Document:

Exhibit 10.24

 

uniQure N.V.

 

Share Option Agreement
  Granted Under 2014 Share Incentive Plan

 

1.                                      Grant of Option.

 

This agreement evidences the grant by uniQure N.V., a public limited company incorporated under the laws of the Netherlands (the “Company”), on [·] (the “Grant Date”) to [·] (the “Participant”), of an option to purchase, in whole or in part, on the terms provided herein and in the Company’s 2014 Share Incentive Plan (the “Plan”), a total of [·] ordinary shares, [€0.0·] par value per share, of the Company (“Ordinary Shares”) at [·] per share.  Unless earlier terminated, this option shall expire at 17:00, Central European time, on [·] (the “Final Exercise Date”).

 

It is intended that the option evidenced by this agreement shall not be an incentive stock option as defined in Section 422 of the U.S. Internal Revenue Code of 1986, as amended, and any regulations promulgated thereunder (the “Code”).  Except as otherwise indicated by the context, the term “Participant”, as used in this option, shall be deemed to include any person who acquires the right to exercise this option validly under its terms.

 

2.                                      Vesting Schedule.

 

This option will become exercisable (“vest”) as to 25% of the original number of Ordinary Shares on the first anniversary of the Grant Date and as to an additional 6.25% of the original number of Ordinary Shares at the end of each successive three-month period following the first anniversary of the Grant Date until the fourth anniversary of the Grant Date.

 

The right of exercise shall be cumulative so that to the extent the option is not exercised in any period to the maximum extent permissible it shall continue to be exercisable, in whole or in part, with respect to all Ordinary Shares for which it is vested until the earlier of the Final Exercise Date or the termination of this option under Section 3 hereof or the Plan.

 

3.                                      Exercise of Option.

 

(a)                                 Form of Exercise.  Each election to exercise this option shall be in writing, signed by the Participant, and received by the Company at its principal office, accompanied by this agreement, or by such other method as shall be approved by the Company, in each case together with payment in full in the manner provided in the Plan.  The Participant may purchase less than the number of shares covered hereby, provided that no partial exercise of this option may be for any fractional share or for fewer than ten whole shares.

 

(b)                                 Continuous Relationship with the Company Required.  Except as otherwise provided in this Section 3, this option may not be exercised unless the Participant, at the time he or she exercises this option, is, and has been at all times since the Grant Date, an employee, officer or a director of, or consultant or advisor (as such terms are defined for purposes of Form S-8 under the Securities Act of 1933, as amended) to, the Company or any other entity the

 

 

employees, officers, directors, consultants, or advisors of which are eligible to receive option grants under the Plan (an “Eligible Participant”).

 

(c)                                  Termination of Relationship with the Company.  If the Participant ceases to be an Eligible Participant for any reason, then, except as provided in paragraphs (d) and (e) below, the right to exercise this option shall terminate three months after such cessation (but in no event after the Final Exercise Date), provided that this option shall be exercisable only to the extent that the Participant was entitled to exercise this option on the date of such cessation.  Notwithstanding the foregoing, if the Participant, prior to the Final Exercise Date, violates the non-competition or confidentiality provisions of any employment contract, confidentiality and nondisclosure agreement or other agreement between the Participant and the Company, the right to exercise this option shall terminate immediately upon written notice to the Participant from the Company describing such violation.

 

(d)                                 Exercise Period Upon Death or Disability.  If the Participant dies or becomes disabled (within the meaning of Section 22(e)(3) of the Code) prior to the Final Exercise Date while he or she is an Eligible Participant and the Company has not terminated such relationship for “cause” as specified in paragraph (e) below, this option shall be exercisable, within the period of one year following the date of death or disability of the Participant, by the Participant (or in the case of death by an authorized transferee), provided that this option shall be exercisable only to the extent that this option was exercisable by the Participant on the date of his or her death or disability, and further provided that this option shall not be exercisable after the Final Exercise Date.

 

(e)                                  Termination for Cause.  If, prior to the Final Exercise Date, the Participant’s employment or other relationship with the Company is terminated by the Company for Cause (as defined below), the right to exercise this option shall terminate immediately upon the effective date of such termination of employment or other relationship.  If, prior to the Final Exercise Date, the Participant is given notice by the Company of the termination of his or her employment or other relationship by the Company for Cause, and the effective date of such employment or other termination is subsequent to the date of the delivery of such notice, the right to exercise this option shall be suspended from the time of the delivery of such notice until the earlier of (i) such time as it is determined or otherwise agreed that the Participant’s employment or  other relationship shall not be terminated for Cause as provided in such notice or (ii) the effective date of such termination of employment or other relationship (in which case the right to exercise this option shall, pursuant to the preceding sentence, terminate immediately upon the effective date of such termination of employment or other relationship).  If the Participant is party to an employment, consulting or severance agreement with the Company that contains a definition of “cause” for termination of employment or other relationship, “Cause” shall have the meaning ascribed to such term in such agreement.  Otherwise, “Cause” shall mean willful misconduct by the Participant or willful failure by the Participant to perform his or her responsibilities to the Company (including, without limitation, breach by the Participant of any provision of any employment, consulting, advisory, nondisclosure, non-competition or other similar agreement between the Participant and the Company), as determined by the Company, which determination shall be conclusive.  The Participant’s employment or other relationship shall be considered to have been terminated for “Cause” if the Company determines, within 30 days after the Participant’s resignation, that termination for Cause was warranted.

 

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4.                                      Withholding.

 

No Ordinary Shares will be issued pursuant to the exercise of this option unless and until the Participant pays to the Company, or makes provision satisfactory to the Company for payment of, any national, federal, state and local or other income, national insurance, social and employment taxes required by law to be withheld in respect of this option.

 

5.                                      Transfer Restrictions.

 

(a)                                 This option may not be sold, assigned, transferred, pledged or otherwise encumbered by the Participant, either voluntarily or by operation of law, except by will or the laws of descent and distribution relevant to the Participant, and, during the lifetime of the Participant, this option shall be exercisable only by the Participant.

 

(b)                                 The Participant agrees that he or she will not transfer any Ordinary Shares issued pursuant to the exercise of this option unless the transferee, as a condition to such transfer, delivers to the Company a written instrument confirming that such transferee shall be bound by all of the terms and conditions of Section 4; provided that such a written confirmation shall not be required with respect to Section 4 after the completion of the lock-up period in connection with the Company’s initial underwritten public offering.

 

6.                                      Nature of the Grant.

 

In accepting the option, the Participant acknowledges that:

 

(a)                                 the Plan is established voluntarily by the Company, it provides for certain criteria in order to be eligible to receive an award, it is restricted in time, it is discretionary in nature and it may be modified, amended, suspended or terminated by the Company at any time, unless otherwise provided in the Plan and this agreement;

 

(b)                                 the grant of the option is voluntary and occasional and does not create any contractual or other right to receive future grants of options, or benefits in lieu of options, even if options have been granted repeatedly in the past;

 

(c)                                  all decisions with respect to future option grants, if any, will be at the sole discretion of the Supervisory Board;

 

(d)                                 the Participant is voluntarily participating in the Plan;

 

(e)                                  the options are an extraordinary item that does not constitute compensation of any kind for services of any kind rendered to the Company, and which is outside the scope of the Participant’s employment or consultancy agreement of his or her corporate mandate, if any;

 

(f)                                   the options are not part of normal or expected compensation or salary for any purposes, including, but not limited to, calculation of any severance, resignation, termination, redundancy, end of service payments, bonuses, long-service awards, pension, retirement or welfare benefits or similar payments and in no event should be considered as compensation for, or relating in any way, to past services for the Company;

 

3

 

(g)                                  in the event that the Participant is not an employee of uniQure N.V., the options and the Participant’s participation in the Plan will not be interpreted to form an employment or service contract or relationship with the Company;

 

(h)                                 the future value of the underlying Ordinary Shares is unknown and cannot be predicted with certainty; if the Participant’s options never vest, the Participant will not be able to exercise the options; and

 

(i)                                     in consideration of the options, no claim or entitlement to compensation or damages shall arise from termination of the options or from any decrease in value of the options or Ordinary Shares acquired upon exercise of the options resulting from termination of the Participant’s employment, consultancy or corporate mandate by or with the Company (for any reason whatsoever and whether or not in breach of contract or local laws) and the Participant irrevocably releases the Company from any such claim that may arise.

 

7.                                      Data Privacy.

 

The Participant hereby explicitly and unambiguously consents to the collection, use and transfer, in electronic or other form, of his or her personal data as described in this agreement by and among, as applicable, his or her employer or contracting party and the Company for the exclusive purpose of implementing, administering and managing his or her participation in the Plan.

 

The Participant understands that the Company holds certain personal information about him or her, including, but not limited to, his or her name, home address and telephone number, work location and phone number, date of birth, hire date, details of all options or any other entitlement to Ordinary Shares awarded, cancelled, exercised, vested, unvested or outstanding in the Participant’s favor, for the purpose of implementing, administering and managing the Plan (“Personal Data”).  The Participant understands that Personal Data may be transferred to any third parties assisting in the implementation, administration and management of the Plan, that these recipients may be located in the Participant’s country or elsewhere, and that the recipient’s country may have different data privacy laws and protections than the Participant’s country.  The Participant understands that he or she may request a list with the names and addresses of any potential recipients of the Personal Data by contacting his or her local human resources representative. The Participant authorizes the recipients to receive, possess, use, retain and transfer the Personal Data, in electronic or other form, for the purposes of implementing, administering and managing his or her participation in the Plan, including any requisite transfer of such Personal Data as may be required to a broker or other third party with whom the Participant may elect to deposit any Ordinary Shares acquired upon exercise of the options. The Participant understands that Personal Data will be held only as long as is necessary to implement, administer and manage his or her participation in the Plan.  The Participant understands that he or she may, at any time, view Personal Data, request additional information about the storage and processing of Personal Data, require any necessary amendments to Personal Data or refuse or withdraw the consents herein, in any case without cost, by contacting in writing his or her local human resources representative. The Participant understands, however, that refusing or withdrawing his or her consent may affect his or her ability to participate in the Plan.  For more information on the consequences of Participant’s refusal to consent or withdrawal of consent, the

 

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Participant understands that he or she may contact his or her local human resources representative.

 

8.                                      Provisions of the Plan.

 

This option is subject to the provisions of the Plan (including the provisions relating to amendments to the Plan), a copy of which is furnished to the Participant with this option.

 

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The Company has caused this option to be executed by its duly authorized officer.

 

 

	
 
    	
UNIQURE   N.V.
    
	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
By:
    	
 
    
	
 
    	
Name:
    	
 
    
	
 
    	
Title:
    	
 
    

 

 

PARTICIPANT’S ACCEPTANCE

 

The undersigned hereby accepts the foregoing option and agrees to the terms and conditions thereof.  The undersigned hereby acknowledges receipt of a copy of the Company’s 2014 Share Incentive Plan.

 

 

	
 
    	
PARTICIPANT
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
Name:
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
Address:
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
 
    

 

7Exhibit 10.32

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

Execution Copy
 CONFIDENTIAL

 

COLLABORATION AND LICENSE AGREEMENT

 

BY AND BETWEEN

 

4D MOLECULAR THERAPEUTICS, LLC

 

AND

 

UNIQURE BIOPHARMA B.V.

 

JANUARY 17, 2014

 

 

TABLE OF CONTENTS

 

	
 
    	
 
    	
Page
    
	
ARTICLE I
    	
DEFINITIONS
    	
1
    
	
 
    	
1.1
    	
“4DMT AAV Capsid Variant”
    	
1
    
	
 
    	
1.2
    	
“4DMT   AAV Capsid Variant Library”
    	
2
    
	
 
    	
1.3
    	
“4DMT   Intellectual Property”
    	
2
    
	
 
    	
1.4
    	
“4DMT   Know-How”
    	
2
    
	
 
    	
1.5
    	
“4DMT   Patent Right”
    	
2
    
	
 
    	
1.6
    	
“AAV”
    	
2
    
	
 
    	
1.7
    	
“AAV   Capsid Variant”
    	
2
    
	
 
    	
1.8
    	
“AAV   Capsid Variant Library”
    	
2
    
	
 
    	
1.9
    	
“Accounting   Standards”
    	
2
    
	
 
    	
1.10
    	
“Affiliate”
    	
2
    
	
 
    	
1.11
    	
“Animal   POC”
    	
3
    
	
 
    	
1.12
    	
“Business   Day”
    	
3
    
	
 
    	
1.13
    	
“Calendar   Quarter”
    	
3
    
	
 
    	
1.14
    	
“Calendar   Year”
    	
3
    
	
 
    	
1.15
    	
“Candidate   Success Criteria”
    	
3
    
	
 
    	
1.16
    	
“CEO”
    	
3
    
	
 
    	
1.17
    	
“Clinical   Trial(s)”
    	
3
    
	
 
    	
1.18
    	
“Clinical   POC”
    	
3
    
	
 
    	
1.19
    	
“Commercially   Reasonable Efforts”
    	
3
    
	
 
    	
1.20
    	
“Commercialization”   or “Commercialize”
    	
4
    
	
 
    	
1.21
    	
“Compound”
    	
4
    
	
 
    	
1.22
    	
“Confidential   Information”
    	
4
    
	
 
    	
1.23
    	
“Control”
    	
4
    
	
 
    	
1.24
    	
“Core   4DMT Intellectual Property”
    	
4
    
	
 
    	
1.25
    	
“Core   4DMT Know-How”
    	
4
    
	
 
    	
1.26
    	
“Core   4DMT Patent Right”
    	
4
    
	
 
    	
1.27
    	
“Core   uniQure Intellectual Property”
    	
4
    
	
 
    	
1.28
    	
“Core   uniQure Know-How”
    	
4
    
	
 
    	
1.29
    	
“Core   uniQure Patent Right”
    	
4
    
	
 
    	
1.30
    	
“Cover”,   “Covering” or “Covered”
    	
5
    
	
 
    	
1.31
    	
“Default”
    	
5
    
	
 
    	
1.32
    	
“Delivery   Success Criteria”
    	
5
    
	
 
    	
1.33
    	
“Development”   or “Develop”
    	
5
    
	
 
    	
1.34
    	
“EMA”
    	
5
    
	
 
    	
1.35
    	
“European   Union” or “EU”
    	
5
    
	
 
    	
1.36
    	
“FDA”   or “Food and Drug Administration”
    	
5
    
	
 
    	
1.37
    	
“Field”
    	
5
    
	
 
    	
1.38
    	
“First   Commercial Sale”
    	
5
    
	
 
    	
1.39
    	
“FTE”
    	
6
    
	
 
    	
1.40
    	
“FTE   Costs”
    	
6
    
	
 
    	
1.41
    	
“FTE   Rate”
    	
6
    

 

i

 

	
 
    	
1.42
    	
“Fully   Burdened Manufacturing Cost”
    	
6
    
	
 
    	
1.43
    	
“Gene   Therapy Construct”
    	
6
    
	
 
    	
1.44
    	
“GLP   Tox Compound”
    	
6
    
	
 
    	
1.45
    	
“GLP   Tox Study”
    	
6
    
	
 
    	
1.46
    	
“Good   Laboratory Practices”
    	
6
    
	
 
    	
1.47
    	
“Governmental   Authority”
    	
7
    
	
 
    	
1.48
    	
“Grant   Letter”
    	
7
    
	
 
    	
1.49
    	
“IGT”
    	
7
    
	
 
    	
1.50
    	
“Indication”
    	
7
    
	
 
    	
1.51
    	
“Initial   Research Term”
    	
7
    
	
 
    	
1.52
    	
“Initiation”
    	
7
    
	
 
    	
1.53
    	
“Invention”
    	
7
    
	
 
    	
1.54
    	
“Invoice”
    	
7
    
	
 
    	
1.55
    	
“Know-How”
    	
7
    
	
 
    	
1.56
    	
“Law”
    	
8
    
	
 
    	
1.57
    	
“Lead   Optimization”
    	
8
    
	
 
    	
1.58
    	
“Licensed   IP”
    	
8
    
	
 
    	
1.59
    	
“Materials”
    	
8
    
	
 
    	
1.60
    	
“NDA”
    	
8
    
	
 
    	
1.61
    	
“Net   Sales”
    	
8
    
	
 
    	
1.62
    	
“Party”   and “Parties”
    	
9
    
	
 
    	
1.63
    	
“Patent   Rights”
    	
9
    
	
 
    	
1.64
    	
“Phase   I Study”
    	
9
    
	
 
    	
1.65
    	
“Phase   III Study”
    	
9
    
	
 
    	
1.66
    	
“Pivotal   Study”
    	
10
    
	
 
    	
1.67
    	
“Pre-agreed”
    	
10
    
	
 
    	
1.68
    	
“Prior   Confidentiality Agreement”
    	
10
    
	
 
    	
1.69
    	
“Product”
    	
10
    
	
 
    	
1.70
    	
“Project   Team”
    	
10
    
	
 
    	
1.71
    	
“Prosecution   and Maintenance”
    	
10
    
	
 
    	
1.72
    	
“Regulatory   Approval”
    	
10
    
	
 
    	
1.73
    	
“Regulatory   Authority”
    	
10
    
	
 
    	
1.74
    	
“Research   Compound”
    	
11
    
	
 
    	
1.75
    	
“Research   Plan”
    	
11
    
	
 
    	
1.76
    	
“Research   Program”
    	
11
    
	
 
    	
1.77
    	
“Research   Selection Process”
    	
11
    
	
 
    	
1.78
    	
“Research   Term”
    	
11
    
	
 
    	
1.79
    	
“Research   Year”
    	
11
    
	
 
    	
1.80
    	
“Royalty   Bearing Compound”
    	
11
    
	
 
    	
1.81
    	
“Royalty   Bearing Product”
    	
11
    
	
 
    	
1.82
    	
“Royalty   Term”
    	
11
    
	
 
    	
1.83
    	
“Selected   Capsid Variant”
    	
12
    
	
 
    	
1.84
    	
“Selection   Process”
    	
12
    
	
 
    	
1.85
    	
“Sublicensee”
    	
12
    
	
 
    	
1.86
    	
“Territory”
    	
12
    
	
 
    	
1.87
    	
“Third   Party”
    	
12
    

 

ii

 

	
 
    	
1.88
    	
“Third   Party Distributor”
    	
12
    
	
 
    	
1.89
    	
“UC   AAV Capsid Variant”
    	
12
    
	
 
    	
1.90
    	
“UC   Patent Right”
    	
12
    
	
 
    	
1.91
    	
“UC   Product”
    	
12
    
	
 
    	
1.92
    	
“UCB   Agreements”
    	
12
    
	
 
    	
1.93
    	
“uniQure   Intellectual Property”
    	
13
    
	
 
    	
1.94
    	
“uniQure   Know-How”
    	
13
    
	
 
    	
1.95
    	
“uniQure   Patent Right”
    	
13
    
	
 
    	
1.96
    	
“Valid   Claim”
    	
13
    
	
 
    	
1.97
    	
Additional   Definitions
    	
13
    
	
 
    	
 
    	
 
    	
 
    
	
ARTICLE II
    	
GOVERNANCE
    	
15
    
	
 
    	
2.1
    	
Project Leaders
    	
15
    
	
 
    	
2.2
    	
Joint   Research Steering Committee
    	
15
    
	
 
    	
2.3
    	
Subcommittees
    	
16
    
	
 
    	
2.4
    	
Meetings
    	
16
    
	
 
    	
2.5
    	
Decision-making
    	
16
    
	
 
    	
2.6
    	
Limitations   on JRSC Authority
    	
18
    
	
 
    	
 
    	
 
    	
 
    
	
ARTICLE III
    	
RESEARCH PROGRAM
    	
18
    
	
 
    	
3.1
    	
General
    	
18
    
	
 
    	
3.2
    	
Conduct   of the Research Program
    	
19
    
	
 
    	
3.3
    	
Candidate   Success Criteria
    	
19
    
	
 
    	
3.4
    	
Selection   of AAV Capsid Variants
    	
21
    
	
 
    	
3.5
    	
Materials   and Know-How Transfer/Use of Compounds
    	
21
    
	
 
    	
3.6
    	
Third   Party Intellectual Property
    	
22
    
	
 
    	
3.7
    	
Records   and Reports
    	
22
    
	
 
    	
 
    	
 
    	
 
    
	
ARTICLE IV
    	
DEVELOPMENT AND   COMMERCIALIZATION OF PRODUCTS; DILIGENCE
    	
23
    
	
 
    	
4.1
    	
Responsibility
    	
23
    
	
 
    	
4.2
    	
Diligence
    	
23
    
	
 
    	
4.3
    	
Progress   Reports
    	
23
    
	
 
    	
4.4
    	
Proposed   Products in the Field
    	
24
    
	
 
    	
4.5
    	
Pharmacovigilance
    	
25
    
	
 
    	
4.6
    	
Marking
    	
26
    
	
 
    	
 
    	
 
    	
 
    
	
ARTICLE V
    	
GRANTS OF RIGHTS
    	
26
    
	
 
    	
5.1
    	
Licenses to uniQure
    	
26
    
	
 
    	
5.2
    	
Licenses   to 4DMT
    	
27
    
	
 
    	
5.3
    	
Sublicenses
    	
28
    
	
 
    	
5.4
    	
Rights   Retained by the Parties
    	
28
    
	
 
    	
5.5
    	
Section 365(n) of   the Bankruptcy Code
    	
28
    
	
 
    	
5.6
    	
Exclusivity
    	
28
    
	
 
    	
5.7
    	
UCB   Agreement Pass-Through Provisions
    	
29
    

 

iii

 

	
ARTICLE VI
    	
PAYMENTS; ROYALTIES AND   REPORTS
    	
31
    
	
 
    	
6.1
    	
Initial License Payment
    	
31
    
	
 
    	
6.2
    	
Research   Program Funding
    	
31
    
	
 
    	
6.3
    	
Research   and Development Milestone Payments
    	
32
    
	
 
    	
6.4
    	
Royalties
    	
34
    
	
 
    	
6.5
    	
Sublicense   Consideration
    	
35
    
	
 
    	
6.6
    	
Reports;   Payments
    	
36
    
	
 
    	
6.7
    	
Books   and Records; Audit Rights
    	
36
    
	
 
    	
6.8
    	
Withholding   Taxes
    	
37
    
	
 
    	
6.9
    	
United   States Dollars
    	
37
    
	
 
    	
6.10
    	
Payment   Method and Currency Conversion
    	
37
    
	
 
    	
6.11
    	
Blocked   Payments
    	
37
    
	
 
    	
6.12
    	
Late   Payments
    	
38
    
	
 
    	
 
    	
 
    	
 
    
	
ARTICLE VII
    	
PATENTS
    	
38
    
	
 
    	
7.1
    	
Disclosure
    	
38
    
	
 
    	
7.2
    	
Ownership
    	
38
    
	
 
    	
7.3
    	
uniQure   Prosecution and Maintenance of Patent Rights
    	
39
    
	
 
    	
7.4
    	
4DMT   Prosecution and Maintenance of Patent Rights
    	
39
    
	
 
    	
7.5
    	
Prosecution   and Maintenance of Joint Patent Rights
    	
40
    
	
 
    	
7.6
    	
Third   Party Infringement
    	
41
    
	
 
    	
7.7
    	
Patent   Invalidity Claim
    	
43
    
	
 
    	
7.8
    	
Patent   Term Extensions
    	
43
    
	
 
    	
7.9
    	
Orange   Book; Paragraph IV Certification
    	
43
    
	
 
    	
7.10
    	
CREATE   Act
    	
44
    
	
 
    	
 
    	
 
    	
 
    
	
ARTICLE VIII
    	
CONFIDENTIALITY AND   PUBLICATION
    	
45
    
	
 
    	
8.1
    	
Confidentiality Obligations
    	
45
    
	
 
    	
8.2
    	
Exceptions   to Confidentiality
    	
45
    
	
 
    	
8.3
    	
Authorized   Disclosure
    	
45
    
	
 
    	
8.4
    	
Scientific   Publications
    	
46
    
	
 
    	
8.5
    	
Press   Releases and Other Permitted Disclosures
    	
47
    
	
 
    	
 
    	
 
    	
 
    
	
ARTICLE IX
    	
REPRESENTATIONS AND   WARRANTIES; INDEMNIFICATION
    	
48
    
	
 
    	
9.1
    	
Representations and Warranties of the Parties
    	
48
    
	
 
    	
9.2
    	
Representations   and Warranties of 4DMT
    	
49
    
	
 
    	
9.3
    	
Representations   and Warranties of uniQure
    	
50
    
	
 
    	
9.4
    	
No   Other Warranties
    	
50
    
	
 
    	
9.5
    	
Indemnification   by uniQure
    	
51
    
	
 
    	
9.6
    	
Indemnification   by 4DMT
    	
51
    
	
 
    	
9.7
    	
Procedure
    	
52
    
	
 
    	
9.8
    	
uniQure   Indemnity to UC
    	
52
    
	
 
    	
9.9
    	
Insurance
    	
52
    
	
 
    	
9.10
    	
No   Consequential or Punitive Damages
    	
54
    

 

iv

 

	
ARTICLE X
    	
TERM AND TERMINATION
    	
54
    
	
 
    	
10.1
    	
Term and Expiration
    	
54
    
	
 
    	
10.2
    	
Termination
    	
54
    
	
 
    	
10.3
    	
Effect   of Termination
    	
56
    
	
 
    	
10.4
    	
Effect   of Expiration or Termination; Survival
    	
58
    
	
 
    	
 
    	
 
    	
 
    
	
ARTICLE XI
    	
DISPUTE RESOLUTION
    	
58
    
	
 
    	
11.1
    	
Seeking Consensus
    	
58
    
	
 
    	
11.2
    	
Arbitration
    	
58
    
	
 
    	
 
    	
 
    	
 
    
	
ARTICLE XII
    	
MISCELLANEOUS
    	
60
    
	
 
    	
12.1
    	
Governing Law
    	
60
    
	
 
    	
12.2
    	
Waiver
    	
60
    
	
 
    	
12.3
    	
Notices
    	
60
    
	
 
    	
12.4
    	
Entire   Agreement; Amendment
    	
61
    
	
 
    	
12.5
    	
Headings
    	
61
    
	
 
    	
12.6
    	
Severability
    	
61
    
	
 
    	
12.7
    	
Assignment
    	
61
    
	
 
    	
12.8
    	
Counterparts
    	
62
    
	
 
    	
12.9
    	
Force   Majeure
    	
62
    
	
 
    	
12.10
    	
Third   Party Beneficiaries
    	
62
    
	
 
    	
12.11
    	
Relationship   of the Parties
    	
62
    
	
 
    	
12.12
    	
Performance   by Affiliates
    	
63
    
	
 
    	
12.13
    	
Construction
    	
63
    

 

List of Schedules

 

	
Exhibit A
    	
Commitment   Letter from uniQure B.V.
    
	
Schedule 1.5
    	
4DMT   Patent Rights
    
	
Schedule 1.41
    	
Outline   of Budget for Research Plan
    
	
Schedule 1.54
    	
Draft   Invoice
    
	
Schedule 1.75
    	
Outline   of Research Plan
    

 

v

 

COLLABORATION AND LICENSE AGREEMENT

 

This Collaboration and License Agreement (this “Agreement”) is entered into as of January 17, 2014 (the “Effective Date”), by and between 4D Molecular Therapeutics, LLC, a limited liability company organized and existing under the laws of the State of Delaware and having a principal office located at 19 Rima Court, Danville, CA 94526 (“4DMT”), and uniQure biopharma B.V., a corporation organized and existing under the laws of The Netherlands and having a principal office located at Meibergdreef 61, 1105 BA Amsterdam, The Netherlands (“uniQure”).

 

INTRODUCTION

 

1.                                      4DMT is a biopharmaceutical company focused on discovering and developing novel adeno-associated viral vectors for delivery of nucleic acids to target cells.

 

2.                                      uniQure is a biopharmaceutical company focused on the research, development, manufacturing and marketing of gene therapy based biopharmaceutical products.

 

3.                                      4DMT and uniQure desire to conduct a research collaboration to identify improved AAV Capsid Variants (as defined below).

 

4.                                      As of even date herewith, uniQure B.V., an Affiliate of uniQure, has executed and delivered to 4DMT a commitment letter in the form set forth in Exhibit A.

 

5.                                      uniQure desires to receive from 4DMT exclusive rights under 4DMT’s intellectual property rights to research (subject to 4DMT’s retained rights to conduct research under the Research Program), Develop, manufacture and Commercialize Selected Capsid Variants, Royalty Bearing Compounds and Royalty Bearing Products in the Field (each as defined below) pursuant to this Agreement.

 

NOW, THEREFORE, in consideration of the mutual covenants contained herein, and other good and valuable consideration, the receipt of which is hereby acknowledged, 4DMT and uniQure agree as follows effective as of the Effective Date:

 

ARTICLE I

 

DEFINITIONS

 

Unless specifically set forth to the contrary herein, the following terms, whether used in the singular or plural, shall have the respective meanings set forth below:

 

1.1                               “4DMT AAV Capsid Variant”.  4DMT Capsid Variant means any AAV Capsid Variant that does not carry a Gene Therapy Construct contained in a Royalty Bearing Compound or Royalty Bearing Product.

 

 

1.2                               “4DMT AAV Capsid Variant Library”.  4DMT AAV Capsid Variant Library means any AAV Capsid Variant Library constructed by or licensed to 4DMT, including all AAV Capsid Variant Libraries provided to 4DMT pursuant to the UCB Agreements.

 

1.3                               “4DMT Intellectual Property”.  4DMT Intellectual Property means the 4DMT Know-How and the 4DMT Patent Rights.

 

1.4                               “4DMT Know-How”.  4DMT Know-How means Know-How that is (a) Controlled by 4DMT or its Affiliates as of the Effective Date or during the Research Term, and (b) necessary or useful to conduct the Research Program or to research, Develop, make and have made, use or Commercialize the relevant Selected Capsid Variant, Royalty Bearing Compound or Royalty Bearing Product.  4DMT Know-How includes Core 4DMT Know-How but does not include Joint Know-How.

 

1.5                               “4DMT Patent Right”.  4DMT Patent Right means any Patent Right Controlled by 4DMT or its Affiliates as of the Effective Date or during the Term that Covers 4DMT Know-How.  Schedule 1.5 lists the 4DMT Patent Rights existing as of the Effective Date.  4DMT Patent Rights include Core 4DMT Patent Rights but do not include Joint Patent Rights.

 

1.6                               “AAV”.  AAV means adeno-associated virus.

 

1.7                               “AAV Capsid Variant”.  AAV Capsid Variant means an AAV capsid that is modified as compared to the wild type sequence.

 

1.8                               “AAV Capsid Variant Library”.  AAV Capsid Variant Library means a collection of variant AAV capsid open reading frames inserted into an AAV genome in a manner that renders such variants genome replication-competent with the appropriate helper virus functions and capable of being selected and evolved to optimize their ability to deliver nucleic acid sequences to human or animal cells.

 

1.9                               “Accounting Standards”.  Accounting Standards means, with respect to uniQure and its Affiliates, International Financial Reporting Standards (“IFRS”) or, to the extent applicable, generally accepted accounting principles as practiced in the United States (“GAAP”), and with respect to 4DMT and its Affiliates, GAAP, in each case as they exist from time to time, consistently applied.

 

1.10                        “Affiliate”.  Affiliate means, with respect to a Party, any entity that directly or indirectly controls, is controlled by, or is under common control with such Party.  As used in this definition, the term “control” means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of an entity, whether through ownership of voting securities, by contract or otherwise.  For purposes of this definition, “control” shall be presumed to exist if one of the following conditions are met: (a) in the case of corporate entities, direct or indirect ownership of more than fifty percent (50%) of the stock or shares having the right to vote for the election of directors, and (b) in the case of non-corporate entities, direct or indirect ownership of more than fifty percent (50%) of the equity interest with the power to direct the management and policies of such non-corporate entities.

 

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1.11                        “Animal POC”.  Animal POC means demonstration of safety and a Pre-agreed level of therapeutic efficacy, including a change in the levels of a Pre-agreed disease relevant biomarker in some cases as a substitute for therapeutic efficacy, in a Pre-agreed animal model.

 

1.12                        “Business Day”.  Business Day means a day that is not a Saturday, Sunday or a day on which banking institutions in New York, New York, USA or Amsterdam, The Netherlands are authorized by Law to remain closed.

 

1.13                        “Calendar Quarter”.  Calendar Quarter means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31; provided, however, that the first Calendar Quarter hereunder shall commence on the Effective Date and the final Calendar Quarter hereunder shall end on the effective date of termination or expiration of this Agreement.

 

1.14                        “Calendar Year”.  Calendar Year means each successive period of twelve (12) months commencing on January 1 and ending on December 31; provided, however, that the first Calendar Year hereunder shall commence on the Effective Date and the final Calendar Quarter hereunder shall end on the effective date of termination or expiration of this Agreement.

 

1.15                        “Candidate Success Criteria”.  Candidate Success Criteria means the criteria that an AAV Capsid Variant identified through a Research Selection Process (or any Research Compound containing such AAV Capsid Variant) must meet before it progresses to the next stage of the Research Program, as determined and approved by the JRSC, and as further described in Section 3.3(a).

 

1.16                        “CEO”.  CEO means the Chief Executive Officer of a Party or, if there is no Chief Executive Officer of a Party, the Board Chairperson or senior-most executive officer or equivalent of such Party.

 

1.17                        “Clinical Trial(s)”.  Clinical Trial(s) means a Phase I Study, a Phase II clinical study, a Pivotal Study or a Phase III Study.

 

1.18                        “Clinical POC”.  Clinical POC means demonstration of safety and a Pre-agreed level of therapeutic efficacy, including a change in the levels of a Pre-agreed disease relevant biomarker in some cases as a substitute for therapeutic efficacy, in a Pre-agreed number of human patients.

 

1.19                        “Commercially Reasonable Efforts”.  Commercially Reasonable Efforts means, with respect to a Party, the efforts required in order to carry out a task in a diligent and sustained manner without undue interruption or delay, which level is at least commensurate with the level of effort that a similarly situated Third Party would devote to a product of similar market potential and having similar commercial and scientific advantages and disadvantages resulting from its own research efforts or to which it has rights, taking into account its safety and efficacy, regulatory status, the competitiveness of the marketplace, its proprietary position, pricing, reimbursement, launching strategy and other market-specific factors, and all other relevant factors.

 

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1.20                        “Commercialization” or “Commercialize”.  Commercialization or Commercialize means any activity directed to obtaining pricing or reimbursement approvals, marketing, promoting, distributing, importing, exporting, offering to sell or selling a product, or to have any such activity performed.  When used as a verb, “Commercialize” means to engage in Commercialization.

 

1.21                        “Compound”.  Compound means an AAV Capsid Variant carrying a Gene Therapy Construct.

 

1.22                        “Confidential Information”.  Confidential Information means any and all information and data, including all uniQure Know-How, 4DMT Know-How and Joint Know-How, and all other scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, financial and commercial information or data, whether communicated in writing or orally or by any other method, which is provided by one Party to the other Party in connection with this Agreement or the Prior Confidentiality Agreement.  All Core uniQure Know-How shall be considered the Confidential Information of uniQure, with respect to which: (a) uniQure shall be considered the disclosing Party, (b) 4DMT shall be considered the receiving Party, and (c) clauses (b) and (e) of Section 8.2 shall not apply.  All Core 4DMT Know-How shall be considered the Confidential Information of 4DMT, with respect to which: (i) 4DMT shall be considered the disclosing Party, (ii) uniQure shall be considered the receiving Party, and (iii) clauses (b) and (e) of Section 8.2 shall not apply.

 

1.23                        “Control”.  Control means, with respect to any item of or right under Patent Rights or Know-How, the possession (whether by ownership or license, other than a license pursuant to this Agreement) of the ability of a Party or, as applicable, its Affiliate (subject to Section 12.7), to grant access to, or a license or sublicense of, such items or right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party existing at the time such Party would be required hereunder to grant the other Party such access or license or sublicense.

 

1.24                        “Core 4DMT Intellectual Property”.  Core 4DMT Intellectual Property means Core 4DMT Know-How and Core 4DMT Patent Rights.

 

1.25                        “Core 4DMT Know-How”.  Core 4DMT Know-How means any Know-How [**].

 

1.26                        “Core 4DMT Patent Right”.  Core 4DMT Patent Right means any Patent Right that Covers the Core 4DMT Know-How.

 

1.27                        “Core uniQure Intellectual Property”.  Core uniQure Intellectual Property means Core uniQure Know-How and Core uniQure Patent Rights.

 

1.28                        “Core uniQure Know-How”.  Core uniQure Know-How means any Know-How [**].

 

1.29                        “Core uniQure Patent Right”.  Core uniQure Patent Right means any Patent Right that Covers the Core uniQure Know-How.

 

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1.30                        “Cover”, “Covering” or “Covered”.  Cover, Covering or Covered means, with respect to a product, technology, process or method that, in the absence of ownership of or a license granted under a Valid Claim, the manufacture, use, offer for sale, sale or importation of such product or the practice of such technology, process or method would infringe such Valid Claim (or, in the case of a Valid Claim that has not yet issued, would infringe such Valid Claim if it were to issue).

 

1.31                        “Default”.  Default means with respect to a Party that (a) any representation or warranty of such Party set forth herein shall have been untrue in any material respect when made or (b) such Party shall have failed to perform any material obligation set forth in this Agreement.

 

1.32                        “Delivery Success Criteria”.  Delivery Success Criteria means the following criteria that determines whether an AAV Capsid Variant demonstrates improved delivery or function of a Gene Therapy Construct:  [**].

 

1.33                        “Development” or “Develop”.  Development or Develop means pre-clinical and clinical drug development activities, including:  test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, development-stage manufacturing, quality assurance/quality control procedure development and performance with respect to clinical materials, statistical analysis and report writing and clinical studies, regulatory affairs, and all other pre-Regulatory Approval activities.  When used as a verb, “Develop” means to engage in Development.

 

1.34                        “EMA”.  EMA means the European Medicines Agency, or any successor agency.

 

1.35                        “European Union” or “EU”.  European Union or EU means the countries that are members of the European Union, as redefined from time to time.

 

1.36                        “FDA” or “Food and Drug Administration”.  FDA or Food and Drug Administration means the United States Food and Drug Administration, or any successor agency.

 

1.37                        “Field”.  Field means the delivery of Gene Therapy Constructs to cells in (a) the central nervous system (“CNS”) or (b) the liver, in each case where such delivery is for the purpose of effecting expression of the applicable RNA or amino acid sequence in the targeted cells and is potentially useful for the diagnosis, treatment, palliation or prevention of a disease or medical condition in humans or animals, irrespective of the administration site or mode of administration (e.g., intravenous, direct injection, subcutaneous or intrathecal) of the Compound used to effect delivery.  For clarity, intravenous administration of any Compound targeted to cells in other organs (i.e., not specifically targeted to liver or CNS tissues), including for treatment of neoplastic and eye disorders, is excluded from the Field.

 

1.38                        “First Commercial Sale”.  First Commercial Sale means, with respect to any Royalty Bearing Product and a country, the first sale for end use or consumption of such Royalty Bearing Product in such country after all required approvals, including Regulatory Approval, have been granted by the Regulatory Authority of such country.  For clarity, sales for

 

5

 

test marketing, sampling and promotional uses, clinical trials purposes or compassionate use shall not constitute a First Commercial Sale.

 

1.39                        “FTE”.  FTE means [**] hours of work devoted to or in support directly of the Research Program that is carried out by one or more qualified scientific or technical employees of 4DMT or its Affiliates, measured in accordance with 4DMT’s normal time allocation practices from time to time.  Overtime, and work on weekends, holidays and the like, shall not be counted with any multiplier (e.g., time-and-a-half or double time) toward the number of hours that are used to calculate the FTE contribution.  The portion of an FTE billable for one (1) individual during a Calendar Quarter shall be determined by dividing the number of hours worked directly by said individual on the Research Program during such Calendar Quarter by [**] hours.

 

1.40                        “FTE Costs”.  FTE Costs means, for any Calendar Quarter, the number of FTEs multiplied by the FTE Rate.

 

1.41                        “FTE Rate”.  FTE Rate means the amount for each FTE as set forth in Schedule 1.41.

 

1.42                        “Fully Burdened Manufacturing Cost”.  Fully Burdened Manufacturing Cost means, as applicable to a Royalty Bearing Product, the cost of manufacturing such Royalty Bearing Product, which is equal to the sum of (a) for such Royalty Bearing Product (or components thereof), the costs of all direct material, direct labor and allocable manufacturing overhead consumed, provided, or procured by a Party, in each case for the manufacture of such Royalty Bearing Product, and (b) for such Royalty Bearing Product (or components thereof) made by a Third Party, the out-of-pocket costs paid to such Third Party by a Party; in each case (a) and (b) to the extent such costs are incurred by a Party or its Affiliates and to the extent such costs are reasonably allocable to the manufacture of such Royalty Bearing Product.  For clarity, Fully Burdened Manufacturing Cost excludes costs of excess capacity.  Fully Burdened Manufacturing Cost shall be calculated in a manner consistent with Accounting Standards.

 

1.43                        “Gene Therapy Construct”.  Gene Therapy Construct means any nucleic acid sequence that encodes an RNA or an amino acid sequence that is intended to be delivered to a targeted tissue to treat, prevent or ameliorate a disease or condition.

 

1.44                        “GLP Tox Compound”.  GLP Tox Compound means a Research Compound that uniQure, in its sole discretion, elects to progress to GLP Tox Studies to be conducted by or on behalf of uniQure in accordance with Section 3.3(a).

 

1.45                        “GLP Tox Study”.  GLP Tox Study means a formal toxicology study of a Research Compound conducted under Good Laboratory Practices that is required to obtain approval from a regulatory authority, whether the FDA or otherwise, to begin conducting Clinical Trials.

 

1.46                        “Good Laboratory Practices”.  Good Laboratory Practices means the then-current good laboratory practice standards promulgated or endorsed by the FDA, as defined in 21

 

6

 

C.F.R. Part 58 (or such other comparable regulatory standards in jurisdictions outside the U.S. to the extent applicable to the relevant study, as they may be updated from time to time).

 

1.47                        “Governmental Authority”.  Governmental Authority means any United States federal, state or local or any foreign government, or political subdivision thereof, or any multinational organization or authority or any authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof), or any governmental arbitrator or arbitral body.

 

1.48                        “Grant Letter”.  Grant Letter means each of the Option Agreements, dated as of even date herewith, by and between uniQure’s Affiliate, uniQure B.V., and (a) in the first case, Dr. David Schaffer and (b) in the second case, Dr. David Kirn.

 

1.49                        “IGT”.  IGT means Integrative Gene Therapeutics, Inc., a California corporation, which jointly owns with UC certain of the UC Patent Rights.

 

1.50                        “Indication”.  Indication means any disease, condition or syndrome.

 

1.51                        “Initial Research Term”.  Initial Research Term means the period commencing on the Effective Date and ending on the [**] anniversary thereof.

 

1.52                        “Initiation”.  Initiation means, with respect to a Clinical Trial, the first dosing of a participant in such Clinical Trial.

 

1.53                        “Invention”.  Invention means any new and useful process, article of manufacture, compound, composition of matter, formulation or apparatus, or any improvement thereof, discovery or finding, which is patentable.

 

1.54                        “Invoice”.  Invoice means an original invoice sent by 4DMT to uniQure with respect to any payment due hereunder substantially in the form attached hereto as Schedule 1.54.

 

1.55                        “Know-How”.  Know-How means (a) any scientific or technical information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, that is not in the public domain, including databases, practices, methods, techniques, specifications, formulations, formulae, protein sequences, nucleic acid sequences, AAV Capsid Variants, AAV Capsid Variant Libraries, Gene Therapy Constructs, Compounds, knowledge, know-how, trade secrets, skill, experience, test data including pharmacological, medicinal chemistry, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, and manufacturing process and development information, results and data, and (b) any biological, chemical, or physical material or composition of matter that is not in the public domain or otherwise generally available to the public.

 

7

 

1.56                        “Law”.  Law means all laws, statutes, rules, codes, regulations, orders, judgments or ordinances applicable to a Party, this Agreement or the activities contemplated hereunder.

 

1.57                        “Lead Optimization”.  Lead Optimization means the discovery phase dedicated to the evaluation of new AAV Capsid Variants derived from an AAV Capsid Variant Library following a Research Selection Process to identify one or more Research Compounds that meet Delivery Success Criteria.

 

1.58                        “Licensed IP”.  Licensed IP means the 4DMT Intellectual Property, Core uniQure Intellectual Property, and Joint Intellectual Property.

 

1.59                        “Materials”.  Materials means any tangible chemical or biological research materials that are provided or otherwise made available by one Party to the other Party under the terms of Section 3.4 for use in performance of the Research Program; provided, however, that Materials will not include any AAV Capsid Variants or AAV Capsid Variant Libraries.

 

1.60                        “NDA”.  NDA means a New Drug Application or Biologics License Application filed with the FDA or any other application required for the purpose of marketing or selling or commercially using a therapeutic or prophylactic product to be filed with a Regulatory Authority in a non-U.S. country or group of countries, including a Product License Application or Marketing Authorization Application (“MAA”) in the European Union or Japan.

 

1.61                        “Net Sales”.  Net Sales means, with respect to a Royalty Bearing Product, the gross amount of sales of such Royalty Bearing Product invoiced by uniQure or its Affiliates to Third Parties, less the following to the extent related to such Royalty Bearing Product and incurred by such uniQure or its Affiliates and invoiced to the Third Party:

 

(a)                                 sales returns and allowances actually paid, granted or accrued, including trade, quantity and cash discounts and any other adjustments, including those granted on account of price adjustments or billing errors;

 

(b)                                 rejected goods, damaged or defective goods, recalls, returns;

 

(c)                                  rebates, chargeback rebates, compulsory rebates, reimbursements or similar payments granted or given to wholesalers or other distributors, buying groups or health care insurance carriers;

 

(d)                                 non-collectable receivables;

 

(e)                                  customs or excise duties, sales tax, consumption tax, value added tax, and other taxes (except income taxes); or

 

(f)                                   charges for packing, freight, shipping and insurance.

 

Each of the foregoing deductions shall be determined as incurred in the ordinary course of business in type and amount consistent with good industry practice and in accordance with

 

8

 

Accounting Standards on a basis consistent with uniQure’s audited consolidated financial statements.  For clarity, sales by uniQure or its Affiliates of a Royalty Bearing Product to a Third Party Distributor of such Royalty Bearing Product in a given country shall be considered a sale to a Third Party customer.  All such discounts, allowances, credits, rebates, and other deductions shall be fairly and equitably allocated to the Royalty Bearing Products and other products of uniQure and its Affiliates such that the Royalty Bearing Product does not bear a disproportionate portion of such deductions.

 

In the event any Royalty Bearing Product is sold for consideration other than cash, Net Sales for such sale shall be the average price of such Royalty Bearing Product sold for cash during the relevant period in the relevant country.

 

In the event that any discount, reduction, payment or rebate is offered for a Royalty Bearing Product where such Royalty Bearing Product is sold to a Third Party customer as part of a grouped set of products, the applicable discount, reduction, payment or rebate for such Royalty Bearing Product in such arrangement shall be based on the weighted average discount, reduction, payment or rebate of such grouped set of products.

 

Any Royalty Bearing Products used for promotional or advertising purposes (in reasonable and customary amounts) or used for Clinical Trials or other research purposes shall not be included in Net Sales.  Donations for charity reasons or compassionate use shall also not be included in Net Sales.

 

1.62                        “Party” and “Parties”.  Party means uniQure or 4DMT individually, and Parties means uniQure and 4DMT collectively.

 

1.63                        “Patent Rights”.  Patent Rights means patents, patent applications or provisional patent applications, utility models and utility model applications, petty patents, innovation patents, patents of addition, divisionals, continuations, continuation-in-part applications, continued prosecution applications, requests for continued examinations, reissues, renewals, reexaminations and extensions and supplementary protection certificates granted in relation thereto, in any country of the world.  For clarity, Patent Rights shall include any Patent Right that claims priority to or common priority with such Patent Rights.

 

1.64                        “Phase I Study”.  A Phase I Study is a human clinical trial conducted in any country that meets the requirements of 21 CFR §312.21(a).  By way of example and not limitation, a Phase I Study is usually performed as a single or multiple dose clinical study in healthy volunteers or patients to assess specific administration, distribution, metabolism, excretion (ADME), safety and tolerability, bioavailability/bioequivalence or exploratory efficacy (in the sense of demonstrating “proof-of-principle”) of an investigational drug, and the emphasis in Phase I is usually on safety and tolerability and it is typically used to plan patient dosing in Phase II clinical studies.  For clarity, a Phase I Study may also represent the initial phase of a combined Phase Ib/II clinical study.

 

1.65                        “Phase III Study”.  A Phase III Study is a human clinical trial conducted in any country that meets the requirements of 21 CFR §312.21(c).  By way of example and not limitation, a Phase III Study is a large scale clinical study (usually several hundreds of patients)

 

9

 

performed after preliminary evidence suggesting effectiveness of the drug has been obtained in Phase II clinical studies, and it is intended to gather the pivotal information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and, along with earlier Clinical Trials, to provide an adequate basis for Regulatory Approval.  For clarity, a Phase III Study may also represent the second part of a combined Phase II/III clinical study.

 

1.66                        “Pivotal Study”.  A Pivotal Study is a human clinical trial conducted in any country, the principal purpose of which is to establish safety and efficacy of a Royalty Bearing Product in patients with the applicable Indication and to gather the pivotal information about such safety and effectiveness that is needed to evaluate the overall benefit-risk relationship of the drug and, along with earlier Clinical Trials, to provide an adequate basis for Regulatory Approval.  A Pivotal Study includes any human clinical trial intended as a pivotal study of such Royalty Bearing Product regarding such Indication, such as a phase II/III or phase IIb clinical trial, whether or not such study is a traditional Phase III Study.

 

1.67                        “Pre-agreed”.  Pre-agreed means on terms that are determined by the JRSC in accordance with Section 2.5.

 

1.68                        “Prior Confidentiality Agreement”.  Prior Confidentiality Agreement means the Two Way Confidentiality Disclosure Agreement between uniQure and 4DMT, dated August 26, 2013.

 

1.69                        “Product”.  Product means any preparation in final form, either for sale by prescription, over-the-counter or any other method, or for administration to human patients in Clinical Trials, for any and all uses, and in any and all formulations and combinations, which preparation contains a Compound.

 

1.70                        “Project Team”.  Project Team means the 4DMT and uniQure personnel involved in the Research Program, including the Project Leaders.

 

1.71                        “Prosecution and Maintenance”.  Prosecution and Maintenance means, with respect to a Patent Right, the preparation, filing, prosecution and maintenance of such Patent Right, as well as reexaminations, reissues and the like with respect to such Patent Right, together with the conduct of interferences, the defense of oppositions and other similar proceedings with respect to the particular Patent Right; and “Prosecute and Maintain” shall have the correlative meaning.

 

1.72                        “Regulatory Approval”.  Regulatory Approval means the technical, medical and scientific licenses, registrations, authorizations and approvals (including approvals of NDAs and labeling approvals) of any Regulatory Authority necessary for the distribution, marketing, promotion, offer for sale, use, import, export or sale of a Royalty Bearing Product in a regulatory jurisdiction.

 

1.73                        “Regulatory Authority”.  Regulatory Authority means any applicable Governmental Authority involved in granting approvals for the manufacturing, marketing, reimbursement or pricing of a Royalty Bearing Product in the Territory or any portion thereof,

 

10

 

including the FDA and EMA (as applicable), and any successor Governmental Authority having substantially the same function.

 

1.74                        “Research Compound”.  Research Compound means a Compound containing a Designated Capsid Variant that is the subject of activities under the Research Program.

 

1.75                        “Research Plan”.  Research Plan means the research plan developed by the Parties that sets forth the activities to be undertaken during the Research Term with respect to the Research Program and the budget for such activities.  The initial outline of the Research Plan is attached as Schedule 1.75.

 

1.76                        “Research Program”.  Research Program means a program of collaborative research to be undertaken by the Parties pursuant to the Research Plan to identify optimized AAV Capsid Variants for use in the Field that demonstrate improved expression of the delivered Gene Therapy Construct in the targeted tissue as compared to currently available AAV Capsid Variants.

 

1.77                        “Research Selection Process”.  Research Selection Process means the iterative evolution or isolation of lead AAV Capsid Variants from one or more 4DMT AAV Capsid Variant Libraries in cells (cultured or primary) in vitro or in animals in vivo intended to result in the identification of AAV Capsid Variants demonstrating Pre-agreed properties suitable to proceed into Lead Optimization using a Pre-agreed evaluation methodology and that are targeted to a specified target tissue.  A given Research Selection Process is different from another Research Selection Process if such Research Selection Process was conducted to identify AAV Capsid Variants that specifically target a different tissue or are delivered by means of a different mode of administration (e.g., such process was conducted to identify AAV Capsid Variants useful for intravenous, direct injection, subcutaneous or intrathecal delivery means).

 

1.78                        “Research Term”.  Research Term means the Initial Research Term and, if applicable, the Extended Research Term.

 

1.79                        “Research Year”.  Research Year means a twelve (12) month period beginning on the Effective Date or on any anniversary thereof.

 

1.80                        “Royalty Bearing Compound”.  Royalty Bearing Compound means a Compound containing a Selected Capsid Variant.

 

1.81                        “Royalty Bearing Product”.  Royalty Bearing Product means a Product containing a Royalty Bearing Compound.

 

1.82                        “Royalty Term”.  Royalty Term means, with respect to a Royalty Bearing Product, on a Royalty Bearing Product-by-Royalty Bearing Product and a country-by-country basis, the period beginning on the First Commercial Sale of such Royalty Bearing Product in such country by uniQure or any of its Affiliates or Sublicensees, and ending on latest of:  (a) the expiration of the last Valid Claim within the Licensed IP Covering such Royalty Bearing Product in such country, (b) the expiration of any applicable exclusivity, including orphan drug status or

 

11

 

data exclusivity, and any extension thereto, granted by a Regulatory Authority in such country with respect to such Royalty Bearing Product, or (c) the tenth (10th) anniversary of the date of the First Commercial Sale by uniQure or any of its Affiliates or Sublicensees of such Royalty Bearing Product in such country.

 

1.83                        “Selected Capsid Variant”.  Selected Capsid Variant means [**].

 

1.84                        “Selection Process”.  Selection Process means the iterative evolution or isolation of lead AAV Capsid Variants from one or more AAV Capsid Variant Libraries in cells (cultured or primary) in vitro or in animals in vivo intended to result in the identification of AAV Capsid Variants demonstrating properties suitable to a specified target tissue.  A given Selection Process is different from another Selection Process if such Selection Process was conducted to identify AAV Capsid Variants that specifically target a different tissue or are delivered by means of a different mode of administration (e.g., such process was conducted to identify AAV Capsid Variants useful for intravenous, direct injection, subcutaneous or intrathecal delivery means).

 

1.85                        “Sublicensee”.  Sublicensee means, with respect to uniQure, a Third Party to whom uniQure (or its Affiliate or another of its Sublicensees) has granted a license or sublicense under the Licensed IP to Develop, make and have made, use or Commercialize a Royalty Bearing Product; provided, however, that a Sublicensee shall not include any Third Party Distributor.

 

1.86                        “Territory”.  Territory means all countries and territories in the world.

 

1.87                        “Third Party”.  Third Party means an entity other than uniQure, 4DMT and their respective Affiliates.

 

1.88                        “Third Party Distributor”.  Third Party Distributor means any Third Party that provides (but does not Develop) Royalty Bearing Products directly to customers under agreement with uniQure, its Affiliates or Sublicensees.

 

1.89                        “UC AAV Capsid Variant”.  UC AAV Capsid Variant means any AAV Capsid Variant provided to 4DMT pursuant to the UCB Agreements.

 

1.90                        “UC Patent Right”.  UC Patent Right means any Patent Right licensed to 4DMT pursuant to the UCB Agreements.

 

1.91                        “UC Product”.  UC Product means a Royalty Bearing Product that is Covered by a UC Patent Right.

 

1.92                        “UCB Agreements”.  UCB Agreements means (a) the Exclusive License and Bailment Agreement between 4DMT and the Regents of the University of California (“UC”), Agreement Control No. 2014-03-0089, dated December 19, 2013; (b) the Exclusive License and Bailment Agreement between 4DMT and UC, Agreement Control No. 2014-03-0090, dated December 19, 2013; and (c) the Agreement for Use of Certain Biological Materials between 4DMT and UC, Agreement Control No. 2014-30-0088, dated December 19, 2013, in each case in the form provided to uniQure by 4DMT as of the Effective Date.

 

12

 

1.93                        “uniQure Intellectual Property”.  uniQure Intellectual Property means uniQure Know-How and uniQure Patent Rights.

 

1.94                        “uniQure Know-How”.  uniQure Know-How means Know-How that is (a) Controlled by uniQure or its Affiliates as of the Effective Date or during the Term, and (b) necessary or useful to conduct the Research Program or to research, Develop, make and have made, use or Commercialize the relevant Selected Capsid Variant, Royalty Bearing Compound or Royalty Bearing Product.  uniQure Know-How includes Core uniQure Know-How but does not include Joint Know-How.

 

1.95                        “uniQure Patent Right”.  uniQure Patent Right means any Patent Right Controlled by uniQure or its Affiliates as of the Effective Date or during the Term that Covers uniQure Know-How.  uniQure Patent Rights include Core uniQure Patent Rights but do not include Joint Patent Rights.

 

1.96                        “Valid Claim”.  Valid Claim means (a) a claim of an issued patent that has not expired or been abandoned, or been revoked, held invalid or unenforceable by a patent office, court or other governmental agency of competent jurisdiction in a final and non-appealable judgment (or judgment from which no appeal was taken within the allowable time period), or (b) a claim within a patent application which application has not been pending for more than [**] years from the date of its priority filing date and which claim has not been irretrievably revoked, irretrievably cancelled, irretrievably withdrawn, held invalid or abandoned by a patent office, court or other governmental agency of competent jurisdiction in a final and non-appealable judgment (or judgment from which no appeal was taken within the allowable time period), or finally determined to be unallowable in a decision from which an appeal cannot or can no longer be taken; provided, however, that with respect to the UC Patent Rights licensed under the Exclusive License and Bailment Agreement between 4DMT and UC, Agreement Control No. 2014-03-0089, the foregoing [**] year limitation shall be extended to [**] years.

 

1.97                        Additional Definitions.  Each of the following definitions is set forth in the section of this Agreement indicated below:

 

	
Definition:
    	
 
    	
Section:
    
	
 
    	
 
    	
 
    
	
4DMT
    	
 
    	
Preamble
    
	
4DMT Indemnitees
    	
 
    	
9.5
    
	
Acquiring/Acquired Party
    	
 
    	
5.6(b)
    
	
Additional Cure Period
    	
 
    	
10.2(a)
    
	
Agreement
    	
 
    	
Preamble
    
	
Audited Party
    	
 
    	
6.7
    
	
Auditing Party
    	
 
    	
6.7
    
	
Bankruptcy Code
    	
 
    	
5.5
    
	
CNS
    	
 
    	
1.37
    
	
CREATE Act
    	
 
    	
7.10
    
	
Damages
    	
 
    	
9.5
    
	
Defaulting Party
    	
 
    	
10.2(a)
    

 

13

 

	
Definition:
    	
 
    	
Section:
    
	
 
    	
 
    	
 
    
	
Designated Capsid Variant
    	
 
    	
3.4(a)
    
	
Dispute
    	
 
    	
11.1
    
	
Effective Date
    	
 
    	
Preamble
    
	
Equipment Payment
    	
 
    	
6.2(c)
    
	
Excluded Claim
    	
 
    	
11.2
    
	
Executives
    	
 
    	
2.5(b)
    
	
Extended Research Term
    	
 
    	
3.1(c)
    
	
Failure to Amend
    	
 
    	
4.4(d)
    
	
Fair Market Value
    	
 
    	
6.5(b)(iii)
    
	
GAAP
    	
 
    	
1.9
    
	
GLP Tox Candidate Review Period
    	
 
    	
3.3(a)
    
	
IFRS
    	
 
    	
1.9
    
	
Initiating Party
    	
 
    	
7.6(d)
    
	
Joint Counsel
    	
 
    	
7.5
    
	
Joint Intellectual Property
    	
 
    	
7.2(a)
    
	
Joint Know-How
    	
 
    	
7.2(a)
    
	
Joint Patent Rights
    	
 
    	
7.2(a)
    
	
JRSC
    	
 
    	
2.2(a)
    
	
M&A Event
    	
 
    	
12.7
    
	
MAA
    	
 
    	
1.60
    
	
Non-Defaulting Party
    	
 
    	
10.2(a)
    
	
Orange Book
    	
 
    	
7.9(a)
    
	
Paragraph IV Certification
    	
 
    	
7.9(b)
    
	
Paragraph IV Proceeding
    	
 
    	
7.9(b)(ii)
    
	
Project Leader
    	
 
    	
2.1
    
	
Records
    	
 
    	
3.7(a)(i)
    
	
Replacement Product
    	
 
    	
6.3(b)(3)
    
	
SEC Filing
    	
 
    	
8.5(c)
    
	
Sublicense Consideration
    	
 
    	
6.5(b)
    
	
Sublicense Income Sharing Percentages
    	
 
    	
6.5(a)
    
	
Term
    	
 
    	
10.1
    
	
Third Party Claim
    	
 
    	
9.5
    
	
Third Party Competitive Product
    	
 
    	
4.4(a)
    
	
Third Party Proposal
    	
 
    	
4.4(a)
    
	
Third Party Proposed Products
    	
 
    	
4.4(a)
    
	
Third Party Proposer
    	
 
    	
4.4(a)
    
	
Trade Secret Election
    	
 
    	
7.3(b)
    
	
USPTO
    	
 
    	
7.10
    
	
UC
    	
 
    	
1.88
    
	
uniQure
    	
 
    	
Preamble
    
	
uniQure Indemnitees
    	
 
    	
9.6
    

 

14

 

ARTICLE II

 

GOVERNANCE

 

2.1                               Project Leaders.  Within [**] Business Days after the Effective Date, each Party will appoint (and provide written notice to the other Party of the identity of) a senior representative having a general understanding of pharmaceutical discovery and development issues to act as its project leader under this Agreement (each, a “Project Leader”).  The Project Leaders will serve as the contact point between the Parties with respect to the Research Program, and will be primarily responsible for: (a) facilitating the flow of information and otherwise promoting communication, coordination of the day-to-day work and collaboration between the Parties; (b) providing single point communication for seeking consensus internally within the respective Party’s organization; and (c) raising cross-Party or cross-functional disputes in a timely manner.  The Project Leaders shall conduct regular telephone conferences as deemed necessary or appropriate, to exchange informal information regarding the progress of the Research Program.  Each Party may change its designated Project Leaders from time to time upon prior written notice to the other Party.  Each Project Leader may designate a substitute to temporarily perform the functions of that Project Leader by prior written notice to the other Party.

 

2.2                               Joint Research Steering Committee.

 

(a)                                 Composition.  Promptly after the Effective Date, the Parties shall establish a joint research steering committee (the “JRSC”).  The JRSC shall be comprised of at least [**] named representatives of uniQure and at least [**] named representatives of 4DMT, one of whom shall be David Schaffer (unless due to his death, illness or disability), or such other numbers as the Parties may agree in writing.  As soon as practicable after the Effective Date (but in no event more than [**] Business Days after the Effective Date), each Party shall designate by written notice to the other Party its initial representatives on the JRSC.  Each Party may replace one or more of its non-mandatory representatives, in its sole discretion, effective upon written notice to the other Party of such change.  These representatives shall have appropriate technical credentials, experience and knowledge, and ongoing familiarity with the Research Program.  The JRSC shall be disbanded upon expiration of the Research Term.

 

(b)                                 Function and Powers of the JRSC.  During the Research Term, the JRSC’s responsibilities shall include: (i) approving the initial Research Plan and any amendment thereto, including allocation of tasks and resources; (ii) developing and approving the Candidate Success Criteria; (iii) developing and approving parameters for Animal POC; (iv) developing and approving parameters for Clinical POC; (v) determining the frequency of meetings of the Project Team, or subgroups of the Project Team, and the members of the Project Team to attend such meetings, which meetings are expected to occur at least [**], with such meetings expected to occur in person at least [**]; (vi) reviewing, approving procedures, and making recommendations regarding Lead Optimization; (vii) determining whether a Research Compound achieves the relevant Delivery Success Criteria; (viii) proposing Research Compounds that have achieved the Delivery Success Criteria for uniQure’s acceptance as GLP Tox Compounds; (ix) providing a forum for discussion of the Research Plan, the status of the 

 

15

 

Research Program, and relevant data; (x) serving as a forum for informal resolution of disagreements that may arise in the relation to the Parties’ activities under the Research Program, including any disagreement within any subcommittee; (xi) determining and approving the overall strategy for publications and presentations pursuant to Section 8.4; and (xii) considering and acting upon such other matters as may be specified in this Agreement.  Any decision made by the JRSC under this Section 2.2(b) shall be deemed a decision of the JRSC, as applicable, for purposes of this Agreement.

 

2.3                               Subcommittees.  The JRSC may establish and disband such subcommittees as deemed necessary by the JRSC.  Each such subcommittee shall consist of the same number of representatives designated by each Party, which number shall be mutually agreed by the Parties.  Each Party shall be free to change its representatives on written notice to the other Party or to send a substitute representative to any subcommittee meeting.  Each Party’s representatives and any substitute for a representative shall be bound by a written agreement with confidentiality obligations substantially the same as those set forth in ARTICLE VIII.  The rules for the conduct of each subcommittee, and the scope of its responsibilities, shall be determined by the JRSC, provided that no subcommittee shall have the authority to bind the Parties hereunder, and each subcommittee shall report to the JRSC.

 

2.4                               Meetings.  The JRSC shall each hold at least [**].  Upon necessity, either Party shall be entitled to request additional meetings of the JRSC.  Meetings of the JRSC shall be effective only if at least [**] representatives of each Party are present or participating.  The location of meetings shall be as agreed by the Parties, and may be held in person, alternating locations between the Parties, or by telephone conference call or by videoconference; provided, however, that at least [**] meetings of the JRSC each Calendar Year are held in person.  4DMT’s costs and expenses incurred in connection with preparing for and participating in all such meetings shall be paid for by uniQure in accordance with the budget for the Research Plan.  Either Party may, from time to time, invite additional representatives or consultants to attend JRSC meetings; provided that at least [**] Business Days’ prior written notice is given of a Party’s intention to invite such other representatives or consultants and providing full details about the name, employer and professional background of such other representatives or consultants.  Each representative and consultant participating in or attending a JRSC meeting shall be bound by a written agreement with confidentiality obligations substantially the same as those set forth in ARTICLE VIII.  The JRSC shall be co-chaired by a representative from each Party.  The chairpersons shall set the agendas for the JRSC meeting in advance.  Within ten (10) Business Days prior to each scheduled meeting, each Party shall, in accordance with Section 3.7(b), provide a report to the JRSC detailing its progress with respect to the Research Program.  The Parties will rotate the responsibility for recording, preparing and issuing minutes for each JRSC meeting, to be circulated within [**] Business Days after each meeting.

 

2.5                               Decision-making.

 

(a)                                 Initial Dispute Resolution Procedures.  Subject to the provisions of this Section 2.5, actions to be taken by the JRSC shall be taken only following a unanimous vote, with each Party, through its representatives, having one (1) vote.  If any subcommittee fails to 

 

16

 

reach unanimous agreement (with each Party, through its representatives, having one (1) vote) for a period in excess of [**] Business Days, the matter shall be referred to the JRSC.

 

(b)                                 Referral of Unresolved Matters to Executives.  If, in accordance with Section 2.5(a), the JRSC does not resolve any matter considered by it within [**]Business Days after the matter is first considered by it, the matter may be referred by either Party to the CEO of 4DMT and CEO of uniQure (the “Executives”) to be resolved by negotiation in good faith as soon as practicable, but in no event later than [**] Business Days after referral.  Such resolution, if any, of a referred issue by the Executives shall be final and binding on the Parties.  Any decision made by the Executives under this Section 2.5(b) shall be deemed a decision of the JRSC for purposes of this Agreement.

 

(c)                                  Final Decision-Making.  If a dispute referred to the Executives pursuant to Section 2.5(b) has not been resolved in accordance with Section 2.5(b), then, subject to Section 2.5(d), uniQure shall have the final decision-making authority.  Any decision made by uniQure pursuant to this Section 2.5(c) shall be deemed a decision of the JRSC for purposes of this Agreement.

 

(d)                                 Exceptions.  Notwithstanding Section 2.5(c), uniQure shall not have the right to exercise such decision-making authority (i) in a manner that excuses uniQure from any of its obligations specifically enumerated under this Agreement; (ii) in a manner that negates any consent rights or other rights specifically allocated to 4DMT under this Agreement; (iii) to resolve any dispute regarding whether a milestone event set forth in Section 6.3 has been achieved by uniQure by determining that such event has not been achieved; (iv) in a manner that would require 4DMT to perform activities (A) for which uniQure will not reimburse 4DMT’s costs (except as expressly set forth in this Agreement), (B) that 4DMT has not agreed to perform as set forth in this Agreement or the Research Plan, or as otherwise agreed in writing by 4DMT, or (C) that require 4DMT to use any Know-How or other technology not contemplated in the Research Plan and that is not developed internally by 4DMT and with respect to the use of which 4DMT would owe a royalty or other payment; (v) in a manner that would change the total number of 4DMT FTEs or the allocation among the various technical disciplines as set forth in the Research Plan; (vi) in a manner that would reduce payments committed to 4DMT pursuant to this Agreement or take away 4DMT’s right to perform activities that 4DMT has previously agreed to perform as set forth in the Research Plan; (vii) in a manner that would require 4DMT to perform any act that it reasonably believes to be inconsistent with any Law or any approval, order, policy, guidelines of a Regulatory Authority or ethical requirements or ethical guidelines; (viii) to determine that uniQure has fulfilled any obligation under this Agreement or that 4DMT has breached any obligation under this Agreement; or (ix) to amend the relevant Delivery Success Criteria.  In the event that any matter set forth in the preceding clauses (i)-(ix) is unresolved through the JRSC and subsequently such dispute cannot be resolved by the Executives in accordance with Section 2.5(b), then either (A) for all such matters set forth in the preceding clauses (iv)-(vi), there shall be no change in the Research Plan or associated budget unless the Parties otherwise mutually agree in writing, (B) for all such matters set forth in the preceding clauses (i), (ii), (vii) and (viii), either Party may require the specific issue to be referred to binding arbitration pursuant to Section 11.2, or (C) for all such matters set forth in the preceding clauses (iii) and (ix), either Party may require the specific issue to be submitted to a 

 

17

 

panel of external scientific experts to review the dispute pursuant to the remainder of this Section 2.5(d).  Each Party shall select, upon either Party’s request, one (1) external scientific expert within [**] Business Days after such request, and the two (2) so selected shall choose a third (3rd) external scientific expert within an additional [**] Business Days to resolve the dispute, and all three (3) shall serve as neutrals.  Each expert must be free of any conflict of interest with respect to either or both Parties and their Affiliates and shall have expertise in the matters concerning the unresolved dispute.  The decision of the external scientific expert panel shall be issued within [**] Business Days after nomination of the third external expert and shall be final and binding on the Parties.  The Parties agree to share equally the cost of the proceedings, including fees of the panel members; provided, that each Party shall bear its own attorneys’ fees and associated costs and expenses.

 

2.6                               Limitations on JRSC Authority.  The JRSC and any subcommittee shall have only the powers assigned expressly to it in this ARTICLE II and elsewhere in this Agreement, and shall not have any power to amend, modify or waive compliance with this Agreement.  In furtherance thereof, each Party shall retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers or discretion shall be delegated or vested in the JRSC or any subcommittee unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing.

 

ARTICLE III

 

RESEARCH PROGRAM

 

3.1                               General.

 

(a)                                 Objectives.  The objectives of the Research Program are to (i) identify and characterize AAV Capsid Variants and Research Compounds, (ii) optimize such AAV Capsid Variants and Research Compounds and (iii) conduct other research activities with respect to Research Compounds containing Gene Therapy Constructs of interest in place of marker or other proof-of-principle genes with which screening and AAV Capsid Variant optimization may have been performed, in each case to identify Research Compounds that meet the Delivery Success Criteria, with the objective of having such Research Compounds accepted by uniQure for Animal POC and subsequently as GLP Tox Compounds, consistent with the Candidate Success Criteria.

 

(b)                                 Research Plan.  The Parties shall agree to the Research Plan and shall conduct the Research Program in accordance with the Research Plan.  The JRSC shall endeavor to approve the initial Research Plan (including its associated budget) within [**] days after the Effective Date, which initial Research Plan shall set forth the tasks to be undertaken by the Parties (including relevant technology to be used and Materials to be provided) under the Research Program.

 

(c)                                  Extended Research Term.  In the event that uniQure reasonably believes that the Parties will not complete the activities under the Research Plan during the Initial Research Term, then uniQure, at its sole discretion, may extend the Research Term to complete

 

18

 

the goals of such Research Plan as then in effect for an additional [**] month period from the expiration of the Initial Research Term (the “Extended Research Term”).  uniQure may so extend the Research Term by giving written notice to 4DMT at least [**] months prior to the expiration of the Initial Research Term.  The Parties shall mutually agree upon the number of FTEs at 4DMT needed to perform the research during the Extended Research Term, as well as out-of-pocket costs, and uniQure shall provide funding for such FTEs and out-of-pocket costs in accordance with Section 6.2(a) and, if the Parties are unable to agree on such matters prior to the expiration of the Initial Research Term, then the Research Term shall expire at the end of the Initial Research Term.  The Parties may further extend the Extended Research Term by mutual written agreement.

 

3.2                               Conduct of the Research Program.

 

(a)                                 4DMT and uniQure shall each use Commercially Reasonable Efforts to conduct the Research Program in accordance with the Research Plan.  In addition, uniQure shall use Commercially Reasonable Efforts to assess reasonably promptly whether each Designated Capsid Variant provided to uniQure in connection with assessing the Delivery Success Criteria can be manufactured in insect cells.

 

(b)                                 Either Party shall have the right to utilize the services of any Third Party to perform its obligations under the Research Plan to the extent that such Third Party is specifically approved in the Research Plan or otherwise approved by the JRSC, provided that any permitted Third Party must have entered into a written agreement with such Party that includes terms and conditions (i) protecting and limiting use and disclosure of Confidential Information at least to the same extent as under ARTICLE VIII, and (ii) requiring the Third Party and its personnel to assign to such Party all right, title and interest in and to any intellectual property (and intellectual property rights) created or conceived in connection with performance of subcontracted activities.  Each Party shall remain at all times fully liable for its responsibilities under this Agreement.

 

(c)                                  4DMT and uniQure shall conduct the Research Program in accordance with all applicable Laws, including, if and as applicable, Good Laboratory Practices.  Each Party hereby certifies that it will not employ or otherwise use in any capacity in performing any activity hereunder the services of any person or entity known to it to be debarred under 21 USC §335a.

 

(d)                                 If the JRSC determines that it is desirable to transfer the AAV Capsid Variant Libraries into baculovirus, then prior to such transfer, the Parties will negotiate in good faith an amendment to this Agreement specifying the allocation of ownership of Materials, Know-How, and Patent Rights.  Except as otherwise agreed by the Parties in writing, in no event shall 4DMT transfer the 4DMT AAV Capsid Variant Libraries to uniQure, and in no event shall uniQure transfer its baculovirus insect cell manufacturing Know-How to 4DMT.

 

3.3                               Candidate Success Criteria.

 

(a)                                 Within [**] days following the date on which the Research Plan is approved by the JRSC, the JRSC shall determine and approve the minimum Candidate Success

 

19

 

Criteria applicable to each class or series of Research Compounds.  For clarity, the Candidate Success Criteria shall include the criteria necessary to move from testing AAV capsid gene-containing AAV Capsid Variants to marker or other Gene Therapy Construct of interest-containing AAV Capsid Variants, for testing for compatibility with or optimization or adaption to uniQure’s insect cell manufacturing process, and for testing insect cell compatible Research Compounds for gene delivery efficiency in comparison to a relevant reference vector using Research Compounds and reference vector stocks prepared in insect cells by uniQure using uniQure SOPs and release specifications.  The objectives of the Research Program will always be to identify the best possible AAV Capsid Variants for delivery of Gene Therapy Constructs to target cells, rather than to identify AAV Capsid Variants that merely meet the minimum Candidate Success Criteria specified in the Research Plan.  Subsequently in the Research Program (i.e., when AAV Capsid Variants have been accepted by uniQure as being ready for Animal POC testing or in parallel with the identification with lead AAV Capsid Variants for Lead Optimization), the JRSC will (i) agree on disease models for testing Gene Therapy Constructs of interest for efficacy against particular target diseases, (ii) agree on procedures for testing in these animal disease models and the Candidate Success Criteria in these models intending to result in data sufficient for submission to regulatory authorities, and (iii) recommend that Research Compounds meeting these criteria should proceed to GLP Tox Studies.  The Candidate Success Criteria shall in all of cases (i)-(iii) be expected to be able to be met only using Research Compound stocks that have been prepared by uniQure in insect cells using standard uniQure SOPs in comparison to reference vectors also prepared by uniQure in the same way.  Notwithstanding the foregoing, the Candidate Success Criteria shall be deemed to have been met for any Research Compound that uniQure advances into GLP Tox Studies.

 

(b)                                 The JRSC may, from time to time during the Research Term, nominate a Research Compound that has achieved the Candidate Success Criteria for Animal POC (provided, however, that the JRSC may, as appropriate, nominate a Research Compound that has not achieved all the Candidate Success Criteria) for consideration as a GLP Tox Compound.  uniQure will consider all data relating to the nominated Research Compound for designation as a GLP Tox Compound, including data generated by either uniQure or 4DMT pursuant to this Agreement.  Such data shall include the results from all tests and other measures included in the Candidate Success Criteria and such other information and results as uniQure reasonably requests from 4DMT.  Within [**] days after delivery to uniQure of such data (the applicable “GLP Tox Candidate Review Period”), uniQure shall provide 4DMT written notice whether uniQure accepts such nominated Research Compound as a GLP Tox Compound and intends to Develop and Commercialize such nominated Research Compound in accordance with the terms of this Agreement.  Notwithstanding the foregoing, uniQure shall be deemed to have accepted as a GLP Tox Compound any Research Compound that it advances into pre-clinical Development conducted under Good Laboratory Practices.

 

(c)                                  uniQure shall pay any applicable milestone payment as set forth in Section 6.3(a) for each Research Compound that uniQure advances into Animal POC as a potential GLP Tox Compound pursuant to this Section 3.3.  For clarity, uniQure has the right to select any number of Research Compounds for Animal POC as potential GLP Tox Compounds without an additional payment for any such selection once the applicable milestone payments in

 

20

 

Section 6.3(a) have become payable for the first [**] Research Compounds for such Research Selection Process.

 

3.4                               Selection of AAV Capsid Variants.

 

(a)                                 Within [**] days after 4DMT provides uniQure with the list of AAV Capsid Variant sequences arising from each Research Selection Process and all other data arising from or relating to such Research Selection Process, uniQure shall submit by written notice to 4DMT a list specifying up to [**] AAV Capsid Variants from each such Research Selection Process (the “Designated Capsid Variants”).  If uniQure has not provided such written notice to 4DMT within [**] days, 4DMT shall provide written notice to uniQure of the date that the foregoing [**] day period will expire, and the Parties will have the option to agree an extension by mutual consent, not to be unreasonably withheld.

 

(b)                                 Prior to the [**] of the expiration of the Research Term, uniQure shall submit by written notice to 4DMT a list specifying up to [**] AAV Capsid Variants from the list of Designated Capsid Variants for each Research Selection Process.  All AAV Capsid Variants included in such list shall be included as “Selected Capsid Variants,” subject to the terms and conditions of this Agreement.  For clarity, all modifications by uniQure to the Selected Capsid Variants and other modifications set forth in Section 1.83 shall also be deemed “Selected Capsid Variants” for purposes of the payment obligations under this Agreement.  4DMT shall provide written notice to uniQure if uniQure has not provided such list to 4DMT by the date that is [**] of the expiration of the Research Term.

 

(c)                                  For clarity, the subset of Designated Capsid Variants not subsequently selected as Selected Capsid Variants may be used and licensed by 4DMT to Third Parties outside the Field, but only if they also arise from a Selection Process conducted outside the Field.  Unless such subset of Designated Capsid Variants also arise from a Selection Process conducted outside the Field, 4DMT may not conduct any research using such subset of Designated Capsid Variants unless otherwise agreed under the Research Plan.  For further clarity, Selected Capsid Variants may not be used, or licensed to Third Parties, by 4DMT or its Affiliates outside the Field.

 

3.5                               Materials and Know-How Transfer/Use of Compounds.

 

(a)                                 In order to facilitate the Research Program, each Party shall, as set forth in the Research Plan, provide to the other Party certain Materials and, subject to Section 3.6, Know-How Controlled by the supplying Party for use by the other Party in furtherance of the Research Program.  In addition, 4DMT shall transfer to uniQure such quantities of Designated Capsid Variants as the JRSC may reasonably request from time to time during the Research Term to exercise its rights hereunder.  All Materials and Know-How provided by one Party to the other Party remain the sole property of the supplying Party.

 

(b)                                 All Materials transferred pursuant to the Research Program shall be used (i) only for the specific purpose provided for in the Research Plan, and (ii) solely under the control of the receiving Party.  The Materials may not be used or delivered to or for the benefit of any Third Party without the prior written consent of the supplying Party, and shall not

 

21

 

be used in research or testing involving human subjects, except as expressly contemplated in the Research Plan or in accordance with this Agreement.  All Materials shall be returned to the supplying Party or destroyed (at the election of the supplying Party) promptly after completion of the use permitted under this Agreement.

 

(c)                                  THE MATERIALS ARE PROVIDED “AS IS” AND WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHT OF ANY THIRD PARTY.

 

(d)                                 At the end of the Research Term, upon request by uniQure, 4DMT shall promptly provide to uniQure all quantities of the Royalty Bearing Compounds in 4DMT’s possession and shall promptly destroy other Research Compounds.

 

3.6                               Third Party Intellectual Property.  The conduct of activities under the Research Plan will use Patent Rights or Know-How licensed by 4DMT pursuant to the UCB Agreements, subject to the terms and conditions of the UCB Agreements.  4DMT shall be solely responsible for all obligations under the UCB Agreements, including any and all payments and royalties due thereunder.  In developing the Research Plan, the Parties shall discuss whether any Third Party Patent Rights or Know-How, other than Patent Rights or Know-How licensed by 4DMT pursuant to the UCB Agreements, will be utilized in the conduct of activities under the Research Plan.  4DMT shall disclose to uniQure the details of any restrictions on use or payment obligations of which it is aware that would be triggered by such use of Third Party Patent Rights or Know-How in the Research Program.  If the Parties mutually agree to use any inventions claimed in any Patent Right or use any Know-How that is licensed to or has been acquired by 4DMT other than pursuant to the UCB Agreements, and if such use would require the payment of additional consideration to the Third Party from which the Patent Rights or Know-How was licensed or acquired, then such Patent Right or Know-How shall be deemed under the Control of 4DMT, provided that uniQure expressly agrees in writing to bear any such additional consideration actually to be paid by 4DMT to the Third Party (which amounts uniQure may offset pursuant to Section 6.4(c)(ii)) with respect to the Development, manufacture or Commercialization of Royalty Bearing Compounds or Royalty Bearing Products.  For clarity, nothing in this Section 3.6 shall limit uniQure’s rights to obtain from a Third Party, independent of 4DMT, a license or other right with respect to such Third Party’s Patent Rights or Know-How.

 

3.7                               Records and Reports.

 

(a)                                 Records.

 

(i)                                     4DMT shall maintain records, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall fully and properly reflect all work done and results achieved in the performance of the Research Program by or on behalf of 4DMT (the “Records”), including the procedures, techniques and methodologies used, the progress made, and any Invention conceived or reduced to practice or

 

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otherwise made within the scope of or in connection with the Research Program.  As part of keeping the Records, 4DMT shall ensure that all of its personnel, and all of its agents that are involved in the Research Program, will keep accurate laboratory notebooks, which laboratory notebooks: (A) shall be duly signed, dated and witnessed; and (B) shall be created and maintained in accordance with its standard operating procedures that would be sufficient to allow for said laboratory notebooks to be used in any proceeding before the United States Patent and Trademark Office or United States courts, in order to establish the date of invention for any Invention in accordance with the United States patent laws.  During the Term, 4DMT shall, upon written request by uniQure, which shall not be unreasonably made:  (1) make all Records available for inspection and review by uniQure during normal business hours in a timely manner; and (2) provide copies of the Records or any part thereof to uniQure, as reasonably requested by uniQure.

 

(ii)                                  After a Research Compound has been accepted by uniQure as a GLP Tox Compound, uniQure shall have the right to request that a copy of the relevant portions of the laboratory notebooks relating to all stages of the generation of such GLP Tox Compound be provided by 4DMT to uniQure. After such request by uniQure, 4DMT shall provide such copies of the laboratory notebooks promptly to uniQure, which shall be maintained by uniQure as 4DMT’s Confidential Information.

 

(b)                                 Reports to the JRSC.  Between [**] and [**] Business Days prior to each scheduled JRSC meeting, the Parties shall provide to the JRSC a written report on the progress of the Research Program, summarizing the work performed under the Research Program and evaluating the work performed in relation to the goals of the Research Program.  Each Party shall provide such other information required by the Research Program or reasonably requested by the other Party and reasonably available, relating to the progress of the goals or performance of the Research Program.

 

ARTICLE IV

 

DEVELOPMENT AND COMMERCIALIZATION OF PRODUCTS; DILIGENCE

 

4.1                               Responsibility.  uniQure shall have full responsibility, at its sole expense, for the worldwide research, Development, manufacturing and Commercialization of Compounds and Products in the Field, subject to the payment obligations and other relevant terms and conditions of this Agreement.

 

4.2                               Diligence.  uniQure shall use Commercially Reasonable Efforts (itself or through an Affiliate or Sublicensee) to Develop, manufacture and Commercialize Royalty Bearing Compounds and Royalty Bearing Products in the Field (and, to the extent applicable under Section 4.4(b), Third Party Proposed Products and Third Party Competitive Products).

 

4.3                               Progress Reports.  After the end of the Research Term and continuing until the First Commercial Sale of a Royalty Bearing Product in any country in the Territory, uniQure shall provide, within [**] days after each [**] of each Calendar Year, a written progress report to 4DMT that summarizes the activities undertaken and the status of uniQure’s 

 

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Development efforts with respect to the Royalty Bearing Compounds and Royalty Bearing Products (and, to the extent applicable under Section 4.4(b), Third Party Proposed Products and Third Party Competitive Products) during the [**] months that ended on the immediately prior [**], as applicable.

 

4.4                               Proposed Products in the Field.

 

(a)                                 If, at any time after the Research Term, a Third Party makes a bona fide proposal to 4DMT for Developing and Commercializing a Product in the Field (a “Third Party Proposed Product”) using 4DMT Know-How or Joint Know-How, or the making, using or selling of which in the absence of an appropriate license would infringe a Valid Claim under the 4DMT Patent Rights or Joint Patent Rights, then 4DMT promptly shall notify uniQure of the proposal of such Third Party (“Third Party Proposer”) and shall provide uniQure with such information regarding such Third Party proposal, including a development plan and a plan to finance such activities (“Third Party Proposal”) as uniQure may reasonably request to evaluate such Third Party Proposal and its potential conflict with the ongoing efforts and future plans of uniQure.  At any time after the Research Term, 4DMT may make a bona fide proposal to uniQure for Developing and Commercializing a Product in the Field (a “4DMT Proposed Product”), including a development plan and a plan to finance such activities.  Within [**] days after receipt of a notice from 4DMT of a Third Party Proposal or 4DMT Proposed Product, uniQure shall notify 4DMT whether uniQure is conducting or is interested in conducting research or Development of such Third Party Proposed Product, 4DMT Proposed Product, or a Product that uniQure believes in good faith is or would be competitive with such Third Party Proposed Product or 4DMT Proposed Product (a “Competitive Product”).

 

(b)                                 If uniQure notifies 4DMT that uniQure is conducting or is interested in conducting research or Development of such Third Party Proposed Product, 4DMT Proposed Product or Competitive Product, uniQure shall, within [**] months after such notice, deliver to 4DMT a plan (including projected timelines) for the research and Development thereof and, thereafter, shall use Commercially Reasonable Efforts to research, Develop, manufacture and Commercialize such Third Party Proposed Product, 4DMT Proposed Product or Competitive Product consistent with the requirements under Section 4.2 in accordance with such plan.  Each progress report provided to 4DMT under Section 4.3 from and after the date of uniQure’s notice under this Section 4.4(d) shall contain a summary of the activities undertaken and the status of uniQure’s research and Development efforts with respect to such Third Party Proposed Product, 4DMT Proposed Product, or Competitive Product during the [**] months that ended on the immediately prior [**], as applicable.

 

(c)                                  If uniQure notifies 4DMT that uniQure is not conducting and is not interested in conducting research or Development of such Third Party Proposed Product, 4DMT Proposed Product, or Competitive Product, the Parties shall meet to determine whether the grant of an appropriate license, in the case of a Third Party Proposer, or an amendment to this Agreement, in the case of 4DMT, is necessary or appropriate in light of the circumstances, including consideration by the Parties of each of their respective rights and obligations.  If 4DMT determines after such meeting and due consideration that the grant of a license to such Third Party Proposer or amendment to this Agreement, as applicable, is necessary or appropriate,

 

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uniQure shall have [**] months after the date of receipt of written notice of such determination (or such longer time as shall be agreed to by the Parties in writing) to negotiate and enter into, as applicable, either (i) a sublicense under any relevant 4DMT Patent Rights to provide such Third Party Proposer with sufficient rights under the 4DMT Patent Rights (and no other intellectual property rights of any kind or Controlled by any person or entity) to research, Develop, manufacture and Commercialize the Third Party Proposed Product in the Field on commercially reasonable terms to be agreed by uniQure and such Third Party Proposer or (ii) an amendment to this Agreement to provide 4DMT with sufficient rights under the 4DMT Patent Rights to research, Develop, manufacture and Commercialize the 4DMT Proposed Product in the Field on commercially reasonable terms to be agreed by uniQure and 4DMT.  uniQure and such Third Party Proposer or 4DMT, as applicable, shall define and agree on the uniQure Know-How and uniQure Patent Rights necessary to Develop or Commercialize AAV Capsid Variants to be licensed in such sublicense or amendment, as applicable.

 

(d)                                 In the case of a Third Party Proposer, if uniQure fails to enter into such a sublicense agreement within such [**]month period, uniQure shall promptly (but in any event within [**] days after the end of such period) provide 4DMT in writing an explanation for such failure along with the proposed terms offered by uniQure to such Third Party Proposer.  If 4DMT determines in its good faith judgment based on reasonable inquiry that the terms offered by uniQure to such Third Party Proposer were not commercially reasonable, 4DMT shall notify uniQure of such determination and provide uniQure with an additional [**] days to enter into a sublicense with such Third Party Proposer.  If uniQure fails to enter into an agreement with such Third Party Proposer within such additional [**] day period, or in the case of a 4DMT Proposed Product, if uniQure and 4DMT fail to enter into an amendment to this Agreement within the [**] month negotiation period (a “Failure to Amend”), then 4DMT shall be free to dispute pursuant to ARTICLE XI whether uniQure has complied with its obligations under this Section 4.4.

 

(e)                                  If uniQure or its Affiliates or Sublicensees ceases Development and Commercialization of all Royalty Bearing Compounds and all Royalty Bearing Products for a continuous period of [**] despite using Commercially Reasonable Efforts as required under Section 4.2, (i) uniQure shall provide written notice of such decision to 4DMT, and (ii) if 4DMT thereafter exercises its rights under this Section 4.4 with respect to a 4DMT Proposed Product and a Failure to Amend occurs, then 4DMT may submit the unresolved terms of such amendment for determination by binding arbitration pursuant to ARTICLE XI.  In any such arbitration, the arbitrators shall be instructed to establish the commercially reasonable terms of such amendment within [**] days after the third arbitrator is appointed.

 

4.5                               Pharmacovigilance.  Within [**] months after the Effective Date, the Parties shall enter into an agreement governing the exchange of adverse event safety data (including post-marketing spontaneous reports) received by a Party and its Affiliates, including such data received from, in the case of uniQure, its Sublicensees or, in the case of 4DMT, its licensees, relating to any AAV Capsid Variant provided to uniQure by 4DMT hereunder in order to monitor the safety of all Compounds and Products and to meet reporting requirements with any applicable Regulatory Authority.  Such data sharing agreement shall not require the sharing of data that would disclose confidential know-how or trade secrets of a Party or its Affiliates, or in the case of uniQure, its Sublicensees or, in the case of 4DMT, its licensees, if such data may

 

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be cross-referenced, such as through a Drug Master File, to satisfy the requirements of Law and any applicable Regulatory Authority.

 

4.6                               Marking.  Prior to the issuance in the United States of Patent Rights included in the UC Patent Rights, uniQure agrees to mark Royalty Bearing Product(s) Covered by any UC Patent Right (or their containers or labels) sold in the United States under the licenses granted in this Agreement with the words “Patent Pending,” and following the issuance in the United States of one or more Patent Rights included in the UC Patent Rights, with the patent numbers of the UC Patent Right(s) Covering such Royalty Bearing Product.  All Royalty Bearing Products Covered by any UC Patent Right sold in other countries will be marked in such manner as to conform with the patent Laws and practice of such countries.

 

ARTICLE V

 

GRANTS OF RIGHTS

 

5.1                               Licenses to uniQure.

 

(a)                                 Research License to uniQure.  Subject to the terms and conditions of this Agreement, 4DMT hereby grants to uniQure, and uniQure hereby accepts, during the Research Term and any applicable GLP Tox Candidate Review Period in effect as of the end of the Research Term, an exclusive (but not as to 4DMT), worldwide, royalty-free, non-sublicenseable license under the 4DMT Intellectual Property and 4DMT’s interest in the Joint Intellectual Property, solely to (i) conduct activities assigned to uniQure under the Research Plan, (ii) evaluate Research Compounds, or (iii) evaluate the data developed in the conduct of activities under the Research Plan during the Research Term.

 

(b)                                 Development and Commercialization License to uniQure.  Subject to the terms and conditions of this Agreement, 4DMT hereby grants to uniQure, and uniQure hereby accepts, an exclusive (even as to 4DMT), worldwide, milestone- and royalty-bearing license, including the right to grant sublicenses in accordance with Section 5.3, under the 4DMT Intellectual Property and 4DMT’s interest in the Joint Intellectual Property, to research (subject to 4DMT’s retained rights to conduct research under the Research Program), Develop, make and have made, use and Commercialize Selected Capsid Variants, Royalty Bearing Compounds, and Royalty Bearing Products in the Field.

 

(c)                                  Recordation.  Following the Effective Date or at any time during the Term, 4DMT at the request and expense of uniQure shall promptly register or record the licenses granted to uniQure under this Agreement with the appropriate patent offices in all applicable countries of the Territory; provided that such registration or recordation specifies the applicable limitations of such license, and provided further that such registration shall have no effect on the allocation of Prosecution and Maintenance rights and obligations set forth in ARTICLE VII.  In the event any of the licenses granted to uniQure under this Agreement are terminated in accordance with the terms of this Agreement, uniQure shall promptly take such actions and execute such documents as are reasonably requested by 4DMT to cancel such

 

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registration(s) or recordation(s) in the applicable countries with respect to the terminated license grants.

 

5.2                               Licenses to 4DMT.

 

(a)                                 Research License to 4DMT.  Subject to the terms and conditions of this Agreement, uniQure hereby grants to 4DMT, and 4DMT hereby accepts, during the Research Term and any applicable GLP Tox Candidate Review Period in effect as of the end of the Research Term, a non-exclusive, worldwide, royalty-free, non-sublicenseable license under the uniQure Intellectual Property, solely to the extent necessary to conduct activities assigned to 4DMT under the Research Plan.

 

(b)                                 Grant-Back License to 4DMT Outside the Field.  uniQure hereby grants to 4DMT, and 4DMT hereby accepts, a non-exclusive, worldwide, royalty-free license, including the right to grant sublicenses through multiple tiers, under the Patent Rights and Know-How Controlled by uniQure that (i) arise from activities that are conducted under this Agreement in connection with Royalty Bearing Compounds and Royalty Bearing Products in the course of making modifications to Selected Capsid Variants and (ii) claim or cover compositions of matter or general methods of use of Selected Capsid Variants that are applicable outside the Field  (for clarity, excluding Patent Rights and Know-How claiming or covering (A) insect cell manufacturing technology, including technology or sequence modifications for adapting AAV Capsid Variants to insect cells or insect cell expression vectors and systems, or (B) compositions, methods of manufacture, or methods of use of Gene Therapy Constructs, but for further clarity, including such Patent Rights and Know-How claiming or covering compositions combining Gene Therapy Constructs in general and AAV Capsid Variants in general or general methods of making or using such combinations of Gene Therapy Constructs and AAV Capsid Variants), to research, Develop, make and have made, use and Commercialize 4DMT AAV Capsid Variants (excluding Selected Capsid Variants), and Products containing such 4DMT AAV Capsid Variants, in all cases outside the Field.  For the avoidance of doubt, 4DMT’s practice of the foregoing license shall be subject to its exclusivity obligations set forth in Section 5.6.  If any Patent Rights or Know-how subject to the foregoing license are subject to agreements between uniQure and a Third Party that require payments to be made to the Third Party by reason of the practice of the rights granted to 4DMT under this Section 5.2(b), such Patent Rights and Know-How shall only be deemed Controlled by uniQure if 4DMT agrees in writing to pay to uniQure the portion of the amounts due to such Third Party that is reasonably attributable to the practice of such rights.

 

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5.3                               Sublicenses.  uniQure shall have the right to grant sublicenses under the license granted to it under Section 5.1(b) to Affiliates of uniQure and Third Parties; provided that any sublicense granted to a Third Party under this Agreement shall be pursuant to a written agreement that subjects such Sublicensee to all relevant restrictions and limitations set forth in this Agreement.  uniQure shall provide 4DMT with the name and address of each Sublicensee of its rights under this ARTICLE V, the date of the grant of the sublicense and a description of the rights granted promptly after the execution and delivery of the sublicense agreement.  uniQure shall remain responsible for the performance of its Sublicensees, and shall ensure that each Sublicensee complies with the applicable terms and conditions of this Agreement.

 

5.4                               Rights Retained by the Parties.  Except as expressly set forth in this Agreement, neither Party shall acquire any license or other intellectual property interest, by implication or otherwise, in any Confidential Information of the other Party or under any Patent Right or Know-How in which such other Party or its Affiliates has rights.  Without limiting the generality of the foregoing, any of 4DMT’s rights to 4DMT Intellectual Property not specifically licensed to uniQure shall be retained by 4DMT, and any of uniQure’s rights to uniQure Intellectual Property not specifically licensed to 4DMT shall be retained by uniQure.

 

5.5                               Section 365(n) of the Bankruptcy Code.  All rights and licenses granted under or pursuant to any section of this Agreement are and will otherwise be deemed to be for purposes of Section 365(n) of the United States Bankruptcy Code (Title 11, U.S. Code), as amended or any comparable Law outside the United States (the “Bankruptcy Code”), licenses of rights to “intellectual property” as defined in Section 101(35A) of the Bankruptcy Code.  The Parties will retain and may fully exercise all of their respective rights and elections under the Bankruptcy Code.  Each Party agrees that the other Party, as licensee of such rights under this Agreement, will retain and may fully exercise all of its rights and elections under the Bankruptcy Code or any other provisions of applicable Law outside the United States that provide similar protection for “intellectual property.” The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against a Party under the Bankruptcy Code or analogous provisions of applicable Law outside the United States, the other Party will be entitled to a complete duplicate of (or complete access to, as appropriate) the intellectual property licensed to such other Party and all embodiments of such intellectual property, to the extent necessary for such other Party to practice the licenses granted to it pursuant to this Agreement under such intellectual property, which, if not already in such other Party’s possession, will be promptly delivered to it upon such other Party’s written request thereof.  Any agreement supplemental hereto will be deemed to be “agreements supplementary to” this Agreement for purposes of Section 365(n) of the Bankruptcy Code.

 

5.6                               Exclusivity.

 

(a)                                 Of 4DMT.  During the Term, 4DMT agrees to work exclusively with uniQure to research, Develop, manufacture and Commercialize AAV Capsid Variants, Compounds and Products in the Field, and Selected Capsid Variants, Royalty Bearing Compounds and Royalty Bearing Products in any field.  In furtherance of the foregoing, 4DMT agrees, subject to the exceptions set forth in Section 5.6(b), that during the Term, it and its Affiliates shall not disclose any 4DMT Know-How or Joint Know-How, or grant rights to any

 

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Third Party, to research, Develop, manufacture or Commercialize (i) any AAV Capsid Variant, Compound or Product in the Field or (ii) any Selected Capsid Variant, Royalty Bearing Compound or Royalty Bearing Product inside or outside the Field, in each case outside the scope of this Agreement.  For clarity, notwithstanding the foregoing, 4DMT and its Affiliates may themselves, and may enter into licensing agreements and grant rights to Third Parties under 4DMT Intellectual Property, to research, Develop, manufacture or Commercialize any AAV Capsid Variants, Compound or Product (other than a Selected Capsid Variant, Royalty Bearing Compound or Royalty Bearing Product) outside the Field, as long as the relevant AAV Capsid Variant arose from a Selection Process conducted outside the Field.  The Parties acknowledge that if 4DMT or its Affiliates or licensees research, Develop, manufacture or Commercialize AAV Capsid Variants that are not subject of the Research Program and products containing such AAV Capsid Variants that are demonstrated to be specifically targeted to cells not included in the CNS or the liver by any route of administration, as long as the relevant AAV Capsid Variant arose from a Selection Process conducted outside the Field, that such activities shall not be deemed to violate the terms of this Section 5.6(a).  For purposes of further clarity and without limiting the foregoing, if an AAV Capsid Variant (other than a Selected Capsid Variant) is generated from a Selection Process for a specified target tissue other than the CNS or the liver, including for treatment of neoplastic and eye disorders, then such AAV Capsid Variant shall be deemed to be specifically targeted to cells not included in the CNS or the liver; provided that such AAV Capsid Variant may not then be used for the purpose of targeting cells in the CNS or the liver.

 

(b)                                 Exceptions.  The prohibitions set forth in Section 5.6(a) do not apply where 4DMT’s or its Affiliates’ (the “Acquiring/Acquired Party”) involvement in such activity results from its acquisition of or by a Third Party (by merger or otherwise), and such former Third Party was engaged in such activity prior to such acquisition or merger; provided that (i) the Acquiring/Acquired Party shall not provide any such former Third Party with rights or access to the 4DMT Intellectual Property for use in connection with activities prohibited by this Section 5.6 if undertaken by the Acquiring/Acquired Party, and (ii) in the case where the Acquiring/Acquired Party acquires a Third Party (by merger or otherwise), the Acquiring/Acquired Party does not expand the scope of, or increase the financial commitment to, such Third Party activities from what it was immediately prior to the acquisition.

 

(c)                                  uniQure Independent Activities.  The Parties acknowledge and agree that uniQure will conduct research, Development, manufacturing and Commercialization activities independently of this Agreement, inside and outside of the Field, including with respect to AAV Capsid Variants, AAV Capsid Variant Libraries, Gene Therapy Constructs, Compounds and Products, and no provision of this Agreement shall apply to any such activity.

 

5.7                               UCB Agreement Pass-Through Provisions.  uniQure acknowledges that 4DMT has provided it with a copy of the executed UCB Agreements, and agrees that this Agreement is subject in all respects to the terms and conditions of the UCB Agreements.  Notwithstanding the generality of the foregoing:

 

(a)                                 uniQure acknowledges that UC (and, to the extent applicable, IGT) may publish any and all technical data resulting from any research performed by UC (and, to the 

 

29

 

extent applicable, IGT) relating to the inventions disclosed in the UC Patent Rights, and UC (and, to the extent applicable, IGT) expressly reserves the right to use such inventions, UC AAV Capsid Variants and related technology for its educational and research purposes, to disseminate the UC AAV Capsid Variants and other tangible materials associated with, or required to practice such inventions or the UC Patent Rights to researchers at nonprofit institutions for their educational and research purposes, and to permit other nonprofit institutions to use the UC AAV Capsid Variants to practice the UC Patent Rights for education and research purposes.

 

(b)                                 uniQure shall keep 4DMT informed of its large/small entity status, as defined in 15 U.S.C. 632.

 

(c)                                  uniQure acknowledges that certain of the inventions disclosed in the UC Patent Rights were funded in part by the U.S. Government, and agrees that in accordance with 35 U.S.C. 204, to the extent required by Law, any products covered by the UC Patent Rights and sold in the United States will be substantially manufactured in the United States.

 

(d)                                 uniQure acknowledges that 4DMT’s exclusive rights, privileges, and licenses under the UCB Agreements will expire on the date of the last-to-expire Valid Claim under the UC Patent Rights covered in each agreement, respectively, unless earlier terminated.

 

(e)                                  For any sublicense under the UC Patent Rights that uniQure grants under Section 5.3, uniQure shall ensure that (i) such further sublicense is subject to a written sublicense agreement and is bound by all of the applicable terms, conditions, obligations, restrictions and other covenants of the UCB Agreements that protect or benefit UC’s (and, if applicable, the U.S. Government’s) rights and interests to the same extent that this Agreement does, and (ii) it or the Sublicensee shall, within [**] days after executing such sublicense agreement, furnish to 4DMT for delivery to UC, subject to any confidentiality provisions, all material terms of such sublicense pertaining to UC’s interests, including the Sublicensee’s name and address, and indemnification of UC as provided in this Agreement.

 

(f)                                   The Parties acknowledge and agree that upon termination of the UCB Agreements for any reason, uniQure’s sublicenses under the UC Patent Rights under this Agreement will remain in effect and will be assigned to UC, except that UC will not be bound to perform any duties or obligations set forth herein that extend beyond the duties and obligations of UC set forth in the UCB Agreements.

 

(g)                                  uniQure acknowledges that nothing contained in this Agreement will be construed as conferring any right to use in advertising, publicity or other promotional activities any name, trademark, trade name, or other designation of UC (including any contraction, abbreviation, or simulation of any of the foregoing), and that unless required by Law, regulation, or rules of a securities exchange, or consented to in writing by UC, the use by uniQure of the name “The Regents of the University of California” or the name of any University of California campus in advertising, publicity or other promotional activities is expressly prohibited.

 

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ARTICLE VI

 

PAYMENTS; ROYALTIES AND REPORTS

 

6.1                               Initial License Payment.  In consideration of the rights to 4DMT Intellectual Property granted herein, uniQure shall pay to 4DMT non-creditable and non-refundable sums of: (a) One Hundred Thousand Dollars ($100,000) within [**] Business Days after the later of (i) the Effective Date and (ii) receipt of an Invoice for such amount and a duly signed original of this Agreement and, thereafter, (b) [**] Dollars ($[**]) within [**] Business Days after the later of (i) the JRSC’s approval of the initial Research Plan (including its associated budget) and (ii) receipt of an Invoice for such amount.

 

6.2                               Research Program Funding.

 

(a)                                 Out-of-Pocket Costs.  Following approval of the Research Plan (including its associated budget), uniQure shall fund all out-of-pocket costs to be incurred by 4DMT as specifically contemplated in the Research Plan, in accordance with the agreed-upon budget for such costs set forth in the Research Plan or as otherwise agreed to by uniQure.  On or before the first date of each Calendar Quarter during the Research Term, uniQure shall pay 4DMT for such out-of-pocket costs to be incurred by 4DMT during such Calendar Quarter.  Within [**] days after the end of each Calendar Quarter during the Research Term, 4DMT shall provide uniQure with a statement identifying such out-of-pocket costs incurred by 4DMT and paid to Third Parties in connection with the Research Program during such Calendar Quarter, in reasonable detail and with appropriate supporting documentation.  If the supporting documentation shows that uniQure has overpaid or underpaid the out-of-pocket costs for such Calendar Quarter, 4DMT will, together with the supporting documentation, (i) send uniQure a credit note for the amount overpaid, upon which uniQure may credit the amount overpaid against any other payment due by uniQure under this Agreement, or if no other payment is due under this Agreement, 4DMT shall within [**] days refund the amount overpaid to uniQure, or (ii) send uniQure an Invoice for the amount underpaid, which uniQure shall pay within [**] days after uniQure’s receipt of such Invoice.  For clarity, no out-of-pocket costs will be paid by uniQure unless covered by an agreed-upon budget for such expenses set forth in the Research Plan or as otherwise agreed to by uniQure.

 

(b)                                 4DMT Committed FTEs.  It is the Parties’ intent that the Research Program will support the number of 4DMT FTEs in the performance of the activities under the Research Plan during the Research Term, as specified in the Research Plan and approved by the JRSC.  Following approval of the Research Plan (including its associated budget), on or before the first day of each Calendar Quarter during the Research Term, uniQure shall pay 4DMT the FTE Costs for FTEs in the then-current Research Plan for such Calendar Quarter; provided that such payment may be pro rated in the first and last Calendar Quarters of the Research Term.  Within [**] days after the end of each Calendar Quarter during the Research Term, 4DMT shall provide supporting documentation for the purpose of verifying the calculation of the FTE charges paid by uniQure for such Calendar Quarter.  If the supporting documentation shows that uniQure has overpaid or underpaid the FTE payments for such Calendar Quarter, 4DMT will, together with the supporting documentation, (i) send uniQure a credit note for the amount

 

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overpaid, upon which uniQure may credit the amount overpaid against any FTE or other payment due by uniQure under this Agreement, or if no other payment is due under this Agreement, 4DMT shall within [**] days refund the amount overpaid to uniQure, or (ii) send uniQure an Invoice for the amount underpaid, which uniQure shall pay within [**] days after uniQure’s receipt of such Invoice.  For clarity, no FTE Costs will be paid by uniQure unless covered by an agreed-upon budget for such FTEs set forth in the Research Plan or as otherwise agreed to by uniQure.

 

(c)                                  Equipment Payment Reimbursement.  Any amount paid by uniQure pursuant to Section 6.2(a) for the purchase of equipment (“Equipment Payment”) shall be subject to partial reimbursement by 4DMT in accordance with this Section 6.2(c).  For each of the first [**] Third Party collaborations 4DMT enters into after the Effective Date, 4DMT shall reimburse uniQure for a pro rata portion of the Equipment Payment based on the following formula:  [**].  For example, if 4DMT conducts [**] Research Selection Processes hereunder and [**] Selection Processes for the first such Third Party collaboration in which such equipment was actually used, 4DMT shall reimburse uniQure for [**] percent ([**]%) of the Equipment Payments.  If 4DMT subsequently conducts another [**] Selection Processes for the second Third Party collaboration in which such equipment was actually used, 4DMT shall reimburse uniQure for a further [**] percent ([**]%) of Equipment Payments, since the [**] Research Selection Processes it conducted for uniQure represents [**] of the aggregate Selection Processes conducted by 4DMT for uniQure and for the first [**] Third Party collaborations 4DMT entered into after the Effective Date.  4DMT shall pay uniQure any such amount payable under this Section 6.2(c) within [**] days after the end of the Calendar Quarter during which 4DMT conducted any Selection Process for either of the first [**] Third Party collaborations 4DMT enters into after the Effective Date in which such equipment was actually used, and shall contemporaneously provide uniQure with a written report detailing the calculation of such amount.

 

6.3                               Research and Development Milestone Payments.

 

(a)                                 Research Milestone Payments.  uniQure shall pay to 4DMT the non-refundable, non-creditable milestone payments set forth below upon the occurrence of the applicable milestone event on a Research Selection Process-by-Research Selection Process basis:

 

	
Milestone Event
    	
 
    	
Payment
    
	
(i)
    	
[**]
    	
 
    	
[**]
    
	
(ii)
    	
[**]
    	
 
    	
[**]
    
	
(iii)
    	
[**]
    	
 
    	
[**]
    

 

For clarity, if the milestone event set forth in Section 6.3(a)(i) is achieved by a first Research Compound and the corresponding milestone payment is made to 4DMT, and the milestone is subsequently achieved by a second or a third Research Compound from the same Research Selection Process, then uniQure shall not be obligated to pay

 

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the milestone payment set forth in Section 6.3(a)(i) upon such achievement and shall pay instead the milestone payment set forth in Section 6.3(a)(ii) for the second such Research Compound and the milestone payment set forth in Section 6.3(a)(iii) for the third such Research Compound.  For clarity, no milestone payment under this Section 6.3(a) shall by payable for any achievement by a fourth or subsequent Research Compound from the same Research Selection Process.

 

(b)                                 Development Milestone Payments.  uniQure shall pay to 4DMT the non-refundable, non-creditable milestone payments set forth below upon the occurrence of the applicable milestone event, on a Royalty Bearing Product-by-Royalty Bearing Product and Indication-by-Indication basis:

 

	
Milestone Event
    	
 
    	
Payment
    
	
(i)
    	
[**]
    	
 
    	
[**]
    
	
(ii)
    	
[**]
    	
 
    	
[**]
    
	
(iii)
    	
[**]
    	
 
    	
[**]
    
	
(iv)
    	
[**]
    	
 
    	
[**]
    
	
(v)
    	
[**]
    	
 
    	
[**]
    

 

(1)                                 The achievement of milestone events set forth in Section 6.3(b)(i) through Section 6.3(b)(v) shall be determined on a Royalty Bearing Product-by-Royalty Bearing Product and Indication-by-Indication basis.  The achievement by a Royalty Bearing Product of the same milestone event that had been achieved by a different Royalty Bearing Product shall trigger another payment of the applicable milestone payment.  The achievement by a Royalty Bearing Product of the same milestone event with respect to a different Indication also shall trigger another payment of the applicable milestone payment.  For purposes hereof, one Royalty Bearing Product shall be different from another Royalty Bearing Product if it contains a different delivered nucleic acid and is Developed to treat a different Indication.  An Indication that is a subset of or encompasses within its scope another Indication shall not be deemed a different Indication from such other Indication.

 

(2)                                 The achievement of any later-listed milestone event set forth in Section 6.3(b)(ii) through Section 6.3(b)(v) shall cause payment for any earlier-listed milestone event in Section 6.3(b)(i) through Section 6.3(b)(iv) to become payable if such earlier-listed milestone event had not already become payable.

 

(3)                                 Notwithstanding the foregoing, if (A) Development of a Royalty Bearing Product is terminated after any milestone payment set forth in Section 6.3(b)(i) through Section 6.3(b)(v) has been

 

33

 

made with respect to such Royalty Bearing Product and (B) another Royalty Bearing Product is selected to replace the terminated Royalty Bearing Product for the same Indication (“Replacement Product”), then there shall be no payment due upon achievement of the same milestone by such Replacement Product for which 4DMT already received a milestone payment for the original Royalty Bearing Product.  For purposes of this Section 6.3(b), if Development of a Royalty Bearing Product is terminated, any Royalty Bearing Product containing a Research Compound from the same Research Selection Process, and Developed for the same Indication as such terminated Royalty Bearing Product, shall be deemed a Replacement Product.

 

(c)                                  Payment of Milestones.  uniQure shall provide written notice to 4DMT of the achievement of any milestone event set forth in Section 6.3(a) or Section 6.3(b) within [**] Business Days after the occurrence of such milestone event, and shall make the corresponding milestone payment within [**] days after receipt of an Invoice therefor.

 

6.4                               Royalties.  On a Royalty Bearing Product-by-Royalty Bearing Product basis, uniQure shall pay to 4DMT royalties on worldwide Net Sales as provided in this Section 6.4:

 

(a)                                 Royalty Rate.  uniQure shall pay to 4DMT royalties on Net Sales of each Royalty Bearing Product by uniQure and its Affiliates equal to [**] percent ([**]%) of all such Net Sales of such Royalty Bearing Product achieved during the applicable Calendar Year.

 

(b)                                 Royalty Term.  uniQure’s royalty obligations to 4DMT under this Section 6.4 shall be in effect on a country-by-country and Royalty Bearing Product-by-Royalty Bearing Product basis during the relevant Royalty Term.  Upon expiration of the Royalty Term for a Royalty Bearing Product in a country, the license under Section 5.1(b) shall be fully paid-up, irrevocable, perpetual and exclusive under the relevant Licensed IP for such Royalty Bearing Product in such country.

 

(c)                                  Royalty Adjustments.

 

(i)                                     Non-Patented Product.  If a Royalty Bearing Product is sold in a country and the composition of matter, formulation, or method of use of such Royalty Bearing Product is not Covered by a Valid Claim within the Licensed IP in such country at the time of sale, then the royalty rate for such Royalty Bearing Product in such country shall be reduced by [**] percent ([**]%) of the applicable rate determined pursuant to Section 6.4(a), unless such Royalty Bearing Product embodies an Invention with respect to which uniQure made a Trade Secret Election, in which case no such reduction shall apply.

 

(ii)                                  Third Party Offset.  If uniQure is required, in order to avoid infringement of any Patent Right not licensed hereunder that Covers the composition of matter, formulation, or method of use of a Royalty Bearing Product, to obtain a license from a Third Party in order to Develop, make, have made, use or Commercialize such Royalty Bearing Product in a country in the Territory and to pay a royalty or other consideration under such license (including in connection with the settlement of a patent infringement claim), then the royalty payments due under Section 6.4(a) with respect to Net Sales for such Royalty Bearing

 

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Product in such country shall be reduced by [**] percent ([**]%) of the amounts payable by uniQure to such Third Party for such license that are reasonably and appropriately allocable to such Royalty Bearing Product in such country, provided that in no event shall the foregoing reduce the amount of royalties payable to 4DMT in any Calendar Quarter by more than [**]percent ([**]%) of the amount determined pursuant to Section 6.4(a), as adjusted by application of the terms of Section 6.4(c)(i).

 

(iii)                               Limits on Deductions.  Except as expressly provided in this Section 6.4, there shall not be any offset to or deduction from the royalties payable pursuant to this Section 6.4.  Notwithstanding Sections 6.4(c)(i) and (ii) to the contrary, in no event shall the cumulative effect of the deductions in Sections 6.4(c)(i) and (ii) reduce the royalties to less than [**] percent ([**]%) of the amounts determined pursuant to Section 6.4(a).

 

6.5                               Sublicense Consideration.

 

(a)                                 uniQure shall pay to 4DMT the following percentages (“Sublicense Income Sharing Percentages”) of Sublicense Consideration received by uniQure for sublicenses under the Licensed IP under this Agreement:

 

(i)                                     [**] percent ([**]%) for any sublicense that (A) is granted prior to initiating Animal POC for any Compound or Product that is subject of the sublicense and (B) does not require uniQure to manufacture any such Compound or Product for Clinical Trial or commercial purposes;

 

(ii)                                  [**] percent ([**]%) for any sublicense that (A) is granted prior to initiating Animal POC for any Compound or Product that is subject of the sublicense and (B) requires uniQure to manufacture any such Compound or Product for Clinical Trial or commercial purposes;

 

(iii)                               [**] percent ([**]%) for any sublicense that does not meet the criteria set forth in Section 6.5(a)(i) or Section 6.5(a)(ii) above;

 

provided, however, that none of subsections (i), (ii) or (iii) shall result in uniQure paying to 4DMT under this Section 6.5 a percentage of any Sublicense Consideration consisting of royalties from Sublicensees on sales of UC Products during the applicable Royalty Term that is less than [**] percent ([**]%) of Net Sales by such Sublicensee of such UC Products.

 

(b)                                 The term “Sublicense Consideration” shall mean consideration of any kind received by uniQure from a Sublicensee for the grant of a sublicense under this Agreement, such as upfront fees, royalties or milestone fees and including any premium paid by the Sublicensee over the Fair Market Value (as defined below) for stock of uniQure in consideration for such sublicense; provided, however, the following are not included in Sublicense Consideration:

 

(i)                                     Support for activities of uniQure relating to the research, Development, manufacturing or Commercialization of Royalty Bearing Products, which shall not exceed the fully burdened cost (and in the case of manufacturing costs, the Fully Burdened 

 

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Manufacturing Cost) for undertaking such activities performed by or for uniQure (including Third Parties on uniQure’s behalf) by more than [**] percent ([**]%);

 

(ii)                                  Proceeds derived from debt financing and any loans to uniQure by the Sublicensee;

 

(iii)                               Consideration received for the purchase of stock in uniQure or its Affiliate to the extent that the price per share for such equity does not exceed the Fair Market Value of such stock.  The term “Fair Market Value” shall mean the average price at which the stock in question is publicly trading at for [**] days prior to the earlier of (A) the date of the announcement of its purchase by the Sublicensee or (B) the date of its purchase by the Sublicensee, or if the stock is not publicly traded, the value of such stock as determined in good faith by the Board of Directors of uniQure or its applicable Affiliate as of the time of receipt of payment; and

 

(iv)                              Reimbursement of uniQure’s patent costs related to Patent Rights.

 

6.6                               Reports; Payments.  Within [**] days after the end of each Calendar Quarter during which there are Net Sales giving rise to a payment obligation under Section 6.4 or uniQure received Sublicense Consideration giving rise to a payment obligation under Section 6.5, (a) uniQure shall submit to 4DMT a report (i) identifying for each Royalty Bearing Product the Net Sales for such Royalty Bearing Product for each country for such Calendar Quarter, the calculation of royalties (including gross sales and all deductions taken from gross sales and all reductions pursuant to Section 6.4(c)), and the royalties payable to 4DMT and (ii) identifying the Sublicense Consideration received by uniQure in such Calendar Quarter and the one or more Sublicense Income Sharing Percentages applicable to such Sublicense Consideration, and (b) uniQure shall pay to 4DMT all royalties payable by uniQure under Section 6.4 and portions of Sublicense Consideration payable by uniQure under Section 6.5.

 

6.7                               Books and Records; Audit Rights.  Each Party (the “Audited Party”) shall keep (and shall cause its Affiliates and Sublicensees to keep) complete, true and accurate books and records in accordance with its Accounting Standards in sufficient detail for the other Party (the “Auditing Party”) to determine the payments due and costs incurred under this Agreement.  Each Auditing Party shall have the right, [**] at its own expense, to have an independent, certified public accounting firm of nationally recognized standing, selected by the Auditing Party and reasonably acceptable to the Audited Party, review any such records of the Audited Party in the location(s) where such records are maintained by the Audited Party upon reasonable notice (which shall be no less than [**] days prior notice) and during regular business hours and under obligations of strict confidence, for the sole purpose of verifying the accuracy of the amounts paid under this Agreement within a [**] Calendar Year period preceding the date of the request for review.  The report of such accounting firm shall be limited to a certificate stating whether any report made or invoice or payment submitted by the Audited Party during such period is accurate or inaccurate, the actual amounts of 4DMT out-of-pocket expenses under Section 6.2(a), FTE Costs under Section 6.2(b), Equipment Payment reimbursements under Section 6.2(c), and any payments under Section 3.6, and the amount of any Net Sales, milestone, royalty 

 

36

 

or other payment discrepancy.  No other information shall be provided to the Auditing Party.  The Audited Party shall receive a copy of each such report concurrently with receipt by the Auditing Party.  Should such inspection lead to the discovery of a discrepancy to the Auditing Party’s detriment, the Audited Party shall pay the amount of the discrepancy within [**] days after its receipt from the accounting firm of the certificate showing the amount of the discrepancy.  The Auditing Party shall pay the full cost of the review unless (a) uniQure was the Audited Party and the audited determined an underpayment of milestones or royalties which is greater than [**] percent ([**]%) of the amount due for the applicable period, in which case uniQure shall pay the reasonable costs charged by such accounting firm for such review, or (b) 4DMT was the Audited Party and the audit determined an overpayment of 4DMT out-of-pocket expenses under Section 6.2(a) or FTE Costs under Section 6.2(b), or underpayment of Equipment Payment reimbursements under Section 6.2(c), which is greater than [**] percent ([**]%) of the amount due for the applicable period, in which case 4DMT shall pay the reasonable costs charged by such accounting firm for such review.  Any overpayment of royalties by uniQure revealed by an inspection shall be fully creditable against future royalty payments under Section 6.4.

 

6.8                               Withholding Taxes.  Subject to the provisions of Section 12.7, if Laws require withholding by uniQure of taxes imposed upon 4DMT on account of any royalty or other payment paid under this Agreement, such taxes shall be deducted by uniQure as required by Law from such remittable royalty or other payment and shall be paid by uniQure to the proper tax authorities; provided that before making any such deduction or withholding, uniQure shall give 4DMT notice of the intention to make such deduction or withholding, which notice shall include the authority, basis and method of calculation for the proposed deduction or withholding, and shall be provided to the extent practicable at least a reasonable period of time before such deduction or withholding is required, in order for 4DMT to obtain reduction of or relief from such deduction or withholding.  Official receipts of payment of withholding taxes shall be secured and sent to 4DMT as evidence of such payment.  The Parties shall exercise their best efforts to ensure that any withholding tax imposed is reduced as far as possible under the provisions of any relevant tax treaty.

 

6.9                               United States Dollars.  All dollar ($) amounts specified in this Agreement are United States dollar amounts.

 

6.10                        Payment Method and Currency Conversion.  Except as otherwise provided herein, all payments due to a Party hereunder shall be due and payable within [**] days after receipt of an invoice from the other Party and shall be paid via a bank wire transfer to such bank account as such Party shall designate.  For the purposes of determining the amount of any payment due to 4DMT hereunder for the relevant Calendar Quarter under Section 6.4 or Section 6.5, amounts received by uniQure in any foreign currency shall be converted into United States dollars in accordance with the normal business practice of uniQure, as applied consistently across its business.

 

6.11                        Blocked Payments.  If, by reason of applicable Laws in any country in the Territory, it becomes impossible or illegal for uniQure or any of its Affiliates or Sublicensees to transfer, or have transferred on its behalf, royalties or other payments to 4DMT, uniQure shall 

 

37

 

promptly notify 4DMT of the conditions preventing such transfer and such royalties or other payments shall be deposited in local currency in the relevant country to the credit of 4DMT in a recognized banking institution with a good creditworthiness, such banking institution to be designated by 4DMT or, if none is designated by 4DMT within [**] days, in a recognized banking institution selected by uniQure or its Affiliate or Sublicensee, as the case may be, and identified in a written notice given to 4DMT.  If so deposited in a foreign country, uniQure shall provide, or cause its Affiliate or Sublicensee to provide, reasonable cooperation to 4DMT so as to allow 4DMT to assume control over such deposit as promptly as practicable.

 

6.12                        Late Payments.  Any payment not made within [**] Business Days after the due date for such payment pursuant to the terms of this Agreement shall bear interest at a rate of the thirty-day U.S. dollar LIBOR rate effective for the date that payment was due (as published in The Wall Street Journal, Eastern Edition) plus [**] per annum.  Calculation of interest will be made for the exact number of days the payment was past due based on a year of 360 days (actual days/360).

 

ARTICLE VII

 

PATENTS

 

7.1                               Disclosure.  Each Party shall promptly disclose to the other Party any Inventions that it or its Affiliates or Sublicensees or their employees, independent contractors, or agents solely or jointly make, conceive, reduce to practice, or otherwise discover under this Agreement, and each Party shall maintain and make available to the other Party records regarding any Inventions that it has an obligation to assign under Section 7.2(a).

 

7.2                               Ownership.

 

(a)                                 uniQure shall solely own all Core uniQure Intellectual Property, and 4DMT shall solely own all Core 4MDT Intellectual Property.  Without additional consideration, each Party shall assign and hereby does assign to the other Party such of its right, title, and interest in and to such Patent Rights (and shall require its Affiliates and Sublicensees, and all employees, independent contractors and their employees, and agents of such Party and its Affiliates and Sublicensees to so assign to the other Party such of their right, title, and interest) as is necessary to effectuate the allocation of right, title, and interest as set forth in this Section 7.2(a).

 

(b)                                 Except as set forth in Section 7.2(a), as between the Parties, (i) each Party shall solely own all Know-How and Inventions invented solely by employees, agents and consultants of such Party or its Affiliates, and any Patent Right related thereto, subject to the licenses granted under ARTICLE V, and (ii) Know-How and Inventions invented jointly by employees, agents, or consultants of the Parties or their Affiliates (“Joint Intellectual Property”, which includes any Patent Right Covering such Know-How and Inventions (“Joint Patent Rights”) and any Know-How included in such Joint Intellectual Property (“Joint Know-How”)) shall be jointly owned, subject to the licenses granted under ARTICLE V.  Inventorship shall be 

 

38

 

determined in accordance with U.S. patent Laws for purposes of determining ownership in accordance with the foregoing.

 

(c)                                  Except as expressly provided in this Agreement, and subject to any restriction herein (including the licenses and exclusivity granted under ARTICLE V), (i) each joint owner may engage in research, Development, manufacturing and Commercialization activities relating to Joint Intellectual Property, and (ii) each may assign, license, sell or otherwise encumber or transfer any such interest without the prior written approval of the other Party and without obligation to account or provide compensation to the other Party.

 

7.3                               uniQure Prosecution and Maintenance of Patent Rights.

 

(a)                                 uniQure shall be solely responsible for the Prosecution and Maintenance of the uniQure Patent Rights, including the Core uniQure Patent Rights, at its sole expense and its sole discretion.  uniQure shall give 4DMT an opportunity to review the text of each application, office action response or other substantive document for [**] (but not any other uniQure Patent Right) before filing with any patent office in the Territory, shall consider 4DMT’s reasonable comments with respect thereto, and shall supply 4DMT with a copy of each such application, office action response or other substantive document as filed, together with notice of its filing date and serial number.

 

(b)                                 uniQure shall have the sole right to determine whether any patent application is filed with respect to any Core uniQure Know-How and whether to maintain any Invention included in the Core uniQure Know-How as a trade secret.  uniQure shall provide 4DMT with written notice if uniQure elects not to file a patent application claiming any particular Invention included in the Core uniQure Know-How specifically relating to compositions of matter of, methods of use of, or methods of making any Selected Capsid Variant because uniQure prefers to maintain such Invention as a trade secret (each, a “Trade Secret Election”).

 

(c)                                  uniQure shall notify 4DMT at least [**] days in advance of any applicable deadline if (i) uniQure decides that it does not wish to continue the Prosecution and Maintenance of a [**] for which no substitute has been filed, or (ii) uniQure decides that it intends to abandon claim scope in a [**], which claim scope is intended to be maintained by 4DMT, in which case, with respect to this clause (ii), 4DMT may assume responsibility for such claim scope by filing a divisional application restricted to such claim scope.  In such cases (i) or (ii), uniQure shall allow 4DMT to assume responsibility for Prosecution and Maintenance of such Core uniQure Patent Right or divisional application at 4DMT’s expense.  If 4DMT assumes such responsibility, then 4DMT may designate any counsel of its choice reasonably acceptable to uniQure to handle the Prosecution and Maintenance of such Core uniQure Patent Right or divisional application (which shall otherwise continue to be part of the Core uniQure Patent Rights).

 

7.4                               4DMT Prosecution and Maintenance of Patent Rights.  4DMT shall be solely responsible for the Prosecution and Maintenance of the 4DMT Patent Rights, including the Core 4DMT Patent Rights, at its sole expense and its sole discretion.  4DMT will reasonably 

 

39

 

inform uniQure regarding the Prosecution and Maintenance of 4DMT Patent Rights (including in any case, an update at least [**]).  Notwithstanding the foregoing, the Parties acknowledge that UC will handle the Prosecution and Maintenance of the UC Patent Rights in accordance with the terms of the UCB Agreements.

 

7.5                               Prosecution and Maintenance of Joint Patent Rights.  The Prosecution and Maintenance of any Joint Patent Right shall be through a mutually selected patent counsel.  Within [**] days following the Effective Date, the Parties shall agree on a patent counsel (“Joint Counsel”) who shall be engaged by both Parties for the Prosecution and Maintenance of all such Joint Patent Rights.  The following terms shall apply to each Joint Patent Right:

 

(a)                                 The Parties shall instruct Joint Counsel to conduct its activities as follows:  The Joint Counsel shall give uniQure and 4DMT (or each Party’s designee) an opportunity to review the text of each application, office action response or other substantive document for a Joint Patent Right before filing with any patent office in the Territory, shall incorporate uniQure’s and 4DMT’s (or each Party’s designee) reasonable comments with respect thereto, and shall supply uniQure and 4DMT (or each Party’s designee) with a copy of each such application, office action response or other substantive document as filed, together with notice of its filing date and serial number.  In the event that 4DMT and uniQure provide Joint Counsel with conflicting instructions regarding the Prosecution and Maintenance of a Joint Patent Right, Joint Counsel shall make the Parties aware of such conflicting instructions and, if the Parties are not able to resolve such conflict within a reasonable time prior to the applicable filing deadline, the Joint Counsel shall take such action as would reasonably be expected to maximize the scope, extent and coverage of such Joint Patent Right.

 

(b)                                 Both Parties shall cooperate with Joint Counsel in Prosecution and Maintenance of patent applications for Joint Patent Rights, including providing Joint Counsel with data and other information as appropriate with respect thereto.

 

(c)                                  Joint Counsel shall keep uniQure and 4DMT advised of the status of the Prosecution and Maintenance of Joint Patent Rights, including actual and prospective patent filings for Joint Patent Rights, and shall provide each Party with advance copies of any and all papers related thereto.  Joint Counsel shall promptly give notice to uniQure and 4DMT of the grant, lapse, revocation, surrender, invalidation or abandonment of any Joint Patent Right.

 

(d)                                 The Parties shall equally share all fees and costs charged by Joint Counsel with respect to the Prosecution and Maintenance of Joint Patent Rights and all other mutually agreed and approved out-of-pocket costs and expenses incurred by either Party in connection with such Prosecution and Maintenance of Joint Patent Rights.

 

(e)                                  uniQure shall notify 4DMT and Joint Counsel at least [**] days in advance of the next deadline if (A) uniQure decides that it does not wish to continue paying for the Prosecution and Maintenance of a particular Joint Patent Right for which no substitute has been filed, or (B) uniQure decides that it intends to abandon claim scope in a Joint Patent Right which claim scope is intended to be maintained by 4DMT, in which case, with respect to this clause (B), 4DMT may assume responsibility for such claim scope by filing a divisional 

 

40

 

application restricted to such claim scope.  In such cases (A) or (B), uniQure shall allow 4DMT to assume responsibility for Prosecution and Maintenance of the respective Patent Rights, including payments incurred after [**] days after receipt of uniQure’s notice.  If 4DMT assumes such responsibility, then: (i) 4DMT may designate any counsel of its choice to handle the Prosecution and Maintenance of such Joint Patent Right or of the divisional application and it shall cease to be a part of the Joint Patent Rights; (ii) uniQure shall lose its licenses to such former Joint Patent Right or divisional application under ARTICLE V and such former Joint Patent Right or divisional application shall be deemed a 4DMT Patent Right; and (iii) uniQure shall and hereby does transfer and assign all right, title and interest in said former Joint Patent Right or of the divisional application to 4DMT as the sole owner.  If 4DMT decides not to assume such responsibility, then it shall instruct Joint Counsel to abandon the Prosecution and Maintenance of such Joint Patent Right or not to file such divisional application.

 

(f)                                   4DMT shall notify uniQure and Joint Counsel at least [**] days in advance of the next deadline if (A) 4DMT decides that it does not wish to continue paying for the Prosecution and Maintenance of a particular Joint Patent Right for which no substitute has been filed, or (B) 4DMT decides that it intends to abandon claim scope in a Joint Patent Right which claim scope is intended to be maintained by uniQure, in which case, with respect to this clause (B), uniQure may assume responsibility for such claim scope by filing a divisional application restricted to such claim scope.  In such cases (A) or (B), 4DMT shall allow uniQure to assume responsibility for Prosecution and Maintenance of the respective Patent Rights, including payments incurred after [**] days after receipt of 4DMT’s notice.  If uniQure assumes such responsibility, then: (i) uniQure may designate any counsel of its choice to handle the Prosecution and Maintenance of such Joint Patent Right or of the divisional application and it shall cease to be a part of the Joint Patent Rights and no further uniQure royalty obligations shall exist under this Agreement with respect thereto; (ii) 4DMT shall lose its licenses to such former Joint Patent Right or divisional application under ARTICLE V and such former Joint Patent Right or divisional application shall be deemed a uniQure Patent Right; and (iii) 4DMT shall and hereby does transfer and assign all right, title and interest in said former Joint Patent Right or of the divisional application to uniQure as the sole owner.  If uniQure decides not to assume such responsibility, then it shall instruct Joint Counsel to abandon the Prosecution and Maintenance of such Joint Patent Right or not to file such divisional application.

 

7.6                               Third Party Infringement.

 

(a)                                 Notice.  Each Party shall promptly report in writing to the other Party any known or suspected (i) infringement of any of the 4DMT Patent Rights, uniQure Patent Rights or Joint Patent Rights, or (ii) unauthorized use or misappropriation of any of the 4DMT Know-How, uniQure Know-How or Joint Know-How, of which such Party becomes aware and shall provide the other Party with all available evidence regarding such known or suspected infringement or unauthorized use.

 

(b)                                 Enforcement of Solely Owned Patent Rights.  uniQure shall have the sole right to enforce the uniQure Patent Rights, including the Core uniQure Patent Rights.  Subject to UC’s rights under the UCB Agreements with respect to any UC Patent Right included in the 4DMT Patent Rights, 4DMT shall have the sole right to enforce any 4DMT Patent Right, 

 

41

 

including the Core 4DMT Patent Rights.  Each Party shall cooperate in the prosecution of any such suit brought by the enforcing Party as may be reasonably requested by the enforcing Party; provided that the enforcing Party shall promptly reimburse all out-of-pocket expenses (including reasonable counsel fees and expenses) actually incurred by the non-enforcing Party in connection with such cooperation.

 

(c)                                  Enforcement of Joint Patent Rights.

 

(i)                                     In the Field.  uniQure shall have the first right, but not the obligation, to initiate a lawsuit or take other reasonable action to enforce the Joint Patent Rights against any infringement in the Field.  4DMT shall cooperate in the prosecution of any such suit as may be reasonably requested by uniQure, including joining any action as party-plaintiff at uniQure’s sole discretion; provided that uniQure shall promptly reimburse all out-of-pocket expenses (including reasonable counsel fees and expenses) actually incurred by 4DMT in connection with such cooperation.

 

(ii)                                  Outside the Field.  4DMT shall retain any and all rights to initiate a lawsuit or take other reasonable action to enforce the Joint Patent Rights against any infringement outside the Field.  uniQure shall cooperate in the prosecution of any such suit as may be reasonably requested by 4DMT, including joining any action as party-plaintiff at 4DMT’s sole discretion; provided that 4DMT shall promptly reimburse all out-of-pocket expenses (including reasonable counsel fees and expenses) actually incurred by uniQure in connection with such cooperation.

 

(iii)                               Step-In Right.  If either Party does not initiate a lawsuit or take other reasonable action pursuant to this Section 7.6(c) (the “Non-Enforcing Party”), then the other Party (the “Enforcing Party”) shall have the right, but not the obligation, to initiate such lawsuit or take such other action, after providing [**] days’ notice to the Non-Enforcing Party and giving good faith consideration to the Non-Enforcing Party’s reason(s) for not initiating a lawsuit or taking other action.  For this purpose, the Non-Enforcing Party shall cooperate in the prosecution of any such suit as may be reasonably requested by the Enforcing Party, including joining any action as party-plaintiff at the Non-Enforcing Party’s sole discretion; provided, that the Enforcing Party shall promptly reimburse all out-of-pocket expenses (including reasonable counsel fees and expenses) actually incurred by the Non-Enforcing Party in connection with such cooperation.

 

(d)                                 Conduct of Certain Actions; Costs.  The Party initiating legal action shall have the sole and exclusive right to select counsel for any suit initiated by it pursuant to Section 7.6(b) or 7.6(c) (the “Initiating Party”).  The Initiating Party shall bear its own out-of-pocket costs incurred in any such legal action, including the fees and expenses of the counsel selected by it.  The other Party shall have the right to participate and be represented in any such legal action (in cases where such other Party has standing) by its own counsel at its own expense.  The Initiating Party shall have the final say about the strategy and decisions in the suit and any settlement.

 

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(e)                                  Recoveries.  Any amount recovered in any action or settlement of any such action shall be allocated first to equally reimburse each Party’s actual out-of-pocket costs (including reasonable attorneys’ fees and expenses) incurred in such action and any amount remaining shall be allocated to the Initiating Party; provided that if uniQure is the Initiating Party with respect to any such suit to enforce any Patent Right included in the Licensed IP in the Field, then, with respect to any remaining portion of such recovery, (i) any amount that reflects punitive or exemplary damages shall be allocated [**] percent ([**]%) to uniQure and [**] ([**]%) to 4DMT, and (ii) any other amounts shall be treated as Net Sales and subject to payment of royalties under Section 6.4(a); and provided further that if uniQure is the Initiating Party with respect to any such suit to enforce any Joint Patent Right outside the Field, or if 4DMT is the Initiating Party with respect to any such suit to enforce any Joint Patent Right in the Field, any amount remaining shall be allocated [**].

 

7.7                               Patent Invalidity Claim.  Each Party shall promptly notify the other in the event of any legal or administrative action by any Third Party against a 4DMT Patent Right, uniQure Patent Right or Joint Patent Right of which it becomes aware, including any nullity, revocation, reexamination or compulsory license proceeding.  To the extent such action is in connection with an enforcement of such Patent Right under Section 7.6, the Parties’ rights with respect to defending any such Patent Right in any such proceeding shall correspond to those set forth in Section 7.6.

 

7.8                               Patent Term Extensions.

 

(a)                                 uniQure shall have full and exclusive right to determine and control all filings of requests for any patent term extension or supplemental patent certificate or their equivalents in any country in the Territory for any uniQure Patent Right, including any Core uniQure Patent Right, and all costs and expenses relating thereto shall be paid by uniQure.

 

(b)                                 4DMT shall have full and exclusive right to determine and control all filings of requests for any patent term extension or supplemental patent certificate or their equivalents in any country in the Territory for any 4DMT Patent Right, including any Core 4DMT Patent Right, and all costs and expenses relating thereto shall be paid by 4DMT.

 

(c)                                  The Parties shall jointly determine how to defend any such action relating to any Joint Patent Right.

 

(d)                                 The Parties shall reasonably cooperate with each other in obtaining patent term extensions or supplemental protection certificates or their equivalents in any country in the Territory.

 

7.9                               Orange Book; Paragraph IV Certification.

 

(a)                                 uniQure shall have the right, but not the obligation, to list any uniQure Patent Rights in the then-current edition of the FDA publication “Approved Drug Products With Therapeutic Equivalence Evaluations” (the “Orange Book”), or equivalent patent listings in other countries.

 

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(b)                                 With respect to any notification provided by a Third Party to uniQure or 4DMT under 21 U.S.C. § 355(j)(2)(B) making a certification described in 21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to any uniQure Patent Right that is listed for a Royalty Bearing Product in the Orange Book, or equivalent actions in other countries, (each a “Paragraph IV Certification”), the following shall apply notwithstanding Sections 7.6 and 7.7:

 

(i)                                     Without any avoidable delay, however at the latest within [**] Business Days after receipt of any notification of a Paragraph IV Certification, such Party shall notify the other Party in writing and attach of copy of such notification.  uniQure and 4DMT shall thereafter consult and cooperate fully to determine a course of action with respect to any such proceeding, including the negotiation of the offer of confidential access.

 

(ii)                                  With respect to any uniQure Patent Right, uniQure shall have the sole right to initiate any infringement proceeding as a result of such Paragraph IV Certification (a “Paragraph IV Proceeding”) with respect to a Royalty Bearing Product, including by commencing a patent infringement action under 35 U.S.C. § 271(e)(2)(A), and shall bear the expense of any such Paragraph IV Proceeding and, if legally required, may commence such action in 4DMT’s or the relevant 4DMT Affiliate’s name and on 4DMT’s or the relevant 4DMT Affiliate’s behalf.

 

(iii)                               Section 7.6(e) shall apply if any amount is recovered in any Paragraph IV Proceeding or settlement of any Paragraph IV Proceeding under this Section 7.9(b).

 

7.10                        CREATE Act.  Each Party acknowledges and agrees that this Agreement is a “joint research agreement” as contemplated by 35 U.S.C. § 102(c), and that all Inventions are intended to have the benefit of the rights and protections conferred by the Cooperative Research and Enhancement Act of 2004 (the “CREATE Act”).  In the event that a Party seeks to rely on the foregoing and to invoke the CREATE Act with respect to any Invention, such Party will give prior written notice to the other Party of its intent to invoke the CREATE Act and of each submission or disclosure such Party intends to make to the United States Patent and Trademark Office (the “USPTO”) pursuant to the CREATE Act, including: (a) any disclosure of the existence or contents of this Agreement to the USPTO, (b) the disclosure of any “subject matter developed by the other Party” (as such term is used in the CREATE Act) in an information disclosure statement or otherwise, or (c) the filing of any terminal disclaimer over the intellectual property of the other Party, it being agreed that no such submission, disclosure or filing shall be made by such Party without the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed, except that no such consent shall be required to disclose to the USPTO, through an information disclosure statement or otherwise, any “subject matter developed by the other Party” that was previously published or included in a published patent application by the other Party.  The other Party will provide reasonable cooperation to such Party in connection with such Party’s efforts to invoke and rely on the CREATE Act.

 

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ARTICLE VIII

 

CONFIDENTIALITY AND PUBLICATION

 

8.1                               Confidentiality Obligations.  Each Party shall (a) maintain in confidence the Confidential Information of the other Party to the same extent such Party maintains its own confidential information, (b) not disclose such Confidential Information to any Third Party without the prior written consent of the other Party, and (c) not use such Confidential Information for any purpose except those permitted by this Agreement.  Such obligations shall survive for a period of [**] years after termination or expiration of this Agreement, except that such obligations shall survive with respect to any Confidential Information identified by the disclosing Party as a trade secret for so long as such Confidential Information remains a trade secret.

 

8.2                               Exceptions to Confidentiality.  Notwithstanding the foregoing, the obligations of confidentiality set forth in Section 8.1 shall not apply to information that, in each case as demonstrated by competent written documentation:

 

(a)                                 is publicly disclosed or made generally available to the public by the disclosing Party, either before or after it becomes known to the receiving Party;

 

(b)                                 was known to the receiving Party, without any obligation to keep it confidential, prior to the date of first disclosure by the disclosing Party to the receiving Party, as shown by the receiving Party’s files and records;

 

(c)                                  is subsequently disclosed to the receiving Party by a Third Party lawfully in possession thereof without obligation to keep it confidential and without a breach of such Third Party’s obligations of confidentiality;

 

(d)                                 has been publicly disclosed or made generally available to the public other than through any act or omission of the receiving Party or its Affiliates in breach of this Agreement; or

 

(e)                                  has been independently developed by the receiving Party without the aid, application or use of the disclosing Party’s Confidential Information (the competent written proof of which must be contemporaneous with such independent development).

 

8.3                               Authorized Disclosure.  Notwithstanding Section 8.1, a Party may disclose Confidential Information of the other Party to the extent such disclosure is reasonably necessary in the following instances:

 

(a)                                 Prosecuting and Maintaining Patent Rights in accordance with this Agreement;

 

(b)                                 making filings with Regulatory Authorities in accordance with this Agreement;

 

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(c)                                  complying with applicable Laws or submitting information to tax or other Governmental Authorities; provided that if a Party is required by Law to make any public disclosure of Confidential Information of the other Party, to the extent it may legally do so, it will give reasonable advance notice to the other Party of such disclosure and will use its reasonable efforts to secure confidential treatment of such Confidential Information prior to its disclosure (whether through protective orders or otherwise);

 

(d)                                 to its Affiliates, and to prospective and actual acquirers, licensees, sublicensees, employees, consultants, agents, accountants, lawyers, advisors, investors and underwriters, on a need to know basis, each of whom prior to disclosure must be bound by written or professional ethical obligations of confidentiality and non-use equivalent in scope to those set forth in this ARTICLE VIII and that are of reasonable duration in view of the circumstances of the disclosure; or

 

(e)                                  to the extent mutually agreed to in writing by the Parties.

 

8.4                               Scientific Publications.  During the Research Term, neither Party shall first publish or first present in a public forum the scientific or technical results of any activity performed pursuant to this Agreement without the opportunity for prior review and comment by the other Party.  Each Party agrees to provide the other Party with the opportunity to review any proposed abstract, manuscript or scientific presentation (including any verbal presentation) that relates to its activities performed pursuant to this Agreement during the Research Term, at least [**] days prior to its intended submission for publication and agrees, upon request, not to submit any such abstract or manuscript for publication until the other Party is given a reasonable period of time up to [**] months to secure patent protection for any material in such publication that it believes to be patentable.  Both Parties understand that a reasonable commercial strategy may require delay of publication of information or filing of patent applications first with respect to activities performed or results obtained pursuant to this Agreement during the Research Term, or not to publish at all if necessary to preserve trade secrets.  The Parties agree to review and decide whether to delay publication of such information to permit filing of patent applications.  Neither Party shall have the right to publish or present any Confidential Information of the other Party, except as provided in Section 8.3.  After the Research Term, each Party and its Affiliates may publish or present results, data or scientific findings of any of their activities performed after the Research Term without the prior review of the other Party, provided that such publication or presentation does not disclose any of the other Party’s Confidential Information.  After the Research Term, neither Party nor its Affiliates may publish or present any of the results, data or scientific findings of any activity performed by the other Party or its Affiliates pursuant to this Agreement without prior review and prior written consent of such other Party.  Nothing contained in this Section 8.4 shall prohibit the inclusion of information necessary for a patent application; provided that the non-filing Party is given a reasonable opportunity to review the information to be included prior to submission of such patent application.  For clarity, any publication under this Section 8.4 shall be consistent with uniQure’s internal publication strategy, which shall be made available to 4DMT upon request.  Nothing contained in this Section 8.4 shall prohibit either Party from disclosing the results, data or scientific findings of any activity performed by the other Party or its Affiliates pursuant to this Agreement without prior review and prior written consent of the other Party, where required, as reasonably 

 

46

 

determined by the disclosing Party’s legal counsel, by applicable Law; provided that if a Party is required by Law to make any such disclosure, to the extent it may legally do so, it will give reasonable advance notice to the other Party of such disclosure and will use its reasonable efforts to secure confidential treatment of such information prior to its disclosure (whether through protective orders or otherwise).

 

8.5                               Press Releases and Other Permitted Disclosures.

 

(a)                                 4DMT and uniQure each agree not to disclose any of the terms and conditions of this Agreement to any Third Party, except as described below in this Section 8.5.  The Parties will cooperate in the release of a mutually agreed upon press release announcing the collaboration contemplated by this Agreement as soon as practicable after the Effective Date.  Subject to the other provisions of this Agreement, no other press release, public statement or public disclosure concerning the existence or terms of this Agreement shall be made, either directly or indirectly, by either Party, without first obtaining the written approval of the other Party, which such approval shall not be unreasonably withheld or delayed beyond [**] Business Days (or [**] Business Days if the Party wishing to make such disclosure or any of its controlling Affiliates is then a public company) following submission to the approving Party of a draft of the respective press release, public statement or public disclosure.  In no event shall any such subsequent press release, public statement or public disclosure by 4DMT disclose, if previously undisclosed, the identity of any Compound or Product or the stage of development of any Compound or Product that uniQure is researching, Developing, manufacturing, or Commercializing; provided that for clarity, uniQure may disclose, without the written approval of 4DMT, the identity of any Compound or Product or the stage of development of any Compound or Product that uniQure is researching, Developing, manufacturing, or Commercializing.  In no event shall any such subsequent press release, public statement or public disclosure by a Party disclose, if previously undisclosed, the financial terms of this Agreement; provided that 4DMT may disclose the receipt of, and uniQure may disclose the payment of, any milestone payment but not the amount of such milestone payment; provided, further, however, that if disclosure of the amount of a milestone payment is required by applicable Law, by applicable stock exchange regulation, or by order or other ruling of a competent court, as set forth in Section 8.5(c), then 4DMT or uniQure, as the case may be, may also disclose such amount in a public statement or disclosure.  Once any public statement or public disclosure has been approved in accordance with this Section 8.5, then either Party may appropriately communicate information contained in such permitted statement or disclosure.

 

(b)                                 Either Party may disclose the existence and terms of this Agreement in confidence to its attorneys, to UC, and to each of the following, under an agreement with terms of confidentiality and non-use no less rigorous than the terms contained in this Agreement and, as applicable, to use such information solely for the purpose permitted pursuant to the applicable subsection of this Section 8.5(b):

 

(i)                                     professional accountants, consultants, or auditors;

 

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(ii)                                  bankers or other financial advisors, in connection with an initial public offering, private financing or other strategic transaction, or corporate valuation for internal purposes;

 

(iii)                               potential acquirers (and their respective attorneys and professional advisors), in connection with a potential merger, acquisition or reorganization; provided that the Party making the disclosure has a bona fide offer (e.g., a signed term sheet or letter of intent, even if non-binding) from such Third Party for such a transaction;

 

(iv)                              to actual or potential investors, lenders or permitted assignees of such Party (and their respective attorneys and professional advisors); or

 

(v)                                 to actual or potential licensees or sublicensees of such Party (and their respective attorneys and professional advisors); provided that such disclosure in the case of 4DMT shall not include any financial terms, the Candidate Success Criteria, the Delivery Success Criteria, or Schedule 1.75.

 

(c)                                  Notwithstanding the foregoing provisions of this ARTICLE VIII, a Party may disclose the existence and terms of this Agreement, however excluding, as far as legally possible, Schedule 1.75, or the Parties’ activities under this Agreement, where required, as reasonably determined by the legal counsel of the disclosing Party, by applicable Law, by applicable stock exchange regulation or by order or other ruling of a competent court, although, to the extent practicable, the other Party shall be given [**] Business Days advance notice of any such legally required disclosure to comment and reasonably consider such comments provided by such other Party on the proposed disclosure.  In case either Party is obliged to publish this Agreement as a “material agreement” in accordance with the U.S. stock exchange regulations (“SEC Filing”), this Agreement shall be redacted by the filing Party as far as legally possible, and the filing Party shall cooperate with the other Party reasonably in advance to such SEC Filing to enable the other Party to review and comment on the scope of such redaction.

 

ARTICLE IX

 

REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION

 

9.1                               Representations and Warranties of the Parties.  uniQure and 4DMT each represent, warrant and covenant to the other that:

 

(a)                                 subject to approval by uniQure B.V.’s Class A shareholders of uniQure’s entry into this Agreement, as of the Effective Date, it has the authority and right to enter into and perform this Agreement and grant the rights embodied herein, and it is not aware of any legal impediment that could inhibit its ability to perform its obligations under this Agreement;

 

(b)                                 as of the Effective Date, its execution, delivery and performance of this Agreement does not conflict with, or constitute a breach of, any order, judgment, agreement or instrument to which it is a party or is otherwise bound;

 

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(c)                                  it shall comply in all material respects with all Laws applicable to its actions under this Agreement; and

 

(d)                                 as of the Effective Date, no consent of any Third Party is required for such Party to grant the licenses and rights granted to the other Party under this Agreement or to perform its obligations hereunder.

 

9.2                               Representations and Warranties of 4DMT.  4DMT represents, warrants and covenants to uniQure that:

 

(a)                                 as of the Effective Date, Schedule 1.5 is compiled accurately and, to the extent set forth in Section 1.5, is complete regarding the subject matter set forth therein;

 

(b)                                 as of the Effective Date, 4DMT has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in 4DMT Intellectual Property in a manner inconsistent with the terms hereof;

 

(c)                                  as of the Effective Date, 4DMT has valid and existing licenses, free and clear of all liens, charges and encumbrances, to the 4DMT Patent Rights not owned by 4DMT;

 

(d)                                 as of the Effective Date, to 4DMT’s knowledge, the conception, development and reduction to practice of the 4DMT Intellectual Property has not constituted or involved the misappropriation of trade secrets of any Third Party or the infringement of issued Patent Rights of any Third Party;

 

(e)                                  as of the Effective Date, 4DMT has not received any written notice of any unauthorized use, infringement, or misappropriation by any person or entity, including any current or former employee or consultant of 4DMT, of any 4DMT Intellectual Property;

 

(f)                                   as of the Effective Date, to 4DMT’s knowledge, there are no claims, judgments, settlements pending or any action with respect to the 4DMT Intellectual Property;

 

(g)                                  as of the Effective Date, to 4DMT’s knowledge, uniQure’s use of the 4DMT Intellectual Property, as reasonably anticipated to be used in the conduct of the Research Program, will not infringe any valid Patent Right existing as of the Effective Date and owned by any Third Party;

 

(h)                                 all of 4DMT’s personnel and employees, and Third Parties, including agents and consultants, hired by 4DMT and involved in the Research Program are, or when hired will be, under a written obligation to assign to 4DMT any right they may have in any Invention first invented, discovered, made, conceived or reduced to practice in the conduct of activities pursuant to the Research Program, and all intellectual property rights therein;

 

(i)                                     it will not, after the Effective Date, enter into any written or oral contractual obligation with any Third Party that would be inconsistent with the obligations that 

 

49

 

arise on its part out of this Agreement or that would deprive uniQure of the benefits of or rights granted under this Agreement;

 

(j)                                    as of the Effective Date, each of the UCB Agreements is in full force and effect, and 4DMT will not, after the Effective Date, terminate, amend or otherwise modify any of the terms thereof without prior written consent from uniQure, or take any action or refrain from taking any action that would permit UC to terminate any UCB Agreement (it being recognized that if the Selected Capsid Variants are not UC AAV Capsid Variants, and UC terminates any UCB Agreement, 4DMT shall not be deemed to be in breach of the foregoing), and 4DMT shall promptly provide uniQure with a copy of each notice it receives from UC under any UCB Agreement; and

 

(k)                                 if, during the Term, 4DMT has reason to believe that it or any of its employees, officers, subcontractors, or consultants rendering services hereunder (i) is or shall be debarred or convicted of a crime under 21 U.S.C. Section 335a, or (ii) is or shall be under indictment under said Section 335a, then 4DMT shall immediately notify uniQure in writing.

 

For purposes of this Section 9.2, “knowledge” shall mean the actual knowledge of 4DMT, including David Schaffer and David Kirn.

 

9.3                               Representations and Warranties of uniQure.  uniQure represents, warrants and covenants to 4DMT that:

 

(a)                                 all of uniQure’s personnel and employees, and Third Parties, including agents and consultants, hired by uniQure and involved in the Research Program are, or when hired will be, under a written obligation to assign to uniQure any right they may have in any Invention first invented, discovered, made, conceived or reduced to practice in the conduct of activities pursuant to the Research Program, and all intellectual property rights therein;

 

(b)                                 it will not, after the Effective Date, enter into any written or oral contractual obligation with any Third Party that would be inconsistent with the obligations that arise on its part out of this Agreement or that would deprive 4DMT of the benefits of or rights granted under this Agreement;

 

(c)                                  if, during the Term, uniQure has reason to believe that it or any of its employees, officers, subcontractors, or consultants rendering services hereunder (i) is or shall be debarred or convicted of a crime under 21 U.S.C. Section 335a, or (ii) is or shall be under indictment under said Section 335a, then uniQure shall immediately notify 4DMT in writing.

 

9.4                               No Other Warranties.

 

(a)                                 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH HEREIN, THE PARTIES MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND PARTICULARLY THAT PRODUCT(S) WILL BE SUCCESSFULLY DEVELOPED HEREUNDER, AND IF PRODUCT(S) ARE DEVELOPED, WITH RESPECT TO SUCH PRODUCT(S), THE 

 

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PARTIES DISCLAIM ALL IMPLIED WARRANTIES OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

 

(b)                                 uniQure acknowledges that UC has not warranted to 4DMT under the UCB Agreements as to the validity of any Patent Rights or that practice under such Patent Rights shall be free of infringement.  UNIQURE, ITS AFFILIATES AND ITS SUBLICENSEE(S) AGREE THAT (I) THE LICENSES GRANTED PURSUANT TO THE UCB AGREEMENTS, THE UC AAV CAPSID VARIANTS, AND THE ASSOCIATED INVENTIONS ARE PROVIDED WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESSED OR IMPLIED; (II) UC MAKES NO REPRESENTATION OR WARRANTY THAT ANY INVENTION CLAIMED BY THE UC PATENT RIGHTS, THE UC AAV CAPSID VARIANTS, THE UC PATENT RIGHTS, OR THE UC PRODUCTS WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY RIGHT; AND (III) IN NO EVENT WILL UC BE LIABLE FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES RESULTING FROM EXERCISE OF THE LICENSES GRANTED PURSUANT TO THE UCB AGREEMENTS OR THE USE OF ANY INVENTION CLAIMED BY THE UC PATENT RIGHTS, THE UC AAV CAPSID VARIANTS, THE UC PATENT RIGHTS, OR THE UC PRODUCTS.

 

9.5                               Indemnification by uniQure.  uniQure shall indemnify, hold harmless and defend 4DMT, its Affiliates and all of their respective officers, directors, employees, agents and shareholders (collectively, the “4DMT Indemnitees”) from and against any and all losses, damages, liabilities, judgments, fines, amounts paid in settlement, expenses and costs of defense (including reasonable attorneys’ fees and witness fees) (collectively, “Damages”) resulting from any demand, claim, action or proceeding brought or initiated by a Third Party (each a “Third Party Claim”) against any 4DMT Indemnitee to the extent arising out of: (a) a Default by uniQure; (b) the negligence or willful misconduct of a uniQure Indemnitee; or (c) the use, Development, Commercialization, storage or other exploitation of any Compound or Product by uniQure, its Affiliates, Sublicensees, Third Party Distributors, or Third Party independent contractors; provided that (i) the 4DMT Indemnitees shall comply with the procedures set forth in Section 9.7(a); and (ii) such indemnity shall not apply to the extent such Third Party Claim is subject to indemnification by 4DMT under Section 9.6.

 

9.6                               Indemnification by 4DMT.  4DMT shall indemnify, hold harmless and defend uniQure, its Affiliates and all of their respective officers, directors, employees, agents, and shareholders (collectively, the “uniQure Indemnitees”) from and against any and all Damages resulting from any Third Party Claim against any uniQure Indemnitee to the extent arising out of: (a) a Default by 4DMT; (b) the negligence or willful misconduct of a 4DMT Indemnitee; or (c) the use, Development, Commercialization, storage or other exploitation of any 4DMT AAV Capsid Vector, Compound or Product (other than a Royalty Bearing Compound or Royalty Bearing Product) by 4DMT, its Affiliates, sublicensees or Third Party independent contractors; provided that (i) the uniQure Indemnitees shall comply with the procedures set forth in Section 9.7(b); and (ii) such indemnity shall not apply to the extent such Third Party Claim is subject to indemnification by uniQure under Section 9.5.

 

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9.7                               Procedure.

 

(a)                                 To be eligible for the 4DMT Indemnitees to be indemnified hereunder, 4DMT shall provide uniQure with prompt notice of the Third Party Claim giving rise to the indemnification obligation under Section 9.5 and the exclusive ability to defend or settle any such claim; provided however that uniQure shall not enter into any settlement for damages, or that imposes upon 4DMT any obligation or liability, without 4DMT’s prior written consent, such consent not to be unreasonably withheld, delayed or conditioned. 4DMT shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by uniQure.

 

(b)                                 To be eligible for the uniQure Indemnitees to be indemnified hereunder, uniQure shall provide 4DMT with prompt notice of the Third Party Claim giving rise to the indemnification obligation under Section 9.6 and the exclusive ability to defend or settle any such claim; provided however that 4DMT shall not enter into any settlement for damages, or that imposes upon uniQure any obligation or liability, without uniQure’s prior written consent, such consent not to be unreasonably withheld, delayed or conditioned.  uniQure shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by 4DMT.

 

9.8                               uniQure Indemnity to UC.  uniQure shall, and shall require its Sublicensees to, indemnify, defend, and hold harmless UC and IGT, and their officers, employees, and agents; sponsor(s) of the research that led to the inventions disclosed in the UC Patent Rights and the UC AAV Capsid Variants; and the inventors of any UC Patent Rights and their employers against any and all losses, damages, costs, fees, and expenses resulting from Third Party claims and suits arising out of uniQure’s activities under this Agreement or of any Sublicensee activities under any sublicense agreement granting rights under the UC Patent Rights or the UC AAV Capsid Variants, or any use or possession of the UC AAV Capsid Variants resulting from uniQure’s exploitation of its rights thereto.  This indemnification will include any product liability claims.  uniQure will keep UC informed of its defense of any claims pursuant to this Section 9.8, and UC will cooperate reasonably in any such suit.  If UC invokes the provisions of this Section 9.8, UC will not make any admissions or take any actions in such claim or suit that may prejudice or impair uniQure’s ability to defend such claim or suit without uniQure’s prior written consent, and uniQure will not admit liability or wrongdoing on behalf of UC without UC’s prior written consent.

 

9.9                               Insurance.  Each Party shall procure and maintain insurance or self-insurance, including general liability insurance and product liability insurance, adequate to cover its obligations hereunder and that are consistent with normal business practices of prudent companies similarly situated, at all times during which any Research Compound, Royalty Bearing Compound, or Royalty Bearing Product is being Developed, clinically tested in human subjects or Commercialized by or on behalf of such Party, its Affiliates or sublicensees, including, in the case of uniQure, its Sublicensees.  It is understood that any such insurance or self-insurance shall not be construed to create a limit of a Party’s liability with respect to its indemnification obligations under this ARTICLE IX.  Each Party shall provide the other Party with written evidence of such insurance or self-insurance upon request.  Each Party shall provide 

 

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the other Party with written notice at least [**] days prior to the cancellation, non-renewal or material change in such insurance or self-insurance which could adversely affect rights hereunder.  Without limiting the generality of the foregoing:

 

(a)                                 uniQure, at its sole cost and expense, will ensure that the applicable entity performing activities in connection with any work performed hereunder, whether uniQure, an Affiliate, or a Sublicensee, will obtain, keep in force, and maintain the following insurance:

 

(i)                                     prior to the start of Clinical Trials of a UC Product, commercial form general liability insurance (contractual liability included) with limits as follows:

 

	
Each Occurrence
    	
 
    	
[**]
    
	
Products/Completed   Operations Aggregate
    	
 
    	
[**]
    
	
Personal   and Advertising Injury
    	
 
    	
[**]
    
	
General   Aggregate
    	
 
    	
[**]
    

 

(ii)                                  Upon the start of any Clinical Trials of a UC Product, commercial form general liability insurance (contractual liability included), and product liability insurance if not otherwise included, with limits as follows:

 

	
Each Occurrence
    	
 
    	
[**]
    
	
Products/Completed   Operations Aggregate
    	
 
    	
[**]
    
	
Personal   and Advertising Injury
    	
 
    	
[**]
    
	
General   Aggregate
    	
 
    	
[**]
    

 

(iii)                               upon the First Commercial Sale of a UC Product, commercial form general liability insurance (contractual liability included), and product liability insurance if not otherwise included, with limits as follows:

 

	
Each Occurrence
    	
 
    	
[**]
    
	
Products/Completed   Operations Aggregate
    	
 
    	
[**]
    
	
Personal   and Advertising Injury
    	
 
    	
[**]
    
	
General   Aggregate
    	
 
    	
[**]
    

 

If the above insurance is written on a claims-made form, it shall continue for [**] years following termination or expiration of this Agreement.

 

(iv)                              worker’s compensation as legally required in the jurisdiction in which uniQure, an Affiliate, or a Sublicensee, as applicable, is doing business.

 

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uniQure will promptly notify UC of any material reduction in the insurance coverages below the amounts required hereunder.

 

(b)                                 Within [**] days after the Effective Date, uniQure will furnish 4DMT with certificates of insurance evidencing compliance with all requirements.  Such certificates will:

 

(i)                                     where possible, provide for [**] days’ ([**] days for non-payment of premium) advance written notice to 4DMT and UC of any cancellation of insurance coverages described above in Section 9.9(a);

 

(ii)                                  indicate that 4DMT and UC have been endorsed as additional insureds under the coverage described above in Section 9.9(a); and

 

(iii)                               include a provision that the coverages described above in Section 9.9(a) will be primary and will not participate with, nor will be excess over, any valid and collectable insurance or program of self-insurance maintained by 4DMT or UC.

 

9.10                        No Consequential or Punitive Damages.  EXCEPT WITH RESPECT TO (a) THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER THIS AGREEMENT WITH RESPECT TO THIRD PARTY CLAIMS, (b) A BREACH OF THE CONFIDENTIALITY OBLIGATIONS OF ARTICLE VIII, (c) A BREACH OF SECTION 5.6, OR (d) A PARTY’S WILLFUL MISCONDUCT, NEITHER PARTY HERETO WILL BE LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES, INCLUDING LOST PROFITS, ARISING FROM OR RELATING TO THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES.

 

ARTICLE X

 

TERM AND TERMINATION

 

10.1                        Term and Expiration.  This Agreement shall be effective as of the Effective Date and unless terminated earlier pursuant to Section 10.2, this Agreement shall continue in effect until the expiration of all of uniQure’s payment obligations hereunder (the “Term”).  Upon expiration, all licenses granted hereunder shall be fully paid-up, perpetual and irrevocable.  Notwithstanding the foregoing, this Agreement shall be void ab initio if uniQure B.V.’s Class A shareholders have not approved uniQure’s entry into this Agreement and the Grant Letters by January 31, 2014, or if David Schaffer has not been elected to the Supervisory Board of uniQure B.V. by January 31, 2014.

 

10.2                        Termination.

 

(a)                                 Termination of Agreement for Cause.

 

(i)                                     This Agreement may be terminated at any time during the Term upon written notice by either Party (the “Non-Defaulting Party”) upon Default of the other

 

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Party (the “Defaulting Party”), which Default remains uncured for [**] days after written notice requesting cure of such Default.  The Non-Defaulting Party shall provide written notice to the Defaulting Party, which notice shall identify the Default, the intent to so terminate and the actions or conduct that it considers would be an acceptable cure of such Default.  If the Defaulting Party disputes the Default under this Section 10.2(a), then the issue of whether the Non-Defaulting Party may properly terminate this Agreement on expiration of the applicable cure period shall be resolved in accordance with ARTICLE XI.  If, as a result of such dispute resolution process, it is determined that the alleged Defaulting Party committed a Default and the Defaulting Party does not cure such Default within [**] days after the date of such dispute resolution award (the “Additional Cure Period”), then such termination shall be effective as of the expiration of the Additional Cure Period.  If the Parties dispute whether such Default was so cured, either Party alone may request the same tribunal to determine whether it was so cured, and the Parties shall cooperate to allow such determination to be made within [**] days after such request by either Party.  Any such dispute resolution proceeding does not suspend any obligation of either Party hereunder, and each Party shall use reasonable efforts to mitigate any damage.  If, as a result of any such dispute resolution proceeding, it is determined that the alleged Defaulting Party did not commit such Default (or such Default was cured in accordance with this Section 10.2(a)), then no termination shall be effective, and this Agreement shall continue in full force and effect.  Notwithstanding the foregoing, if 4DMT is the Non-Defaulting Party and the claimed Default by uniQure as the Defaulting Party relates to one or more Compounds or Products, and not this entire Agreement, then this Agreement shall be terminated only with respect to the Indication for which such Compound(s) or Product(s) were intended to treat and such Indication shall be removed from the Field.

 

(ii)                                  Notwithstanding Section 10.2(a)(i), uniQure shall have the right to terminate this Agreement during the Research Term immediately upon written notice to 4DMT if David Schaffer ceases to be a representative of 4DMT on the JRSC or is otherwise unavailable to direct 4DMT’s Research Program activities during any consecutive fifteen (15) Business Day period, in each case for any reason other than his death, illness or disability, which shall be deemed a Default by 4DMT.

 

(b)                                 Termination for Bankruptcy.  To the extent allowed under applicable Law, either Party shall have the right to terminate this Agreement in the event of the commencement of any proceeding in or for bankruptcy, insolvency, dissolution or winding up by or against the other Party (other than pursuant to a corporate restructuring) that is not dismissed or otherwise disposed of within sixty (60) days thereafter.

 

(c)                                  Termination for Futility.  uniQure shall have the right terminate this Agreement immediately upon written notice to 4DMT summarizing the basis for such termination if, at any point prior to the first (1st) anniversary of the Effective Date, the JRSC determines that (i) it would be futile to continue the Research Program, including if the JRSC determines that any Candidate Success Criteria or Delivery Success Criteria cannot be met through use of the 4DMT Intellectual Property following the reasonable efforts of 4DMT to achieve such Candidate Success Criteria or Delivery Success Criteria or (ii) 4DMT is not making bona fide efforts to achieve the timelines set forth in the Research Plan.

 

55

 

(d)                                 Termination for Convenience.  uniQure shall have the right terminate this Agreement at any time after the Research Term, for any reason or for no reason, by giving 4DMT ninety (90) days’ prior written notice thereof.

 

(e)                                  Special Termination Right of 4DMT.  In the event that (i) uniQure B.V. does not complete an underwritten public offering of its ordinary shares pursuant to an effective registration statement under the U.S. Securities Act of 1933 and the listing of its ordinary shares on the Nasdaq Global Market by September 1, 2014, December 31, 2014, or December 31, 2015, as the case may be, and (ii) uniQure B.V. has not agreed in writing to pay the applicable “Cash-Out Amount” provided for in Article 4c of each of the Grant Letters in respect of options that will vest on the first vesting date following such applicable date, 4DMT shall have the right to terminate this Agreement by providing written notice thereof to uniQure within thirty (30) days following such applicable date, and any such termination shall be effective as of the thirtieth (30th) day following such applicable date.

 

10.3                        Effect of Termination

 

(a)                                 If uniQure terminates this Agreement under Section 10.2(a) or Section 10.2(b):

 

(i)                                     uniQure’s licenses pursuant to this Agreement shall continue; provided however that uniQure shall continue to fulfill uniQure’s payment obligations with respect to milestones and royalties under ARTICLE VI; and provided further that uniQure may reduce such payment obligations by the amount of monetary damage suffered by uniQure as a direct result of 4DMT’s Default, as determined (A) in a final decision of the arbitrators in accordance with Section 11.2 or, with respect to an Excluded Claim, a court of competent jurisdiction, which decision is not appealable or has not been appealed within the time allowed for appeal, or (B) by the Parties in a settlement agreement;

 

(ii)                                  4DMT shall, within [**] days after the effective date of such termination, return or cause to be returned to uniQure, copies of all uniQure’s Confidential Information and uniQure Intellectual Property and all Materials provided by uniQure, except that 4DMT may retain one copy of uniQure’s Confidential Information solely for legal archive purposes and to exercise the licenses granted to 4DMT which survive termination of this Agreement;

 

(iii)                               For clarity, uniQure shall be released of its ongoing diligence obligations under Section 4.2 and uniQure and 4DMT shall be released of their disclosure and information exchange obligations under ARTICLE III and ARTICLE IV;

 

(iv)                              For clarity, the JRSC and its subcommittees shall not meet anymore;

 

(v)                                 No further options under each Grant Letter shall vest from and after the effective date of such termination; and

 

56

 

(vi)                              If this Agreement is terminated pursuant to Section 10.2(a)(ii), uniQure shall continue to fund the FTEs included in the Research Plan pursuant to Section 6.2(b) for the [**] months immediately following the effective date of such termination.

 

(b)                                 Upon termination of this Agreement by uniQure under Section 10.2(c) or Section 10.2(d), or by 4DMT under Section 10.2(a), Section 10.2(b), or Section 10.2(e):

 

(i)                                     For clarity, uniQure’s licenses pursuant to Section 5.1 and 4DMT’s exclusivity obligations pursuant to Section 5.6 shall terminate as of the effective date of such termination;

 

(ii)                                  Effective as of the effective date of such termination, the license granted to 4DMT under Section 5.2(b) shall be automatically expanded to include the Selected Capsid Variants and all fields of use;

 

(iii)                               uniQure shall, within [**] days after the effective date of such termination, return or cause to be returned to 4DMT, copies of all 4DMT’s Confidential Information and 4DMT Intellectual Property and all Materials provided by 4DMT; except that uniQure may retain one copy of the 4DMT Confidential Information solely for legal archive purposes;

 

(iv)                              4DMT shall, within [**] days after the effective date of such termination, return or cause to be returned to uniQure, copies of all uniQure’s Confidential Information and uniQure Intellectual Property and all Materials provided by uniQure, except that 4DMT may retain one copy of uniQure’s Confidential Information solely for legal archive purposes and to exercise the licenses granted to 4DMT which survive termination or are granted upon termination of this Agreement;

 

(v)                                 For a period of [**] months, if termination occurs after Regulatory Approval of Royalty Bearing Products, uniQure and its Affiliates shall be entitled to finish work in progress and to sell any of the Royalty Bearing Products remaining in inventory in accordance with the terms of this Agreement to the extent such Royalty Bearing Products were being sold in the Territory at the time of termination, provided that such sales shall be subject to the royalty and milestone provisions of this Agreement;

 

(vi)                              If this Agreement is terminated pursuant to Section 10.2(c), (A) uniQure shall continue to fund the FTEs included in the Research Plan pursuant to Section 6.2(b) for the [**] months immediately following the effective date of such termination, but in no event for less than [**] after the Effective Date, and (B) no further options under each Grant Letter shall vest from and after the date that [**] percent ([**]%) of all options under such Grant Letter have vested; and

 

(vii)                           If this Agreement is terminated pursuant to Section 10.2(e), uniQure shall continue to fund the FTEs included in the Research Plan pursuant to Section 6.2(b) for the [**] months immediately following the effective date of such termination, but in no event for less than [**] after the Effective Date.

 

57

 

Notwithstanding the foregoing, if such termination is under Section 10.2(a) solely with respect to one or more given Indication(s), then uniQure’s licenses pursuant to Section 5.1  do not terminate but the Field is automatically narrowed to exclude the relevant Indication(s), and 4DMT’s exclusivity obligations pursuant to Section 5.6 terminate solely with respect to the relevant Indications; subsection (ii) shall apply; the license granted to 4DMT under Section 5.2(b) shall be automatically expanded to include the relevant Indication(s) rather than all fields of use; and uniQure’s obligations under subsection (iii) shall be limited to copies of 4DMT’s Confidential Information and 4DMT Intellectual Property and Materials that relate solely to the relevant Indication(s).

 

10.4                        Effect of Expiration or Termination; Survival.

 

(a)                                 Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination.  Any expiration or termination of this Agreement shall be without prejudice to the rights of either Party against the other accrued or accruing under this Agreement prior to expiration or termination, including the obligation to pay royalties for Royalty Bearing Product(s) sold prior to such expiration or termination.  Termination of this Agreement shall be in addition to, and shall not prejudice, the Parties’ remedies at law or in equity, including the Parties’ ability to receive legal damages or equitable relief with respect to any breach of this Agreement, regardless of whether or not such breach was the reason for the termination.

 

(b)                                 The provisions of ARTICLE I, ARTICLE VII, ARTICLE VIII, ARTICLE XI, ARTICLE XII, and Sections 4.5, 5.2(b), 5.4, 5.5, 6.2(c), 9.4, 9.5, 9.6, 9.7, 9.8, 9.9, 9.10, 10.3 and 10.4 shall survive any expiration or termination of this Agreement, and with respect to those Royalty Bearing Products in such countries for which uniQure retains a Development and Commercialization license after the expiration or termination of this Agreement, the provisions of ARTICLE VI shall also survive.

 

ARTICLE XI

 

DISPUTE RESOLUTION

 

11.1                        Seeking Consensus.  If any dispute arises out of, in connection with or related to this Agreement, including disputes over the interpretation, performance, enforcement or breach of this Agreement, including any dispute that is not within the jurisdiction of the JRSC, (a “Dispute”), excluding any dispute resolved in accordance with Section 2.5(c) (subject to Section 2.5(d)), then upon the written request of either Party, the matter shall be referred to the Executives, who shall meet in a good faith effort to resolve the dispute within [**] days.  If the Parties’ Executives cannot agree on a resolution of the Dispute within such [**] day period, then it shall be resolved pursuant to the remaining provisions of this ARTICLE XI.

 

11.2                        Arbitration.  If the Parties do not fully settle a Dispute pursuant to Section 2.5 (only as to those matters that may be referred to arbitration) or 11.1, as applicable, and a Party wishes to pursue the matter, each such Dispute that is not an Excluded Claim (as defined below) shall be finally resolved by binding arbitration in accordance with the Rules of 

 

58

 

Arbitration of the ICC (International Chamber of Commerce) and judgment on the arbitration award may be entered in any court having jurisdiction thereof.

 

(a)                                 The arbitration shall be conducted by a panel of three (3) persons.  Within [**] days after initiation of arbitration, each Party shall select one person to act as arbitrator and the two Party-selected arbitrators shall select a third arbitrator within [**] days after their appointment.  If the arbitrators selected by the Parties are unable or fail to agree upon the third arbitrator, the third arbitrator shall be appointed by the ICC.  The place of arbitration shall be New York City, New York, and all proceedings and communications shall be in English.

 

(b)                                 Either Party may apply to the arbitrators for interim injunctive relief until the arbitration award is rendered or the Dispute is otherwise resolved.  Either Party also may, without waiving any remedy under this Agreement, seek from any court having jurisdiction any injunctive or provisional relief necessary to protect the rights or property of that Party pending the arbitration award.  The scope of the authority of the arbitrators shall be limited to the strict application of law.  The arbitrators shall have no authority to award punitive or any other type of damages not measured by a Party’s compensatory damages, except as permitted by Section 9.10.  Each Party participating in an arbitration pursuant to the terms of this Agreement shall, subject to the award of the arbitrators, pay an equal share of the arbitrators’ fees.  The arbitrators shall have the power to award recovery of all costs (including reasonable attorney’s fees, administrative fees, arbitrators’ fees and court costs) to the prevailing Party.

 

(c)                                  Neither Party shall be required to give general discovery of documents, but may be required to produce documents or testimony that are relevant or considered relevant by the arbitrators to the Dispute.  It is the objective and intent of the Parties that any arbitration proceeding be conducted in such a manner that a decision will be rendered by the arbitrators within [**] days after the third arbitrator is appointed to the panel, and the Parties and the panel selected in the manner provided above will adopt rules and procedures intended to implement such objective and intent.

 

(d)                                 Except to the extent necessary to confirm or vacate an award or as may be required by Law (including applicable securities laws or the rules of any stock exchange on which a Party’s securities may then be listed), neither a Party nor an arbitrator may disclose the existence, content, or results of arbitration without the prior written consent of both Parties.  In no event shall arbitration be initiated after the date when commencement of a legal or equitable proceeding based on the dispute, controversy or claim would be barred by the applicable New York statute of limitations.

 

(e)                                  The Parties agree that any payment made pursuant to this Agreement pending resolution of the Dispute shall be refunded or credited if the arbitrators or court determines that such payments are not due.

 

As used in this Section 11.2, the term “Excluded Claim” shall mean a Dispute that concerns (a) the validity, enforceability, scope or infringement of a patent, trademark or copyright; or (b) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory.

 

59

 

ARTICLE XII

 

MISCELLANEOUS

 

12.1                        Governing Law.  This Agreement shall be governed by and construed in accordance with the Laws of the State of New York, other than any principle of conflict or choice of laws that would cause the application of the Laws of any other jurisdiction.

 

12.2                        Waiver.  Waiver by a Party of a breach hereunder by the other Party shall not be construed as a waiver of any succeeding breach of the same or any other provision.  No delay or omission by a Party to exercise or avail itself of any right, power or privilege that it has or may have hereunder shall operate as a waiver of any right, power or privilege by such Party.  No waiver shall be effective unless made in writing with specific reference to the relevant provision(s) of this Agreement and signed by a duly authorized representative of the Party granting the waiver.

 

12.3                        Notices.  All notices, instructions and other communications hereunder or in connection herewith shall be in writing, shall be sent to the address specified in this Section 12.3 and shall be: (a) delivered personally; (b) transmitted by facsimile; (c) sent by registered or certified mail, return receipt requested, postage prepaid; or (d) sent via a reputable international overnight delivery service.  Any such notice, instruction or communication shall be deemed to have been delivered (i) upon receipt if delivered by hand, (ii) when transmitted with electronic confirmation of receipt, if transmitted by facsimile (if such transmission is on a Business Day; otherwise, on the next Business Day following such transmission), provided that an original document is sent via an internationally recognized overnight delivery service (receipt requested), (iii) three (3) Business Days after it is sent by registered or certified mail, return receipt requested, postage prepaid, or (iv) one (1) Business Day after it is sent via a reputable international overnight delivery service.

 

	
If to 4DMT,   to:
    	
4D Molecular Therapeutics, LLC
    
	
 
    	
19 Rima Court
    
	
 
    	
Danville, CA 94526
    
	
 
    	
Attention: David Schaffer
    
	
 
    	
Facsimile: (650) 463-2600
    
	
 
    	
 
    
	
with a copy   to:
    	
Latham & Watkins LLP
    
	
 
    	
140 Scott Drive
    
	
 
    	
Menlo Park, CA 94025
    
	
 
    	
Attention: Alan Mendelson and Judith   Hasko
    
	
 
    	
Facsimile: (650) 463-2600
    

 

60

 

	
If to   uniQure, to:
    	
uniQure biopharma B.V.
    
	
 
    	
P.O. Box 22506
    
	
 
    	
1100 DA Amsterdam
    
	
 
    	
The Netherlands
    
	
 
    	
Attention: CEO
    
	
 
    	
Facsimile: +31 20 566 9272
    
	
 
    	
 
    
	
with a copy   to:
    	
Wilmer Cutler Pickering Hale and Dorr   LLP
    
	
 
    	
60 State Street
    
	
 
    	
Boston, MA 02109 USA
    
	
 
    	
Attention: David Redlick
    
	
 
    	
Facsimile: (617) 526-5000
    

 

or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith.

 

12.4                        Entire Agreement; Amendment.  This Agreement (including its Exhibits and Schedules) contains the complete understanding of the Parties with respect to the subject matter hereof and supersedes all prior understandings and writings relating to such subject matter.  In particular, it supersedes and replaces the Prior Confidentiality Agreement and any and all term sheets relating to the transactions contemplated by this Agreement and exchanged between the Parties or their Affiliates prior to the Effective Date.  No amendment, change or addition to this Agreement will be effective or binding on either Party unless reduced to writing and duly executed on behalf of both Parties.

 

12.5                        Headings.  Headings in this Agreement are for convenience of reference only and shall not be considered in construing this Agreement.

 

12.6                        Severability.  If any provision or portion thereof in this Agreement is for any reason held to be invalid, illegal or unenforceable, the same shall not affect any other portion of this Agreement, as it is the intent of the Parties that this Agreement shall be construed in such fashion as to maintain its existence, validity and enforceability to the greatest extent possible.  In any such event, this Agreement shall be construed as if such clause of portion thereof had never been contained in this Agreement, and there shall be deemed substituted therefor such provision as will most nearly carry out the intent of the Parties as expressed in this Agreement to the fullest extent permitted by applicable Law.

 

12.7                        Assignment.  Neither this Agreement nor any right or obligation hereunder may be assigned or otherwise transferred by any Party without the consent of the other Party; provided, however, that any Party may, without such consent, assign this Agreement, in whole or in part: (a) to any of its respective Affiliates; provided that the assigning Party shall remain jointly and severally liable with such Affiliate in respect of all obligations so assigned, or (b) to any successor in interest by way of merger, acquisition or sale of all or substantially all of its assets to which this Agreement relates (an “M&A Event”).  Any assignment not in accordance with this Section 12.7 shall be void.  Each Party agrees that, notwithstanding any provision of this Agreement to the contrary, neither the assignment of this Agreement by a Party in 

 

61

 

connection with an M&A Event, nor the occurrence of such M&A Event (whether or not a formal assignment of this Agreement occurs), shall provide the non-assigning Party with rights or access to any intellectual property or technology of the acquirer of the assigning Party or its Affiliates that were not Affiliates of the assigning Party prior to such M&A Event.  If uniQure assigns its rights and obligations hereunder to an Affiliate or Third Party outside the United States or The Netherlands pursuant to this Section 12.7, and if such Affiliate or Third Party shall be required by applicable Law to withhold additional taxes from or in respect of any amount payable under this Agreement as a result of such assignment, then any such amount payable under this Agreement shall be increased to take into account the additional taxes withheld as may be necessary so that, after making all required withholdings, 4DMT receives an amount equal to the sum it would have received had no such assignment been made.

 

12.8                        Counterparts.  This Agreement may be executed in any number of counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument.  Signatures provided by facsimile transmission or in Adobe Portable Document Format (PDF) sent by electronic mail shall be deemed to be original signatures.

 

12.9                        Force Majeure.  No Party shall be liable for failure of or delay in performing obligations (other than payment obligations) set forth in this Agreement, and no Party shall be deemed in breach of its obligations, if such failure or delay is due to a natural disaster, explosion, fire, flood, tornado, thunderstorm, hurricane, earthquake, war, terrorism, riot, embargo, loss or shortage of power, labor stoppage, substance or material shortage, events caused by reason of laws of any Governmental Authority, events caused by acts or omissions of a Third Party or any other cause reasonably beyond the control of such Party, if the Party affected gives prompt notice of any such cause to the other Party.  The Party giving such notice shall thereupon be excused from such of its obligations hereunder as it is thereby disabled from performing for so long as it is so disabled, provided, however, that such affected Party commences and continues to use its Commercially Reasonable Efforts to cure such cause.

 

12.10                 Third Party Beneficiaries.  None of the provisions of this Agreement shall be for the benefit of or enforceable by any Third Party, other than a 4DMT Indemnitee under Section 9.5 or uniQure Indemnitee under Section 9.6.  No such Third Party shall obtain any right under any provision of this Agreement or shall by reason of any such provision make any claim in respect of any debt, liability or obligation (or otherwise) against either Party.

 

12.11                 Relationship of the Parties.  Each Party shall bear its own costs incurred in the performance of its obligations hereunder without charge or expense to the other, except as expressly provided in this Agreement.  Neither Party shall have any responsibility for the hiring, termination or compensation of the other Party’s employees or for any employee compensation or benefits of the other Party’s employees.  No employee or representative of a Party shall have any authority to bind or obligate the other Party for any sum or in any manner whatsoever, or to create or impose any contractual or other liability on the other Party without said other Party’s approval.  For all purposes, and notwithstanding any other provision of this Agreement to the contrary, the legal relationship under this Agreement of each Party to the other Party shall be that 

 

62

 

of independent contractor.  Nothing in this Agreement shall be construed to establish a relationship of partners or joint ventures between the Parties.

 

12.12                 Performance by Affiliates.  To the extent that this Agreement imposes obligations on Affiliates of a Party or permits a Party to exercise its rights or perform its obligations through its Affiliates, such Party agrees to cause its Affiliates to perform such obligations and shall guarantee performance of this Agreement by its Affiliates.  If any disagreement arises out of the performance of this Agreement by an Affiliate of a Party, or the alleged failure of an Affiliate to comply with the conditions and obligations of this Agreement, the Party seeking to resolve such dispute shall have the right do so directly with the other Party, without any obligation to first pursue an action against, or recovery from, the Affiliate which is alleged to have caused a breach of this Agreement.

 

12.13                 Construction.  Each Party acknowledges that it has been advised by counsel during the course of negotiation of this Agreement, and, therefore, that this Agreement shall be interpreted without regard to any presumption or rule requiring construction against the Party causing this Agreement to be drafted.  Any reference in this Agreement to an ARTICLE, Section, subsection, paragraph, clause, or Schedule shall be deemed to be a reference to any article, section, subsection, paragraph, clause, schedule or exhibit, of or to, as the case may be, this Agreement.  Except where the context otherwise requires, (a) wherever used, the use of any gender will be applicable to all genders; (b) the word “or” is used in the inclusive sense (and/or); (c) any definition of or reference to any agreement, instrument or other document refers to such agreement, instrument other document as from time to time amended, supplemented or otherwise modified (subject to any restriction on such amendments, supplements or modifications set forth herein or therein); (d) any reference to any Law refers to such Law as from time to time enacted, repealed or amended; (e) the words “herein”, “hereof” and hereunder”, and words of similar import, refer to this Agreement in its entirety and not to any particular provision hereof; and (f) the words “include”, “includes” and “including” shall be deemed to be followed by the phrase “but not limited to”, “without limitation” or words of similar import.

 

[Signature page follows]

 

63

 

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

 

	
UNIQURE BIOPHARMA B.V.
    	
 
    	
4D MOLECULAR THERAPEUTICS, LLC
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
BY:
    	
/s/   Jörn Aldag
    	
 
    	
BY:
    	
/s/ David Schaffer
    
	
NAME: Jörn Aldag
    	
 
    	
 
    	
NAME: David Schaffer
    	
 
    
	
TITLE: Chief Executive Officer
    	
 
    	
TITLE: Co-Founder, Member
    
							

 

64

 

Exhibit A

 

COMMITMENT LETTER FROM UNIQURE B.V.

 

Incorporated by reference to Exhibit 10.35 to the Company’s Registration Statement on Form F-1 filed with the Commission on January 17, 2014

 

EXHIBIT A - Page 1

 

Schedule 1.5

 

4DMT PATENT RIGHTS

 

[**]

 

SCHEDULE 1.5 - Page 1

 

Schedule 1.41

 

OUTLINE OF BUDGET FOR RESEARCH PLAN

 

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of one page was omitted.

 

[**]

 

SCHEDULE 1.41 - Page 1

 

Schedule 1.54

 

DRAFT INVOICE

 

	
Invoice To:
    	
Invoice No.
    	
#
    
	
<<Company name>>
  <<address>> 

 

Attention: <<name, title>> 
   uniQure Contract No.:
    	
Invoice Date:
    	
<<date>>
    

 

Invoice From:

<<Company name>>

<<address>>

 

	
Description
    	
 
    	
Amount
    	
 
    
	
Pursuant to   <<contract and section reference>>
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
<<payment   type>>
    	
 
    	
$
    	
0.00
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
(i) 
    	
 
    	
 
    	
 
    
	
(ii) Total   Payment Due 
    	
 
    	
$
    	
0.00
    	
 
    
	
(iii) 
    	
 
    	
 
    	
 
    

 

Wire Instructions:

 

Bank Name:

Bank Address:

Bank Contact:

Routing/transit:

Beneficiary:

Beneficiary Account #:

 

Payment Due:                 <<contract payment terms>>

 

SCHEDULE 1.54 - Page 1

 

Schedule 1.75

 

OUTLINE OF RESEARCH PLAN

 

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of one page was omitted.

 

[**].

 

SCHEDULE 1.75 - Page 1

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