Exhibit 10.5

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO
THE COMPANY IF DISCLOSED.

COLLABORATION AND LICENSE AGREEMENT

 

BY AND BETWEEN

 

4D MOLECULAR THERAPEUTICS, INC

 

AND

 

UNIQURE BIOPHARMA B.V.

 

August 6, 2019

 

 

 

 

COLLABORATION AND LICENSE AGREEMENT

This Collaboration and License Agreement (this “Agreement” or “New CLA”) is
entered into and made effective on August 6, 2019 (the “New CLA Effective
Date”), by and between 4D Molecular Therapeutics, Inc., a corporation organized
and existing under the laws of the State of Delaware and having a principal
office located at 5858 Horton St, Emerystation North, Suite 460, Emeryville, CA
94608 (“4DMT”), and uniQure biopharma B.V., a corporation organized and existing
under the laws of The Netherlands and having a principal office located at
Paasheuvelweg 25a, 1105 BP Amsterdam, The Netherlands (“uniQure”).

INTRODUCTION

1.         4DMT is a biopharmaceutical company focused on research, development,
manufacturing and marketing of novel adeno-associated viral vectors for delivery
of nucleic acids to target cells and gene therapy biopharmaceutical products
based thereon.

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 for 4DMT to conduct a new research
program  to identify improved AAV Capsid Variants (as defined below) for
delivery to liver (in the case of some such AAV Capsid Variants) or the central
nervous system (in the case of others).

4.         4DMT and uniQure have previously entered into a Collaboration and
License Agreement effective on January 17th, 2014, (the “Original CLA”) pursuant
to which, 4DMT and uniQure had a collaboration for the identification of novel
AAV Capsid Variants for development and commercialization as therapeutic
products in the Field (defined below), and the Parties are, concurrent with the
execution of this Agreement, amending and restating the Original CLA in its
entirety by entering into an Amended and Restated Collaboration and License
Agreement, effective of even date herewith (the “Amended and Restated CLA”),
and, through the execution of this Agreement and the Amended and Restated CLA,
the Parties have resolved the matters that were referred to and described in
correspondence between the Parties dated February 28, 2019 with respect to the
Original CLA.

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), develop, manufacture and commercialize certain gene therapy
Products based on use of New Capsid Variants (defined below) to deliver
Transgenes (defined below) based on Restricted Targets (defined below) in the
Field pursuant to this Agreement, and subject to 4DMT’s Step-In Rights (defined
below).

6.         4DMT desires to retain non-exclusive rights to, exclude from the
exclusive grant described above the non-exclusive rights to, and/or receive from
uniQure non-exclusive rights under uniQure’s intellectual property rights to,
research,  develop, manufacture and commercialize certain gene therapy products
based on use of New Capsid Variants to deliver Transgenes based on Restricted
Targets within and outside of the Field, in accordance with 4DMT’s Step-In
Rights pursuant to this Agreement.

 

 

 

 

7.         uniQure also desires to receive from 4DMT non-exclusive rights under
4DMT’s intellectual property rights to research,  develop, manufacture and
commercialize certain gene therapy products based on use of New Capsid Variants
to deliver Transgenes based on targets other than Restricted Targets
(Non-Restricted Targets, more particularly defined below), in accordance with
uniQure’s Step-In Rights pursuant to this Agreement.

8.         4DMT would retain all other rights to New Capsid Variants (e.g.,
rights to New Capsid Variants outside the Field and related to Non-Restricted
Targets), subject to uniQure’s Step-In Rights for Non-Restricted Targets and
information rights as described herein.

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 AAV Capsid Variant means any AAV
Capsid Variant that does not carry a Gene Therapy Construct contained in a
Royalty Bearing Construct 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 any New Capsid Variant, or a
Royalty Bearing Construct or Royalty Bearing Product due to the presence of such
New Capsid Variant therein.  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.  4DMT Patent Rights include Core 4DMT Patent Rights
but do not include Joint Patent Rights.

1.6      “4DMT Product” . 4DMT Product means a Royalty Bearing Product that (a)
delivers a Transgene that Affects a Non-Restricted Target (or variant of a
Non-Restricted Target), or (b) that delivers a Transgene that Affects a
Restricted Target (or variant of a Restricted Target), and, in the case of (b)
(but to avoid doubt, this is not required for (a)), 4DMT has obtained

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non-exclusive rights to Develop and Commercialize such Royalty-Bearing Product
pursuant to the exercise of its Step-In Rights in Section 4.4.  Notwithstanding
anything express or implied, no 4DMT Product shall deliver a Transgene that
relates to any Restricted Target for which 4DMT has not obtained rights to
deliver as part of a Royalty-Bearing Product pursuant to the exercise of its
Step-In Rights under Section 4.4.

1.7      “4D Product Patent”. 4D Product Patent means any Product Patent upon
which 4DMT’s or its Affiliates’ personnel are properly named inventors (as
determined under U.S. patent law) and uniQure’s and its Affiliates’ are not.

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

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

1.10    “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.

1.11    “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.

1.12    “Affects”.  Affects, with respect to a Transgene and a Target, means
that the Transgene (a) encodes such Target or a variant of such Target, (b)
knocks down the mRNA corresponding to such Target or a variant of such Target,
(c) encodes an antibody or other protein that specifically binds the protein
encoded by such Target, or (d) otherwise directly affects such Target (e.g., via
gene editing) or the protein that such Target encodes.

1.13    “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.

1.14    “Animal POC”.  Animal POC means demonstration of gene expression and/or
gene function of a Transgene cassette for a Target, in an animal model or
patient-derived cells; provided that such demonstration shall be in an
established, relevant animal model of a disease, if available.

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1.15    “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.

1.16    “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.

1.17    “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

1.18    “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.

1.19    “CNS”.  CNS means the central nervous system. [***]

1.20    “CNS Term”.  The CNS Term means the period beginning on the New CLA
Effective Date and ending on the later of (a) [***] ([***]) years from the date
of initiation of work under the Research Plan for CNS, and (b) the date on which
4DMT delivers [***] ([***]) (i.e., when it has delivered [***]) New CNS Variants
to uniQure with the Vector Characterization Data with respect to each of such
[***] ([***]) New CNS Variants that the Research Plan for CNS requires 4DMT to
provide.  It is understood that the Selection Processes giving rise to such New
CNS Variants shall be the Selection Processes directed at identifying
CNS-targeted variants as defined and called for in the Research Plan, or, if
such Selection Processes do not yield [***] ([***]) New CNS Variants meeting the
Delivery Success Criteria (that can then proceed into the studies that generate
Vector Characterization Data in accordance with the Research Plan for CNS), then
Selection Processes for CNS-targeted AAV Capsid Variants that 4DMT conducts in
addition or as follow-ups to (but in each case not in replacement or in lieu of)
such CNS-directed Selection Processes called for in the Research Plan, and in
any event meeting the requirements of Section 3.1. If 4DMT conducts such
in-addition-to and/or follow-up CNS-directed Selection Processes, then the
Vector Characterization Data that 4DMT would have to report to uniQure in order
for the applicable New CNS Variants to count as one of the [***] ([***]) New CNS
Variants of clause (b) of the first sentence of this definition, shall be
equivalent to the Vector Characterization Data that 4DMT is required to report
to uniQure under the Research Plan with respect to the New CNS Variants that it
delivers thereunder.  uniQure’s information and input rights as to any such
additional Selection Processes that 4DMT may choose to conduct are as provided
for in Section 3.1.

1.21    “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

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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.

1.22    “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.

1.23    “Construct”.  Construct means an AAV Capsid Variant carrying and
comprising  a Gene Therapy Construct.

1.24    “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.

1.25    “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.

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

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

1.28    “Core 4DMT Patent Right”.  Core 4DMT Patent Right means any Patent Right
that Covers the Core 4DMT Know-How, including New Variant Patents.

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

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

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1.31    “Core uniQure Patent Right”.  Core uniQure Patent Right means any Patent
Right that Covers the Core uniQure Know-How. For clarity, Core uniQure Patent
Rights excludes New Variant Patents.

1.32    “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). With respect to a composition, “Coverage” exists if the
applicable Valid Claim claims such composition, its method of manufacture, or
its methods of use.

1.33    “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.

1.34    “Delivery Success Criteria”.  Delivery Success Criteria means the
following criteria that determines whether a given AAV Capsid Variant
demonstrates superior delivery to the CNS or liver for introduction into those
additional validation and characterization studies that are defined in the
applicable Research Plan:  [***].

1.35    “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.

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

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

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

1.39    “Field”.  Field means the delivery of Gene Therapy Constructs to cells
in (a) the 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, cure,
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 Construct
used to effect delivery.  For clarity, intravenous or intrathecal administration
of any Construct targeted to cells in other organs (i.e., not specifically
targeted to liver or CNS tissues), including for treatment of neoplastic and eye
disorders, are excluded from the Field.

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

1.41    “Gene Therapy Construct”.  Gene Therapy Construct means any Transgene
that is packaged into an AAV Capsid Variant to form a Construct, and is intended
to be delivered to a targeted tissue to treat, cure, prevent or ameliorate a
disease or condition of the CNS or liver by any gene therapy application or
modality.

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

1.43    “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.

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

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

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

1.47    “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.

1.48    “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, Constructs, 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.

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

1.50     “Licensed IP”.  Licensed IP means the 4DMT Intellectual Property, the
Joint Intellectual Property, and the Intellectual Property licensed by uniQure
to 4DMT pursuant to Section 5.2.

1.51    “Liver Term”.  The Liver Term means the period beginning on the New CLA
Effective Date and ending on the later of (a) [***] ([***]) years from the date
of initiation of work under the Research Plan for Liver, and (b) the date on
which 4DMT delivers [***] ([***]) (i.e., when it has delivered [***]) New Liver
Variants to uniQure with the Vector Characterization Data with respect to each
of such [***] ([***]) New Liver Variants that the Research Plan for Liver
requires 4DMT to provide.  It is understood that the Selection Processes giving
rise to such New Liver Variants shall be the Selection Processes directed at
identifying liver -targeted variants as defined and called for in the Research
Plan, or, if such Selection Processes do not yield [***] ([***]) New Liver
Variants meeting the Delivery Success Criteria (that can then proceed into the
studies that generate Vector Characterization Data in accordance with the
Research Plan for Liver), then Selection Processes for liver-targeted AAV Capsid
Variants that 4DMT conducts in addition or as follow-ups to (but in each case
not in replacement or in lieu of) such liver-directed Selection Processes called
for in the Research Plan, and in any event meeting the requirements of Section
3.1. If 4DMT conducts such in-addition-to and/or follow-up liver -directed
Selection Processes, then the Vector Characterization Data that 4DMT would have
to report to uniQure in order for the applicable New Liver Variants to count as
one of the [***] ([***]) New Liver Variants of clause (b) of the first sentence
of this definition, shall be equivalent to the Vector Characterization Data that
4DMT is required to report to uniQure under the Research Plan with respect to
the New Liver Variants that it delivers thereunder.  uniQure’s information and
input rights as to any such additional Selection Processes that 4DMT may choose
to conduct are as provided for in Section 3.1.

1.52    “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 3.3 for use in performance of the
Research Program; provided,  however, that Materials will not include any AAV
Capsid Variant Libraries.

1.53    “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.

1.54    “Net Sales”.  Net Sales means, with respect to a Royalty Bearing Product
(either a uniQure Product or a 4DMT Product, as applicable), the gross amount of
sales of such Royalty Bearing Product invoiced by a Party or its Affiliates to
Third Parties, less the following to the extent related to such Royalty Bearing
Product and incurred by such Party or its Affiliates and invoiced to the Third
Party:

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(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  Accounting Standards on a basis consistent with such Party’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.

1.55    “New Capsid Variant(s)”.  New Capsid Variant means any New CNS Variant
or New Liver Variant.

1.56    “New CNS Variant(s)”.  New CNS Variant means any AAV Capsid Variant
identified by 4DMT or its Affiliate, or any Third Party pursuant to rights
granted by 4DMT or its Affiliate, during the CNS Term in a Selection Process
designed to identify AAV Capsid Variants

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specifically targeting cells of the CNS, but excluding any such AAV Capsid
Variants that are Selected Capsid Variants.  An AAV Capsid Variant is
“identified” in a Selection Process when it is sequenced. An AAV Capsid Variant
does not need to satisfy (or necessarily have been tested against) the
applicable Delivery Success Criteria to qualify as a New CNS Variant.

If data of the types listed in the definition of Vector Characterization Data
that is generated by, for or under right from 4DMT demonstrate that an AAV
Capsid Variant from any other Selection Process (i.e., one not under the
Research Plan of this Agreement or one that was not designed to identify AAV
Capsid Variants specifically targeting cells of the CNS) conducted by, for or
under right from 4DMT during the CNS Term is improved or superior to the top
[***] ([***]) New CNS Variants arising under the Research Program in the
following ways, then 4DMT will share the Vector Characterization Data with
uniQure:[***]

In that case, any such AAV Capsid Variant with respect to which 4DMT is required
to share such data of the types listed in Vector Characterization Data
demonstrating such improvement or superiority ((a) or (b) or (c)) shall be
deemed a New CNS Variant, and such data shall be deemed Vector Characterization
Data.  It is understood that 4DMT is not under any obligation to generate such
data (nor to have it generated for or under right from 4DMT), nor to perform any
research or other activities not set forth in the Research Plan, but that,
pursuant to the terms of this Agreement, uniQure may further investigate any
such deemed New CNS Variants.

1.57    “New Liver Variant(s)”.  New Liver Variant means any AAV Capsid Variant
identified by 4DMT or its Affiliate, or any Third Party pursuant to rights
granted by 4DMT or its Affiliate, during the Liver Term in a Selection Process
designed to identify AAV Capsid Variants specifically targeting cells of the
liver, but excluding any such AAV Capsid Variants that are Selected Capsid
Variants.  An AAV Capsid Variant is “identified” in a Selection Process when it
is sequenced. An AAV Capsid Variant does not need to satisfy (or necessarily
have been tested against) the applicable Delivery Success Criteria to qualify as
a New Liver Variant.

If data of the types listed in the definition of Vector Characterization Data
that is generated by, for or under right from 4DMT demonstrate that an AAV
Capsid Variant from any other Selection Process (i.e., one not under the
Research Plan of this Agreement or one that was not designed to identify AAV
Capsid Variants specifically targeting cells of the liver) conducted by, for or
under right from 4DMT during the Liver Term is improved or superior to the top
[***] ([***]) New Liver Variants arising under the Research Program in the
following ways, then 4DMT will share the Vector Characterization Data with
uniQure:[***]

In that case, any such AAV Capsid Variant with respect to which 4DMT is required
to share such data of the types listed in Vector Characterization Data
demonstrating such improvement or superiority ((a) or (b) or (c)) shall be
deemed a New Liver Variant, and such data shall be deemed Vector
Characterization Data.  It is understood that 4DMT is not under any obligation
to generate such data (nor to have it generated for or under right from 4DMT),
nor to perform any research or other activities not set forth in the Research
Plan, but that, pursuant to the terms of this Agreement, uniQure may further
investigate any such deemed New Liver Variants.

-  10  -

 

 

1.58    “New Variant Patent”. New Variant Patent means any Patent Right Covering
one or more New Capsid Variants (for clarity, whether by their composition,
method of use, or method of manufacture).  It is understood that New Variant
Patents (1) may include dependent claims directed to the combination of a New
Capsid Variant and a Transgene and (2) do not include any Patent Rights claiming
inventions that are conceived and reduced to practice solely by employees,
agents and/or consultants of uniQure or its Affiliate independently and outside
of the Research Program, without the use of information pertaining to a Selected
Capsid Variant or New Capsid Variant sequence disclosed to uniQure under this
Agreement or the Amended and Restated CLA.

1.59    “Non-Restricted Targets” means all Targets within the Field that are not
Restricted Targets.

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

1.61    “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.

1.62    “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 Construct.

1.63    “Product Patent”. Any Patent Right Covering an invention invented
pursuant to the activities conducted under this Agreement, the independent
claims of which Patent Right are specifically drawn to a Construct combining (i)
a New Capsid Variant and (ii) the Gene Therapy Construct of a given Product, and
that does not claim priority to any New Variant Patent.

1.64    “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.

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

-  11  -

 

 

1.66    “Research Plan for CNS”.  Research Plan for CNS means the research plan
providing for one (1) or more Selection Processes intended to identify AAV
Capsid Variants for delivery to the CNS, that is attached as Schedule 2.

1.67    “Research Plan for Liver”.  Research Plan for Liver means the research
plan providing for one (1) or more Selection Processes intended to identify AAV
Capsid Variants for delivery to the liver, that is attached as Schedule 2.

1.68    “Research Program”.  Research Program means, collectively, the program
of research to be undertaken by 4DMT as described in the Research Plan for CNS
and the Research Plan for Liver.

1.69    “Research Term”.  Research Term means the period commencing on the New
CLA Effective Date and ending on the date of expiration of the Liver Term or the
CNS Term, whichever expires later.

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

1.71    “Restricted Target(s)”, Restricted Target(s) means, the [***] ([***])
Targets to be selected by uniQure from within the Field, each of such [***]
([***]) Targets is to be selected by uniQure within the [***] ([***]) day period
commencing on the New CLA Effective Date, and each of which must relate to a
disease or condition of the CNS or the liver.

1.72    “Royalty Bearing Construct”.  Royalty Bearing Construct means a
Construct containing a New Capsid Variant and a Gene Therapy Construct that
Affects a Restricted Target or a Non-Restricted Target (but not any Target that
is not a Restricted Target or a Non-Restricted Target).

1.73    “Royalty Bearing Product”.  Royalty Bearing Product means a Product
containing a Royalty Bearing Construct.

1.74    “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 a Party 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 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 a Party
or any of its Affiliates or Sublicensees of such Royalty Bearing Product in such
country.

1.75    “Selected Capsid Variant”.  Selected Capsid Variant means the AAV Capsid
Variants listed in Schedule 3 to this Agreement.

1.76    “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

-  12  -

 

(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.  For clarity, a Selection Process can be one that is
performed by 4DMT or its Affiliate either for itself or for, with or by any
Third Party under rights granted by 4DMT to such Third Party, and need not be
one that is conducted under the Research Program of this Agreement or designed
for the same type of tissue in order to qualify under this definition. .

1.77    “Step-In Rights”.  Step-In Rights means, on a AAV Capsid Variant-by-AAV
Capsid Variant and Target-by-Target basis, the rights of uniQure or of 4DMT,
respectively, to step-in and obtain non-exclusive license rights with respect to
a New Capsid Variant for delivery of a Transgene that Affects a Non-Restricted
Target (in the case of uniQure) or a Restricted Target (in the case of 4DMT), in
each case pursuant to the provisions of Section 4.4.

1.78    “Sublicensee”.  Sublicensee means, with respect to a Party, a Third
Party to whom such Party (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.

1.79    “Target”. Target means the biological gene or genetic material of
interest to affect a disease or condition of the CNS or liver.

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

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

1.82    “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.

1.83    “Transgene”. Transgene means (a) a given nucleic acid sequence that
encodes an RNA sequence, and (b) any functionally equivalent sequence variants
of such given nucleic acid sequence, [***].

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

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

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

1.87    “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

-  13  -

 

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.

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

1.89     “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
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 New
Capsid Variant, or a Royalty Bearing Compound or Royalty Bearing Product due to
the presence of such New Capsid Variant therein.  uniQure Know-How includes Core
uniQure Know-How but does not include Joint Know-How.

1.90    “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.

1.91    “uniQure Product”.  uniQure Product means a Royalty Bearing Product that
(a) delivers a Transgene that  Affects a Restricted Target (or variant of a
Restricted Target), or (b) that delivers a Transgene that  Affects a
Non-Restricted Target (or variant of a Non-Restricted Target), and in the case
of (b) uniQure has obtained non-exclusive rights to Develop and Commercialize
such Royalty-Bearing Product pursuant to the exercise of its Step-In Rights in
Section 4.4. Notwithstanding anything express or implied, no uniQure Product
shall deliver any Transgene that relates to any Non-Restricted Target for which
uniQure has not obtained rights to deliver as part of a Royalty-Bearing Product
pursuant to the exercise of its Step-In Rights under Section 4.4.

1.92    “uniQure Product Patent”. uniQure Product Patent means any Product
Patent upon which uniQure’s or its Affiliates’ personnel are properly named
inventors (as determined under U.S. patent law) and 4DMT and its Affiliates’ are
not.

1.93    “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.

-  14  -

 

“Vector Characterization Data” means any and all data, results and other
Know-How that is generated either by or on behalf of a Party or its Affiliate,
whether alone or together with, by or for any of its Third Party licensees,
contractors or collaborators, with respect to any New Capsid Variant, in regards
to any of the following with respect to such New Capsid Variant:[***]

1.94    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

Additional Cure Period

10.2(a)

Agreement

Preamble

Audited Party

6.5

Auditing Party

6.5

Bankruptcy Code

5.4

CREATE Act

7.10

Damages

9.5

Defaulting Party

10.2(a)

Dispute

11.1

Effective Date

Preamble

Excluded Claim

11.2

Executives

2.3(b)

Fair Market Value

6.3(b)(iii)

GAAP

1.11

IFRS

1.11

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

2.1(a)

M&A Event

12.7

MAA

1.53

Non-Defaulting Party

10.2(a)

Orange Book

7.9(a)

Paragraph IV Certification

7.9(b)

Paragraph IV Proceeding

7.9(b)(ii)

Records

3.5(a)(i)

SEC Filing

8.5(c)

Sublicense Consideration

6.3(b)

Sublicense Income Sharing Percentages

6.3(a)

Term

10.1

Third Party Claim

9.5

Trade Secret Election

7.3(b)

-  15  -

 

 

 

Definition:

Section:

 

 

USPTO

7.10

UC

1.87

uniQure

Preamble

uniQure Indemnitees

9.6

 

ARTICLE II

 

GOVERNANCE

2.1      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) providing a forum for discussion of
the Research Plan for Liver and the Research Plan for CNS, the status of the
Research Program, and relevant data (but not making any decisions with respect
thereto, other than as provided in clause (iii) of this sentence or as provided
in Section 2.6); (ii) serving as a forum for informal resolution of
disagreements that may arise in the relation to the Parties’ activities under
the Research Program (but not deciding any such disagreement); and (iii)
amending the Research Plan for Liver and/or the Research Plan for CNS, solely in
the circumstances described in and under the terms and conditions of Section
2.6.

2.2      Meetings.  The JRSC shall each hold at least [***] per Calendar Quarter
during the Research Term.  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 for Liver or Research Plan for CNS, as
applicable.  Either Party may, from time to time, invite additional
representatives or consultants to attend JRSC meetings; provided that at least
[***] ([***]) Business Days’ prior

-  16  -

 

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
3.5(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.

2.3      Decision-making.

(a)        Initial Dispute Resolution Procedures.  Subject to the provisions of
this Section 2.3, 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.  Notwithstanding the foregoing, and subject to Section 2.6, in the
circumstances described in such Section, [***] shall have the final say and
final decision-making authority on any and all disputes pertaining to any
amendments to the Research Plan for CNS or amendments to the Research Plan for
Liver, and any such final decision by [***] on such matters shall not be subject
to further review by referral to Executives or otherwise under this Section 2.3
or under any of the dispute resolution provisions of this Agreement.

(b)        Referral of Unresolved Matters to Executives.  If, in accordance with
Section 2.3(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 2.3(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 2.3(b) has not been resolved in accordance with Section
2.3(b), then, subject to Section 2.3(d), [***] shall have the final
decision-making authority.  Any decision made by [***] pursuant to this Section
2.3(c) shall be deemed a decision of the JRSC for purposes of this Agreement.

(d)        Exceptions.  Notwithstanding Section 2.3(c), [***] shall not have the
right to exercise such decision-making authority (i) in a manner that excuses
[***] 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 [***] under this Agreement; (iii) in a manner that would require
[***] to perform activities (A) for which [***] (except as expressly set forth
in this Agreement), (B) that [***], or (C) that [***]; (iv) in a manner that
would take away [***]’s right to perform activities that [***] has previously
agreed to perform as set forth in the Research Plan; (v) in a manner that would
require [***] to perform any act that it reasonably believes to be

-  17  -

 

inconsistent with any Law or any approval, order, policy, guidelines of a
Regulatory Authority or ethical requirements or ethical guidelines; (vi) to
determine that [***] has fulfilled any obligation under this Agreement or that
[***] has breached any obligation under this Agreement; or (vii) to amend the
relevant Delivery Success Criteria.

(e)        This Section 2.3 (and each of its subsections) shall not be used to
imply any greater decision-making authority on the part of the JRSC than is set
forth in Section 2.1(b) (i.e., the JRSC’s sole decision-making authority is to
decide upon amendments to the Research Plan for CNS and the Research Plan For
Liver, subject always and solely in the circumstance and manner stated in
Section 2.6).

2.4      Limitations on JRSC Authority.  The JRSC 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 unless such delegation or
vesting of rights is expressly provided for in this Agreement or the Parties
expressly so agree in writing.

2.5      Sharing of Vector Characterization and Other Data at the JRSC.   Each
Party shall share with and disclose to the other Party the Vector
Characterization Data obtained by such Party with respect to New Capsid
Variants, pursuant to the requirements of Section 4.3.  Each Party shall do so
during the Research Term and thereafter, and whether such Vector
Characterization Data is generated within or outside of the Research
Program.  During the Research Term, 4DMT will keep the JRSC informed of: (a) any
and all reasonably relevant data and information generated under the Research
Program (including Vector Characterization Data; and (b) all New CNS Variants
and New Liver Variants that have been identified by 4DMT,  [***], in connection
with the next JRSC meeting after their identification.

2.6      Amendments to Research Plans.  Notwithstanding anything express or
implied in this Agreement, the JRSC shall only have the power to amend the
Research Plan for CNS and the Research Plan for Liver in the following
circumstances: (a) the then-current version of the applicable research plan
(i.e., the Research Plan for CNS or the Research Plan for Liver) cannot be
carried out as written; or (b) the JRSC achieves unanimous consensus (with no
exercise of any final say) that a change needs to be made and as to the change.

ARTICLE III

 

RESEARCH PROGRAM

3.1      Objectives of the Research Program.  The Research Program under this
Agreement shall be defined, collectively, by the activities as described in the
Research Plan for CNS and the Research Plan for Liver, each as appended to this
Agreement as of the Effective Date (or as they may be amended in accordance with
this Agreement).  The objective of the Research Plan for CNS is for 4DMT to
identify [***] ([***]) New CNS Variants that meet the applicable Delivery
Success Criteria for entry into validation studies, the Vector Characterization
Data from which validation studies will be the package of data that 4DMT is
required to provide

-  18  -

 

to uniQure in order to satisfy its obligation to present [***] ([***]) New CNS
Variants with the required Vector Characterization Data.  The objective for the
Research Plan for Liver is to identify the New Liver Variants that meet the
applicable Delivery Success Criteria, the Vector Characterization Data from
which validation studies will be the package of data that 4DMT is required to
provide to uniQure in order to satisfy its obligation to present [***] ([***])
New Liver Variants with the required Vector Characterization Data.  As and to
the extent provided for in the Research Plan, 4DMT would provide quantities of
such New Capsid Variants to uniQure for testing.  If the CNS Selection Processes
or the liver Selection Processes of the Research Program do not yield at least
[***] ([***]) New Capsid Variants meeting the applicable Delivery Success
Criteria for entry into validation studies to generate the required Vector
Characterization Data packages, then (a) if requested by 4DMT, uniQure may (but
is not required to) [***]; and/or (b) [***].

3.2      Conduct of the Research Program.

(a)        4DMT shall initiate work on the Research Plan for Liver and the
Research Plan for CNS within [***] ([***]) weeks after the New CLA Effective
Date.  Any amendments to the Research Plan for CNS or the Research Plan for
Liver will be only as agreed by the JRSC.

(b)        4DMT shall use Commercially Reasonable Efforts to conduct the
Research Program in accordance with the Research Plan for CNS and the Research
Plan for Liver.  4DMT shall have an affirmative obligation during the term the
Research Program and thereafter during the term of this Agreement to disclose
all data and other information related to the Research Plan on a timely basis,
including, without limitation, all Vector Characterization Data created pursuant
to the Research Program, the Research Plan for Liver, and the Research Plan for
CNS, as well as the existence and status of all New Capsid Variants generated
outside the Research Program during the applicable CNS Term or Liver Term (as
applicable based on whether the variant at issue is a New CNS Variant or a New
Liver Variant), and all Vector Characterization Data associated with such New
Capsid Variants.  For clarity, New CNS Variants only arise during the CNS Term,
and New Liver Variants only arise during the Liver Term, even though they, or
the Vector Characterization Data with respect thereto, may be later reported
between the Parties.

(c)        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.

(d)        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

-  19  -

 

§335a.  For clarity, each of the New CNS Variants and each of the New Liver
Variants to be entered into validation studies under the Research Program shall
meet the applicable Delivery Success Criteria as defined in the Research Plans
unless the Parties in their discretions agree otherwise in writing.

3.3      Materials and Know-How Transfer/Use of Constructs.

(a)        In order to facilitate the Research Program, each Party shall, to the
extent set forth in the Research Plan, provide to the other Party certain
Materials and, subject to Section 3.4, Know-How Controlled by the supplying
Party for use by the other Party in furtherance of the Research Program.  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 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, to the extent that samples have not
already been provided to uniQure under the Research Program, 4DMT shall promptly
provide to uniQure samples of New Capsid Variants that are at that time in
4DMT’s possession.  For clarity, this means the quantities specified in the
Research Plan, not all quantities of New Capsid Variants at that time in 4DMT’s
possession.  Other than as may be provided in the Research Plan, 4DMT shall not
be required to transfer any Royalty Bearing Constructs to uniQure, unless the
Parties mutually otherwise agree in writing in their discretions at a later
date.

3.4      Third Party Intellectual Property.  The conduct of activities under the
Research Plan may 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

-  20  -

 

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 6.2(c)(ii)) with respect to the Development, manufacture or
Commercialization of Royalty Bearing Constructs or Royalty Bearing
Products.  For clarity, nothing in this Section 3.4 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.

3.5      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 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)       In connection with uniQure’s exercise of its back-up right for patent
filing as relates to the New Variant Patents (if applicable), 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 the applicable New Capsid
Variants 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.

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ARTICLE IV

 

DEVELOPMENT AND COMMERCIALIZATION OF PRODUCTS; DILIGENCE

4.1      Responsibility.

(a)        uniQure shall have the full right, but not the obligation, at its
sole expense, for the worldwide research, Development, manufacturing and
Commercialization of uniQure Products pursuant to the exercise by uniQure of its
rights under this Agreement (including its ownership rights and/or its exercise
of any of the licenses granted to uniQure under Section 5.1(b)) in accordance
with the terms and conditions and limitations of such license rights, and,
subject to the payment obligations under Article VI and all other relevant terms
and conditions of this Agreement.  For clarity, this does not apply to those 4D
Products, if any, addressing Restricted Targets pursuant to 4DMT’s non-exclusive
rights after an exercise of 4DMT’s Step-In Rights that results in 4DMT obtaining
non-exclusive rights to such 4DMT Products addressing Restricted
Targets.  Moreover, it does not apply to any 4DMT Products directed to a
Non-Restricted Target, even after an exercise by uniQure of its Step-In Rights
related to a uniQure Product to such Non-Restricted Target.

(b)        4DMT shall have the full right, but not the obligation, at its sole
expense, for the worldwide research, Development, manufacturing and
Commercialization of 4DMT Products pursuant to the exercise by 4DMT of its
rights under this Agreement (including its ownership rights and/or its exercise
of any of the licenses granted to 4DMT under Section 5.2(c)) in accordance with
the terms and conditions and limitations of such license rights, and subject to
the payment obligations under Article VI and all other relevant terms and
conditions of this Agreement.  For clarity, this does not apply to those uniQure
Products, if any, addressing Non-Restricted Targets pursuant to uniQure’s
non-exclusive rights after an exercise of uniQure’s Step-In Rights that results
in uniQure obtaining non-exclusive rights to such uniQure Products addressing
Non-Restricted Targets.

4.2      Diligence.  No Party will have any diligence obligations with respect
to either 4DMT Products or uniQure Products, except as provided in Section 4.4
with respect to Proposed Products, and the circumstance in which either a
not-stepping-in Party chooses to pursue a Proposed Product in lieu of allowing
the other Party to obtain rights thereto pursuant to such other Party’s Step-In
Rights, or in the circumstance in which the stepping-in Party obtains
non-exclusive rights to such Proposed Product.

4.3      Obligation to Share Vector Characterization Data for AAV Capsid
Variants.

(a)        Commencing on the New CLA Effective Date and continuing throughout
the Term, uniQure shall provide, within [***] ([***]) days after each January
31st and July 31st of each Calendar Year, a written report to 4DMT that
summarizes the Vector Characterization Data generated by or on behalf of uniQure
or its Affiliate or Sublicensee with respect to each New Capsid Variant for
which any research, Development, Commercialization or other vector
characterization activities were conducted by or on behalf of uniQure or its
Affiliate or Sublicensee during the [***].

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(b)        Commencing on the New CLA Effective Date and continuing throughout
the Term, 4DMT shall provide, within [***] ([***]) days after each January 31st
and July 31st of each Calendar Year, a written report to uniQure that summarizes
the Vector Characterization Data generated by or on behalf of uniQure or its
Affiliate or Sublicensee with respect to each AAV Capsid Variant or New Capsid
Variant for which any research, Development, Commercialization or other vector
characterization activities were conducted by or on behalf of 4DMT or its
Affiliate or Sublicensee during the [***].

(c)        Either Party may terminate its obligation to provide written reports
pursuant to this Section 4.3 after the Research Term, if it ceases all research,
development, commercialization or other activities that would result in the
generation of any further unreported Vector Characterization Data with respect
to New Capsid Variants, and the Party provides written notice to the other Party
so stating and also certifying that all Vector Characterization Data that is
required to be reported with respect to New Capsid Variants has been so
reported.

4.4      Step-In Rights of each Party for Proposed Products.

(a)        Step-In Rights of 4DMT.

(i)         At any time after the expiration of the CNS Term (for products based
on New CNS Variants) or the Liver Term (for products based on New Liver
Variants), 4DMT may make a bona fide proposal to uniQure for Developing and
Commercializing a Product using a New Capsid Variant in the Field to deliver a
Transgene that Affects any Restricted Target (each, 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 4DMT Proposed
Product, uniQure shall notify 4DMT whether uniQure is conducting or is
interested in conducting research or Development of such 4DMT Proposed Product,
or a Product that uniQure believes in good faith is or would be competitive with
such 4DMT Proposed Product (a “Competitive Product”).  4DMT shall have the right
to select a maximum total of [***] ([***]) Proposed Products as 4DMT Proposed
Products per calendar year under this Section 4.4 and under Section 4.4 of the
Amended and Restated CLA, such total to be determined in the aggregate under
this Agreement and the Amended and Restated CLA, taken collectively.

(ii)       If uniQure notifies 4DMT in good faith that uniQure is conducting or
is interested in conducting research or Development of such 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 4DMT
Proposed Product or Competitive Product 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 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, uniQure
Proposed Product or Competitive Product during the [***].

(iii)      If uniQure notifies 4DMT that uniQure is not conducting and is not
interested in conducting research or Development of such 4DMT Proposed Product,
or

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Competitive Product, then the date of uniQure’s such written notice (or the
deadline therefor, if uniQure is required to provide such notice and fails to
provide notice by such date whether clause (ii) above or this clause (iii) would
otherwise), then this shall be the “Effective Time” for such 4DMT Proposed
Product and the applicable Restricted Target, and the license to 4DMT in Section
5.2(c) shall become effective as of the Effective Time.

(b)        Step-In Rights of uniQure.

(i)         At any time after the expiration of the CNS Term (for products based
on New CNS Variants) or the Liver Term (for products based on New Liver
Variants), uniQure may make a bona fide proposal to 4DMT for Developing and
Commercializing a Product using a New Capsid Variant in the Field to deliver a
Transgene that Affect any Non-Restricted Target (each, a “uniQure Proposed
Product”), including a development plan and a plan to finance such
activities.  Within [***] ([***]) days after receipt of a notice from uniQure of
a uniQure Proposed Product, 4DMT shall notify uniQure whether 4DMT is conducting
or is interested in conducting research or Development of such uniQure Proposed
Product, or a Product that 4DMT believes in good faith is or would be
competitive with such uniQure Proposed Product (a “4D Competitive
Product”).  uniQure shall have the right to select a maximum total of [***]
([***]) Proposed Products as uniQure Proposed Products per year under this
Section 4.4.

(ii)       If 4DMT notifies uniQure in good faith that 4DMT is conducting or is
interested in conducting research or Development of such uniQure Proposed
Product or Competitive Product, 4DMT shall within [***] ([***]) months after
such notice, deliver to uniQure 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
uniQure Proposed Product or Competitive Product in accordance with such
plan.  Each progress report provided to uniQure under Section 4.3 from and after
the date of 4DMT’s notice under this Section shall contain a summary of the
activities undertaken and the status of 4DMT’s research and Development efforts
with respect to such Third Party Proposed Product, uniQure Proposed Product,
4DMT Proposed Product or Competitive Product during the [***].

(iii)      If 4DMT notifies uniQure that 4DMT is not conducting and is not
interested in conducting research or Development of such uniQure Proposed
Product, or Competitive Product, then the date of 4DMT’s such written notice (or
the deadline therefor, if 4DMT is required to provide such notice and fails to
provide notice by such date whether clause (ii) above or this clause (iii) would
otherwise apply), then this shall be the “UQ Effective Time” for such uniQure
Proposed Product and the applicable Non-Restricted Target, and the license to
uniQure in Section 5.1(b)(ii) shall become effective as of the UQ Effective
Time.

(c)        General Rights of 4DMT Related to Non-Restricted Targets.  For
clarity, 4DMT owns the New Variant Patents and has the right to pursue 4DMT
Products delivering Transgenes that Affect Non-Restricted Targets, without the
need to obtain any rights under this Section 4.4 (i.e., as a default matter 4DMT
has the right to pursue 4DMT Products delivering Transgenes that Affect
Non-Restricted Targets, with no need to “step in” to obtain such rights, and for
that reason, 4DMT’s Step-In Rights under this Section 4.4 do not apply to 4DMT
Products delivering Transgenes that Affect Non-Restricted Targets).

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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 Constructs 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 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, 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 for Liver or the Research
Plan for CNS, (ii) evaluate Constructs, or (iii) evaluate the data developed in
the conduct of activities under the Research Program or during the Research
Term.  This license is intended to include the right for uniQure to make
sequence modifications to New Capsid Variants solely for the purpose of (1)
adapting New Capsid Variants to insect cells or insect cell expression vectors
and systems, and/or (2) modifying any “Selected Capsid Variants” as defined in
the Amended and Restated CLA with or to include any motif, mutation, or
substitution identified under this New CLA; provided that (x) uniQure shall
promptly disclose to 4DMT all AAV Capsid Variants resulting from such
activities, (y) such resulting AAV Capsid Variants shall be deemed New Capsid
Variants for all purposes under this Agreement, and (z) the Patent Rights that
may be filed with respect to such resulting deemed New Capsid Variants shall be
deemed New Variant Patents for all purposes under this Agreement, and the
Know-How with respect thereto shall be deemed the subject matter of New Variant
Patents (whether or not Patent Rights are ever filed with respect to such
Know-How) and therefore Core 4DMT Know-How, for all purposes under this
Agreement.  For clarity, the obligations of uniQure under the foregoing clauses
(x), (y) and (z) with respect to any uniQure-modified New Capsid Variants or any
uniQure-modified Selected

-  25  -

 

Capsid Variants as described in the foregoing sentence shall not apply to any
AAV Capsid Variant (or any modification or improvement thereof) that is
identified or generated by uniQure or any of its Affiliates or Sublicensees
independently and outside of the Research Program, without the use of any
information disclosed to uniQure pursuant to this Agreement or the Amended and
Restated CLA as to the sequence of any New Capsid Variant or Selected Capsid
Variant.

(b)        Development and Commercialization Licenses to uniQure.

Exclusive License for use of New Capsid Variants in connection with the
Restricted Targets.  Subject to the terms and conditions of this Agreement, and
on a New Capsid Variant-by-New Capsid Variant basis, 4DMT hereby grants to
uniQure, and uniQure hereby accepts, an exclusive (even as to 4DMT, except
solely to the extent that 4DMT obtains non-exclusive rights within the scope of
this license pursuant to an exercise of 4DMT’s Step-In Rights), worldwide,
royalty-bearing license, including the right to grant sublicenses in accordance
with Section 5.3, under the 4DMT Intellectual Property (including all Vector
Characterization Data reported by 4DMT to uniQure under this Agreement) and
4DMT’s interest in the Joint Intellectual Property, to research (subject to
4DMT’s retained rights to conduct research under the Research Program and to
research Constructs related to Restricted Targets for potential exercise of
4DMT’s Step-In Rights in relation thereto), Develop, make and have made, use,
import, sell and Commercialize the New Capsid Variants, and any modifications or
improvements thereto, as and into Royalty Bearing Constructs and Royalty Bearing
Products in the Field.  For clarity, the license granted to uniQure under this
paragraph shall expressly include the right to create improvements or
modifications to the sequence or composition of matter of any New Capsid
Variant, provided that such improved or modified sequence or composition of
matter is used solely in connection with  the applicable Restricted Target in
the Field, and (x) uniQure shall promptly disclose to 4DMT all resulting AAV
Capsid Variants made, (y) such resulting AAV Capsid Variants shall be deemed New
Capsid Variants for all purposes under this Agreement, and (z) the Patent Rights
that may be filed with respect to such resulting deemed New Capsid Variants
shall be deemed New Variant Patents for all purposes under this Agreement, and
the Know-How with respect thereto shall be deemed the subject matter of New
Variant Patents (whether or not Patent Rights are ever filed with respect to
such Know-How) and therefore Core 4DMT Know-How, for all purposes under this
Agreement.  For clarity, the obligations of uniQure under the foregoing clauses
(x), (y) and (z) with respect to any uniQure-modified New Capsid Variants
described in the foregoing sentence shall not apply to any AAV Capsid Variant
(or any modification or improvement thereof) that is identified or generated by
uniQure or any of its Affiliates or Sublicensees independently and outside of
the Research Program, without the use of any information disclosed to uniQure
pursuant to this Agreement or the Amended and Restated CLA as to the sequence of
any New Capsid Variant or Selected Capsid Variant.

(c)        Non-Exclusive License for Proposed Products elected by uniQure
pursuant to its Step-In Rights under Section 4.4.

(i)         Subject to the terms and conditions of this Agreement (including
4DMT’s retained rights related to Products delivering Transgenes related to the
applicable Non-Restricted Target), and on a New Capsid Variant by New Capsid
Variant basis, effective upon the UQ Effective Time for the applicable
Non-Restricted Target and New Capsid Variant under Section 4.4(b), 4DMT hereby
grants to uniQure, and uniQure hereby accepts, a non-

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exclusive, worldwide, royalty-bearing license, including the right to grant
sublicenses in accordance with Section 5.3, under the 4DMT Intellectual Property
(including all Vector Characterization Data reported by 4DMT to uniQure under
this Agreement) and 4DMT’s interest in the Joint Intellectual Property, to
research, Develop, make and have made, use and Commercialize the uniQure
Proposed Product to the applicable Non-Restricted Target as Royalty Bearing
Constructs and Royalty Bearing Products within the Field.  Such license may
become effective one (1) or more times, in connection with one (1) or more
elections by uniQure under Section 4.4 that result in the UQ Effective Time
occurring under Section 4.4(b) for the applicable uniQure Proposed Product,
Non-Restricted Target, and New Capsid Variant.  For clarity, the license granted
under this paragraph to uniQure shall expressly include the right to create
improvements or modifications to the sequence or composition of matter of any
New Capsid Variant, provided that such improved or modified sequence or
composition of matter is used solely in connection with  the applicable
Non-Restricted Target in the Field.

(ii)       In order to enable uniQure to research Constructs related to
Non-Restricted Targets for the potential exercise of uniQure’s Step-In Rights
pursuant to Section 4.4, uniQure shall have, and 4DMT hereby grants to uniQure,
a non-exclusive research-use-only license to use any and all Vector
Characterization Data reported to uniQure by 4DMT and any other necessary 4DMT
Intellectual Property, on a New Capsid Variant by New Capsid Variant basis,
regardless of whether such New Capsid Variant was generated or identified under
this Agreement or outside of this Agreement, to the extent necessary for uniQure
to evaluate whether to exercise its Step-In Rights pursuant to Section 4.4.

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

(e)        Grant-Back License to uniQure. 4DMT hereby grants to uniQure, and
uniQure hereby accepts, a non-exclusive, worldwide, royalty-free license,
including the right to grant sublicenses through multiple tiers, under the 4DMT
Patent Rights and 4DMT Know-How that (i) arise from activities that are
conducted under this Agreement in connection with Royalty Bearing Constructs and
Royalty Bearing Products in the course of making modifications to New Capsid
Variants and (ii) claim or cover compositions of matter or general methods of
use of New Capsid Variants (for 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, import, sell and Commercialize New
Capsid Variants, and Products containing New Capsid Variants in connection
solely with the Restricted Targets and any Non-Restricted Targets licensed to
uniQure pursuant to the Step-In Rights under Section 4.4.

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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, 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 Program during the
Research Term.

(b)        Grant-Back License to 4DMT.  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 pursuant to the licenses granted by 4DMT to
uniQure in Section 5.1 (including such Patent Rights and Know-How licensed to
uniQure pursuant to Section 5.1 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), and to use the Vector Characterization Data reported by
uniQure to 4DMT under this Agreement, to research, Develop, make and have made,
use and Commercialize New Capsid Variants, and Products containing New Capsid
Variants, in all cases outside the Field or within 4D Products within the scope
of rights within which 4DMT is entitled to research, Develop, and Commercialize
4D Products under this Agreement.  For the avoidance of doubt, 4DMT’s practice
of the foregoing license shall be subject to the license rights of uniQure under
Section 5.1 and its right to grant sublicenses under Section 5.3.

(c)        Non-Exclusive License for Proposed Products elected by 4DMT pursuant
to its Step-In Rights under Section 4.4.  Subject to the terms and conditions of
this Agreement (including uniQure’s retained rights related to Products
delivering Transgenes that Affect the applicable Restricted Target), and on a
New Capsid Variant-by-New Capsid Variant basis, effective upon the Effective
Time with respect to the given 4DMT Proposed Product and Restricted Target
pursuant to Section 4.4(a), uniQure hereby grants to 4DMT, and 4DMT hereby
accepts, a non-exclusive, worldwide, royalty-bearing license, including the
right to grant sublicenses in accordance with Section 5.3, under the uniQure
Intellectual Property that is necessary or useful due to the presence of the
applicable New Capsid Variant (including all Vector Characterization Data
reported by uniQure to 4DMT under this Agreement) and uniQure’s interest in the
Joint Intellectual Property, to research, Develop, make and have made, use and
Commercialize such 4DMT Proposed Products as Royalty Bearing Constructs and
Royalty Bearing Products within the Field.  Any licenses granted pursuant to
this Section are limited to only uniQure Intellectual Property that specifically
relates to New Capsid Variants, including patent claims specifying a New Capsid
Variant (if any) or specifically claiming any methods of use or making any New
Capsid Variants (if any), and excluding all other uniQure Intellectual Property,
including compositions of matter or methods of making compositions of matter and
methods of manufacturing Products (but not the New Capsid Variants therein)
pursuant to this Agreement.  Such license may become effective one (1) or more
times, in connection with one (1) or more elections by 4DMT under Section 4.4
that result in the Effective Time occurring under Section 4.4(a)(iii) for the
applicable Proposed Product and Restricted Target.

5.3      Sublicenses.  Each Party  shall have the right to grant sublicenses
(through multiple tiers) under the license granted to it under Section 5.1(b)
(in the case of uniQure) or

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Section 5.2(c) (in the case of 4DMT) to its Affiliates 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.  Each Party
granting a sublicense shall provide the other Party  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.  The Party granting the
sublicense 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      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 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

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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.

ARTICLE VI

 

PAYMENTS; ROYALTIES AND REPORTS

6.1       [Intentionally omitted].

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6.2      Royalties.

(I)        Royalties Payable by uniQure for uniQure Products.

On a Royalty Bearing Product-by-Royalty Bearing Product basis, uniQure shall pay
to 4DMT royalties on worldwide Net Sales of uniQure Products as provided in this
Section 6.2:

(a)        Royalty Rate.  uniQure shall pay to 4DMT royalties on Net Sales of
each Royalty Bearing Product Commercialized 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 6.2 for uniQure Products 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 6.2(I)(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 6.2(I)(a) with respect to Net Sales
for such Royalty Bearing 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 [***] by more than [***] percent
([***]%) of the amount determined pursuant to Section 6.2(I)(a), as adjusted by
application of the terms of Section 6.2(I)(c)(i).

(iii)      Limits on Deductions.  Except as expressly provided in this Section
6.2, there shall not be any offset to or deduction from the royalties payable
pursuant to this Section 6.2.  Notwithstanding Sections 6.2(c)(i) and (ii) to
the contrary, in no event shall the cumulative effect of the deductions in
Sections 6.2(I)(c)6.2(c)(i) and (ii) reduce the royalties to less than [***]
percent ([***]%) of the amounts determined pursuant to Section 6.2(I)(a).

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(II)       Royalties Payable by 4DMT for 4DMT Products.

On a Royalty Bearing Product-by-Royalty Bearing Product basis, for each 4DMT
Product Commercialized by 4DMT and its Affiliates, 4DMT shall pay to uniQure
royalties on annual worldwide Net Sales of such 4DMT Product as provided in this
Section 6.2:

(a)        Royalty Rate.  4DMT shall pay to uniQure royalties on Net Sales of
each Royalty Bearing Product Commercialized by 4DMT 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.  4DMT’s royalty obligations to uniQure under this
Section 6.2 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 5.2(c) shall be fully paid-up, irrevocable, perpetual and
non-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 6.2(a), unless such Royalty
Bearing Product embodies an Invention with respect to which 4DMT made a Trade
Secret Election, in which case no such reduction shall apply.

(ii)       Third Party Offset.  If 4DMT 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 6.2(a) with respect to Net Sales for
such Royalty Bearing Product in such country shall be reduced by [***] percent
([***]%) of the amounts payable by 4DMT 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 uniQure in any [***] by more than [***] percent ([***]%)
of the amount determined pursuant to Section 6.2(a), as adjusted by application
of the terms of Section 6.2(c)(i).

(iii)      Limits on Deductions.  Except as expressly provided in this Section
6.2, there shall not be any offset to or deduction from the royalties payable
pursuant to this Section 6.2.  Notwithstanding Sections 6.2(II)(c)(i) and (ii)
to the contrary, in no event shall the cumulative effect of the deductions in
Sections 6.2(c)(i) and (ii) reduce the royalties to less than [***] percent
([***]%) of the amounts determined pursuant to Section 6.2(II)(a).

6.3      Sublicense Consideration.

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(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 Construct or Product that is subject of the
sublicense and (B) does not require uniQure to manufacture any such Construct or
Product for Clinical Trial or commercial purposes;

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

(iii)      [***] percent ([***]%) for any sublicense that does not meet the
criteria set forth in Section 6.3(a)(i) or Section 6.3(a)(ii) above;

provided,  however, that none of subsections (i), (ii) or (iii) shall result in
uniQure paying to 4DMT under this Section 6.3 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 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

-  33  -

 

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

 

(c)        4DMT shall pay to uniQure the following percentages (“4D Sublicense
Income Sharing Percentages”) of 4D Sublicense Consideration received by 4DMT 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 Construct or Product that is subject of the
sublicense and (B) does not require 4DMT to manufacture any such Construct or
Product for Clinical Trial or commercial purposes;

(ii)       [***] percent ([***]%) for any sublicense that (A) is granted prior
to initiating Animal POC for any Construct or Product that is subject of the
sublicense and (B) requires 4DMT to manufacture any such Construct or Product
for Clinical Trial or commercial purposes;

(iii)      [***] percent ([***]%) for any sublicense that does not meet the
criteria set forth in Section 6.3(a)(i) or Section 6.3(a)(ii) above;

provided,  however, that none of subsections (i), (ii) or (iii) shall result in
4DMT paying to uniQure under this Section 6.3 a percentage of any 4D 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.

(d)        The term “4D Sublicense Consideration” shall mean consideration of
any kind received by 4DMT 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 4DMT in consideration for such sublicense; provided,
 however, the following are not included in Sublicense Consideration:

(i)         Support for activities of 4DMT 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 Manufacturing Cost) for undertaking such activities
performed by or for 4DMT (including Third Parties on 4DMT’s behalf) by more than
[***] percent ([***]%);

(ii)       Proceeds derived from debt financing and any loans to 4DMT by the
Sublicensee;

(iii)      Consideration received for the purchase of stock in 4DMT 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

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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 4DMT or its applicable
Affiliate as of the time of receipt of payment; and

(iv)       Reimbursement of 4DMT’s patent costs related to Patent Rights.

(e)        For purposes of this Article 6, “Sublicense Consideration received by
uniQure” shall include Sublicense Consideration received by uniQure’s Affiliates
(applying the definition of Sublicense Consideration mutatis mutandis to such
Affiliates) and “4D Sublicense Consideration received by 4D” shall include 4D
Sublicense Consideration received by 4DMT’s Affiliates (applying the definition
of Sublicense Consideration mutatis mutandis to such Affiliates).

6.4      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 6.2 or uniQure (or 4DMT, as applicable) received
Sublicense Consideration or 4D Sublicense Consideration giving rise to a payment
obligation under Section 6.3, (a) uniQure (or 4DMT as applicable) shall submit
to 4DMT (or uniQure as applicable) 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
6.2(c)), and the royalties payable to 4DMT (or uniQure as applicable) and
(ii) identifying the Sublicense Consideration received by uniQure (or 4DMT as
applicable) in such Calendar Quarter and the one or more Sublicense Income
Sharing Percentages applicable to such Sublicense Consideration, or 4D
Sublicense Income Sharing Percentages applicable to such 4D Sublicense
Consideration and (b) uniQure (or 4DMT as applicable) shall pay to 4DMT (or
uniQure as applicable) all royalties payable under Section 6.2 and portions of
Sublicense Consideration or 4D Sublicense Consideration payable under Section
6.3.

6.5      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 under this Agreement.  Each Auditing Party shall have the right,
once annually 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 [***] 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, and the amount
of any Net Sales, Sublicense Consideration, 4D Sublicense Consideration, royalty
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

-  35  -

 

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 the audit determined an underpayment of royalties by
the Audited Party which is greater than [***] percent ([***]%) of the amount due
for the applicable period, in which case the Audited Party shall pay the
reasonable costs charged by such accounting firm for such review.  Any
overpayment of royalties by uniQure (or 4DMT, as applicable) revealed by an
inspection shall be fully creditable against future royalty payments by such
Audited Party under Section 6.2.

6.6      Withholding Taxes.

(a) 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.

(b) Subject to the provisions of Section 12.7, if Laws require withholding by
4DMT of taxes imposed upon uniQure on account of any royalty or other payment
paid under this Agreement, such taxes shall be deducted by 4DMT as required by
Law from such remittable royalty or other payment and shall be paid by 4DMT to
the proper tax authorities; provided that before making any such deduction or
withholding, 4DMT shall give uniQure 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 uniQure to obtain
reduction of or relief from such deduction or withholding.  Official receipts of
payment of withholding taxes shall be secured and sent to uniQure 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.

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

6.8      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
hereunder for the relevant Calendar Quarter under Section 6.2 or Section 6.3,
amounts received by a Party in any foreign currency shall be converted into
United States dollars

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in accordance with the normal business practice of such Party , as applied
consistently across its business.

6.9      Blocked Payments.  (a)  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 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.

(b)  If, by reason of applicable Laws in any country in the Territory, it
becomes impossible or illegal for 4DMT or any of its Affiliates or Sublicensees
to transfer, or have transferred on its behalf, royalties or other payments to
uniQure, 4DMT shall promptly notify uniQure 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 uniQure in a recognized
banking institution with a good creditworthiness, such banking institution to be
designated by uniQure or, if none is designated by uniQure within [***] ([***])
days, in a recognized banking institution selected by 4DMT or its Affiliate or
Sublicensee, as the case may be, and identified in a written notice given to
uniQure.  If so deposited in a foreign country, 4DMT shall provide, or cause its
Affiliate or Sublicensee to provide, reasonable cooperation to uniQure so as to
allow uniQure to assume control over such deposit as promptly as practicable.

6.10    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).

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7.2      Ownership.

(a)        uniQure shall solely own all Core uniQure Intellectual Property, and
4DMT shall solely own all Core 4DMT Intellectual Property.   Without limiting
the generality of the foregoing, this means that 4DMT shall own the New Variant
Patents, and uniQure shall own the uniQure Product Patents.  All other
Inventions arising under this Agreement or the Parties’ activities hereunder,
shall be owned by inventorship.  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 Inventions, Know-How and 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) and agrees to take all necessary actions and execute any documents as
is necessary to effectuate the allocation of right, title, and interest as set
forth in this Section 7.2(a).

(b)        Except as otherwise expressly 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 determined in
accordance with U.S. patent Laws for purposes of determining ownership in
accordance with the foregoing.  Except as explicitly provided for herein, the
nature of the ownership rights in Joint Patent Rights shall be equivalent to the
rights of co-inventors under U.S. patent law in the absence of a written
agreement.

(c)        Except as expressly provided in this Agreement, and subject to any
restriction herein (including the licenses 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 a Core uniQure Patent Right specifically relating
to [***] (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

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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 (each, a “Trade Secret Election”).

(c)        Notwithstanding anything express or implied and provided that a
Patent Right has not been filed hereunder with respect to a New Capsid Variant,
uniQure shall give reasonable notice to 4DMT (no less than [***] ([***]) days)
prior to filing a uniQure Product Patent disclosing a New Capsid Variant, and
the Parties shall cooperate reasonably in the filing of such uniQure Product
Patent, including coordinating the timely filing of a Patent Right with respect
to a New Capsid Variant and, where appropriate, the simultaneous filing of such
patents by each Party.

7.4      4DMT Prosecution and Maintenance of Patent Rights.

(a)        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 inform uniQure regarding
the Prosecution and Maintenance of 4DMT Patent Rights ([***]).  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.

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

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

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:

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(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 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 [***].  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.

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(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 [***].  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, 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)         Restricted Target Products.  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 by a
Product that delivers a Transgene related to a Restricted Target.  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

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reasonable counsel fees and expenses) actually incurred by 4DMT in connection
with such cooperation.

(ii)       Non-Restricted Target Products.  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 that is (A) outside the Field, and/or (B)
by Products related to Non-Restricted Targets.  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 of 4D.  If uniQure does not initiate a lawsuit or take
other reasonable action pursuant to this Section 7.6(c) regarding infringement
or alleged infringement of a New Variant Patent, then 4DMT shall have the right,
but not the obligation, to initiate such lawsuit or take such other action,
after providing [***] ([***]) days’ notice to uniQure and giving good faith
consideration to  uniQure’s reason(s) for not initiating a lawsuit or taking
other action.  For this purpose, uniQure shall cooperate in the prosecution of
any such suit as may be reasonably requested by 4DMT, including joining any
action as party-plaintiff if needed for standing purposes; 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.

(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.

(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 for recoveries for infringement within the Field, the
amount of remaining recovery received by the Initiating Party or its Affiliate
will be [***].

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

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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.  4DMT shall have the
right, but not the obligation, to list any 4DMT Patent Rights in the
then-current edition of the Orange Book, or equivalent patent listings in other
countries.

(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

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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.

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;

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(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;

(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 and obtaining the permission of the
other Party, except that either Party may publish or first present in a public
forum any information related to the Research Program and/or any pre-clinical or
clinical results obtained by such Party pertaining to any New Capsid Variants,
without the need

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to obtain the other Party’s review or permission, provided that the publication
or presentation does not disclose the sequence of any New Capsid Variant for
which a Patent Right has not yet been filed under this Agreement, and provided
in the case of uniQure that the publication must only present data and
information as to a Royalty-Bearing Construct or Royalty-Bearing Product for
which uniQure at that time holds a commercialization license under this
Agreement, not a New Capsid Variant outside the context of a Royalty-Bearing
Construct or Royalty-Bearing Product for which uniQure at that time holds a
commercialization license under this Agreement.

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 Construct or Product or the stage of development of any
Construct 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 Construct or Product or the stage
of development of any Construct 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 payment but not the amount of such payment; provided,  further,
 however, that if disclosure of the amount of a 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
Delivery Success Criteria, nor any other contents of the Research Plan for Liver
nor the Research Plan for CNS.

(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 2, 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)        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;

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

-  47  -

 

(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)        [Intentionally omitted.]

(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 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

-  48  -

 

that if the New 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 [***].

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 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

-  49  -

 

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 Construct 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 Variant, Construct or Product (other than a uniQure Product
Developed, or Commercialized by uniQure, its Affiliate, or Sublicensee) 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.

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.

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(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 Construct, Royalty Bearing Construct, 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 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:

 

-  51  -

 

 

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.

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

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(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 and
4DMT’s payment obligations hereunder (the “Term”).  Upon expiration, all
licenses granted hereunder shall be fully paid-up, perpetual and irrevocable.

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 Party (the “Defaulting Party”), which Default remains uncured for ninety
(90) 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 sixty (60) 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 thirty
(30) 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.

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Notwithstanding the foregoing, if the claimed Default relates to one or more
Royalty-Bearing Constructs or Royalty-Bearing Products, and not this entire
Agreement, then this Agreement shall be terminated only with respect to the
Indication for which such Royalty-Bearing Construct(s) or Royalty-Bearing
Product(s) were intended to treat and if uniQure was the Defaulting Party then
additionally such Indication shall be removed from the Field.

(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 Delivery Success
Criteria cannot be met through use of the 4DMT Intellectual Property following
the reasonable efforts of 4DMT to achieve such Delivery Success Criteria or (ii)
4DMT is not making bona fide efforts to achieve the timelines set forth in the
Research Plan.

(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.

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 royalties and Sublicense Consideration 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 4.4 (if any) and uniQure and 4DMT shall be released of
their disclosure and information exchange obligations under ARTICLE III and
ARTICLE IV;

-  54  -

 

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

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  will not terminate but the Field is automatically
narrowed to exclude the relevant Indication(s); the license granted to 4DMT
under Section 5.2(b) shall be automatically adjusted to include the relevant
Indication(s) rather than all fields of use; and uniQure’s obligations under
subsection (ii) shall be limited to copies of 4DMT’s Confidential Information
and 4DMT Intellectual Property and Materials that relate solely to the relevant
Indication(s).

(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) or Section 10.2(b):

(i)         For clarity, uniQure’s licenses pursuant to Section 5.1 and Step-In
Rights under Section 4.4 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 New 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; and

(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 provisions of this Agreement.

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

-  55  -

 

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 (but not Sections 7.4(c) nor
7.6-7.9), ARTICLE VIII, ARTICLE XI, ARTICLE XII, and Sections 4.5, 5.2(b), 5.4,
5.5, 5.6, 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 as to uniQure Products in such
countries.

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 2.3(c) (subject to Section 2.3(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 2.3 (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 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.

-  56  -

 

Each Party participating in an arbitration pursuant to the terms of this
Agreement shall, [***].  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.

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

-  57  -

 

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, Inc.
5858 Horton St

Emerystation North, Suite 460

Emeryville, CA 94608

Attention: CEO
Facsimile:

 

 

with a copy to:

Latham & Watkins LLP
140 Scott Drive
Menlo Park, CA 94025
Attention:  [***]
Facsimile:  [***]

 

 

And a required email copy to:

[***]

 

 

If to uniQure, to:

uniQure biopharma B.V.
P.O. Box 22506
1100 DA Amsterdam
The Netherlands
Attention:  CEO
Facsimile:  [***]

 

 

with a copy to:

[***]

 

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.

-  58  -

 

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 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

-  59  -

 

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
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.

-  60  -

 

[Signature page follows]

 

-  61  -

 

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

 

 

 

 

 

 

UNIQURE BIOPHARMA B.V.

    

4D MOLECULAR THERAPEUTICS, INC.

 

 

 

 

 

 

BY:

s/s Lilly Burggraaf

 

BY:

s/s David Kirn

NAME:

Lilly Burggraaf

 

NAME:

David Kirn, MD

TITLE:

Vice President, Global Human Resources

 

TITLE:

Chief Executive Officer

 

 

 

-  62  -

 

SCHEDULE 1

DRAFT INVOICE

[***]

 

 

SCHEDULE 1.47 - Page 1

 

 

SCHEDULE 2

RESEARCH PLAN

[***]

 

 

SCHEDULE 1.66- Page 1

 

 

 

SCHEDULE 3

SELECTED CAPSID VARIANTS

[***]