section 4.4, AMT shall pay to ST. JUDE the following percentages of consideration received for sublicenses under this Agreement:

 

(i)                                     [**] percent ([**]%) for a sublicense granted [**];

 

(ii)                                  [**] percent ([**]%) for a sublicense granted [**]; and

 

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(iii)                               [**] percent ([**]%) for a sublicense granted [**].

 

This payment shall be due, without the need for invoice from ST. JUDE, within [**] days of the receipt the payment made to AMT by a Sublicensee under a sublicense agreement.  Such sublicense consideration shall include consideration of any kind received by AMT from a Sublicensee for the grant of a sublicense under this Agreement, such as upfront fees or milestone fees and including any premium paid by the Sublicensee over the Fair Market Value (as such term is defined in subsection (iii) below) for stock of AMT in consideration for such sublicense. However, not included in such sublicense consideration are:

 

(i)                                     Support for research, Development and/or manufacturing activities corresponding directly to the Development of Licensed Products, which do not exceed the fully-burdened cost for undertaking such research, Development, and/or manufacturing performed by or for AMT (including third parties on AMT’s behalf), each pursuant to a specific agreement including a performance plan and commensurate budget;

 

(ii)                                  Proceeds derived from debt financing, to the extent that such financing is at market rates, and any loans to AMT by the Sublicensee:

 

(iii)                               Consideration received for the purchase of an equity interest in AMT to the extent that the price per share for such equity does not exceed by more than [**] percent ([**]%) the Fair Market Value of AMT’s stock.  The term Fair Market Value shall mean the average price that the stock in question is publicly trading at for twenty (20) days prior to the announcement of its purchase by the Sublicensee or if the stock is not publicly traded, the value of such stock as determined by the most recent private financing through a financial investor (an entity whose sole interest in AMT is financial);

 

(iv)                              Reimbursement of AMT’s patent costs related to Patent Rights; and

 

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(v)                                 Any and all amounts paid to AMT by a Sublicensee as royalties on sales of Licensed Product sold by the Sublicensee under a sublicense.

 

4.6                               Late Payment.  For any late payment AMT shall pay an interest penalty based on the amount owed at a daily accrual rate equal to the lesser of [**] percent ([**]%) per annum or the highest rate permissible by law.

 

5.                                      ROYALTY REPORTS; PAYMENTS; RECORDS

 

5.1                               First Sale.  AMT shall report to ST. JUDE the date of first commercial sale of a Licensed Product within [**] days of its occurrence.

 

5.2                               Reports and Payments.  Within [**] days after the conclusion of each Royalty Reporting Period, AMT shall deliver to ST. JUDE a report of Net Sales for each Licensed Product during the prior Royalty Reporting Period on a country-by-country basis. Such report shall include the amount of gross sales and the amount of all deductions and reductions taken in each category identified in the definition of Net Sales in sufficient detail to allow ST. JUDE to verify the Net Sales calculation, the amount of Net Sales, and the total royalty payable on Net Sales in U.S. dollars, together with the exchange rates used for conversion.  All such reports shall be considered Confidential Information of which AMT is the Disclosing Party and the provisions of Section 7 of this Agreement shall apply to such reports.  If no royalties are due to ST. JUDE for any Royalty Reporting Period, the report shall so state. Concurrent with the report, AMT shall remit to ST. JUDE any payment due for the applicable Royalty Reporting Period. Unless other arrangements are made, payment shall be remitted to the following address:

 

St. Jude Children’s Research Hospital

P.O. Box 1000, Department # 516

Memphis, TN 38148-0516

 

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5.3                               Records.

 

(i)                                     AMT shall maintain, and shall require its Sublicensees to maintain complete and accurate records of all Net Sales under this Agreement which records shall contain sufficient information to permit auditors to confirm the accuracy of any reports delivered to ST. JUDE under Section 5.2.  The relevant party shall retain such records relating to a given Royalty Reporting Period for at least [**] years after the conclusion of that Royalty Reporting Period.

 

(ii)                                  Upon [**] working days notice by ST. JUDE, ST. JUDE shall have the right, at its expense, to cause accountants from a nationally-recognized accounting firm to inspect the records of AMT (but not Sublicensees) for the period covering Royalty Reporting Periods ending no more than [**] years prior to the date of the inspection (including records of royalty accounting received from their Sublicensees) during normal business hours for the sole purpose of verifying any reports and payments delivered under this Section 5.2. ST. JUDE may exercise its rights under this Section 5.3 only [**].

 

(iii)                               The Parties shall reconcile any underpayment or overpayment within [**] days after the auditor delivers the results of the audit. In the event that any audit performed under this Section reveals an underpayment in excess of [**] percent ([**]%) in any Royalty Reporting Period, AMT shall bear the full cost of such audit.

 

(iv)                              Prior to any such audit taking place, such firm of accountants shall undertake to AMT that they shall keep all information and data contained in the records of AMT strictly confidential and shall not disclose such information or copies of such records to any third person including ST. JUDE, but shall only use the same for the

 

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purpose of the reviews and/or calculations which they need to perform in order to verify the reports delivered under Section 5.2 of this Agreement.

 

(v)                                 Upon timely request by ST. JUDE, AMT shall, at the expense of ST. JUDE, have any Sublicensee accounting to AMT for royalties audited under the audit provisions agreed between AMT and the Sublicensee, and AMT shall report to ST. JUDE the outcome. If there is a discrepancy identified upon such an audit the provisions of Section 5.3(iii) shall apply in like manner.

 

6.                                      PATENTS AND INFRINGEMENT

 

6.1                               Responsibility for Patent Rights.  Title to all Patent Rights shall remain with ST. JUDE and ST. JUDE shall retain primary responsibility for the drafting, filing, prosecution, and maintenance of all Patent Rights.  ST. JUDE shall appoint and retain external patent counsel approved by AMT.  ST. JUDE shall keep AMT informed of all developments including promptly furnishing AMT with all patent office communications.  ST. JUDE shall, to the satisfaction of AMT, implement all reasonable requests of AMT with respect to the drafting, filing, prosecution, and maintenance of all Patent Rights.

 

6.2                               Reimbursement of Patent Expenses.  AMT shall reimburse ST. JUDE for all out of pocket patent-related expenses incurred by ST. JUDE pursuant to Section 6.1 related to Patent Rights during the term of this Agreement within [**] days after ST. JUDE invoices AMT subject to the provisions of this Section.  Such invoice shall contain a breakdown of the expenses and be accompanied by supporting evidence of such expenses as appropriate including copies of invoices from external patent counsel.  ST JUDE shall instruct its patent counsel to communicate with AMT directly on all matters pertaining to the activities of patent counsel, including the giving of forward cost estimates, but copying ST JUDE on all e-mails and other correspondence.

 

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6.2.1                     If ST. JUDE grants an exclusive license under the Patent Rights outside of the Field, ST. JUDE shall promptly notify AMT. In such an event, from the effective date of that license, AMT shall be responsible for [**] percent ([**]%) of the patent-related expenses only.

 

6.3                               Abandonment.  AMT may elect, upon [**] days written notice to ST. JUDE, to cease payment of the expenses associated with obtaining or maintaining patent protection for one or more patents or applications within the Patent Rights in one or more countries.  In such event, AMT shall forfeit all rights under this Agreement with respect to such patent within the Patent Rights in such country(ies). ST. JUDE shall have the right, at its sole expense, to prepare, file, prosecute, and maintain any patents or patent applications under Patent Rights abandoned by AMT.

 

6.4                               Infringement.

 

(i)                                     Notification of Infringement.  Each Party agrees to provide written notice to the other Party promptly (i) after becoming aware of or having a reasonable suspicion of any infringement of the Patent Rights in the Field or (ii) upon becoming aware of any action alleging invalidity or non-infringement of the Patent Rights in the Field.

 

(ii)                                  AMT Right to Enforce Patent Rights in the Field.  AMT shall have the right, under its own control and at its own expense, to prosecute any third party infringement of the Patent Rights in the Field including negotiating sublicense agreements with such third parties at its discretion.  At least [**] days prior to a potential claim, AMT shall notify ST. JUDE in writing of the nature of the anticipated action and the party(ies) against whom the anticipated action may be taken.  It is understood that any sublicense rights granted hereunder shall not forgive any royalty payments that would otherwise be due to ST. JUDE based on sales of Licensed Products by the Sublicensee without consultation with ST. JUDE.  If AMT succeeds in any such

 

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infringement proceedings whether at trial or by way of settlement, any recovery by AMT in such proceedings brought by AMT shall first be used to reimburse AMT for all reasonable out-of-pocket costs and legal fees incurred to conduct such proceedings.  Out of any remaining damages actually received by AMT relating to infringement of the Patent Rights, AMT shall pay to ST. JUDE an amount equivalent to the payment which would have been due to ST. JUDE on the balance as if they were Net Sales, along with an accounting of the recovery and the reasonable out-of-pocket costs and legal fees.

 

In the event that AMT fails to initiate an infringement action within [**] months after it first becomes aware of such infringement or notifies ST. JUDE that it does not intend to initiate such action, ST. JUDE shall have the right to prosecute such infringement, under its sole control and its sole expense, and any recovery obtained shall be retained by ST. JUDE. AMT shall provide all necessary assistance to ST. JUDE in relation to such proceedings and ST. JUDE shall on demand by AMT indemnify AMT against the costs of such activity, unless AMT elects to be separately represented (which shall be at AMT’s discretion), in which case such separate representation shall be at AMT’s cost and expense.

 

(iii)                               ST. JUDE as Indispensable Party.  If, in the reasonable opinion of AMT’s counsel, ST. JUDE should be a named party to any such suit, AMT may name ST. JUDE as a party, provided that AMT shall hold ST. JUDE harmless from, and if necessary indemnify ST. JUDE against, any costs (including attorney fees), expenses or liability that ST. JUDE may incur in connection with such action unless ST. JUDE elects to be separately represented in which case such separate representation shall be at ST. JUDE’s own cost and expense.

 

(iv)                              Cooperation.  Each Party agrees to cooperate fully in any action under this Section 6.4, which is controlled by the other Party, provided that the controlling Party

 

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reimburses the cooperating Party promptly for any costs and expenses incurred by the cooperating Party in connection with providing such assistance.

 

6.5                               Third Party Patent Rights.  Each Party shall promptly notify the other Party of any third party patent rights relevant to the Development or Commercialisation of the Licensed Product of which it becomes aware including by making appropriate searches for these as and when it considers appropriate.  To the extent possible, whilst preserving attorney-client privilege, the Parties’ patent counsel shall share copies of all external and internal opinions on the likelihood of grant and/or validity of relevant third party patent rights

 

7.                                      CONFIDENTIAL INFORMATION; PUBLICITY

 

7.1                               Confidential Information.

 

(i)                                     Obligations.  Except to the extent authorized in Section 7.1(i) of this Agreement, and for so long as the exceptions set out below in Section 7.1(ii) do not apply, the Receiving Party shall, in relation to any Confidential Information (i) maintain such Confidential Information in confidence using the same duty of care it would use to protect its own information of a like kind (and in any event no less than reasonable care), except that the Receiving Party may disclose or permit the disclosure of any Confidential Information to its Sublicensees (to the extent necessary to effect the relevant Sublicense) and its trustees, directors, officers, employees, consultants, and advisors who are obligated to maintain the confidential nature of such Confidential Information and who need to know such Confidential Information for the purpose of this Agreement and for other purposes that may be required or necessary pursuant to this Agreement such as communication with collaborators or regulatory agencies; (ii) use such Confidential Information solely for the purposes of this Agreement; and (iii) allow its Sublicensees, trustees or directors, officers, employees, consultants, and advisors to reproduce the Confidential Information

 

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only to the extent necessary for the purposes of this Agreement, with all such reproductions being considered Confidential Information.

 

(ii)                                  Exceptions.  The obligations of the Receiving Party under Section 7.1(i) above shall not apply to the extent that the Receiving Party can demonstrate by written evidence that certain Confidential Information (a) was in the public domain prior to the time of its disclosure under this Agreement; (b) entered the public domain after the time of its disclosure under the Agreement through means other than an unauthorized disclosure resulting from an act or omission by the Receiving Party; (c) was independently developed or discovered by the Receiving Party without use of the Confidential Information; (d) is or was disclosed to the Receiving Party at any time, whether prior to or after the time of its disclosure under this Agreement, by a third party having no fiduciary relationship with the Disclosing Party and having no obligation to confidentiality with respect to such Confidential Information; or (e) was previously known to the Receiving Party from sources other than the Disclosing Party at the time of disclosure under this Agreement other than under an obligation of confidentiality.

 

(iii)                               Allowed Disclosure.  Notwithstanding the above obligations of confidentiality and non-use a Receiving Party may:

 

(a)                                 disclose Confidential Information to a competent authority as reasonably necessary to obtain regulatory approval in a particular jurisdiction to the extent consistent with the licenses granted under terms of this Agreement; and

 

(b)                                 disclose Confidential Information: (i) to the extent such disclosure is reasonably necessary to comply with the order of a court; or (ii) to the extent such disclosure is required to comply with a legal requirement,

 

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including to the extent such disclosure is required in publicly filed financial statements or other public statements under rules governing a stock exchange (e.g., EURONEXT, the rules of the United States Securities and Exchange Commission, NASDAQ, NYSE, or any other stock exchange on which securities issued by either Party may be listed); provided, to the extent possible bearing in mind such legal requirements and subject to the next sentence of this Section, such Party shall provide the other Party with a copy of the proposed text of such statements or disclosure [**] Business Days in advance of the date on which the disclosure is to be made to enable the other Party to review and provide comments, unless a shorter review time is agreed.  If the compliance with a legal requirement requires filing of this Agreement, the filing Party shall to the extent possible seek confidential treatment of portions of this Agreement from the relevant competent authority and shall provide the other Party with a copy of the proposed filings at least [**] Business Days prior to filing for the other Party to review any such proposed filing.  Each Party agrees that it will obtain its own legal advice with regard to its compliance with legal requirements and will not rely on any statements made by the other Party relating to such legal requirements; and

 

(c)                                  disclose Confidential Information by filing or prosecuting the Patent Rights, the filing or prosecution of which is contemplated by this Agreement, without violating the above confidentiality provisions; it being understood that publication of such filings occurs in some jurisdictions within [**] months of filing; and

 

(d)                                 in the case where AMT is the Receiving Party disclose Confidential Information to AMT’s contractors (including clinical researchers) distributors, Sublicensee’s, agents, consultants, as such Receiving Party 

 

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reasonably determines is necessary to receive the benefit of the licenses and rights granted or available to it under this Agreement or to fulfil its obligations pursuant to this Agreement; provided, however, any such persons must be obligated to substantially the same extent as set forth in this Section to hold in confidence and not make use of such Confidential Information for any purpose other than that permitted by this Agreement; and

 

(e)                                  disclose Confidential Information: (i) to its actual or potential investment bankers; (ii) to existing and potential investors in connection with an offering or placement of securities for purposes of obtaining financing for its business and to actual and prospective lenders for the purpose of obtaining financing for its business; and (iii) to a bona fide potential acquiror or merger partner for the purposes of evaluating entering into a merger or acquisition, provided, however, any such persons must be obligated to substantially the same extent as set forth in this Section to hold in confidence and not make use of such Confidential Information for any purpose other than those permitted by this Agreement; and

 

(f)                                   disclose Confidential Information to its legal advisers for the purpose of seeking advice.

 

7.2                               Use of Names.

 

(i)                                     AMT and its Sublicensees shall not use the name “St. Jude Children’s Research Hospital” or any variation of that name, or any trademarks or logos belong to ST. JUDE, or the names of any of ST. JUDE’s trustees, officers, faculty, students, employees, or agents, or any adaptation of such names, or any term of this Agreement in any promotional material or other public announcement or disclosure 

 

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or in connection with the marketing or sale of any Licensed Product without the prior written approval of ST. JUDE; except: (a) in annual reports or as part of required regulatory or financial disclosures to the FDA, Securities Exchange Commission or other federal or foreign agencies; and (b) where otherwise required by law, provided that AMT shall notify ST. JUDE in advance of any disclosure to be made under these exceptions.

 

(ii)                                  ST. JUDE shall not use the name “ Amsterdam Molecular Therapeutics B.V.” or any variation of that name, or any term of this Agreement in any promotional material or other public announcement or disclosure without the prior written approval of AMT; except: (a) as part of required reports to state or federal government entities; and (b) where otherwise required by law, provided that ST. JUDE shall notify AMT in advance of any disclosure to be made under these exceptions.

 

7.3                               Publication.  If ST. JUDE wishes to publish or otherwise publically disclose results obtained from its internal research under the Patent Rights in the Field, ST. JUDE shall submit to AMT a confidential copy of the intended publication or disclosure at least [**] days prior to the proposed publication or other disclosure date.  If, AMT believes that the publication or intended disclosure contains patentable subject matter or contains Confidential Information of AMT, AMT shall notify ST. JUDE in writing.

 

7.4                               Marking.  AMT shall mark all Licensed Products intended for use under Patent Rights with appropriate information with respect to Patent Rights in accordance with the statutes of the United States relating to the marking of patented articles (see 35 U.S.C. §287(a)) and corresponding foreign rules and regulations.

 

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8.                                      INDEMNIFICATION AND INSURANCE

 

8.1                               Indemnification.

 

(i)                                     Indemnity.

 

(a)                                 Except with respect to third party claims the subject of this Section, neither Party shall be liable to the other in contract, tort, negligence, breach of statutory duty or otherwise for any loss, damage, costs or expenses of any nature whatsoever incurred or suffered by the other or its Affiliates of a direct nature where the same is a loss of turnover, profits, business or goodwill; or an indirect or consequential or punitive nature, including any indirect or consequential economic loss or other indirect or consequential loss of turnover, profits, loss of enterprise value, business or goodwill or otherwise.

 

(b)                                 AMT shall indemnify, defend and hold ST. JUDE, the American Lebanese Syrian Associated Charities, Inc. (ALSAC; a non-profit, 501(c)(3) corporation which supports ST. JUDE), their present and former trustees, directors, governors, officers, agents, faculty, employees and students (“the Indemnitees”) harmless as against any claims, demands, damages, judgments, fees (including reasonable attorneys fees), expenses, or other costs arising from or incidental to any product liability or other lawsuit, claim, demand or other action brought by a third party as a consequence of the use of clinical data provided by ST. JUDE, the practice of the Patent Rights or the sale of Licensed Products by AMT or Sublicensees, whether or not ST. JUDE, either jointly or severally, is named as a party defendant in any such lawsuit and whether or not ST. JUDE is alleged to be negligent or otherwise responsible for any injuries to persons or property.  Such indemnity shall not extend to any claims, demands, damages, judgments, fees (including reasonable attorneys fees), expenses, or other costs to the extent that the same are determined to be the result of the willful misconduct of ST. JUDE, the American Lebanese Syrian Associated 

 

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Charities, Inc., their present and former trustees, directors, governors, officers, agents, faculty, employees or students  Practice of the Patent Rights or sale of Licensed Products by an Affiliate of AMT or an agent or a Sublicensee or a third party on behalf of or for the account of AMT or by a third party who purchases Licensed Product(s) from AMT, shall be considered AMT’s practice of said Patent Rights for purposes of this Section.  The obligation of AMT to defend, indemnify and hold harmless as set out in this Section shall survive the termination of this Agreement, shall continue even after assignment of rights and responsibilities to an Affiliate or Sublicensee, and shall not be limited by any other limitation of liability elsewhere in this Agreement.

 

(c)                                  In the event that it is ultimately determined that AMT is not obligated to indemnify, defend and hold harmless the Indemnitees as against any claims, demands, damages, judgments, fees (including reasonable attorneys fees), expenses, or other costs, the Indemnitees shall reimburse AMT for any and all costs and expenses (including lawyers’ fees) incurred by AMT in its defense with respect to the Indemnitees.

 

(ii)                                  Procedures.  The Indemnitees agree to provide AMT with prompt written notice of any claim, suit, action, demand, or judgment for which indemnification is sought under this Agreement.  In no event shall AMT be liable for any claims, demands, damages, judgments, fees (including reasonable attorney’s fees), expenses, or other costs that result from a delay by the Indemnitees in providing AMT with such notice.  AMT agrees, at its own expense, to provide attorneys reasonably acceptable to Indemnitees to defend against any such claim, unless Indemnitees elect to be separately represented (which shall be at Indemnitee’s discretion), in which event any costs incurred by the Indemnitees in relation to retaining their own attorneys shall be the sole responsibility of the Indemnitees.  The Indemnitees shall 

 

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cooperate fully with AMT in such defense and will permit AMT to conduct and control such defense and the disposition of such claim, suit, or action (including all decisions relative to litigation, appeal, and settlement).  AMT agrees to keep ST. JUDE informed of the progress in the defense and disposition of such claim and to consult with ST. JUDE with regard to any proposed settlement.

 

(iii)                               Insurance.  Prior to initial human testing or sale of any Licensed Products and thereafter so long as Licensed Products are being sold in any particular country AMT shall establish and maintain appropriate insurance coverage in the minimum amount of [**] dollars ($[**]) per claim, with an aggregate of [**] dollars ($[**]), to cover any liability arising from AMT’s indemnification obligations under this Section 8 with respect to such human testing or sale of Licensed Product.  Prior to initial human testing or sale of any Licensed Product and thereafter so long as Licensed Products are being sold in any particular country, AMT shall establish and maintain, in each country in which AMT or Sublicensees shall test or sell Licensed Products, product liability or other appropriate insurance coverage in the minimum amount of [**] dollars ($[**]) per claim.  AMT will annually present evidence, in the form of a statement in the annual diligence report to ST. JUDE that such coverage is being maintained.  Upon ST. JUDE’S request, AMT will furnish ST. JUDE with a Certificate of Insurance of each insurance policy obtained.  ST. JUDE and ALSAC shall be listed as additional insured’s in AMT’s said insurance policies.  If such insurance is underwritten on a ‘claims made’ basis, AMT agrees that any change in underwriters during the term of this Agreement and thereafter so long as Licensed Products are being sold will require the purchase of ‘prior acts’ coverage to ensure that coverage will be continuous throughout the term of this Agreement and thereafter so long as Licensed Products are being sold.

 

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9.                                      TERM AND TERMINATION

 

9.1                               Term.  This Agreement shall commence on the Effective Date and, and unless sooner terminated in accordance with any of the provisions herein, expire when no further payment is due from AMT to ST. JUDE hereunder in relation to sales of Licensed Product.

 

9.2                               Voluntary Termination by AMT.  AMT shall have the right to terminate this Agreement, for any reason, upon ninety (90) days, prior written notice to ST. JUDE.  Upon termination, a final report as described in Section 5.2 shall be submitted and any previously arising (before the effective termination date) milestone payments, annual fees, royalty payments, and unreimbursed patent expenses due to ST. JUDE shall become immediately payable.

 

9.3                               Termination for Default.  In the event that either Party commits a material breach of its obligations under this Agreement and fails to cure that breach within [**] days after receiving written notice thereof, the other Party may terminate this Agreement immediately upon written notice to the party in breach unless the Party allegedly in breach disputes that a material breach has occurred and submits notice of such dispute to the other Party, following which the Parties shall first try to resolve the dispute within [**] days of such notice and if such dispute cannot be resolved, the dispute shall be subject to the jurisdiction of the courts pursuant to Section 10.7.  For the avoidance of doubt, there shall be no termination of this Agreement pending the outcome of dispute resolution.

 

If the alleged breach involves non payment of any undisputed amounts due ST. JUDE under this Agreement, AMT shall pay an interest penalty based on the amount owed at a daily accrual rate equal to the lesser of [**] percent ([**]%) per annum or the highest rate permissible by law on the unpaid balance until the undisputed amount is paid in full.

 

9.4                               Termination for Insolvency.  ST. JUDE shall have the right to terminate this Agreement on written notice to AMT in the event of the occurrence of insolvency of AMT.

 

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9.5                               Effect of Termination on Sublicensees.  If termination under Sections 9.3 or 9.4 of this Agreement is no fault of a Sublicensee ST. JUDE agrees to enter into a direct license of Patent Rights with any Sublicensee on substantially the same terms as the sublicense between AMT and the Sublicensee with respect to terms pertaining to the Patent Rights, provided that the terms of the sublicense are at least as favorable to ST. JUDE as the terms of this Agreement and prior to the making of any such sub-license by AMT, ST. JUDE will undertake directly to such Sublicensee that ST. JUDE will do this.

 

9.6                               Effect of Termination.  Upon termination, AMT shall cease to utilize Patent Rights and shall so certify to ST. JUDE in writing that Patent Rights are not being used for any purpose by AMT.  Termination shall not affect any rights or obligations which have accrued prior to termination or which by their nature are intended to survive termination such as Section 1, 5.2 (obligation to provide final report and payment), 7, 8.1, 9.5, 10.1, 10.7 and 10.8.  Upon the early termination of this Agreement, AMT may complete and sell any work-in-progress and inventory of Licensed Products that exists as of the effective date of termination, provided that (i) AMT is current in payment of all amounts due ST. JUDE under this Agreement, (ii) AMT pays ST. JUDE the applicable royalty on such sales of Licensed Products in accordance with the terms and conditions of this Agreement, and (iii) AMT shall complete and sell all work-in-progress and inventory of Licensed Products within [**] months after the effective date of termination.

 

10.                               MISCELLANEOUS

 

10.1                        Representation and Warranties of both Parties.

 

(i)                                     Each Party hereby represents and warrants to the other Party, as of the Effective Date, as follows:

 

(a)                                 Such Party has the power and authority and legal right to enter into this Agreement, to perform its obligations and to grant the licenses hereunder,

 

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

 

(b)                                 This Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal and valid obligation binding upon such Party and enforceable against it in accordance with its terms;

 

(c)                                  The execution, delivery and performance of this Agreement by such Party do not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any applicable law or regulation of any governmental body or administrative or other agency having jurisdiction over it;

 

(d)                                 Such Party is aware of no action, suit, inquiry or investigation instituted by any third party that questions or threatens the validity of this Agreement; and

 

(e)                                  All necessary consents, approvals and authorizations of all governmental authorities and other persons required to be obtained by such Party in connection with this Agreement have been obtained.

 

(ii)                                  Further Representations and Warranties of ST. JUDE:

 

(a)                                 ST. JUDE either legally or beneficially owns or controls the entire right, title and interest in and to the Patent Rights licensed hereunder.

 

(b)                                 there is, to its knowledge as of the Effective Date, no action, suit, claim, proceeding or governmental investigation pending or threatened against ST. JUDE with respect to enforceability of the Patent Rights licensed hereunder, either at law or in equity, before any court or administrative

 

27

 

agency or before any governmental department, commission, board, bureau, agency or instrumentality, whether United States or foreign.

 

(c)                                  ST. JUDE has informed AMT in writing of all intellectual property rights of third parties in the Field of which ST. JUDE is aware to the best of ST. JUDE’s knowledge.

 

ST. JUDE MAKES NO OTHER WARRANTIES CONCERNING THE PATENT RIGHTS, INCLUDING WITHOUT LIMITATION ANY EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.  Specifically, ST. JUDE makes no warranty or representation (i) regarding the validity or scope of the Patent Rights, (ii) that exploitation of the Patent Rights or any Licensed Product will not infringe any patents or other intellectual property rights of a third party, and (iii) that any third party is not currently infringing or will not infringe the Patent Rights.

 

10.2                        Force Majeure.  Neither Party will be responsible for its inability to perform any of its obligations under this Agreement resulting from causes beyond the reasonable control of such Party, including without limitation fires, explosion, flood, war, strike, or riot, provided that the nonperforming Party uses reasonable efforts to avoid or remove such causes of nonperformance and continues performance under this Agreement with reasonable dispatch whenever such causes are removed.

 

10.3                        Headings.  All headings are for convenience only and shall not affect the meaning of any provision of this Agreement.

 

10.4                        Binding Effect.  This Agreement shall be binding upon and inure to the benefit of the parties and their respective permitted successors and assigns.

 

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10.5                        Assignment.  The benefit and/or burden of this Agreement may not be assigned by either Party without the prior written consent of the other Party, such consent not to be unreasonably withheld, except that AMT may, without the consent of ST. JUDE assign this Agreement to an Affiliate or to a successor in connection with a merger, consolidation, or sale of all or substantially all of its assets or that portion of its business to which this Agreement relates, but shall notify ST. JUDE of such an assignment within [**] days of its occurrence.  Any assignment in violation of this provision shall be null and void.

 

10.6                        Amendment and Waiver.  This Agreement may be amended, supplemented, or otherwise modified only by means of a written instrument signed by both Parties.  Any waiver of any rights or failure to act in a specific instance shall relate only to such instance and shall not be construed as an agreement to waive any rights or fail to act in any other instance, whether or not similar.

 

10.7                        Governing Law.  This Agreement shall be governed by and construed in accordance with the laws of the State of New York irrespective of any conflicts of law principles or choice of law rules of any state or country.  Any lawsuit that may be brought with respect to this Agreement shall be brought and tried in a court of competent jurisdiction in New York.  AMT represents that choice of law provisions agreed to by parties to a written contract are generally honored under Dutch law.

 

10.8                        Notice.  Any notices required or permitted under this Agreement shall be in writing, shall specifically refer to this Agreement, and shall be sent by hand, recognized national overnight courier, confirmed facsimile transmission, or registered or certified mail, postage prepaid, return receipt requested, to the following address or facsimile numbers of the parties:

 

	
To ST. JUDE:
    	
Office of Technology Licensing
    
	
 
    	
Mail Stop 0742
    
	
 
    	
St. Jude Children’s Research   Hospital
    

 

29

 

	
 
    	
332 North Lauderdale
    
	
 
    	
Memphis, Tennessee 38105 Attn:   Director
    
	
 
    	
 
    
	
 
    	
Facsimile: (901) 495-3148
    
	
 
    	
 
    
	
To AMT:
    	
Amsterdam Molecular Therapeutics   B.V.
    
	
 
    	
Meibergdreef 611105 BA
    
	
 
    	
Amsterdam, The Netherlands
    
	
 
    	
Attn: Anthony Gringeri
    
	
 
    	
 
    
	
 
    	
Facsimile: +31 20 566 9272
    

 

 

All notices under this Agreement shall be deemed effective upon receipt.  A Party may change its contact information upon written notice to the other Party.

 

10.9                        Severability.  In the event that any provision of this Agreement shall be held invalid or unenforceable for any reason, such invalidity or unenforceability shall not affect any other  provision of this Agreement, and the Parties shall negotiate in good faith to modify the Agreement to preserve (to the extent possible) their original intent.  During such negotiation, this Agreement shall be construed as if such provision were deleted by agreement of the Parties.

 

10.10                 Entire Agreement.  This Agreement, together with the Sponsored Research Agreement and the AMT Technology License Agreement between the Parties executed concurrently herewith, constitutes the entire agreement between the Parties with respect to the subject matter and supersedes all prior agreements or understandings between the Parties relating to its subject matter.

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives.

 

30

 

	
Amsterdam Molecular Therapeutics   B.V.
    	
 
    	
St. Jude Children’s Research   Hospital, Inc.
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ A.J. Gringeri
    	
 
    	
By:
    	
/s/ J. Scott Elmer
    
	
 
    	
Anthony Gringeri
    	
 
    	
 
    	
J. Scott Elmer
    
	
 
    	
Chief Operating Officer
    	
 
    	
 
    	
Director, Technology Licensing
    
	
 
    	
 
    	
 
    
	
Date:
    	
4   July 2008
    	
 
    	
Date:
    	
07/07/08
    
							

 

31

 

 

 

ST. JUDE CHILDREN’S RESEARCH HOSPITAL, INC.   (1)

 

and

 

UNIQURE BIOPHARMA BV   (2)

 

 

AMENDMENT N°1 TO THE

EXCLUSIVE LICENSE AGREEMENT

 

 

 

THIS AMENDMENT N°1 TO THE EXCLUSIVE LICENSE AGREEMENT (this “Amendment”), with the effective date of July 12, 2012 (“Effective Date”),

 

BY AND BETWEEN

 

(1)                                 ST. JUDE CHILDREN’S RESEARCH HOSPITAL, INC., a Tennessee not-for-profit corporation located at 262 Danny Thomas Place, Memphis, Tennessee 38105 (“St. Jude”); and

 

(2)                                 UNIQURE BIOPHARMA BV (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 an Exclusive License Agreement dated July 7th, 2008 (hereinafter the “Agreement”).

 

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

 

I.                                        change the name of the licensee from Amsterdam Molecular Therapeutics B.V. (“AMT”) 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 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 financial terms associated with sublicensing, so as to clarifyfinancial obligations due to St.Jude from sublicensing of the patent rights granted in the Agreement by uniQure in order to expedite the development of therapeutics for rare diseases.

 

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 4.5 (i)* is amended to read as follows:

 

* 2nd subsection (f) of Section 4.5.

 

 

(i)                                     Support for research, Development and/or manufacturing activities corresponding directly to the Development and commercial manufacture of Licensed Products, which do not exceed the fully-burdened cost for undertaking such research, Development, and/or manufacturing performed by or for AMT (including third parties on AMT’s behalf), each pursuant to a specific agreement including a performance plan and commensurate budget;

 

IV.                               The following Section 4.7 is added to the Agreement:

 

4.7                               Sublicense consideration apportionment. The percentages referred to under subsections (i), (ii) and (iii) immediately below the first paragraph of Section 4.5 shall apply only to that portion of sublicense consideration attributable to sublicensing of the Patent Rights.  In any agreement which includes the grant of a sublicense to Patent Rights along with other rights and assets held by uniQure that are necessary or desirable for the development, manufacture and sale of Licensed Products, the Parties shall agree on the portion of income from such an agreement that should be attributable to sublicensing of the Patent Rights, taking into account the value of the Patent Rights in comparison to the value of the other rights and assets transferred by uniQure to the sublicensee that are necessary or desirable for the development, manufacture and sale of Licensed Products.

 

2.                                      Miscellaneous: All the other provisions of the Agreement remain unchanged and fully applicable between the Parties, and the terms and definitions used in the Agreement shall, so far as possible, apply to this Amendment.

 

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

 

 

	
St.   Jude Children’s Research Hospital, Inc.
    	
UniQure   biopharma B.V.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
 
    	
 
    	
By:
    	
/s/   PJ Morgan
    
	
Name:
    	
 
    	
 
    	
Name:
    	
PJ   Morgan
    
	
Title:
    	
 
    	
 
    	
Title:
    	
CFO
    
	
Date:
    	
 
    	
 
    	
Date:
    	
12   July 2012

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