Document:

Exhibit 10.8

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote 

omissions.

 

LICENSE AGREEMENT BETWEEN

 

SALK INSTITUTE FOR BIOLOGICAL STUDIES

 

AND

 

AMSTERDAM MOLECULAR THERAPEUTICS BV

 

RNA EXPORT ELEMENT WPRE
 (Woodchuck Hepatitis Virus Posttranscriptional Regulatory Element)

 

GENE THERAPY

 

 

TABLE OF CONTENTS

 

	
 
    	
 
    	
Page
    
	
 
    	
 
    	
 
    
	
1.
    	
DEFINITIONS
    	
1
    
	
 
    	
 
    	
 
    
	
2.
    	
BACKGROUND
    	
2
    
	
 
    	
 
    	
 
    
	
3.
    	
GRANT OF LICENSE
    	
2
    
	
 
    	
 
    	
 
    
	
4.
    	
ROYALTIES AND FEES
    	
2
    
	
 
    	
 
    	
 
    
	
5.
    	
REPORTING AND ACCOUNTING
    	
3
    
	
 
    	
 
    	
 
    
	
6.
    	
BIOLOGICAL MATERIALS
    	
4
    
	
 
    	
 
    	
 
    
	
7.
    	
OWNERSHIP OF INTELLECTUAL PROPERTY
    	
5
    
	
 
    	
 
    	
 
    
	
8.
    	
MAINTENANCE OF PATENT RIGHTS
    	
6
    
	
 
    	
 
    	
 
    
	
9.
    	
TERM AND TERMINATION
    	
6
    
	
 
    	
 
    	
 
    
	
10.
    	
AGENCY
    	
7
    
	
 
    	
 
    	
 
    
	
11.
    	
USE OF SALK’S NAME
    	
7
    
	
 
    	
 
    	
 
    
	
12.
    	
WARRANTY
    	
7
    
	
 
    	
 
    	
 
    
	
13.
    	
DISCLAIMERS
    	
8
    
	
 
    	
 
    	
 
    
	
14.
    	
INDEMNIFICATION AND INSURANCE
    	
8
    
	
 
    	
 
    	
 
    
	
15.
    	
ASSIGNMENT
    	
9
    
	
 
    	
 
    	
 
    
	
16.
    	
U.S. MANUFACTURE
    	
9
    
	
 
    	
 
    	
 
    
	
17.
    	
FOREIGN REGISTRATION
    	
9
    
	
 
    	
 
    	
 
    
	
18.
    	
EXPORT CONTROLS
    	
9
    
	
 
    	
 
    	
 
    
	
19.
    	
NOTICES
    	
10
    
	
 
    	
 
    	
 
    
	
20.
    	
APPLICABLE LAW AND DISPUTE RESOLUTION
    	
10
    
	
 
    	
 
    	
 
    
	
21.
    	
NONWAIVER
    	
11
    
	
 
    	
 
    	
 
    
	
22.
    	
SEVERABILITY
    	
11
    
	
 
    	
 
    	
 
    
	
23.
    	
HEADINGS
    	
11
    
	
 
    	
 
    	
 
    
	
24.
    	
AMENDMENT
    	
11
    
	
 
    	
 
    	
 
    
	
25.
    	
FORCE MAJEURE
    	
11
    
	
 
    	
 
    	
 
    
	
26.
    	
ENTIRE AGREEMENT
    	
12
    
	
 
    	
 
    
	
Schedule A
    	
PATENT RIGHTS
    	
13
    
	
 
    	
 
    	
 
    
	
Schedule B
    	
BIOLOGICAL MATERIALS
    	
14
    
				

 

i

 

LICENSE AGREEMENT

 

Effective as of February 8, 2008 (“Effective Date”), THE SALK INSTITUTE FOR BIOLOGICAL STUDIES, a nonprofit public benefit corporation organized and existing under the laws of the State of California, U.S.A. (“Salk”), and Amsterdam Molecular Therapeutics BV, a corporation organized and existing under the laws of The Netherlands (“Licensee”), agree as follows:

 

1.                                      DEFINITIONS

 

1.1                               “Licensed Patents” shall mean the patents and patent applications listed on Schedule A hereto, and any divisions, continuations, continuations-in-part, reissues and renewals, if any, of the aforementioned.

 

1.2                               “Biological Materials” shall mean the constructs identified in Schedule B (and any materials transferred during the Term) together with any progeny, mutants, modified derivatives, or unmodified derivatives thereof supplied by Salk or created by Licensee that do not significantly alter the original function(s) and/or activity of the construct.  A “modified derivative” means any substance that Licensee may create using the constructs supplied hereunder, or created practicing the Licensed Patents, which substance constitutes a modified element derived from, but functionally equivalent to, the original construct (the WPRE element) identified in Schedule B.  An “unmodified derivative” means any substance that Licensee may create using the constructs supplied hereunder, or created practicing the Licensed Patents, which substance constitutes an important unmodified functional subunit of the originally supplied material.

 

1.3                               “Licensed Technology” shall mean the Licensed Patents and the Biological Materials.

 

1.4                               “Licensed Product” shall mean any product which is composed of or incorporates or is directly or indirectly discovered, developed, produced and/or identified using the Licensed Technology.  The term Licensed Product shall also include any product, the manufacture, use, importation, sale or offer for sale of which in the absence of this license would infringe the Licensed Patents.

 

1.5                               “Field of Use” shall mean the right to use the Licensed Technology for Gene Therapy.

 

1.6                               “Net Sales” shall mean the gross sales price actually charged in arm’s length sales by Licensee or its Affiliates to any third party, in the sale of a Licensed Product less:

 

(i)                                     shipping, storage, packing and insurance expenses, each as actually paid or allowed;

 

(ii)                                  distributor discounts;

 

(iii)                               amounts repaid or credited by reason of rejections, defects or returns or because of retroactive price reductions; and

 

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(iv)                              sales and other excise taxes, use taxes, tariffs, export license fees, government charges and duties actually paid or allowed.

 

1.7                               “Affiliate” shall mean any entity which is controlled by or is under common control with Licensee, where “control” means beneficial ownership of more than fifty percent (50%) of the voting shares or securities or the ability otherwise to elect a majority of the board of directors or other managing authority.

 

1.8                               “Gene Therapy” shall mean the administration directly to a human of a gene transfer system comprising genetic material that encodes a moiety, wherein such moiety serves a material function in the treatment of or prevention of disease, the modification or manipulation of the expression of a gene product(s), or the alteration of the biological properties of living cells in humans.  To clarify, Gene Therapy may include use in vitro in vertebrate cells or administration of a gene transfer system to non-human vertebrate animals for research and development only.

 

2.                                      BACKGROUND

 

2.1                               The inventions disclosed and claimed in the Licensed Patents were conceived and/or developed in the laboratory of [**].  Licensed Patents may have utility, among other tilings, for gene therapy, drug discovery and development and protein expression in cells or transgenic animals.

 

2.2                               Salk represents that it is the owner of and/or has the right to grant licenses under the Licensed Patents.

 

2.3                               Salk and Licensee wish to enter into a license that will encourage the use of the Licensed Technology in the field of Gene Therapy.

 

3.                                      GRANT OF LICENSE

 

3.1                               Licensed Technology.  Subject to the terms and conditions hereof, Salk grants to Licensee and its Affiliates a worldwide, non-exclusive, non-transferable license in and to the Licensed Technology to research, have researched, develop, have developed, make, have made, use, have used, import, have imported, offer for sale, sell and have sold Licensed Products solely in the Field of Use.

 

3.2                               Sublicenses.  Licensee shall not have the right to grant sublicenses.  However, upon request by Licensee, Salk shall grant nonexclusive, worldwide licenses in and to the Patent Rights to for-profit Collaborators of Licensee on terms substantially the same as those set forth herein.

 

4.                                      ROYALTIES AND FEES

 

4.1                               As partial consideration for the rights granted to Licensee under this Agreement and as a nonrefundable and non-creditable license fee, Licensee shall pay to Salk (a) Thirty Thousand Dollars ($30,000.00) in cash, due upon execution, and (b) [**] Dollars ($[**]) in cash

 

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annually thereafter for the Term, beginning on the one-year anniversary date of the Effective Date.  The annual fee is non-refundable and not subject to proration.

 

4.2                               Licensee agrees to pay to Salk the sum of five thousand dollars ($5,000) in cash, due upon execution, as payment of a share of the cost of general administration, filing, prosecution and maintenance of the Patent Rights.

 

4.3                               Licensee shall pay to Salk the following royalties:

 

(i)                                     [**] percent ([**]%) on Net Sales of Licensed Products up to [**] dollars ($[**]), calculated from the Effective Date,

 

(ii)                                  [**] percent ([**]%) on Net Sales of Licensed Products [**] dollars ($[**]) up to [**] dollars ($[**]), calculated from the Effective Date,

 

(iii)                               [**] percent ([**]%) on Net Sales of Licensed Products over [**] dollars ($[**]), calculated from the Effective Date.

 

4.4                               All payments made to Salk under Paragraphs 4.1 and 4.2 of this Agreement shall be made on the dates defined therein.  Royalty payments made to Salk under Paragraph 4.3 of this Agreement shall be made quarterly.  All payments made to Salk under this Agreement shall be made by wire transfer to the account of Salk at:

 

	
Send   wire to:
    	
Bank of   America, San Francisco, CA
    
	
Route No. (ABA#):
    	
0260-0959-3
    
	
Swift   No.:
    	
BOFAUS3N
    
	
Credit   to:
    	
The   Salk Institute for Biological Studies
    
	
Account   No.:
    	
[**]
    
	
Branch   Name:
    	
B of A   San Diego Commercial Banking Office #1450
    
	
Additional   Message:
    	
Sender’s   name, purpose of wire, & Attn: Constance Mueller, Patent and License   Administrator
    

 

or any other bank account that may be notified in writing by Salk to Licensee from time to time.

 

4.5                               No royalty payment shall be altered by any tax on royalties which may be imposed on, applied to or withheld from the payment.  Licensee shall be responsible for the satisfaction of the taxes so that the payments to Salk are not reduced thereby.

 

5.                                      REPORTING AND ACCOUNTING

 

5.1                               Licensee agrees to keep proper records of scientific research and keep books of account in accordance with international financial reporting standards.  Such records and books shall include all information necessary for the accurate determination of royalty and other payments to Salk.  Following launch of Licensed Product, Licensee agrees to deliver to Salk, within [**] days after each calendar quarter, a report showing the information on which payments herein provided are calculated, including a breakdown of income from sales of each Licensed Product, and to accompany each such report with the payment shown to be due

 

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thereby.  All amounts accrued for the benefit of Salk shall be deemed held in trust for the benefit of Salk until payment of such amounts is made pursuant to this Agreement.

 

5.2                               Licensee agrees to make a written report to Salk within [**] days after the termination date of this Agreement, reporting all royalty income payable hereunder which was not previously reported to Salk.

 

5.3                               Except as Salk may otherwise instruct Licensee under Paragraph 5.6, all amounts payable hereunder by Licensee to Salk shall be payable in United States currency in San Diego, California.

 

5.4                               On reasonable written notice, Salk, at its own expense, shall have the right to have an independent party reasonably acceptable to the Licensee, inspect and audit the books and records of Licensee and its Affiliates at their offices during usual business hours for the sole purpose of, and only to the extent necessary for, determining the correctness of payments due under this Agreement.  Such examination with respect to any fiscal year shall not take place later than [**] years following the expiration or termination of this Agreement.  The expense of any such audit shall be borne by Salk; provided, however, that, if the audit discloses an error in excess of [**] percent ([**]%) in favor of Licensee, then Licensee shall pay, in addition to the amount of any underpayment, the cost to Salk of the audit.

 

5.5                               Royalties based on Net Sales in any foreign country shall be payable to Salk in the United States in United States Dollars.  Dollar amounts shall be calculated using the foreign exchange rate, as published by the Wall Street Journal, in effect for such foreign currency on the last business day of each quarter for which a report is required.  Where royalties are due for Net Sales in a country where, for reasons of currency, tax or other regulations, transfer of foreign currency out of such country is prohibited, Licensee has the right to place Salk’s royalties in a bank account in such country in the name of and under the sole control of Salk; provided, however, that the bank selected be reasonably acceptable to Salk and that Licensee inform Salk of the location, account number, amount and currency of money deposited therein.  After Salk has been so notified, those monies shall be considered as royalties duly paid to Salk and will be completely controlled by Salk.

 

5.6                               Licensee shall be responsible for any and all taxes that may be levied by a proper taxing authority on royalties or other payments accruing to Salk under this Agreement.  Such taxes may not be deducted from royalties or other payments to be paid to Salk hereunder.  Licensee acknowledges that Salk, as a not-for-profit corporation, does not qualify under U.S. tax laws for a tax credit on any taxes paid by Licensee.

 

5.7                               Late Payments.  Late payments shall be subject to a charge of [**] percent ([**]%) per month compounded, or $[**] per month, whichever is greater.  The payment of such late charges shall not prevent Salic from exercising any other rights it may have as a consequence of the lateness of any payment.

 

6.                                      BIOLOGICAL MATERIALS

 

6.1                               Upon execution of this Agreement, Salk or its designee shall make available to Licensee the Biological Materials described in Schedule B.  Thereafter, Licensee may request

 

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and obtain from Salk additional quantities of said Biological Materials that Salk has in its possession and does not need for its own research or to meet other contractual obligations, at reasonable charge by Salk for handling and shipping.  If Salk fails to fulfill the request of Licensee for Biological Materials, Licensee shall be free to produce such Biological Materials itself, or to purchase such Biological Materials from a source authorized by Salk.

 

6.2                               Title to Biological Materials shall remain with Salk.  Licensee shall have only the right to use Biological Materials in accordance with the grant of rights under Paragraph 3 hereof, and shall not use Biological Materials for any other purpose.  Title to Licensed Products shall remain with the Licensee save that the Licensee acknowledges that it cannot make, have made, use, have used, import, have imported, offer for sale, sell or have sold Licensed Products without a license from Salk.  Licensee shall not permit Biological Materials or any sample thereof to be distributed or delivered to any person whatsoever, other than to its own employees and those of its Affiliates to be used as permitted herein.  Licensee shall refer to Salk requests for Biological Materials from other research investigators or others.

 

6.3                               Licensee shall notify Salk of any improvements (including, but not limited to, modified derivatives and variants) to the Biological Materials made by Licensee or its Affiliates, irrespective of whether any such improvements were made in collaboration with Salk or any of its employees.  At Salk’s request, Licensee shall provide the laboratory of [**] with reasonable quantities of such improvements, and scientists in the laboratory of [**] shall have the right to use them for their internal research.  Title to all such improvements shall remain with Licensee.

 

6.4                               Licensee acknowledges that Biological Materials are experimental in nature and may have unknown characteristics.  Licensee further agrees to use prudence and reasonable care in the use, handling, storage, transportation, disposition and containment of Biological Materials and all products derived therefrom.

 

6.5                               Licensee shall comply with all applicable Governmental laws and regulations, and with all published Governmental guidelines, pertaining to the use, handling, storage, transportation, disposition and containment of Biological Materials and all products derived therefrom.

 

6.6                               BIOLOGICAL MATERIALS ARE PROVIDED WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED.

 

7.                                      OWNERSHIP OF INTELLECTUAL PROPERTY

 

Licensee (for itself and its Affiliates) acknowledges and agrees that Salk is and shall remain (as to Licensee) the owner of the Licensed Patents and Biological Materials, subject to the rights of the Federal Government as set forth in 35 U.S.C. §200 et seq., and that Licensee (including its Affiliates) has no rights in or to the Licensed Patents and Biological Materials other than the rights specifically granted herein.

 

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8.                                      MAINTENANCE OF PATENT RIGHTS

 

8.1                               Salk shall have full control over prosecution and maintenance of the patents contained in the Patent Rights.

 

8.2                               In the event Licensee’s use of Licensed Technology becomes the subject of a claim for patent or other proprietary right infringement anywhere in the world, the parties shall promptly give notice to the other and meet to consider the claim and the appropriate course of action.

 

9.                                      TERM AND TERMINATION

 

9.1                               Term.  Unless earlier terminated under this Paragraph 9, this Agreement shall become effective as of the date of this Agreement and expire on a country-by-country basis on the later to occur of the following (the “Term”):

 

(a)                                 fifteen (15) years from and after the Effective Date of this Agreement; or

 

(b)                                 the date of expiration of the last to expire of any patent included in the Licensed Patents; or

 

(c)                                  abandonment of the last remaining patent application included in the Licensed Patents.

 

9.2                               Termination by Either Party.  This Agreement may be terminated by either party, if the other party substantially fails to perform or otherwise materially breaches any of the material terms, covenants or provisions of this Agreement, such termination to be effected by giving written notice of intent to terminate to the breaching party stating the grounds therefor.  The party receiving the notice shall have [**] days thereafter to correct such breach.  If such breach is not corrected within said [**] days after notice as aforesaid, then this Agreement shall automatically terminate.

 

9.3                               Consequences of Termination.

 

(a)                                 In the event of expiration of this Agreement pursuant to Paragraph 9.1 Licensee and its Affiliates shall have a fully paid-up, royalty free license in and to the Licensed Technology to research, have researched, develop, have developed, make, have made, use, have used, import, have imported, offer for sale, sell and have sold Licensed Products in the Field of Use.

 

(b)                                 In the event of expiration of this Agreement or termination of the Agreement for any reason whatsoever:

 

(i)                                     Licensee shall not thereby be discharged from any liability or obligation to Salk which became due or payable prior to the effective date of such expiration or termination; and

 

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(ii)                                  The rights and obligations of the parties under Paragraphs 6, 7, 9.3, 10, 11, 12, 13 and 14 shall survive any termination of this Agreement.

 

(iii)                               Licensee shall promptly return all materials, samples, documents, information, and other materials which embody or disclose Licensed Technology; provided, however, that Licensee shall not be obligated to provide Salk with proprietary information which Licensee can show that it independently developed.  Licensee shall be permitted to retain copies of technical information in documentary form obtained from Salk where required to do so by reason of any statute, ordinance or regulation of any federal, state or local governmental entity.

 

(c)                                  In the event of termination of the Agreement pursuant to Paragraph 9.2:

 

(i)                                     Licensee agrees not to use Licensed Technology or said technical information after termination of this Agreement.  If at termination Licensee or its Affiliates then possess Licensed Product, have started the manufacture thereof or have accepted orders therefor, Licensee and its Affiliates shall have the right to sell their inventories thereof, complete the manufacture thereof and market such fully manufactured Licensed Product, in order to fulfill such accepted orders, subject to the obligation of Licensee to pay Salk the royalty payments therefor as provided in Paragraph 4 of this Agreement;

 

(ii)                                  Subject to Paragraph 9.3(c)(i), Licensee shall discontinue, and shall cause its Affiliates to discontinue, the manufacture, use, marketing and sale of Licensed Products;

 

(iii)                               Licensee shall provide a final report of the type described in Paragraph 5.1, including any allowable post-termination sales; and

 

(iv)                              All rights transferred by Salk to Licensee hereunder shall revert to Salk, and Licensee agrees to execute all instruments necessary and desirable to revest said rights in Salk.

 

10.                               AGENCY

 

Licensee shall not be deemed to be an agent of Salk as a result of any transaction under or related to this Agreement, and shall not in any way pledge Salk’s credit or incur any obligation on behalf of Salk.

 

11.                               USE OF SALK’S NAME

 

Licensee may make it known in promotional and technical literature that Licensed Products are offered under license from Salk; provided, however, that such use shall not state or imply that Salk has any relationship with Licensee other than as licensor-licensee.

 

12.                               WARRANTY

 

Subject to Salk’s obligations to the U.S. Government under Public Law 96-517, as amended, and any implementing regulations, Salk warrants to the best of its knowledge and

 

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belief that it is the owner of the Licensed Patents, free of any liens, encumbrances, restrictions and other legal and equitable claims.

 

13.                               DISCLAIMERS

 

13.1                        Nothing in this Agreement shall be construed as:

 

(a)                                 a warranty or representation by Salk as to the validity or scope of the Licensed Patents;

 

(b)                                 a warranty or representation by Salk that anything made, used, sold or otherwise disposed of under any license granted in this Agreement is or will be free from infringement of patents of third parties;

 

(c)                                  an obligation of Salk to bring or prosecute actions or suits against third parties for infringement of Licensed Patents;

 

(d)                                 conferring the right to use in advertising, publicity or otherwise any trademark, trade name, insignia, name, or names, or any contraction, abbreviation, adaptation of Salk, except to identify, where appropriate, Salk as the licensor of the Licensed Patents;

 

(e)                                  an obligation of Salk to furnish any know-how; or

 

(f)                                   a grant by implication, estoppel, or otherwise of any licenses under patent applications or patents of Salk or other persons other than as provided in Paragraph 3 hereof.

 

13.2                        SALK MAKES NO REPRESENTATION, EXCEPT AS EXPRESSLY SET FORTH IN PARAGRAPH 12 OF THIS AGREEMENT, AND EXTENDS NO WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES AS TO TITLE, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

 

13.3                        In no event will Salk be liable for any incidental, special or consequential damages resulting from the exercise of Licensee’s rights under the license granted pursuant to this Agreement or the use of the Licensed Patents.

 

14.                               INDEMNIFICATION AND INSURANCE

 

14.1                        Licensee agrees to indemnify, hold harmless and defend Salk, its trustees, officers, employees and agents, the sponsors of the research that led to the Licensed Technology, and the inventors of the patents and patent applications included in the Licensed Patents against any and all liability and/or damages with respect to any claims, suits, demands, judgments or causes of action arising out of third party claims concerning (a) the research, development, manufacture, storage, sale or other distribution, or any other use of Licensed Products or Licensed Technology, or exercise of rights granted hereunder, by Licensee, its Affiliates, distributors, agents or representatives; (b) the use by end-users and other third parties of such Licensed Products; and/or (c) any representation, warranty or statement by Licensee or its Affiliates, distributors, agents or representatives, concerning Salk, the Licensed Technology or the Licensed Patents.  In the event any such claims, demands or actions are made, Licensee shall

 

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defend Salk at Licensee’s sole expense by counsel selected by Licensee, subject to approval by Salk, which is not to be unreasonably withheld.  No settlement, consent judgment or other voluntary final disposition may be entered into without the prior written consent of Salk, which consent shall not be unreasonably withheld.

 

14.2                        In addition to the foregoing, Licensee shall maintain, during the Term, comprehensive general liability insurance, including products liability insurance, with reputable and financially secure insurance carriers to cover the activities of Licensee and its Affiliates.  Licensee shall maintain comprehensive general liability insurance beyond the expiration or termination of this Agreement during any period that any product, process, or service, relating to, or developed pursuant to, this Agreement is being commercially distributed or sold by Licensee, or an Affiliate or agent of Licensee; and thereafter for a period of [**] years.

 

15.                               ASSIGNMENT

 

This Agreement may not be assigned by Licensee without the prior written consent of Salk, which shall not unreasonably be withheld; provided, however, that Licensee may assign all of its rights and obligations under this Agreement in connection with a merger, sale of assets or other transaction involving a change in control of Licensee’s business.  Salk shall release Licensee of its rights and obligations under this agreement upon receipt of writing from successor or assignee expressly agreeing to be bound by all the terms and provisions of this Agreement.  Upon assignment of this Agreement to a successor or assignee the term “ Licensee” as used herein shall mean such successor assignee.

 

16.                               U.S. MANUFACTURE

 

To comply with US Government regulations for the licensing of federally funded inventions, Licensee and its Affiliates will commit that Licensed Products sold in the US will be manufactured substantially in the US.  Notwithstanding the foregoing, if during the term of the License Agreement Licensee or its Affiliates can provide compelling evidence to Salk that such manufacture in the US would impose an extraordinary burden on Licensee or its Affiliates, Salk shall at that time agree to seek a waiver from the US Government with respect to the requirement that Licensed Products for sale in the US be manufactured substantially in the US.  Licensee understands that Salk cannot guarantee that such waiver can be obtained.  Licensee shall bear all costs associated with seeking such waiver.

 

17.                               FOREIGN REGISTRATION

 

Licensee agrees to register this Agreement with any foreign governmental agency that requires such registration, and Licensee shall pay all costs and legal fees in connection therewith.  In addition, Licensee shall assure that all foreign laws affecting this Agreement or the sale of Licensed Products are fully satisfied.

 

18.                               EXPORT CONTROLS

 

It is understood that Salk is subject to United States laws and regulations controlling the export of technical data, computer software, laboratory prototypes and other commodities (such laws include the Arms Export Control Act, as amended and Export Administration Act), and that

 

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its obligations hereunder are contingent on compliance with applicable United States export laws and regulations.  The transfer of certain technical data and commodities by Licensee may require a license from the cognizant agency of the United States Government and/or written assurances by Licensee that Licensee shall not export data or commodities to certain foreign countries without prior approval of such agency.  Salk neither represents that a license shall not be required nor that, if required, it shall be issued.  Licensee shall not engage in any activity in connection with this Agreement that is in violation of any applicable U.S. law.

 

19.                               NOTICES

 

19.1                        All notices, demands or other writings provided to be given, made or sent, or which may be given, made or sent by either party to the other shall be deemed to have been fully given, made or sent when made in writing and deposited in the first-class mail, postage prepaid, or delivered to a commercial courier, charges prepaid, and addressed as follows:

 

	
To Salk:
    	
Salk Institute   for Biological Studies
    
	
 
    	
10010 North   Torrey Pines Road
    
	
 
    	
La Jolla,   California 92037 U.S.A.
    
	
 
    	
Attn:
    	
Licensing   Administrator
    
	
 
    	
 
    	
Office of   Technology Management
    
	
 
    	
 
    	
 
    
	
To Licensee:
    	
Amsterdam   Molecular Therapeutics BV
    
	
 
    	
Meibergdreef 61
    
	
 
    	
PO Box 22506
    
	
 
    	
1100 DA Amsterdam
    
	
 
    	
The Netherlands
    
	
 
    	
 
    
	
 
    	
Attn:   Dr. Anthony Gringeri
    
	
 
    	
 
    
	
 
    	
Chief Operating   Officer
    

 

19.2                        Either party may, upon written notice, change the address to which any notice or payment is made.

 

20.                               APPLICABLE LAW AND DISPUTE RESOLUTION

 

20.1                        This Agreement is made in accordance with and shall be governed and construed in accordance with the laws of the State of California, as applied to contracts executed and performed entirely within the State of California, without regard to conflict of laws rules.

 

20.2                        The parties hereby irrevocably submit to the jurisdiction of a court of competent jurisdiction in the State of California, San Diego County, and, by execution and delivery of this Agreement, each (a) accepts, generally and unconditionally, the jurisdiction of such court and any related appellate court, and (b) irrevocably waives any objection it may now or hereafter have as to the venue of any such suit, action or proceeding brought in such court or that such court is an inconvenient forum.

 

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20.3                        If a dispute arises between the parties relating to the interpretation or performance of this Agreement or the grounds for the termination thereof, the parties agree to hold a meeting, within [**] days of a request by either party for such meeting, attended by individuals with decision-making authority regarding the dispute, to attempt in good faith to negotiate a resolution of the dispute prior to pursuing other available remedies.  If the dispute remains unresolved [**] days after the first meeting for the purpose of dispute resolution, then each party shall have the right to pursue alternate dispute resolution or other remedies legally available to resolve the dispute.  In the case of such alternate dispute resolution or other legal remedies, the prevailing party will be entitled to receive from this other party its reasonable attorneys’ fees and costs.  If both parties receive judgment in any dollar amount, the court will determine the prevailing party, taking into consideration the merits of the claims asserted by each party, the amount of the judgment received by each party and the relative equities between the parties.

 

21.                               NONWAIVER

 

The waiver of either party hereto of any right hereunder or of the failure to perform or of a breach by the other party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other party whether of a similar nature or otherwise.

 

22.                               SEVERABILITY

 

If any term, condition or provision of this Agreement is held to be unenforceable by a court having proper jurisdiction for any reason, it shall, if possible, be interpreted rather than voided, in order to achieve the intent of the parties to this Agreement to the extent possible.  In any event, all other terms, conditions and provisions of this Agreement shall be deemed valid and enforceable to the full extent of the law.

 

23.                               HEADINGS

 

The headings used in this Agreement are for convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement.

 

24.                               AMENDMENT

 

No amendment or modification hereof shall be valid or binding upon the parties unless made in writing and signed by both parties.

 

25.                               FORCE MAJEURE

 

Any delays in performance by any party under this Agreement (other than the payment of monies due) shall not be considered a breach of this Agreement if and to the extent caused by occurrences beyond the reasonable control of the party affected, including but not limited to, acts of god, embargoes, governmental restrictions, strikes or other concerted acts of workers, fire, flood, explosion, riots, wars, civil disorder, rebellion or sabotage.  The party suffering such occurrence shall immediately notify the other party and any time for performance hereunder shall be extended by the actual time of delay caused by the occurrence.

 

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26.                               ENTIRE AGREEMENT

 

This Agreement and Schedules A and B attached hereto contain the entire agreement and understanding between the parties with respect to the subject matter hereof, and merge all prior discussions, representations and negotiations with respect to the subject matter of this Agreement.

 

In Witness Whereof, the parties hereto have executed this Agreement by their duly authorized officers or representatives.

 

 

	
 
    	
SALK INSTITUTE   FOR BIOLOGICAL STUDIES COMPANY
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
By:
    	
/s/ Anne-Marie   Mueller
    
	
 
    	
 
    	
Anne-Marie   Mueller
    
	
 
    	
 
    	
Senior Director,   Office of Technology Management
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
COMPANY
    
	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
By:
    	
/s/ Anthony   Gringeri
    
	
 
    	
 
    	
Name: Anthony J.   Gringeri, Ph.D.
    
	
 
    	
 
    	
Title: Chief   Operating Officer
    

 

12

 

Schedule A

 

PATENT RIGHTS

 

WPRE

 

[**]

 

13

 

Schedule B

 

Biological Materials

 

WPRE (Woodchuck Hepatitis Virus Posttranscriptional Regulatory Element) as described in Journal of Virology Vol. 72, No. 6, p. 5085-5092 (June 1998)

 

14

 

FIRST AMENDMENT TO LICENSE AGREEMENT ID 2008-0006

 

This First Amendment to a License Agreement between the parties dated February 8, 2008 (this “First Amendment”) is effective this XX day of May, 2013 (the “Amendment Date”), by and between the THE SALK INSTITUTE FOR BIOLOGICAL STUDIES, a nonprofit public benefit corporation organized and existing under the laws of the State of California, USA, having an office at 10010 North Torrey Pines Road, La Jolla, CA 92037 (“Salk”) and uniQure biopharma BV (formerly AMSTERDAM MOLECULAR THERAPEUTICS BV), having a principal place of business at P.O. Box 22506 1100 DA Amsterdam The Netherlands (“Licensee”).

 

BACKGROUND

 

WHEREAS, Salk is the owner of certain patents and biological materials related to RNA Export Element and Methods of Use developed in the laboratory of [**] of the Salk faculty;

 

WHEREAS, Salk and Licensee executed a License Agreement dated February 8, 2008 (the “License Agreement”) in which Salk granted to Licensee a non-exclusive license to such patents and biological materials as specifically set forth in the License Agreement; and

 

WHEREAS, effective April 26, 2012, Licensee changed its name from AMSTERDAM MOLECULAR THERAPEUTICS BV to uniQure’s biopharma BV with no change in corporate structure; and

 

WHEREAS, the parties now desire to make certain changes to the License Agreement, effective as of the Amendment Date.

 

NOW, THEREFORE, in consideration of the foregoing and for good and valuable consideration, the receipt and sufficiency which are hereby acknowledged, the parties hereby agree as follows:

 

1.                                     Amendments to Section 1.

 

(a) Section 1.6.  The second line of Section 1.6 of the Agreement is hereby amended and restated as follows:

 

“sales by Licensee, its Affiliates or Sublicensees to any third party, in the sale of a Licensed Product less: ”

 

A new sentence is hereby added to the end of Section 1.6 as follows:

 

“In the event of a sale of a Licensed Product from Licensee to a Sublicensee followed by a subsequent sale of such Licensed Product by the Sublicensee, royalties on Net Sales shall be payable to Salk only once, on the sale that would result in the highest royalty to Salk. ”

 

(b) Section 1.9.  A new Section 1.9 is hereby added to the Agreement as follows:

 

1

 

“ “Non-Royalty Sublicense Income” shall mean execution fees, maintenance fees, milestone fees and all other non-royalty payments received by Licensee from its Sublicensees pursuant to any sublicense granted pursuant to Section 2.3 hereunder. ”

 

(c) Section 1.10.  A new Section 1.10 is hereby added to the Agreement as follows:

 

“ “Sublicense” shall mean any agreement or multiple agreements with a non-Affiliate third parry in which Licensee grants the third party any of the rights granted to Licensee in Section 3.1. ”

 

(d) Section 1.11.  A new Section 1.11 is hereby added to the Agreement as follows:

 

“ “Sublicensee” shall mean any non-Affiliate third party to whom Licensee has granted a Sublicense. ”

 

2.                                      Amendments to Section 3.

 

(a) Section 3.2.  Section 3.2 of the Agreement is hereby deleted and replaced as follows:

 

“ 3.2  Subject to the terms and conditions hereof, Licensee shall have the right to grant Sublicenses under the license granted in Section 3.1 upon prior written approval of each proposed Sublicensee by Salk, not to be unreasonably withheld, provided that (i) no Sublicensee shall have the right to sublicense, (ii) such Sublicenses include a royalty rate upon Sublicensee’s Net Sales in an amount at least equal to the rate set forth in Section 4.3, (iii) Sublicenses entered into by Licensee shall conform in all material respects to the applicable terms and conditions of this Agreement and Sublicensees shall be subject to all applicable restrictions, limitations and obligations imposed on Licensee hereunder, and (iv) the sublicensed rights of any Sublicensee shall terminate upon termination of this Agreement. In the event this License Agreement is terminated or upon the expiration of the Term, such Sublicenses shall at Salk’s sole discretion, which shall not be unreasonably withheld, be automatically become a direct license with Salk.  Licensee agrees to forward to Salk a copy of any and all Sublicenses promptly upon execution thereof, but in no event later than [**] days after each such Sublicense has been executed by both parties thereto.”

 

3.                                      Amendments to Section 4.

 

(a) Section 4.6.  A new Section 4.6 is hereby added to the Agreement as follows:

 

“4.6 Licensee shall pay Salk a Sublicense fee, nonrefundable and noncreditable against royalties, of Five Thousand Dollars ($5,000.00), due within [**] business days from the Effective Date of this First Amendment. ”

 

(b) Section 4.7.  A new Section 4.7 is hereby added to the Agreement as follows:

 

“ 4.7 Licensee shall pay Salk on a quarterly basis a share of Non-Royalty Sublicense Income of [**] percent ([**]%). ”

 

2

 

4.                                      Amendments to Section 5.

 

(a) Section 5.1.  Section 5.1 of the Agreement is hereby deleted and replaced as follows:

 

“5.1  Licensee agrees to keep, and agrees to require each of its Sublicensees to keep, proper records of scientific research and keep books of account in accordance with international financial reporting standards. Such records and books shall include all information necessary for the accurate determination of royalty and other payments owed to Salk. Following launch of any Licensed Product, Licensee, on behalf of itself, its Affiliates and its Sublicensees, agrees to deliver to Salk, within [**] days after each calendar quarter, a report showing the information on which payments herein provided are calculated, including a breakdown of income from sales of each Licensed Product, and to accompany each such report with the payment shown to be due thereby. All amounts accrued for the benefit of Salk shall be deemed held in trust for the benefit of Salk until each payment of such amounts is made pursuant to this Agreement. ”

 

(b) Section 5.4 . Section 5.4 of the Agreement is hereby deleted and replaced as follows:

 

“ 5.4  On reasonable written notice, Salk, at its own expense, shall have the right to have an independent party reasonably acceptable to the Licensee or its Sublicensee, as applicable, inspect and audit the books and records of Licensee, its Affiliates and any Sublicensee at their offices during usual business hours for the sole purpose of, and only to the extent necessary for, determining the correctness of payments due under this Agreement. Such examination with respect to any fiscal year shall not take place later than [**] years following the expiration or termination of this Agreement. The expense of any such audit shall be borne by Salk; provided, however, that if the audit discloses an error in excess of [**] percent ([**]%) in favor of Licensee, then Licensee shall pay, in addition to the amount of any underpayment, the cost to Salk of the audit. ”

 

5.                                      Amendments to Section 6.

 

(a) Section 6.3.  Section 6.3 of the Agreement is hereby deleted and replaced as follows:

 

“6.3    Licensee shall notify Salk of any improvements (including, but not limited to, modified derivatives and variants) to the Biological Materials made by Licensee, its Affiliates, or Sublicensees, irrespective of whether any such improvements were made in collaboration with Salk or any of its employees. At Salk’s request, Licensee shall provide Salk with reasonable quantities of such improvements, and Salk scientists shall have the right to use them for their internal research. Title to all such improvements shall remain with Licensee, its Affiliates or Sublicensees, as applicable. ”

 

6.                                      Amendments to Section 7.

 

Section 7 of the Agreement is hereby deleted and replaced as follows:

 

“ Licensee (for itself and its Affiliates) acknowledges and agrees, and will require any Sublicensees to acknowledge and agree, that Salk is and shall remain (as to Licensee, its Affiliates and any Sublicensees) the owner of the Licensed Patents and Biological Materials,

 

3

 

subject to the rights of the Federal Government as set forth in 35 U.S.C. §200, et seq., and that neither Licensee nor its Affiliates or Sublicensees has any rights in or to the Licensed Patents and Biological Materials other that the rights specifically granted herein. All rights not expressly granted in this Agreement are reserved to Salk. ”

 

7.                                      Amendments to Section 9.

 

(a) Section 9.3(b)(i).  Section 9.3(b)(i) of the Agreement is hereby deleted and replaced as follows:

 

“ (i)    Neither Licensee, its Affiliates or its Sublicensees shall thereby be discharged from any liability or obligation to Salk which became due or payable prior to the effective date of such expiration or termination; and ”

 

(b) Section 9.3(b)(iii). Section 9.3(b)(iii) of the Agreement is hereby deleted and replaced as follows:

 

“(iii)   Licensee shall, and shall ensure that its Affiliates and Sublicensees, promptly return all materials, samples, documents, information, and other materials which embody or disclose Licensed Technology; provided, however, that Licensee, its Affiliates and its Sublicensees shall not be obligated to provide Salk with proprietary information which Licensee, its Affiliate and its Sublicensee, as applicable, can show that it independently developed. Licensee, its Affiliates and its Sublicensees shall be permitted to retain copies of technical information in documentary form obtained from Salk where required to do so by reason of any statute, ordinance or regulation of any federal, state, or local government entity.”

 

(c) Section 9.3(ci).  Section 9.3(c)(i) of the Agreement is hereby deleted and replaced as follows:

 

“(i)     Licensee agrees, and shall require its Affiliates and Sublicensees to agree, not to use Licensed Technology or said technical information after termination of this Agreement. If at termination Licensee, its Affiliates, or Sublicensees then possess Licensed Product, have started the manufacture thereof or have accepted orders therefor, Licensee, its Affiliates, or Sublicensees shall have the right to sell their inventories thereof, complete the manufacture thereof and market such fully manufactured Licensed Product, in order to fulfill such accepted orders, subject to the obligation of Licensee, its Affiliates, and Sublicensees to pay Salk the royalty payments therefor as provided in Paragraph 4 of this Agreement; ”

 

(d) Section 9.3(c)(ii). Section 9.3(c)(ii) of the Agreement is hereby deleted and replaced as follows:

 

“ (ii)  Subject to Paragraph 9.3(c)(i), Licensee shall, and shall require its Affiliates and Sublicensees to, discontinue the manufacture, use, marketing and sale of Licensed Products;”

 

4

 

(e) Section 9.3(c)(iii). Section 9.3(c)(iii) of the Agreement is hereby deleted and replaced as follows:

 

“(iii)  Licensee, on behalf of itself, its Affiliates and its Sublicnesees, shall provide a final report of the type described in Paragraph 5.1, including any allowable post-termination sales; and ”

 

8.                                      Amendments to Section 13.

 

(a) Section 13.3.  Section 13.3 of the Agreement is hereby deleted and replaced as follows:

 

“13.3 IN NO EVENT WILL SALK BE LIABLE TO LICENSEE, ITS AFFILIATES, ITS SUBLICENSEES OR ANY THIRD PARTY FOR ANY CONSEQUENTIAL, INDIRECT, PUNITIVE, EXEMPLARY, SPECIAL, OR INCIDENTAL DAMAGES, INCLUDING ANY LOST PROFITS OR LOSS OF DATA, ARISING FROM OR RELATING TO THIS AGREEMENT OR THE LICENSED TECHNOLOGY. SALK’S TOTAL CUMULATIVE LIABILITY IN CONNECTION WITH THIS AGREEMENT AND THE LICENSED TECHNOLOGY, WHETHER IN CONTRACT OR TORT OR OTHERWISE, WILL NOT EXCEED THE AMOUNTS PAID TO SALK UNDER THIS AGREEMENT WITHIN TWELVE (12) MONTHS PRECEDING THE CLAIM. ”

 

9.                                      Amendments to Section 14.

 

(a) Section 14.1.  Section 14.1 of the Agreement is hereby deleted and replaced as follows:

 

“ 14.1 Licensee agrees to indemnify, hold harmless and defend Salk, its trustees, officers, employees and agents, the sponsors of the research that led to the Licensed Technology, and the inventors of the patents and patent applications included in the Licensed Patents (hereinafter the “Indemnitees”) against any and all liability and/or damages with respect to any claims, suits, demands, judgments or causes of action arising out of (a) the research, development, manufacture, storage, sale or other distribution, or any other use of Licensed Products or Licensed Technology, or exercise of rights granted hereunder, by Licensee, its Affiliates, its Sublicensees, or its distributors, agents or representatives; (b) the use by end-users and other third parties of Licensed Products or Licensed Technology; and/or (c) any representation, warranty or statement by Licensee or its Affiliates, Sublicensees, distributors, agents or representatives, concerning the Indemnitees, the Licensed Technology or Licensed Products. In the event any such claims, demands or actions are made.  Licensee shall defend the Indemnitees at Licensee’s sole expense by counsel selected by Licensee, subject to approval by Salk, which is not to be unreasonably withheld. No settlement, consent judgment or other voluntary final disposition may be entered into without the prior written consent of Salk, which consent shall not be unreasonably withheld.”

 

(b) Section 14.2.  Section 14.2 of the Agreement is hereby deleted and replaced as follows:

 

5

 

“ 14.2  Licensee shall maintain, and shall require its Affiliates and Sublicensees to maintain, continuously and without interruption during the Term (as defined in Section 9.1), comprehensive general liability insurance, including products liability insurance, with reputable and financially secure insurance carriers to cover the activities of Licensee, its Affiliates and its Sublicensees. Such insurance (a) shall include endorsements naming Salk as an additional insured and waiving any right of subrogation against Salk, (b) shall require prior notice to Salk before cancellation, and (c) shall be written to cover claims incurred, discovered, manifested, or made during or after the expiration of this Agreement. Such insurance shall have a minimum limit of [**] dollars ($[**]) per specific occurrence and a minimum limit of [**] dollars ($[**]) for aggregate liability insurance; provided, however, that not less than [**] days before the earlier date upon which Licensee or its Affiliates or Sublicensees (i) initiates testing of Licensed Products in a clinical trial involving human subjects for purposes of diagnosis or treatment, or (ii) makes a commercial sale of any Licensed Product, such coverage shall be increased to a minimum limit of [**] dollars ($[**]) per specific occurrence and a minimum limit of [**] dollars ($[**]) for aggregate liability insurance. Licensee shall maintain insurance as required by this Section 14.2 beyond the expiration or termination of this Agreement during any period that any product, process, or service, relating to, or developed pursuant to, this Agreement is being commercially distributed or sold by Licensee or a Sublicensee, Affiliate or agent of Licensee and thereafter for a period of [**] years. The minimum amounts of insurance coverage required shall not be construed to create a limit of Licensee’s liability with respect to its indemnification under this Agreement. Failure of Licensee to comply with the requirements of this Section 14.2 shall be considered a material breach of the Agreement. ”

 

(c) Section 14.3.  A new Section 14.3 is hereby added to the Agreement as follows:

 

“14.3  Licensee shall furnish a certificate of insurance evidencing primary coverage and additional insured requirements and provide Salk with copies of subsequent annual certificates of insurance. Licensee shall provide Salk with written notice at least [**] days prior to the cancellation, non-renewal or material change in such insurance; if Licensee does not obtain replacement insurance providing comparable coverage within such [**] day period, Salk shall have the right to terminate this Agreement effective at the end of such [**] day period without notice or any additional waiting periods. ”

 

10.                               Amendments to Section 16.  Section 16 of the Agreement is hereby deleted and replaced as follows:

 

“16. To comply with US Government regulations for the licensing of federally funded inventions, Licensee, its Affiliates and its Sublicensees will commit that Licensed Products sold in the US will be manufactured substantially in the US. Notwithstanding the foregoing, if during the term of the License Agreement Licensee, its Affiliates and/or its Sublicensees can provide reasonably compelling evidence to Salk that such manufacture in the US would impose an extraordinary burden on Licensee, its Affiliate or any Sublicensee, Salk shall at that time agree to seek a waiver from the US Government with respect to the requirement that Licensed Products or Licensed Services for sale in the US be manufactured substantially in the US. Licensee understands that Salk cannot

 

6

 

guarantee that such waiver can be obtained. Licensee shall bear all costs associated with seeking such waiver. ”

 

11.                               Schedule A.  Schedule A of the Agreement is hereby deleted and replaced in its entirety by the attached, amended Schedule A.

 

12.                               Miscellaneous.

 

a.                                      Except as specifically amended above, all terms of the Agreement shall remain in full force and effect To the extent that there are any inconsistencies between the terms of the Agreement and the terms of this First Amendment, the terms of this First Amendment shall prevail.

 

b.                                      The parties acknowledge that this First Amendment and the Agreement set forth the entire understanding and intentions of the parties hereto as to the subject matter hereof and supersedes all previous understandings between the parties, written or oral, regarding such subject matter.

 

IN WITNESS WHEREOF, the parties have executed this First Amendment as of the Amendment Date.

 

 

	
 
    	
SALK INSTITUTE   FOR BIOLOGIC STUDIES
    
	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
By
    	
/s/ Paul Roben
    
	
 
    	
 
    	
Name:
    	
Paul Roben
    
	
 
    	
 
    	
Title:
    	
Senior Director,
    
	
 
    	
 
    	
 
    	
Office of Technology   Development
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
LICENSEE
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
By
    	
 
    
	
 
    	
 
    	
Name:
    	
 
    
	
 
    	
 
    	
Title:
    	
 
    

 

7

 

Schedule A

 

PATENT RIGHTS

 

WPRE

 

[**]

 

8Exhibit 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.

 

1

 

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

 

2

 

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

 

3

 

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

 

4

 

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.

 

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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

 

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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.

 

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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
    	
 
    	
 
    

 

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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.

 

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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

 

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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.

 

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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
    	
 
    	
 
    

 

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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
    	
 
    	
 
    

 

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