Exhibit 10.18


 


Confidential
Treatment Requested


 


EXECUTION
COPY


 


License
Agreement


 


This LICENSE AGREEMENT (“Agreement”) is entered
into as of November 4, 2018 (“Effective Date”) by and between REGENXBIO Inc., a corporation organized under
the laws of the State of Delaware, with offices at 9600 Blackwell Road, Suite 210, Rockville, MD 20850 (“Licensor”),
and Abeona Therapeutics Inc., a corporation organized under the laws of the State of Delaware, with offices at 1330 Avenue of the
Americas, 33rd Floor, New York, NY 10019 (“Licensee”). Licensor and Licensee are hereinafter referred to individually
as a “Party” and collectively as the “Parties.”


 


WHEREAS, Licensor has rights under certain Licensed Patents
(as defined herein) pertaining to adeno-associated virus serotype 9;


 


WHEREAS, Licensee desires to obtain from Licensor an exclusive
license under the Licensed Patents under the terms set forth herein; and


 


WHEREAS, the Licensee has determined, and the Licensor has relied
upon such determination, that the Agreement does not require regulatory approval under the Hart-Scott-Rodino Antitrust Improvements
Act of 1976, as amended.


 


NOW, THEREFORE, in consideration of the promises and covenants
contained in this Agreement, and intending to be legally bound, the Parties hereby agree as follows:


 


Article
1: Definitions


 


1.1          “AAV9”
means (a) the recombinant adeno-associated virus serotype 9 vector with the specified sequence set forth in GenBank **** and (b)
any recombinant adeno-associated virus derivatives of such serotype 9 vector that are covered by the claims of the Licensed Patents.


 


1.2          “Affiliate”
means any legal entity directly or indirectly, during the term of this Agreement, controlling, controlled by, or under common control
with another entity. For purposes of this Agreement, “control” means the direct or indirect ownership of more than
50% of the outstanding voting securities of a legal entity, or the right to receive more than 50% of the profits or earnings of
a legal entity, or the right to control the policy decisions of a legal entity. An entity may be or become an Affiliate of an entity
and may cease to be an Affiliate of an entity, in each case, during the term of this Agreement.


 


1.3          “Calendar
Quarter” means each three-month period or any portion thereof, beginning on January 1, April 1, July 1, and October 1.


 




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1.4         “Change
of Control” means (i) any transaction or series of related transactions following which the holders of Licensee’s
capital stock or membership or equity interests immediately prior to such transaction or series of related transactions collectively
are the owners of less than 50% of the outstanding equity interests of Licensee entitled to (a) vote with respect to the election
of directors (or positions having a similar function) or (b) receive the proceeds upon any sale, liquidation or dissolution of
Licensee; (ii) a sale, transfer, or other disposition, in a single transaction or series of related transactions, of all or a material
portion of Licensee’s interest in the Licensed Products; (iii) a sale, transfer, or other disposition, in a single transaction
or series of related transactions, of all or a material portion of Licensee’s right title, or interest in its assets taken
as a whole; or (iv) the merger of Licensee with a Third Party by operation of law or otherwise.


 


1.5         “CLN1
Field” means the treatment of Neuronal Ceroid Lipfuscinosis-1, also known as infantile Batten disease, in humans by in
vivo gene therapy using AAV9 to deliver the PPT1 gene.


 


1.6         “CLN3
Field” means the treatment of Neuronal Ceroid Lipfuscinosis-3, also known as juvenile Batten disease, in humans by in
vivo gene therapy using AAV9 to deliver the CLN3 gene.


 


1.7         “Confidential
Information” means and includes all technical information, inventions, developments, discoveries, software, know-how,
methods, techniques, formulae, animate and inanimate materials, data, processes, finances, business operations or affairs, and
other proprietary ideas, whether or not patentable or copyrightable, of either Party that are (a) marked or otherwise identified
as confidential or proprietary at the time of disclosure in writing; or (b) if disclosed orally, visually, or in another non-written
form, identified as confidential at the time of disclosure and summarized in reasonable detail in writing as to its general content
within 30 days after original disclosure. The Parties acknowledge that (i) the terms and conditions of this Agreement and (ii)
the records and reports referred to in Section 3.6 will be deemed the Confidential Information of both Parties, regardless of whether
such information is marked or identified as confidential. In addition, information provided to Licensee pursuant to the provisions
of Section 7.1 will be deemed the Confidential Information of Licensor, regardless of whether such information is marked or identified
as confidential. Notwithstanding the foregoing, Confidential Information will not include the following, in each case, to the extent
evidenced by competent written proof of the Receiving Party:


 


1.7.1        information
that was already known to the Receiving Party, other than under an obligation of confidentiality, at the time of disclosure by
the Disclosing Party;


 


1.7.2        information
that was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving
Party;


 


1.7.3        information
that became generally available to the public or otherwise part of the public domain after its disclosure, other than through any
act or omission of the Receiving Party in breach of this Agreement;


 


1.7.4        information
that is independently discovered or developed by the Receiving Party without the use of Confidential Information of the Disclosing
Party; or


 


1.7.5        information
that was disclosed to the Receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation
to the Disclosing Party not to disclose such information to others.


 




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1.8         “Conflicting
License” means the license agreement **** that licenses rights under the Licensed Technology on a non-exclusive, sublicensable
basis for the treatment of MPSIII Type A in human beings by in vivo administration.


 


1.9         “Disclosing
Party” has the meaning set forth in Section 5.1.


 


1.10       “Domain
Antibody” ****.


 


1.11       “FDA”
means the United States Food and Drug Administration, or a successor agency in the United States with responsibilities comparable
to those of the United States Food and Drug Administration.


 


1.12       “Fields”
means the CLN1 Field, the CLN3 Field, the MPS IIIA Field and the MPS IIIB Field (individually, the CLN1 Field, the CLN3 Field,
the MPS IIIA Field and the MPS IIIB Field are hereinafter referred to as a “Field”).


 


1.13       “GSK
Agreement” means that certain License Agreement entered into between Licensor and SmithKline Beecham Corporation, effective
on March 6, 2009, as amended by that certain Amendment to License Agreement dated April 15, 2009, and as further amended from time
to time.


 


1.14       “First
Commercial Sale” of a Licensed Product means the first transfer by Licensee, its Affiliates or Sublicensees for value
in an arms’-length transaction to an independent third party distributor, agent or end user in a country after obtaining
all approvals from Regulatory Authorities necessary for such transfer in such country. For clarity, sales or transfers of a product
for clinical trial purposes, compassionate or similar use or indigent programs shall not constitute a “First Commercial Sale”
hereunder.


 


1.15       “Know-How”
means any and all ideas, information, know-how, data, research results, writings, inventions, discoveries, and other technology
(including any proprietary materials), whether or not patentable or copyrightable.


 


1.16       Licensed
Back Improvements” has the meaning ascribed to it in Section 2.5.2.


 


1.17       “Licensed
Know-How” means any Know-How Licensor provides to Licensee pursuant to Section 2.6.


 


1.18       “Licensed
Patents” means, to the extent they cover AAV9, (a) all United States patents and patent applications listed in Exhibit
A, including patents arising from such patent applications; (b) any re-examination certificates thereof; (c) the foreign counterparts
of the patents and patent applications in subsections (a) and (b); (d) extensions, continuations, divisionals, and re-issue applications
of the patents and patent applications in subsections (a) through (c); and (e) continuations-in-part to the extent that the continuations-in-part
contain one or more claims directed to the invention or inventions disclosed in the patent and patent applications in subsections
(a) through (c); provided that “Licensed Patents” will not include any claim of a patent or patent application covering
any Manufacturing Technology.


 




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1.19       “Licensed
Product” means (a) any AAV9 product that is made, made for, used, sold, offered for sale, or imported by Licensee, its
Affiliates, and any of its or their Sublicensees, (i) the manufacture, use, sale, offer for sale, or import of which product, in
the absence of the license granted pursuant to this Agreement, would infringe or is covered by at least one Valid Claim in the
country of manufacture, use, sale, offer for sale, or import, including products manufactured by a process that would infringe
or is covered by at least one Valid Claim in the country of manufacture, use, sale, offer for sale, or import or (ii) that incorporates,
was developed using, or is produced or manufactured through the use of Licensed Know-How (it being understood that Licensee shall
be deemed to be using Licensed Know-How based upon the license it receives under this Agreement); or (b) any service sold by Licensee,
its Affiliates, and any of its or their Sublicensees with respect to the administration of any AAV9 product to patients that (i)
in the absence of the license granted pursuant to this Agreement, would infringe or is covered by at least one Valid Claim in the
country of sale or (ii) that incorporates, was developed using, or is produced or manufactured through the use of Licensed Know-How
(it being understood that Licensee shall be deemed to be using Licensed Know-How based upon the license it receives under this
Agreement).


 


1.20       “Licensed
Technology” means, collectively, the Licensed Patents and Licensed Know-How.


 


1.21       “Manufacturing Technology” means any and all patents, patent applications, Know-How, and all intellectual property
rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that claim,
cover or relate to the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents
related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the
methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications,
scale up methods, any and all improvements, modifications, and changes thereto, and any and all activities associated with such
manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided
to Regulatory Authorities and the information contained therein are deemed Manufacturing Technology.


 


1.22       “MPS
IIIA Field” means the treatment of Mucopolysaccharidosis type IIIA, also known as Sanfilippo Syndrome Type A, in humans
by in vivo gene therapy using AAV9 to deliver the SGSH gene.


 


1.23       “MPS
IIIB Field” means the treatment of Mucopolysaccharidosis type IIIB, also known as Sanfilippo Syndrome Type B, in humans
by in vivo gene therapy using AAV9 to deliver the NAGLU gene.


 


1.24       “Net
Sales” means the gross receipts from sales or other disposition of a Licensed Product (including fees for services within
the definition of “Licensed Product”) by Licensee and/or its Affiliates and/or any Sublicensees to Third Parties less
the following deductions that are directly attributable to a sale, specifically and separately identified on an invoice or other
documentation and actually borne by Licensee, its Affiliates, or any Sublicensees: ****. In the event consideration other than
cash is paid to Licensee, its Affiliates, or any Sublicensees, for purposes of determining Net Sales, the Parties shall use the
cash consideration that Licensee, its Affiliates, or any Sublicensees would realize from an unrelated buyer in an arm’s length
sale of an identical item sold in the same quantity and at the time and place of the transaction, as determined jointly by Licensor
and Licensee based on transactions of a similar type and standard industry practice, if any.


 




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1.25       “Penn
Agreement” means that certain License Agreement entered into between Licensor and The Trustees of the University of Pennsylvania,
effective on February 24, 2009, as amended by that letter agreement dated March 6, 2009, by that certain Second Amendment to License
Agreement effective on September 9, 2014, and by that certain Third Amendment to License Agreement effective on April 29, 2016,
and as further amended from time to time.


 


1.26       “Prosecute”
means preparation, filing, and prosecuting patent applications and maintaining patents, including any reexaminations, reissues,
oppositions, inter partes review, and interferences.


 


1.27       “Receiving
Party” has the meaning set forth in Section 5.1.


 


1.28       “REGENXBIO
Licensors” means SmithKline Beecham Corporation (or any successor thereto under the GSK Agreement) and The Trustees of
the University of Pennsylvania (or any successor thereto under the Penn Agreement), if any Licensed Technology is sublicensed from
the Penn Agreement.


 


1.29       “Regulatory
Authority” means any national, supra-national, regional, state or local regulatory agency, department, bureau, commission,
council or other governmental entity with authority over (a) the distribution, importation, exportation, manufacture, production,
use, storage, transport, clinical testing or sale of a Licensed Product, including the FDA, or (b) setting the price and/or reimbursement
for a Licensed Product.


 


1.30       “Retained
Rights” has the meaning set forth in Section 2.2.


 


1.31       “Sublicensee”
means (i) any Third Party or Affiliate to whom Licensee grants a sublicense of some or all of the rights granted to Licensee under
this Agreement as permitted by this Agreement; and (ii) any other Third Party or Affiliate to whom a sublicensee described in clause
(i) has granted a further sublicense as permitted by this Agreement.


 


1.32       “Third
Party” means any person or entity other than a Party to this Agreement or Affiliates of a Party to this Agreement.


 


1.33       “Valid
Claim” means a claim of an issued and unexpired patent (including any patent claim the term of which is extended by any
extension, supplementary protection certificate, patent term restoration, or the like) included within the Licensed Patents or
a claim of a pending patent application included within the Licensed Patents, that has not lapsed, been abandoned, been held revoked,
or been deemed unenforceable or invalid by a non-appealable decision or an appealable decision from which no appeal was taken within
the time allowed for such appeal of a court or other governmental agency of competent jurisdiction.


 




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Article
2: License Grants


 


2.1         License
Grant. Subject to the terms and conditions of this Agreement, including the Retained Rights, Licensor hereby grants to Licensee
an exclusive, sublicensable (as provided in Section 2.4 only), non-transferable (except as provided in Section 10.2), royalty-bearing,
worldwide license under the Licensed Technology to make, have made, use, import, sell, and offer for sale Licensed Products using
AAV9 solely in the Fields, including, for the avoidance of doubt, the right to conduct research and development; provided that
with respect to the MPSIIIA Field, the license granted under this Section 2.1 shall be exclusive with the exception of those rights
Licensor has granted under the Conflicting License.


 


2.2         Retained
Rights. Except for the rights and licenses specified in Section 2.1, no license or other rights are granted to Licensee under
any intellectual property of Licensor, whether by implication, estoppel, or otherwise and whether such intellectual property is
subordinate, dominant, or otherwise useful for the practice of the Licensed Technology. Notwithstanding anything to the contrary
in this Agreement, Licensor may use and permit others to use the Licensed Technology for any research, development, commercial,
or other purposes outside of the Fields. Without limiting the foregoing, and notwithstanding anything in this Agreement to the
contrary, Licensee acknowledges and agrees that the following rights are retained by Licensor and the REGENXBIO Licensors (individually
and collectively, the “Retained Rights”), whether inside or outside the Fields:


 


2.2.1        The
rights and licenses granted in Section 2.1 shall not include any right (and Licensor and the REGENXBIO Licensors retain the exclusive
(even as to Licensee), fully sublicensable right) under the Licensed Technology to make, have made, use, sell, offer to sell, and
import Domain Antibodies that are expressed by an adeno-associated vector, including AAV9.


 


2.2.2        Licensor
and the REGENXBIO Licensors retain the following rights with respect to the Licensed Technology:


 


		(a)	A non-exclusive, sublicensable right under the Licensed Technology to make, have made, use, sell, offer to sell, and import
products that deliver RNA interference and antisense drugs using an adeno-associated vector, including AAV9; and



 


		(b)	A non-exclusive right for the REGENXBIO Licensors (which right is sublicensable by the REGENXBIO Licensors) to use the Licensed
Technology for non-commercial research purposes and to use the Licensed Technology for such REGENXBIO Licensors’ discovery
research efforts with non-profit organizations and collaborators.



 


2.2.3       The
rights and licenses granted in Section 2.1 shall not include any right (and Licensor retains the exclusive (even as to Licensee),
fully sublicensable right) under the Licensed Technology:


 






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		(a)	to conduct commercial reagent and services businesses, which includes the right to make, have made, use, sell, offer to sell,
and import research reagents, including any viral vector construct; provided that, for clarity, such rights retained by Licensor
shall not include the right to conduct clinical trials in humans in the Fields; or



 


		(b)	to use the Licensed Technology to provide services to any Third Parties; provided that Licensee’s license under Section
2.1 does include the right to provide the service of the administration of Licensed Products to patients.



 


2.2.4        Licensor
retains the fully sublicensable right under the Licensed Technology to grant non-exclusive research and development licenses to
Affiliates and Third Parties; provided that such research and development rights granted by Licensor shall not include the right
to conduct clinical trials in humans in the Fields or any rights to sell products in the Fields.


 


2.2.5        The
Trustees of the University of Pennsylvania may use and permit other non-profit organizations or other non-commercial entities to
use the Licensed Technology for educational and research purposes.


 


2.3         Government
Rights. Licensee acknowledges that the United States government retains certain rights in intellectual property funded in whole
or part under any contract, grant, or similar agreement with a federal agency. The license grants hereunder are expressly subject
to all applicable United States government rights, including any applicable requirement that products resulting from such intellectual
property sold in the United States must be substantially manufactured in the United States.


 


2.4         Sublicensing.


 


2.4.1        The
license granted pursuant to Section 2.1 is sublicensable by Licensee to any Affiliates or Third Parties; provided that any such
sublicense must comply with the provisions of this Section 2.4 (including Section 2.4.2).


 


2.4.2        The
right to sublicense granted to Licensee under this Agreement is subject to the following conditions:


 


		(a)	Licensee may only grant sublicenses pursuant to a written sublicense agreement with the Sublicensee. Licensor must receive
written notice as soon as practicable following execution of any such sublicenses. Any further sublicenses granted by any Sublicensees
(to the extent permitted hereunder) must comply with the provisions of this Section 2.4 (including Section 2.4.2) to the same extent
as if Licensee granted such sublicense directly.



 


		(b)	In each sublicense agreement, the Sublicensee must be required to comply with the terms and conditions of this Agreement to
the same extent as Licensee has agreed and must acknowledge that Licensor is an express third party beneficiary of such terms and
conditions under such sublicense agreement.



 




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		(c)	The official language of any sublicense agreement shall be English.



 


		(d)	Within **** after entering into a sublicense, Licensor must receive a copy of the sublicense written in the English language
for Licensor’s records and to share with the REGENXBIO Licensors. The copy of the sublicense may be redacted to exclude confidential
information of the applicable Sublicensee, but such copy shall not be redacted to the extent that it impairs Licensor’s (or
the REGENXBIO Licensors’) ability to ensure compliance with this Agreement; provided that, if either of the REGENXBIO Licensors
requires a complete, unredacted copy of the sublicense, Licensee shall provide such complete, unredacted copy.



 


		(e)	Licensee’s execution of a sublicense agreement will not relieve Licensee of any of its obligations under this Agreement.
Licensee is and shall remain **** to Licensor for all of Licensee’s duties and obligations contained in this Agreement and
for any act or omission of an Affiliate or Sublicensee that would be a breach of this Agreement if performed or omitted by Licensee,
and Licensee will be deemed to be in breach of this Agreement as a result of such act or omission.



 


2.5         Improvements.


 


2.5.1        Licensee
hereby grants to Licensor a non-exclusive, worldwide, royalty-free, transferable, sublicensable, irrevocable, perpetual license:


 


		(a)	to use any Licensed Back Improvements (and any intellectual property rights with respect thereto) consummate in scope to the
Retained Rights, and



 


		(b)	to practice the Licensed Back Improvements (and any intellectual property rights with respect thereto) in connection with AAV9,
including the right to research, develop, make, have made, use, offer for sale, and sell products and services; provided that Licensor
shall have no right, under the license in this Section 2.5.1(b), to practice the Licensed Back Improvements in the Fields.



 


2.5.2        For
purposes of this Agreement, “Licensed Back Improvements” means any patentable modifications or improvements
developed by Licensee, any Affiliates, or any Sublicensees to any vector that is the subject of a claim within the Licensed Patents.


 


2.5.3        Licensee
agrees to provide prompt notice to Licensor upon the filing of any patent application covering any Licensee Invention and/or any
Licensed Back Improvement, together with a reasonably detailed description of, or access to, such Licensee Inventions and/or Licensed
Back Improvement to permit the practice of any such invention or improvement.


 




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2.6         Transfer
of Licensed Know-How. During the **** following the Effective Date, at Licensee’s sole expense, to the extent not previously
disclosed or provided to Licensee, (a) Licensor will deliver to Licensee copies of Licensed Know-How set forth in Exhibit B
in the form that such Licensed Know-How then exists; and (b) Licensor will disclose to Licensee any development Know-How, including
through in-person or telephonic meetings at such times and places as agreed to by the Parties, relating to the Licensed Products
that Licensor agrees to provide to Licensee following a written request from Licensee. Licensee acknowledges and agrees that all
Licensed Know-How disclosed pursuant to this Section 2.6 will be deemed “Confidential Information” of Licensor,
regardless of whether such information is marked or identified as confidential and without an obligation to summarize oral information.


 


2.7         Regulatory
Rights. Upon request, Licensee shall grant Licensor a “right of reference” for the FDA or any equivalent foreign
regulatory body to any submissions containing ****. Upon request, Licensor shall grant Licensee a “right of reference”
for the FDA or any equivalent foreign regulatory body to any submissions containing ****.


 


2.8         Collaboration
Activities. Solely upon the written request of Licensee, Licensor may, in its sole discretion after receipt of such request,
engage in collaboration activities with Licensee related to ****.


 


2.9         Section
365(n) of the Bankruptcy Code. All rights and licenses granted to Licensee or Licensor under or pursuant to 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 (the “Bankruptcy Code”) or any comparable law outside the United States, 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 and any comparable law outside the United States.


 


Article
3: Consideration


 


3.1        Initial
Fee. In partial consideration of the rights and licenses granted to Licensee under this Agreement, Licensee shall pay Licensor
an initial fee of $20,000,000, which shall be payable as follows: (a) $10,000,000 within **** after the Effective Date; and (b)
$10,000,000 within twelve (12) months of the Effective Date; provided that any unpaid portion of the initial fee shall be immediately
payable upon termination of this Agreement or a Change of Control.


 


3.2        Annual
Fees. In partial consideration of the rights and licenses granted to Licensee under this Agreement, Licensee shall pay Licensor
annual fees of $100,000,000, which shall be payable as follows: (i) $20,000,000 on the second anniversary of the Effective Date;
(ii) $20,000,000 on the third anniversary of the Effective Date; (iii) $20,000,000 on the fourth anniversary of the Effective Date;
(iv) $20,000,000 on the fifth anniversary of the Effective Date; and (v) $20,000,000 on the sixth anniversary of the Effective
Date. In the event of termination of the Agreement prior to the second anniversary of the Effective Date, Licensee shall pay Licensor
any unpaid amounts recited in (i) within **** of such termination. In the event of a Change of Control and to the extent that payments
(i), (ii), (iii), (iv) and/or (v) above have not been received by Licensor from Licensee, Licensee shall pay Licensor any such
unpaid amounts recited in (i), (ii), (iii), (iv) or (v) (subject to adjustments in amounts due for any terminated Fields in accordance
with Section 6.6.6, provided such termination is effective prior to the Change of Control) within **** of the Change of Control.


 




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3.3         Milestone
Fees. In partial consideration of the rights and licenses granted to Licensee under this Agreement, Licensee shall pay Licensor
the following milestone payments:


 


	 Milestone	Milestone Payment
	1.  Cumulative Net Sales of Licensed Products first reaching ****	****
	2.  Cumulative Net Sales of Licensed Products first reaching ****	****
	Total:	$60,000,000


 


3.3.1        For
clarity, each milestone payment set forth in Section 3.3 is payable only once.


 


3.4         Royalties.
In further consideration of the rights and licenses granted to Licensee under this Agreement, Licensee shall pay to Licensor a
royalty of **** on Net Sales of Licensed Products, subject to the reductions in royalty rates set forth in Section 3.4.1.


 


3.4.1        Third
Party Royalties Stacking Provision. If Licensee must obtain a license from a Third Party to avoid infringement of such Third
Party’s rights in order to manufacture, use, or commercialize a given Licensed Product and if the royalties required to be
paid to such Third Party for such license, together with those royalties payable to Licensor, in the aggregate, exceed **** of
Net Sales for any Licensed Product, then the royalty owed to Licensor for that Licensed Product will be reduced by an amount calculated
as follows:


 


STACKING ROYALTY CALCULATIONS


 


R = (C * (A / (A+B)))


 


Where

R = reduction of Licensor royalty,

A = unreduced Licensor royalty,

B = sum of all Third Party royalties,

C = increment of projected total royalty above ****.


 


Example Calculation:


 


	Assume:	i)    all Third Party royalties = ****
	 	ii)   unreduced Licensor royalty = ****
	 	iii)  projected total royalty = ****


 


R = (**** - ****) * (**** / (**** + ****))


R = (**** * ****)


R = ****


Licensor Stacked Royalty = **** – **** = ****
(but subject to the cap described below which limits the reduction to **** in the aggregate)


 




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Notwithstanding the foregoing, Licensee will pay to
Licensor no less than **** of the royalties that Licensee would otherwise pay to Licensor with respect to Net Sales of Licensee
if there were no royalties due to Third Parties.


 


3.4.2        Adjustment
of Royalties For Licenses. On a Licensed Product-by-Licensed Product, country-by-country basis, upon the date on which the
manufacture, use, sale, offer for sale, or import of a Licensed Product does not infringe or is not covered by a Valid Claim in
such country, then the royalty percentage applicable to Net Sales of such Licensed Product under this Section 3.4 in such country
shall be reduced by ****.


 


3.4.3        Royalty
Payment Period. Licensee’s obligation hereunder for payment of a royalty under this Section 3.4 on the Net Sales of Licensed
Products in a given country will end on a country-by-country, Licensed Product-by-Licensed Product basis on the later of: (i) expiration,
lapse, abandonment, or invalidation of the last Valid Claim of the Licensed Patents to expire, lapse, become abandoned or become
unenforceable for the applicable Licensed Product in the applicable country, or (ii) **** from the First Commercial Sale of the
applicable Licensed Product in the applicable country.


 


3.5         Sublicense
Fees.


 


3.5.1        In
further consideration of the rights and licenses granted to Licensee under this Agreement, Licensee will pay Licensor **** of any
sublicense fees (****) received by Licensee or its Affiliates from a Third Party for the Licensed Technology from any Sublicensee
or from any person or entity granted any option to obtain a sublicense (“Sublicensing Revenue”).


 


3.5.2        With
respect to the obligations under this Section 3.5, Licensee shall not be required to submit any amounts received from a Third Party
for the following:


 


		(a)	Reimbursement or payment of Licensee’s actual costs or on an arm’s length cost plus arrangement for research, development,
and/or manufacturing activities performed by Licensee or its Affiliates corresponding directly to the research, development and/or
manufacturing of Licensed Products pursuant to a specific agreement;



 


		(b)	Any and all amounts paid to Licensee or its Affiliates by a Sublicensee as royalties on sales of
Licensed Product sold by the Sublicensee under a sublicense agreement; and



 


		(c)	Consideration received for the purchase of an equity interest in Licensee or its Affiliates at
fair market value or in the form of loans at arm’s length rates of interest.



 




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3.5.3        If
Licensee or its Affiliates receives sublicense fees from Sublicensees or from any person or entity granted any option to obtain
a sublicense under this Agreement in the form of non-cash consideration, then Licensee shall pay Licensor a cash payment as required
under Section 3.5 determined based on the fair market value of such non-cash consideration. If Licensee or its Affiliate enters
into any sublicense that is not an arm’s length transaction, fees due under this Section 3.5 will be calculated based on
the fair market value of such transaction, at the time of the transaction, assuming an arm’s length transaction made in the
ordinary course of business, as determined jointly by Licensor and Licensee based on transactions of a similar type and standard
industry practice, if any.


 


3.5.4        To
the extent Licensee or its Affiliates receives payment from a Third Party relating to one or more of the milestone events set forth
in the table in Section 3.3, then the amount of the payment made to Licensor under such Section 3.3 with respect to such milestone
event shall not be deemed sublicense fees under this Section 3.5; instead, the amounts due under this Section 3.5 shall be calculated
by applying the applicable sublicense fee rate set forth in Section 3.5 above to the sublicense fees received by Licensee or its
Affiliates from such Third Party after deducting the amount of the payment under Section 3.3.


 


3.6         Reports
and Records.


 


3.6.1        Licensee
must deliver to Licensor within **** after the end of each Calendar Quarter after the First Commercial Sale of a Licensed Product
a report setting forth the calculation of the royalties due to Licensor for such Calendar Quarter on a Licensed Product by Licensed
Product basis, including:


 


		(a)	Number of Licensed Products included within Net Sales, listed by country;



 


		(b)	Gross consideration for Net Sales of Licensed Product, including all amounts invoiced, billed, or received, listed by country;



 


		(c)	Qualifying costs to be excluded from the gross consideration, as described in Section 1.24, listed by category of cost and
by country;



 


		(d)	Net Sales of Licensed Products listed by country;



 


		(e)	A detailed accounting of any royalty reductions applied pursuant to Section 3.4.1;



 


		(f)	Royalties owed to Licensor; and



 


		(g)	The computations for any applicable currency conversions.



 


3.6.2        Licensee
shall pay the royalties due under Section 3.4 within **** following the last day of the Calendar Quarter in which the royalties
accrue. Licensee shall send the royalty payments along with the report described in Section 3.6.1.


 


3.6.3        Within
**** after the occurrence of a milestone event described in Section 3.3, Licensee must deliver to Licensor a report describing
the milestone event that occurred, together with a payment of the applicable amount due to Licensor pursuant to Section 3.3.


 


3.6.4        Within
**** after the receipt of any fees from any Third Party as described in Section 3.5, Licensee must deliver to Licensor a report
describing the fees received, together with a payment of the applicable amount due to Licensor pursuant to Section 3.5.


 




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3.6.5        All
financial reports under this Section 3.6 will be certified by the chief financial officer of Licensee or Licensee’s qualified
financial representative.


 


3.6.6        Licensee
shall maintain and require its Affiliates and all Sublicensees to maintain, complete, and accurate books and records that enable
the royalties, fees, and payments payable under this Agreement to be verified. The records must be maintained for **** after the
submission of each report under Article 3. Upon reasonable prior written notice to Licensee, Licensee and its Affiliates and all
Sublicensees will provide Licensor and/or the REGENXBIO Licensors (and their respective accountants) with access to all of the
relevant books, records, and related background information required to conduct a review or audit of the royalties, fees, and payments
payable to Licensor under this Agreement to be verified. Access will be made available: (a) during normal business hours; (b) in
a manner reasonably designed to facilitate the auditing party’s review or audit without unreasonable disruption to Licensee’s
business; and (c) no more than once each calendar year during the term of this Agreement and for a period of **** thereafter. Licensee
will promptly pay to Licensor the amount of any underpayment determined by the review or audit, plus accrued interest. If the review
or audit determines that Licensee has underpaid any payment by **** or more, then Licensee will also promptly pay the costs and
expenses of Licensor and the REGENXBIO Licensors and their respective accountants in connection with the review or audit. If the
review or audit determines that Licensee has overpaid any payment, then Licensor shall refund the overpayment to Licensee.


 


3.7         Currency,
Interest.


 


3.7.1        All
dollar amounts referred to in this Agreement are expressed in United States dollars. All payments to Licensor under this Agreement
must be made in United States dollars.


 


3.7.2        If
Licensee receives payment in a currency other than United States dollars for which a royalty or fee or other payment is owed under
this Agreement, then (a) the payment will be converted into United States dollars at the conversion rate for the foreign currency
as published in the eastern edition of the Wall Street Journal, N.Y. edition or other equivalent publication as mutually
agreed upon by the Parties, as of the last business day of the Calendar Quarter in which the payment was received by Licensee;
and (b) the conversion computation will be documented by Licensee in the applicable report delivered to Licensor under Section
3.6.


 


3.7.3       All
amounts that are not paid by Licensee when due will accrue interest from the date due until paid at a rate equal to 1.5% per month
(or the maximum allowed by law, if less).


 


3.8         Taxes
and Withholding.


 


3.8.1       All
payments hereunder will be made free and clear of, and without deduction or deferment in respect of, and Licensee shall pay and
be responsible for, and shall hold Licensor harmless from and against, any taxes, duties, levies, fees, or charges, including sales,
use, transfer, excise, import, and value added taxes (including any interest, penalties, or additional amounts imposed with respect
thereto) but excluding withholding taxes to the extent provided in Section 3.8.2. At the request of Licensee, Licensor will give
Licensee such reasonable assistance, which will include the provision of documentation as may be required by the relevant tax authority,
to enable Licensee to pay and report and, as applicable, claim exemption from or reduction of, such tax, duty, levy, fee, or charge.


 




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3.8.2        If
any payment made by Licensee hereunder becomes subject to withholding taxes with respect to Licensor’s gross or net income
under the laws of any jurisdiction, then Licensee will deduct and withhold the amount of such taxes for the account of Licensor
to the extent required by law and will pay the amounts of such taxes to the proper governmental authority in a timely manner and
promptly transmit to Licensor appropriate proof of payment of such withholding taxes. At the request of Licensor, Licensee will
give Licensor such reasonable assistance, which will include the provision of appropriate certificates of such deductions made
together with other supporting documentation as may be required by the relevant tax authority, to enable Licensor to claim exemption
from or reduction of, or otherwise obtain repayment of, such withholding taxes, and will upon request provide such additional documentation
from time to time as is reasonably required to confirm the payment of withholding tax.


 


Article
4: Diligence


 


4.1         Diligence
Obligations. Licensee will use commercially reasonable efforts to develop, commercialize, market, promote, and sell Licensed
Products in the Field. Commercially reasonable efforts means efforts equivalent to those utilized by ****. Without limiting the
foregoing, Licensee will meet the following: acceptance by the FDA or foreign equivalent of an investigational new drug application
for a Licensed Product in the CLN1 Field and CLN3 Field by no later than****; provided, however, that, if Licensee expects not
to achieve the milestone on or before the specified deadline in either the CLN1 Field or the CLN3 Field, Licensee may extend any
deadline in either or both Field(s) for an additional **** per extension by paying Licensor an extension fee of **** per Field
on or before such deadline and the deadline shall then be extended by an additional ****. Licensee will only be****.


 


4.2         Development
Plans.


 


4.2.1       
For each Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development
Plan”). The initial Development Plans for the Licensed Product in the Field will be delivered within **** after the Effective
Date.


 


4.2.2        Each
Development Plan will cover the next 2 years, and will include future development activities to be undertaken by Licensee, its
Affiliates, or any Sublicensees during the next reporting period under Section 4.3 relating directly to the Licensed Product, Licensee’s
strategy to bring the Licensed Product to commercialization, and projected timeline for completing the necessary tasks to accomplish
the goals of the strategy.


 


4.2.3        Following
receipt by Licensor of each Development Plan, Licensor will promptly notify Licensee of any comments or requested revisions, and
the Parties will thereupon negotiate any appropriate revisions in good faith. With respect to development milestones to be set
forth in the initial Development Plans for the Field, the Parties will agree upon reasonable milestones and completion dates to
be set forth in the Development Plan (and any amendments thereto).


 




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4.3         Reporting.
Within **** after the Effective Date and within **** of each December 1 thereafter, Licensee shall provide Licensor with written
progress reports, setting forth in such detail as Licensor may reasonably request, the progress of the development, evaluation,
testing, and commercialization of each Licensed Product. Licensee will also notify Licensor within **** of the First Commercial
Sale by Licensee, its Affiliates, or any Sublicensees of each Licensed Product. Such a report (“Development Progress Report”),
setting forth the current stage of development of Licensed Products, shall include:


 


4.3.1        Date
of Development Progress Report and time covered by such report;


 


4.3.2        Major
activities and accomplishments completed by Licensee, its Affiliates, and any Sublicensees relating directly to the Licensed Products
since the last Development Progress Report;


 


4.3.3        Significant
research and development projects relating directly to the Licensed Products currently being performed by Licensee, its Affiliates,
and any Sublicensees and good faith, but non-binding, projected dates of completion;


 


4.3.4        A
development plan covering the next two years at least, which will include future development activities to be undertaken by Licensee,
its Affiliates, or any Sublicensees during the next reporting period relating directly to the Licensed Products, Licensee’s
strategy to bring the Licensed Products to commercialization, and projected timeline for completing the necessary tasks to accomplish
the goals of the strategy;


 


4.3.5        Projected
total development remaining before product launch of each Licensed Product; and


 


4.3.6        Summary
of significant development efforts using the Licensed Technology being performed by Third Parties, including the nature of the
relationship between Licensee and such Third Parties.


 


4.4         Confidential
Information. The Parties agree that Development Progress Reports shall be deemed Licensee’s Confidential Information;
provided that Licensor may share a copy of such reports with the REGENXBIO Licensors.


 


4.5         Improvements.
Simultaneously with the Development Progress Report, Licensee shall deliver a detailed description of any Licensed Back Improvements,
if not previously provided pursuant to Section 2.5.3.


 




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Article
5: Confidentiality


 


5.1         Treatment
of Confidential Information. Each Party, as a receiving party (a “Receiving Party”), agrees that it will
(a) treat Confidential Information of the other Party (the “Disclosing Party”) as strictly confidential; (b)
protect the Confidential Information of the Disclosing Party with at least the same degree of care as it protects its own confidential
and proprietary information, and in any event with not less than a reasonable degree of care; (c) not disclose such Confidential
Information to Third Parties without the prior written consent of the Disclosing Party, except as may be permitted in this Agreement;
provided that any disclosure permitted hereunder shall be under confidentiality agreements with provisions at least as stringent
as those contained in this Agreement; and (d) not use such Confidential Information for purposes other than those authorized expressly
in this Agreement. The Receiving Party agrees to ensure that its employees who have access to Confidential Information are obligated
in writing to abide by confidentiality obligations at least as stringent as those contained under this Agreement.


 


5.2         Public
Announcements.


 


5.2.1        The
Parties agree they will issue a joint press release in the form attached hereto as Exhibit C. Except as provided in Section
5.2.2, any press releases by either Party with respect to the other Party or any other public disclosures concerning the existence
of or terms of this Agreement shall be subject to review and approval by the other Party. Once the joint press release or any other
written statement is approved for disclosure by both Parties, either Party may make subsequent public disclosure of the contents
of such statement without the further approval of the other Party.


 


5.2.2        Notwithstanding
Section 5.2.1, Licensor has the right to publish (through press releases, scientific journals, or otherwise) and refer to any clinical,
regulatory, or research results related to Licensee’s Licensed Product or AAV9 program that have been publicly disclosed
by Licensee, including referring to Licensee by name as a licensee of Licensor, which publication or referral by Licensor shall
not require the prior consent of Licensee.


 


5.3         Authorized
Disclosure. Notwithstanding the provisions of Section 5.1 or 5.2, either Party may disclose the other’s Confidential
Information or make such a disclosure of the existence of and/or terms of this Agreement to any ****; provided that, in each case,
such recipient of Confidential Information is obligated to keep such information confidential on terms no less stringent than those
set forth in this Agreement. Furthermore, Licensee agrees that Licensor may share a copy of this Agreement, reports and notices
provided by Licensee to Licensor pursuant to the terms of this Agreement, and copies of sublicense agreements provided to Licensor
hereunder, with the REGENXBIO Licensors to the extent required by the GSK Agreement and the Penn Agreement, under confidentiality.
In the event that the Receiving Party receives service of legal process that purports to compel disclosure of the Disclosing Party’s
Confidential Information or becomes obligated by law, rule, regulation or rules of a security exchange, to disclose the Confidential
Information of the Disclosing Party or the existence of or terms of this Agreement to any governmental authority, then, to the
extent legally permitted, the Receiving Party shall promptly notify the Disclosing Party, so that the Disclosing Party may seek
an appropriate protective order or other remedy with respect to narrowing the scope of such requirement and/or waive compliance
by the Receiving Party with the provisions of this Agreement. The Receiving Party will, at the Disclosing Party’s request
and expense, provide the Disclosing Party with reasonable assistance in obtaining such protective order or other remedy. If, in
the absence of such protective order or other remedy, the Receiving Party is nonetheless required by law, rule, regulation or rules
of a security exchange, to disclose the existence of or terms of this Agreement or other Confidential Information of the Disclosing
Party, then the Receiving Party may disclose such Confidential Information without liability hereunder; provided that the Receiving
Party shall furnish only such portion of the Confidential Information that is legally required to be disclosed and only to the
extent required by law.


 


5.4         Term
of Confidentiality. The obligations of this Article 5 shall continue for a period of **** following the expiration or termination
of this Agreement.


 




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Article
6: TERM AND Termination


 


6.1         Term
of Agreement. This Agreement will commence on the Effective Date and continue in effect on a country-by-country, Licensed Product-by-Licensed
Product basis until the later of: (i) the expiration, lapse, abandonment, or invalidation of the last Valid Claim of the Licensed
Patents to expire, lapse, become abandoned, become unenforceable for the applicable Licensed Product in the applicable country,
or (ii) 10 years from the First Commercial Sale of the applicable Licensed Product in the applicable country, unless sooner terminated
in accordance with Section 6.2, Section 6.3, Section 6.4 or Section 6.5 of this Agreement. Upon expiration of the Agreement with
respect to a Licensed Product in a country, the license grant to Licensee pursuant to Section 2.1 shall become irrevocable, perpetual,
fully paid-up and royalty-free with respect such Licensed Product and such country.


 


6.2         Licensee’s
Right to Terminate. Licensee may, upon six months’ prior written notice to Licensor, terminate this Agreement for any
reason, with or without cause. In exercising such termination right, Licensee may terminate the Agreement in its entirety or, if
desired, Licensee may specify in the written notice that this Agreement is terminating only with respect to one or more Field.


 


6.3         Termination
for Breach.


 


6.3.1        Licensor
may terminate this Agreement, if Licensee is late in paying to Licensor royalties, fees, or any other monies due under this Agreement,
and if Licensee does not pay Licensor in full within 15 days upon written demand from Licensor, which termination shall be effective
immediately upon the expiration of such 15-day cure period.


 


6.3.2        Either
Party may terminate this Agreement, if the other Party materially breaches this Agreement and does not cure such material breach
within 30 days after written notice of the breach, which termination shall be effective immediately upon the expiration of such
30-day cure period. Notwithstanding the above, if Licensee disputes in good faith that such material breach exists, and gives Licensor
written notice of such dispute within 30 days following Licensee’s receipt of Licensor’s notice of default, then, Licensor
may not terminate this agreement until the dispute is resolved in accordance with Section 10.6; provided that Licensor shall be
entitled to terminate this Agreement at the end of the original 30-day cure period, without waiting for resolution of the dispute
in accordance with Section 10.6, if the breach by Licensee of this Agreement would cause Licensor to be in breach of the GSK Agreement
or the Penn Agreement.


 


6.4         Termination
for Insolvency. Licensor shall have the right to terminate this Agreement, upon notice to the Licensee, in the event that:


 


(a)            Licensee
shall have: (i) voluntarily commenced any proceeding or filed any petition seeking relief under the bankruptcy, insolvency or other
similar laws of any jurisdiction, (ii) applied for, or consented to, the appointment of a receiver, trustee, custodian, sequestrator,
conciliator, administrator or similar official for it or for all or substantially all of its property, (iii) filed an answer admitting
the material allegations of a petition filed against or in respect of it in any such proceeding, (iv) made a general assignment
for the benefit of creditors of all or substantially all of its assets, (v) admitted in writing its inability to pay all or substantially
all of its debts as they become due, or (vi) taken corporate action for the purpose of effecting any of the foregoing; or


 




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(b)           An involuntary
proceeding shall have been commenced, or any involuntary petition shall have been filed, in a court of competent jurisdiction seeking:
(i) relief in respect of Licensee, or of its property, under the bankruptcy, insolvency or similar laws of any jurisdiction, (ii)
the appointment of a receiver, trustee, custodian, sequestrator, conciliator, administrator or similar official for the Licensee
or for all or substantially all of its property, or (iii) the winding-up or liquidation of the Licensee; and, in each case, such
proceeding or petition shall have continued undismissed for 60 days, or an order or decree approving or ordering any of the foregoing
shall have continued unstayed, unappealed and in effect for 30 days.


 


6.5         Patent
Challenge.


 


6.5.1        Licensor
may terminate this Agreement, effective immediately upon written notice to Licensee, upon the commencement by Licensee or any of
its Affiliates of a Patent Challenge.


 


6.5.2        Licensee
shall include in each sublicense agreement entered into with a Sublicensee a right of Licensee to terminate such sublicense agreement
if such Sublicensee commences a Patent Challenge; and Licensee shall terminate the sublicense agreement, effective immediately
upon written notice to the Sublicensee, if the Sublicensee commences a Patent Challenge. If a Sublicensee commences a Patent Challenge
and Licensee fails to terminate the applicable sublicense agreement, then Licensor may terminate this Agreement, effective immediately
upon written notice to the Licensee.


 


6.5.3        For
purposes of this Section 6.5, “Patent Challenge” means any action against Licensor or the REGENXBIO Licensors,
including an action for declaratory judgment, to declare or render invalid or unenforceable the Licensed Patents, or any claim
thereof.


 


6.6         Effects
of Termination. The effects of termination by Licensee pursuant to Section 6.2, by either Party, as applicable, under Section
6.3, or by Licensor pursuant to Section 6.4 or 6.5 shall be as follows:


 


6.6.1        The
applicable licenses granted by Licensor hereunder shall terminate, and Licensee, its Affiliates, and (unless the sublicense agreement
is assigned pursuant to Section 6.6.2) all Sublicensees shall cease to make, have made, use, import, sell, and offer for sale all
Licensed Products and shall cease to otherwise practice the Licensed Technology under the terminated licenses; provided that Licensee,
its Affiliates, and its Sublicensees shall have the right to continue to sell their existing inventories of Licensed Products under
the terminated licenses for a period not to exceed **** after the effective date of such termination;


 




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6.6.2        If
termination is by Licensor pursuant to Sections 6.3, 6.4 or 6.5, then, at Licensor’s request, Licensee shall assign to Licensor
any or all sublicenses granted to Third Parties to the extent of the rights licensed to Licensee hereunder and sublicensed to the
Sublicensee; provided that (i) prior to such assignment, Licensee shall advise Licensor whether such Sublicensee is then in full
compliance with all terms and conditions of its sublicense and continues to perform thereunder, and, if such Sublicensee is not
in full compliance or is not continuing to perform, Licensor may elect not to have such sublicense assigned; and (ii) following
such assignment, Licensor shall not be liable to such Sublicensee with respect to any obligations of Licensee to the Sublicensee
that are not consistent with, or not required by, Licensor’s obligations to Licensee under this Agreement; and all sublicenses
not requested to be assigned to Licensor shall terminate. If termination is for any other reason, then all sublicenses shall terminate;


 


6.6.3        If
termination is by Licensee pursuant to Section 6.2 or by Licensor pursuant to Section 6.3, 6.4, or 6.5, then Licensee shall grant,
and hereby grants, to Licensor a non-exclusive, perpetual, irrevocable, worldwide, royalty-free, transferable, sublicensable license
under any patentable modifications or improvements (and any intellectual property rights with respect thereto) developed by Licensee,
any Affiliates, or any Sublicensees to any vector that is the subject of a claim within any of the Licensed Patents, for use by
Licensor for the research, development, and commercialization of products in any therapeutic indication;


 


6.6.4        Licensee
shall pay all monies then-owed to Licensor under this Agreement;


 


6.6.5        Each
Receiving Party shall, at the Disclosing Party’s request, return all Confidential Information of the Disclosing Party. Notwithstanding
the foregoing, one copy may be kept by either Party for a record of that Party’s obligations; and


 


6.6.6        If
termination is with respect to one or more Field, but not all Fields, then the provisions of this Section 6.6 shall only apply
with respect to the terminated Field(s), and this Agreement shall continue with respect to the non-terminated Field(s); provided
that if termination is by Licensee pursuant to Section 6.2 with respect to one or more Fields, but not all Fields at any time,
then the amount of any unpaid annual fee(s) due under Section 3.2 shall be reduced by **** for each terminated Field; provided
further that such reduction shall not apply to the amount due under Section 3.2(i).


 


6.7           Survival.
Licensee’s obligation to pay all monies due and owed to Licensor under this Agreement that have matured as of the effective
date of termination or expiration shall survive the termination or expiration of this Agreement. In addition, the provisions of
Section 2.2, (Retained Rights), Section 2.3 (Government Rights), Section 2.5 (Improvements), Article 3 (Consideration) (with respect
to any final reports or to the extent any amounts are due but unpaid), Section 3.6 (Reports and Records), Section 4.4 (Confidential
Information), Article 5 (Confidentiality), Article 6 (Term and Termination), Section 8.4 (Disclaimer of Warranties, Damages), Section
8.5 (Indemnification), Section 8.6 (Insurance), Article 9 (Use of Name), and Article 10 (Additional Provisions) shall survive such
termination or expiration of this Agreement in accordance with their respective terms.


 


Article
7: Patent Maintenance; Patent Infringement


 


7.1         Prosecution
of Licensed Patents. As between Licensor and Licensee, the Parties agree as follows:


 




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7.1.1        Licensor
shall have the sole right, but not the obligation, to Prosecute patent applications and issued patents within Licensed Patents,
in Licensor’s sole discretion. Subject to Section 7.1.3, Licensor shall provide Licensee with a reasonable opportunity to
review and provide comments in connection with the Prosecution of the Licensed Patents; and Licensor shall keep Licensee reasonably
informed as to all material developments with respect to such Licensed Patents and shall supply to Licensee copies of material
communications received and filed in connection with the Prosecution of such Licensed Patents.


 


7.1.2        Nothing
in this Agreement obligates Licensor to continue to Prosecute any patent applications or issued patents, and Licensee acknowledges
that Licensor shall have no obligation to undertake any inter-party proceedings, such as oppositions, inter partes review, or interferences,
or to undertake any re-examination or re-issue proceedings, in either case, with respect to the Licensed Patents.


 


7.1.3        Licensee
acknowledges that The Trustees of the University of Pennsylvania control Prosecution of the Licensed Patents, with Licensor having
certain rights to review. Licensee acknowledges and agrees that (a) the rights and obligations under this Section 7.1 are subject
to the rights of the REGENXBIO Licensors set forth in the GSK Agreement and Penn Agreement with respect to the Licensed Patents,
and (b) Licensor’s obligations under this Agreement only apply to the extent of Licensor’s rights with respect to participation
in Prosecuting the Licensed Patents under the GSK Agreement and the Penn Agreement. Licensor shall have the sole right, but not
the obligation, to Prosecute patent applications and issued patents within Licensed Patents, in Licensor’s sole discretion.


 


7.2         Infringement
Actions Against Third Parties.


 


7.2.1        Licensee
is responsible for notifying Licensor promptly of any infringement of Licensed Patents (other than Retained Rights) that may come
to Licensee’s attention, including any “patent certification” filed in the United States under 21 U.S.C. §
355(b)(2) or 21 U.S.C. § 355(j)(2) or similar provisions in other jurisdictions alleging the invalidity, unenforceability
or non-infringement of any Licensed Patents, and any notification received pursuant to subsection (k) of 42 U.S.C. § 262 for
any Licensed Product that becomes a “reference product.” However, Licensee is under no obligation to search for potential
infringers.


 


7.2.2        As
between Licensor and Licensee, but subject to any obligations of Licensor to the REGENXBIO Licensors, Licensor shall have the sole
right, but not the obligation, to prosecute any such infringement ****. In any action to enforce any of the Licensed Patents, Licensee,
at the request and expense of Licensor, shall cooperate to the fullest extent reasonably possible, including in the event that,
if Licensor is unable to initiate or prosecute such action solely in its own name, Licensee shall join such action voluntarily
and shall execute all documents necessary to initiate litigation to prosecute, maintain, and settle such action. Nothing in this
Agreement obligates Licensor to bring or prosecute lawsuits against Third Parties for infringement of any Licensed Patents.


 


7.2.3        Licensee
shall have no right to undertake prosecution of any such infringement.


 




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7.3         Defense
of Infringement Claims. In the event Licensee or Licensor becomes aware that Licensee’s or any of its Affiliates’
or any Sublicensees’ practice of the Licensed Patents is the subject of a claim for patent infringement by a Third Party,
that Party shall promptly notify the other, and the Parties shall consider the claim and the most appropriate action to take. Licensee
shall cause each of its Affiliates and each Sublicensee to notify Licensee promptly in the event such entity becomes aware that
its practice of the Licensed Patents is the subject of a claim of patent infringement by another. To the extent Licensor takes
any action, Licensor (or the REGENXBIO Licensors) shall have the right to require Licensee’s reasonable cooperation in any
such suit, upon written notice to Licensee; and Licensee shall have the obligation to participate upon Licensor’s request,
in which event, Licensor shall bear the cost of Licensee’s participation. Without Licensor’s prior written permission,
which shall not be unreasonably withheld or denied, Licensee must not settle or compromise any such suit in a manner that imposes
any material obligations or restrictions on Licensor or the REGENXBIO Licensors or grants any rights to the Licensed Patents other
than rights that Licensee has the right to grant under this Agreement.


 


Article
8: COVENANTS, Warranties; Indemnification


 


8.1         Covenant
not to Sue. Licensor agrees that it shall not commence any action against Licensee or any Third Party solely for the work that
Third Party is performing on behalf of Licensee for **** prior to the Effective Date.


 


8.2         Representations
and Warranties by Licensor. Licensor represents and warrants to Licensee as of the Effective Date:


 


8.2.1        Licensor
has the right, power, and authority to enter into this Agreement and to grant to Licensee the rights specified in this Agreement;


 


8.2.2        This
Agreement when executed shall become the legal, valid, and binding obligation of it, enforceable against it, in accordance with
its terms;


 


8.2.3        There
are no actions, suits, proceedings, or arbitrations pending or, to Licensor’s knowledge, threatened against Licensor relating
to the Licensed Patents that would be inconsistent with the rights granted to Licensee under this Agreement;


 


8.2.4        To
Licensor’s knowledge, (a) the Licensed Patents are solely owned by The Trustees of the University of Pennsylvania, and (b)
no Third Party (other than the REGENXBIO Licensors) has any right, interest, or claim in or to such Licensed Patents in the Fields
that are inconsistent with those granted to Licensee in the Fields under this Agreement (it being understood that the rights previously
granted in the Conflicting License shall not be deemed to conflict with the licenses granted under this Agreement);


 


8.2.5        Licensor
has not received any written notice from any Third Party patentee alleging infringement of such Third Party’s patents by
the practice of the Licensed Patents in the Fields; and


 


8.2.6        Licensor
shall not, without the prior written consent of Licensee (such consent not to be unreasonably withheld or delayed), amend the Conflicting
License in a manner that would materially and adversely affect Licensee’s rights and benefits under this Agreement during
the term of this Agreement.


 




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8.3         Representations
and Warranties by Licensee. Licensee represents and warrants to Licensor as of the Effective Date that:


 


8.3.1        Licensee
has the right, power, and authority to enter into this Agreement and to grant the rights granted by it hereunder;


 


8.3.2        This
Agreement when executed shall become the legal, valid, and binding obligation of it, enforceable against it, in accordance with
its terms;


 


8.3.3        Licensee
has the ability and the resources, including financial resources, necessary to carry out its obligations under this Agreement;
and


 


8.3.4        There
are no actions, suits, proceedings, or arbitrations pending or, to Licensee’s knowledge, threatened against Licensee that
would impact Licensee’s activities under this Agreement.


 


8.4           Disclaimer
of Warranties, Damages. EXCEPT AS SET FORTH IN SECTION 8.2, THE LICENSED TECHNOLOGY, LICENSED PRODUCTS, AND ALL RIGHTS LICENSED
UNDER THIS AGREEMENT ARE PROVIDED ON AN “AS IS” BASIS, AND LICENSOR MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS
OR IMPLIED, WITH RESPECT THERETO. BY WAY OF EXAMPLE BUT NOT OF LIMITATION, EXCEPT AS SET FORTH IN SECTION 8.2, LICENSOR MAKES NO
REPRESENTATIONS OR WARRANTIES, AND HEREBY DISCLAIMS ALL EXPRESS AND IMPLIED REPRESENTATIONS AND WARRANTIES, (i) OF COMMERCIAL UTILITY,
ACCURACY, COMPLETENESS, PERFORMANCE, TITLE, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OR ENFORCEABILITY OF THE
LICENSED TECHNOLOGY, AND PROFITABILITY; OR (ii) THAT THE USE OF THE LICENSED TECHNOLOGY, OR LICENSED PRODUCTS WILL NOT INFRINGE
ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS OF THIRD PARTIES. EXCEPT AS SET FORTH HEREIN, NONE OF LICENSOR AND
THE REGENXBIO LICENSORS SHALL BE LIABLE TO LICENSEE, LICENSEE’S SUCCESSORS OR ASSIGNS, ANY SUBLICENSEES, OR ANY THIRD PARTY
WITH RESPECT TO: (a) ANY CLAIM ARISING FROM USE OF THE LICENSED TECHNOLOGY, LICENSED PRODUCTS, AND ANY OR ALL RIGHTS LICENSED UNDER
THIS AGREEMENT OR FROM THE DEVELOPMENT, TESTING, MANUFACTURE, USE, OR SALE OF LICENSED PRODUCTS; OR (b) ANY CLAIM FOR LOSS OF PROFITS,
LOSS OR INTERRUPTION OF BUSINESS, OR FOR INDIRECT, SPECIAL, INCIDENTAL, EXEMPLARY, PUNITIVE, OR CONSEQUENTIAL DAMAGES OF ANY KIND,
INCLUDING ANY ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT OR THE EXERCISE OF RIGHTS HEREUNDER, REGARDLESS OF ANY NOTICE
OF SUCH DAMAGES. NOTHING IN THIS SECTION 8.4 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER
PARTY UNDER SECTION 8.5 OR TO LIMIT A PARTY’S LIABILITY FOR BREACHES OF ITS OBLIGATION REGARDING CONFIDENTIALITY UNDER ARTICLE
5.


 




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8.5         Indemnification.


 


8.5.1        By
Licensee. Licensee shall defend, indemnify, and hold harmless Licensor, the REGENXBIO Licensors, and their respective shareholders,
members, officers, trustees, faculty, students, contractors, agents, and employees (individually, a “Licensor Indemnified
Party” and, collectively, the “Licensor Indemnified Parties”) from and against any and all Third Party
liability, loss, damage, action, claim, fee, cost, or expense (including attorneys’ fees) (individually, a “Third
Party Liability” and, collectively, the “Third Party Liabilities”) suffered or incurred by the Licensor
Indemnified Parties from claims of such Third Parties that result from or arise out of: ****; provided, however, that Licensee
shall not be liable for claims to the extent based on any breach by Licensor of the representations, warranties, or obligations
of this Agreement or the gross negligence or intentional misconduct of any of the Licensor Indemnified Parties. Without limiting
the foregoing, Licensee must defend, indemnify, and hold harmless the Licensor Indemnified Parties from and against any Third Party
Liabilities resulting from:


 


(a)          any
**** or other claim of any kind related to the **** by a Third Party of a Licensed Product that **** by Licensee, its Affiliates,
any Sublicensees, their respective assignees, or vendors;


 


(b)         any
claim by a Third Party that the ****; and


 


(c)         ****
conducted by or on behalf of Licensee, its Affiliates, any Sublicensees, their respective assignees, or vendors relating to the
Licensed Technology or Licensed Products, including any claim by or on behalf of a ****.


 


8.5.2        Indemnification
Procedure. Licensee, as an indemnifying party (an “Indemnifying Party”), shall not be permitted to settle
or compromise any claim or action giving rise to Third Party Liabilities in a manner that imposes any restrictions or obligations
on Licensor, the REGENXBIO Licensors or any indemnified party (an “Indemnified Party”) without Licensor’s
prior written consent that grants any rights to the Licensed Technology or Licensed Products other than those Licensee has the
right to grant under this Agreement without Licensor’s prior written consent. The Indemnifying Party shall be permitted to
control any litigation or potential litigation involving the defense of any claim subject to indemnification pursuant to this Section
8.5, including the selection of counsel, with the reasonable approval of the Indemnified Party. If an Indemnifying Party fails
or declines to assume the defense of any such claim or action within **** after notice thereof, then the Indemnified Party may
assume the defense of such claim or action at the cost and risk of the Indemnifying Party, and any Third Party Liabilities related
thereto shall be conclusively deemed a Third Party Liability of the Indemnifying Party. The indemnification rights of an Indemnified
Party contained in this Agreement are in addition to all other rights that such Indemnified Party may have at law or in equity
or otherwise. The Indemnifying Party will pay directly all Third Party Liabilities incurred for defense or negotiation of any claim
hereunder or will reimburse the Indemnified Party for all documented Third Party Liabilities incident to the defense or negotiation
of any such claim within **** after the Indemnifying Party’s receipt of invoices for such fees, expenses, and charges.


 




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8.6         Insurance.
Licensee will procure and maintain insurance policies for the following coverages with respect to product liability, personal injury,
bodily injury, and property damage arising out of Licensee’s (and its Affiliates’ and any Sublicensees’) performance
under this Agreement: (a) during the term of this Agreement, comprehensive general liability, including broad form and contractual
liability, in a minimum amount of **** combined single limit per occurrence (or claim) and **** in the aggregate annually; (b)
prior to the commencement of clinical trials involving Licensed Products and thereafter for a period of not less than **** (or
such longer period as Licensee is required by applicable law to continue to monitor the participants in the clinical trial), clinical
trials coverage in amounts that are reasonable and customary in the U.S. pharmaceutical industry, subject always to a minimum limit
of **** combined single limit per occurrence (or claim) and **** in the aggregate annually; and (c) from prior to the First Commercial
Sale of a Licensed Product until **** after the last sale of a Licensed Product, product liability coverage, in amounts that are
reasonable and customary in the U.S. pharmaceutical industry, subject always to a minimum limit of **** combined single limit per
occurrence (or claim) and **** in the aggregate annually. Licensor may review periodically the adequacy of the minimum amounts
of insurance for each coverage required by this Section 8.6, and Licensor reserves the right to require Licensee to adjust the
limits accordingly. The required minimum amounts of insurance do not constitute a limitation on Licensee’s liability or indemnification
obligations to the Licensor Indemnified Parties under this Agreement. The policies of insurance required by this Section 8.6 will
be issued by an insurance carrier with an A.M. best rating of **** or better and will name Licensor as an additional insured with
respect to Licensee’s performance (and its Affiliates’ and any Sublicensees’) under this Agreement. Licensee
will provide Licensor with insurance certificates evidencing the required coverage within **** after the Effective Date and the
commencement of each policy period and any renewal periods. Each certificate will provide that the insurance carrier will notify
Licensor in writing at least **** prior to the cancellation or material change in coverage. Licensee will cause all Sublicensees
to comply with the terms of this Section 8.6 to the same extent as Licensee.


 


Article
9: Use of Name


 


9.1         Licensee,
its Affiliates, any Sublicensees, and all of its and their employees and agents must not use Licensor’s, the University of
Pennsylvania’s, or SmithKline Beecham Corporation’s name, seal, logo, trademark, or service mark (or any adaptation
thereof) or the name, seal, logo, trademark, or service mark (or any adaptation thereof) of any of such entities’ representative,
school, organization, employee, or student in any way without the prior written consent of Licensor or such entity, as applicable,
unless required to do so pursuant to applicable law, rule, regulation or rules of a securities exchange; provided, however that
Licensee may acknowledge the existence and general nature of this Agreement, subject to Section 5.2 or 5.3, as applicable.


 


9.2         Licensor
and all of its employees and agents must not use Licensee’s name, seal, logo, trademark, or service mark (or any adaptation
thereof) in any way without the prior written consent of Licensee; provided, however that Licensor may acknowledge the existence
and general nature of this Agreement, subject to Section 5.2 or 5.3, as applicable, and refer to Licensee as a licensee of Licensor.


 




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Article
10: Additional Provisions


 


10.1       Relationship.
Nothing in this Agreement shall be deemed to establish a relationship of principal and agent between Licensee and Licensor, nor
any of their agents or employees for any purpose whatsoever, nor shall this Agreement be construed as creating any other form of
legal association or arrangement which would impose liability upon one Party for the act or failure to act of the other Party.


 


10.2       Assignment.
The rights and obligations of Licensee and Licensor hereunder shall inure to the benefit of, and shall be binding upon, their respective
permitted successors and assigns. Licensee may not assign or otherwise transfer (by operation of law or otherwise) this Agreement
or any of its rights or obligations under this Agreement without the prior written consent of Licensor, which consent is in the
absolute discretion of Licensor (except Licensee shall have the right to assign this Agreement without Licensor’s consent
to a wholly owned Affiliate, in which case Licensee shall remain responsible for the performance of this Agreement by such Affiliate);
provided, however, Licensee shall be permitted to transfer (by operation of law or otherwise) this Agreement without Licensor’s
consent in connection with a Change of Control; provided that, Licensee: (i) requires any transferee or successor to agree in writing
to be legally bound by this Agreement to the same extent as Licensee and provides Licensor with a copy of such undertaking; (ii)
provides Licensor with written notice of the Change of Control to Licensor within five days of the consummation of the transaction
resulting in a Change of Control of Licensee; (iii) provides Licensor with a copy of the definitive agreement for the Change of
Control of Licensee with five days of the consummation of the transaction (provided, that Licensee shall be entitled to include
customary redactions in such copy provided to Licensor, to the extent such redacted information is not necessary to verify compliance
with the terms of this Agreement or otherwise required by the Penn Agreement and/or GSK Agreement); and (iv) makes all payments
required as a result of a Change of Control under Article 3. Notwithstanding anything to the contrary in this Agreement, for clarity,
in case of a Licensee Change of Control, in no event shall any intellectual property rights owned or controlled by the acquirer
or its Affiliates immediately prior to such Licensee Change of Control be included in any of the licenses granted to Licensor under
this Agreement. Licensor may assign this Agreement and its rights and obligations without the consent of Licensee. No assignment
shall relieve the assigning Party of responsibility for the performance of any accrued obligations that it has prior to such assignment.
Any attempted assignment by Licensee in violation of this Section 10.2 shall be null and void and of no legal effect.


 


10.3       Waiver.
A waiver by either Party of a breach of any provision of this Agreement will not constitute a waiver of any subsequent breach of
that provision or a waiver of any breach of any other provision of this Agreement.


 


10.4       Notices.
Notices, payments, statements, reports, and other communications under this Agreement shall be in writing and shall be deemed to
have been received as of the date received if sent by public courier (e.g., Federal Express), by Express Mail, receipt requested,
by facsimile, or by electronic mail (with a copy of such facsimile or electronic mail also sent by one of the other methods of
delivery) and addressed as follows:


 




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	If for Licensor:	with a copy to:
	 	 
	REGENXBIO Inc.

9600 Blackwell Road

Suite 210

Rockville, MD 20850

USA

Attn:  Chief Executive Officer

Telephone:240-552-8181

Facsimile:240-652-9692	REGENXBIO Inc.

9600 Blackwell Road

Suite 210

Rockville, MD 20850

USA

Attn:  General Counsel

Telephone:240-552-8181

Facsimile:240-652-9692
	 	 
	If for Licensee:	with a copy to:
	 	 
	
        Abeona Therapeutics Inc.

        1330 Avenue of the Americas, 33rd Floor

        New York, NY 10019

        USA

        Attention: Chief Executive Officer

        Telephone: 646-813-4713

        Facsimile:
	
        Morgan, Lewis & Bockius LLP

        One Federal Street

        Boston, MA 02210

        USA

        Attention: Jack Concannon, Esq.

        Telephone: 617-951-8000

        Facsimile: 617-951-7326



 


Either Party may change its official address upon written notice
to the other Party in accordance with this Section 10.4.


 


10.5       Applicable
Law. This Agreement shall be construed and governed in accordance with the laws of the State of New York, without giving effect
to conflict of law provisions that may require the application of the laws of another jurisdiction. Subject to Section 10.6, the
Parties hereby submit to the exclusive jurisdiction of and venue in the courts located in the State of Delaware with respect to
any and all disputes concerning the subject of this Agreement.


 


10.6       Dispute
Resolution. In the event of any controversy or claim arising out of or relating to this Agreement, the Parties shall first
attempt to resolve such controversy or claim through good faith negotiations for a period of not less than **** following notification
of such controversy or claim to the other Party. If such controversy or claim cannot be resolved by means of such negotiations
during such period, then such controversy or claim shall be resolved by binding arbitration administered by the American Arbitration
Association (“AAA”) in accordance with the Commercial Arbitration Rules of the AAA in effect on the date of
commencement of the arbitration, subject to the provisions of this Section 10.6. The arbitration shall be conducted as follows:


 


10.6.1      The
arbitration shall be conducted by three arbitrators, each of whom by training, education, or experience has knowledge of the research,
development, and commercialization of biological therapeutic products in the United States. The arbitration shall be conducted
in English and held in New York, New York.


 




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10.6.2      In
its demand for arbitration, the Party initiating the arbitration shall provide a statement setting forth the nature of the dispute,
the names and addresses of all other parties, an estimate of the amount involved (if any), the remedy sought, otherwise specifying
the issue to be resolved, and appointing one neutral arbitrator. In an answering statement to be filed by the responding Party
within **** after confirmation of the notice of filing of the demand is sent by the AAA, the responding Party shall appoint one
neutral arbitrator. Within **** from the date on which the responding Party appoints its neutral arbitrator, the first two arbitrators
shall appoint a chairperson.


 


10.6.3      If
a Party fails to make the appointment of an arbitrator as provided in Section 10.6.2, the AAA shall make the appointment. If the
appointed arbitrators fail to appoint a chairperson within the time specified in Section 10.6.2 and there is no agreed extension
of time, the AAA shall appoint the chairperson.


 


10.6.4      The
arbitrators will render their award in writing and, unless all Parties agree otherwise, will include an explanation in reasonable
detail of the reasons for their award. Judgment upon the award rendered by the arbitrators may be entered in any court having jurisdiction
thereof, including in the courts described in Section 10.5. The arbitrators will have the authority to grant injunctive relief
and other specific performance; provided that the arbitrators will have no authority to award damages in contravention of this
Agreement, and each Party irrevocably waives any claim to such damages in contravention of this Agreement. The arbitrators will,
in rendering their decision, apply the substantive law of the State of Delaware, without giving effect to conflict of law provisions
that may require the application of the laws of another jurisdiction. The decision and award rendered by the arbitrators will be
final and non-appealable (except for an alleged act of corruption or fraud on the part of the arbitrator).


 


10.6.5      The
Parties shall use their reasonable efforts to conduct all dispute resolution procedures under this Agreement as expeditiously,
efficiently, and cost-effectively as possible.


 


10.6.6      All
expenses and fees of the arbitrators and expenses for hearing facilities and other expenses of the arbitration will be borne equally
by the Parties unless the Parties agree otherwise or unless the arbitrators in the award assess such expenses against one of the
Parties or allocate such expenses other than equally between the Parties. Each of the Parties will bear its own counsel fees and
the expenses of its witnesses except to the extent otherwise provided in this Agreement or by applicable law.


 


10.6.7      Compliance
with this Section 10.6 is a condition precedent to seeking relief in any court or tribunal in respect of a dispute, but nothing
in this Section 10.6 will prevent a Party from seeking equitable or other interlocutory relief in the courts of appropriate jurisdiction,
pending the arbitrators’ determination of the merits of the controversy, if applicable to protect the confidential information,
property, or other rights of that Party or to otherwise prevent irreparable harm that may be caused by the other Party’s
actual or threatened breach of this Agreement.


 


10.7         No
Discrimination. Licensee, its Affiliates, and Licensee shall use reasonable efforts to require that any Sublicensees, in their
respective activities under this Agreement, shall not discriminate against any employee or applicant for employment because of
race, color, sex, sexual, or affectional preference, age, religion, national, or ethnic origin, handicap, or because he or she
is a disabled veteran or a veteran (including a veteran of the Vietnam Era).


 




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10.8       Compliance
with Law. Licensee (and its Affiliates’ and any Sublicensees’) must comply with all prevailing laws, rules, and
regulations that apply to its activities or obligations under this Agreement. Without limiting the foregoing, it is understood
that this Agreement may be subject to United States laws and regulations controlling the export of technical data, computer software,
laboratory prototypes, and other commodities, articles, and information, including the Arms Export Control Act as amended in the
Export Administration Act of 1979 and that Licensee’s obligations are contingent upon compliance with applicable United States
export laws and regulations. The transfer of certain technical data and commodities may require a license from the cognizant agency
of the United States Government and/or written assurances by Licensee that Licensee shall not export data or commodities to certain
foreign countries without prior approval of such agency. Licensor neither represents that a license is not required nor that, if
required, it will issue.


 


10.9       Entire
Agreement. This Agreement embodies the entire understanding between the Parties relating to the subject matter hereof and supersedes
all prior understandings and agreements, whether written or oral, including that certain Mutual Non-Disclosure Agreement dated
May 16, 2018 between the Parties. All “Confidential Information” (as defined in such Mutual Non-Disclosure Agreement)
disclosed by one Party to the other Party pursuant to such Mutual Non-Disclosure Agreement shall be deemed “Confidential
Information” of such disclosing Party under this Agreement (unless and until it falls within one of the exclusions set forth
in Section 1.7). This Agreement may not be varied except by a written document signed by duly authorized representatives of both
Parties.


 


10.10     Marking.
Licensee, its Affiliates, and any Sublicensees shall mark any Licensed Product (or their containers or labels) made, sold, or otherwise
distributed by it or them with any notice of patent rights necessary or desirable under applicable law to enable the Licensed Patents
to be enforced to their full extent in any country where Licensed Products are made, used, sold, offered for sale, or imported.


 


10.11     Severability
and Reformation. If any provision of this Agreement is held to be invalid or unenforceable by a court of competent jurisdiction,
then such invalid or unenforceable provision will be automatically revised to be a valid or enforceable provision that comes as
close as permitted by law to the Parties’ original intent; provided that, if the Parties cannot agree upon such valid or
enforceable provision, then the remaining provisions of this Agreement will remain in full force and effect, unless the invalid
or unenforceable provisions are of such essential importance to this Agreement that it is to be reasonably assumed that the Parties
would not have entered into this Agreement without the invalid or unenforceable provisions.


 


10.12     Further
Assurances. Each Party hereto agrees to execute, acknowledge, and deliver such further instruments, and to do all other reasonable
acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.


 




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10.13     Interpretation;
Construction. The captions to the several Articles and Sections of this Agreement are included only for convenience of reference
and shall not in any way affect the construction of, or be taken into consideration in interpreting, this Agreement. In this Agreement,
unless the context requires otherwise, (a) the word “including” shall be deemed to be followed by the phrase “without
limitation” or like expression; (b) references to the singular shall include the plural and vice versa; (c) references to
masculine, feminine, and neuter pronouns and expressions shall be interchangeable; (d) the words “herein” or “hereunder”
relate to this Agreement; (e) “or” is disjunctive but not necessarily exclusive; (f) the word “will” shall
be construed to have the same meaning and effect as the word “shall”; (g) all references to “dollars” or
“$” herein shall mean U.S. Dollars; (h) unless otherwise provided, all reference to Sections, Articles, and exhibits
in this Agreement are to Sections, Articles, and exhibits of and in this Agreement; and (i) whenever this Agreement refers to a
number of days, such number shall refer to calendar days unless business days are specified. Business days shall mean a day on
which banking institutions in Washington, D.C. are open for business. Each Party represents that it has been represented by legal
counsel in connection with this Agreement and acknowledges that it has participated in the drafting hereof. In interpreting and
applying the terms and provisions of this Agreement, the Parties agree that no presumption will apply against the Party which drafted
such terms and provisions.


 


10.14     Cumulative
Rights and Remedies. The rights and remedies provided in this Agreement and all other rights and remedies available to either
Party at law or in equity are, to the extent permitted by law, cumulative and not exclusive of any other right or remedy now or
hereafter available at law or in equity. Neither asserting a right nor employing a remedy shall preclude the concurrent assertion
of any other right or employment of any other remedy, nor shall the failure to assert any right or remedy constitute a waiver of
that right or remedy.


 


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


 




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


 


	REGENXBIO INC.	 	ABEONA THERAPEUTICS INC.
	 	 	 
	By:	/s/ Kenneth Mills	 	By:  	/s/ Frank Carsten Thiel
	Name:	Kenneth Mills	 	Name:  	Frank Carsten Thiel
	Title:	President & CEO	 	Title:  	Chief Executive Officer


 




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Exhibit A

Licensed Patents (****)


 


	Application #	Patent #	Filing Date	Country	Status
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****


 




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Exhibit B

Licensed Know-How


 


****


 




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Exhibit C

Press Release


 


REGENXBIO and Abeona Therapeutics Announce
Worldwide Exclusive Licenses for the Treatment of Four Rare Lysosomal Storage Disorders Using NAV AAV9 Vector


 


		·	REGENXBIO grants Abeona new licenses to NAV AAV9 for the development and commercialization of treatments for MPS IIIA, MPS
IIIB, CLN1 and CLN3 Batten Disease 



		·	REGENXBIO could receive up to $180 million, including $40 million in guaranteed payments 



 


ROCKVILLE, Md., Nov. 5, 2018 (PRNEWSWIRE)
— REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through
the curative potential of gene therapy based on its proprietary NAV® Technology Platform, and Abeona Therapeutics
Inc. (Nasdaq: ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for
life-threatening rare genetic diseases, today announced a license agreement to REGENXBIO’s NAV AAV9 vector for the treatment
of four diseases: Sanfilippo syndrome type A (MPS IIIA), Sanfilippo syndrome type B (MPS IIIB), Infantile Batten Disease, also
known as neuronal ceroid lipofuscinosis type 1 (CLN1 Disease), and Juvenile Batten Disease, also known as neuronal ceroid lipofuscinosis
type 3 (CLN3 Disease).


 


Under the terms of the agreement, REGENXBIO
has granted Abeona an exclusive worldwide license (subject to certain non-exclusive rights previously granted for MPS IIIA), with
rights to sublicense, to REGENXBIO’s NAV AAV9 vector for the development and commercialization of gene therapies for the
treatment of MPS IIIA, MPS IIIB, CLN1 Disease and CLN3 Disease. In return for these rights, REGENXBIO will receive a guaranteed
$20 million upfront payment, $10 million of which will be paid upon signing and $10 million of which will be paid within 12 months
of the effective date. In addition, REGENXBIO will receive a total of $100 million in annual fees, payable upon the second through
sixth anniversaries of the agreement, $20 million of which is guaranteed. REGENXBIO is also eligible to receive potential commercial
milestone payments of up to $60 million. REGENXBIO will also receive low double-digit royalties on net sales of products incorporating
the licensed intellectual property.


 


“This license agreement further validates the potential
of NAV AAV9 for the treatment of systemic and CNS manifestations of lysosomal storage diseases, as well as the strength of our
intellectual property portfolio,” said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. “We are
pleased to initiate our partnership with Abeona as they continue to advance multiple programs using NAV AAV9 through and towards
clinical trials in indications with significant unmet medical need.”


 


“This agreement is an important milestone that underpins
the therapeutic potential we see in our Sanfilippo syndrome and Batten disease programs featuring the NAV AAV9 vector, which have
the potential to transform the lives of patients,” said Carsten Thiel, Ph.D., Chief Executive Officer of Abeona. “Data
from our clinical and preclinical programs and the success of the NAV AAV9 vector observed in other indications strongly positions
the platform as a leading technology for investigational gene therapies for the systemic and CNS manifestations of lysosomal storage
diseases.”


 


About Sanfilippo Syndrome 


Sanfilippo syndrome, or MPS type III, is a group of rare genetic
lysosomal storage diseases with no approved treatments. MPS III is characterized by aggressive behavior, seizures, loss of speech
or vision, an inability to sleep, and premature death. An estimated 70% of children with MPS III do not reach age 18. The underlying
cause of the syndrome is a missing enzyme that is essential to breaking down heparan sulfate. As a result, partially synthesized
heparan sulfate accumulates in the central nervous system, including the brain and spinal cord, causing progressive damage. MPS
III is categorized by the single gene defects associated with each type of the syndrome - A, B, C or D. The hallmark feature of
MPS IIIA is a deficiency in the SGSH enzyme, while MPS IIIB is distinguished by a marked decrease in NAGLU enzyme activity.


 




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About Batten Disease


Infantile and juvenile forms of Batten disease, known as CLN1
and CLN3, are rare autosomal recessive genetic disorders with no approved treatments. Batten disease is fatal, and most do not
live past their twenties or thirties. The underlying cause of the disorder is a deficiency in proteins critical to lysosomal function
that lead to abnormal buildup of lipopigments, and result in neuroinflammation and neurodegeneration. CLN1 and CLN3 are differentiated
by mutations of their respective genes, yet the first noticeable sign of all forms of Batten disease is often vision impairment
that can progress to blindness. Developmental regression is another hallmark of the disease, as children lose the ability to speak
in complete sentences and to walk or sit, among other manifestations. Later in life, affected children may have recurrent seizures,
heart problems, behavioral problems, and difficulty sleeping.


 


About REGENXBIO Inc.


REGENXBIO is a leading clinical-stage
biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO's NAV Technology
Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel
AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees
are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas.


 


About Abeona Therapeutics Inc. 


Abeona Therapeutics Inc. is a clinical-stage
biopharmaceutical company developing cell and gene therapies for life-threatening rare genetic diseases. Abeona's lead programs
include EB-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (RDEB), ABO-102 (AAV-SGSH), an adeno-associated
virus (AAV) based gene therapy for Sanfilippo syndrome type A (MPS IIIA) and ABO-101 (AAV-NAGLU), an adeno-associated virus (AAV)
based gene therapy for Sanfilippo syndrome type B (MPS IIIB). Abeona is also developing ABO-201 (AAV-CLN3) gene therapy for CLN3
disease, ABO-202 (AAV-CLN1) for treatment of CLN1 disease, EB-201 for epidermolysis bullosa (EB), ABO-301 (AAV-FANCC) for Fanconi
anemia (FA) disorder and ABO-302 using a novel CRISPR/Cas9-based gene editing approach to gene therapy for rare blood diseases.
In addition, Abeona is developing a proprietary vector platform, AIMTM, for next generation product candidates. For more information,
visit www.abeonatherapeutics.com.


 


REGENXBIO Forward-Looking Statements


This press release includes "forward-looking
statements," within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. These statements express a belief, expectation or intention and are generally accompanied
by words that convey projected future events or outcomes such as "believe," "may," "will," "estimate,"
"continue," "anticipate," "design," "intend," "expect," "could," "plan,"
"potential," "predict," "seek," "should," "would" or by variations of such words
or by similar expressions. The forward-looking statements include statements relating to, among other things, REGENXBIO's future
operations and cash flow. REGENXBIO has based these forward-looking statements on its current expectations and assumptions and
analyses made by REGENXBIO in light of its experience and its perception of historical trends, current conditions and expected
future developments, as well as other factors REGENXBIO believes are appropriate under the circumstances. However, whether actual
results and developments will conform with REGENXBIO's expectations and predictions is subject to a number of risks and uncertainties,
including the timing of enrollment, commencement and completion and the success of clinical trials conducted by REGENXBIO, its
licensees and its partners, the timing of commencement and completion and the success of preclinical studies conducted by REGENXBIO
and its development partners, the timely development and launch of new products, the ability to obtain and maintain regulatory
approval of product candidates, the ability to obtain and maintain intellectual property protection for product candidates and
technology, trends and challenges in the business and markets in which REGENXBIO operates, the size and growth of potential markets
for product candidates and the ability to serve those markets, the rate and degree of acceptance of product candidates, and other
factors, many of which are beyond the control of REGENXBIO. Refer to the "Risk Factors" and "Management's Discussion
and Analysis of Financial Condition and Results of Operations" sections of REGENXBIO's Annual Report on Form 10-K for the
year ended December 31, 2017 and comparable "risk factors" sections of REGENXBIO's Quarterly Reports on Form
10-Q and other filings, which have been filed with the U.S. Securities and Exchange Commission (SEC) and are available on the SEC's
website at www.sec.gov. All of the forward-looking statements made in this press release are expressly qualified by the cautionary
statements contained or referred to herein. The actual results or developments anticipated may not be realized or, even if substantially
realized, they may not have the expected consequences to or effects on REGENXBIO or its businesses or operations. Such statements
are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking
statements. Readers are cautioned not to rely too heavily on the forward-looking statements contained in this press release. These
forward-looking statements speak only as of the date of this press release. REGENXBIO does not undertake any obligation, and specifically
declines any obligation, to update or revise any forward-looking statements, whether as a result of new information, future events
or otherwise.


 




    	****Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
 




     


    

 


Confidential
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REGENXBIO CONTACT:


 


Investors

Natalie Wildenradt, 646-681-8192

natalie@argotpartners.com




Media

Adam Pawluk, 202-591-4063

apawluk@jpa.com


 




    	****Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.