Exhibit 10.2

[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II)
WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

Execution Copy

 

AMENDED AND RESTATED COLLABORATION AND LICENSE AGREEMENT

This AMENDED AND RESTATED COLLABORATION AND LICENSE AGREEMENT (“Agreement”) is
entered into as of June 3, 2019 (“A&R Effective Date”) by and between Ultragenyx
Pharmaceutical Inc., a corporation organized under the laws of the State of
Delaware, with offices at 60 Leveroni Court, Novato, CA 94949 (“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 Therapeutics, Inc. was 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, as of March 31, 2019, Dimension Therapeutics, Inc. has been merged with
and into Ultragenyx Pharmaceutical Inc., and Dimension Therapeutics, Inc. has
ceased its separate corporate existence;

WHEREAS, as a result of such merger, references made to “Dimension” herein shall
be treated as references to Ultragenyx Pharmaceutical Inc.;

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;

WHEREAS, the Parties are party to that certain Collaboration and License
Agreement, dated as of June 18, 2014 (such agreement, the “Original Agreement”,
and the date thereof, the “Original Effective Date”), under which the Parties
entered into a collaboration for the purpose of researching, developing and
commercializing adeno-associated virus based gene therapy products for treatment
of hemophilia A; and

WHEREAS, the Parties desire to amend and restate the Original Agreement in its
entirety and replace the Original Agreement with this Agreement.

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:

 

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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.

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

 

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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.  

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 develop
a GT Product and 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 medical, ethical and 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

 

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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 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.  

 

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1.17“Dimension Know-How” means any Know-How that (a) is Controlled by Dimension
or any of its Controlled Affiliates as of the Original Effective Date or comes
into the Control of Dimension or any of its Controlled Affiliates after the
Original 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 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 Original 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 Original
Effective Date or that come into the ownership or Control

 

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of Dimension or its Controlled Affiliates after the Original 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 in the Joint Patents.  Dimension Patents as of the Original
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.

1.21Intentionally Omitted.

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 [***] Dollars ($[***]), 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

 

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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.

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.

 

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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.

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, minus all Post-Administration Antihemophilic Factor
administered 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.

 

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

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 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[***] imposed 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,

 

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continuations-in-part, divisionals, renewals and all patents granted thereon,
and all reissues, 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“POC Data” means the data from the POC Trial necessary to assess
Demonstration of Clinical POC (whether or not there is a subsequent positive
determination of Demonstration of POC).  

1.55“Post-Administration Antihemophilic Factor” means, [***].

1.56“Proof of Concept Trial” or “POC Trial” means the Phase I human proof of
concept trial in patients for a GT Product as described in the First IND (as
defined in Section 2.13). For clarity, the protocol for the POC Trial may be
amended provided that the part of the POC Trial in which the POC Data are
generated shall not be amended in such a way that it adversely impacts the
timing or generation of the POC Data.

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

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

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

1.60“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);

 

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

1.61“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.

1.62“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.

1.63“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 [***]. The Research Budget as of the A&R Effective Date is set forth in
Exhibit D-3.

1.64“Research Plan” means the research plan addressing the activities to be
performed hereunder, and as such research plan may be amended in writing 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 the Parties, including the pre-clinical and regulatory work necessary to
commence the POC Trial and clinical work necessary for receipt of the POC Data,
(c) the primary and secondary endpoints of the POC Trial, (d) manufacturing /
CMC development for purposes of providing the POC Trial Material (as defined
below), (e) projected timelines for completion of the described activities, and
(f) the Research Budget.  The Research Plan as of the A&R Effective Date is set
forth in Exhibit D-1.   

1.65“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 one such Licensed
GT Product forward into the POC Trial and receipt of the POC Data, pursuant to
the Research Plan during the Research Term.

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

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

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

1.69“Sublicensed Know-How” means any Know-How that (a) is Controlled by
Dimension as of the Original Effective Date or that comes into the Control of
Dimension after the Original 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 POC Trial
Material or 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

 

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the foregoing criteria; and provided further that “Sublicensed Know-How” does
not include any Patent Rights.  

1.70“Sublicensed Patents” means (a) the Patent Rights listed in Exhibit A, and
(b) all other Patent Rights that cover or claim any POC Trial Material, 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 Original Effective
Date or that come into the Control of Dimension after the Original Effective
Date and during the 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.  

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

1.72“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.

1.73“Territory” means the entire world.

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

1.75 “[***] 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.

1.76“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 during the
Research Term for the purpose of researching and developing, until Demonstration
of Clinical POC, of at least one GT Product for use in the Field, which Bayer
shall have the exclusive right to further develop, seek Regulatory Approval for,
and if successful, Commercialize in the Territory, all in accordance with this
Agreement. To that end, under the oversight of the JSC and JRDC, Dimension will
be responsible for performing those research and development activities

 

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allocated to it 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 and shall conduct the POC Trial, including
distributing in finished form the POC Trial Material for the conduct thereof.
Except as otherwise agreed by the Parties pursuant to Section 3.4, following
completion of the transition plan set forth in Exhibit G (the “Transition
Plan”), Bayer will be solely (except as expressly stated in this Agreement,
including in Section 3.4) responsible, at its own cost, for performing any
remaining activities set forth in the Research Plan and all subsequent
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.  

2.2.1During the Research Term and subject to the oversight of the JRDC,
Dimension shall be responsible only for carrying out, by itself or through a
Third Party, the tasks assigned to Dimension 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. To the extent that tasks are allocated to Bayer under the Research
Plan, it shall use Commercially Reasonable Efforts in the performance of such
tasks.

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 or Bayer, as the holder of the First IND (as defined in
Section 2.13), 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 the Parties have 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 as of the A&R Effective Date is set forth
in Exhibit D-1.  Within [***] after the Original 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.  The Operating Plan
as of the A&R Effective Date is attached hereto as Exhibit D-2 and forms 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

 

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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) each Party 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 a [***] basis, the JRDC shall review
and update as needed the then-current Research Plan.  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. Following transfer of the First IND
the need for unanimous approval shall no longer apply and Dimension shall not be
required to perform any activities without its consent, to be granted or
withheld in Dimension’s sole discretion.

2.3.4Major Amendments to the Research Budget.  The Parties agree and acknowledge
that (a) the Research Budget as of the Original 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 [***] overall (or
with respect to any given calendar year), 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. Following transfer of the First IND the need for unanimous
approval shall no longer apply and Dimension shall not be required to perform
any activities without its consent, to be granted or withheld in Dimension’s
sole discretion.

 

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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 and
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 Original Effective Date with respect to the good faith estimate and
assumptions in the Research Budget regarding costs associated with process
transfer and manufacturing of clinical supplies by Dimension’s contract
manufacturer 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). Bayer may engage a subcontractor in the performance of Bayer’s
obligations under the Research Plan pursuant to this Section 2.4, mutatis
mutandis.

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 its activities
under the

 

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Research Plan, which estimate will be consistent with the applicable Operating
Plan and Research Budget. Within [***] following the [***], 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.

Invoices will be sent to Bayer at the following address:

 

Bayer HealthCare

Pharma West Coast

PO Box 416

Pittsburgh PA 15230

USA

 

2.5.2Intentionally Omitted.  

2.5.3Cost Overruns.  If the Parties determine that Dimension’s costs and
expenses for [***] in performing its activities under the Research Plan 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 [***] days of receipt by
Dimension of the next Milestone Payment stated in Section 6.2, if such Milestone
Event is achieved. The foregoing proviso in the previous sentence shall not
apply with respect to the Research Budget or other costs or expenses incurred on
or after the A&R Effective Date.  For clarity, a Cost Overrun is intended to be
an increase to the costs of the Research Plan arising from an oversight or
failure on the part of Dimension to budget its activities correctly or
efficiently, and not an increase to such costs arising from changes in the
nature and scope of activities performed under the Research Plan or changes to
the underlying assumptions regarding such activities and their costs, which are
addressed under Section 2.3.4.  Bayer acknowledges and agrees that, as of the
A&R Effective Date, there are no Cost Overruns and that Dimension will not owe
any reimbursement to Bayer pursuant to this Section 2.5.3.

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 [***] 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.  

 

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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.

2.7Pre-Clinical and Clinical Supplies.  As part of the Research Plan, until
transfer of manufacturing responsibilities as defined in the Transition 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.  Unless otherwise agreed by the Parties, Dimension shall
be responsible for, and shall compile, submit and shall initially have ownership
of, the IND filed by or on behalf of Dimension for any GT Product or component
thereof, necessary in order to conduct its activities under the Research Plan.
Notwithstanding that Dimension will be the initial holder of the First IND and
will transfer all sponsor obligations to Bayer for the POC Trial, Dimension
acknowledges that to the extent imposed by applicable Law, for the period of
time that Dimension is the holder of the First IND, Dimension will have certain
responsibilities for information and support related to the POC Trial and owed
to Bayer in Bayer’s role as bearing the responsibilities of the sponsor of 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 such 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 such GT Product. It is intended that at a time
mutually agreed upon by the Parties and as described in the Transition Plan,
Dimension shall assign and transfer to Bayer, at Bayer’s expense, the First IND.
Following such assignment and transfer, Bayer shall assume responsibility for
communicating and interacting with all Regulatory Authorities. 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. Notwithstanding the foregoing, title to all
POC Trial Material will pass to Bayer upon delivery of the same, such delivery
to occur Ex Works (the facility of the relevant manufacturer). “POC Trial
Material” means the GT Product made available by or on behalf of Dimension to
Bayer in bulk drug product form for purposes of conducting the POC Trial. Bayer
hereby agrees to use the POC Trial Material solely for purposes of conducting
the POC Trial and for any additional activities that are relevant to the
development

 

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of a Licensed GT Product in accordance with this Agreement.  Bayer acknowledges
that Bayer will be responsible for secondary packaging, secondary labeling and
clinical distribution of the POC Trial Material.

2.10Research Records and Reports.  Each Party 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 purposes. Each
Party shall have the right, during normal business hours and upon reasonable
advance notice, to review and copy all such records maintained by the other
Party and to obtain access to the originals in accordance with the terms of the
Quality Agreement (as defined below) 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, the Parties will discover and develop [***] GT Produc[***]
and the Parties will coordinate to undertake the POC Trial for [***] GT Product,
which [***] GT Product, upon receipt of the POC Data, shall be deemed a
“Licensed GT Product,” after which point, Bayer’s licenses set forth in Section
5.1 (a) and (b) shall apply, and Bayer shall have sole responsibility for
further development, manufacture and Commercialization of such Licensed GT
Product.  For clarity, any POC Trial Material that remains following receipt by
a Party of POC Data will be Licensed GT Product and Bayer may use and dispose of
the same in accordance with this Agreement.

2.11.2Failure to Achieve POC.  In the event [***] Licensed GT Product is the
subject of the 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 Demonstration of
Clinical POC, 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
the [***] Licensed GT Product or a 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 Plan remains in place) agree a new
Research Plan and Research Budget, and [***], and as necessary the Parties shall
extend the Research Term or reinstate a Research Term to accommodate such
activities, and any such additional GT Product as to which such an additional
POC Trial is conducted

 

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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 receipt by a
Party of POC Data for the Licensed GT Product, Bayer 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 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.

2.12Transition Plan.  Without limiting Dimension’s obligations under any
agreement reached by the Parties pursuant to Section 3.4, each Party will
conduct the activities allocated to it in the Transition Plan.  For the
avoidance of doubt, Dimension shall, [***], in accordance with the Transition
Plan, 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.  

2.13First IND.  “First IND” means IND # 18124 submitted by or on behalf of
Dimension to the FDA on or about April 12, 2018, as may be amended from time to
time.

2.14Amendment and Restatement.  The Parties hereby acknowledge and agree that
this Agreement amends and restates the Original Agreement in its entirety and
the Original

 

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Agreement is replaced with and superseded by, this Agreement.  Any activities
conducted under the Original Agreement shall be deemed to have been conducted
under this Agreement.

Article 3:  LATER STAGE DEVELOPMENT AND COMMERCIALIZATION

3.1General Responsibilities.  Following completion of the Transition Plan and
except as otherwise agreed by the Parties pursuant to Section 3.4, Bayer shall
be solely responsible for (i) the planning and conduct of all later development
of such GT Product or Licensed GT Product in the Field in the Territory, (ii)
all regulatory submissions and approvals (including all INDs and MAAs) for such
GT Product or 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.  

3.2Development Activities.

3.2.1Bayer’s Efforts.  Bayer, itself or through one or more Affiliates or
Sublicensees, shall use Commercially Reasonable Efforts to conduct and complete
the POC Trial, 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 (except as
stated in Exhibit D-4) 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 GT
Product or 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 with respect to
obtaining Regulatory Approval of the GT Product or 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 GT
Product or Licensed GT Product.

 

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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.

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.  Following delivery of the POC Trial Material in
accordance with the Transition Plan and that certain Quality Agreement entered
into by and between the Parties or any of their Affiliates, dated on or about
April 25, 2018 (the “Quality Agreement”), 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,
Dimension shall provide the support outlined in Exhibit D-4, and shall negotiate
in good faith an agreement to provide reasonable additional support and
assistance as Bayer might consider to be necessary in connection with the
manufacturing process. Dimension shall not be obligated to provide any such
additional support prior to the Parties entering into a written agreement with
respect to the same, which shall provide for reasonable compensation to be
paid.  

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 Original 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

 

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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 every [***] 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 Original
Effective Date of this 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, subject in all events to Sections 2.3.3 and
2.3.4, (a) until transfer of the First IND to Bayer, 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) following
transfer of the First IND to Bayer, [***] 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.  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

 

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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 Original Effective Date, but no later
than [***] following the Original 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 Original 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 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,

 

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(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
the sponsor of the POC Trial to the 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.  

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

 

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Party to the JSC for resolution, in which forum, until transfer of the First IND
to Bayer, Dimension’s representatives to the JSC 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. Following transfer of
the First IND to Bayer, subject in all events to Sections 2.3.3 and 2.3.4, [***]
representative shall have the final say with respect to such decision or
dispute.

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 Regulatory
Approval.  The JPT shall meet at least [***] 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

 

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Treatments, solely in the Field; (b) a non-exclusive, sublicenseable,
non-transferable (except as provided in Section 13.2), [***] license under the
Dimension Manufacturing Patents to manufacture or have manufactured (i) the GT
Product that comprises the POC Trial Material, solely for purposes of conducting
subsequent clinical trials of such GT Product, (ii) the Licensed GT Product,
(iii) Licensed Treatment and/or (iv) any Compound/Vector used therein, in each
case ((i)-(iv)), solely in the Field; and (c) a non-exclusive,
non-sublicenseable, non-transferable (except as provided in Section 13.2), [***]
license under the Dimension POC Technology to use the POC Trial Material solely
to conduct the POC Trial and as permitted pursuant to Section 2.9. “Dimension
POC Technology” means (i) 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 A&R Effective
Date or that come into the ownership or Control of Dimension or its Controlled
Affiliates after the A&R Amendment Effective Date and prior to the completion of
the POC Trial (other than through the grant of a license by Bayer hereunder),
and (D) cover the use of the POC Trial Material in the POC Trial and (ii) any
Know-How that (A) is Controlled by Dimension or any of its Controlled Affiliates
as of the A&R Amendment Effective Date or comes into the Control of Dimension or
any of its Controlled Affiliates after the A&R Amendment Effective Date and
prior to the completion of the POC Trial (other than through the grant of a
license by Bayer hereunder), (B) is reasonably necessary or useful for the use
of the POC Trial Material in the POC Trial and as permitted pursuant to Section
2.9, 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 Dimension under the ReGenX Agreement or another agreement with ReGenX.

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 or Dimension POC
Technology. Notwithstanding anything to the contrary in this Agreement,
Dimension may use and permit 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 under the Licensed Technology 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

 

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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.

5.5Government 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.  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 term.

(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

 

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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:

(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 5.7.1b) 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

 

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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.

5.11.2Bayer.  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 any [***], other than the Licensed GT
Products or any Compound/Vector used therein under this Agreement.

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.  

 

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5.12.2Right of First Notice.  If, during the period commencing on [***] and
ending on the [***] (“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 [***]. The Parties hereby acknowledge
and agree that Dimension fulfilled its obligations under this Section 5.12.2
with respect to the entire world prior to the A&R Effective Date.

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 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 Original
Effective Date.  

 

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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

[***]

Five Million Dollars ($5,000,000)

2

[***]

Ten Million Dollars ($10,000,000)

3

[***]

[***] Dollars

4

[***]

[***] Dollars

5

[***]

[***] Dollars

6

[***]

[***] Dollars

7

[***]

[***] Dollars

8

[***]

[***] Dollars

 

Total

[***] Dollars

 

Each milestone payment is payable [***] Dollars, 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 [***] Dollars [***] Dollars 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 GT 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 GT 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 [***], then all development milestone events relating to [***] shall
be deemed to have been met.  To that end, if

 

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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, [***].

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

 

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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 [***] 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 Original 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 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:

 

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

(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 [***] following the month in which the invoice was
received. If invoices are received by Bayer at the below address after [***],
then payments shall be made by the [***].

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 [***] days 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 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

 

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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

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:

Wire Transfer Instructions

[***]

[***]

[***]

[***]

[***]

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 IFRS.

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

 

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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 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
complete the POC Trial and 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 clinical development and
regulatory activities by Bayer and its Affiliates and Sublicensees with respect
to the POC Trial Material or Licensed GT Product, as applicable.

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 conduct
of the POC Trial, to the extent relating to obligations that have been allocated
to it, and 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

 

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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

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.  

 

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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 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;

 

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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 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

 

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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, during or 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 GT Product that comprises the POC
Trial Material or Licensed GT Product in the Field in the Territory Bayer may
terminate this Agreement upon [***] notice.

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 [***] days after written notice from Dimension to Bayer unless within
such [***] days Bayer or its Affiliates causes such Patent Challenge to
terminate.  “Patent Challenge” means any [***].  

9.7Termination for Insolvency.

 

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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.

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

 

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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 and Dimension POC 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;

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 the POC Trial Material or 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 at Bayer’s expense 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 such clinical trials 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.

9.9.4If 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 POC Trial Material, Licensed GT Products or
any Licensed Treatments as they were being developed or Commercialized at the
time of termination, solely in the

 

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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 or Dimension POC Technology to the extent such
patents, Know-How (including all data and regulatory submissions), or other
intellectual property pertains to the POC Trial Material, Licensed GT Products
or Licensed Treatments that were being developed or Commercialized by Bayer at
the time of 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 POC Trial Material or Licensed
GT Products as then being developed or Commercialized containing any expression
construct provided by Dimension to Bayer as part of the Dimension POC Technology
or 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 POC
Trial Material, 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.  

9.9.5If termination occurs prior to completion of the POC Trial for whatever
reason, Bayer shall transfer to Dimension or its designee the First IND together
with any of its foreign counterparts, including any supplements or amendments
that may exist as at the effective date of termination.

9.9.6The 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.

9.9.7Each 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

 

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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.

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

 

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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 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

 

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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:

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, [***].

 

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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 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 [***], shall
[***], including in the event that, [***]. In prosecuting any such Product
Infringement, [***].

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 [***], shall [***],
including in the event that, [***].

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 [***], 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 [***]
and [***], [***] 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.  

10.8.2Without 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 Original 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 Original
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 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.

 

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11.2Additional Representations and Warranties of Dimension.  Dimension
represents and warrants as of the Original 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 Original Effective
Date, and to Dimension’s knowledge, all Licensed Know-How in existence as of the
Original 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 patent offices 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
Original 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 Original 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
Original Effective Date; provided, however, that Dimension makes no
representation in this Section 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 as of the Original
Effective Date, no Third Party is infringing or has infringed any Licensed
Patents or has misappropriated any Licensed Know-How;

 

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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.

11.2.10.1As of the Original Effective Date, Dimension 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 Original Effective Date.

11.2.10.2Dimension represents and warrants to Bayer that, as of the Original
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.  

11.2.10.3As of the Original Effective Date, Dimension further covenants and
agrees that (a) it will take all steps necessary to maintain in full force and
effect, the ReGenX Agreement with respect to the Field 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) that relates to the Field; (d) it will promptly
send to Bayer copies of all other material correspondence related to the Field
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.  

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

 

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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.

11.4Disclaimer of Warranties, Damages.  EXCEPT AS SET FORTH IN SECTIONS 11.1 AND
11.2, THE Dimension POC Technology, LICENSED TECHNOLOGY, POC TRIAL MATERIAL,
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 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.

 

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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 Dimension POC
Technology, Licensed Technology, POC Trial Material, 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 product liability or other claim of any kind related to the use of
defective POC Trial Material, but solely to the extent the POC Trial Material is
defective due to circumstances following delivery of the POC Trial Material to
Bayer in accordance with that certain letter agreement by and between the
Parties, dated May 23, 2018 (the “Letter Agreement”)

(c)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

(d)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 9.9.4.

 

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11.5.2By 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) supply by Dimension’s contract manufacturer of defective POC Trial
Material, but solely to the extent the POC Trial Material is defective due to
circumstances prior to delivery of the POC Trial Material to Bayer in accordance
with the Letter Agreement, (iii) any breach by Dimension (or its Affiliates) of
its representations, warranties, or obligations of this Agreement; and (iv)
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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11.6Insurance.  Within [***] of the Original 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 such 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.

13.2.2Notwithstanding 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).

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.

13.3Waiver.  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.

13.4Notices.  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:

Ultragenyx Pharmaceutical Inc.

60 Leveroni Court

Novato, CA 94949

Attn: SVP, Business Development and Alliance Management

Ultragenyx Pharmaceutical Inc.

60 Leveroni Court

Novato, CA 94949

Attn: General Counsel

If for Bayer:

with a copy to:

Bayer HealthCare LLC
455 Mission Bay Boulevard South
San Francisco, CA 94158
Attn:  Alliance Manager
Facsimile: [***]

Bayer HealthCare LLC

800 Dwight Way

Berkeley, CA 94710

Attn: Law & Patents

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

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

 

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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 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 Fidelity Biosciences Corp. (and then
disclosed by Fidelity Biosciences Corp. to Bayer) pursuant to that certain
Confidentiality Agreement dated September 10, 2012 between Dimension and
Fidelity Biosciences Corp. or pursuant to any other agreements between them will
be deemed “Confidential Information” under this Agreement (unless and until it
falls within one of the exclusions set forth in Section 1.11).  For the
avoidance of doubt, this Agreement amends and restates the Original Agreement
and the Original Agreement shall be of no force or effect as of the A&R
Effective Date.  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 POC
Trial Material and 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 Dimension POC
Technology, Sublicensed Patents and Dimension Patents to

 

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

 

be enforced to their full extent in any country where POC Trial Material or
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.

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.

ULTRAGENYX PHARMACEUTICAL INC.

BAYER HEALTHCARE LLC

By:   /s/ Karah Parschauer

By:  /s/ Chris Haskell

Name:  Karah Parschauer

Name: Chris Haskell

Title:   VP & Secretary

Title:   VP and Site Head of West Coast Innov.        Center

 

 

 

 

 

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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:

 

•

[***]

 

•

[***]

 

•

[***]

 

•

[***]

 

 

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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 5.12).  

 

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.  

 

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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.

 

 

 

 

 

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Exhibit D-1
Research Plan

 

[see attached]

 

 

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Exhibit D-2

Operating Plan

 

[see attached]

 

 

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Exhibit D-3
Research Budget

 

 

[see attached]

 

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Exhibit D-4
Regulatory and Manufacturing Support

 

[see attached]

 

 

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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

 

o

[***]

 

o

[***]

 

o

[***]

 

 

•

Pre-existing antibodies against [***]

 

o

[***]

 

o

[***]

 

 

•

Feasibility of highest dose level tested

 

o

[***]

 

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Exhibit F

 

Press Releases

[see attached]

 

 

 

 

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Exhibit G

 

Transition Plan

Function

Activity

Projected Completion Date*

Regulatory

[***]

[***]

[***]

CMC

[***]

[***]

Pharmaceutical Development

[***]

[***]

Nonclinical

 

[***]

[***]