Exhibit 10.15

 

Execution Version

 

***Text Omitted and Filed Separately with the Securities and Exchange Commission

Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

COLLABORATION AND LICENSE AGREEMENT

 

This COLLABORATION AND LICENSE AGREEMENT (“Agreement”) is entered into as of
June 18, 2014 (“Effective Date”) by and between Dimension Therapeutics, Inc., a
corporation organized under the laws of the State of Delaware, with offices at 1
Main Street, 13th Floor, Cambridge, MA 02142 (“Dimension”), and Bayer HealthCare
LLC, a limited liability company organized under the laws of the State of
Delaware, with offices at 455 Mission Bay Blvd South, San Francisco, CA 94158
(“Bayer”). Dimension and Bayer are hereinafter referred to individually as a
“Party” and collectively as the “Parties.”

 

WHEREAS, Dimension has been granted exclusive rights by its licensor, ReGenX
Biosciences, LLC (“ReGenX”) under certain patents and know-how which have been
licensed to ReGenX from its upstream licensors, Glaxo SmithKline (as successor
in interest to SmithKline Beecham Corporation, “GSK”) and the Trustees of the
University of Pennsylvania (“UPenn”), pertaining to various recombinant
adeno-associated virus vectors and their use in gene therapy treatments for
hemophilia;

 

WHEREAS, Dimension has expertise in the research, identification and early stage
development of gene therapy treatments in humans;

 

WHEREAS, Bayer is a leading pharmaceutical company that has technology and
expertise in developing and commercializing therapies for human genetic
diseases, including hemophilia; and WHEREAS, the Parties desire to enter into a
collaboration for the purpose of researching, developing and commercializing
adeno-associated virus based gene therapy products for treatment of hemophilia
A;

 

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“[…***…] Expense Report” has the meaning set forth in Section 2.5.1.

 

1.2“Affiliate” means any legal entity directly or indirectly controlling,
controlled by, or under common control with another entity. For purposes of this
Agreement, an entity shall be deemed to “control” another entity if it owns or
controls, directly or indirectly, more than 50% of the outstanding voting
securities of such other entity, or has the right to receive more than 50% of
the profits or earnings of such other entity, or has the right to control the
policy decisions of such other entity.

 

 

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1.3“Antihemophilic Factor” means the MAA-approved exogenous recombinant
antihemophilic factor (i.e., rFVIII) labeled for use in the Field and
administered by or on behalf of Bayer, its Affiliates or Sublicensees to a
patient for prophylactic and non-interventional purposes.

 

1.4“Biosimilar Treatment” means on a country-by-country basis, a treatment that
is introduced in the applicable country in the Territory by an entity other than
Bayer or a Sublicensee or their respective Affiliates, which (a) contains or
incorporates a therapeutic or prophylactic agent that is the same or equivalent
(by FDA, EMA or other applicable Regulatory Authority standards, on a
country-by-country basis) to the Licensed GT Product; and (b) has been granted
Regulatory Approval by an abridged procedure in reliance in whole or in part on
(i) the prior Regulatory Approval in such country of the Licensed GT Product and
Licensed Treatment, or (ii) the safety and efficacy data generated for the prior
Regulatory Approval for such Licensed Treatment or Licensed GT Product.

 

1.5“Business Day” means a day other than a Saturday, Sunday or any day on which
commercial banks located in California, New Jersey, and Massachusetts are
authorized or obligated by law to be closed.

 

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

 

1.7“Change of Control” means, with respect to a Party (the “Acquired Entity”):

 

(a)any sale, exchange, transfer, or issuance to or acquisition in one
transaction or a series of related transactions by one or more Third Parties of
shares representing more than fifty percent (50%) of the aggregate ordinary
voting power entitled to vote for the election of directors represented by the
issued and outstanding stock of the Acquired Entity or any Affiliate that
directly or indirectly controls the Acquired Entity, whether such sale,
exchange, transfer, issuance or acquisition is made directly or indirectly, by
merger or otherwise, or beneficially or of record;

 

(b)a merger, consolidation, reorganization, business organization, joint venture
or similar transaction under applicable Law of the Acquired Entity with a Third
Party in which the shareholders of the Acquired Entity or any Affiliate that
directly or indirectly controls the Acquired Entity immediately prior to such
transaction do not continue to hold immediately following the closing of such
transaction at least fifty percent (50%) of the aggregate ordinary voting power
entitled to vote for the election of directors represented by the issued and
outstanding stock of the entity surviving or resulting from such transaction; or

 

(c)a sale or other disposition of all or substantially all of the assets of the
Acquired Entity to one or more Third Parties in one transaction or a series of
related transactions.

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For purposes of clarity, the term “Change of Control,” with respect to a Party,
is not intended to include: (i) an underwritten public offering of Dimension’s
common stock pursuant to a Registration Statement on Form S-1 under the 1933
Act, as amended; or (ii) any sale of shares of capital stock of a Party, in a
single transaction or series of related transactions, principally for bona fide
equity financing purposes in which such Party issues new securities solely to
institutional investors for cash or the cancellation or conversion of
indebtedness of such Party or a combination thereof for the purpose of financing
the operations and business of such Party.

 

1.8“Commercialization” or “Commercialize” means any and all activities directed
to the marketing, promotion, offering for sale and sale of a pharmaceutical or
therapeutic product, both, to the extent permitted by law, before Regulatory
Approval has been obtained, and after, and all commercial manufacturing
activities, as well as any post-Regulatory Approval clinical trials. When used
as a verb, “to Commercialize” and “Commercializing” means to engage in
Commercialization and “Commercialized” has a corresponding meaning.

 

1.9“Commercially Reasonable Efforts” means: (a) with respect to Dimension’s
obligation under this Agreement to research and develop GT Products in the
Field, the level of efforts normally used by a similarly situated
biopharmaceutical company in meeting the objective(s) set forth in the Research
Plan; and (b) with respect to Bayer’s obligation under this Agreement to
Commercialize a Licensed GT Product and Licensed Treatments, the level of
efforts and resources normally used by Bayer for a similar product owned or
controlled by it of similar market potential at a similar stage in the
development or life of such product, taking into account issues of safety,
efficacy, product profile, the competitiveness of the marketplace, the
proprietary position of the product, the regulatory structure involved,
profitability of the product and other relevant commercial factors.

 

1.10“Compound/Vector” means any gene transfer agent that contains a gene that
expresses either (a) the Factor VIII protein, or (b) any variant of the Factor
VIII protein (e.g., […***…]).

 

1.11“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 by
the Disclosing Party as confidential or proprietary at the time of disclosure in
writing; or (b) if disclosed orally, visually, or in another non-written form,
identified by the Disclosing Party as confidential at the time of disclosure; or
(c) if not marked as provided in clause (a) or otherwise identified as provided
in clause (b), would reasonably be understood by a Third Party receiving such
information as being confidential or proprietary in nature. The Parties
acknowledge that (i) the terms and conditions of this Agreement and (ii) the
records and reports referred to in Section 6.5 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 Bayer pursuant
to the provisions of Section 10.2 will be deemed the Confidential Information of
Dimension, regardless of whether such information is marked or identified as
confidential. Notwithstanding the foregoing, Confidential Information

 

 

 

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will not include the following, in each case, to the extent evidenced by
competent written proof of the Receiving Party:

 

1.11.1information that was already known to the Receiving Party other than under
an obligation of confidentiality at the time of disclosure by the Disclosing
Party;

 

1.11.2information that was generally available to the public or otherwise part
of the public domain at the time of its disclosure to the Receiving Party;

 

1.11.3information 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;

 

1.11.4information that is independently discovered or developed by the Receiving
Party without the use of Confidential Information of the Disclosing Party; or

 

1.11.5information 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.

 

1.12“Control” or “Controlled” means with respect to any Know-How, Patent Rights
or other intellectual property right, that a Party has a license (other than a
license granted to such Party under this Agreement) to such Know-How, Patent
Rights or other intellectual property right and, in each case, has the ability
to grant to the other Party access, a license, or a sublicense (as applicable)
to the foregoing on the terms and conditions set forth in this Agreement without
violating the terms of any agreement or other legally enforceable arrangement
with any Third Party.

 

1.13“Controlled Affiliate” means, as to any Party, an Affiliate under the direct
or indirect control of such Party, within the meaning of Section 1.2.

 

1.14“Controlling Affiliate” means, as to any Party, an Affiliate that directly
or indirectly controls such Party within the meaning of Section 1.2.

 

1.15“Cost Overrun” has the meaning set forth in Section 2.5.3.

 

1.16“Demonstration of Clinical POC” means that the criteria set forth in Exhibit
E have been met, as determined by the Parties in accordance with Section 2.11.4.

 

1.17“Dimension Know-How” means any Know-How that (a) is Controlled by Dimension
or any of its Controlled Affiliates as of the Effective Date or comes into the
Control of Dimension or any of its Controlled Affiliates after the Effective
Date and at any time during the term of this Agreement (other than through the
grant of a license by Bayer hereunder), (b) is reasonably necessary or useful
for the development, manufacture or Commercialization of Licensed GT Products,
Licensed Treatments, or for Bayer to perform its obligations under this
Agreement, and (c) is neither (i) Sublicensed Know-How, nor (ii) any
Manufacturing Technology which is other than […***…] Know-How, and that comes
into the Control of

 

 

 

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Dimension under the ReGenX Agreement or another agreement with ReGenX.
“Dimension Know-How” includes but is not limited to all biological, chemical,
structure-activity relationship, pharmacological, toxicological, manufacturing,
preclinical and clinical information relating to Licensed GT Products or the
Compound/Vector used in such product. For the avoidance of doubt, Dimension
Know-How includes Dimension’s interest in the Joint Inventions, but does not
include any Patent Rights. It is expressly understood that, in the event of a
Change of Control of Dimension, the Dimension Know-How shall not include any
Know-How that is owned or controlled by a Controlling Affiliate and (i) existing
prior to the closing of such Change of Control, or (ii) developed by or on
behalf of such Controlling Affiliate after such Change of Control without the
use of the Dimension Know-How in existence prior to the closing of such Change
of Control, or (iii) developed by or on behalf of such Controlling Affiliate
after such Change of Control and not directly related to any Licensed GT Product
or any Compound/Vector used therein. It is understood that the burden shall be
on Dimension to establish that the foregoing exclusions apply, and such
exclusions shall apply only if the Controlling Affiliate remains a separate
legal entity to Dimension.

 

1.18“Dimension Manufacturing Patents” means all Patent Rights that (a) are not
Sublicensed Patents, (b) come into the ownership or Control of Dimension or its
Controlled Affiliates after the Effective Date and during the term of this
Agreement (other than through the grant of a license by Bayer hereunder), and
(c) claim inventions relating to the process of manufacture of any Licensed GT
Product, Licensed Treatment or any Compound/Vector, which inventions were not
generated in the conduct of the manufacturing development set forth in the
Research Plan, but were generated by or on behalf of Dimension prior to Bayer’s
submission of the first MAA for a Licensed GT Product. It is expressly
understood that in the event of a Change of Control of Dimension, the Dimension
Manufacturing Patents shall not include any Patent Rights owned or controlled by
a Controlling Affiliate and (i) existing prior to the closing of such Change of
Control of Dimension, (ii) existing after the closing of such Change of Control
and claiming inventions made by or on behalf of such Controlling Affiliate prior
to the closing of such Change of Control, (iii) claiming only inventions made
after such Change of Control without the use of the Dimension Know-How in
existence prior to the closing of such Change of Control, or (iv) claiming only
inventions made after such Change of Control and not directly related to the
Licensed Treatment, Licensed GT Product or the Compound/Vector used therein. It
is understood that the burden shall be on Dimension to establish that the
foregoing exclusions apply, and such exclusions shall apply only if the
Controlling Affiliate remains a separate legal entity to Dimension.

 

1.19“Dimension Patents” means all Patent Rights that (a) are not Sublicensed
Patents, (b) are not Dimension Manufacturing Patents, (c) are owned or
Controlled by Dimension or its Controlled Affiliates as of the Effective Date or
that come into the ownership or Control of Dimension or its Controlled
Affiliates after the Effective Date and during the term of this Agreement (other
than through the grant of a license by Bayer hereunder), and (d) cover (i) the
development, use or Commercialization of any Licensed GT Product, Licensed
Treatment or any Compound/Vector used therein or (ii) the manufacture of any
Licensed GT Product, Licensed Treatment or any Compound/Vector used therein to
the extent such Patent Rights cover inventions that were generated in the
conduct of the manufacturing development as set forth in the Research Plan. For
the avoidance of doubt, Dimension Patents include Dimension’s interest

 

 

 

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in the Joint Patents. Dimension Patents as of the Effective Date are listed in
Exhibit A. It is expressly understood that in the event of a Change of Control
of Dimension, the Dimension Patents shall not include any Patent Rights owned or
controlled by a Controlling Affiliate and (i) existing prior to the closing of
such Change of Control of Dimension, (ii) existing after the closing of such
Change of Control and claiming inventions made by or on behalf of such
Controlling Affiliate prior to the closing of such Change of Control, (iii)
claiming only inventions made after such Change of Control without the use of
the Dimension Know-How in existence prior to the closing of such Change of
Control, or (iv) claiming only inventions made after such Change of Control and
not directly related to the Licensed Treatment, Licensed GT Product or the
Compound/Vector used therein. It is understood that the burden shall be on
Dimension to establish that the foregoing exclusions apply, and such exclusions
shall apply only if the Controlling Affiliate remains a separate legal entity to
Dimension.

 

1.20“Disclosing Party” has the meaning set forth in Section 8.1.

 

1.21“Estimated Quarterly Payment” has the meaning set forth in Section 2.5.1.

 

1.22“Existing Licenses” means the GSK Agreement and Penn Agreement.

 

1.23“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.

 

1.24“Field” means any and all human therapeutic uses to treat and diagnose
hemophilia A (and expressly not hemophilia B or any other form of hemophilia
other than hemophilia A).

 

1.25“First Commercial Sale” means, on a country-by-country basis (a) the first
commercial sale of a Licensed Treatment by Bayer, its Sublicensees or their
respective Affiliates to a person or entity who is not Bayer, its Sublicensees
or their respective Affiliates in such country after grant of Regulatory
Approval in the applicable country or jurisdiction, provided that where such a
first commercial sale has occurred in a country for which pricing approval is
necessary for widespread sale, then such sale shall not be deemed a First
Commercial Sale until such pricing approval has been obtained; or (b) any
compassionate use or named patient basis sale in such country, following the
date upon which cumulative Net Sales (across all countries in the Territory)
received from any compassionate use or named patient program by Bayer, its
Affiliate or Sublicensees equals […***…], provided the Licensed Treatment
Administration Sales and Licensed Treatment Monitoring Sales with respect to the
Licensed GT Products administered pursuant to such programs is greater than the
fully loaded costs of such Licensed GT Products. For the avoidance of doubt,
supply of Licensed GT Product as samples or to patients for clinical trials or
other similar purposes shall not be considered a First Commercial Sale.

 

1.26“GSK Agreement” means that certain License Agreement entered into between
ReGenX and GSK, effective on March 6, 2009, as amended by that certain Amendment
to License Agreement dated April 15, 2009, and as amended from time to time.

 

 

 

 

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1.27“GT Product” means:

 

(a)a pharmaceutical product or medical therapy for repairing, modulating the
expression of, or inserting a functional version of, the Factor VIII protein but
not any other target or locus, which product or therapy (1) contains or employs
at least one Compound/Vector and (2) does not contain or employ any other gene
or variant of such gene that is other than the Factor VIII protein or a variant
of the Factor VIII protein; or

 

(b)a pharmaceutical product or medical therapy that contains or employs a human
cell or tissue made using a product or therapy described in (a).

 

1.28“IND” means (a) an Investigational New Drug Application as defined in the
U.S. Federal Food, Drug, and Cosmetic Act, as amended, and regulations
promulgated thereunder or any successor application or procedure required to
initiate clinical testing of a GT Product in humans in the United States; (b) a
counterpart of an Investigational New Drug Application that is required in any
other country or regulatory jurisdiction other than the United States before
beginning clinical testing of the GT Product in humans in such country or
regulatory jurisdiction; and (c) all supplements and amendments to any of the
foregoing.

 

1.29“Joint Inventions” has the meaning set forth in Section 10.1.

 

1.30“Joint Patents” has the meaning set forth in Section 10.1.

 

1.31“Joint Project Team” or “JPT” has the meaning set forth in Section 4.3.

 

1.32“Joint Research and Development Committee” or “JRDC” means the research and
development oversight committee comprised of representatives of Dimension and
Bayer, as further described in Section 4.2.

 

1.33“Joint Steering Committee” or “JSC” means the oversight committee comprised
of two (2) representatives each of Dimension and Bayer, as further described in
Section 4.1.

 

1.34“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.

 

1.35“Laws” means all laws, statutes, rules, regulations, ordinances and other
pronouncements having the effect of law of any federal, national, multinational,
state, provincial, county, city or other political subdivision, domestic or
foreign.

 

1.36“Licensed Back Improvements” means any patentable modifications or
improvements developed by Bayer, any of its Affiliates, or any Sublicensees to
any vector that is the subject of a claim within the Licensed Patents.

 

1.37“Licensed GT Product” has the meaning set forth in Section 2.11.

 

 

 

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1.38“Licensed Know-How” means the Dimension Know-How and the Sublicensed
Know-How.

 

1.39“Licensed Patents” means the Dimension Patents and the Sublicensed Patents.

 

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

 

1.41“Licensed Treatment” means any (a) Licensed GT Product in any and all modes
of administration, presentations, formulations and dosages, that either (i) the
manufacture, use, sale, offer for sale, or import of which is covered by, or
which, in the absence of the licenses granted pursuant to this Agreement, would
infringe, at least one Valid Claim of a Sublicensed Patent or Dimension Patent,
in the country of manufacture, use, sale, offer for sale, or import; or (ii) is
generated through the use of Sublicensed Know-How or Dimension Know-How; and/or
(b) service with respect to the administration to patients of any Licensed GT
Product described in clause (a)(i) or (a)(ii) above in this Section 1.41; and/or
(c) service with respect to the monitoring as to the effectiveness or safety in
patients of any Licensed GT Product described in clause (a)(i) or (a)(ii) above
in this Section 1.41.

 

1.42“Licensed Treatment Administration Sales” means, with respect to a given
patient in the Field to whom a Licensed Treatment is administered, the gross
amount invoiced by Bayer, its Affiliate or Sublicensee to Third Parties, and
recognized in their respective accounting books as income, for the initial
administration of such Licensed Treatment to such patient.

 

1.43“Licensed Treatment Monitoring Sales” means, with respect to a given patient
in the Field to whom a Licensed Treatment has been administered, the gross
amounts invoiced to Third Parties by Bayer, its Affiliates or Sublicensees on or
after receipt of the Licensed Treatment Administration Sale, and recognized in
their respective accounting books as income, for either services rendered in the
monitoring of such patient, and/or the continuing effectiveness of the Licensed
GT Product with respect to such patient.

 

1.44“Licensed Treatment Sales” means with respect to a given period, all
Licensed Treatment Administration Sales and all Licensed Treatment Monitoring
Sales during such period, […***…]. For illustrative purposes only, Exhibit B
sets forth examples for calculating Licensed Treatment Sales based on Licensed
Treatment Administration Sales, Licensed Treatment Monitoring Sales, and any
Post-Administration Antihemophilic Factor administered.

 

1.45“MAA” means either a New Drug Application filed with the FDA as described in
21 C.F.R. § 314, a Biological License Application (BLA) pursuant to 21 C.F.R. §
601.2, or any equivalent or any corresponding application in any country or
regulatory jurisdiction other than the United States.

 

1.46“Major Market Country” means […***…].

 

1.47“Manufacturing Technology” means any and all Patent Rights, Know-How, and
all intellectual property rights associated therewith, and including all
tangible embodiments thereof, that are necessary or useful for the manufacture
of any Licensed GT Product or

 

 

 

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Compound/Vector used therein, or research or commercial reagents related
thereto, 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,
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.

 

1.48“Net Sales” means, with respect to a given period, the Licensed Treatment
Sales made during such period less the following deductions that are directly
attributable to Licensed Treatment Administration Sales or, to the extent
applicable, any Licensed Treatment Monitoring Sales:

 

1.48.1[…***…];

 

1.48.2[…***…] upon the sale of a Licensed GT Product and […***…];

 

1.48.3[…***…] in connection with the Licensed Treatment Administration Sales;

 

1.48.4[…***…] of a Licensed GT Product; and

 

1.48.5[…***…] in connection with Licensed Treatment Administration Sales.

 

Sales between and among Bayer and its Affiliates or Sublicensees of Licensed GT
Products shall be excluded from the computation of Net Sales, except where
[…***…], but Net Sales shall include […***…].

 

For the purpose of calculating Net Sales, the Parties recognize that: (a)
[…***…]; and (b) in such cases, […***…].

 

In the event the Licensed GT Product is sold […***…], Net Sales for such
[…***…]. If, on a country-by-country basis, […***…], then Net Sales will be
[…***…]. If, on a country-by-country basis, […***…].

 

[…***…] shall not be considered in determining Net Sales; provided, however,
that […***…].

 

All amounts used to calculate Licensed Treatment Sales shall be applied in
accordance with IFRS, […***…].

 

1.49“Operating Plan” has the meaning assigned to it in Section 2.3.1.

 

1.50“Patent Rights” means issued patents and pending patent applications in any
country or region, including all provisional, non-provisionals, substitutions,
continuations, continuations-in-part, divisionals, renewals and all patents
granted thereon, and all reissues,

 

 

 

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reexaminations, extensions, confirmations, revalidations, registrations and
patents of addition thereof, including supplementary protection certificates.

 

1.51“Penn Agreement” means that certain License Agreement entered into between
ReGenX and UPenn, effective on February 24, 2009, as amended by that letter
agreement dated March 6, 2009, and as amended from time to time.

 

1.52“Phase II/III Trial” means a human clinical trial of a Licensed GT Product
according to 21 C.F.R. 312.21(b) and (c) (or their successor regulations or any
equivalent regulation with respect to jurisdictions outside of the United
States);

 

1.53“Pivotal Clinical Trial” means a human clinical trial of a Licensed GT
Product and/or Licensed Treatment (a) […***…] or (b) the Phase III portion (as
defined in the protocol) of a Phase II/III Trial or other similar designation as
approved by the FDA, or the corresponding regulations outside the U.S.

 

1.54“Post-Administration Antihemophilic Factor” […***…].

 

1.55“Proof of Concept Trial” or “POC Trial” means the Phase I human proof of
concept trial in patients for a GT Product as set forth in, and conducted
pursuant to, the Research Plan.

 

1.56“Prosecute” means preparation, filing, and prosecuting patent applications
and maintaining patents, including any reexaminations, reissues, inter party’s
reviews, post-grant reviews, oppositions, and interferences.

 

1.57“Receiving Party” has the meaning set forth in Section 8.1.

 

1.58“ReGenX Agreement” means that certain License Agreement entered into between
Dimension and ReGenX, effective on October 31, 2013, as amended from time to
time.

 

1.59“ReGenX Improvements” means any patent or patent application that meets all
of the following criteria:

 

(a)is directed to any of: the composition of recombinant adeno-associated virus
vectors, methods of use of such vectors, or methods of developing such vectors,
but, in each case, only to the extent of such claims; and

 

(b)is reasonably necessary for any of: the use, sale, offer for sale, or import
of Licensed Products in the Field (as such capitalized terms are defined in the
ReGenX Agreement);

 

provided that “ReGenX Improvements” will not include any Manufacturing
Technology.

 

1.60“Regulatory Approval” means, with respect to particular country or
territory, the approval of the MAA or similar approval required to sell a
Licensed GT Product and/or Licensed Treatment in such country or territory,
including, where required by applicable Law, pricing and reimbursement approval.

 

 

 

 

 

 

 

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1.61“Regulatory Authority” means any country, federal, supranational, state or
local regulatory agency, department, bureau or other governmental or regulatory
authority having the administrative authority to regulate the development or
marketing of pharmaceutical products in any country or other jurisdiction, and
includes the FDA in the US and the European Medicines Agency in the EU.

 

1.62“Research Budget” means the budget attached to this Agreement as Exhibit
D-3, as may be amended from time to time as provided for in this Agreement, and
covering […***…].

 

1.63“Research Plan” means the research plan addressing the activities to be
performed by Dimension during the Research Term through completion of the POC
Trial, as set forth in Section 2.3, and as such research plan may be amended
from time to time. The Research Plan shall contain (a) a description of the
process for identifying the criteria for selecting GT Products as potential
clinical candidates, […***…], (b) a description of the specific activities to be
performed by Dimension, including the pre-clinical and regulatory work necessary
to commence the POC Trial and clinical work necessary for the completion of the
POC Trial, (c) the primary and secondary endpoints of the POC Trial, (d)
manufacturing / CMC development, and (e) projected timelines for completion of
the described activities.

 

1.64“Research Program” means the research collaboration between the Parties,
under the direction and oversight of the JRDC, aimed at the discovery of one or
more suitable Licensed GT Products for hemophilia A and moving such Licensed GT
Products forward to completion of a POC Trial, pursuant to the Research Plan
during the Research Term.

 

1.65“Research Term” means the period following the Effective Date for Dimension
to conduct and complete the Research Plan, unless earlier terminated as provided
under Section 2.2 of this Agreement.

 

1.66“Retained Rights” has the meaning set forth in Section 5.3.

 

1.67“Royalty Term” has the meaning set forth in Section 6.4.2.

 

1.68“Sublicensed Know-How” means any Know-How that (a) is Controlled by
Dimension as of the Effective Date or that comes into the Control of Dimension
after the Effective Date and during the term of this Agreement, (b) is licensed
to Dimension under the ReGenX Agreement, and (c) is reasonably necessary for the
use, sale, offer for sale, or import of Licensed GT Products in the Field;
provided that “Sublicensed Know-How” will not include any Manufacturing
Technology, other than […***…] Know-How, that comes into the Control of
Dimension under the ReGenX Agreement and which otherwise meets the foregoing
criteria; and provided further that “Sublicensed Know-How” does not include any
Patent Rights.

 

1.69“Sublicensed Patents” means (a) the Patent Rights listed in Exhibit A, and
(b) all other Patent Rights that cover or claim any Licensed GT Product or
Licensed Treatment or component thereof, or use thereof in the Field, and that
(i) are Controlled by Dimension as of the Effective Date or that come into the
Control of Dimension after the Effective Date and during the

 

 

 

* The specific required criteria known as […***…].

 

 

 

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term of this Agreement, and (ii) are licensed to Dimension under the ReGenX
Agreement, provided that “Sublicensed Patents” will not include any claim of a
patent or patent application owned or controlled by ReGenX covering any
Manufacturing Technology.

 

1.70“Sublicensed Technology” means, collectively, the Sublicensed Patents and
Sublicensed Know-How.

 

1.71“Sublicensee” means any Third Party or Affiliate to whom Bayer grants a
sublicense of some or all of the rights granted to Bayer under this Agreement as
permitted by this Agreement.

 

1.72“Territory” means the entire world.

 

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

 

1.74“[…***…] Know-How” means unpatented Know-How that, as of October 30, 2013,
(a) is Controlled by ReGenX pursuant to the Existing Licenses or pursuant to
ReGenX’s ownership thereof, and (b) is directed […***…]; provided that,
notwithstanding the scope of the license grant in Section 5.1(a), any rights
granted to Bayer under this Agreement with respect to the […***…] Know-How will
be limited to use of such Know-How in the Field.

 

1.75“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 Sublicensed Patents or Dimension Patents or a claim of a pending patent
application included within the Sublicensed Patents or Dimension Patents, which
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 and, in the case of a pending
application, that has been pending for less than […***…] years from the priority
date of the claim.

 

ARTICLE 2

 

RESEARCH AND DEVELOPMENT PROGRAM

 

2.1Collaboration Overview. Dimension and Bayer shall collaborate for the purpose
of researching and developing, until conclusion of a POC Trial to be conducted
by Dimension of at least one GT Product for use in the Field based initially on
the […***…] vector, which Bayer shall, post POC Trial, have the exclusive right
to further develop, seek Regulatory Approval for, and if successful,
Commercialize in the Territory. To that end, under the oversight of the JSC and
JRDC, Dimension will be responsible for performing those research and
development activities set forth in the Research Plan, and subject to any
limitations set forth in Section 2.5, Bayer shall fund Dimension’s efforts under
the Research Plan in accordance with the Research Budget. Following completion
of the POC Trial, Bayer will be solely responsible, at its own

 

 

 

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cost, for performing all further development and Commercialization activities
for each Licensed GT Product in the Field and in the Territory.

 

2.2Responsibilities of the Parties during the Research Term.

 

2.2.1  During the Research Term and subject to the oversight of the JRDC,
Dimension shall be solely responsible for carrying out the tasks, until
completion of and including the conduct of the POC Trial, as set forth in the
Research Plan. Dimension shall use Commercially Reasonable Efforts in the
performance of its obligations under the Research Plan during the Research Term.
Upon request by Dimension, Bayer shall provide reasonable consulting and
technical support in order to assist Dimension in carrying out its Research
Program obligations. Bayer shall pay the costs and expenses described in the
Research Budget as provided in Section 2.5.

 

2.2.2Notwithstanding the foregoing, (a) to the extent the data from any studies
conducted prior to the conduct of the POC Trial, or the requirements of any
Regulatory Authority, result in the Parties mutually agreeing, through the JSC,
to terminate early the Research Plan (and not to proceed under Section 2.11.2),
or (b) where Dimension, as the holder of the IND, is required by Regulatory
Authorities in the U.S. or E.U. to terminate the further clinical development of
all Licensed GT Products (provided that Dimension has exerted Commercially
Reasonable Efforts to modify the Research Plan (consistent with Section 2.3.2)
to comply with the requirements of Regulatory Authorities), the Parties shall
not proceed under Section 2.11.2, and the Research Term will terminate early and
the Parties will agree to wind up the conduct of the activities under the
Research Plan in an orderly fashion.

 

2.3Research Plan, Research Budget, and Operating Plans.

 

2.3.1Plans. The overall Research Plan is set forth in Exhibit D-1 and the
Research Budget is set forth in Exhibit D-3. Within […***…] after the Effective
Date, or longer as agreed by the Parties, the Parties shall develop and finalize
a detailed operating plan for carrying out the activities set forth in the
Research Plan over the ensuing […***…], which such operating plan shall contain
the description, time-line and portion of the Research Budget covering such
activities (the “Operating Plan”). Such Operating Plan shall be consistent with
the terms of this Agreement, the Research Plan and the Research Budget and shall
be attached hereto as Exhibit D-2 and form a part of this Agreement. In the
event of an inconsistency between the Research Plan, Operating Plan and this
Agreement, the terms of this Agreement will prevail and in the event of an
inconsistency between the Research Plan and an Operating Plan, the terms of the
Research Plan will prevail, unless otherwise agreed in writing by the Parties.

 

2.3.2Amendments and Revisions to Operating Plan and Research Plan. During the
Research Term, (a) Dimension shall provide the JRDC with […***…] written reports
describing the progress made against the goals set forth in the Operating Plan,
and (b) the JRDC shall on a […***…] basis review and update the Operating Plan,
and make necessary amendments (including any increase in the Research Budget)
for the Research Plan activities to be covered in the upcoming […***…],
consistent with Sections 2.3.3, 2.3.4, and 2.3.5. On […***…] basis, the JRDC
shall review and update as needed the then-current Research Plan.

 

 

 

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Any amendments or modifications to the Research Plan and any Operating Plan
shall require the approval of the JRDC (and the JSC, as applicable) and shall be
subject to the applicable terms of this Agreement, and the JRDC shall be
required to formally document updates to the Research Plan and Operating Plan as
part of the agreed upon and accepted minutes of the […***…] meetings of the
JRDC.

 

2.3.3Minor Amendments to the Research Budget. In the course of its […***…]
review of the Operating Plan, either Party may propose to the JRDC amendments to
the then-current annual Research Budget associated with such Operating Plan, to
reflect actual costs or minor changes to the Research Plan, and the terms of
Section 4.1.4 shall apply to any final decision related to such amendment;
provided, however, that if any such proposed amendment to the Research Budget
causes the then-current annual Research Budget to increase by more than […***…],
such amendment to the Research Budget shall require the unanimous approval of
the JSC in accordance with Section 2.3.4.

 

2.3.4Major Amendments to the Research Budget. The Parties agree and acknowledge
that (a) the Research Budget as of the Effective Date represents the good faith
estimate of the Parties as to the costs of the activities set forth in the
Research Plan, and the extent of activities to be included within the Research
Plan itself, (b) subject to Section 2.3.5, such Research Budget is based upon
certain assumptions, including but not limited to regulatory requirements,
pre-clinical testing, manufacturing requirements, and clinical development
activities, as such assumptions are further set forth in Exhibit D-3; and (c)
changes to the Research Plan likely will be required where any material changes
to such assumptions and/or the activities to be conducted under the Research
Plan are agreed upon by the Parties. Accordingly, the Parties agree that any
increase to the Research Budget of more than […***…], shall require the
unanimous approval of the JSC, and that unless and until such approval is
obtained (i) […***…] shall not be obligated to fund any amount over the expense
caps set forth in the then-current agreed upon Research Budget; and (ii) […***…]
shall not be required to undertake any activities that are not funded fully by
the then-current agreed upon Research Budget due to a change in assumptions
underlying such activities and their associated costs, or due to any expansion
of the scope or nature of any such activity.

 

2.3.5Assumptions in the Research Budget. In addition to any amendments to the
Research Budget permitted under Section 2.3.3 or 2.3.4, on […***…] basis through
the JRDC, the Parties shall in good faith review the assumptions in the
then-current Research Budget and make any appropriate adjustments to such
assumptions. Such adjustments by the Parties will at a minimum take into
account: any changes in regulatory requirements that may impact clinical
development activities, including but not limited to, the number of patients and
duration of treatment of the clinical studies set forth in the Research Plan, or
the cost per patient; and any unanticipated issues in manufacturing process
development. The JRDC shall formally document any such updates to the
assumptions in the Research Budget as part of the agreed upon and accepted
minutes of the […***…] meetings of the JRDC, and shall prepare and approve a
revised Research Budget reflecting such agreed upon revised assumptions.

 

2.3.6Uncertainty Regarding Certain Costs. The Parties recognize that,
notwithstanding Sections 2.3.4 and 2.3.5, significant uncertainty exists as of
the Effective Date

 

 

 

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with respect to the good faith estimate and assumptions in the Research Budget
regarding (a) costs associated with clinical process transfer and manufacturing
of clinical supplies by Dimension’s contract manufacturer, and (b) costs for the
conduct of the POC Trial, and the Parties agree to use good faith efforts to
manage and provide for such costs including prompt adjustments to the Research
Budget as necessary once greater clarity regarding such costs is obtained. The
provisions of Section 2.3.4 shall apply if such adjustments result in the
Research Budget increasing by more than […***…].

 

2.4Subcontractors. Dimension may engage any consultant, subcontractor, or other
vendor conducting Dimension’s obligations under the Research Plan (each, a
“Subcontractor”) to perform any work under the Research Program; provided that
all such engagements and any contracts related to such engagements are subject
to prior approval by the JRDC, to the extent not already approved as part of and
named within the Research Plan or any Operating Plan. Such contracts shall
include provisions, including intellectual property provisions, adequate for
Bayer to enjoy the licenses granted hereunder as though Dimension had performed
the contracted work. To facilitate approval by the JRDC, Dimension shall
identify each Subcontractor, the activities proposed to be performed by such
Subcontractor and the budget for such activities. The JRDC in its discretion may
request a copy of the proposed contract with the Subcontractor prior to
approving such contract. Dimension shall be solely responsible for the
management of its permitted Subcontractors. Any agreement with a permitted
Subcontractor pertaining to the Research Program shall be consistent with the
provisions of this Agreement. Dimension shall ensure that no consultant,
subcontractor or other vendor it instructs in connection with the Research Plan
is or has been debarred by the FDA (or other Regulatory Authority outside the
US) pursuant to its authority under Sections 306(a) and (b) of the U.S. Food,
Drug, and Cosmetic Act (21 U.S.C. §335(a) and (b)) (or analogous provisions
outside the US), or is the subject of any investigation or proceeding which may
result in such debarment by the FDA (or other Regulatory Authority in countries
outside the US).

 

2.5Funding of Research.

 

2.5.1Payment to Dimension. […***…] Dimension will estimate the total costs and
expenses expected to be incurred during such […***…] in performing the
activities under the Research Plan, which estimate will be consistent with the
applicable Operating Plan and Research Budget. Dimension will then provide an
invoice to Bayer […***…], which invoice shall be for […***…] costs and expenses
expected to be incurred for such […***…]. Bayer will pay such invoice (an
“Estimated […***…] Payment”) within […***…] of receipt. Within […***…] following
the end of each […***…], Dimension will provide Bayer with a report containing
an account of tasks actually performed and the costs and expenses actually
incurred during such […***…] (the “[…***…] Expense Report”). Such report will
specify in reasonable detail all costs and expenses incurred during such […***…]
and an invoice for such costs and expenses shall accompany the […***…] Expense
Report. Bayer shall pay such invoices within […***…] of their receipt by Bayer.
The foregoing mechanism will be used, with appropriate adjustments, in respect
of calendar year 2014, with the initial estimated total costs and expenses
expected to be incurred during the remainder of 2014, together with invoice,
submitted by Dimension within […***…] of the Effective Date.

 

 

 

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Invoices will be sent to Bayer at the following address:

 

Bayer HealthCare
Pharma West Coast
Attn:  Frederick Roepke
PO Box 416
Pittsburgh PA 15230 USA

 

2.5.2Annual True-Up. Within […***…] of the end of the applicable […***…] the
Parties will reconcile the costs and expenses set forth in […***…] Expense
Reports presented by Dimension in respect of the applicable […***…] (“Total
Actual Expenses”) with the sum of the costs and expenses paid by Bayer in
respect of the first […***…] Expense Reports plus the Estimated […***…] Payment
(“Actual Plus Estimated Expenses”). If the Parties determine that the Actual
Plus Estimated Expenses exceed Total Actual Expenses, then the amount of such
excess will be credited against the amount due by Bayer in respect of the first
[…***…] of the following […***…] (or, if no such payment is anticipated,
refunded by Dimension to Bayer within […***…] of such determination). If the
Parties determine that Total Actual Expenses exceed Actual Plus Estimated
Expenses, but that such actual costs and expenses are nonetheless within […***…]
of the then-current Research Budget for the applicable […***…], then Bayer will
include the excess amount owed to Dimension with the amount due by Bayer in
respect of the first […***…] of the next […***…] (or, if no such payment is
anticipated, paid by Bayer to Dimension upon receipt of an invoice under the
following payment timing terms: if the invoice is received by Bayer at the above
address prior to […***…], then payment shall be made by the […***…] in which the
invoice was received. If the invoice is received by Bayer at the above address
after the […***…], then the payment shall be made by the […***…] in which the
invoice was received).

 

2.5.3Cost Overruns. If the Parties determine that Total Actual Expenses exceed
Actual Plus Estimated Expenses, and such Total Actual Expenses are greater than
[…***…] of the then-current Research Budget for the applicable […***…] (such
excess over such percentage, a “Cost Overrun”), then Bayer shall have no
obligation to pay the Cost Overrun unless Dimension obtains Bayer’s consent. If
consent is provided, Bayer will pay the excess amount to Dimension; provided,
however, if at the conclusion of the Research Plan, the actual amount expended
by Bayer, including the Cost Overruns, is greater than the overall cap set forth
in the then-current Research Budget, Dimension shall reimburse Bayer the amount
of such Cost Overruns in excess of such cap within […***…] of receipt by
Dimension of the next Milestone Payment stated in Section 6.2, if such Milestone
Event is achieved. In addition, Dimension agrees that where it anticipates
during a given […***…] that its actual costs and expenses will likely result in
a Cost Overrun for such […***…], Dimension will give notice promptly to Bayer of
such anticipated Cost Overrun. […***…].

 

2.5.4Expense Records. Dimension shall maintain complete and accurate books,
records and accounts used for the determination of all costs and expenses
incurred in connection with the performance of its obligations under the
Research Plan and in accordance with the Research Budget, in sufficient detail
to confirm the accuracy of any payments required under this Agreement, which
books, records and accounts will be retained by Dimension for

 

 

 

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[…***…] after creation thereof, or longer as is required by applicable Law. Such
books, records and accounts shall be kept in accordance with Dimension’s
then-current accounting procedures. Bayer shall have the right, during normal
business hours and upon reasonable advance notice, to review and copy all such
records maintained by Dimension.

 

2.5.5Currency. All payments made under this Section 2.5 will be payable in US
Dollars.

 

2.6Bayer’s Expenses. Bayer shall be solely responsible for its own costs and
expenses incurred in conducting any activities under the Research Plan or
otherwise in support of the Research Program.

 

2.7   Pre-Clinical and Clinical Supplies. As part of the Research Plan,
Dimension shall be responsible for manufacturing or having manufactured
sufficient supplies of GT Products and any Compounds/Vectors needed in the
conduct of its activities under the Research Plan.

 

2.8Regulatory Matters. Dimension shall be responsible for, and shall compile,
submit and have ownership of, all INDs for any GT Product or component thereof,
necessary in order to conduct its activities under the Research Plan, including
the POC Trial. Dimension shall provide to Bayer a copy of all written
substantive communications from and with any Regulatory Authority involving a
regulatory submission for a GT Product or any Compound/Vector or any other
component thereof sufficiently in advance, where feasible, to enable Bayer to
have a meaningful opportunity to provide input on the content of such submission
and, if requested by Bayer, to participate in scientific advice meetings with
the Regulatory Authority related to the GT Product. Following the conduct of the
POC Trial and a GT Product becoming a Licensed GT Product, Dimension shall
assign and transfer to Bayer, at Bayer’s expense, any and all such INDs. Any
orphan designation for the Licensed GT Product and/or the Field for which
Dimension has filed or intends to file an IND will be in the name of Bayer or
one of its Affiliates.

 

2.9Materials. To facilitate the conduct of the Research Plan activities, either
Party may provide to the other Party, free of charge, certain biological
materials or chemical compounds owned by or licensed to the supplying Party for
use by the other Party (such materials or compounds and any progeny and
derivatives thereof, collectively, “Materials”). All such Materials shall remain
the sole property of the supplying Party, shall be used only in the fulfillment
of obligations or exercise of rights under this Agreement and solely under the
control of the receiving Party, shall not be used or delivered to or for the
benefit of any Third Party without the prior written consent of the supplying
Party, and shall not be used in research or testing involving human subjects,
unless expressly agreed.

 

2.10Research Records and Reports. Dimension shall maintain complete, current and
accurate records and laboratory notebooks of all activities it conducts under
the Research Program, and all data and other information resulting from such
activities. Such records shall reflect all work done and results achieved in the
performance of the Research Program in good scientific manner (including in
accordance with applicable GLP, GMP and GCP, where appropriate in conformance
with the Research Plan) as appropriate for regulatory and patent

 

 

 

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purposes. Bayer shall have the right, during normal business hours and upon
reasonable advance notice, to review and copy all such records maintained by
Dimension and to obtain access to the originals to the extent necessary or
useful for regulatory and patent purposes.

 

2.11Licensed GT Products; Demonstration of Clinical POC.

 

2.11.1Designation. The Parties intend that during the Research Term and under
the Research Plan, Dimension will discover and develop […***…] GT Produc[…***…]
and complete a POC Trial for […***…] GT Product, which […***…] GT Product, upon
completion (successful or not) of such POC Trial, shall be deemed a “Licensed GT
Product” after which point, Bayer’s licenses set forth in Section 5.1 shall
apply, and Bayer shall have sole responsibility for further development,
manufacture and Commercialization of such Licensed GT Product.

 

2.11.2Failure to Achieve POC. In the event […***…] Licensed GT Product is the
subject of a POC Trial, but fails to achieve Demonstration of Clinical POC (as
determined pursuant to Section 2.11.4), at Bayer’s discretion and request, the
Parties shall amend the Research Plan and Research Budget to add activities to
identify and develop […***…] GT Product and conduct a POC Trial for such […***…]
GT Product (the “Backup Product”) and as needed, extend the then-current
Research Term to conduct such activities. Such Backup Product, upon completion
of its POC Trial, shall also become a Licensed GT Product, subject to the
license grants set forth in Section 5.1, and the Parties shall determine if such
Backup Product achieves Demonstration of Clinical POC pursuant to Section
2.11.4.

 

2.11.3Follow On Products. If notwithstanding Demonstration of Clinical POC for
[…***…] Licensed GT Product or […***…] Backup Product, Bayer requests, at any
time prior to Bayer’s submission of the first MAA for a Licensed GT Product,
that an additional GT Product also be identified and made the subject of an
additional POC Trial, the Parties shall discuss in good faith such request, and
if mutually agreed, shall either modify the then-current Research Plan and
Research Budget to include such activities or (if no Research Plain remains in
place) agree a new Research Plan and Research Budget, and […***…], and as
necessary the Parties shall extend the Research Term reinstate a Research Term
to accommodate such activities, and any such additional GT Product as to which
such an additional POC Trial is conducted would be deemed also a Licensed GT
Product and subject to Bayer’s license grants set forth in Section 5.1.

 

2.11.4Determination of Demonstration of Clinical POC. The process for
determining achievement of Demonstration of Clinical POC for a Licensed GT
Product shall be as set forth in this Section 2.11.4. Following completion of
the POC Trial for the Licensed GT Product (or, if applicable, the Backup
Product), Dimension will present the results of such trial, and all other
relevant data, to the JSC and the JSC will act in good faith to apply the
criteria set forth in Exhibit E to such data and results and determine if such
criteria for Demonstration of Clinical POC have been met. If the JSC determines
that such criteria have been met, then Demonstration of Clinical POC will be
deemed to have been achieved and Dimension will invoice Bayer for the applicable
milestone payment as set forth and in accordance with Section 6.2. If the JSC
determines that such criteria in Exhibit E have not been met with respect to the

 

 

 

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initial Licensed GT Product then the Parties may proceed in accordance with
Section 2.11.2. In the event of any disagreement within the JSC on the
application of the criteria set forth in Exhibit E, and/or whether Demonstration
of Clinical POC has been achieved, the Parties shall within […***…] of the
meeting of the JSC in which it was unable to so determine such achievement,
identify and appoint a mutually agreed upon independent industry expert (the
“Expert”). In such case, each Party shall provide the Expert with the relevant
data as well as a briefing document setting forth specific detailed reasons
underlying such Party’s position, and the Expert shall within an additional
[…***…] following his appointment, apply the criteria and make the
determination, in a writing stating his reasons for such position, of whether
Demonstration of Clinical POC has been achieved, which determination shall be
final and binding on the Parties. All costs associated with identifying and
utilizing such Expert shall be borne equally by the Parties. Following a
positive determination by the Expert that Demonstration of Clinical POC has been
achieved, Dimension will invoice Bayer for the applicable milestone payment as
set forth and in accordance with Section 6.2. For the avoidance of doubt, in
determining the achievement of Demonstration of Clinical POC hereunder, either
by the JSC or the Expert, the criteria stated in Exhibit E shall be strictly
applied and shall not be modified in any way. No opinion as to materiality or
relevance of any of the results or data (including their applicability to any
particular patient) shall replace or modify the specific figures and other
criteria expressly stated in Exhibit E. Furthermore, the Expert shall make his
decision based on the data and briefing documents submitted to him. If he is
unable to make a decision without additional information or data, Demonstration
of Clinical POC will be deemed not to have been achieved.

 

2.12Transfer of Technology. Promptly after completion of the POC Trial,
Dimension shall, […***…], conduct all necessary technology transfer (including
Materials) to Bayer as reasonably necessary for Bayer to practice the licenses
granted under Section 5.1 with respect to such Licensed GT Product.

 

2.13Completion of the POC Trial. Wherever used in this Agreement the expression
“completion of the POC Trial” shall occur when data base is locked per protocol,
which means that all CRFs have been entered and audit has cleared all those
entries.

 

ARTICLE 3

 

LATER STAGE DEVELOPMENT AND COMMERCIALIZATION

 

3.1General Responsibilities. Following completion of the POC Trial with respect
to a Licensed GT Product, Bayer shall be solely responsible for (i) the planning
and conduct of all later development of such Licensed GT Product in the Field in
the Territory, (ii) all regulatory submissions and approvals (including all INDs
and MAAs) for such Licensed GT Product and interactions with regulatory
authorities, (iii) the selection of the countries in the Territory in which
Bayer will pursue and maintain Regulatory Approvals, including at a minimum the
U.S. and at least […***…] Major Market Countr[…***…]; and (iv) Commercialization
of such Licensed GT Product in the Territory, all at its sole expense.

 

 

 

 

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3.2Development Activities.

 

3.2.1Bayer’s Efforts. Following completion of the POC Trial with respect to a
Licensed GT Product, Bayer, itself or through one or more Affiliates or
Sublicensees, shall use Commercially Reasonable Efforts to conduct a Pivotal
Trial and such other clinical development activities as are required to obtain
Regulatory Approval in the U.S. and at least […***…] Major Market Countr[…***…]
in the Territory for the Licensed GT Product. Bayer shall ensure that no
consultant, subcontractor or other vendor it instructs in connection with such
development is or has been debarred by the FDA (or other Regulatory Authority
outside the U.S.) pursuant to its authority under Sections 306(a) and (b) of the
U.S. Food, Drug, and Cosmetic Act (21 U.S.C. §335(a) and (b)) (or analogous
provisions outside the U.S.), or is the subject of any investigation or
proceeding which may result in such debarment by the FDA (or other Regulatory
Authority in countries outside the U.S.).

 

3.2.2Regulatory Submissions and Approvals. Bayer shall be solely responsible for
filing for and shall own all Regulatory Approvals and submissions therefor. To
the extent permitted by applicable Laws, Bayer shall permit Dimension to attend
in an observatory capacity only all meetings with Regulatory Authorities in the
U.S., to the extent related to a Licensed GT Product, including, but not limited
to, all in-person meetings and all telephone conferences.

 

3.2.3Updates. Bayer shall update the JSC on its progress in obtaining Regulatory
Approval of the Licensed GT Product, including providing to the JSC in advance
of its meeting a written summary (which may be in presentation style) that
includes sufficient detail for Dimension’s representatives to understand the
activities planned by Bayer and Bayer’s anticipated timelines for performing
such activities, and any material interactions with Regulatory Authorities. In
addition, each Party shall immediately notify the other of any information it
receives regarding any threatened or pending action, inspection or communication
by or from any Third Party, including a Regulatory Authority, that may
materially affect the development, manufacturing, Commercialization or
regulatory status of a Licensed GT Product.

 

3.2.4PV Agreement. If requested by Bayer the Parties will enter into an
Agreement setting forth the specific procedures to be used by the Parties to
coordinate the investigation and exchange of reports of adverse drug experiences
and product complaints with respect to Licensed GT Products to ensure timely
communication to Regulatory Authorities and compliance with Laws.

 

3.3Commercialization.

 

3.3.1Responsibilities. Bayer will have the exclusive right to conduct, and be
solely responsible for, all aspects of the Commercialization of Licensed GT
Products in the Field in the Territory, including: (a) developing and executing
a commercial launch and pre-launch plan, (b) negotiating with applicable
governmental authorities regarding the price and reimbursement status of
Licensed GT Products; (c) marketing and promotion; (d) booking sales and
distribution and performance of related services; (e) handling all aspects of
order processing, invoicing and collection, inventory and receivables; and (f)
providing customer support, including handling medical queries, and performing
other related functions. As between the Parties, Bayer shall bear all of its
costs and expenses incurred in connection with such Commercialization
activities.

 

 

 

 

 

 

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3.3.2Compliance. Bayer shall be responsible for conforming its practices and
procedures to applicable Laws relating to the marketing, detailing and promotion
of Licensed GT Products and/or Licensed Treatments in the Territory.

 

3.4Manufacturing Assistance. From and after completion of the POC Trial, Bayer
shall be responsible for the manufacture of the Licensed GT Products for
clinical or commercial use, including any process development and scale up.
Notwithstanding the foregoing, in sufficient advance of any Phase II/III Trial
by Bayer (including prior to completion of the POC Trial), Dimension and Bayer
shall meet and discuss and, if Bayer considers it appropriate, engage ReGenX and
any other necessary Third Parties for purposes of developing processes necessary
to enable Bayer’s commercial manufacturing of the Licensed GT Product for use in
the Field.

 

ARTICLE 4

 

GOVERNANCE

 

4.1Joint Steering Committee.

 

4.1.1Formation and Dissolution. The JSC shall be formed as soon as possible, but
no later than […***…] following the Effective Date of this Agreement and, unless
otherwise agreed by the Parties, shall dissolve at the time of initial
Regulatory Approval in the U.S., or earlier should Dimension elect to
discontinue the JSC following Demonstration of Clinical POC. The JSC shall be
comprised of […***…] representatives from each Party. If mutually agreed by the
JSC members on a case-by-case basis, the JSC may invite other non-members to
participate in the discussions and meetings of the JSC, provided that such
participants shall have no voting authority at the JSC. Each Party may
substitute its representative from time-to-time effective only upon the consent
of the other Party, not to be unreasonably withheld. The JSC shall have no
permanent chairman.

 

4.1.2Responsibilities. The JSC shall be responsible for overseeing the overall
collaboration established under this Agreement, and to that end, for (i)
creating and maintaining a collaborative work environment within and among the
Parties, and (ii) addressing any disputes as they may arise in the JRDC and
(iii) determining whether Demonstration of Clinical POC has been achieved, and
(iv) unless otherwise specified, serving as the initial point of contact to
resolve any disputes between the Parties. The JSC will have solely the powers
assigned to it in this Article 4 and elsewhere expressly in this Agreement, and
will not have any power to amend, modify, or waive compliance with this
Agreement.

 

4.1.3Meetings. The JSC shall meet in person or by teleconference not less than
[…***…] during the Research Term, and thereafter, once […***…] until
dissolution. Meetings of the JSC shall be alternately hosted by the Parties on
such dates and at such times, places and format (i.e. whether the meeting will
be in person or by teleconference) as agreed to by the members of the JSC;
provided, that at least one meeting in each calendar year during the Research
Term shall be in person. Dimension shall host the first meeting of the JSC at a
mutually agreeable time and place no later than […***…] from the Effective Date
of this

 

 

 

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Agreement. Each Party shall be responsible for all its own expenses relating to
attendance at or participation in JSC meetings. The representatives shall
alternate acting as chairman of each meeting, and in that capacity shall be
responsible for sending out in advance the agenda for any such meeting and
minuting the results of such meeting for review and approval within […***…]
after each JSC meeting. Such minutes shall be deemed approved unless one or more
members of the JSC objects to the accuracy of such minutes within […***…] of
receipt. For the avoidance of doubt, the chairman shall have no casting vote.
Meetings of the JSC shall be effective only if at least one (1) representative
of each Party is present or participating in such meeting.

 

4.1.4Decision-Making. The JSC will strive to reach consensus in all decisions
before it. The representative from each Party will have one (1) vote on behalf
of that Party. The representatives serving on the JSC shall use good faith
efforts to seek consensus in the JSC’s decision making process and to make
decisions that are consistent with the then existing Operating Plan and Research
Plan. In the event such consensus is not obtained within […***…] of the JSC
reviewing and discussing an issue, (a) until completion of the POC Trial
Dimension’s representative shall have final say with respect to any decision
involving any amendment to, or the conduct of any activities under, the Research
Plan, Research Budget, or any Operating Plan; provided that Dimension’s
representatives shall not have the right in the exercise of such final say to
amend, revise or extend the Research Plan or Research Budget in a manner that
(i) changes the primary and secondary endpoints of the POC Trial; (ii) imposes
any material additional obligations on Bayer or (iii) results in any Cost
Overrun or increases the overall Research Budget by more than […***…] of the
then-current Research Budget; and (b) […***…] representative shall have the
final say with respect to any decision involving development activities as
outlined in Section 3.2, or Commercialization as outlined in Section 3.3, or any
manufacture of Licensed GT Products following completion of the POC Trial. For
clarity, the determination of whether Demonstration of Clinical POC has been
achieved for a Licensed GT Product will be in accordance with Section 2.11.4.
Following Demonstration of Clinical POC the JSC will function primarily as an
information exchange forum and the existence of the JSC and Bayer’s
participation therein does not affect any decision-making discretion or right
that Bayer otherwise possesses under this Agreement,

 

4.2Joint Research and Development Committee.

 

4.2.1Formation. The Parties shall form a Joint Research and Development
Committee as soon as possible after the Effective Date, but no later than
[…***…] following the Effective Date of this Agreement. The JRDC shall be
comprised of an equal number of representatives from each Party. If mutually
agreed by all JRDC members, the JRDC may invite non-members (including ReGenX
personnel) to participate in the discussions and meetings of the JRDC, provided
that such participants shall have no voting authority at the JRDC. Each Party
shall notify the other Party in writing of its initial representatives to the
JRDC within […***…] after the Effective Date, and may substitute one or more
representatives from time-to-time effective upon written notice to the other
Party, provided that such representatives are suitably qualified and experienced
for the tasks and responsibilities to be fulfilled. A designated representative
of Dimension will be the chairman of the JRDC, and in such capacity, he/she
shall be responsible for setting the agenda for meetings of the JRDC, with input
from the other

 

 

 

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members, and for conducting the meetings of the JRDC. Except as stated above the
chairman will have no casting vote.

 

4.2.2Responsibilities. The JRDC shall be responsible for oversight of the
conduct of research and development under the Research Plan during the Research
Term. In addition to the foregoing general responsibilities, the JRDC shall in
particular:

 

(a)Review, discuss and approve any proposed Operating Plan or the Research
Budget and timelines in the Research Plan and under each Operating Plan, or
amendments thereto,

 

(b)manage the overall strategy for the research and development of potential
Licensed GT Products under the Research Plan

 

(c)prioritize GT Products for further research and development under the
Research Plan,

 

(d) determine criteria to be set forth in the Research Plan for selection of a
development candidate with respect to a GT Product, and whether such criteria
have been met,

 

(e)make decisions on whether and how to continue activities under the Research
Plan at each decision point set forth in such Research Plan, based on the
then-available data and results and consistent with the criteria set forth in
such Research Plan,

 

(f)oversee Dimension’s efforts to obtain any and all requisite INDs with respect
to any development candidate GT Products,

 

(g)perform such other functions as appropriate to further the purposes of the
Research Program, as expressly set forth in this Agreement or as determined by
the Parties in writing,

 

(h)be responsible for ensuring the submission of clinical trial information by
Dimension, as sponsor, to relevant public databases (e.g. ClinicalTrials.gov)
when legally required and ensuring consistency between all postings. In addition
(and at a minimum), the JRDC will ensure compliance with the requirements of the
latest version of “Joint Position on the Disclosure of Clinical Trial
Information via Clinical Trial Registries and Databases” as defined by IPFMA,
PhRMA, EFPIA, and JAMA will be followed for all trials globally; and

 

(i)agree on a publication strategy based on the Parties’ normal practices and
policies.

 

The JRDC will have solely the powers assigned to it in this Article 4 and
elsewhere expressly in this Agreement, and will not have any power to amend,
modify, or waive compliance with this Agreement.

 

 

 

 

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4.2.3Meetings. The JRDC shall meet at least […***…] per Calendar Quarter, unless
the Parties mutually agree in writing to a different frequency for such
meetings. Either Party may also call a special meeting of the JRDC (by
videoconference or teleconference) by at least […***…] prior written notice to
the other Party in the event such Party reasonably believes that a significant
matter must be addressed prior to the next regularly scheduled meeting, and such
Party shall provide the JRDC, no later than […***…] prior to the special
meeting, with materials reasonably adequate to enable an informed decision. No
later than […***…] prior to any meeting of the JRDC, the chairperson of the JRDC
shall prepare and circulate an agenda for such meeting; provided, however, that
either Party may propose additional topics to be included on such agenda, either
prior to or in the course of such meeting. The JRDC may meet in person, by
videoconference or by teleconference, provided, however, at least […***…] shall
be in person unless the Parties mutually agree in writing to waive such
requirement in lieu of a videoconference or teleconference. In-person JRDC
meetings shall be held at locations alternately selected by Dimension and by
Bayer. Each Party shall bear the expense of its respective JRDC members’
participation in JRDC meetings. Meetings of the JRDC shall be effective only if
at least one (1) representative of each Party is present or participating in
such meeting. The chairperson of the JRDC shall be responsible for preparing
reasonably detailed written minutes of all JRDC meetings that reflect, without
limitation, all material decisions made at such meetings. The JRDC chairperson
shall send draft meeting minutes to each member of the JRDC for review and
approval within […***…] after each JRDC meeting. Such minutes shall be deemed
approved unless one or more members of the JRDC objects to the accuracy of such
minutes within […***…] of receipt.

 

4.2.4Decision-Making. The JRDC will strive to reach consensus in all decisions
before it. The representatives from each Party will have, collectively, one (1)
vote on behalf of that Party. The representatives serving on the JRDC shall use
good faith efforts to seek consensus in the JRDC’s decision making process. In
the event such consensus is not obtained within […***…] of the JRDC reviewing
and discussing an issue, the matter may be referred by either Party to the JSC
for resolution, in which forum Dimension’s representatives shall have the final
say with respect to such decision or dispute; provided that Dimension’s
representatives shall not have the right in the exercise of such final say to
amend, revise or extend the Research Plan in a manner that (i) imposes any
material additional obligations on […***…] or (ii) results in any Cost Overrun.

 

4.2.5Discontinuation of the JRDC. The JRDC shall continue to exist until the
first to occur of (a) expiration of the Research Term, or (b) the Parties
mutually agreeing to disband the JRDC. After the JRDC is disbanded, any
decisions previously within its purview shall be decisions between the Parties,
but governed by the decision making rules set forth in Section 4.2.4 as they
apply to a Party’s representatives on the JRDC.

 

4.3Joint Project Team. Within […***…] following dissolution of the JSC, the
Parties agree to form a joint project team (the “Joint Project Team” or “JPT”).
The JPT’s purpose will be to facilitate the exchange of information with respect
to (a) the commercialization, including reimbursement strategies, regarding the
Licensed GT Product and Licensed Treatment and Dimension’s gene therapy
products, in particular, in the field of Hemophilia B, and (b) the continued
clinical development of the Licensed GT Product post

 

 

 

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Regulatory Approval. The JPT shall meet at least every […***…] either
telephonically or in person, unless the Parties mutually agree in writing to a
different frequency for such meetings. For clarity, the JPT functions primarily
as an information exchange forum and does not affect any decision-making
discretion or right that Bayer otherwise possesses under this Agreement.

 

4.4Alliance Manager. Each of Dimension and Bayer shall appoint a representative
who possesses a general understanding of clinical, regulatory, manufacturing and
marketing issues to act as its Alliance Manager (“Alliance Manager”). Each
Alliance Manager will be responsible for:

 

(a)coordinating the various functional activities of Dimension and Bayer, as
described in this Agreement;

 

(b)providing single-point communication for seeking consensus both within the
respective Party’s organization and with the other Party’s organization
regarding key issues, as appropriate, including facilitating review of external
corporate communications; and

 

(c)identifying and raising cross-Party and/or cross-functional disputes to the
appropriate committee or management in a timely manner.

 

ARTICLE 5

 

LICENSE GRANT; EXCLUSIVITY; NEGOTIATION RIGHTS

 

5.1License Grant. Subject to the terms and conditions of this Agreement,
including the Retained Rights, Dimension hereby grants to Bayer (a) an exclusive
(even as to Dimension), sublicensable (as provided in Section 5.6 only),
non-transferable (except as provided in Section 13.2), royalty-bearing license,
under the Licensed Technology to make, have made, use, administer, monitor,
import, sell, and offer for sale Licensed GT Products and Licensed Treatments,
solely in the Field; and (b) a non-exclusive, sublicensable, non-transferable
(except as provided in Section 13.2), […***…] license under Dimension
Manufacturing Patents to manufacture or have manufactured Licensed GT Product,
Licensed Treatment or any Compound/Vector used therein, solely in the Field.

 

5.2Upstream Retained Rights for Hemophilia A. Notwithstanding the licenses
granted in Section 5.1, Bayer acknowledges and agrees that, ReGenX’s direct and
indirect licensors retain the following rights: to the extent any Sublicensed
Technology pertains to recombinant adeno-associated virus serotype 8, an
exclusive, sublicensable right to make, have made, use, sell, offer for sale,
and import products for the treatment of hemophilia A.

 

5.3Other Retained Rights. Except for the rights and licenses specified in
Section 5.1, no license or other rights are granted to Bayer under any
intellectual property of Dimension or ReGenX, whether by implication, estoppel,
or otherwise, whether, in the case of ReGenX, any such intellectual property
dominates or is dominated by the Licensed Technology. Notwithstanding anything
to the contrary in this Agreement, Dimension may use and permit

 

 

 

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others to use the Licensed Technology for any research, development, commercial,
or other purposes, outside of the Field. Dimension shall use reasonable efforts
and impose conditions on any of its licensees to whom it grants rights outside
the Field to prevent use (intentional or unintentional) of the Licensed
Technology inside the Field. Without limiting the foregoing, and notwithstanding
anything in this Agreement to the contrary, Bayer acknowledges and understands
that ReGenX and its direct and indirect licensors retain the rights under the
Sublicensed Technology set forth in Exhibit C (individually and collectively,
the “Retained Rights”).

 

5.4Regained Rights. The Parties acknowledge that the Retained Rights with
respect to hemophilia A set forth in Section 5.2 are excluded from this
Agreement because of currently existing rights granted by ReGenX to other
licensees or Third Parties. If ReGenX (and subsequently Dimension, pursuant to
the ReGenX Agreement) regains the rights described in Section 5.2, following
Dimension’s receipt of notification from ReGenX of such event, Dimension will
notify Bayer of same, together with a description of the rights granted or
regained, in which case, such rights will no longer be considered Retained
Rights, and the license granted to Bayer under Section 5.1(a) with respect to
Sublicensed Technology will no longer be subject to such Retained Rights.

 

5.5   Government Rights. Bayer acknowledges that, pursuant to Title 35 of the
United States Code, Sections 200-204, the United States government may retain
certain rights in intellectual property contained within the Sublicensed
Technology if it has been funded in whole or part under any contract, grant, or
similar agreement with a federal agency. The license grant hereunder is
expressly subject to any 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 absent, with respect to such manufacturing requirement, a waiver
of such requirement obtained from the applicable governmental agency. At Bayer’s
request Dimension will assist Bayer and provide necessary documentation and
support in order to obtain such a waiver.

 

5.6Sublicensing.

 

5.6.1Right to Sublicense. The licenses granted pursuant to Section 5.1 are
sublicensable (a) by Bayer to any Affiliates without prior consent by Dimension,
or (b) by Bayer to any Third Parties upon Dimension’s prior written consent
(such consent not to be unreasonably withheld); provided that any such
sublicense (to an Affiliate or to a Third Party) must comply with the provisions
of this Section 5.6 (including Section 5.6.2). The use, marketing and sale of
Licensed Treatment by Bayer’s Affiliates shall be deemed to be use, marketing
and sale by Bayer and shall not require a sublicense.

 

5.6.2Conditions. The right to sublicense granted to Bayer under this Agreement
is subject to the following conditions as they relate to sublicenses of the
Sublicensed Technology:

 

(a)Bayer may only grant sublicenses to Third Parties through multiple tiers
pursuant to a written sublicense agreement with the Sublicensee.

 

 

 

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Dimension must receive written notice as soon as practicable following execution
of any such sublicenses with Third Parties.

 

(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 Bayer has
agreed and, in each sublicense agreement with a Third Party, must acknowledge
that ReGenX is an express third party beneficiary of such terms and conditions
under such sublicense agreement; provided that nothing shall prevent Bayer from
granting sublicenses of more limited scope than Bayer’s rights, e.g., in a more
limited territory, field of use, or

 

(c)The official language of any sublicense agreement with a Third Party shall be
English.

 

(d) Within […***…] after entering into a sublicense with a Third Party,
Dimension must receive a copy of the sublicense written in the English language
for Dimension’s records and to share with ReGenX and its licensors under the
Existing Licenses. The copy of the sublicense may be redacted to exclude
confidential information of the applicable Sublicensee or of Bayer to the extent
not relevant to Dimension or ReGenX, but such copy shall not be redacted to the
extent that it impairs Dimension’s (or ReGenX’s or any of its licensors’)
ability to ensure compliance with this Agreement.

 

(e)   With respect to sublicense agreements with Affiliates, Bayer shall notify
/Dimension of the identity of all such Affiliates to which a sublicense is
granted, and upon any request of ReGenX, shall provide to ReGenX a copy of such
sublicense, in English, within […***…], for ReGenX to send GSK and UPenn.

 

(f)Notwithstanding subsections (d) and (e) above, Bayer acknowledges and agrees
that in the event any of ReGenX’s licensors under the Existing Licenses have a
contractual right to require, and do require, a complete, unredacted copy of
Bayer’s sublicense agreement granted under this Section 5.6, then Bayer will
provide such complete, unredacted copy.

 

5.6.3Bayer’s execution of a sublicense agreement will not relieve Bayer of any
of its obligations under this Agreement. Bayer is and shall remain primarily
liable to Dimension for all of Bayer’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 Bayer, and Bayer will
be deemed to be in breach of this Agreement as a result of such act or omission.

 

5.7Bayer’s Improvements.

 

5.7.1Grant Back. Bayer hereby grants to Dimension a non-exclusive, worldwide,
[…***…], transferable, sublicensable, irrevocable, perpetual license:

 

 

 

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(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 any recombinant adeno-associated
virus vectors, including the right to research, develop, make, have made, use,
offer for sale, and sell products and services; provided that, during the term
of this Agreement, Dimension and its sublicensees shall have no right under the
license in this Section 5.7.1(b) to practice the Licensed Back Improvements in
the Field except as necessary to carry out Dimension’s obligations hereunder..

 

5.7.2Notice. Bayer agrees to provide prompt notice to Dimension upon the filing
of any patent application covering any Licensed Back Improvement, together with
a reasonably detailed description of or access to such Licensed Back Improvement
to permit the practice of any such invention or improvement.

 

5.8ReGenX Improvements. Dimension agrees to provide notice to Bayer promptly
following receipt of notice from ReGenX of the filing of any patent application
covering any ReGenX Improvement, together with such description of or access to
such ReGenX Improvement as is received by Dimension from ReGenX to permit the
practice of any such improvement. Upon Dimension’s receipt of notice from ReGenX
of the filing of any patent application covering any ReGenX Improvement,
Sublicensed Patents in Exhibit A attached hereto will be modified to add such
patent application.

 

5.9Covenants Related to ReGenX Agreement. During the term of this Agreement,
without the prior written consent of Bayer Dimension agrees not to exercise its
right to terminate and will not amend the ReGenX Agreement if such termination
or amendment would materially or adversely alter the rights of Bayer under this
Agreement. In addition, Dimension agrees that it shall not agree to any exercise
by ReGenX of its right to terminate the Existing Licenses without first
consulting with and obtaining the consent of, Bayer, except to the extent any
such termination is in part and relates only to Sublicensed Technology uses
outside the Field […***…].

 

5.10Third Party Beneficiary. Bayer agrees and acknowledges that ReGenX is an
express third party beneficiary of the terms and conditions of this Agreement as
they relate to the terms and conditions of the ReGenX Agreement.

 

5.11Exclusivity.

 

5.11.1Dimension. Dimension hereby covenants that Dimension shall not, alone or
in collaboration with a Third Party, (a) during the Research Term conduct
clinical development of, and (b) during the term of this Agreement
Commercialize, […***…], other than the Compounds/Vectors, GT Products and
Licensed GT Products in accordance with the provisions of this Agreement.

 

 

 

 

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5.11.2  Bayer.  Bayer hereby covenants that (a) during the term of this
Agreement, and (b) for a period of […***…] after termination of this Agreement
if terminated by Bayer for convenience pursuant to Section 9.2, Bayer and its
Affiliates, either on their own or in collaboration with a Third Party, shall
not conduct clinical development of or Commercialize […***…], other than the
Licensed GT Products or any Compound/Vector used therein under this

 

5.12Hemophilia B Program.

 

5.12.1Dimension’s Rights. Bayer acknowledges and understands that Dimension
intends to develop and, if successful, Commercialize one or more gene therapy
treatments for hemophilia B utilizing the Sublicensed Technology (the
“Hemophilia B Program”). Subject to Dimension’s obligations under Sections
5.12.2 and 5.12.3, as between the Parties, Dimension shall have all rights, and
be solely responsible for […***…], to (i) pursue any such development or
Commercialization activities with respect to such Hemophilia B Program and any
products arising therefrom, (ii) enter into any licensing, asset sale,
distribution, collaboration or other similar arrangements with any Third Party
with respect to such Hemophilia B Program, or (iii) elect to terminate and not
pursue any such Hemophilia B Program and revert such rights, as and to the
extent required, to ReGenX pursuant to the ReGenX Agreement.

 

5.12.2Right of First Notice. If, during the period commencing on […***…] and
ending on […***…] (“Notice Period”), Dimension elects for the first time to
enter into discussions with a Third Party for rights to develop and
Commercialize (or just to Commercialize) products arising out of its Hemophilia
B Program in any country of the Territory, Dimension shall provide Bayer with
[…***…], and Bayer will have a period of […***…] in which to inform Dimension of
its potential interest in negotiating for such rights (the “Expression of
Interest Notice”). Dimension shall review any such Expression of Interest Notice
[…***…], and […***…]. Nothing in this Section 5.12.2 shall obligate Dimension or
Bayer to enter into any license or other arrangement with respect to the
Hemophilia B Program. For clarity, Dimension’s obligation to provide written
notice to Bayer under this Section 5.12.2 shall only apply […***…].

 

5.12.3Rights Post POC Trial. If, after […***…], Bayer desires to enter into
negotiations with Dimension with respect to obtaining rights to develop and
Commercialize products arising out of its Hemophilia B Program in any country of
the Territory, it shall have the one-time right to so notify Dimension in
writing, and upon receipt of such notice Dimension shall, within […***…], notify
Bayer in writing whether and to what extent Dimension still retains such rights
to the Hemophilia B Program in the Territory (the “Availability Notice”), and
upon receipt of such Availability Notice, Bayer may elect to deliver to
Dimension, within […***…], a notice of its interest in entering into
negotiations with Dimension for a license to such then-remaining rights held by
Dimension (the “Negotiation Notice”). Upon receipt of such Negotiation Notice,
Dimension and Bayer shall negotiate in good faith the terms of such a potential
license agreement for such then-remaining rights, for a period of […***…] (or
longer or fewer, to the extent the Parties agree to extend or terminate such
discussions mutually) a term sheet or letter of intent with the level of detail
similar to that of the term sheet exchanged between the Parties with respect to
this Agreement and the Licensed GT Products, and

 

 

 

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Dimension shall not enter into any license or other arrangement with a Third
Party for such rights until the lapse of such […***…] period. Nothing in this
Section 5.12.3 shall obligate Dimension or Bayer to enter into any license or
other arrangement with respect to the Hemophilia B Program.

 

5.12.4Consultation. Without limiting Sections 5.12.2 and 5.12.3, the Parties
agree to consult with one another within the JSC and the JPT, and to the extent
they determine, each in its sole discretion and to the extent allowed by
applicable Law, that coordinating and communicating to one another with respect
to their development, regulatory and Commercialization activities in the Field
and in the field of hemophilia B gene therapy treatments, would be likely to
have a positive impact on the advancement of the regulatory pathway and
Commercialization of gene therapy treatments for hemophilia generally.

 

ARTICLE 6

 

CONSIDERATION

 

6.1License Fee. In consideration of the licenses granted to Bayer under Section
5.1, Bayer shall pay to Dimension a non-refundable, non-creditable license fee
of Twenty Million Dollars ($20,000,000) within […***…] of receipt of an invoice
therefor, which such invoice may be delivered to Bayer on or after the Effective
Date.

 

6.2Development and Commercial Milestone Payments. Bayer shall make the following
one-time development milestone payments to Dimension in connection with the
first achievement by Bayer or its Affiliates or Sublicensees of the following
development and commercial events. Bayer shall pay to Dimension the applicable
amount within […***…] of receipt of an invoice issued no earlier than the date
of such achievement. Dimension shall provide written notice to Bayer of the
occurrence of any of the […***…] milestones set forth below, and Bayer shall
provide written notice to Dimension of the occurrence of any of the […***…]
milestones, in each case no later than […***…] following the occurrence of the
relevant milestone. The […***…] milestone, “[…***…],” shall be determined as set
forth in Section 2.11.4.

 

No.

 

Development Milestone Event

 

Milestone Payment

 

1

 

[…***…]

 

[…***…]

 

2

 

[…***…]

 

[…***…]

 

3

 

[…***…]

 

[…***…]

 

4

 

[…***…]

 

[…***…]

 

5

 

[…***…]

 

[…***…]

 

6

 

[…***…]

 

[…***…]

 

7

 

[…***…]

 

[…***…]

 

8

 

[…***…]

 

[…***…]

 

 

 

Total

 

[…***…]

 

 

 

†

The specific required criteria known as “D4” are, as of the Effective Date, set
forth in that certain email communication from Bayer to Dimension dated April
30, 2014.

 

 

 

 

 

 

 

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Each milestone payment is payable […***…], regardless of the number of times the
corresponding event is achieved by a Licensed GT Product and/or Licensed
Treatment and regardless of the number of Licensed GT Products and/or Licensed
Treatments to achieve such event. Under no circumstances shall Bayer be
obligated to pay Dimension more than […***…] pursuant to this Section 6.2.

 

For the avoidance of doubt, the Parties acknowledge and agree that, (a) with
respect to Milestone […***…] above, in the event that some but not all of the
criteria for […***…] are met for a Licensed Product and/or Licensed Treatment,
such that there is no current achievement of […***…] as defined, then to the
extent the subsequent milestone event (i.e., Milestone […***…]) is achieved at a
later date for such Licensed Product and/or Licensed Treatment, […***…] shall be
deemed to have occurred at such later date and the corresponding milestone
payments for both Milestone […***…] and Milestone […***…] shall be paid
together; and (b) if the […***…], then all development milestone events relating
to […***…] shall be deemed to have been met. To that end, if for any reason, any
such related milestone payments have not been made, such milestone payments
shall be due and owing upon […***…]. For example: if […***…] and any of
Milestone Events […***…] or […***…] have not been paid for any reason, all such
unpaid milestones shall be paid together with the payment of the milestone
payment for the achievement of development Milestone Event […***…].

 

6.3Sales Milestones. Bayer shall make the following one-time sales milestone
payments to Dimension when the aggregate annual Net Sales of all Licensed
Treatments in all countries in the Territory by Bayer and its Affiliates and
Sublicensees in a calendar year first reach the amount specified below. Bayer
shall pay to Dimension such amount within […***…] following receipt of an
invoice issued no earlier than the date of Bayer’s notice of such achievement.
Bayer shall provide written notice to Dimension within […***…] in which such
event is achieved for the first time.

 

Sales Milestone Event

 

Milestone Payment

 

[…***…]

 

[…***…]

 

[…***…]

 

[…***…]

 

[…***…]

 

[…***…]

 

Total

 

[…***…]

 

 

Under no circumstances shall Bayer be obligated to pay Dimension more than
[…***…] pursuant to this Section 6.3. For the avoidance of doubt, more than one
of the foregoing milestones with respect to the relevant aggregate Net Sales may
occur in any given calendar year. For illustrative purposes only, […***…].

 

 

 

 

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6.4Royalties.

 

6.4.1Royalty Rates. Bayer shall pay to Dimension during the Royalty Term
royalties on aggregate annual Net Sales of all Licensed Treatments in the Field
in the Territory, as calculated by multiplying the applicable royalty rate below
by the corresponding amount of incremental Net Sales of all such Licensed
Treatments in the Territory in each calendar year:

 

Aggregate Annual Net Sales

 

Royalty Percentage

 

[…***…]

 

[…***…]

%

[…***…]

 

[…***…]

%

[…***…]

 

[…***…]

%

 

6.4.2Royalty Term. Bayer’s obligation hereunder for payment of a royalty under
this Section 6.4 on the Net Sales of Licensed Treatments in a given country will
commence on the First Commercial Sale of such Licensed Treatment, and end on a
Licensed Treatment-by-Licensed Treatment and country-by-country basis upon the
later to occur of: (a) the date when […***…] (b) […***…] from the date of First
Commercial Sale of the Licensed Treatment (the “Royalty Term”).

 

6.4.3Biosimilar Treatment. Upon entry of one or more Biosimilar Treatments in a
country in the Territory, and where the total number of patients in such country
receiving Biosimilar Treatments as their initial treatment reaches, in […***…],
a market share of […***…] or greater of the total number of patients in such
country receiving as their initial treatment, either Licensed Treatment or a
Biosimilar Treatment (the “Biosimilar Market Trigger Event”), the Net Sales of
Licensed Treatments in such country shall be reduced […***…] before including
same into total Net Sales in all countries in the Territory for the purpose of
calculating the applicable royalty rates set forth in this Section 6.4. It is
expressly understood and agreed, however, that (a) no such deduction to Net
Sales shall apply to a Licensed Treatment (or its associated Licensed Treatment
Monitoring Sales) to the extent the Licensed Treatment Administration Sale of
such Licensed Treatment in such country occurred […***…], and (b) such reduction
shall cease in the event the foregoing […***…] or greater market share condition
is no longer satisfied in such country. All such determinations of patients
shall be based upon a mutually acceptable calculation method using market share
data provided by a reputable and mutually agreed upon provider, such as IMS
Health, or similar data provider in countries where IMS Health is not operating.

 

6.4.4Royalty Stacking. If Bayer reasonably determines in good faith that it is
necessary to obtain either (i) a license from one or more Third Parties to make,
have made, use, sell, offer to sell and/or import Licensed GT Products in the
Field in one or more countries in the Territory, which such license is for a
patent reasonably believed by Bayer to dominate one or more claims of Licensed
Patents in existence as of the Effective Date and covering the Licensed GT
Product, or (ii) a license under one or more process patents to make or have
made the Licensed GT Product, and where, but for such license, Bayer would not
be lawfully able to manufacture the Licensed GT Product, then in either or both
cases, the amount of Bayer’s royalty payments under Section 6.4 with respect to
Net Sales for such Licensed GT Product for a given period shall be reduced by
[…***…] of the amount of the payments paid under such other license(s) for that
same period; provided that such Third Party payments are attributable to sales
made by Bayer or its Affiliates or Sublicensees that are used in the calculation
of Net Sales on

 

 

 

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which Bayer’s royalty payment obligation to Dimension is based. Notwithstanding
the foregoing, the adjustment of royalties under this Section 6.4.4 will in no
event reduce the royalty rate to less than […***…] of the applicable rate set
forth in Section 6.4.1.

 

6.4.5ReGenX Obligations. […***…] shall be responsible for any and all payments
owed to ReGenX pursuant to the ReGenX Agreement.

 

6.5Reports and Records.

 

6.5.1Bayer must deliver to Dimension within […***…] after the end of each
[…***…] after the First Commercial Sale of a Licensed Treatment a report setting
forth the calculation of the royalties due to Dimension for such […***…],
including:

 

(a)Number of Licensed Treatments included within Net Sales, listed by

 

(b) Licensed Treatment Sales and Net Sales of Licensed Treatments listed by
country;

 

(c)Royalties owed to Dimension, listed by category.

 

6.5.2Upon receipt of an invoice, Bayer shall pay the royalties due under Section
6.4. If invoices are received by Bayer at the below address by […***…], then
payments shall be made by the […***…]. If invoices are received by Bayer at the
below address after […***…], then payments shall be made by […***…].

 

6.5.3Bayer 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 (a) […***…] with respect to Bayer and its Sublicensees, and
(b) […***…] with respect to Bayer’s Affiliates, in each case after the
submission of each report under Article 6. No more frequently than once during
each calendar year during the term of this Agreement and the […***…] period
thereafter, Bayer will permit Dimension’s (or as applicable, ReGenX’s or its
licensors under the Existing Licenses) auditors from any auditing firm to which
Bayer has no reasonable objection, and with at least […***…] advance notice at
any time during normal business hours, accompanied at all times, to inspect,
audit and copy reasonable amounts of relevant accounts and records of Bayer and
its Affiliates and reports submitted to Bayer and its Affiliates from
Sublicensees, for the sole purpose of verifying the accuracy of the calculation
of payments to Dimension pursuant to this Section 6.5. The accounts, records and
reports related to any particular period of time may only be audited one time
under this Section 6.5. Dimension will cause its auditors not to provide
Dimension with any copies of such accounts, records or reports and not to
disclose to Dimension any information other than information relating solely to
the accuracy of the accounting and payments made by Bayer pursuant to this
Section. Dimension will cause its auditors to promptly provide a copy of their
report to Bayer. If such audit determines that payments are due to Dimension,
Bayer will, following receipt of an invoice, pay to Dimension any such
additional amounts within […***…] after the date on which such

 

 

 

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auditor’s written report is delivered to Bayer and Dimension, unless such audit
report is disputed by Bayer, in which case the dispute will be resolved in
accordance with Section 13.6. If such audit determines that Bayer has overpaid
any amounts to Dimension, Dimension will refund any such overpaid amounts to
Bayer within […***…] after the date on which such auditor’s written report is
delivered to Bayer and Dimension. Any such inspection of records will be at
Dimension’s expense unless such audit discloses a deficiency in the payments
made by Bayer (whether for itself or on behalf of its Affiliates) of more than
[…***…] of the aggregate amount payable for the relevant period, in which case
Bayer will bear the cost of such audit. Notwithstanding anything to the contrary
in and without limiting the foregoing, Bayer acknowledges and agrees that it may
also be subject to the separate access or audit rights of ReGenX’s licensors in
accordance with the terms of the Existing Licenses, and if such a licensor
exercises such access or audit rights, the provisions of Section 3.5.4 of the
ReGenX Agreement will govern, unless such licensor otherwise consents to
applying the provisions of this Section 6.5.3. Dimension acknowledges the
disruption and effort required to provide information to be disclosed during an
audit, and Dimension shall endeavor to avoid multiple audits covering the same
audit period. Without prejudice to the foregoing, Dimension shall not conduct an
audit of any period for which ReGenX or any of the licensors under the Existing
Licenses have already conducted an audit or have given notice that they intend
to conduct such an audit. In addition, Dimension shall enforce any rights it has
under the ReGenX Agreement to limit the scope of any audit that might be
demanded pursuant to the ReGenX Agreement.

 

6.6Payment Currency, Interest.

 

6.6.1Payment Address. All invoices shall be sent to the following address:

 

Bayer HealthCare 
Pharma West Coast 
Attn:  […***…] 
PO Box 416 
Pittsburgh PA 15230 
USA

 

6.6.2Payments made by Wire Transfer. All payments made to Dimension under the
Agreement shall be made by wire transfer to the following bank account, or such
other bank account as notified by Dimension to Bayer from time to time:

 

Domestic Wire Transfer (originating in the U.S.):

[…***…]

[…***…]

[…***…]

[…***…]

[…***…]

 

International Wire Transfer:

[…***…]

[…***…]

 

 

 

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[…***…]

[…***…]

[…***…]

[…***…]

 

6.6.3All dollar amounts referred to in this Agreement are expressed in United
States dollars. All payments to Dimension under this Agreement must be made in
United States dollars.

 

6.6.4Net Sales made in currencies other than USD will be converted into USD
using the average exchange rate for the applicable […***…] as for Bayer’s
internal accounting and reporting process consistently applied, which in any
event shall comply with 1FRS.

 

6.6.5Any payments due under the Agreement shall be due on such date as specified
in the Agreement. Any failure by Bayer to make a payment by the date when due
shall obligate Bayer to pay interest on the due payment to Dimension. The
interest period shall commence on the due date (inclusive) and end on the
payment date (exclusive). Interest shall be calculated based on the actual
number of days in the interest period divided by 360. The interest rate shall be
equal to […***…], plus a premium of one percentage point, or shall be equal to
an interest rate according to local legal provisions, whatever is lower.

 

6.6.6All payments by Bayer to Dimension for funding of the Research Program are
as set forth in and will be in accordance with Section 2.5.

 

6.7Withholding Tax. The Parties agree to cooperate with one another and use
reasonable efforts to reduce or eliminate tax withholding or similar obligations
in respect of royalties, milestone payments, and other payments made by Bayer to
Dimension under this Agreement. Any Party required to make a payment under this
Agreement shall be entitled to deduct and withhold from the amount payable the
tax for which the paying Party is liable under any provision of applicable tax
law. No deduction shall be made or a reduced amount shall be deducted if the
paying Party is timely furnished by payee with all documents required for the
application of a zero or reduced rate according to the respective Double
Taxation Treaty. Any withheld tax shall be treated as having been paid by paying
Party to payee for all purposes of this Agreement, provided that each Party
shall provide the other with reasonable assistance to enable the recovery, as
permitted by applicable Laws, of such withholding taxes, such recovery to be for
the benefit of the Party bearing such withholding tax. Paying Party shall timely
forward the tax receipts certifying the payments of withholding tax on behalf of
payee. Any assignment of this Agreement by paying Party which causes a higher
withholding tax rate than would be applicable without the assignment shall be
borne by paying Party. If paying Party failed to deduct withholding tax but is
still required by applicable tax law to pay withholding tax on account of payee
to the tax authorities, payee shall assist paying Party with regard to all
procedures required in order to obtain reimbursement by tax authorities or, in
case tax authorities will not reimburse withholding tax to paying Party, payee
will immediately refund the tax amount.

 

6.8Value Added Tax. All agreed consideration is exclusive of Value Added Tax
(“VAT”). VAT applies and shall be invoiced additionally according to the
applicable VAT law

 

 

 

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and shall be paid to Dimension, if payable by Dimension to the respective tax
authority and after receipt of a correct invoice in accordance with the
applicable VAT law.

 

ARTICLE 7

 

DILIGENCE

 

7.1Diligence Obligations. Bayer will use Commercially Reasonable Efforts to
develop, Commercialize, market, promote, and sell at least one Licensed GT
Product or Licensed Treatment in the Field in the US and the Major Market
Countries.

 

7.2Development Plans. The Parties acknowledge that pursuant to the ReGenX
Agreement, Dimension is required to provide ReGenX with a development plan and
budget covering the […***…] of development activities with respect to the
Licensed GT Product and Licensed Treatment, and to provide […***…] updates to
such development plan and budget. Bayer agrees to cooperate with Dimension in
the provision of information in meeting Dimension’s obligation under the ReGenX
Agreement, and such cooperation may include sharing a copy of the Research Plan
(or portions thereof) with ReGenX, answering follow up questions ReGenX may
have, or providing certain information regarding the later stage clinical
development and regulatory activities by Bayer and its Affiliates and
Sublicensees following the POC Trial.

 

7.3Development Reporting. Within […***…] of […***…] during the term of this
Agreement, Bayer shall provide Dimension with written progress reports through
the JSC and JPT, setting forth in reasonable detail the progress of the
development, evaluation, testing, and commercialization of each Licensed GT
Product and Licensed Treatment. Bayer will also notify Dimension within […***…]
of the First Commercial Sale by Bayer, its Affiliates, or any Sublicensees of
each Licensed Treatment. Such a report (“Development Progress Report”), setting
forth the current stage of development of Licensed GT Products, shall include:

 

7.3.1Date of Development Progress Report and time covered by such report;

 

7.3.2Major activities and accomplishments completed by Bayer, its Affiliates,
and any Sublicensees relating directly to the Licensed GT Product since the last
Development Progress Report;

 

7.3.3Significant research and development projects relating directly to the
Licensed GT Product currently being performed by Bayer, its Affiliates, and any
Sublicensees and projected dates of completion;

 

7.3.4Development activities anticipated for the next […***…];

 

7.3.5Projected total development remaining before product launch of each
Licensed Treatment; and

 

 

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7.3.6Summary of significant development efforts using the Sublicensed Technology
being performed by Third Parties, including the nature of the relationship
between Bayer and such Third Parties.

 

7.4Confidential Information. The Parties agree that Development Progress Reports
shall be deemed Bayer’s Confidential Information; provided that Dimension may
share a copy of such reports with ReGenX and with ReGenX’s licensors under the
Existing Licenses, subject to obligations of confidentiality.

 

7.5Improvements. Simultaneously with the Development Progress Report, Bayer
shall deliver a detailed description of any Licensed Back Improvements, if not
previously provided.

 

ARTICLE 8

 

CONFIDENTIALITY

 

8.1Treatment 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) 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 be under
confidentiality agreements with provisions at least as stringent as those
contained in this Agreement; and (c) 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 of the other Party are obligated in writing to abide by
confidentiality obligations at least as stringent as those contained under this
Agreement. Dimension shall also maintain Licensed Know-How as confidential to
the extent that it relates solely to the Field, subject to the provisions of
this Article 8.

 

8.2Public Announcements.

 

8.2.1The Parties agree they will each issue a press release in a form as
outlined in Exhibit F and at such time as is agreed upon by the Parties. Except
as provided in Section 8.2.3, Section 8.3 and Section 8.4, any other 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.

 

8.2.2After release of such agreed upon press release, if either Party desires to
make a public announcement concerning the material terms of this Agreement or
any activities hereunder, such Party shall give reasonable prior advance notice
of the proposed text of such announcement to the other Party for its prior
review and approval (except as otherwise provided herein), which approval shall
not be unreasonably withheld or delayed, except that in the case of a press
release or governmental filing determined by such Party, based on advice of
counsel, to be required by law, the disclosing Party shall provide the other
Party with such advance notice as it reasonably can and shall not be required to
obtain approval therefor. Neither Party shall be

 

 

 

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required to seek the permission of the other Party to repeat any information
that has already been publicly disclosed by such Party, or by the other Party,
in accordance with this Section 8.2, provided such information remains accurate
as of such time.

 

8.2.3The Parties acknowledge that either or both Parties may be obligated to
file under applicable Laws a copy of this Agreement with the U.S. Securities and
Exchange Commission or other governmental authorities both in the US and
elsewhere. Each Party shall be entitled to make such a required filing, provided
that it requests confidential treatment of the confidential commercial terms and
sensitive technical terms hereof and thereof to the extent such confidential
treatment is reasonably available to such Party. In the event of any such
filing, each Party will provide the other Party with a copy of this Agreement
marked to show provisions for which such Party intends to seek confidential
treatment and shall reasonably consider and incorporate the other Party’s
reasonable comments thereon to the extent consistent with the legal
requirements, with respect to the filing Party, governing disclosure of material
agreements and material information that must be publicly filed.

 

8.3Authorized Disclosure. Notwithstanding the provisions of Section 8.1 or 8.2,
either Party may disclose Confidential Information of the other Party, or make
such a disclosure of the existence of and/or terms of this Agreement:

 

8.3.1to any Affiliates, legal advisors, accountants, and, in each case whether
actual or bona fide potential, to collaboration partners (such as CMOs, CROs and
other vendors providing services relating to the subject matter of the
Agreement), licensees, acquirers, investors, lenders, and other potential
financing sources; 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.

 

8.3.2if such disclosure is reasonably necessary (i) for filing or prosecuting
Patent Rights as contemplated by this Agreement; (ii) to comply with the
requirements of regulatory authorities with respect to obtaining and maintaining
Regulatory Approval of a Licensed GT Product or Licensed Treatment; or (iii) for
prosecuting or defending litigation;

 

8.3.3such disclosure is reasonably necessary or desirable to comply with
applicable Laws, including regulations promulgated by applicable security
exchanges, court order, administrative subpoena or order;

 

8.3.4in connection with Bayer’s development, manufacture or Commercialization of
the Licensed GT Products or Licensed Treatment in the Field in the Territory,
including, without limitation, to existing or potential distributors, service
providers, Sublicensees, Affiliates, or collaboration partners, contractors or
investigators, under substantially the same confidentiality obligations as are
set forth herein, except that the confidentiality obligations shall have a term
of at least […***…]; or

 

8.3.5such disclosure is to ReGenX and its licensors solely as required under the
terms of, and subject to, the ReGenX Agreement, and under the condition that
ReGenX does not

 

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disclose Confidential Information to others (except as may be required under the
Existing Licenses).

 

8.4Compelled Disclosure. 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 to disclose the
Confidential Information of the Disclosing Party or the existence of or terms of
this Agreement to any governmental authority, 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 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 to disclose the existence of or
terms of this Agreement or other Confidential Information of the Disclosing
Party, 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.

 

8.5Term of Confidentiality. The obligations of this Article 8 shall continue for
a period of […***…] following the expiration or termination of this Agreement.

 

ARTICLE 9

 

TERM AND TERMINATION

 

9.1Term of Agreement. This Agreement, unless sooner terminated as provided in
this Agreement, expires upon the expiration of the Royalty Term. Upon expiration
of this Agreement (but not early termination), (a) Bayer’s license to Licensed
Know-How under Section 5.1 will become non-exclusive, perpetual, irrevocable,
[…***…] with respect to the Dimension Know-How and Sublicensed Know-How,
provided that with respect to Sublicensed Know-How such license will remain
limited to the Field and subject to the Retained Rights, and (b) Bayer’s license
to Dimension Manufacturing Patents under Section 5.1(b) will become perpetual.

 

9.2Bayer’s Right to Terminate for Convenience. At any time Bayer may, upon
[…***…] prior written notice to Dimension, terminate this Agreement for any
reason. In exercising such termination right, Bayer may terminate the Agreement
in its entirety or, if desired, Bayer may specify in the written notice that
this Agreement is terminating only with respect to one or more country within
the Territory; provided, however, that, should Bayer terminate with respect to
both the U.S. and all Major Market Countries, this Agreement will terminate in
its entirely unless otherwise agreed by the Parties.

 

9.3Bayer’s Right to Terminate for Safety. In the event that, following the POC
Trial, Bayer makes a good faith determination in accordance with its standard
practices and procedures for such determinations that there is a material safety
issue with respect to the Licensed GT Product in the Field in the Territory
Bayer may terminate this Agreement upon […***…] notice.

 

 

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9.4Bayer’s Right to Terminate for Failure to achieve Demonstration of Clinical
POC. If the initial Licensed GT Product or the Backup Product fails to achieve
Demonstration of Clinical POC Bayer may, within […***…] of being notified of
such failure, upon […***…] notice, terminate this Agreement.

 

9.5Termination for Breach. Dimension may terminate this Agreement if Bayer is
late in paying to Dimension any milestones or royalties, fees or any other
monies due under this Agreement, and Bayer does not pay Dimension in full within
[…***…] upon written demand from Dimension, which termination shall be effective
immediately upon the expiration of such […***…] cure period, provided that no
demand will be issued prior to expiration of the due date for payment, and
provided further that Bayer is not disputing on a bona fide basis that a payment
is due. Either Party may terminate this Agreement, if the other Party materially
breaches (other than nonpayment) this Agreement and does not cure such material
breach within […***…] after written notice of the breach, which termination
shall be effective immediately upon the expiration of such […***…] cure period.
Notwithstanding the foregoing, if the default is not reasonably capable of being
cured within the […***…] cure period by the defaulting Party and such defaulting
Party is making a good faith effort to cure such default, the cure period shall
be extended by no more than […***…]. Bayer acknowledges and understands that:
(a) in the event the nature of a breach by Bayer causes Dimension (as a
sublicensor hereunder) to be in breach of the ReGenX Agreement, the applicable
cure periods as set forth in the ReGenX Agreement are shorter than those set
forth in this Section 9.5; and further, (b) with respect to such breach by Bayer
described in (a), Dimension shall not be responsible for any termination by
ReGenX through exercise of ReGenX’s termination right under the ReGenX
Agreement, where such termination occurs prior to the […***…] cure period given
to Bayer above. For the avoidance of doubt, Bayer shall not be liable or
otherwise responsible to Dimension for any loss, costs, expenses, damages or
liability of any kind arising from a breach or termination of the ReGenX
Agreement attributable to Bayer’s exercise of its rights under this Agreement.
The right of either Party to terminate this Agreement as herein above provided
shall not be affected in any way by its waiver of, or failure to take action
with respect to, any previous default.

 

9.6Patent Challenge. Dimension may terminate this Agreement if Bayer or any of
its Affiliates institutes a Patent Challenge. Such termination will be effective
[…***…] after written notice from Dimension to Bayer unless within such […***…]
Bayer or its Affiliates causes such Patent Challenge to terminate. “Patent
Challenge” means […***…].

 

9.7Termination for Insolvency.

 

9.7.1Dimension may terminate this Agreement, effective immediately upon written
notice to Bayer, if Bayer or any of its Controlling Affiliates experiences any
Trigger Event.

 

9.7.2Bayer shall include in each sublicense agreement entered into with a
Sublicensee a right of Bayer to terminate such sublicense agreement if such
Sublicensee experiences any event corresponding to a Trigger Event; and Bayer
shall terminate the sublicense agreement, effective immediately upon written
notice to the Sublicensee, if the Sublicensee experiences any such event.

 

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9.7.3For purposes of this Section 9.7, “Trigger Event” means any of the
following (provided they are not for purposes of reorganization): (a) if Bayer
(i) becomes insolvent, becomes bankrupt, or generally fails to pay its debts as
such debts become due, (ii) is adjudicated insolvent or bankrupt, (iii) admits
in writing its inability to pay its debts, (iv) suffers the appointment of a
custodian, receiver, or trustee for it or its property and, if appointed without
its consent, is not discharged within […***…], (v) makes an assignment for the
benefit of creditors, or (vi) suffers proceedings being instituted against it
under any law related to bankruptcy, insolvency, liquidation, or the
reorganization, readjustment, or release of debtors and, if contested by it, not
dismissed or stayed within […***…]; or (b) the calling by Bayer of a meeting of
its creditors with a view to arranging a composition or adjustment of its debts.
Bayer acknowledges and understands that: (1) the timing periods in (iv) and (vi)
above differ from those set forth in the definition of “Trigger Event” in
Section 6.4.3 of the ReGenX Agreement, which are […***…] and […***…],
respectively, and (2) in the event such difference causes Dimension (as a
sublicensor hereunder) to be in breach of the ReGenX Agreement, Dimension shall
not be responsible for any termination by ReGenX through exercise of ReGenX’s
termination right under the ReGenX Agreement, where the termination is due to
such difference. Bayer shall not be liable or otherwise responsible to Dimension
for any loss, costs, expenses, damages or liability of any kind arising from a
breach or termination of the ReGenX Agreement due to such difference or
otherwise attributable to Bayer’s exercise of its rights under this Agreement.

 

9.8Applicability of Section 365(n) of the Bankruptcy Code. In the event either
Party becomes a debtor under Title 11 of the U.S. Code, this Agreement shall be
deemed to be, for purposes of Section 365(n) of Title 11, a license to
“Intellectual Property” as defined therein and the other Party and its
Affiliates, and each of their successors and assigns as licensees shall have the
rights and elections as specified in Section 365(n) of Title 11 of the U.S.
Code. Without limiting the foregoing, upon termination of this Agreement by a
trustee or executor of either Party which has rejected this Agreement pursuant
to any non-contractual rights afforded to it by applicable bankruptcy law and/or
a U.S. or foreign bankruptcy court or other tribunal of competent jurisdiction,
all rights and licenses herein granted to the other Party shall nonetheless
continue in full force and effect in accordance with the terms of this
Agreement.

 

9.9Effects of Termination. The effect of termination by Bayer pursuant to
Sections 9.2, 9.3, or 9.4 and by either Party, as applicable, under Sections 9.5
or 9.7, or by Dimension pursuant to Section 9.6 shall be as follows:

 

9.9.1The licenses and sublicenses granted by Dimension hereunder shall
terminate, and Bayer, its Affiliates, and (unless the sublicense agreement is
assigned pursuant to Section 9.9.2) all Sublicensees shall cease to make, have
made, use, import, sell, and offer for sale all Licensed GT Products and shall
cease to otherwise practice the Licensed Technology; provided that Bayer, its
Affiliates, and Sublicensees, shall have the right to continue to sell their
existing inventories of Licensed GT Products for a period not to exceed […***…]
after the effective date of such termination, and provided also that Bayer, its
Affiliates and Sublicensees shall have the right to continue to supply Licensed
GT Products or support any Licensed Treatment to the extent required by any
Regulatory Authority, but in each case subject to any payment obligations to
Dimension under Article 6;

 

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9.9.2Bayer shall have the right to assign to Dimension any or all sublicenses
granted to Third Parties to the extent of the rights licensed to Bayer hereunder
and sublicensed to the Sublicensee; provided that (i) prior to such assignment,
Bayer shall advise Dimension 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, Dimension may elect not to have such sublicense assigned;
and (ii) such assignment shall be subject to Dimension not being liable to such
Sublicensee with respect to any obligations of Bayer to the Sublicensee that are
not consistent with, or not required by, Dimension’s obligations to Bayer under
this Agreement; and all sublicenses not requested to be assigned to Dimension
shall terminate;

 

9.9.3If termination is by Bayer pursuant to Section 9.2, 9.3 or 9.4, or by
Dimension pursuant to Section 9.5, 9.6, or 9.7:

 

(a)if, at the time of such termination, there are any ongoing clinical trials
with respect to Licensed GT Products in the Field, the Parties shall, at
Dimension’s option, negotiate in good faith and adopt a plan to wind-down such
trial activities in an orderly fashion or, at Dimension’s election, promptly
transition such development activities to Dimension or its designee, with due
regard for patient safety and the rights of any subjects that are participants
in any clinical trials of the Licensed GT Products and take any actions
Dimension deems reasonably necessary or appropriate to avoid any human health or
safety problems and in compliance with all applicable Laws; and

 

(b)Bayer shall grant, and hereby grants (effective only upon any such
termination of this Agreement), to Dimension a non-exclusive, perpetual,
irrevocable, worldwide, […***…], transferable, sublicensable license to any
Licensed Back Improvements, for use by Dimension and ReGenX for the research,
development, and commercialization of products in any therapeutic indication.

 

9.9.4  If termination is by Bayer pursuant to Section 9.2:

 

(a)Bayer shall grant, and hereby grants (effective only upon any such
termination of this Agreement), to Dimension an exclusive (even as to Bayer),
worldwide, […***…], transferable, perpetual, irrevocable license, with the right
to grant sublicenses, under the Bayer Technology to make, have made, use,
import, sell, and offer for sale the Licensed GT Products or any Licensed
Treatments as they were being developed or Commercialized at the time of
termination, solely in the Field. For this purpose, the “Bayer Technology” means
Bayer’s patents, Know-How, and other intellectual property that are improvements
or modifications to or that are based on or derived in whole or in part from or
that otherwise relate to any Licensed Technology to the extent such patents,
Know-How (including all data and regulatory submissions), or other intellectual
property pertains to the Licensed GT Products or Licensed Treatments that were
being developed or Commercialized by Bayer at the time of

 

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termination. To effectuate such license, upon any such termination of this
Agreement, Bayer will promptly disclose to Dimension all Bayer Technology not
already known to Dimension;

 

(b)Bayer will transfer to Dimension ownership of any Regulatory Approvals then
in Bayer’s, its Affiliates’, or any Sublicensee’s (to the extent a sublicense is
terminated and not assigned) name related to the Licensed GT Products as then
being developed or Commercialized containing any expression construct provided
by Dimension to Bayer as part of the Licensed Technology and notify the
appropriate regulatory authorities and take any other action reasonably
necessary to effect such transfer of ownership; and

 

(c)At Dimension’s request Bayer shall transfer any biological materials or
compounds that Bayer has manufactured or had manufactured relating to the
Licensed GT Product or Licensed Treatment and that is in Bayer’s possession as
at the date of termination. Dimension shall pay for such materials and compounds
at cost, without any markup.

 

9.9.5The Parties acknowledge and agree that, if the GSK Agreement is terminated
as described in Section 6.5 of the GSK Agreement, then, as provided in Section
6.5.2 thereof, ReGenX will assign the ReGenX Agreement to the licensor of the
GSK Agreement to the extent the ReGenX Agreement is related solely to the rights
and products licensed to ReGenX under the GSK Agreement.

 

9.9.6Each Receiving Party shall, at the other Party’s request, return all
Confidential Information and any remaining Materials of the Disclosing Party.
Notwithstanding the foregoing, one copy of such Confidential Information may be
kept by either Party for a record of that Party’s obligations.

 

If termination is only with respect to a particular country or region within the
Territory, but not all countries, then the provisions of this Section 9.9 shall
only apply with respect to the terminated country(ies), and this Agreement shall
continue with respect to the non-terminated countries.

 

9.10Survival. Bayer’s obligation to pay all monies due and owed to Dimension
under this Agreement which 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 Sections 5.11.2 (Exclusivity: Bayer), 9.1 (Term of
Agreement), 9.8 (Applicability of Section 365(n) of the Bankruptcy Code), 9.9
(Effects of Termination), 9.10 (Survival), 10.1 (Ownership of Inventions), 11.4
(Disclaimer of Warranties, Damages), and 11.5 (Indemnification), and Articles 1
(Definitions), 6 (Consideration)(but only in respect of payments that have
accrued and become payable prior to the effective date of termination), 8
(Confidentiality), 12 (Use of Name) and 13 (Additional Provisions) shall survive
such termination or expiration of this Agreement in accordance with their
respective terms.

 

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ARTICLE 10

 

PATENT MAINTENANCE; PATENT INFRINGEMENT

 

10.1Ownership of Inventions. Each Party shall own all Know-How generated solely
by it and its Affiliates and their respective employees, agents and independent
contractors in the course of conducting such Party’s activities under this
Agreement (“Sole Inventions”) and any Patent Rights arising therefrom (the
“Bayer Patents” in the case of Bayer’s Sole Inventions). All Know-How generated
jointly by employees, Affiliates, agents, or independent contractors of each
Party in the course of performing activities under this Agreement (collectively,
“Joint Inventions”), and all Patent Rights contained within such Joint
Inventions (collectively, “Joint Patents”), shall be owned jointly by the
Parties in accordance with joint ownership interests of co-inventors under U.S.
patent laws (that is, each Party shall have full rights to license, assign and
exploit such Joint Inventions (and any patents arising therefrom) anywhere in
the world, without any requirement of gaining the consent of, or accounting to,
the other Party), subject to the covenants and licenses granted herein and
subject to any other intellectual property held by such other Party. For
purposes of determining whether Inventorship shall be a Sole Invention or a
Joint Invention under this Agreement, inventorship shall be determined in
accordance with U.S. patent laws.

 

10.2Disclosure of Inventions. Dimension shall promptly disclose to Bayer all
Sole Inventions, and each Party shall promptly disclose to the other Party any
Joint Inventions, including any invention disclosures or similar documents
submitted to it by its employees, agents or independent contractors describing
such inventions, and all other information relating to such inventions to the
extent necessary or useful for the preparation, filing and maintenance of any
Patent Rights with respect to such inventions.

 

10.3Prosecution of Dimension Patents. As between Dimension and Bayer, the
Parties agree as follows:

 

10.3.1Dimension shall have the sole right to Prosecute patent applications and
issued patents within Dimension Patents in Dimension’s sole discretion and at
its own expense. Dimension shall provide Bayer with a reasonable opportunity to
review and provide comments in connection with the Prosecution of the Dimension
Patents; and Dimension shall keep Bayer reasonably informed as to all material
developments with respect to such Dimension Patents and shall supply to Bayer
copies of material communications received and filed in connection with the
Prosecution of such Dimension Patents.

 

10.3.2Dimension agrees to Prosecute any patent applications or issued patents
within the Dimension Patents in good faith. If Dimension decides not to file, to
abandon or not to maintain any of such Dimension Patents, in each case where a
claim may cover a Licensed GT Product or GT Product, then Dimension shall
provide Bayer with […***…] prior written notice of such decision (or such other
longer period of time reasonably necessary to allow Bayer to assume such
responsibilities, at the sole discretion of Dimension). In such event, Bayer
shall have the right, at its option, to the extent Dimension is permitted by
obligations owed to Third Parties, to have assigned to it the said Dimension
Patents. If assignment is not possible, Bayer

 

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shall have a non-exclusive, perpetual, irrevocable, royalty-free license with
respect to those Dimension Patents. In either case (assignment or non-exclusive
license) the Patent Rights will cease to be Dimension Patents.

 

10.4Prosecution of Joint Patents. As between Dimension and Bayer, the Parties
agree as follows:

 

10.4.1Dimension shall have the sole right to Prosecute patent applications and
issued patents within Joint Patents in Dimension’s discretion and at its own
expense. Dimension shall provide Bayer with a reasonable opportunity to review
and provide comments in connection with the Prosecution of the Joint Patents;
and Dimension shall keep Bayer reasonably informed as to all material
developments with respect to such Joint Patents and shall supply to Bayer copies
of material communications received and filed in connection with the Prosecution
of such Joint Patents.

 

10.4.2Dimension agrees to Prosecute any patent applications or issued patents
within the Joint Patents in good faith. If Dimension decides not to file, to
abandon or not to maintain any of such Joint Patents, then Dimension shall
provide Bayer with […***…] prior written notice of such decision (or such other
longer period of time reasonably necessary to allow Bayer to assume such
responsibilities, at the sole discretion of Dimension). In such event, Bayer
shall have the right, at its option, to have assigned to it Dimension’s interest
in such Joint Patents, and such Patent Rights shall cease to be Dimension
Patents.

 

10.5Prosecution of Bayer Patents. As between Dimension and Bayer, the Parties
agree as follows:

 

10.5.1Bayer shall have the sole right to Prosecute patent applications and
issued patents within Bayer Patents in Bayer’s sole discretion and at its own
expense. Bayer shall provide Dimension with a reasonable opportunity to review
and provide comments in connection with the Prosecution of the Bayer Patents;
and Bayer shall keep Dimension reasonably informed as to all material
developments with respect to such Bayer Patents and shall supply to Dimension
copies of material communications received and filed in connection with the
Prosecution of such Bayer Patents.

 

10.5.2Bayer agrees to Prosecute any patent applications or issued patents within
the Bayer Patents in good faith. If Bayer decides not to file, to abandon or not
to maintain any of such Bayer Patents that claim only a Licensed GT Product or
GT Product and no other product or component thereof, then Bayer shall provide
Bayer with […***…] prior written notice of such decision (or such other longer
period of time reasonably necessary to allow Dimension to assume such
responsibilities, at the sole discretion of Bayer). In such event, Dimension
shall have the right, at its option, to control the filing, prosecution and/or
maintenance of any such Bayer Patents, at its own expense, and the Parties shall
have the rights with respect to such Bayer Patents as set forth in Section
10.5.1 (with the Parties’ roles reversed).

 

10.6Prosecution of Sublicensed Patents. Bayer acknowledges and agrees that, in
accordance with the terms of the ReGenX Agreement:

 

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10.6.1ReGenX retains the sole right to Prosecute patent applications and issued
patents within the Sublicensed Patents, in ReGenX’s sole discretion. Subject to
Section 10.6.3, and subject to ReGenX providing Dimension with a reasonable
opportunity to review and provide comments in connection with the Prosecution of
the Sublicensed Patents, Dimension shall provide Bayer with same, to the extent
such Sublicensed Patents cover or claim the Licensed GT Products in the Field;
and Dimension shall keep Bayer reasonably informed as to all material
developments with respect to such Sublicensed Patents and shall supply to Bayer
copies of material communications received from ReGenX and filed in connection
with the Prosecution of such Sublicensed Patents.

 

10.6.2Bayer acknowledges that […***…] has no obligation to undertake any
inter-party proceedings, such as oppositions or interferences, or to undertake
any re-examination or re-issue proceedings, in either case, with respect to the
Sublicensed Patents.

 

10.6.3Bayer acknowledges that the University of Pennsylvania controls
Prosecution of the Sublicensed Patents under the Penn Agreement, with ReGenX
having certain rights to review.

 

10.7Product Infringement Actions Against Third Parties.

 

10.7.1Notification. If either Party becomes aware of any existing or threatened
infringement of any Dimension Patent, Bayer Patent or Sublicensed Patent by the
manufacture, use or sale of a gene therapy product for use in the Field (a
“Product Infringement”), it shall promptly notify the other Party in writing to
that effect, and the Parties will consult with each other regarding any actions
to be taken with respect to such Product Infringement.

 

10.7.2Dimension Patents (including Joint Patents). As between Dimension and
Bayer, the Parties agree as follows:

 

10.7.2.1[…***…] shall have the first right, but not the obligation, to prosecute
any Product Infringement of those Dimension Patents (including Joint Patents) in
each case that claim […***…] (the “[…***…] Patents”) at its own expense. In any
action to enforce any of such […***…] Patents, […***…], at the request and
[…***…], shall […***…], including in the event that, […***…].

 

10.7.2.2If […***…] elects not to pursue any infringement of a […***…] Patent,
[…***…] shall have the second right, but not obligation, to prosecute such
Product Infringement of such […***…] Patents, at […***…]. In any such action to
enforce any of the […***…] Patents, […***…], at the request and […***…], shall
[…***…]. In prosecuting any such Product Infringement, […***…].

 

10.7.2.3[…***…] shall have the right, but not the obligation, to prosecute any
infringement of those Dimension Patents (including Joint Patents) that are not
[…***…] Patents (the “[…***…] Patents”) in its sole discretion. If […***…]
elects not to pursue any infringement of a […***…] Patent in a country in the
Territory, provided that such […***…] Patent is […***…],[…***…] shall have the
second right, but not the obligation, to prosecute a

 

 

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Product Infringement of such […***…] Patent, at […***…] expense, in such
country. If any Third Parties also have licenses under such […***…] Patents,
[…***…] shall take account of such Third Party rights in exercising its rights
hereunder, and shall take […***…]. In any such action by […***…] to enforce any
of the […***…] Patents, […***…], at the request and expense of […***…], shall
[…***…], including in the event that, […***…].

 

10.7.2.4Any recovery of damages by Bayer or Dimension for any Product
Infringement pursuant to this Section 10.7.2 shall be applied, as between
Dimension and Bayer, first to reimburse each such Party for costs and expenses
(including reasonable attorneys’ fees and costs) incurred by such Party in
connection with such suit, second, compensatory damages will be […***…], and the
balance remaining, if any, from any such recovery shall be […***…].

 

10.7.3Enforcement of Joint Patents in […***…]. As between Dimension and Bayer,
the Parties agree as follows:

 

10.7.3.1[…***…] shall have the first right, but not obligation, to prosecute any
infringement of Joint Patents that is […***…], at […***…] expense. In any action
to enforce any of such Joint Patents, […***…], at the request and […***…], shall
[…***…].

 

10.7.3.2If […***…] elects not to pursue any such infringement of a Joint Patent,
then […***…] shall have the second right, but not obligation, to prosecute such
infringement of the Joint Patent, at […***…]. In any such action to enforce any
of the Joint Patents, […***…], at the request […***…], shall […***…], including
in the event that, […***…].

 

10.7.3.3Any recovery of damages by the Party undertaking enforcement or defense
of a suit for infringement of a Joint Patent under this Section 10.7.3 shall be
applied, as between Bayer and Bayer, first to reimburse each such Party for
costs and expenses (including reasonable attorneys’ fees and costs) incurred by
such Party in connection with such suit, second, compensatory damages will be
[…***…], and the balance remaining, if any, from any such recovery shall be
[…***…].

 

10.7.4Sublicensed Patents. Bayer acknowledges and agrees that, in accordance
with the ReGenX Agreement:

 

10.7.4.1Bayer understands and acknowledges that pursuant to the ReGenX
Agreement, […***…] has the first right, but not the obligation, to prosecute any
infringement of Sublicensed Patents at […***…]. In any action to enforce any of
the Sublicensed Patents, […***…], at the request and expense of […***…], shall
[…***…], including in the event that, […***…].

 

10.7.4.2If […***…] elects not to pursue any infringement of a Sublicensed Patent
and such Sublicensed Patent is being infringed by […***…], then as between
[…***…] shall have the first right […***…], but not obligation, to prosecute
such

 

 

 

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[…***…] with respect to such […***…], at […***…] expense. In any such action to
enforce any of the Sublicensed Patents, […***…], at the request […***…], shall
[…***…], including in the event that […***…]. In prosecuting any such […***…].

 

10.7.4.3Any recovery of damages by […***…] for any infringement other than a
[…***…] shall be retained […***…]. Any recovery of damages by the Party
undertaking enforcement or defense of a suit for […***…] shall be applied, as
between […***…], first to reimburse each such Party for costs and expenses
(including reasonable attorneys’ fees and costs) incurred by such Party in
connection with such suit, and the balance remaining, if any, from any such
recovery shall be, […***…].

 

10.7.4.4Bayer acknowledges and agrees that […***…] obligations under the ReGenX
Agreement to enforce any Sublicensed Patents […***…], and that […***…] retain
the […***…] right to […***…], all as set forth in the ReGenX Agreement and the
Existing Licenses. Dimension will […***…] under the ReGenX Agreement if
reasonably requested by Bayer.

 

10.8Defense of Infringement Claims.

 

10.8.1In the event Bayer or Dimension becomes aware that Bayer’s or any of its
Affiliates’ or any Sublicensees’ practice of any invention claimed in the
Sublicensed Patents or Dimension Patents is the subject of a claim of
infringement of any patent owned by a Third Party, that Party shall promptly
notify the other, but Bayer shall have exclusive right to take action to defend
or abate any such claim brought against Bayer or any of its Affiliates or
Sublicensees, and shall do so at its own expense and subject to Section 10.8.2.

 

10.8.2 Without Dimension’s prior written permission, Bayer must not settle or
compromise any such suit in a manner that imposes any material obligations or
restrictions on ReGenX or any of its direct or indirect licensors under the
Existing Licenses or grants any rights to the Sublicensed Patents or Dimension
Patents other than rights that Bayer has the right to grant under this
Agreement.

 

ARTICLE 11

 

WARRANTIES; INDEMNIFICATION

 

11.1Mutual Representations and Warranties. Each Party hereby represents and
warrants to the other Party as follows:

 

11.1.1Corporate Existence. As of the Effective Date, it is a company or
corporation duly organized, validly existing, and in good standing under the
Laws of the jurisdiction in which it is incorporated.

 

11.1.2Corporate Power, Authority and Binding Agreement. As of the Effective
Date, (i) it has the corporate power and authority and the legal right to enter
into this Agreement and perform its obligations hereunder; (ii) it has taken all
necessary corporate action on its part required to authorize the execution and
delivery of this Agreement and the performance of its

 

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obligations hereunder; and (iii) this Agreement has been duly executed and
delivered on behalf of such Party, and constitutes a legal, valid, and binding
obligation of such Party that is enforceable against it in accordance with its
terms.

 

11.2Additional Representations and Warranties of Dimension. Dimension represents
and warrants as of the Effective Date and, as applicable, covenants to Bayer as
follows:

 

11.2.1Title; Control; Encumbrances. Dimension has not granted any Third Party
any rights under any Licensed Patents in existence as of the Effective Date, and
to Dimension’s knowledge, all Licensed Know-How in existence as of the Effective
Date is free and clear from any mortgages, pledges, liens, security interests,
conditional and installment sale agreements, encumbrances, charges or claims of
any kind (subject to the rights retained by ReGenX in the ReGenX Agreement).
Dimension has the full and legal rights and authority to license to Bayer the
Licensed Technology in the manner set forth in this Agreement;

 

11.2.2Inventorship.  To Dimension’s knowledge, the inventorship of each Licensed
Patent is properly identified on each such patent;

 

11.2.3Good Standing. To Dimension’s knowledge, all official fees, maintenance
fees and annuities for the Licensed Patents have been paid and all
administrative procedures with Governmental Authorities have been completed for
the Licensed Patents such that the Licensed Patents are subsisting and in good
standing;

 

11.2.4Duty of Disclosure. Dimension has complied with and, to Dimension’s
knowledge ReGenX has complied with, the U.S. PTO duty of disclosure respecting
the prosecution of all of Dimension Patents and, in the case of ReGenX, the
Sublicensed Patents;

 

11.2.5Notice of Infringement/Misappropriate. Dimension has not received any
written notice from any Third Party asserting or alleging, nor does Dimension
have any knowledge of any basis for any assertion or allegation, that any
research, manufacture or development of GT Products by Dimension prior to the
Effective Date infringed or misappropriated the intellectual property rights of
such Third Party;

 

11.2.6No Conflicts. Dimension has not entered, and shall not enter, into any
agreement with any Third Party that is in conflict with the rights granted to
Bayer under this Agreement, and has not taken any action that would in any way
prevent it from granting the rights granted to Bayer under this Agreement, or
that would otherwise materially conflict with or adversely affect Bayer’s rights
under this Agreement;

 

11.2.7Third Party Technology. To Dimension’s knowledge, (i) the manufacture,
development and Commercialization of Licensed GT Products, as contemplated by
Dimension as of the Effective Date, will not infringe or misappropriate any
intellectual property rights of a Third Party, and (ii) there are no pending
Third Party patent applications that, if issued with the published or currently
pending claims, would be infringed by the manufacture, development or Licensed
GT Products or any components thereof, as contemplated by Dimension as of the
Effective Date; provided, however, that Dimension makes no representation in
this Section

 

 

 

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11.2.7 with respect to any formulation or delivery system that may be used for a
Licensed Treatment;

 

11.2.8Third Party Infringement. To Dimension’s knowledge, no Third Party is
infringing or has infringed any Licensed Patents or has misappropriated any
Licensed Know-How;

 

11.2.9No Proceeding. There are no pending, or, to Dimension’s knowledge, no
threatened, adverse actions, suits or proceedings (including interferences,
reissues, re-examinations, cancellations or oppositions) against Dimension
involving the Licensed Patents;

 

11.2.10ReGenX Agreement.

 

11.2.10.1Dimension represents and warrants to Bayer that it has provided to
Bayer a true, correct and complete copy thereof, but for redaction of (a) the
royalty rates, (b) any other payment amounts, (c) certain terms not essential in
determining the extent of the grant of rights to Bayer hereunder or that Bayer,
as a prudent pharmaceutical company, might reasonably consider relevant in
determining whether to enter into this Agreement on the terms and conditions
contained herein, as such agreement is in effect as of the Effective Date.

 

11.2.10.2Dimension represents and warrants to Bayer that, as of the Effective
Date the ReGenX Agreement is in full force and effect, and that Dimension is not
in breach of, nor do any circumstances exist upon which ReGenX might claim that
Dimension is in breach of, the ReGenX Agreement; provided, however, despite
Dimension’s material compliance with the ReGenX Agreement, certain provisions
under this Agreement, including without limitation the timing provisions in
Sections 6.5 and 9.5 and the definition in Section 9.7.3, are different from and
not technically in compliance with the terms of the ReGenX Agreement, and
accordingly, Bayer acknowledges and understands that any breach by Dimension, or
termination by ReGenX, of the ReGenX Agreement resulting from such differences
shall not constitute a breach of this Section 11.2.10.2 and of Section
11.2.10.3. For the avoidance of doubt, Dimension is not relieved of its
obligations under this Agreement because compliance with or fulfillment of such
obligations may give rise to a breach of the ReGenX Agreement.

 

11.2.10.3Dimension further covenants and agrees that (a) it will take all steps
necessary to maintain in full force and effect, the ReGenX Agreement for the
term thereof (b) it will not assign (except to an Affiliate or an assignment to
a Third Party to which this Agreement has been assigned as permitted under
Section 13.2, amend, restate, terminate in whole or in part, or otherwise modify
the ReGenX Agreement in any way that adversely affects Bayer’s rights under this
Agreement without the prior written consent of Bayer; (c) it will provide Bayer
with prompt notice of any claim of a breach under the ReGenX Agreement or notice
of termination of the ReGenX Agreement made by either Dimension or ReGenX (or
any party acting on behalf of such counterparty); (d) it will promptly send to
Bayer copies of all other material correspondence to or from the counterparty to
such ReGenX Agreement; and (e) it will enforce its rights under the ReGenX to
the extent necessary to maintain Bayer’s rights hereunder.

 

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11.3Mutual Covenants.

 

11.3.1No Debarment. In the course of the development of Licensed GT Products and
Licensed Treatments, neither Party shall use any employee or consultant who has
been debarred by any regulatory authority or, to such Party’s knowledge, is the
subject of debarment proceedings by a regulatory authority. Each Party shall
notify the other Party promptly upon becoming aware that any of its employees or
consultants who are involved with the development of Licensed GT Products and
Licensed Treatments hereunder has been debarred or is the subject of debarment
proceedings by any regulatory authority.

 

11.3.2Compliance. Each Party and its Affiliates shall comply in all material
respects with all applicable Laws in the development and Commercialization of GT
Products, Licensed GT Products and Licensed Treatments and performance of its
obligations under this Agreement, including, to the extent applicable to such
Party and its activities hereunder, the statutes, regulations and written
directives of the FDA, the EMA and any regulatory authority having jurisdiction
in the Territory, the FD&C Act, the Prescription Drug Marketing Act, the Federal
Health Care Programs Anti-Kickback Law, 42 U.S.C. 1320a-7b(b), the statutes,
regulations and written directives of Medicare, Medicaid and all other health
care programs, as defined in 42 U.S.C. § 1320a-7b(f), and the Foreign Corrupt
Practices Act of 1977, each as may be amended from time to time.

 

11.4  Disclaimer of Warranties, Damages. EXCEPT AS SET FORTH IN SECTIONS 11.1
AND 11.2, THE LICENSED TECHNOLOGY, LICENSED GT PRODUCTS, LICENSED TREATMENTS,
AND ALL RIGHTS LICENSED BY EITHER PARTY TO THE OTHER UNDER THIS AGREEMENT ARE
PROVIDED ON AN “AS IS” BASIS, AND NEITHER PARTY MAKES ANY REPRESENTATIONS OR
WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT THERETO. BY WAY OF EXAMPLE BUT NOT
OF LIMITATION, EXCEPT AS SET FORTH IN SECTIONS 11.1 AND 11.2, NEITHER PARTY
MAKES ANY REPRESENTATIONS OR WARRANTIES, AND HEREBY DISCLAIMS ALL EXPRESS AND
IMPLIED REPRESENTATIONS AND WARRANTIES, (i) OF COMMERCIAL UTILITY, ACCURACY,
COMPLETENESS, PERFORMANCE, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
VALIDITY OR ENFORCEABILITY OF ANY RIGHTS LICENSED BY EITHER PARTY TO THE OTHER,
AND PROFITABILITY; OR (ii) THAT THE USE OF ANY RIGHTS GRANTED BY EITHER PARTY TO
THE OTHER, INCLUDING ANY PRODUCTS RESULTING THEREFROM, WILL NOT INFRINGE ANY
PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS OF THIRD PARTIES.
EXCEPT AS SET FORTH IN THIS AGREEMENT, NEITHER PARTY OR ANY OF SUCH PARTY’S
DIRECT OR INDIRECT LICENSORS SHALL BE LIABLE TO THE OTHER PARTY, ITS SUCCESSORS
OR ASSIGNS, OR ANY SUBLICENSEES OF EITHER PARTY, OR ANY THIRD PARTY WITH RESPECT
TO: (a) ANY CLAIM ARISING FROM USE OF ANY OR ALL RIGHTS LICENSED UNDER THIS
AGREEMENT OR FROM THE DEVELOPMENT, TESTING, MANUFACTURE, USE, OR SALE OF
PRODUCTS ARISING THEREFROM; OR (b) ANY CLAIM FOR LOSS OF PROFITS, LOSS OR
INTERRUPTION OF BUSINESS, OR FOR INDIRECT, SPECIAL, INCIDENTAL, PUNITIVE, OR
CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING ANY ARISING FROM OR RELATING TO ANY
BREACH OF THIS AGREEMENT OR THE EXERCISE OF RIGHTS

 

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HEREUNDER, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION
11.4 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS
OF EITHER PARTY UNDER SECTION 11.5 OR TO LIMIT A PARTY’S LIABILITY FOR BREACHES
OF ITS OBLIGATION REGARDING CONFIDENTIALITY UNDER ARTICLE 8.

 

11.5Indemnification.

 

11.5.1By Bayer. Bayer shall defend, indemnify, and hold harmless Dimension, its
Affiliates, ReGenX and the licensors under the Existing Licenses, and their
respective shareholders, members, partners, officers, trustees, faculty,
students, contractors, agents, and employees (individually, a “Dimension
Indemnified Party” and, collectively, the “Dimension 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 Dimension Indemnified Parties from claims of such Third Parties
that result from or arise out of: (i) the research, development, testing, use,
manufacture, promotion, sale, or other disposition of any Licensed Technology or
Licensed GT Products by Bayer, its Affiliates, any Sublicensees, their
respective assignees, or vendors acting on behalf of any of the foregoing; (ii)
any breach by Bayer (or its Affiliates or any Sublicensees) of its
representations, warranties, or obligations of this Agreement; and (iii) Bayer’s
gross negligence or intentional misconduct or that of Bayer’s Affiliates or
Sublicensees; provided, however, that Bayer shall not be liable for claims based
on any breach by Dimension of its representations, warranties, or obligations of
this Agreement or the gross negligence or intentional misconduct of any of the
Dimension Indemnified Parties. Without limiting the foregoing, but subject to
the proviso contained in the preceding sentence, Bayer must defend, indemnify,
and hold harmless the Dimension Indemnified Parties from and against any Third
Party Liabilities resulting from:

 

(a)any product liability or other claim of any kind related to the use by a
Third Party of a Licensed GT Product that was manufactured, sold, or otherwise
disposed of by Bayer, its Affiliates, any Sublicensees, their respective
assignees, or vendors;

 

(b)any claim by a Third Party that the practice of the Licensed Technology, or
the design, composition, manufacture, use, sale, or other disposition of any
Licensed Treatment infringes or violates any patent, copyright, trade secret,
trademark, or other intellectual property right of such Third Party; and

 

(c)   clinical trials or studies conducted by or on behalf of Bayer, its
Affiliates, any Sublicensees, their respective assignees, or vendors relating to
the Licensed Treatment or Licensed GT Products, including any claim by or on
behalf of […***…] of any such clinical trial or study.

 

For the avoidance of doubt, the indemnities granted by Bayer shall not apply in
respect of any activities conducted following the exercise by Dimension of its
rights under Section

 

 

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11.5.2              By Dimension.  Dimension shall defend, indemnify, and hold
harmless Bayer, its Affiliates and Sublicensees and their respective
shareholders, members, partners, officers, trustees, contractors, agents, and
employees (individually, a “Bayer Indemnified Party” and, collectively, the
“Bayer Indemnified Parties”) from and against any and all Third Party
Liabilities suffered or incurred by the Bayer Indemnified Parties from claims of
such Third Parties that result from or arise out of:  (i) the research,
development, testing, use, manufacture, promotion, sale, or other disposition of
any GT Product, Compound/Vector or any product outside the Field or within the
scope of the Retained Rights by Dimension, ReGenX or its Affiliates and their
respective licensees or sublicensees, assignees, or vendors acting on behalf of
any of the foregoing; (ii) any breach by Dimension (or its Affiliates) of its
representations, warranties, or obligations of this Agreement; and
(iii) Dimension’s gross negligence or intentional misconduct or that of ReGenX
or Dimension’s or ReGenX’s respective Affiliates, licensees and sublicensees;
provided, however, that Dimension shall not be liable for claims based on any
breach by Bayer of its representations, warranties, or obligations of this
Agreement or the gross negligence or intentional misconduct of any of the Bayer
Indemnified Parties.

 

11.5.3Indemnification Procedure. Each Party, 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 (i) that imposes
any restrictions or obligations on the indemnified party (an “Indemnified
Party”) or, if Bayer is the Indemnifying Party, on ReGenX or its licensors under
the Existing Licenses, without the other Party’s prior written consent, (ii) if
Bayer is the Indemnifying Party, that grants any rights to the Licensed
Technology or Licensed GT Products other than those Bayer has the right to grant
under this Agreement without Dimension’s prior written consent, or (iii) if
Dimension is the Indemnifying Party, that grants any rights that are
inconsistent with those granted to Bayer under this Agreement without Bayer’s
prior written consent. The Indemnified Party shall notify the Indemnifying Party
within […***…] of becoming aware of any claim or claims asserted or threatened
against the Indemnified Party that could give rise to a right of indemnification
under this Agreement, provided however that the failure to give such notice
shall not relieve the Indemnifying Party of its indemnity obligation hereunder
except to the extent that such failure materially prejudices its rights
hereunder. 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 11.5, including the selection of
counsel. The Indemnified Party shall keep the Indemnifying Party apprised of all
material developments with respect to the claim and promptly provide the
Indemnifying Party with copies of all correspondence and documents exchanged by
the Indemnified Party and the opposing party(ies) to such litigation. The
Indemnified Party may not compromise or settle such litigation without the prior
written consent of the Indemnifying Party, such consent not to be unreasonably
withheld or delayed. The indemnification rights of a Indemnified Party contained
in this Agreement are in addition to all other rights which 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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11.6                        Insurance.  Within […***…] of the Effective Date,
each Party will procure and maintain product liability insurance policies during
the term of the Agreement for claims related to bodily injury or death caused by
the Licensed GT Products.  In lieu of insurance coverage described in the
preceding sentence, Bayer shall have the right to undertake a program of
self-insurance to cover the obligations hereunder, with financial protection
comparable to that arranged by it for its own protection with regard to other
products in its portfolio.  Prior to […***…], and thereafter for a period
required by applicable Law in order to continue to monitor the participants in
the clinical trial, clinical trials coverage will be arranged in amounts that
are reasonable and customary in the location where the clinical trial is being
conducted.  Such insurance coverage will be arranged by Dimension if it is the
sponsor of the applicable clinical trial and shall be arranged by Bayer if it is
the sponsor of the applicable clinical trial.

 

ARTICLE 12

 

USE OF NAME

 

Except as permitted by this Agreement, Bayer, its Affiliates, any Sublicensees,
and all of its and their employees and agents must not use ReGenX’s and, to the
extent relating to the subject matter of this Agreement, the University of
Pennsylvania’s and 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 Dimension or such entity, as applicable; provided,
however that Bayer may acknowledge the existence and general nature of this
Agreement. The foregoing limitations shall apply mutatis mutandis, to
Dimension’s use of Bayer’s or its Affiliates or Sublicensees name, logo, seal,
trademark or service marks.

 

ARTICLE 13

 

ADDITIONAL PROVISIONS

 

13.1Relationship. Nothing in this Agreement shall be deemed to establish a
relationship of principal and agent between Bayer and Dimension, 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.

 

13.2Assignment. Subject to Sections 13.2.1 through 13.2.6 below, this Agreement
will be binding upon and inure to the benefit of the Parties hereto and their
respective successors and permitted assigns, each of which such successors and
permitted assigns will be deemed to be a Party hereto for all purposes hereof.

 

13.2.1Subject to Section 13.2.2 and 13.2.3, no Party may assign, delegate or
otherwise transfer either this Agreement or any of its rights, interests, or
obligations hereunder without the prior written approval of the other Party.

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13.2.2              Notwithstanding Section 13.2.1 each Party, upon providing
the other Party written notice, may without the consent of the other Party,
(i) assign any or all of its rights and interests hereunder to one or more of
its Affiliates, (ii) designate one or more of its Affiliates to perform its
obligations hereunder, in each case, so long as the assigning Party is not
relieved of any liability hereunder and so long as any such Affiliate remains
such Party’s Affiliate; provided, however, that such Affiliate
assignee(s) provide the other Party with written acknowledgement of and
agreement to the assigning Party’s obligations under the Agreement that were
assigned to it.

 

13.2.3Notwithstanding Section 13.2.1 each Party (or its permitted successive
assignees or transferees hereunder), upon providing the other Party prior
written notice (at least […***…] prior to the effectiveness of such assignment),
may without the consent of the other Party, assign or transfer this Agreement as
a whole to an entity that succeeds to all or substantially all of the business
or assets of such Party related to the subject matter of this Agreement, so long
as the assigning Party is not relieved of any liability hereunder and such
assignment is a Qualified Assignment.

 

13.2.4For the purposes of this Agreement, a “Qualified Assignment” means any
transaction that:

 

(a)is made in compliance with Law, including securities, tax and corporation
laws;

 

(b)includes the assignee’s written acknowledgement (to the assigning Party) of
and agreement to assume all of the assigning Party’s obligations under the
Agreement;

 

(c)                                  is made to an assignee that is, and will be
after giving effect to the relevant assignment, Solvent;

 

(d)                                 is made to an assignee that is not subject
at the time of such assignment to any order, decree or petition providing for
(i) the winding-up or liquidation of such person, (ii) the appointment of a
receiver over the whole or part of the assets of such person or (iii) the
bankruptcy or administration of such person;

 

(e)                                  is not a voidable fraudulent conveyance;

 

(f)                                   is made to an assignee that is at the time
of such assignment not debarred under 21 U.S.C.  §30 or under investigation or
threatened to be debarred under 21 U.S.C.  §30; and

 

(g)                                  will not cause a material increase in
taxes, costs or expenses to the non-assigning Party (unless the assigning Party
or the assignee has agreed to compensate the non-assigning Party for the same).

 

 

 

 

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13.2.5Notwithstanding Sections 13.2.1 through 13.2.4 above, (i) each Party may
at any time assign its rights, interests and obligations provided for hereunder
to any person by merger or in the course of a Change of Control; or (ii) with
the prior written consent of the other Party.

 

13.2.6For purposes of this Section 13.2, “Solvent” means, with respect to any
entity as on any date of determination, that as of such date, (i) the value of
the assets of such entity is greater than the total amount of liabilities
(including contingent and unliquidated liabilities) of such entity, (ii) such
entity is able to pay all liabilities of such entity as such liabilities mature
and (iii) such entity does not have unreasonably small capital (taking into
account such entity’s obligations hereunder). In computing the amount of
contingent or unliquidated liabilities at any time, such liabilities shall be
computed at the amount that, in light of all the facts and circumstances
existing at such time, represent the amount that can reasonably be expected to
become an actual or matured liability. In computing the value of the assets of
an entity, the value shall be determined in the context of current facts and
circumstances affecting such entity.

 

13.3  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.

 

13.4  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, or by facsimile (with a copy of
such facsimile also sent by one of the other methods of delivery) and addressed
as follows:

 

If for Dimension:

 

with a copy (which shall not constitute notice) to:

 

 

 

Dimension Therapeutics, Inc.

 

Cooley LLP

1 Main Street, 13th Floor

 

3175 Hanover Street

Cambridge, MA 02142

 

Palo Alto, CA 94304

USA

 

USA

Attn: President and CEO

 

Attn: Barbara A. Kosacz, Esq.

Facsimile: […***…]

 

Facsimile: […***…]

 

 

 

If for Bayer:

 

with a copy to:

 

 

 

Bayer HealthCare LLC

 

Bayer HealthCare LLC

455 Mission Bay Boulevard South

 

800 DwightWay

San Francisco, CA 94158

 

Berkeley 94710

Attn: Alliance Manager

 

Attn: Law & Patents

Facsimile: […***…]

 

 

 

Either Party may change its official address upon written notice to the other
Party.

 

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13.5Applicable 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 13.6, the Parties hereby submit to the exclusive jurisdiction
of and venue in the federal courts located in the State of New York with respect
to any and all disputes concerning the subject of this Agreement.

 

13.6Dispute 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 between senior executives
of each Party with authority to resolve the dispute 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 (including the ICDR Rules relating to discovery) in effect on the date of
commencement of the arbitration, subject to the provisions of this Section 13.6.
The arbitration shall be conducted as follows:

 

13.6.1The 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.

 

13.6.2In 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.

 

13.6.3If a Party fails to make the appointment of an arbitrator as provided in
Section 13.6.2, the AAA shall make the appointment. If the appointed arbitrators
fail to appoint a chairperson within the time specified in Section 13.6.2 and
there is no agreed extension of time, the AAA shall appoint the chairperson.

 

13.6.4The 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 13.5. 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 New York, without giving effect to conflict of
law provisions that may require the application of the laws of

 

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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).

 

13.6.5The Parties shall use their reasonable efforts to conduct all dispute
resolution procedures under this Agreement as expeditiously, efficiently, and
cost-effectively as possible.

 

13.6.6All 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.

 

13.6.7Compliance with this Section 13.6 is a condition precedent to seeking
relief in any court or tribunal in respect of a dispute, but nothing in this
Section 13.6 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.

 

13.7No Discrimination. Both Parties and their respective Affiliates, and any
Sublicensees, agents, contractors and licensees, 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).

 

13.8Compliance with Law. Both Parties (and their respective Affiliates and any
Sublicensees, agents, contractors and licensees) 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 Bayer’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 Bayer that Bayer shall not export data or commodities to
certain foreign countries without prior approval of such agency. Dimension
neither represents that a license is not required nor that, if required, it will
issue.

 

13.9Entire 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. All “Confidential
Information” disclosed by Dimension to […***…] will be deemed “Confidential
Information” under this Agreement (unless and until it

 

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falls within one of the exclusions set forth in Section 1.11). This Agreement
may not be varied except by a written document signed by duly authorized
representatives of both Parties.

 

13.10Marking. Bayer, its Affiliates, and any Sublicensees shall mark any
Licensed GT 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 Sublicensed Patents and Dimension
Patents to be enforced to their full extent in any country where Licensed GT
Products are made, used, sold, offered for sale, or imported.

 

13.11Severability 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, 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.

 

13.12Further Assurances. Each Party hereto agrees to execute, acknowledge, and
deliver such further instruments, and to do all other acts, as may be necessary
or appropriate in order to carry out the purposes and intent of this Agreement.

 

13.13Interpretation; 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 and exhibits in this Agreement are to Sections 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. 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.

 

13.14Cumulative 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.

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13.15Counterparts. 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.

 

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

 

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

 

DIMENSION THERAPEUTICS, INC

 

BAYER HEATHCARE, LLC

 

 

 

 

 

By:

/s/ Thomas R. Beck

 

By:

/s/ Habib Dable

Name:

Thomas R. Beck

 

Name:

Habib Dable

Title:

President and CEO

 

Title:

EVP, Global Head, Specialty Medicine

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Exhibit A
Sublicensed Patents & Dimension Patents

 

Sublicensed Patents:

 

App #

 

Title

 

Inventors

 

Nos.

 

Penn Docket #

[…***…]

 

[…***…]

 

[…***…]

 

[…***…]

 

[…***…]

[…***…]

 

[…***…]

 

[…***…]

 

[…***…]

 

[…***…]

[…***…]

 

[…***…]

 

[…***…]

 

[…***…]

 

[…***…]

[…***…]

 

[…***…]

 

[…***…]

 

[…***…]

 

[…***…]

[…***…]

 

[…***…]

 

[…***…]

 

[…***…]

 

[…***…]

[…***…]

 

[…***…]

 

[…***…]

 

[…***…]

 

[…***…]

[…***…]

 

[…***…]

 

[…***…]

 

[…***…]

 

[…***…]

[…***…]

 

[…***…]

 

[…***…]

 

[…***…]

 

[…***…]

 

Dimension Patents:  […***…]

 

 

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Exhibit B

Licensed Treatment Sales

 

The following are examples (not intended to be exhaustive) of the calculation of
Licensed Treatment Sales. In principle the Parties have agreed upon two payment
mechanisms for the commercialization of Licensed Treatments; these are:

 

1.Annuity Payment Scheme (the figures mentioned below are hypothetical and do
not reflect actual or anticipated prices):

•                  […***…]

•                  […***…]

•                  […***…]

•                  […***…]

•                  […***…]

 

Table 1: […***…] (which rolls up into the definition of Net Sales) for purposes
of determining royalty payments to Dimension in relation to the amount of
[…***…] figures picked at random (and represent an example only):

 

Retail price of […***…] (as a % of
Licensed Treatment Monitoring
Sales for such patient)

 

% of […***…] Licensed
Treatment Monitoring Sales to
be included in Licensed
Treatment Sales/Net Sales for
royalty purposes

[…***…]

 

[…***…]

[…***…]

 

[…***…]

[…***…]

 

[…***…]

[…***…]

 

[…***…]

[…***…]

 

[…***…]

 

2.One-time (lump sum) Payment Scheme:

 

•                  […***…]

•                  […***…]

•                  […***…]

•                  […***…]

*** Confidential Treatment Requested ***

--------------------------------------------------------------------------------

 

Exhibit C
Sublicensed Technology Retained Rights

 

Bayer acknowledges and understands that ReGenX and its direct and indirect
licensors under the Existing Licenses retain certain rights under the
Sublicensed Technology, whether inside or outside the Field, as further set
forth below:

 

1.

Retained Rights. ReGenX’s direct and indirect licensors retain the following
rights with respect to the Sublicensed Technology:

 

 

(a)

A non-exclusive, sublicensable right under the Sublicensed 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; and

 

 

(b)

A non-exclusive right for ReGenX’s direct and indirect licensors (which right is
sublicensable by such licensors) to use the Sublicensed Technology for
non-commercial research purposes and to use the Sublicensed Technology for such
licensors’ discovery research efforts with non-profit organizations and
collaborators.

 

2.

Domain Antibodies. The rights and licenses granted in Section 5.1 shall not
include any right (and Dimension’s direct and indirect licensors retain the
exclusive (even as to Dimension and Bayer), fully sublicensable right) under the
Sublicensed Technology to make, have made, use, sell, offer to sell, and import
Domain Antibodies (as defined in the ReGenX Agreement) that are expressed by an
adeno-associated vector.

 

3.Hemophilia B.

 

 

a.

The rights and licenses granted in Section 5.1 shall not include any right (and
ReGenX’s direct and indirect licensors retain the exclusive (even as to
Dimension and Bayer), fully sublicensable right) under the Sublicensed
Technology that covers the rAAV serotype 8, to make, have made, use, sell, offer
for sale, and import products for the treatment of all forms of hemophilia B
(notwithstanding Bayer’s rights under Section 5.10).

 

 

b.

ReGenX’s direct and indirect licensors retain the following rights (even as to
Dimension) with respect to the Sublicensed Technology: a non-exclusive,
sublicensable right to make, have made, use, sell, offer for sale, and import
all of the various serotypes of any adeno-associated vector that is the subject
of at least one claim in the Sublicensed Patents solely for non-commercial
research in the area of hemophilia B (notwithstanding Bayer’s rights under
Section 5.12).

 

4.

Hemophilia A. ReGenX’s direct and indirect licensors retain the following rights
with respect to the Sublicensed Technology: to the extent Sublicensed Technology
pertains to recombinant adeno-associated virus serotype 8, an exclusive,
sublicensable right to make, have made, use, sell, offer for sale, and import
products for the treatment of hemophilia A.

 

*** Confidential Treatment Requested ***

--------------------------------------------------------------------------------

 

5.

Service Businesses. The rights and licenses granted in Section 5.1 shall not
include any right (and ReGenX’s direct and indirect licensors retain the
exclusive (even as to Dimension and Bayer), fully sublicensable right) under the
Sublicensed Technology:

 

 

(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 ReGenX’s direct and indirect licensors shall not include the right
to conduct clinical trials in humans in the Field; or

 

 

(b)

to use the Sublicensed Technology to provide services to any Third Parties;
provided that, for clarity, Bayer’s license under Section 5.1 does include the
right to administer Licensed GT Products to patients.

 

6.

Research Rights. ReGenX’s direct and indirect licensors retain the fully
sublicensable right under the Sublicensed Technology to grant non-exclusive
research and development licenses to their Affiliates and Third Parties;
provided that such development rights granted by ReGenX’s direct and indirect
licensors shall not include the right to conduct clinical trials in humans in
the Field or any rights to sell products in the Field.

 

7.

Non-Commercial Entities. The University of Pennsylvania may use and permit other
non-profit organizations or other non-commercial entities to use the Sublicensed
Technology solely for educational, research, and other non-commercial purposes.

*** Confidential Treatment Requested ***

--------------------------------------------------------------------------------

 

Exhibit D-1
Research Plan

 

[see attached]

 

*** Confidential Treatment Requested ***

--------------------------------------------------------------------------------

 

 

Hem A tasts & timeline

 

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*** Confidential Treatment Requested ***

--------------------------------------------------------------------------------

 

 

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*** Confidential Treatment Requested ***

--------------------------------------------------------------------------------

 

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*** Confidential Treatment Requested ***

--------------------------------------------------------------------------------

 

Exhibit D-2
Operating Plan

 

[to be finalized and attached within […***…] after the Effective Date]

*** Confidential Treatment Requested ***

--------------------------------------------------------------------------------

 

Exhibit D-3
Research Budget

 

[see attached]

 

*** Confidential Treatment Requested ***

--------------------------------------------------------------------------------

 

Overall Hem A Project Budget

 

 

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Budget Estimates with greatest uncertainty include:

 

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Not Included at this time:

 

•[…***…]

*** Confidential Treatment Requested ***

--------------------------------------------------------------------------------

 

 

2014 — 2015 Budget

 

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2014 — 2015 Activities included are the following:

 

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*** Confidential Treatment Requested ***

--------------------------------------------------------------------------------

 

Exhibit E Demonstration of Clinical POC

 

The Clinical Proof of Concept will be considered having been achieved when all
of the following criteria are met:

 

•                  Efficacy and Safety

 

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•                  Pre-existing antibodies against […***…]

 

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•                  Feasibility of highest dose level tested

 

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*** Confidential Treatment Requested ***

--------------------------------------------------------------------------------

 

Exhibit F

 

Press Releases

 

[see attached]

 

 

*** Confidential Treatment Requested ***

--------------------------------------------------------------------------------

 

 

[g201802210546040554834.jpg]

 

[g201802210546040564835.jpg]

 

Press release

Not intended for US or UK media

Bayer HealthCare AG

Communications

51368 Leverkusen

Germany

Phone:  +49 214 30-1

www.bayerhealthcare.com

 

Bayer HealthCare Press release Not intended for US or UK media Bayer HealthCare
and Dimension Therapeutics to Develop Novel Gene Therapy for Hemophilia A

 

Leverkusen, June 23, 2014 - Bayer HealthCare (Bayer) and Dimension Therapeutics,
a company focused on developing novel adeno-associated virus (AAV) gene therapy
treatments for rare diseases, have entered into a collaboration for the
development and commercialization of a novel gene therapy for the treatment of
hemophilia A.

 

“Bayer is a worldwide leader in the treatment of hemophilia and we are highly
committed to advancing innovative treatment options for patients with hemophilia
A,” said Prof. Dr. Andreas Busch, Member of the Bayer HealthCare Executive
Committee and Head of Global Drug Discovery. “We are excited to partner with
Dimension to jointly harness the power of gene therapy to drive the development
of new long-term options in treating this disease.”

 

“Currently available replacement therapies for hemophilia A are often
administered intravenously multiple times a week and may be required for life,
depending on the severity of a patient’s disease,” said Thomas R. Beck, M.D.,
chief executive officer of Dimension Therapeutics. “Gene therapy offers the
potential to transform the treatment of hemophilia by inserting a correct
version of the faulty gene responsible for the disease. We are proud to partner
with Bayer, a leader in the treatment of hemophilia A, to develop a therapy with
the potential to significantly change the treatment landscape and improve
quality of life for patients.”

 

Under the terms of the agreement, Dimension will receive an upfront payment of
$20 million and will be eligible for development and commercialization milestone
payments of up to $232 million. Dimension will be responsible for all
pre-clinical development activities and the Phase I/IIa clinical trial, with
funding from Bayer. Depending on the results of the Phase I/IIa clinical trial,
Bayer will conduct the confirmatory Phase III trial, make all regulatory
submissions, and will have worldwide rights to commercialize the potential
future product for the treatment of hemophilia A. Dimension is eligible to
receive tiered royalties based on product sales.

 

Dimension’s AAV vector technology allows for systemic intravenous administration
of the clotting factor gene in vivo, which has been shown in preclinical studies
to target the liver

 

 

 

*** Confidential Treatment Requested ***

1

--------------------------------------------------------------------------------

 

resulting in long lasting expression of FVIII protein at therapeutic levels.
Dimension’s vectors are enabled by REGENX Biosciences’ proprietary NAV®
technology.

 

About Hemophilia A

 

Hemophilia A, also known as factor VIII deficiency or classic hemophilia, is a
largely inherited bleeding disorder in which one of the proteins needed to form
blood clots in the body is missing or reduced. Hemophilia A, the most common
type of hemophilia, is caused by a deficient or defective blood coagulation
protein, known as factor VIII. Hemophilia A is characterized by prolonged or
spontaneous bleeding, especially into the muscles, joints, or internal organs.

 

About Hematology at Bayer

 

Bayer is committed to delivering science for a better life by advancing a
portfolio of innovative treatments. Bayer Hematology includes an approved
treatment for hemophilia A and compounds in development for hemophilia A, sickle
cell anemia, and other blood and bleeding disorders. Together, these compounds
reflect the company’s commitment to research and development in these disease
states.

 

About Dimension Therapeutics

 

Dimension Therapeutics is a gene therapy company focused on developing novel
therapies to treat rare diseases. Formed in 2013, the Dimension team comprises
biotech industry veterans and renowned thought leaders in gene therapy and rare
diseases. The company is focused on building its adeno-associated virus (AAV)
therapeutic discovery platform and advancing multiple gene therapy programs in
rare diseases, and is advancing a wholly-owned hemophilia B program towards
clinical development. Dimension’s partnerships with REGENX Biosciences and the
University of Pennsylvania provide Dimension with exclusive gene therapy
intellectual property and preferred access to multiple best-in-class AAV vector
systems. Dimension has been funded by Fidelity Biosciences and OrbiMed Advisors.
For more information, please visit www.dimensiontx.com.

 

About Bayer HealthCare

 

The Bayer Group is a global enterprise with core competencies in the fields of
health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup
of Bayer AG with annual sales of EUR 18.9 billion (2013), is one of the world’s
leading, innovative companies in the healthcare and medical products industry
and is based in Leverkusen, Germany. The company combines the global activities
of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions.
Bayer Healthcare’s aim is to discover, develop, manufacture and market products
that will improve human and animal health worldwide. Bayer HealthCare has a
global workforce of 56,000 employees (Dec. 31, 2013) and is represented in more
than 100 countries. More information is available at
http://www.healthcare.bayer.com. Our online press service is just a click away:
press.healthcare.bayer.com

 

Contact:

 

Diana Scholz, Tel. +49 30 468 193183
E-Mail: diana.scholz@bayer.com

 

 

 

*** Confidential Treatment Requested ***

2

--------------------------------------------------------------------------------

 

Folgen Sie uns auf Facebook: http://www.facebook.com./healthcare.bayer

 

ds(2014-0267E)

 

Forward-Looking Statements

 

This release may contain forward-looking statements based on current assumptions
and forecasts made by Bayer Group or subgroup management. Various known and
unknown risks, uncertainties and other factors could lead to material
differences between the actual future results, financial situation, development
or performance of the company and the estimates given here. These factors
include those discussed in Bayer’s public reports which are available on the
Bayer website at www.bayer.com. The company assumes no liability whatsoever to
update these forward-looking statements or to conform them to future events or
developments.

 

News Release Tweet

 

Text (max. 110 characters incl. spaces): Bayer HealthCare and Dimension
Therapeutics to Develop Novel Gene Therapy for Hemophilia A

BHC NEWS: >> more information about XY

 

 

*** Confidential Treatment Requested ***

3