Exhibit 10.2

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***],
HAS BEEN OMITTED BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
DATED AS OF MARCH 31, 2015

BY AND BETWEEN

BRICKELL BIOTECH, INC. AND

KAKEN PHARMACEUTICAL CO., LTD.

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

TABLE OF CONTENTS
Page

ARTICLE 1
DEFINITIONS    1

ARTICLE 2
LICENSES    13

2.1
License Grants    13

2.2
Additional Licensing Provisions    14

2.3
Performance by Affiliates, Subcontractors and Sublicensees    14

2.4
[***]    16

2.5
Field Expansion    16

2.6
Restrictive Covenants    16

2.7
[***] License Agreement    17

2.8
Disclaimer of Patent Application from License    18

ARTICLE 3
GOVERNANCE    18

3.1
Development and Regulatory Committee    18

3.2
Limits on JDRC and Committee Authority    20

3.3
Decision Making    20

3.4
Actions    20

3.5
Exchange of Information    20

3.6
Minutes of JDRC Meetings    20

ARTICLE 4
DEVELOPMENT    21

4.1
Overview    21

4.2
Development Activities, [***] Clinical Trials, Missed Development Dates and
Compliance    22

4.3
Development Plan    23

4.4
Development Costs    24

4.5
Records, Reports and Information    25

4.6
Development Data    25

4.7
Right of Reference and Use    26

4.8
Access to Records    26

4.9
Rights to Audit    26

4.10
Dispute Resolution Procedures    27

ARTICLE 5
REGULATORY    27

5.1
Regulatory Filings and Regulatory Approvals    27

5.2
Communications    29

 
i
 

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

TABLE OF CONTENTS
Page

5.3
Adverse Event Reporting; Safety Data Exchange and Medical Inquiries    29

5.4
Regulatory Authority Communications Received by a Party    30

5.5
Recall, Withdrawal, or Market Notification of Product    30

ARTICLE 6
COMMERCIALIZATION    31

6.1
Commercialization in the Field in the Territory    31

6.2
Commercialization Reports    31

6.3
Promotional Materials    32

6.4
Commercialization Data    32

6.5
Global Branding Strategy    32

ARTICLE 7
SUPPLY    33

7.1
Supply by [***]    33

7.2
Phase III Clinical Supply Agreement, Commercial Supply Agreement and Quality
Agreements    33

7.3
Alternative Source of Phase III Clinical and Trial Commercial Supply    34

ARTICLE 8
PAYMENTS    34

8.1
Upfront Payment    34

8.2
Milestone Payments    34

8.3
Royalties    35

8.4
Taxes and Withholding    36

8.5
Currency Conversion    36

8.6
Late Payments    37

8.7
Records; Audits    37

ARTICLE 9
INTELLECTUAL PROPERTY MATTERS    38

9.1
Ownership of Intellectual Property    38

9.2
Disclosures; Disputes Regarding Inventions    38

9.3
Patent Filings, Prosecution and Maintenance    39

9.4
Defense and Enforcement of Patents    40

9.5
Patent Marking    44

9.6
Patent Challenge    44

ARTICLE 10
REPRESENTATIONS, WARRANTIES AND COVENANTS    44

10.1
Mutual Representations and Warranties    44

10.2
Additional Representations, Warranties and Covenants of Brickell    45

 
ii
 

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

TABLE OF CONTENTS
Page

10.3
Brickell Product Development    47

10.4
Disclaimer    47

10.5
No Other Representations or Warranties    47

ARTICLE 11
INDEMNIFICATION    47

11.1
Indemnification by Brickell    47

11.2
Indemnification by Kaken    47

11.3
Indemnification Procedures    48

11.4
Limitation of Liability    49

11.5
Insurance    50

ARTICLE 12
CONFIDENTIALITY    50

12.1
Confidential Information    50

12.2
Confidentiality Obligations    51

12.3
Permitted Disclosure and Use    51

12.4
Notification    52

12.5
Publicity; Filing of this Agreement    52

12.6
Publication    53

12.7
Use of Names    53

12.8
Survival    53

ARTICLE 13
TERM AND TERMINATION    53

13.1
Term    53

13.2
Termination for Breach    54

13.3
Termination as a Result of Bankruptcy    54

13.4
Termination by Kaken    54

ARTICLE 14
EFFECTS OF TERMINATION AND EXPIRATION    54

14.1
Termination By Brickell and Certain Terminations by Kaken    54

14.2
Termination by Kaken    56

14.3
Expiration of this Agreement    56

14.4
Accrued Rights    57

14.5
Survival    57

14.6
Remedies in Lieu of Termination    57

14.7
Rights in Bankruptcy    57

ARTICLE 15
DISPUTE RESOLUTION    58

 
iii
 

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

TABLE OF CONTENTS
Page

15.1
General    58

15.2
Disputes Arising Between the Parties    58

15.3
Dispute Resolutions    58

15.4
Patent and Trademark Dispute Resolution    58

15.5
Arbitration    58

15.6
Injunctive Relief    59

ARTICLE 16
GENERAL TERMS    59

16.1
Entire Agreement; Amendment    59

16.2
Force Majeure    59

16.3
Notices    59

16.4
No Strict Construction; Interpretation    60

16.5
Assignment and Delegation    60

16.6
Compliance with Applicable Law; Further Actions    61

16.7
Third Party Beneficiary    61

16.8
Severability    61

16.9
No Waiver    61

16.10
Independent Contractors    61

16.11
English Language; Governing Law    61

16.12
Counterparts    62

List of Schedules
Schedule 1.5 [***] Patents Schedules
Schedule 2.7 [***] License Agreement
Schedule 4.3.2 Initial Development Plan Overview
Schedule 7 Terms for Phase II and Phase III Clinical Supply Agreement

 
iv
 

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

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
This License, Development and Commercialization Agreement (this “Agreement”),
dated as of March 31, 2015 (the “Effective Date”), is made by and between
Brickell Biotech, Inc., a Delaware corporation (“Brickell”) and Kaken
Pharmaceutical Co. Ltd., a company legally organized and existing under the laws
of Japan (“Kaken”). Brickell and Kaken are sometimes referred to herein
individually as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, Brickell has developed and is currently further developing a
pharmaceutical product hereinafter defined as the Product for the treatment of
[***];
WHEREAS, Kaken has significant experience in the development and
commercialization of pharmaceutical products in the Territory; and WHEREAS,
Kaken and Brickell desire to establish a collaboration for the further
development and commercialization of the Product in the Field in the Territory.
NOW THEREFORE, in consideration of the foregoing premises and the mutual
promises, covenants and conditions contained in this Agreement, the Parties
agree as follows:
ARTICLE 1
DEFINITIONS
As used in this Agreement, the following initially capitalized terms shall have
the meanings set forth in this Article 1 or as otherwise defined elsewhere in
this Agreement:
1.1    “Affiliate” means any Person directly or indirectly controlled by,
controlling or under common control with, a Party, but only for so long as such
control shall continue. For purposes of this definition, “control” (including,
with correlative meanings, “controlled by”, “controlling” and “under common
control with”) shall be presumed to exist with respect to a Person in the event
of the possession, direct or indirect, of (i) the power to direct or cause the
direction of the management and policies of such Person (whether through
ownership of securities, by contract or otherwise), or (ii) at least fifty
percent (50%) of the voting securities or other comparable equity interests. The
Parties acknowledge that, in the case of certain entities organized under the
laws of certain countries outside of the United States, the maximum percentage
ownership permitted by law for a foreign investor may be less than fifty percent
(50%), and that in such case, such lower percentage shall be substituted in the
preceding sentence, provided that such foreign investor has the power to direct
or cause the direction of the management and policies of such Person. For the
avoidance of doubt, neither of the Parties shall be deemed to be an “Affiliate”
of the other.
1.2    “[***] License Agreement” means that certain License Agreement, dated as
of [***], by and among [***], as amended by [***].

- 1 -

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

1.3    “Brickell Invention” means an Invention that is made solely, or jointly
with a Third Party, by an employee of Brickell or any of its Affiliates or a
Person under an obligation of assignment to Brickell or any of its Affiliates in
connection with the performance of Brickell’s obligations pursuant to this
Agreement.
1.4    “Brickell Know-How” means all Know-How that (i) is Controlled by Brickell
or any of its Affiliates as of the Effective Date which is necessary or
reasonably useful for the Development or Commercialization of the Product in the
Field in the Territory or Manufacture of the Product in the Field, including the
Existing Development Data, or (ii) comes under the Control of Brickell during
the Term (but excluding Brickell Inventions), which is necessary for the
Development or Commercialization of the Product in the Field in the Territory or
the Manufacture of the Product in the Field, including the New Brickell
Development Data.
1.5    “Brickell Patent” means any Patent that (i) is Controlled by Brickell or
any of its Affiliates as of the Effective Date, including the Patents listed in
Schedule 1.5, which is necessary or reasonably useful for the Development or
Commercialization of the Product in the Field in the Territory or the
Manufacture of the Product in the Field, or (ii) comes under the Control of
Brickell during the Term (but excluding Brickell Collaboration Patents), which
is necessary for the Development or Commercialization of the Product in the
Field in the Territory or the Manufacture of the Product in the Field.
1.6    “Brickell Technology” means the Brickell Patents, Brickell Collaboration
Patents, Brickell Know-How and Brickell Inventions.
1.7    “Business Day” means a day (other than Saturday or Sunday) on which banks
are open for business in Tokyo, Japan and in Miami, Florida, U.S.
1.8    “Change of Control” means, with respect to a Person, any of the following
events: (i) any Person is or becomes the beneficial owner (except that a Person
shall be deemed to have beneficial ownership of all shares that any such Person
has the right to acquire, whether such right which may be exercised immediately
or only after the passage of time), directly or indirectly, of a majority of the
total voting power represented by all shares of such Person’s outstanding
capital stock; (ii) such Person consolidates with or merges into another
corporation or entity, or any corporation or entity consolidates with or merges
into such Person, other than (A) a merger or consolidation which would result in
the voting securities of such Person outstanding immediately prior to such
merger or consolidation continuing to represent (either by remaining outstanding
or by being converted into voting securities of the surviving entity or any
parent thereof) a majority of the combined voting power of the voting securities
of such Person or such surviving entity or any parent thereof outstanding
immediately after such merger or consolidation, or (B) a merger or consolidation
effected to implement a recapitalization of such Person (or similar transaction)
in which no Person becomes the beneficial owner, directly or indirectly, of a
majority of the total voting power of all shares of capital stock of such Person
or (iii) such Person transfers all or substantially all of its assets to any
Person other than a wholly owned Affiliate of such Person.

- 2 -

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

1.9    “Clinical Trial” means human clinical studies in which the Product is
administered or otherwise evaluated in humans, including any Phase IV Clinical
Trials sponsored by either Party or co-sponsored by both Parties or investigator
initiated human clinical studies funded or otherwise supported by either Party
or both Parties.
1.10    “Commercialize”, “Commercializing” or “Commercialization” means all
activities directed to the marketing, promotion, selling or offering for sale of
a Product for an indication, including planning, market research, Pre-Marketing,
advertising, educating, marketing, promoting, importing, exporting, distributing
and post-marketing safety surveillance and reporting. For clarity,
“Commercialization” shall not include any activities related to clinical
research, Manufacturing or Development of the Product.
1.11    “Control” means, when used in reference to intellectual property, other
intangible property, or materials, that a Party owns or has a license or
sublicense to such intellectual property, other intangible property or
materials, and has the ability to grant a license or sublicense or other right
to use such intellectual property, other intangible property or materials, as
applicable, as provided for herein.
1.12    “Cover(ed)” means, with respect to any Patent and the subject matter at
issue, that, but for a license granted under a Valid Claim of such Patent, the
manufacture, development, use, sale, offer for sale or importation of the
subject matter at issue would infringe such Valid Claim.
1.13    “Develop”, “Developing” or “Development” means all activities relating
to research, non-clinical, preclinical and clinical trials (including
manufacture of Placebo), toxicology testing, statistical analysis and reporting,
preparation and submission of applications for Regulatory Approval of the
Product, necessary or reasonably useful or otherwise requested or required by a
Regulatory Authority as a condition or in support of obtaining or maintaining
all Regulatory Approvals for the Product and all other development-related
activities that are deemed by the JDRC to be commercially useful, but shall not
include any activities related to Commercialization or Manufacture.
1.14    “Development Activities” means those Development activities undertaken
by or on behalf of a Party or any of its Affiliates with respect to the Product
in the Field in the Territory set forth in the applicable Development Plan.
1.15    “Development Costs” means the costs and expenses incurred by a Party or
any of its Affiliates attributable to, or reasonably allocable to, the
Development Activities set forth in the applicable Development Plan.
1.16    “Dollar” means a U.S. dollar, and “$” shall be interpreted accordingly.
1.17    “Drug Substance” means [***].

- 3 -

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

1.18    “Ex-Territory Exclusive Development Activities” means those Development
activities that are necessary for obtaining or maintaining Regulatory Approval
for the Product in the Field outside the Territory other than U.S.-Japan
Development Activities.
1.19    “Facility” means, as applicable, a Party’s Manufacturing facility and
such other facilities used by such Party (or those of its Affiliates or Third
Party contractors) in the manufacture, packaging, labeling or storage of (a) the
Product or (b) materials utilized in the manufacture, packaging or labeling of
the Product, in each case, with respect to the Product for Development or
Commercialization in the Field in the Territory hereunder.
1.20    “FDA” means the U.S. Food and Drug Administration or its successor.
1.21    “Field” means the [***].
1.22    “First Commercial Sale” means the first sale of the Product in a given
country or other regulatory jurisdiction in the Territory by or on behalf of
Kaken, any of its Affiliates or sublicensees to a Third Party, [***], to the
extent required for sale of a Product in a given country or regulatory
jurisdiction, and any necessary labeling negotiations that may be required [***]
for such Product in such country or regulatory jurisdiction.
1.23    “GAAP” means generally accepted accounting principles in the United
States.
1.24    “Generic Version” means, with respect to the Product in a given country
in the Territory, a Third Party pharmaceutical product (other than the Product
hereunder) that: (i) contains the Drug Substance as the sole active ingredient
and (ii) is legally saleable as a substitute for the Product in such country.
1.25    “Good Clinical Practices” or “GCP” means all applicable Good Clinical
Practice standards for the design, conduct, performance, monitoring, auditing,
recording, analyses and reporting of clinical trials, including, as applicable,
(i) as set forth in European Commission Directive 2001/20/EC relating to the
implementation of good clinical practice in the conduct of clinical trials on
medicinal products for human use, and brought into law by European Commission
Directive 2005/28/EC laying down the principles and detailed guidelines for good
clinical practice for investigational medicinal products, (ii) the International
Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good
Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical
practice for trials on medicinal products in the European Union, (iii) the
Declaration of Helsinki (2004) as last amended at the 52nd World Medical
Association in October 2000 and any further amendments or clarifications
thereto, (iv) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of
Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New
Drug Application), as may be amended from time to time, and (v) the equivalent
Laws in any relevant country, each as may be amended and applicable from time to
time and in each case, that provide for, among other things, assurance that the
clinical data and reported results are credible and accurate and protect the
rights, integrity, and confidentiality of trial subjects.

- 4 -

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

1.26    “Good Laboratory Practices” or “GLP” means all applicable Good
Laboratory Practice standards, including, as applicable, (i) as set forth in
European Commission Directive 2004/10/EC relating to the application of the
principles of good laboratory practices, as may be amended from time to time as
well as any Rules Governing Medicinal Products in the European Community Vol.
III, ISBN 92.825 9619-2 (ex - OECD principles of GLP), (ii) the then-current
good laboratory practice standards promulgated or endorsed by the FDA as defined
in 21 C.F.R. Part 58, and (iii) the equivalent Laws in any relevant country,
each as may be amended and applicable from time to time.
1.27    “Good Manufacturing Practices” or “GMP” means all applicable Good
Manufacturing Practices including, (i) the applicable part of quality assurance
to ensure that products are consistently produced and controlled in accordance
with the quality standards appropriate for their intended use, as defined in
European Commission Directive 2003/94/EC laying down the principals and
guidelines of good manufacturing practice, (ii) the principles detailed in the
U.S. Current Good Manufacturing Practices, 21 C.F.R. Sections 210, 211, 601 and
610, (iii) the Rules Governing Medicinal Products in the European Community,
Volume IV Good Manufacturing Practice for Medicinal Products, (iv) the
principles detailed in the ICH Q7A guidelines, and (v) the equivalent Laws in
any relevant country, each as may be amended and applicable from time to time.
1.28    “Governmental Authority” means any multinational, national, federal,
prefectural, state, local, municipal or other governmental authority of any
nature (including any governmental division, subdivision, department, agency,
bureau, branch, office, commission, council, court or other tribunal), in each
case, having jurisdiction over the applicable subject matter.
1.29    “IFRS” means International Financial Reporting Standards, consistently
applied.
1.30    “IND” means the equivalent application of an Investigational New Drug
Application to the equivalent agency of the FDA in the Territory, such as a
clinical trial application (“CTA”) or a clinical trial exemption (“CTX”), the
filing of which is necessary to commence or conduct clinical testing of a
pharmaceutical product in humans in such jurisdiction.
1.31    “Invention” means any invention or discovery, as determined in
accordance with applicable Laws relating to inventorship in the country in which
such invention or discovery is made.
1.32    “Japanese GAAP” means generally accepted accounting principles in Japan.
1.33    “JPY” means Japanese Yen and “Y” shall be interpreted accordingly.
1.34    “JNDA” means a Japanese New Drug Application as defined in the
Pharmaceutical Affairs Law and the regulations promulgated thereunder.

- 5 -

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

1.35    “Joint Invention” means an Invention that is made jointly by an employee
of, or Person under an obligation of assignment to, each of Brickell and Kaken
or their respective Affiliates.
1.36    “Kaken Applied Know-How” means all Know-How that is (a) (i) Controlled
by Kaken or any of its Affiliates as of the Effective Date or comes under the
Control of Kaken or any of its Affiliates during the Term (other than as a
result of the licenses granted by Brickell to Kaken under this Agreement),
including the New Kaken Development Data, and (ii) incorporated by Kaken in the
Product prior to any termination of this Agreement or (b) a Kaken Invention.
1.37    “Kaken Applied Patent” means any Patent that (a) (i) is Controlled by
Kaken or any of its Affiliates as of the Effective Date or comes under the
Control of Kaken or any of its Affiliates during the Term (other than as a
result of the licenses granted by Brickell to Kaken under this Agreement) and
(ii) claims any Kaken Applied Know-How or (b) is a Kaken Collaboration Patent.
1.38    “Kaken Applied Technology” means the Kaken Applied Know-How and the
Kaken Applied Patents.
1.39    “Kaken Invention” means an Invention that is made, solely or jointly
with a Third Party, by an employee of Kaken or any of its Affiliates or a Person
under an obligation of assignment to Kaken or any of its Affiliates in
connection with the performance of Kaken’s obligations pursuant to this
Agreement.
1.40    “Know-How” means any proprietary data, results, material(s), technology,
and nonpublic information of any type whatsoever, in any tangible or intangible
form, including know-how, trade secrets, practices, techniques, methods,
processes, inventions, developments, specifications, formulations, formulae,
materials or compositions of matter of any type or kind (patentable or
otherwise), software, algorithms, marketing reports and plans, market research,
expertise, technology, test data (including pharmacological, biological,
chemical, biochemical, toxicological, preclinical and clinical test data),
analytical and quality control data, stability data, other study data and
procedures.
1.41    “Laws” means all laws, statutes, rules, regulations, directives,
decisions, ordinances of any Governmental Authority.
1.42    “Lien(s)” means any lien, encumbrance, security interest of any kind
whatsoever including, but not limited to, interests arising from options,
pledges, mortgages, indentures, security agreements, rights of first refusal or
rights of pre-emption, irrespective of whether such Lien arises under any
agreement, covenant, other instrument, the mere operation of statutory or other
Laws or by means of a judgment, order or decree of any court, judicial or
administrative authority, and also means any approval or consent required from a
Third Party to the exercise or full vesting of a right or title.

- 6 -

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

1.43    “Manufacture” or “Manufacturing” means all activities related to the
manufacturing of the Product, or any ingredient thereof (including the Drug
Substance), including manufacturing for clinical use or commercial sale,
in-process and Product testing, release of Product, quality assurance activities
related to manufacturing and release of Product, handling and storage of Product
and ongoing stability tests and regulatory activities related to any of the
foregoing; provided, however, that, for purposes of clarity, “Manufacture” [***]
unless mutually agreed to between the Parties.
1.44    “Manufacturing Cost” means, with respect to the Drug Substance, Product
or Placebo, the costs calculated in accordance with GAAP, Japanese GAAP or IFRS
that relate to the Drug Substance, Product or Placebo, respectively, that is
either (1) supplied by a Third Party or (2) Manufactured directly by a Party or
any of its Affiliates, determined in accordance with the Phase II Clinical
Supply Agreement, Phase III Clinical Supply Agreement or Commercial Supply
Agreement, as applicable.
1.45    “Manufacturing Development Activities” means development of test
methods, stability testing, formulation development, process development,
quality assurance activities, quality control activities, qualification and
validation activities, analytic process development, manufacturing process
validation, scale-up, and all other activities, including CMC-related
activities, necessary for or related to the Manufacture of the Product for use
in the Field.
1.46    “Manufacturing Party” means the Party performing Manufacturing
activities for the Product.
1.47    “Marketing Authorization Application” or “MAA” means an application to
the appropriate Regulatory Authority for approval to sell the Product (but
excluding Pricing Approval) in any particular country or regulatory
jurisdiction, including an NDA filed with the FDA in the United States and a
JNDA filed with the MHLW in Japan.
1.48    “Medical Science Liaison” means an individual who is employed by or on
behalf of Kaken or any of its Affiliates and who provides educational services
and other educational efforts directed towards the medical and/or scientific
community.
1.49    “MHLW’ means Japan’s Ministry of Health, Labor and Welfare.
1.50    “Net Sales” means the gross amount invoiced by or on behalf of Kaken or
any of its Affiliates (or any permitted distributors) or sublicensees on account
of sales of the Product, less the [***]:
(a)    [***];
(b)    [***];
(c)    [***]; and
(d)    [***].

- 7 -

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

A Product shall be considered [***]. In the event Kaken [***], and, in the
[***].
[***], provided that [***].
Net Sales amounts shall be determined from the books and records of Kaken, its
Affiliates and sublicensees maintained in accordance with Japanese GAAP.
1.51    “Patent Challenge” means the commencement of any interference or
opposition proceeding or other challenge to the validity or enforceability of,
or opposition to any extension of or the grant of a supplementary protection
certificate with respect to a Patent.
1.52    “Patents” means patents and patent applications and all substitutions,
divisions, continuations, continuations-in-part, any patent issued with respect
to any such patent applications, any reissue, reexamination, utility models or
designs, renewal or extension (including any supplementary protection
certificate) of any such patent, and any confirmation patent or registration
patent or patent of addition based on any such patent, and all counterparts
thereof in any country.
1.53    “Person” shall mean any corporation, limited or general partnership,
limited liability company, joint venture, trust, unincorporated association,
governmental body, authority, bureau or agency, any other entity or body, or an
individual.
1.54    “Phase I Clinical Trial” means a human clinical trial that is intended
to initially evaluate the safety and/or pharmokinetics of a product or that
would otherwise satisfy the requirements of 21 C.F.R. 312.21(a), or an
equivalent clinical trial in a country other than the United States.
1.55    “Phase II Clinical Trial” means a human clinical trial for which the
primary endpoints include a determination of dose ranges or an indication of
efficacy of a product in patients being studied as described in 21 C.F.R.
312.21(b), or an equivalent clinical trial in a country other than the United
States.
1.56    “Phase IIA Clinical Trials” means one (1) or more human clinical trials
to preliminarily evaluate efficiency and safety of a candidate drug in the
targeted patient population over a range of doses.
1.57    “Phase DE Clinical Trials” means one (1) or more controlled clinical
trial(s) to evaluate further the efficacy and safety of a candidate drug in the
targeted patient population and to define the optimal dosing regimen.
1.58    “Phase III Clinical Trials” means a clinical trial identified as a Phase
III clinical trial in the Development Plan and conducted as a pivotal trial for
purposes of filing a MAA for a Product that provides for the clinical study of
such Product on a sufficient number of patients to confirm with statistical
significance the efficacy, and confirm the safety of such Product, sufficient to
support such MAA for such Product.

- 8 -

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

1.59    “Phase IV Clinical Trials” means certain post-marketing studies to
delineate additional information about a pharmaceutical product’s risks,
benefits, and optimal use, commenced after receipt of regulatory approval for a
product in the indication for which such trial is being conducted.
1.60    “Placebo” means a substance or mixture of substances lacking presence of
Drug Substance, manufactured for purposes of control treatment in Clinical
Trials. For purposes herein, Placebo refers to finished but unlabeled form of
such substance.
1.61    “PMDA” means the Japanese Pharmaceuticals and Medical Devices Agency.
1.62    “Pre-Marketing” means all sales and marketing activities undertaken
prior to and in preparation for the launch of the Product in the Territory.
Pre-Marketing shall include market research, key opinion leader development,
advisory boards, medical education, disease-related public relations, health
care economic studies, sales force training and other pre-launch activities
prior to the First Commercial Sale of the Product in a given country or other
regulatory jurisdiction in the Territory.
1.63    “Pricing Approval” means the approval, agreement, determination or
decision from a Governmental Authority establishing the price and/or
reimbursement for the Product for sale in a given country or regulatory
jurisdiction, as required by applicable Law in such country or other regulatory
jurisdiction prior to the sale of the Product in such country or regulatory
jurisdiction.
1.64    “Product” means a [***] containing the Drug Substance [***].
1.65    “Product Approval” means the approval of a Governmental Authority
necessary for the marketing and sale of the Product in a given country or
regulatory jurisdiction, which may include the approval of an MAA (but shall not
include any Pricing Approvals).
1.66    “Product Complaint” means any written, verbal or electronic expression
of dissatisfaction regarding any Product sold by or on behalf of Kaken (or any
of its Affiliates or sublicensees) in the Territory, including reports of actual
or suspected product tampering, contamination, mislabeling or inclusion of
improper ingredients.
1.67    “Product Specifications” means those Manufacturing, performance, quality
control release, and packaging and labeling specifications for the Product in
the Territory, which are initially as set forth in the applicable Product
Approval for the Product or are otherwise required for a Clinical Trial.
1.68    “Promotional Materials” means all written, printed, video or graphic
advertising, promotional, educational and communication materials (other than
the Product labels and package inserts) for marketing, advertising and promoting
of the Product in the Field in the Territory, for use (i) by a sales
representative or a Medical Science Liaison or (ii) in advertisements, web sites
or direct mail pieces.

- 9 -

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

1.69    “Regulatory Approvals” means all necessary approvals (including INDs,
Product Approvals, Pricing Approvals and, in each case any supplements and
amendments thereto), licenses, registrations or authorizations of any
Governmental Authority, necessary for the manufacture, distribution, use,
promotion and sale of the Product in a given country or regulatory jurisdiction.
1.70    “Regulatory Authority” means, in a particular country or regulatory
jurisdiction, any applicable Governmental Authority involved in granting
Regulatory Approval in such country or regulatory jurisdiction, including, (i)
in the U.S., the FDA, and (ii) in Japan, the MHLW.
1.71    “Regulatory Costs” means the costs and expenses incurred by a Party or
any of its Affiliates attributable to, or reasonably allocable to, the
preparation, obtaining or maintaining of Regulatory Materials and Regulatory
Approvals for the Product, including any filing fees.
1.72    “Regulatory Data” means any and all research data, pharmacology data,
chemistry, manufacturing and control data, preclinical data, clinical data and
all other documentation submitted, or required to be submitted, to Regulatory
Authorities in association with Regulatory Filings for the Product (including
any applicable Drug Master Files (“DMFs”), Chemistry, Manufacturing and Control
(“CMC”) data, or similar documentation).
1.73    “Regulatory Exclusivity” means marketing or data exclusivity conferred
by the applicable Regulatory Authority in a country or jurisdiction on the
holder of a Product Approval for a pharmaceutical product in such country or
jurisdiction, including, regulatory data exclusivity, orphan drug exclusivity,
new chemical entity exclusivity and pediatric exclusivity.
1.74    “Regulatory Materials” means Regulatory Filings, notifications,
communications, correspondence, registrations, Regulatory Approvals and/or other
filings made to, received from or otherwise conducted with a Regulatory
Authority that are necessary in order to Develop, Manufacture, obtain marketing
authorization, market, sell or otherwise Commercialize the Product in a
particular country or regulatory jurisdiction. Regulatory Materials include
INDs, MAAs, presentations, responses, and applications for other Product
Approvals.
1.75    “Regulatory Filings” means any filings that are required for any
Regulatory Approval in the Territory.
1.76    “Royalty Term” means, [***].
1.77    “Territory” means [***].
1.78    “Territory Exclusive Development Activities” means those Development
Activities [***] that are necessary for obtaining or maintaining [***] for the
Product in the Field in the Territory.

- 10 -

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

1.79    “Third Party” means any Person other than Brickell or Kaken or their
respective Affiliates.
1.80    “U.S.” means the United States of America and its possessions and
territories.
1.81    “U.S.-Japan Development Activities” means all Development activities
that are necessary solely for [***], which for clarity, include [***].
1.82    “U.S.-Japan Phase III Clinical Trial” mean the Phase III Clinical Trial
conducted for purposes of [***] for which Brickell shall be responsible for
[***] and for which Kaken shall be responsible for [***] and the other details
of which shall be set forth in the Development Plan.
1.83    “U.S.-Japan Phase III Development Activities” means Development
Activities related to the performance of the U.S.-Japan Phase III Clinical
Trial.
1.84    “Valid Claim” means (a) a claim of an issued and unexpired Brickell
Patent that (i) has not been rejected, revoked or held to be invalid or
unenforceable by a court or other authority of competent jurisdiction, from
which decision no appeal can be further taken or (ii) has not been finally
abandoned, disclaimed or admitted to be invalid or unenforceable through reissue
or disclaimer or (b) a claim included in a pending patent application of a
Brickell Patent (whether filed before or after the Effective Date).
Interpretation. Except where expressly stated otherwise in this Agreement, the
following rules of interpretation apply to this Agreement: (a) “include”,
“includes” and “including” are not limiting; (b) “hereof’, “hereto”, “herein”
and “hereunder” and words of similar import when used in this Agreement refer to
this Agreement as a whole and not to any particular provision of this Agreement;
(c) words of one gender include the other gender; (d) references to a contract
or other agreement mean such contract or other agreement as from time to time
amended, modified or supplemented; (e) references to a Person are also to its
permitted successors and assigns; (f) references to an “Article”, “Section”,
“Exhibit” or “Schedule” refer to an Article or Section of, or an Exhibit or
Schedule to, this Agreement, unless expressly stated otherwise; and (g)
references to a law include any amendment or modification to such law and any
rules and regulations issued thereunder, whether such amendment or modification
is made, or issuance of such rules and regulations occurs, before or after the
date of this Agreement.
Additional Definitions. The following terms have the meanings set forth in the
corresponding Sections of this Agreement:
Term
Section
“Abandoned Collaboration Patents”
9.3.2
“Abandoned Joint Inventions”
9.3.2
“Agreement”
Preamble
“Audit”
8.7
“Audited Party”
8.7

- 11 -

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

“Auditing Party”
8.7
“Bankrupt Party”
14.6
“Breaching Party”
13.2
“Brickell”
Preamble
“Brickell Collaboration Patents”
9.1.1
“CMC”
1.72
“Commercial Supply Agreement”
7.2
“Confidential Information”
12.1
“Controlling Party”
9.4.1(a)
“CTA”
1.29
“CTX”
1.29
“Development Data”
4.6
“Development Plan”
4.3.1
“Development Supply Price”
7.1
“Disclosing Party”
12.1
“DMI’s”
1.72
“Effective Date”
Preamble
“Executive Officer”
15.2
“Existing Development Data”
4.6.1
 
 
“Global Branding Strategy”
6.5
“ICH”
1.25
“Indemnification Claim Notice”
11.3.1
“Indemnified Party” and “Indemnifying Party”
11.3.1
“Indemnitee” and “Indemnitees”
11.3.1
“Infringement Claim”
9.4.1
“Initial Development Plan Overview”
4.3.2
“Joint Collaboration Patents”
9.1.1
“Joint Collaboration Know-How”
9.1.1
“Joint Development and Regulatory
3.1
Committee” or “JDRC”
 
“Kaken”
Preamble
“Kaken Collaboration Patents”
9.1.1
“Kaken Funded Patent Rights”
9.3.1
“Losses”
11.1
“Milestone Notification Notice”
8.2
“New Brickell Development Data”
4.6.2
“New Development Data”
4.6.2
“New Kaken Development Data”
4.6.2
“New Indication”
2.5

- 12 -

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

“Party” or “Parties”
Preamble
“Patent Challenge”
9.6
“Phase II Clinical Supply Agreement”
7.2
“Phase III Clinical Supply Agreement”
7.2
“Quality Agreements”
7.2
“Receiving Party”
12.1
“Recovery”
9.4.2(c)(iv)
“Senior Officer”
4.10
“Term”
13.1
“Third Party Claim”
11.1
“Upfront Payment”
8.1
“VAT”
8.4(a)

ARTICLE 2
LICENSES
2.1    License Grants.
2.1.1    Grant to Kaken. Subject to the terms and conditions of this Agreement,
Brickell hereby grants to Kaken during the Term the following licenses or
sublicenses, as applicable, [***], and including [***]: (i) an [***], (ii) an
[***], (iii) an [***], (iv) [***] and (v) an [***]. The licenses to Manufacture
the Product and Drug Substance shall include the [***] without the prior written
consent of Brickell not to be unreasonably withheld or delayed and, if Brickell
denies such consent, Brickell shall outline its concerns in writing to Kaken and
allow Kaken adequate opportunity to address Brickell’s concerns. For purposes of
this Section 2.1.1, [***], except as otherwise noted.
2.1.2    Grant to Brickell. Subject to the terms and conditions of this
Agreement, Kaken hereby grants to Brickell during the Term the following
licenses or sublicenses, as applicable, each under [***], an [***]: (i) to [***]
and (ii) to [***] and (iii) to [***] or to [***]. The licenses to Manufacture
the Product and Drug Substance shall include the [***] (iii) shall [***] without
the prior written consent of Kaken not to be unreasonably withheld or delayed
and, if Kaken denies such consent, Kaken shall outline its concerns in writing
to Brickell and allow Brickell an adequate opportunity to address Kaken’s
concerns. For purposes of this Section 2.1.2, [***], except as otherwise noted.
2.2    Additional Licensing Provisions.
2.2.1    Negative Covenant. Each Party covenants that it will not use or
practice any of the other Party’s Patent rights or other intellectual property
rights licensed (or sublicensed, as applicable) to it under this Article 2
except for the purposes expressly permitted in the applicable license grant.

- 13 -

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

2.2.2    No Implied Licenses; Retained Rights. Except as explicitly set forth in
this Agreement, neither Party grants any license, express or implied, under its
intellectual property rights to the other Party, whether by implication,
estoppel or otherwise.
2.2.3    Registration with Patent Offices. [***] as an [***] and other similar
Regulatory Authorities in other countries of the Territory and Brickell shall
cooperate with Kaken to effect such registration. Kaken shall cooperate with
Brickell and file any required documentation with Governmental Authorities to
remove such registration upon the expiration or termination of this Agreement.
2.3    Performance by Affiliates, Subcontractors and Sublicensees
2.3.1    Performance by Affiliates. The Parties recognize that each may perform
some or all of its obligations under this Agreement through Affiliates;
provided, however, that each Party shall remain responsible for and be guarantor
of the performance by its Affiliates and shall cause its Affiliates to comply
with the provisions of this Agreement in connection with such performance. Each
Party hereby expressly waives any requirement that the other Party exhaust any
right, power or remedy, or proceed against an Affiliate, for any obligation or
performance hereunder prior to proceeding directly against such Party. Wherever
in this Agreement the Parties delegate responsibility to Affiliates, the Parties
agree that such entities may not make decisions inconsistent with this
Agreement, amend the terms of this Agreement or act contrary to its terms in any
way.
2.3.2    Subcontractors. Each Party shall ensure that each of its subcontractors
accepts and complies with all of the terms and conditions of this Agreement
(including, without limitation, Section 2.6), and such Party shall guarantee its
subcontractors’ performance under this Agreement. Each Party hereby expressly
waives any requirement that the other Party exhaust any right, power or remedy,
or proceed against a subcontractor, for any obligation or performance hereunder
prior to proceeding directly against such Party.
2.3.3    Sublicenses. Subject to the penultimate sentence of Section 2.1.1,
[***] under the license granted pursuant to Section 2.1.1 at any given time
during the Term [***]; provided, however, that, with respect to each such
sublicense (i) Brickell shall be notified in writing at least twenty (20)
Business Days in advance of the grant (including a description of the rights to
be granted, the identity of the sublicensee and the countries involved), and
(ii) Kaken shall obtain the prior written consent of Brickell thereto, such
consent not to be unreasonably withheld. Subject to the penultimate sentence of
Section 2.1.2, [***] under the license granted pursuant to Section 2.1.2 at any
given time during the Term [***]; provided, however, that, with respect to each
such sublicense. Kaken shall be notified in writing within twenty (20) Business
Days of the grant (including a description of the rights to be granted, the
identity of the sublicensee and the countries involved).
2.3.4    Conditions Applicable to Sublicensees and Subcontractors. Each Party
shall ensure that each of its sublicensees and subcontractors accepts and
complies with all applicable terms and conditions of this Agreement, and each
Party shall remain responsible for, and shall guarantee, the performance of its
sublicensees and subcontractors hereunder, and any

- 14 -

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

such sublicense or subcontract shall (a) be subject and subordinate to the terms
and conditions of this Agreement, (b) contain terms and conditions which are
consistent with the terms and conditions of this Agreement, (c) not in any way
diminish, reduce or eliminate any of its obligations under this Agreement, and
(d) impose on the sublicensee or subcontractor all applicable obligations under
the terms of this Agreement, including the reporting, audit, inspection and
confidentiality provisions hereunder, as well as a provision prohibiting such
sublicensee or subcontractor from further sublicensing or subcontracting. Each
Party hereby expressly waives any requirement that the other Party exhaust any
right, power or remedy, or proceed against a sublicensee or subcontractor, for
any obligation or performance hereunder prior to proceeding directly against
such Party. In addition, Kaken agrees to [***].
2.4    [***]. From the [***], each Party hereby covenants that it shall not (and
shall cause its Affiliates not to) [***] pursuant to this Agreement. From the
Effective Date until the [***], each Party hereby covenants that it shall not
(and shall cause its Affiliates not to) [***] pursuant to this Agreement.
Notwithstanding the foregoing, [***].
2.5    Field Expansion. If either Party wishes to [***] the Product [***], then
such Party shall notify the other Party in writing of its proposal to expand the
Field to include [***]; provided, however, that any such expansion of the Field
shall be in [***], including the [***]. Within ninety (90) days of the receipt
of such notice, the other Party shall notify the proposing Party whether or not
it wishes to participate [***]. If the Parties so agree to such expansion of the
Field to include [***], the Parties shall amend this Agreement to give effect to
such expanded Field; provided, however, that, if [***], but shall be free to
Develop and Commercialize the Product in the New Indication in the Territory at
any time after First Commercial Sale of the Product in the Field in the
Territory. For clarity, [***].
2.6    Restrictive Covenants.
2.6.1    Ex-Territory Activities. Kaken hereby covenants and agrees that it
shall not (and shall cause its Affiliates, sublicensees and subcontractors not
to), either directly or indirectly, market, distribute or sell the Product
[***]. Without limiting the generality of the foregoing, with respect to [***],
Kaken [***] (i) engage in [***].
2.6.2    Ex-Field Activities. Kaken hereby covenants and agrees that it shall
not (and shall cause its Affiliates, sublicensees and subcontractors not to),
either directly or indirectly, market, distribute or sell the Product [***].
Without limiting the generality of the foregoing, Kaken [***] (i) engage [***].
2.6.3    Kaken Contracts. In the event that Kaken (or any of its Affiliates)
enters into any agreement with a subcontractor (including any distributor or
wholesaler) or a sublicensee for the Product, it shall include in any and all
such agreements provisions substantially similar to those set forth in Sections
2.6.1 and 2.6.2, such that such subcontractor or sublicensee, as applicable,
shall only be authorized to [***].

- 15 -

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

2.6.4    Within-Territory Activities. Brickell hereby covenants and agrees that
it [***]. Without limiting the generality of the foregoing, with respect to such
countries within the Territory, Brickell [***].
2.6.5    Brickell Contracts. In the event that Brickell (or any of its
Affiliates) enters into any agreements with a subcontractor (including, any
distributors or wholesalers) or a sublicensee for the Product, it shall include
in any and all said agreements provisions substantially similar to those set
forth [***], such that such subcontractor or sublicensee, as applicable, shall
only be authorized to [***].
2.6.6    Jurisdictional Compliance. It is the desire and intent of the Parties
that the restrictive covenants contained in this Section 2.6 be enforced to the
fullest extent permissible under the Laws and public policies applied in each
jurisdiction in which enforcement is sought. Brickell and Kaken believe that the
restrictive covenants in this Section 2.6 are valid and enforceable, However, if
any restrictive covenant should for any reason become or be declared by a
competent court or competition authority to be invalid or unenforceable in any
jurisdiction, such restrictive covenant shall be deemed to have been amended to
the extent necessary in order that such provision be valid and enforceable, and
such amendment shall apply only with respect to the operation of such provision
of this Section 2.6 in the particular jurisdiction in which such declaration is
made.
2.7    [***] License Agreement. Brickell represents and warrants to Kaken that
the license agreement attached to this Agreement [***] is a true copy of the
[***] and is complete other than for material financial terms which have been
redacted, the [***] is in full force and effect and to Brickell’s knowledge no
facts exist that would entitle any party thereto to terminate the [***] or take
legal action material adverse to the interests of either party [***]or to the
Parties to this Agreement. Brickell shall not [***] or agree or consent to any
further amendments [***] that would adversely affect Kaken’s rights under this
Agreement without the prior written consent of Kaken. Brickell shall comply with
all material terms of [***] and each Party shall take any action reasonably
requested by the other Party to prevent [***]. Promptly after the Effective
Date, Brickell shall [***] reasonably satisfactory to Kaken that provides [***]
on the same or substantially similar terms as set forth in [***]. Additionally,
Brickell shall promptly notify Kaken in writing in the event [***] and, if
Brickell fails [***], and, in such case, without limiting any legal, equitable
or other remedies that Kaken may have under applicable Law or this Agreement,
Kaken shall have the right to [***].
2.8    Disclaimer of Patent Application from License. If at any time Kaken no
longer wishes to have a license to any patent applications included in the
Brickell Patents other than any patent applications listed on Schedule 1.5 and
any claims thereof including any substitutions, divisions, continuations or
continuations-in-part, then Kaken [***], and the claims in such patent
application, whether or not such claims subsequently issue as a patent, shall
[***] for purposes of this Agreement.
ARTICLE 3
GOVERNANCE

- 16 -

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

3.1    Development and Regulatory Committee. Within thirty (30) days after the
Effective Date, the Parties shall establish a joint development and regulatory
committee (the “Joint Development and Regulatory Committee” or “JDRC”), which
shall consist of [***]. Each of Kaken and Brickell may replace any or all of its
representatives on the JDRC at any time upon written notice to the other Party.
Such representatives shall [***]. A Party may designate a substitute to
temporarily attend and perform the functions of such Party’s designee at any
meeting of the JDRC. Meetings of the JDRC shall commence at a time to be
mutually agreed upon by the Parties and the JDRC shall meet [***], and in any
case more or less frequently as Kaken and Brickell deem appropriate or as
reasonably requested by either such Party, on such dates and at such places and
times as the Parties shall agree. Meetings of the JDRC shall be in the form
determined by the JDRC, which shall be either in person or by telephone or
videoconference. Any meetings of the JDRC that are held in person shall
alternate between the offices of Kaken and Brickell, or such other place as the
Parties may agree. The members of the JDRC also may convene or be polled or
consulted from time to time by means of telecommunications, video conferences,
electronic mail or correspondence, as deemed necessary or appropriate. Kaken and
Brickell each may, on advance notice to the other Party, invite non-member
employees of such Party to attend meetings of the JDRC. The JDRC shall perform
the following functions:
3.1.1    Review and discuss the Development Plan and any material amendments
thereto;
3.1.2    Review and discuss any matters related to Regulatory Approvals for the
Product in the Field in the Territory;
3.1.3    Review, coordinate and discuss the overall strategy for Developing the
Product in the Field in the Territory, including the overall strategy for
seeking Regulatory Approvals for the Product in the Field in the Territory;
3.1.4    Coordinate the preparation and implementation of the Development Plan;
3.1.5    Facilitate the exchange of information between the Parties regarding
the strategy for implementing the Development Activities, including sharing
Development Data created pursuant to this Agreement and establishing procedures
for the efficient sharing of information and materials necessary or useful for
the Development of the Product in the Field in the Territory and in the U.S.;
3.1.6    Ensure guidance, consultancy and access by both Parties to CMC
information and data in support of filings, facility inspections and Product
launch in the Territory and in the U.S.;
3.1.7    Review the design of the clinical trial protocols and endpoints the
conduct of all Clinical Trials included in the Development Activities as set
forth in the Development Plan;

- 17 -

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

3.1.8    Facilitate the exchange of information between the Parties regarding
the development and contents of all submissions to Regulatory Authorities in the
Territory for Regulatory Approvals and all necessary filing and registration
activities related thereto;
3.1.9    Review and discuss any Manufacturing Development Activities being
performed by the Parties under the Development Plan and coordinate on the
requirements for formulation of the Product in the U.S. and the Territory;
3.1.10    Review and discuss any proposal to change the formulation of the
Product for use in any Development Activities set forth in the applicable
Development Plan;
3.1.11    Review issues regarding pharmacovigilance and safety regarding the
Product in the Territory and outside the Territory; and
3.1.12    Have such other responsibilities as may be mutually agreed by the
Parties in writing from time to time.
3.2    Limits on JDRC and Committee Authority. The JDRC shall not [***]. In
furtherance thereof, each Party shall retain the rights, powers and discretion
granted to it under this Agreement and no such rights, powers or discretion
shall be delegated or vested in the JDRC unless such delegation or vesting of
rights is expressly provided for in this Agreement or the Parties expressly so
agree in writing. For clarity, the JDRC and any other Committee shall have
[***].
3.3    Decision Making. The Parties shall make decisions with respect to the
matters set forth in Section 3.1 that are discussed by the JDRC. All decisions
of the Parties with respect to the matter set forth in Section 3.1 shall be made
by [***], with Kaken and Brickell each having [***]. If the Parties cannot reach
consensus within twenty (20) days after discussing the matter and attempting to
reach such consensus, the disputed matter may be referred to the Senior Officers
for resolution pursuant to Section 4.10.
3.4    Actions. In developing strategies, making decisions and exercising its
rights under this Agreement (including acting through its representatives on any
of the JDRC), each Party shall act in good faith and use its commercially
reasonable efforts to achieve the goals of the then-current Development Plan.
3.5    Exchange of Information. Each Party shall keep the other Party fully and
promptly informed as to its progress and activities relating to the Development
of the Product in the Territory and outside the Territory, including with
respect to regulatory matters and meetings with Regulatory Authorities,
primarily by way of updates to the JDRC at their meetings, or as reasonably
requested from time to time by the other Party.
3.6    Minutes of JDRC Meetings. Any minutes of all JDRC meetings shall be
finalized in English no later than thirty (30) days after the meeting to which
the minutes pertain. Any minutes of JDRC meetings that may be prepared shall
have no legal effect whatsoever nor

- 18 -

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

shall act in any way to amend this Agreement or otherwise alter any of the
Parties rights and obligations set forth herein.
ARTICLE 4
DEVELOPMENT
4.1    Overview.
4.1.1    Overview of Development. Subject to the terms and conditions of this
Agreement, the Parties shall collaborate with respect to the Development of the
Product as set forth in the Development Plan. Each Party shall utilize
adequately skilled personnel to perform or oversee, as applicable, the
Development Activities assigned to it under the Development Plan. Kaken shall be
assigned and perform the [***], which shall consist of [***]. Brickell shall
perform, or have performed, [***] to be performed by Kaken and referenced in the
Initial Development Plan Overview and Manufacturing Development Activities
assigned to Kaken in accordance with [***] and [***]. For clarity, [***].
4.1.2    Manufacturing Development Activities. Subject to the terms and
conditions of this Agreement, the Parties shall collaborate with respect to the
Manufacturing Development Activities for the Product as set forth in the
Development Plan. Each Party shall utilize adequately skilled personnel to
perform or oversee, as applicable, the Manufacturing Development Activities
assigned to it under the Development Plan. The Parties shall [***]. Brickell
shall perform all Manufacturing Development Activities in connection with its
clinical supply obligations under Article 7. Kaken shall perform all
Manufacturing Development Activities in connection with its clinical and
commercial supply obligations under Article 7 (including supply to Brickell).
Notwithstanding anything to the contrary contained in this Agreement, [***].
4.1.3    Certain Additional Restrictions. Kaken agrees and acknowledges that it
and its Affiliates and sublicensees [***] except in accordance with a
Development Plan established pursuant to this Agreement. Brickell agrees and
acknowledges that it and its Affiliates and sublicensees [***] except in
accordance with a Development Plan established pursuant to this Agreement and as
otherwise permitted by the terms of this Agreement. Kaken shall [***] under the
Development Plan, upon the occurrence of (a) any of the events set forth in
[***], (b) [***] after Kaken provides written notice thereof to Brickell or (c)
Brickell [***]. For clarity, in no event [***].
4.2    Development Activities, [***] Clinical Trials, Missed Development Dates
and Compliance.
4.2.1    Development Activities. Each Party shall [***] to carry out the
Development Activities to be assigned to it under the Development Plan and in
accordance with the time frames to be set forth in the Development Plan. Without
limiting the generality of the foregoing:

- 19 -

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

(a)    Kaken shall [***] to conduct the [***] set forth in the Development Plan
in accordance within the timelines set forth in the Development Plan;
(b)    Kaken shall [***] to conduct the Phase I Clinical Trial set forth in the
Development Plan for the Product [***] within the timelines set forth in the
Development Plan;
(c)    Kaken shall [***] to conduct the [***] set forth in the Development Plan
for the Product [***] within the timelines set forth in the Development Plan;
and
(d)    Brickell shall [***] to conduct the [***] set forth in the Development
Plan for the Product [***] and provide Kaken with the clinical study report for
such [***].
4.2.2    [***] Clinical Trials. Either Party [***]and Kaken may thereafter have
the rights to Develop, Commercialize and Manufacture the Product [***] if: (i)
[***] within the time period established by the JDRC for initiating such [***]
as set forth in the Development Plan, (ii) the Regulatory Authorities in Japan
request that Kaken [***] proposed to be used for the Product in the [***]or
(iii) Regulatory Authorities in Japan or the United [***] would need to be
different in order to obtain Regulatory Approvals in [***] and such differences
relate to Manufacturing Development Activities, including, for example,
requiring [***].
4.2.3    Missed Development Dates. Each Party shall promptly inform the other
Party upon determining that it is likely to miss a Development date set forth in
the Development Plan. To the extent that a Party (or any of its Affiliates)
misses such a date by four (4) weeks or more, such Party shall provide to the
JDRC a full explanation for such event.
4.2.4    Compliance. Each Party shall conduct its Development Activities, and
Manufacturing Development Activities set forth in the applicable Development
Plan, consistent with sound and ethical business and scientific practices, and
in compliance with all applicable Laws, GCPs, GLPs and to the extent applicable,
GMPs.
4.3    Development Plan.
4.3.1    General. In connection with the Development of the Product for use in
the Field in the Territory, the Parties shall conduct the Development Activities
pursuant to a comprehensive development plan (the “Development Plan”). The
Development Plan shall set forth, among other things, the following with respect
to the Product in the Field in the Territory:
(a)    any preclinical studies, toxicology studies, pharmaco-economic studies,
process development studies and other clinical studies, in each case, together
with all protocols, endpoints and investigators conducting such studies,
provided however, that the Development Plan shall provide that [***] referenced
in the Initial Development Plan Overview with the formulation of the Product
being used by Brickell in the U.S. as of the Effective Date;

- 20 -

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

(b)    any post-Product Approval clinical trials and studies, including Phase IV
Clinical Trials;
(c)    all regulatory plans and other elements of obtaining and maintaining
Regulatory Approvals in the Field;
(d)    subject to the provisions of Section 4.1.1, the allocation of the
Development Activities, and the Manufacturing Development Activities set forth
in the applicable Development Plan, in each case to be conducted by each Party
and the timeline for completing such Development Activities and Manufacturing
Development Activities, provided however, that [***];
(e)    the plans and timeline for preparing and obtaining Regulatory Approvals;
and
(f)    the Manufacturing Development Activities, as well as the plans, amounts
and timelines for the Manufacture and supply of Product, necessary for the
Development Activities, including the [***] set forth in the applicable
Development Plan, taking into account [***].
4.3.2    Initial Development Plan. An overview of the initial Development Plan
for the Development of the Product is attached to this Agreement as Schedule
4.3.2 (the “Initial Development Plan Overview”). On or before the date that is
sixty (60) days after the Effective Date, the JDRC shall meet to prepare the
initial Development Plan which shall be based on the Initial Development Plan
Overview. Upon completion, the initial Development Plan shall be provided to the
Parties for their written approval. If both Parties provide their written
approval then the initial Development Plan shall be the Development Plan for
purposes of this Agreement. If the Parties do not provide their written approval
of the initial Development Plan within ninety (90) days after receiving it
representatives of the Parties including each Party’s JDRC members shall meet
and attempt to reach agreement on the Development Plan. If after thirty (30)
days the Parties cannot reach agreement on the Development Plan the dispute
shall be resolved pursuant to Section 4.10.
4.3.3    Updating and Amending Development Plan and Additional Development
Activities.
(a)    On or before [***] during the Term beginning in the year after the year
in which the initial Development Plan was approved pursuant to Section 4.3.2,
the JDRC shall review and prepare a draft updated Development Plan which shall
cover the Development Activities to be conducted during the upcoming calendar
year, and the JDRC shall, on at least a quarterly basis, review and make
suggestions to the Parties for amending the then-current Development Plan to
reflect any changes, reprioritizations of, or additions to the Development Plan.
(b)    Any and all changes to the Development Plan shall only be effective when
in writing and signed by an authorized representative of both Parties. Once

- 21 -

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

approved by the Parties, each amended Development Plan shall become effective
and supersede the previous Development Plan as of the date of such approval. Any
disputes with respect to the Development Plan shall be resolved pursuant to
Section 4.10.
4.4    Development Costs.
4.4.1    Territory Exclusive Development Activities. [***].
4.4.2    Ex-Territory Exclusive Development Activities. [***].
4.4.3    [***] Development Activities. Kaken shall bear all Development Costs
for U.S.-Japan Phase III Development Activities [***].
4.4.4    Other [***] Development Activities.
4.5    Records, Reports and Information.
4.5.1    General. Each Party shall maintain current and accurate records of all
work conducted by it under the Development Plan and all data and other
information resulting from such work. Such records shall include, as applicable,
books, records, reports, research notes, charts, graphs, comments, computations,
analyses, recordings, photographs, computer programs and documentation thereof
(e.g., samples of materials and other graphic or written data generated in
connection with the Development Activities). Such records shall properly reflect
all work done and results achieved in the performance of the Development
Activities in sufficient detail and in good scientific manner appropriate for
regulatory and patent purposes. Each Party shall document all preclinical
studies and clinical trials to be conducted pursuant to the Development Plan in
formal written study reports according to applicable national and international
(e.g., ICH, GCP and GLP) guidelines.
4.5.2    Status Updates in the Territory. Each Party shall provide the JDRC with
reports detailing its respective Development Activities under the Development
Plan and the results thereof at least five (5) Business Days prior to any JDRC
meeting and provide updates regarding communications with Regulatory Authorities
during the JDRC meetings. Without limiting the foregoing, each Party shall
promptly, but in any event within five (5) Business Days after receipt thereof,
provide to the other Party copies of any material documents or correspondence
received from any Regulatory Authority related to Development Activities in the
U.S. and Japan.
4.6    Development Data.
4.6.1    Existing Development Data. Subject to the rights and licenses granted
to Kaken herein, [***]. Within thirty (30) days after execution of this
Agreement, Brickell shall provide Kaken with copies of all material reports of
[***] as of the Effective Date in its (or any of its Affiliates’) possession or
control.
4.6.2    New Development Data. All data, know-how and other results generated by
or resulting from or in connection with the conduct of Development Activities
shall be owned

- 22 -

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

[***]. Such data shall include [***]. Such data (i) [***], (ii) if generated by
or resulting from or in connection with [***], and (iii) shall be referred [***]
whether generated by one or both Parties (or their respective Affiliates or
sublicensees). The Party generating [***] shall as soon as reasonably practical
provide the other Party with copies of reports and summaries in English of such
[***].
4.6.3    Preservation of Development Data. Each Party shall preserve and provide
the other Party with a right to access or a right to reference all Existing
Development Data and all New Development Data in order to allow each Party to
comply with applicable Law.
4.7    Right of Reference and Use. Subject to the terms of Sections 2.3, 2.4,
2.5 and 2.6, [***] for the purposes of performing Development Activities and
Commercialization activities pursuant to this Agreement. Subject to the terms of
Sections 2.3, 2.4, and 2.6, [***]. Brickell may further [***].
4.8    Access to Records. Brickell shall have the right, not more than one (1)
time per calendar year, to review all records under the Development Plan
maintained by Kaken at reasonable times, upon written request; provided,
however, that Kaken shall have the right to redact any portions thereof not
solely related to the Development of the Product for use in the Field in the
Territory. Kaken shall have the right, not more than one (I) time per calendar
year, to review all records under the Development Plan maintained by Brickell at
reasonable times, upon written request; provided, however, that Brickell shall
have the right to redact any portions thereof not solely related to the
Development of the Product.
4.9    Rights to Audit.
4.9.1    Kaken shall ensure that Brickell’s authorized representatives and any
Regulatory Authorities, to the extent permitted by applicable Law, may, during
regular business hours and upon reasonable advance written notice, not more than
once annually (except for cause), (i) examine and inspect its facilities or,
subject to any Third Party confidentiality restrictions and other obligations,
the facilities of any subcontractor or any investigator site used by it in the
performance of Development of the Product in the Field in the Territory
hereunder, and (ii) subject to applicable Law and any Third Party
confidentiality restrictions and other obligations, inspect all data,
documentation and work product relating to the activities performed by it, the
subcontractor or investigator site, including the medical records of any patient
participating in any clinical study, in each case generated pursuant to the said
Development. This right to inspect all data, documentation, and work product
relating to the Product in the Field in the Territory may be exercised at any
time during the Term upon reasonable notice (subject to each Party’s record
retention policies then in effect), or such longer period as shall be required
by applicable Law.
4.9.2    Brickell shall ensure that Kaken’s authorized representatives and any
Regulatory Authorities, to the extent permitted by applicable Law, may, during
regular business hours and upon reasonable advance written notice, not more than
once annually (except for cause), (i) examine and inspect its facilities or,
subject to any Third Party confidentiality restrictions and other obligations,
the facilities of any subcontractor or any investigator site used

- 23 -

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

by it in the performance of Development of the Product in accordance with this
Agreement, and (H) subject to applicable Law and any Third Party confidentiality
restrictions and other obligations, inspect all data, documentation and work
product relating to the activities performed by it, the subcontractor or
investigator site, including the medical records of any patient participating in
any clinical study, in each case generated pursuant to the said Development
under the Development Plan. This right to inspect all data, documentation, and
work product relating to the Product may be exercised at any time during the
Term upon reasonable notice (subject to each Party’s record retention policies
then in effect), or such longer period as shall be required by applicable Law.
4.10    Dispute Resolution Procedures. With respect to all disputes arising
between the Parties related to matters discussed by JDRC or otherwise related to
Development of the Product, if the Parties are unable to resolve such dispute
pursuant to Section 3.3 within the time period set forth therein then, either
Party may refer such dispute in writing to the President of each of the Parties,
or a designee from senior management with decision-making authority (the
President or such designee, the “Senior Officer”), for attempted resolution by
good-faith negotiations within fifteen (15) calendar days after such notice is
received. If the Senior Officers are unable to resolve such dispute within ten
(10) calendar days after such dispute is first referred to them pursuant to this
Section 4.10, then:
4.10.1    If the dispute relates to any U.S.-Japan Development Activities, then
Brickell shall have the final decision making authority;
4.10.2    If the dispute relates to any Territory Exclusive Development
Activities, then Kaken shall have the final decision making authority;
4.10.3    If the dispute relates to any Ex-Territory Exclusive Development
Activities, then Brickell shall have the final decision making authority; and
4.10.4    If the dispute relates to any Manufacturing Development Activities,
then Brickell shall have the final decision making authority. Notwithstanding
the foregoing, if Kaken is entitled to exercise its rights set forth in the
penultimate sentence of Section 4.1.2, then Kaken shall have final decision
making for Manufacturing Development Activities for the Product for use in the
Field in the Territory and Brickell shall have final decision making for all
other Manufacturing Development Activities for the Product.
In resolving a dispute hereunder, each Party shall act in good faith. Nothing in
this Section 4.10 shall affect the right of a Party to exercise its rights or
remedies for a breach of this Agreement by the other Party.
ARTICLE 5
REGULATORY
5.1    Regulatory Filings and Regulatory Approvals
5.1.1    General Responsibilities; Ownership of Regulatory Approvals. [***].

- 24 -

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

5.1.2    Reporting. Kaken shall provide Brickell with summaries (in English) of
the IND and NDA submitted to Governmental Authorities in the Territory prior to
filing thereof to give Brickell a reasonable opportunity to review prior to
filing thereof.
5.1.3    Brickell Cooperation. Brickell shall cooperate in good faith with and
provide reasonable assistance to Kaken in connection with all activities
undertaken by Kaken relating to the obtaining and maintaining of the Regulatory
Approvals.
5.1.4    Copies. Kaken shall provide to Brickell: (A) copies in electronic form
containing each Regulatory Filing described in Section 5.1.2 as submitted and
all Regulatory Data relevant thereto (in the original language in which it was
filed) promptly following such submission, (B) summaries (in English) of each
Regulatory Filing as submitted, if any, as soon as reasonably practicable
following submission thereof.
5.1.5    Ownership. [***].
5.1.6    Right of Reference. Brickell, its Affiliates, and their sublicensees,
shall [***] (subject to the last two sentences of Section 2.5) in connection
with the Development, Commercialization and Manufacture of the Product in a
manner consistent and fully in accordance with the terms of this Agreement.
[***].
5.1.7    Provision of Regulatory Information to Kaken. Brickell shall provide
Kaken with summaries of the IND and NDA submitted to Governmental Authorities
[***] that are required for any Regulatory Approval for the Product filed by or
on behalf of, and Controlled by, Brickell and all Regulatory Data relevant
thereto, and [***] solely to support its Development Activities and
Commercialization of the Product in the Field in the Territory and in accordance
with the terms of this Agreement.
5.1.8    Certain Regulatory Approvals.
(a)    Pricing Approvals. To the extent that [***] requires Pricing Approval for
sale of the Product in the Field in such country or regulatory jurisdiction,
Kaken shall (to the extent permitted by applicable Laws) [***] toward obtaining
and maintaining Pricing Approvals [***], in its own name or the name of its
sublicensees.
(b)    Manufacturing Approvals and Manufacturing Related Sections. [***],
including any DMFs and CMC (or equivalent) sections of any Regulatory Materials,
and will provide such Regulatory Materials [***].
5.1.9    Cost of Regulatory Activities. All Regulatory Costs incurred in
connection with the preparation of Regulatory Materials and obtaining of Product
Approvals in the Territory [***].
5.2    Communications. Notwithstanding the foregoing, except as may be required
by applicable Law, Kaken shall not, with respect to the Product, communicate
with (i) any Regulatory Authority having jurisdiction outside the Territory
regarding the Product or (ii) any

- 25 -

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

Regulatory Authority with respect to the Product for use outside the Field, in
each case, unless explicitly provided for in the Development Plan or requested
or permitted in writing to do so by Brickell, or unless requested or ordered to
do so by such Regulatory Authority, in which case Kaken shall as soon as
practicable notify Brickell of such request or order and shall, to the extent
consistent with precedent and normal regulatory approval processes or as
permitted by applicable Law, not take any further actions or communicate with
such Regulatory Authority further until Brickell has provided instruction as to
how to proceed.
5.3    Adverse Event Reporting; Safety Data Exchange and Medical Inquiries
5.3.1    Pharmacovigilance. Kaken shall be responsible for the collection,
review, assessment, tracking and filing of information related to adverse events
associated with the Product in the Field in the Territory (whether or not
Product Approval has been achieved), in each case in accordance with applicable
Law and this Agreement (and Kaken shall ensure that, in the Development and
Commercialization of the Product, it will record, investigate, summarize,
notify, report and review all adverse events in accordance with applicable Law).
Brickell (or its designee) shall be responsible for the collection, review,
assessment, tracking and filing of information related to adverse events
associated with the Product in the countries outside the Territory. The safety
units from each of the Parties shall meet and agree upon a written
pharmacovigilance agreement for exchanging adverse event and other safety
information relating to the Product prior to Kaken’s first clinical activity;
provided that Brickell shall be responsible for maintaining the global safety
database for the Product. Such written pharmacovigilance agreement shall ensure
that adverse event and other safety information is exchanged according to a
schedule that will permit each Party (and its sublicensees or designees) to
comply with applicable Laws and regulatory requirements in their respective
markets.
5.3.2    Medical Inquiries for the Product. For questions and complaints arising
with respect to Development Activities or Commercialization undertaken by Kaken,
Kaken shall be responsible for handling all medical questions or inquiries
[***], including all Product Complaints, with regard to any Product sold by or
on behalf of Kaken (or any of its Affiliates or sublicensees) in each case in
accordance with applicable Law and this Agreement. Kaken shall submit a copy of
any standardized responses to medical inquiries prior to use thereof for
Brickell’s review and comment. Brickell shall immediately forward any and all
medical questions or inquiries which it receives with respect to any Product
sold by or on behalf of Kaken (or any of its Affiliates or sublicensees) in the
Territory to Kaken in accordance with all applicable Laws and Kaken shall
immediately forward to Brickell any and all medical questions or inquiries that
it receives with respect to Product (i) not sold by or on behalf of Kaken (or
any of its Affiliates or sublicensees) in the Territory or (ii) outside the
Territory, in each case in accordance with all applicable Laws.
5.4    Regulatory Authority Communications Received by a Party.
5.4.1    General. Each Party shall immediately inform the other Party of
notification of any action by, or notification or other information which it
receives (directly or indirectly) from, any Regulatory Authority whether inside
the Territory or outside the Territory which (i) raises any material concerns
regarding the safety or efficacy of the Product; (ii)

- 26 -

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

indicates or suggests a potential material liability of either Party to Third
Parties in connection with the Product; (iii) is reasonably likely to lead to a
recall, market withdrawal or market notification with respect to the Product
whether inside the Territory or outside the Territory; or (iv) relates to
expedited and periodic reports of adverse events with respect to the Product
whether inside the Territory or outside the Territory, or Product Complaints,
and which may have an adverse impact on Regulatory Approval or the continued
Commercialization of the Product whether inside the Territory or outside the
Territory. Kaken shall be solely responsible for responding to any such
communications relating to the Product in the Field in the Territory and
Brickell shall be solely responsible for responding to any such communications
relating to the Product in the Field outside the Territory. Each Party shall
reasonably cooperate with and assist the other Party by providing the other
Party, as promptly as practicable after a written request, such information and
documentation which is in such Party’s possession as may be necessary or
reasonably helpful for the other Party to prepare a response to an inquiry from
a Regulatory Authority with respect to the Product in the Field. Each Party
shall also promptly provide the other Party with a copy of all correspondence
received from a Regulatory Authority whether inside the Territory or outside the
Territory specifically regarding the matters referred to above.
5.5    Recall, Withdrawal, or Market Notification of Product. In the event that
any Governmental Authority sends a written notice threatening or initiating any
action to remove the Product from the market in the Field whether inside the
Territory or outside the Territory (in whole or in part), the Party receiving
notice thereof shall notify the other Party of such communication immediately,
but in no event later than two (2) Business Days, after receipt thereof.
Notwithstanding the foregoing, in all cases Kaken shall determine whether to
initiate any recall, withdrawal or market notification of the Product in the
Field in the Territory, and Brickell shall determine whether to initiate any
such recall, withdrawal or market notification of the Product in all other
cases, including the scope of such recall or withdrawal (e.g., a full or partial
recall, or a temporary or permanent recall) or market notification; provided,
however, that, before Kaken or Brickell (as the case may be) initiates a recall,
withdrawal or market notification, the Parties shall promptly meet and discuss
in good faith the reasons therefor, provided that such discussions shall not
delay any action that Kaken or Brickell (as the case may be) reasonably believes
has to be taken in relation to any recall, withdrawal or market notification. In
the event of any such recall, withdrawal or market notification, Kaken or
Brickell (as the case may be), as the distributor of the Product, shall
determine the necessary actions to be taken, and, shall implement such actions,
with the other Party providing reasonable input (which the first Party shall in
good faith consider and incorporate into any recall, withdrawal or market
notification strategy) and reasonable assistance to conduct such recall,
withdrawal or market notification. Without limiting the foregoing, Brickell
shall have the right to propose that a Product recall, withdrawal or market
notification should be initiated by Kaken, but Kaken shall make the final
decision as to whether or not the recall, withdrawal or market notification will
be initiated. Kaken shall at all times utilize its existing tracing system which
will enable the Parties to identify customers within the Territory who have been
supplied with. Product, and to recall such Product from such customers as set
forth in this Section 5.5. Kaken shall bear the costs and expenses of any recall
or withdrawal with respect to the Product in the Field in the Territory
(including costs associated with return, recall or destruction of the Products)
if the cause of the recall is solely attributable to Kaken and Brickell shall
bear the costs and expenses of any recall or withdrawal

- 27 -

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

with respect to the Product in the Field in the Territory (including costs
associated with return, recall or destruction of the Products) if the cause of
the recall is solely attributable to Brickell. In all other cases, Kaken and
Brickell shall share such cost and expense in accordance [***]. For clarity,
Brickell (or its designee), as holder of the Regulatory Approval for the
Products outside the Field and outside the Territory shall have sole discretion
in determining whether to initiate any recall, withdrawal or market notification
of the Products outside the Territory (or in the Territory but outside the
Field), including the scope of such recall or withdrawal (e.g., a full or
partial recall, or a temporary or permanent recall) or market notification, and
nothing contained herein shall limit or otherwise restrict Brickell’s ability
with respect to any such recall or withdrawal or market notification.
ARTICLE 6
COMMERCIALIZATION
6.1    Commercialization in the Field in the Territory. During the Term, Kaken
shall [***] for Commercializing the Product in the Territory for use in the
Field in accordance with the terms and conditions of this Agreement and shall be
responsible [***]. Without limiting the foregoing, Kaken shall [***].
6.2    Commercialization Reports. No later than [***] Kaken will provide
Brickell with a written report in such form as is acceptable to both Parties
which summarizes Kaken’s planned Commercialization Activities. By no later than
March 1st for each calendar year during the Term, summarizing all significant
Commercialization activities with respect to the Product in the Field in the
Territory performed by or on behalf of Kaken (including by any Affiliates of
sublicensees) during the prior calendar year and planned Commercialization
Activities during the next calendar year (including a comparison of
Commercialization activities actually performed in the prior calendar year
against Commercialization activities previously projected to be performed in
such calendar year), and Kaken shall provide interim reports with respect to
such Commercialization activities within fifteen (15) days after the end of each
calendar quarter (or such other time periods as Brickell may reasonably
request).
6.3    Promotional Materials.
6.3.1    Creation of Promotional Materials. [***].
6.3.2    Kaken Ownership of Promotional Materials. During the Term, Kaken shall
own all right, title and interest in and to any Promotional Materials created by
Kaken.
6.3.3    Use of Promotional Materials Exclusively for the Product. The
Promotional Materials, and any aspects of those uniquely tied to the Product,
shall be used by Kaken [***] in accordance with the terms of this Agreement.
6.4    Commercialization Data. [***].
6.5    Global Branding Strategy. To the extent Brickell determines to utilize
[***], Kaken [***], including with respect to any Promotional Materials;
provided, that, in the event

- 28 -

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

Kaken believes the application of the [***], Kaken shall present such concern to
Brickell, and the Parties shall discuss whether appropriate revisions to the
[***] may make it appropriate for use [***]. However, if the Parties are unable
to resolve their differences regarding Kaken’s implementing all or any portion
of [***] after such discussions, Kaken shall [***]. Nothing in this Section 6.5
shall be construed to derogate from Kaken’s ultimate right and responsibility to
[***] to Commercialize the Product in the Territory in accordance with the terms
and conditions of this Agreement.
ARTICLE 7
SUPPLY
7.1    Supply by [***]. As soon as practicable, but, in any event, within sixty
(60) days after the Effective Date, the Parties shall enter into good faith
negotiations regarding the terms of [***], pursuant to which [***] as set forth
in the Development Plan within the timelines set forth in the Development Plan.
The [***].
7.2    Phase III Clinical Supply Agreement, Commercial Supply Agreement and
Quality Agreements. As soon as practicable, but, in any event, within
one-hundred twenty (120) days after the Effective Date, the Parties shall enter
into good faith negotiations regarding the [***]. The [***], all references to
Kaken shall be to Brickell and all references to Brickell shall be to Kaken. As
soon as practicable, but, in any event, promptly [***]. If, despite [***], the
Parties are unable to execute [***]within twenty-four (24) months of the
Effective Date, then the Parties shall meet to establish and implement a [***].
The Parties shall also [***] prior to any supply thereunder, each of which shall
set forth the Parties’ quality and compliance obligations with respect to
Manufacture of the Drug Substance and Product.
7.3    Alternative Source of Phase III Clinical and Trial Commercial Supply.
[***].
ARTICLE 8
PAYMENTS
8.1    Upfront Payment. [***]
8.2    Milestone Payments. Kaken shall pay to Brickell the [***] described in
this Section 8.2 upon [***]. A Party shall notify the other Party in writing of,
but in no event later than twenty (20) Business Days after, [***]. Kaken shall
pay the [***] by wire transfer of immediately available funds into an account
designated by Brickell within twenty (20) Business Days [***], but in all cases
no later than (i) the time that such [***] notice is delivered by Kaken to
Brickell in the event Kaken [***] or (ii) within twenty (20) Business Days [***]
in the event Brickell is [***]; provided, however, that, in no event shall [***]
in this Section 8.2. Each such payment is nonrefundable and noncreditable
against any other payments due hereunder.

- 29 -

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

[***]
[***]
[***]
[***]
Ten Million Dollars
($10,000,000)
[***]
[***]
[***]
[***]
[***]
[***]
[***]

For clarity, [***] shall be due and payable [***].
8.3    Royalties.
8.3.1    Royalty Rates. As further consideration for the rights granted to Kaken
hereunder, and except as set forth in Section 8.3.3 with respect to [***], Kaken
shall pay to Brickell [***]:
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]

[***].
8.3.2    [***] Compensation [***]. [***]
8.3.3    Payments for [***]. [***]
8.3.4    General. [***]
8.4    Taxes and Withholding.
(a)    VAT. The amounts provided for in this Agreement are exclusive of any
value added tax.
(b)    Withholding Tax Matters. Any income or other taxes which Kaken is
required by Law to pay or withhold on behalf of Brickell with respect to any
payments payable to Brickell pursuant to Section 8.3.1 or Section 8.3.3 shall be
deducted from the amount of such payments due, and paid or withheld, as
appropriate, by Kaken on behalf of Brickell. Any such tax required by applicable
Law to be paid or withheld shall be an expense of, and borne by, Brickell. Kaken
shall furnish Brickell with reasonable evidence of such payment or amount
withheld, in electronic or written form, as soon as practicable after such
payment is made or such amount is withheld. The Parties will reasonably
cooperate in completing and filing documents required under the provisions of
any applicable tax laws or under any other applicable Law in

- 30 -

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

connection with the making of any required tax payment or withholding payment,
or in connection with any claim to a refund of or credit for any such payment.
For clarity, amounts shall not be withheld on any other amounts payable by Kaken
hereunder pursuant to Section 8.3.1 or Section 8.3.3.
8.5    Currency Conversion. All payments hereunder shall be made [***]. For the
purpose of calculating any sums due under, or otherwise reimbursable pursuant
to, this Agreement [***], any amount [***] in a manner consistent with such
Party’s normal practices used to prepare its audited financial statements for
external reporting purposes, provided that such practices use a widely accepted
source of published exchange rates, such as the foreign exchange rates [***].
8.6    Late Payments. Any amount required to be paid by a Party hereunder which
is not paid on or within thirty (30) days after the date due shall bear interest
at a rate equal to one percent (1%) per month. Such interest shall be computed
on the basis of a year of 360 days for the actual number of days payment is
delinquent.
8.7    Records; Audits. Kaken and its Affiliates, sublicensees and
subcontractors shall keep true and accurate records and books of account
containing all particulars that may be necessary for the purpose of confirming
the accuracy of, and calculating, as applicable, all amounts payable to Brickell
hereunder (including records of Net Sales), and any other records reasonably
required to be maintained with respect to Kaken’s obligations under this
Agreement, and each Party shall maintain complete and accurate records in
sufficient detail to permit the other Party to confirm the accuracy of all
amounts payable or otherwise reimbursable hereunder, in each case for a minimum
period of five (5) years or such longer period as required by applicable Law.
Each Party shall have a right to request an audit of the other Party in order to
confirm the accuracy of any of the foregoing (an “Audit”); provided, however,
that each Party shall only have the right to request such Audit of the other
Party one time during any given calendar year. Upon the written request by a
Party (the “Auditing Party”) to Audit the other Party (the “Audited Party”), the
Auditing Party shall have the right to engage an independent, internationally
recognized accounting firm to perform a review as is reasonably necessary to
enable such accounting firm to calculate or otherwise confirm the accuracy of
any of the foregoing for the calendar year(s) requested by the Auditing Party;
provided that (i) such accountants shall be given access to, and shall be
permitted to examine and copy such books and records of the Audited Party upon
five (5) days’ prior written notice to the Audited Party, and at all reasonable
times on such Business Days, (ii) prior to any such examination taking place,
such accountants shall enter into a confidentiality agreement with the Audited
Party reasonably acceptable to the Audited Party in order to keep all
information and data contained in such books and records strictly confidential
and shall not disclose such information or copies of such books and records to
any third person including the Auditing Party, but shall only use the same for
the purpose of the reviews and/or calculations which they need to perform in
order to determine any amounts being reviewed, and (iii) such accountants shall
use reasonable efforts to minimize any disruption to the Audited Party’s
business. The Audited Party shall make personnel reasonably available during
regular business hours to answer queries on all such books and records required
for the purpose of the Audit. The accountants shall deliver a copy of their
findings to each of the

- 31 -

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

Parties within twenty (20) days of the completion of the review, and, in the
absence of fraud or manifest error, the findings of such accountant shall be
final and binding on each of the Parties. Any underpayments by a Party shall be
paid to the other Party within twenty (20) days of notification of the results
of such inspection. Any overpayments made by a Party shall be refunded by the
other Party within twenty (20) days of notification of the results of such
inspection. The cost of the accountants shall be the responsibility of the
Auditing Party unless the accountants’ calculation shows that the actual amount
Audited hereunder is different, by more than five percent (5%), from the amounts
as previously calculated by the Audited Party. [***].
ARTICLE 9
INTELLECTUAL PROPERTY MATTERS
9.1    Ownership of Intellectual Property.
9.1.1    General. Subject to the provisions of this Section 9.1.1 and except as
expressly set forth otherwise in this Agreement, (i) [***]. The Parties hereby
agree that (a) [***] and (b) [***]. Each Party shall promptly disclose to the
other Party all Inventions made by it during the Term. The determination of
inventorship for Inventions shall be made in accordance with the applicable Laws
relating to inventorship in the country in which such Invention is made.
9.1.2    Employees. Each Party will require all of its and its Affiliates’
employees to assign all Inventions that are developed, made or conceived by such
employees according to the ownership principles described in Section 9.1.1 free
and clear of all liens, encumbrances, charges, security interests, mortgages or
other similar restrictions. Each Party will also use its commercially reasonable
efforts to require any agents, independent contractors or sublicensees
performing an activity pursuant to this Agreement to assign all Inventions that
are developed, made or conceived by such agents, independent contractors or
sublicensees to Brickell and/or Kaken according to the ownership principles
described in Section 9.1.1 free and clear of all liens, encumbrances, charges,
security interests, mortgages or other similar restrictions.
9.2    Disclosures; Disputes Regarding Inventions. Each Party shall; before
filing a new Patent application (including provisionals and
continuations-in-part) claiming an Invention, promptly disclose such Invention
to the other Party and provide the other Party with a copy of the proposed
patent application at least fifteen (15) days before filing such application or
such shorter time as may be required to preserve Patent rights, including the
avoidance of a statutory bar or prior publication. If the non-filing Party
believes that the filing Party’s proposed Patent application discloses
Confidential Information of the non-filing Party, the non-filing Party shall so
notify the filing Party within such fifteen (15) days after receipt thereof, and
the filing Party shall amend its proposed application to comply with the
confidentiality provisions of this Agreement. If the Parties are in agreement as
to the designation of the Invention as a Brickell Invention, Joint Invention or
Kaken Invention, as applicable, the Parties shall take such actions as are set
forth in Section 9.3. If the Parties disagree as to whether an Invention is a
Brickell Invention, Joint Invention or Kaken Invention, and are unable to reach
agreement within thirty (30) days after commencing discussions, then the
provisions of Article 15 shall apply to such dispute.

- 32 -

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

9.3    Patent Filings, Prosecution and Maintenance.
9.3.1    Brickell Patents.
(a)    Notwithstanding any other provision of this Agreement, promptly after the
Effective Date, Brickell shall, at its own cost and expense, [***].
(b)    Subject to, and without limiting Kaken’s rights under, Section 9.4 of
this Agreement, Brickell shall [***], at its cost and expense. If, during the
Term, Brickell [***], Brickell shall notify Kaken of such intention or decision
at least sixty (60) days (or as soon as possible if less than sixty (60) days)
prior to any filing or payment due date, or any other date that requires action,
in connection with [***].
9.3.2    [***] Patents. Subject to, and without limiting Kaken’s rights under,
Section 9.4 of this Agreement, [***]. Subject to, and without limiting
Brickell’s rights under, Section 9.4 of this Agreement, [***]. The Parties shall
discuss whether to file a Patent claiming [***]. The Parties shall cooperate
reasonably in the prosecution of all [***] and shall share all material
information relating thereto promptly after receipt of such information. If,
during the Term, the prosecuting Party (1) intends to allow [***] or decision at
least thirty (30) days (or as soon as possible if less than thirty (30) days)
prior to any filing or payment due date, or any other date that requires action,
in connection with [***], and the other Party shall thereupon have the right,
but not the obligation, to [***].
9.3.3    Kaken [***] Patents. Kaken shall have the [***]. If, during the Term,
Kaken (i) intends to [***] of such intention or decision at least thirty (30)
days (or as soon as possible if less than thirty (30) days) prior to [***], and
Brickell shall thereupon [***]. Kaken agrees to [***] with respect to any
decision to [***], or with respect to [***].
9.3.4    Cooperation. The Parties agree to cooperate in exercising their rights
or obligations set forth in this Section 9.3, including obtaining and executing
necessary powers of attorney and assignments by the named inventors, providing
relevant technical reports to the filing Party concerning the Invention
disclosed in any Patent that is the subject of this Section 9.3, obtaining
execution of such other documents which are needed in the filing and prosecution
of such Patents, and, as requested by a Party, updating each other regarding the
status of such Patents, and otherwise cooperate with the other Party so far as
reasonably necessary with respect to furnishing all information and data in its
possession reasonably necessary to obtain or maintain such Patents.
9.3.5    Patent Expenses. Any expenses incurred by a Party in connection with
the preparation, filing, prosecution and maintenance of any [***], as
applicable, shall be borne by the Party incurring such expenses.
9.4    Defense and Enforcement of Patents.
9.4.1    Infringement of Third Party Patents. Each of the Parties shall
promptly, but in any event no later than thirty (30) days after receipt of
notice thereof, notify the other

- 33 -

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

Party in writing in the event of any claims by a Third Party of alleged patent
infringement by Kaken or Brickell or any of their respective Affiliates or
sublicensees with respect to the , research, development, manufacture, use,
sale, offer for sale or importation of a Product (each, an “Infringement
Claim”). [***]. With respect to any Infringement Claim in the Field in the
Territory, the Parties shall attempt to negotiate in good faith a resolution
with respect thereto. If the Parties cannot settle such Infringement Claim with
the appropriate Third Parties within thirty (30) days after the receipt of the
notice pursuant to this Section 9.4.1, then the following shall apply:
(a)    In the case of any such claim against Kaken alone or against both Kaken
and Brickell, in each case, with respect to the Product in the Field in the
Territory, then Kaken shall be deemed to be the “Controlling Party” for purposes
of such Infringement Claim. In the case of any claim against (i) Brickell alone,
or (ii) with respect to the Product outside the Territory or outside the Field,
then Brickell shall be deemed to be the “Controlling Party” for purposes of such
Infringement Claim. In the event of worldwide litigation (such that related
cases and/or claims are being pursued both inside and outside the Territory),
each Party shall reasonably assist the other in its role as the Controlling
Party in its respective territory.
(b)    The Controlling Party shall assume control of the defense of such
Infringement Claim. The non-Controlling Party, upon request of the Controlling
Party, agrees to join in any such litigation, and in any event to reasonably
cooperate with the Controlling Party, in each case, at the Controlling Party’s
expense. The non-Controlling Party will have the right to consult with the
Controlling Party concerning such Infringement Claim and to participate in and
be represented by independent counsel in any litigation in which such
non-Controlling Party is a party at its own expense. The Controlling Party shall
have the exclusive right to settle any Infringement Claim without the consent of
the other Party, unless such settlement shall have a material adverse impact on
the other Party (in which case the consent of such other Party shall be
required). For purposes of this Section 9.4.1(b), any settlement that would
involve the waiver of rights (including the rights to receive payments) of such
other Party shall be deemed a material adverse impact and shall require the
consent of such other Party, such consent not to be unreasonably withheld.
(c)    If a Party shall become engaged in or participate in any suit described
in this Section 9.4.1, the other Party shall cooperate, and shall cause its and
its Affiliates’ employees to cooperate, with such Party in all reasonable
respects in connection therewith, including giving testimony and producing
documents lawfully requested, and using its reasonable efforts to make available
to the other, at no cost to the other (other than reimbursement of actually
incurred, reasonable out-of-pocket travel and lodging expenses), such employees
who may be helpful with respect to such suit, investigation, claim or other
proceeding.
9.4.2    Prosecution of Infringers.
(a)    Notice. If either Party (i) receives notice of any patent invalidity
actions, any declaratory judgment actions or any alleged or threatened
infringement of patents or patent applications or misappropriation of
intellectual property [***] comprising the (w) [***],

- 34 -

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

or (ii) learns that a Third Party is infringing or allegedly infringing any
Patent within the [***] in each case, in the Territory, or if any Third Party
claims that any such Patent is invalid or unenforceable it will promptly notify
the other Party thereof, including providing evidence of infringement or the
claim of invalidity or unenforceability reasonably available to such Party.
(b)    Enforcement of Patents.
(i)    (A) As between Brickell and Kaken, Kaken will have the first right (but
not the obligation) to take the appropriate steps to enforce or defend any
Patent within [***] against infringement by a Third Party that is conducting the
manufacture, sale, use, offer for sale or import of any pharmaceutical product
in the Field in the Territory. Kaken may take steps including the initiation,
prosecution and control of any suit, proceeding or other legal action by counsel
of its own choice. Kaken shall bear the costs of such enforcement or defense, as
applicable. Notwithstanding the foregoing, Brickell will have the right, at its
own expense, to be represented in any such action by counsel of its own choice.
(13) As between Brickell and Kaken, Kaken will have the first right (but not the
obligation) to take the appropriate steps to enforce or defend [***] against
infringement by a Third Party that is conducting the manufacture, sale, use,
offer for sale or import of any pharmaceutical product in the Field in the
Territory. Kaken may take steps including the initiation, prosecution and
control of any suit, proceeding or other legal action by counsel of its own
choice. Kaken shall bear the costs of such enforcement or defense, as
applicable. Notwithstanding the foregoing, Brickell will have the right, at its
own expense, to be represented in any such action by counsel of its own choice.
(ii)    If, pursuant to Section 9.4.2(b)(i), Kaken fails to institute such
litigation or otherwise take steps to remedy the infringement of a [***] within
one hundred eighty (180) days of the date one Party has provided notice to the
other Party pursuant to Section 9.4.2(a) of such infringement or claim, then
Brickell will have the right (but not the obligation), at its own expense, to
bring any such suit, action or proceeding by counsel of its own choice and Kaken
will have the right, at its own expense, to be represented in any such action by
counsel of its own choice. [***].
(iii)    As between Brickell and Kaken, Brickell will have the first right (but
not the obligation) to take the appropriate steps to enforce or defend any
Patent within [***] against infringement by a Third Party that is conducting the
manufacture, sale, use, offer for sale or import of any pharmaceutical product
in the Field [***]. Brickell may take steps including the initiation,
prosecution and control of any suit, proceeding or other legal action by counsel
of its own choice. Brickell shall bear the costs of such enforcement or defense,
as applicable. Notwithstanding the foregoing, Kaken will have the right, at its
own expense, to be represented in any such action by counsel of its own choice.
(iv)    If, pursuant to Section 9.4.2(b)(iii), Brickell fails to institute such
litigation or otherwise take steps to remedy the infringement of [***] within
one hundred eighty (180) days of the date one Party has provided notice to the
other Party pursuant to Section 9.4.2(a) of such infringement or claim, then
Kaken will have the right (but not the obligation), at its own expense, to bring
any such suit, action or proceeding by counsel of its own choice and

- 35 -

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

Brickell will have the right, at its own expense, to be represented in any such
action by counsel of its own choice.
(c)    Cooperation; Damages.
(i)    If one Party brings any suit, action or proceeding under Section
9.4.2(b)(i) or (ii), the other Party agrees to be joined as party plaintiff if
necessary to prosecute the suit, action or proceeding and to give the first
Party reasonable authority to file and prosecute the suit, action or proceeding;
provided, however, that neither Party will be required to transfer any right,
title or interest in or to any property to the other Party or any other party to
confer standing on a Party hereunder.
(ii)    The Party not pursuing the suit, action or proceeding hereunder will
provide reasonable assistance to the other Party, including by providing access
to relevant documents and other evidence and making its employees available,
subject to the other Party’s reimbursement of any out-of-pocket costs incurred
by the non-enforcing or defending Party in providing such assistance.
(iii)    Kaken shall not, without the prior written consent of Brickell (in its
sole discretion), enter into any compromise or settlement relating to any claim,
suit or action that it brought under Section 9.4.2 involving [***], that admits
the invalidity or unenforceability of [***], or requires Brickell to pay any sum
of money, or otherwise adversely affects the rights of Brickell with respect to
such Patents, the Product or Brickell’s rights hereunder (including the rights
to receive payments).
(iv)    Any settlements, damages or other monetary awards (a “Recovery”)
recovered pursuant to a suit, action or proceeding brought pursuant to Section
9.4.2(b)(i)(A) will be allocated first to the costs and expenses of the Party
taking such action, and second, to the costs and expenses (if any) of the other
Party, with any remaining amounts (if any) to be allocated as follows: (i) to
the extent that such Recovery is a payment for lost sales of the Product in the
Field in the Territory, any such Recovery shall be retained by Kaken [***] for
purpose of this Agreement and subject to [***] (ii) all remaining Recoveries
shall be payable to Party taking such action to the extent such remaining
Recoveries relate solely to the Product in the Field in the Territory (and, for
purposes of clarity, all remaining Recoveries related to the Product [***] or
[***]shall be payable to Brickell).
(v)    Infringement and Defense of Brickell Patents [***]. For clarity, with
respect to any and all infringement or defense of any [***], Brickell (or its
designee) shall have [***] to bring an appropriate suit or other action against
any Person engaged in such infringement or defense of any such [***], in its
sole discretion and [***].
9.5    Patent Marking. Kaken shall mark the Product marketed and sold by Kaken
(or its Affiliate or distributor) hereunder with appropriate patent numbers or
indicia at Brickell’s reasonable request.
9.6    Patent Challenge.

- 36 -

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

9.6.1    Kaken covenants that shall not and shall cause its Affiliates and
sublicensees not to directly or indirectly (through assistance granted to a
Third Party or otherwise), make any Patent Challenge to any Brickell Patent or
Brickell Collaboration Patent. Kaken will include provisions in all agreements
granting sublicenses of Kaken’s rights hereunder providing that if the Affiliate
or sublicensee of Kaken undertakes a Patent Challenge, then Kaken upon receipt
of written notice from Brickell of such Patent Challenge will terminate the
applicable sublicense agreement. If Kaken fails to so terminate such sublicense
agreement, Brickell may terminate Kaken’s right to sublicense and any
sublicenses previously granted shall automatically terminate. In connection with
such sublicense termination, Kaken shall cooperate with Brickell’s reasonable
requests to cause such a terminated sublicensee to discontinue activities with
respect to the Development, Commercialization and Manufacture of the Drug
Substances and Products.
9.6.2    Brickell covenants that shall not and shall cause its Affiliates and
sublicensees not to, directly or indirectly (through assistance granted to a
Third Party or otherwise), make any Patent Challenge to any Kaken Applied
Patents. Brickell will include provisions in all agreements granting sublicenses
of Brickell’s rights hereunder providing that if the Affiliate or sublicensee of
Brickell undertakes a Patent Challenge, then Brickell upon receipt of written
notice from Kaken of such Patent Challenge will terminate the applicable
sublicense agreement. If Brickell fails to so terminate such sublicense
agreement, Kaken may terminate Brickell’s right to sublicense and any
sublicenses previously granted shall automatically terminate. In connection with
such sublicense termination, Brickell shall cooperate with Kaken’s reasonable
requests to cause such a terminated sublicensee to discontinue activities with
respect to the Development, Commercialization and Manufacture of the Drug
Substances and Products.
ARTICLE 10
REPRESENTATIONS, WARRANTIES AND COVENANTS
10.1    Mutual Representations and Warranties. Each Party hereby represents and
warrants (as applicable) to the other Party as follows, as of the Effective
Date:
10.1.1    Corporate Existence and Power. It is a company or corporation duly
organized, validly existing, and (but only as to Brickell) in good standing
under the laws of the jurisdiction in which it is incorporated, and has full
corporate power and authority and the legal right to own and operate its
property and assets and to carry on its business as it is now being conducted
and as contemplated in this Agreement, including the right to grant the licenses
granted by it hereunder.
10.1.2    Authority and Binding Agreement. (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, except as enforcement may be affected by bankruptcy,
insolvency or other similar laws and by general principles of equity.

- 37 -

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

10.1.3    No Conflicts. The execution, delivery and performance of this
Agreement in accordance with its terms by it does not (i) conflict with any
agreement, instrument or understanding, oral or written, to which it is a party
and by which it may be bound or (ii) violate any Laws of any Governmental
Authority having jurisdiction over it.
10.1.4    All Consents and Approvals Obtained. Except with respect to Regulatory
Approvals for the Development, Manufacturing or Commercialization of the
Product, (i) all necessary consents, approvals and authorizations of, and (ii)
all notices to, and filings by such Party with, all Governmental Authorities and
other Persons required to be obtained or provided by such Party as of the
Effective Date in connection with the execution, delivery and performance of
this Agreement have been obtained and provided, except for those approvals, if
any, not required at the time of execution of this Agreement.
10.2    Additional Representations, Warranties and Covenants of Brickell.
Brickell hereby represents, warrants and covenants to Kaken that, as of the
Effective Date:
10.2.1    To the knowledge of Brickell, the patent applications encompassed
within the [***] if such patent applications were issued as patents would be
valid and enforceable patents and to Brickell’s knowledge nothing has been done
or omitted to be done by which they may cease to be valid and enforceable.
10.2.2    To the knowledge of Brickell, which includes internal searches of
relevant public records, there are no facts which would render the patent
applications encompassed within the [***], if and when issued, invalid or
unenforceable.
10.2.3    There are no claims, judgments or settlements against or owed by
Brickell, nor any pending reissue, reexamination, interference, opposition or
similar proceedings with respect to [***], and Brickell has not received notice,
and is not otherwise aware after conducting internal searches of relevant public
records, in each case as of the Effective Date of any threatened claims or
litigation or any reissue, reexamination, interference, opposition or similar
proceedings seeking to invalidate or otherwise challenge the [***].
10.2.4    [***], Brickell is the sole legal and beneficial owner of all the
[***], free and clear of any Liens, and no Person (including any Affiliate of
Brickell) has any right, interest or claim in or to, and neither Brickell nor
any of its Affiliates has entered into any agreement granting any right,
interest or claim in or to, any [***] to any Third Party (including any academic
organization or agency).
10.2.5    Schedule 1.5 is a complete and accurate list [***].
10.2.6    All application fees in connection with the [***] have been paid and
all material documents and certificates in connection therewith have been filed
with the relevant patent, or other competent Governmental Authority, as the case
may be, for the purposes of obtaining the patent issuance of the [***].

- 38 -

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

10.2.7    Brickell has taken all reasonable steps to maintain the
confidentiality of and otherwise protect and enforce its rights in all
Confidential Information of Brickell that is Brickell Know-How that it holds, or
purports to hold, as a trade secret.
10.2.8    No claim has been made to Brickell by a Third Party which alleges that
Development, Commercialization or Manufacture of the Product infringes the
intellectual property rights of a Third Party.
10.2.9    As of the Effective Date, [***], there have been no public uses or
public disclosures of the inventions claimed in [***] prior to the earliest
filing date of each such respective patent or patent application.
10.2.10        [***] no written claim has been made by Brickell which (i)
alleges that a Third Party is infringing [***], or which otherwise disputes the
right of a Third Party to use the intellectual property rights owned or used by
the Third Party or (ii) alleges any unauthorized disclosure or misappropriation
of [***].
10.2.11        Each director, consultant, contractor and employee of Brickell
has irrevocably assigned in full to Brickell all of such individual’s right,
title and interest in and to [***], where such rights do not vest in Brickell by
operation of law. No current or former employee, director, consultant or
independent contractor of Brickell owns (or, if applicable, will direct against
Brickell) any right, license, claim or interest whatsoever in or with respect to
[***].
10.2.12        [***], no funding, facilities, or personnel of any Governmental
Authority or any college, university, or other educational institution were
used, directly or indirectly, to develop or create, in whole or in part, [***].
10.2.13        [***] neither the execution, delivery, or performance of this
Agreement nor the consummation of any of the transactions contemplated by this
Agreement will, with or without notice or lapse of time, result in, or give any
other Person the right or option to cause or declare: (a) a loss of, or Lien on,
[***], (b) a breach of or default under any contract relating to [***], (c) the
release, disclosure, or delivery of any [***] by or to any escrow agent or other
Person; or (d) the grant, assignment, or transfer to any other Person of any
license or other right to interest under, to, or in any of [***].
10.2.14        Neither Brickell, its shareholders nor its Affiliates have
entered into any agreement for, or are currently in any negotiations for, a
Change of Control of Brickell.
10.3    Brickell Product Development.
10.3.1    All Confidential Information that Brickell has provided to Kaken
related to the Product prior to the Effective Date, is [***], true and complete
in all materials respects.

- 39 -

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

10.3.2    [***], all work related to the Development, Regulatory Approvals,
Manufacture and Commercialization of the Product [***] heretofore has been and
is being managed by Brickell in accordance with all applicable Laws. Brickell is
[***].
10.4    Disclaimer. Kaken understands that the Product is the subject of ongoing
clinical research and development and that Brickell cannot ensure the safety or
usefulness of the Product or that the Product will receive Regulatory Approvals.
In addition, Brickell makes no warranties except as set forth in this Article 10
[***].
10.5    No Other Representations or Warranties. EXCEPT AS EXPRESSLY STATED IN
THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR
IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL
PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY. EXCEPT AS
EXPRESSLY STATED IN THIS AGREEMENT, ALL REPRESENTATIONS AND WARRANTIES, WHETHER
ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.
ARTICLE 11
INDEMNIFICATION
11.1    Indemnification by Brickell. Brickell hereby agrees to save, indemnify,
defend and hold Kaken, its Affiliates, and their respective directors, officers,
agents and employees harmless from and against any and all losses, damages,
liabilities, costs and expenses (including reasonable attorneys’ fees and
expenses) (collectively, “Losses”) arising in connection with any and all
charges, complaints, actions, suits, proceedings, hearings, investigations,
claims, demands, judgments, orders, decrees, stipulations or injunctions by a
Third Party (each a “Third Party Claim”) resulting or otherwise arising from (i)
any breach by Brickell of any of its representations, warranties, covenants or
obligations pursuant to this Agreement or (ii) the negligence or willful
misconduct by Brickell or its Affiliates or their respective officers,
directors, employees, agents, consultants or sublicensee in performing any
obligations under this Agreement; in each case except to the extent that such
Losses are subject to indemnification by Kaken pursuant to Section 11.2.
11.2    Indemnification by Kaken. Kaken hereby agrees to save, indemnify, defend
and hold Brickell, its Affiliates, and their respective directors, agents and
employees harmless from and against any and all Losses arising in connection
with any and all Third Party Claims resulting or otherwise arising from (i) any
breach by Kaken of any of its representations, warranties, covenants or
obligations pursuant to this Agreement or (ii) the negligence or willful
misconduct by Kaken or its Affiliates or their respective officers, directors,
employees, agents, consultants or sublicensees in performing any obligations
under this Agreement.; in each case except to the extent that such Losses are
subject to indemnification by Brickell pursuant to Section 11.1.
11.3    Indemnification Procedures.

- 40 -

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

11.3.1    Notice of Claim. All indemnification claims in respect of any
indemnitee seeking indemnity under Section 11.1 or 11.2, as applicable
(collectively, the “Indemnitees” and each an “Indemnitee”) will be made solely
by the corresponding Party (the “Indemnified Party”). The Indemnified Party will
give the indemnifying Party (the “Indemnifying Party”) prompt written notice (an
“Indemnification Claim Notice”) of any Losses and any legal proceeding initiated
by a Third Party against the Indemnified Party as to which the Indemnified Party
intends to make a request for indemnification under Section 11.1 or 11.2, as
applicable, but in no event will the Indemnifying Party be liable for any Losses
that result from any delay in providing such notice which materially prejudices
the defense of such proceeding. Each Indemnification Claim Notice shall contain
a description of the claim and the nature and amount of such Loss (to the extent
that the nature and amount of such Loss are known at such time). Together with
the Indemnification Claim Notice, the Indemnified Party will furnish promptly to
the Indemnifying Party copies of all notices and documents (including court
papers) received by any Indemnitee in connection with the Third Party Claim.
11.3.2    Control of Defense. At its option, the Indemnifying Party may assume
the defense of any Third Party Claim subject to indemnification as provided for
in Section 11.1 or 11.2, as applicable, by giving written notice to the
Indemnified Party within thirty (30) days after the Indemnifying Party’s receipt
of an Indemnification Claim Notice. Upon assuming the defense of a Third Party
Claim, the Indemnifying Party may appoint as lead counsel in the defense of the
Third Party Claim any legal counsel it selects, and such Indemnifying Party
shall thereafter continue to defend such Third Party Claim in good faith. Should
the Indemnifying Party assume the defense of a Third Party Claim (and continue
to defend such Third Party Claim in good faith), the Indemnifying Party will not
be liable to the Indemnified Party or any other Indemnitee for any legal
expenses subsequently incurred by such Indemnified Party or other Indemnitee in
connection with the analysis, defense or settlement of the Third Party Claim,
unless the Indemnifying Party has failed to assume the defense and employ
counsel in accordance with this Section 11.3.
11.3.3    Right to Participate in Defense. Without limiting Section 11.3.2, any
Indemnitee will be entitled to participate in the defense of a Third Party Claim
for which it has sought indemnification hereunder and to employ counsel of its
choice for such purpose; provided, however, that such employment will be at the
Indemnitee’s own expense unless (i) the employment thereof has been specifically
authorized by the Indemnifying Party in writing, or (ii) the Indemnifying Party
has failed to assume the defense (or continue to defend such Third Party Claim
in good faith) and employ counsel in accordance with this Section 11.3, in which
case the Indemnified Party will be allowed to control the defense.
11.3.4    Settlement. With respect to any Losses relating solely to the payment
of money damages in connection with a Third Party Claim and that will not result
in the Indemnitee becoming subject to injunctive relief and as to which the
Indemnifying Party will have acknowledged in writing the obligation to indemnify
the Indemnitee hereunder, the Indemnifying Party will have the sole right to
consent to the entry of any judgment, enter into any settlement or otherwise
dispose of such Loss, on such terms as the Indemnifying Party, in its reasonable
discretion, will deem appropriate (provided, however, that such terms shall
include a complete

- 41 -

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

and unconditional release of the Indemnified Party from all liability with
respect thereto), and will transfer to the Indemnified Party all amounts which
said Indemnified Party will be liable to pay prior to the time of the entry of
judgment. With respect to all other Losses in connection with Third Party
Claims, where the Indemnifying Party has assumed the defense of the Third Party
Claim in accordance with Section 11.3.2, the Indemnifying Party will have
authority to consent to the entry of any judgment, enter into any settlement or
otherwise dispose of such Loss, provided it obtains the prior written consent of
the Indemnified Party (which consent will be at the Indemnified Party’s
reasonable discretion). The Indemnifying Party that has assumed the defense of
(and continues to defend) the Third Party Claim in accordance with Section
11.3.2 will not be liable for any settlement or other disposition of a Loss by
an Indemnitee that is reached without the written consent of such Indemnifying
Party. Regardless of whether the Indemnifying Party chooses to defend or
prosecute any Third Party Claim, no Indemnitee will admit any liability with
respect to, or settle, compromise or discharge, any Third Party Claim without
first offering to the Indemnifying Party the opportunity to assume the defense
of the Third Party Claim in accordance with Section 11.3.2.
11.3.5    Cooperation. If the Indemnifying Party chooses to defend or prosecute
any Third Party Claim, the Indemnified Party will, and will cause each other
Indemnitee to, cooperate in the defense or prosecution thereof and will furnish
such records, information and testimony, provide such witnesses and attend such
conferences, discovery proceedings, hearings, trials and appeals as may be
reasonably requested in connection with such Third Party Claim. Such cooperation
will include access during normal business hours afforded to the Indemnifying
Party to, and reasonable retention by the Indemnified Party of, records and
information that are reasonably relevant to such Third Party Claim, and making
Indemnitees and other employees and agents available on a mutually convenient
basis to provide additional information and explanation of any material provided
hereunder, and the Indemnifying Party will reimburse the Indemnified Party for
all its reasonable out-of-pocket expenses incurred in connection with such
cooperation.
11.3.6    Expenses of the Indemnified Party. Except as provided above, the
reasonable and verifiable costs and expenses, including fees and disbursements
of counsel, incurred by the Indemnified Party in connection with any Third Party
Claim will be reimbursed on a calendar quarter basis by the Indemnifying Party,
without prejudice to the Indemnifying Party’s right to contest the Indemnified
Party’s right to indemnification and subject to refund in the event the
Indemnifying Party is ultimately held not to be obligated to indemnify the
Indemnified Party.
11.4    Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR
ANY CONSEQUENTIAL, INCIDENTAL, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO
ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF
SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 11.4 IS
INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS
OF ANY PARTY UNDER SECTION 11.1 or 11.2, OR DAMAGES AVAILABLE FOR A PARTY’S
BREACH OF CONFIDENTIALITY OBLIGATIONS UNDER

- 42 -

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

ARTICLE 12. EXCEPT AS EXPRESSLY SET FORTH IN ANY REPRESENTATION OR WARRANTY IN
ARTICLE 10, KAKEN ACKNOWLEDGES AND AGREES THAT BRICKELL HAS MADE NO
REPRESENTATIONS OR WARRANTIES WITH RESPECT TO, AND KAKEN SHALL HAVE NO CLAIM OR
RIGHT (INCLUDING WITH RESPECT TO INDEMNIFICATION PURSUANT TO THIS ARTICLE 11 (OR
OTHERWISE)) WITH RESPECT TO, ANY INFORMATION, DOCUMENTS OR MATERIALS FURNISHED
TO OR FOR KAKEN BY BRICKELL, ANY OF ITS AFFILIATES, OR ANY OF ITS OR THEIR
OFFICERS, DIRECTORS, EMPLOYEES, AGENTS OR ADVISORS, INCLUDING THE CONFIDENTIAL
INFORMATION PACKAGE REGARDING THE PRODUCT PROVIDED TO KAKEN AND ANY INFORMATION,
DOCUMENTS OR MATERIAL MADE AVAILABLE TO KAKEN IN ANY “DATA ROOM”, MANAGEMENT
PRESENTATION OR ANY OTHER FORM IN EXPECTATION OF THE TRANSACTION AND
COLLABORATION CONTEMPLATED HEREBY.
11.5    Insurance. Each Party shall procure and maintain insurance, including
clinical trials insurance and product liability insurance, adequate to cover its
obligations hereunder. Certificates of insurance (in English) evidencing such
coverage will be made available to the other Party upon written request.
ARTICLE 12
CONFIDENTIALITY
12.1    Confidential Information. As used in this Agreement, the term
“Confidential Information” means all information, whether it be written or oral,
including all production schedules, lines of products, volumes of business,
processes, new product developments, product designs, formulae, technical
information, laboratory data, clinical data, patent information, know-how, trade
secrets, financial and strategic information, marketing and promotional
information and data, and other material relating to any products, projects or
processes of one Party (the “Disclosing Party”) that is provided to, or
otherwise obtained by, the other Party (the “Receiving Party”) in connection
with this Agreement (including information exchanged prior to the date hereof in
connection with the transactions set forth in this Agreement, including any
information disclosed by either Party pursuant to the Confidential Disclosure
Agreement between the Parties dated September 9, 2013. Notwithstanding the
foregoing sentence, Confidential Information shall not include any information
or materials that:
(a)    were already known to the Receiving Party (other than under an obligation
of confidentiality), at the time of disclosure by the Disclosing Party, to the
extent such Receiving Party has documentary evidence to that effect;
(b)    were generally available to the public or otherwise part of the public
domain at the time of disclosure thereof to the Receiving Party;
(c)    became generally available to the public or otherwise part of the public
domain after disclosure or development thereof, as the case may be, and other
than through any act or omission of a Party in breach of such Party’s
confidentiality obligations under this Agreement;

- 43 -

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

(d)    were disclosed to a 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; or
(e)    were independently discovered or developed by or on behalf of the
Receiving Party without the use of the Confidential Information belonging to the
other Party, to the extent such Receiving Party has documentary evidence to that
effect.
12.2    Confidentiality Obligations. Each of Kaken and Brickell shall keep all
Confidential Information received from or on behalf of the other Party with the
same degree of care with which it maintains the confidentiality of its own
Confidential Information, but in all cases no less than a reasonable degree of
care. Neither Party shall use such Confidential Information for any purpose
other than in performance of its obligations or the exercise of its rights
pursuant to this Agreement or disclose the same to any other Person other than
to such of its and its Affiliates’ directors, managers, employees; independent
contractors, agents, consultants or sublicensees who have a need to know such
Confidential Information to implement the terms of this Agreement or enforce its
rights under this Agreement; provided, however, that a Receiving Party shall
advise any of its and its Affiliates’ directors, managers, employees,
independent contractors, agents, consultants or sublicensees who receives such
Confidential Information of the confidential nature thereof and of the
obligations contained in this Agreement relating thereto, and the Receiving
Party shall ensure (including, in the case of a Third Party, by means of a
written agreement with such Third Party having terms at least as protective as
those contained in this Article 12) that all such directors, managers,
employees, independent contractors, agents, consultants or sublicensees comply
with such obligations. Upon termination of this Agreement, the Receiving Party
shall return or destroy all documents, tapes or other media containing
Confidential Information of the Disclosing Party that remain in the possession
of the Receiving Party or its directors, managers, employees, independent
contractors, agents, consultants or sublicensees, except that the Receiving
Party may keep one copy of the Confidential Information in the legal department
files of the Receiving Party, solely for archival purposes. Such archival copy
shall be deemed to be the property of the Disclosing Party, and shall continue
to be subject to the provisions of this Article 12. It is understood that
receipt of Confidential Information under this Agreement will not limit the
Receiving Party from assigning its employees to any particular job or task in
any way it may choose, subject to the terms and conditions of this Agreement.
12.3    Permitted Disclosure and Use. Notwithstanding Section 12.2, (i) either
Party may disclose Confidential Information belonging to the other Party only to
the extent such disclosure is reasonably necessary to: (a) comply with or
enforce any of the provisions of this Agreement; (b) comply with applicable Law
or (c) only to the extent such disclosure is reasonably necessary to obtain or
maintain regulatory approval of a Product, as applicable, to the extent such
disclosure is made to a Governmental Authority. If a Party deems it necessary to
disclose Confidential Information of the other Party pursuant to this Section
12.3, such Party shall give reasonable advance written notice of such disclosure
to the other Party to permit such other Party sufficient opportunity to object
to such disclosure or to take measures to ensure confidential treatment of such
information, including seeking a protective order or other

- 44 -

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

appropriate remedy. [***]. In the event that a Party becomes aware that a Third
Party recipient of Confidential Information has breached its confidentiality
obligations, then such Party shall promptly inform the other Party of such
event, and the Parties will cooperate in their investigation of such occurrence
and enforcement of the provisions of the relevant confidentiality agreement.
12.4    Notification. The Receiving Party shall notify the Disclosing Party
promptly upon discovery of any unauthorized use or disclosure of the Disclosing
Party’s Confidential Information, and will cooperate with the Disclosing Party
in any reasonably requested fashion to assist the Disclosing Party to regain
possession of such Confidential Information and to prevent its further
unauthorized use or disclosure.
12.5    Publicity; Filing of this Agreement.
12.5.1    Publicity. Each Party will be permitted to issue a press release
announcing the execution of this Agreement, which the releasing Party will
provide to the other Party in advance for the other Party’s review and consent,
which must be obtained prior to issuance of such press release. Except as
otherwise provided in this Section 12.5, each Party shall maintain the
confidentiality of all provisions of this Agreement, and without the prior
written consent of the other Party, which consent shall not be unreasonably
withheld, neither Party nor its respective Affiliates shall make any press
release or other public announcement of or otherwise disclose the provisions of
this Agreement to any Third Party, except for: (i) disclosure to those of its
directors, officers, employees, accountants, attorneys, underwriters, lenders
and other financing sources, potential strategic partners, advisors, agents and
sublicensees whose duties reasonably require them to have access to this
Agreement, provided that such directors, officers, employees, accountants,
attorneys, underwriters, lenders and other financing sources, advisors, agents
or sublicensees are required to maintain the confidentiality of this Agreement,
(ii) disclosures required by the Tokyo Stock Exchange and any other disclosures
made pursuant to any listing agreement with a national securities exchange, in
which case the disclosing Party shall provide the nondisclosing Party with at
least forty eight (48) hours’ notice unless otherwise not practicable, but in
any event no later than the time the disclosure required by the regulations of
the Tokyo Stock Exchange or national securities exchange or listing agreement is
made, (iii) disclosures as may be required by Law, in which case the disclosing
Party shall provide the nondisclosing Party with prompt advance notice of such
disclosure and cooperate with the nondisclosing Party to seek a protective order
or other appropriate remedy, including a request for confidential treatment in
the case of Brickell for a filing with the Securities and Exchange Commission;
and (iv) other disclosures for which consent has previously been given. A Party
may publicly disclose without regard to the preceding requirements of this
Section 12.5 any information that was previously publicly disclosed pursuant to
this Section 12.5.
12.6    Publication. Kaken shall submit copies of each proposed academic,
scientific, medical and other publication or presentation that contains or
refers to the Brickell Technology or otherwise relates to the Product or any
research or Development related to the Product to Brickell at least thirty (30)
days in advance of submitting such proposed publication or presentation to a
publisher or other Third Party. Brickell shall have the right to review, comment

- 45 -

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

on and consent (but only with respect to Brickell’s Confidential Information) to
each such proposed publication or presentation at its sole discretion. Brickell
shall have the right to remove any of its Confidential Information prior to
submission for publication or presentation. Kaken shall redact or otherwise
modify the proposed publication or presentation to remove any such Confidential
Information of Brickell that Brickell has objected to. In addition, in the event
that the document includes data, information or material generated by Brickell’s
scientists, and professional standards for authorship would be consistent with
including Brickell’s scientists as co-authors of the document, the names of such
scientists will be included as co-authors. Brickell shall submit copies of each
proposed academic, scientific, medical and other publication or presentation
that contains or refers to the Kaken Applied Technology related to the Product
to Kaken at least thirty (30) days in advance of submitting such proposed
publication or presentation to a publisher or other Third Party. Kaken shall
have the right to review, comment on and consent (but only with respect to
Kaken’s Confidential Information) to each such proposed publication or
presentation at its sole discretion. Kaken shall have the right to remove any of
its Confidential Information prior to submission for publication or
presentation. Brickell shall redact or otherwise modify the proposed publication
or presentation to remove any such Confidential Information of Kaken that Kaken
has objected to. In addition, in the event that the document includes data,
information or material generated by Kaken’s scientists, and professional
standards for authorship would be consistent with including Kaken’s scientists
as co-authors of the document, the names of such scientists will be included as
co-authors.
12.7    Use of Names. Except as otherwise set forth in this Agreement, neither
Party shall use the name of the other Party in relation to this transaction in
any public announcement, press release or other public document without the
written consent of such other Party, which consent shall not be unreasonably
withheld; provided, however, that subject to Section 12.5, either Party may use
the name of the other Party in any document filed with any Regulatory Authority
or Governmental Authority, including the FDA and the Securities and Exchange
Commission.
12.8    Survival. The obligations and prohibitions contained in this Article 12
as they apply to Confidential Information shall survive the expiration or
termination of this Agreement for a period of ten (10) years.
ARTICLE 13
TERM AND TERMINATION
13.1    Term. This Agreement shall become effective on the Effective Date and,
unless earlier terminated pursuant to this Article 13, shall remain in effect,
[***] (the “Term”).
13.2    Termination for Breach. Either Party may, without prejudice to any other
remedies available to it at law or in equity, terminate this Agreement upon
written notice to the other Party in the event that the other Party (the
“Breaching Party”) shall have materially breached this Agreement. The Breaching
Party shall have thirty (30) days after written notice thereof was provided to
the Breaching Party by the non-breaching Party to remedy such default. Unless
the Breaching Party has cured any such breach or default prior to the expiration
of such thirty (30) day period, such termination shall become effective upon
receipt of the written notice

- 46 -

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

of termination by the Breaching Party to be given within ten (10) days of the
end of the thirty (30) day period.
13.3    Termination as a Result of Bankruptcy. Each Party shall have the right
to terminate this Agreement upon written notice as a result of the filing or
institution of bankruptcy, reorganization, liquidation or receivership
proceedings, or upon an assignment of a substantial portion of the assets for
the benefit of creditors by the other Party; provided that such termination
shall be effective only if such proceeding is not dismissed within ninety (90)
days after the filing thereof.
13.4    Termination by Kaken.
13.4.1    Termination by Kaken Prior to Regulatory Approval. At any time prior
to the first Regulatory Approval of the Product in the Field in the Territory,
Kaken shall have the right to terminate this Agreement in its entirety [***].
13.4.2    Termination by Kaken After Regulatory Approval. At any time Kaken
shall have the right to terminate this Agreement in its entirety [***].
13.4.3    Performance. During such [***] under Section 13.4.1 or [***] under
Section 13.4.2, Kaken shall continue to perform all of its obligations under
this Agreement, including performing all Development Activities allocated to it
pursuant to the Development Plan then in effect in accordance with the terms and
conditions of this Agreement and bearing all cost associated therewith during
such period.
ARTICLE 14    
EFFECTS OF TERMINATION AND EXPIRATION
14.1    Termination By Brickell and Certain Terminations by Kaken. Without
limiting any other legal or equitable remedies that a Party may have, if this
Agreement is terminated by Brickell in accordance with Sections 13.2 or 13.3 or
if this Agreement is terminated by Kaken in accordance with Section 13.4, then
the following provisions shall apply:
14.1.1    Termination of Licenses. All rights and licenses granted to Kaken
hereunder shall immediately terminate and be of no further force and effect and
Kaken shall cease Developing, Commercializing and Manufacturing the Product
[***].
14.1.2    Survival of License. [***].
14.1.3    Assignments. Kaken will as soon as reasonably practical after receipt
of Brickell’s request, and at no cost to Brickell:
(a)    [***];
(b)    [***];
(c)    [***];

- 47 -

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

(d)    [***];
(e)    [***]; and
(f)    [***];
provided, however, that, to the extent any agreement or other asset described in
this Section 14.1.3 is not assignable by Kaken, then such agreement or other
asset will not be assigned, and, upon the request of Brickell, for a period of
[***] after the termination of this Agreement Kaken will take such steps as may
be reasonably necessary to allow Brickell to obtain and enjoy the benefits of
such agreement or other asset. For purposes of clarity, (1) Brickell shall have
the right to request that Kaken take any or all of the foregoing actions in
whole or in part, or with respect to all or any portion of the assets set forth
in the foregoing provisions and (2) to the extent Brickell requests Kaken to
transfer its right, title and interest in the items set forth in this Section
14.1.3 to Brickell, Kaken shall also cause its Affiliates and sublicensees to
transfer and assign to Brickell all of such Affiliates’ and sublicensees’ right,
title and interest in and to the foregoing items set forth in this Section
14.1.3.
14.1.4    Disclosure and Delivery. Kaken will as soon as reasonably practical
transfer to Brickell copies of any physical embodiment of any Kaken Applied
Know-How, to the extent then used in connection with the Development,
Commercialization or Manufacture of the Product. Such transfer shall be effected
by the delivery of material documents, to the extent such Kaken Applied Know-How
is embodied in such documents.
14.1.5    Disposition of Inventory. Kaken and its Affiliates will be entitled,
[***], as applicable, in accordance with the terms and conditions set forth in
this Agreement and otherwise complies with the terms set forth in this
Agreement.
14.2    Termination by Kaken. Without limiting any other legal or equitable
remedies that Kaken may have, if this Agreement is terminated by Kaken in
accordance with Section 13.2 the provisions of [***] shall apply[***].
14.3    Expiration of this Agreement. Upon expiration of this Agreement pursuant
to Section 13.1 with respect to a given country, all rights and licenses granted
to Kaken shall terminate with respect to such country; provided, however, that,
[***].
14.4    Accrued Rights. Termination or expiration of this Agreement for any
reason will be without prejudice to any rights that will have accrued to the
benefit of a Party prior to the effective date of such termination. Such
termination will not relieve a Party from obligations that are expressly
indicated to survive the termination or expiration of this Agreement.
14.5    Survival. Notwithstanding anything to the contrary contained herein, the
following Sections and Articles shall survive any expiration or termination of
this Agreement: Section 2.2.3 (last sentence), 4.6.3, 4.7, 5.1.6, 8.3 (to the
extent accruing prior to termination), 8.4 through 8.7 and 10.5 and Article 1,
Article 11, Article 12, Article 14, Article 15 and Article

- 48 -

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

16. Except as set forth in this Article 14 or otherwise expressly set forth
herein, upon termination or expiration of this Agreement all other rights and
obligations of the Parties shall cease.
14.6    Remedies in Lieu of Termination. Without limiting any other legal or
equitable rights or remedies available to Kaken whether pursuant to this
Agreement or under applicable Law, in the event Kaken would be entitled to
terminate this Agreement pursuant to Section 13.2 on account of Brickell’s
breach of Sections 2.1, 2.4, 2.5, 2.6, 4.4, 4.6.1, 7.1 or 12.2, and such breach
occurs [***]
14.7    Rights in Bankruptcy. All rights and licenses granted under or pursuant
to this Agreement by Brickell and Kaken are, and shall otherwise be deemed to
be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of
right to “intellectual property” as defined under Section 101 of the U.S.
Bankruptcy Code. The Parties agree that each Party, as licensee of certain
rights under this Agreement, shall retain and may fully exercise all of its
rights and elections under the U.S. Bankruptcy Code. The Parties further agree
that, in the event of the commencement of a bankruptcy proceeding by or against
a Party (such Party, the “Bankrupt Party”) under the U.S. Bankruptcy Code, (a)
the other Party shall be entitled to a complete duplicate of (or complete access
to, as appropriate) any intellectual property licensed to such other Party and
all embodiments of such intellectual property, which, if not already in such
other Party’s possession, shall be promptly delivered to it (x) upon any such
commencement of a bankruptcy proceeding upon such other Party’s written request
therefore, unless the Bankrupt Party elects to continue to perform all of its
obligations under this Agreement or (y) if not delivered under clause (x),
following the rejection of this Agreement by the Bankrupt Party upon written
request therefore by the other Party and (b) the Bankrupt Party shall not
unreasonably interfere with the other Party’s rights to intellectual property
and all embodiments of intellectual property, and shall assist and not
unreasonably interfere with the other Party in obtaining intellectual property
and all embodiments of intellectual property from another entity. The
“embodiments” of intellectual property includes all tangible, intangible,
electronic or other embodiments of rights and licenses hereunder, including all
compounds and products embodying intellectual property, Products, filings with
Regulatory Authorities and related rights and Brickell Know-How in the case that
Brickell is the Bankrupt Party and Kaken Applied Know-How in the case Kaken is
the Bankrupt Party.
ARTICLE 15
DISPUTE RESOLUTION
15.1    General. The Parties recognize that, from time to time during the Term,
disputes may arise as to certain matters which relate to either Party’s rights
and/or obligations hereunder. It is the objective of the Parties to establish
procedures to facilitate the resolution of disputes arising under this Agreement
in an expedient manner by mutual cooperation and without resort to litigation.
To accomplish this objective, the Parties agree to follow the procedures set
forth in this Article 15 to resolve any controversy or claim arising out of,
relating to or in connection with any provision of this Agreement (other than a
dispute addressed in Section 4.10).
15.2    Disputes Arising Between the Parties. With respect to all disputes
arising between the Parties and not from the JDRC, including any alleged failure
to perform, or breach,

- 49 -

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

of this Agreement, or any issue relating to the interpretation or application of
this Agreement, if the Parties are unable to resolve such dispute within thirty
(30) days after such dispute is first identified by either Party in writing to
the other, the Parties shall refer such dispute to the Chief Executive Officers
of each of the Parties, or a designee from senior management with
decision-making authority (the Chief Executive Officer or such designee, the
“Executive Officer”) for attempted resolution by good-faith negotiations within
thirty (30) days after such notice is received.
15.3    Dispute Resolutions. If the Executive Officers are not able to resolve
such dispute referred to them under Section 15.2 within such thirty (30) day
period, then either Party shall have the right, but not the obligation, to
submit such controversy or claim to non-binding mediation with the consent of
the other Party. If the Parties are unable to resolve such dispute within thirty
(30) calendar days after such dispute is mutually referred to non-binding
mediation in accordance with this Section 15.3 or within thirty (30) calendar
days after the dispute is referred to the Chief Executive Officers under Section
15.2, as the case may be, then either Party may refer the matter to arbitration
in accordance with Section 15.5 unless such any dispute, controversy or claim
relating to the scope, validity, enforceability or infringement of any patent
rights covering the manufacture, use or sale of any Product or of any trademark
rights relating to any Product in which case it shall be resolved in accordance
with Section 15.4.
15.4    Patent and Trademark Dispute Resolution. Any dispute, controversy or
claim relating to the scope, validity, enforceability or infringement of any
patent rights covering the manufacture, use or sale of any Product or of any
trademark rights relating to any Product shall be submitted to a court of
competent jurisdiction in the Territory.
15.5    Arbitration. All disputes arising out of or in connection with this
Agreement shall be finally settled under the Rules of Arbitration of the
International Chamber of Commerce (the “Rules”) by three arbitrators. Each party
shall nominate one arbitrator and the two arbitrators so selected shall nominate
the third arbitrator. If the parties’ two arbitrators cannot agree on a third
arbitrator, the third arbitrator shall be appointed by the International Court
of Arbitration of the International Chamber of Commerce in accordance with the
Rules. The place of arbitration shall be San Francisco, California, U.S.A. The
language of the arbitration shall be English. The arbitration and all disputes
determined therein shall be governed by New York law. Unless the parties
otherwise agree, the arbitrators shall apply the International Bar Association
Rules on the Taking of Evidence in International Commercial Arbitration. Unless
the parties otherwise agree, the arbitrators shall not have the power to appoint
experts. The arbitrators shall not issue any award, grant any relief or take any
action that is prohibited by or inconsistent with the provisions of this
Agreement and may not, under any circumstances, award punitive or exemplary
damages. The award rendered by the panel of arbitrators shall be binding upon
the parties hereto and judgment on the award may be entered in any court having
jurisdiction thereof. Each party shall bear its own attorneys’ fees in
connection with any arbitral proceedings and the arbitrators shall not include
attorneys’ fees in any award.

- 50 -

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

15.6    Injunctive Relief. Nothing herein may prevent either Party from seeking
a preliminary injunction or temporary restraining order, in any court of
competent jurisdiction, so as to prevent any Confidential Information from being
disclosed in violation of this Agreement.
ARTICLE 16
GENERAL TERMS
16.1    Entire Agreement; Amendment. This Agreement, including the Schedules
hereto, sets forth the complete, final and exclusive agreement and all the
covenants, promises, agreements, warranties, representations, conditions and
understandings between the Parties hereto with respect to the subject matter
hereof and supersedes, as of the Effective Date, all prior agreements and
understandings between the Parties with respect to the subject matter hereof,
including the Confidential Disclosure Agreement between the Parties dated
September 9, 2013 (which shall remain effective prior to the Effective Date).
There are no covenants, promises, agreements, warranties, representations,
conditions or understandings, either oral or written, between the Parties other
than as are set forth herein and therein. No subsequent alteration, amendment,
change or addition to this Agreement shall be binding upon the Parties unless
reduced to writing and signed by an authorized representative of each Party.
16.2    Force Majeure. A Party shall be excused from the performance of its
obligations under this Agreement to the extent that such performance is
prevented by force majeure and the nonperforming Party promptly provides notice
of the prevention to the other Party. Such excuse shall be continued so long as
the condition constituting force majeure continues and the nonperforming Party
makes reasonable efforts to remove the condition. For purposes of this
Agreement, force majeure shall include conditions beyond the control of the
Parties, including an act of God, war, civil commotion, terrorist act, labor
strike or lock-out, epidemic, failure or default of public utilities or common
carriers, destruction of production facilities or materials by fire, earthquake,
storm or like catastrophe. Notwithstanding the foregoing, a Party shall not be
excused from making payments owed hereunder because of force majeure affecting
such Party, unless such event of force majeure specifically prevents the
prevented Party from making such payments, in which event such prevented Party
shall use commercially reasonable efforts to make such payments through
alternative means; provided, however, that in any case such payments shall
continue to be due and payable hereunder.
16.3    Notices. Any notice required or permitted to be given under this
Agreement shall be in writing, shall specifically refer to this Agreement, and
shall be addressed to the appropriate Party at the address specified below or
such other address as may be specified by such Party in writing in accordance
with this Section 16.3, and shall be deemed to have been given for all purposes
(i) when delivered, if hand-delivered or sent by facsimile or e-mail on a
Business Day, (ii) on the next Business Day if sent by a reputable international
overnight courier service, or (iii) five (5) Business Days after mailing, if
mailed by first-class certified or registered airmail, postage prepaid, return
receipt requested. Unless otherwise specified in writing, the mailing addresses
of the Parties shall be as described below:
If to Brickell:
[***]

- 51 -

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

With a copy to:
[***]

If to Kaken:
[***]

With a copy to:
[***]

16.4    No Strict Construction; Interpretation. This Agreement has been prepared
jointly and shall not be strictly construed against either Party. Ambiguities,
if any, in this Agreement shall not be construed against any Party, irrespective
of which Party may be deemed to have authored the ambiguous provision. The
headings of each Article and Section in this Agreement have been inserted for
convenience of reference only and are not intended to limit or expand on the
meaning of the language contained in the particular Article or Section.
16.5    Assignment and Delegation. Neither Party may assign or transfer this
Agreement or any rights or obligations hereunder without the prior written
consent of the other, except that Brickell may make such an assignment without
Kaken’s consent to (a) Affiliates (provided, however that Brickell will remain
jointly and severally liable with, and will guarantee the performance of, the
relevant Affiliate under this Agreement, and the relevant Affiliate assignee,
will assume in writing all of Brickell’s obligations under this Agreement) and
(b) a successor to substantially all of the business of Brickell to which this
Agreement relates, whether in a merger, sale of stock, sale of assets or other
transaction, provided that such successor agrees to be bound by the terms of
this Agreement. Any assignment or attempted assignment by either Party in
violation of the terms of this Section 16.5 shall be null, void and of no legal
effect. Brickell may delegate one or more of its obligations under this
Agreement to an exclusive licensee of the Product outside the Territory. For
clarity, any Patent, Know-How or Invention, owned or Controlled by an Affiliate
of Brickell that became an Affiliate of Brickell after the Effective Date as a
result of a Change of Control of Brickell shall not be considered Brickell
Technology for purposes of this Agreement.
16.6    Compliance with Applicable Law; Further Actions. Each Party shall comply
with all applicable Law in performing its obligations pursuant to this
Agreement. Each Party also agrees to execute, acknowledge and deliver such
further instruments, and to perform all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this Agreement.
16.7    Third Party Beneficiary. [***].
16.8    Severability. If any one or more of the provisions of this Agreement are
held to be invalid or unenforceable by any court of competent jurisdiction from
which no appeal can be or is taken, such provision or provisions shall be
considered severed from this Agreement and shall not serve to invalidate any
remaining provisions hereof. The Parties shall make a good-faith effort to
replace any invalid or unenforceable provision with a valid and enforceable one
such that the objectives contemplated by the Parties when entering this
Agreement may be realized.
16.9    No Waiver. Any delay in enforcing a Party’s rights under this Agreement
or any waiver as to a particular default or other matter shall not constitute a
waiver of such Party’s

- 52 -

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

rights to the future enforcement of its rights under this Agreement, except with
respect to an express written and signed waiver relating to a particular matter
for a particular period of time.
16.10    Independent Contractors. Each Party shall act solely as an independent
contractor, and nothing in this Agreement shall be construed to give either
Party the power or authority to act for, bind, or commit the other Party in any
way. Nothing herein shall be construed to create the relationship of partners,
principal and agent, or joint-venture partners between the Parties.
16.11    English Language; Governing Law. This Agreement was prepared in the
English language, which language shall govern the interpretation of, and any
dispute regarding, the terms of this Agreement. This Agreement and all disputes
arising out of or related to this Agreement or any breach hereof shall be
governed by and construed under the laws of the State of New York, without
giving effect to any choice of law principles that would require the application
of the laws of a different state.
16.12    Counterparts. This Agreement may be executed in two (2) or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
[No Further Text on This Page]

- 53 -

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

IN WITNESS WHEREOF, the Parties have executed this Agreement by their duly
authorized representatives as of the Effective Date.
BRICKELL BIOTECH, INC.

KAKEN PHARMACEUTICAL CO., LTD.
By: /s/ Andrew Sklawer         
Name: Andrew Sklawer
Title: Co-Founder and Vice President
By: /s/ Tetsuo Onuma         
Name: Tetsuo Onuma         
Title: President and Representative Director

[Signature Page to License, Development and Commercialization Agreement]

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

SCHEDULE 1.5
BRICKELL PATENTS

[***]

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

SCHEDULE 2.7
[***] License Agreement

[***]

1

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

EXHIBIT A
List of Patents and Patent Applications
[***]

2

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

EXHIBIT B

Annual Development Plan for Brickell Biotech, Inc.
[***]

3

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

AMENDMENT NO. I TO
LICENSE AGREEMENT
[***]

1

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

ATTACHMENT A
List of Patents and Patent Applications
[***]

2

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

Exhibit 10.2

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***],
HAS BEEN OMITTED BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED

AMENDMENT
TO
LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
This AMENDMENT (this “Amendment”) to the LICENSE, DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT (the “Agreement”) is made on this 7th day of April,
2015 (the “Amendment Effective Date”), by and between Brickell Biotech, Inc., a
Delaware corporation (“Brickell”), and Kaken Pharmaceutical Co., Ltd., a company
legally organized and existing under the law of Japan (“Kaken”).
WHEREAS, Brickell and Kaken entered into the Agreement on March 31, 2015; and
WHEREAS, Brickell and Kaken desire to amend the Agreement as set forth in this
Amendment.
NOW THEREFORE, in consideration of the foregoing premises and the mutual
promises, covenants and conditions contained in this Amendment, the Parties
agree as follows:
1.    As used in this Amendment, capitalized terms shall have the same meanings
set forth in the Agreement, unless otherwise defined in this Amendment.
2.    Section 8.1 of the Agreement is hereby amended to add the following
sentence at the end thereof:
“In addition, such [***] shall be in consideration for [***] under (a) the
[***]as set forth in Section 2.1.1(i) of the Agreement, with [***], (b) the
[***] as set forth in Section 2.1.1(iii) of the Agreement to Manufacture the
Product and Drug Substance in the Territory for purpose of (a) above, and (c)
the [***]as set forth in Section 2.1.1(iv) to Manufacture the Product and Drug
Substance on Brickell’s behalf in accordance with the [***].”
3.    Section 8.2 of the Agreement is hereby amended to add the following
sentence at the end of the first paragraph thereof:
“[***]: (1) such first development milestone payment (in the amount of Ten
Million Dollars ($10,000,000)) [***].”
4.    Except as specifically set forth in this Amendment, all terms and
conditions of the Agreement shall remain in full force and effect.
5.    This Amendment may be executed in counterparts, each of which shall be
deemed an original, but all of which together shall constitute one and the same
instrument.

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

IN WITNESS WHEREOF, Brickell and Kaken have executed this Amendment by their
respective officers hereunto duly authorized, as of the Amendment Effective
Date.

BRICKELL BIOTECH, INC.

By: /s/ Andrew Sklawer         
Name: Andrew Sklawer
Title: Co-Founder and Vice President

KAKEN PHARMACEUTICAL CO., LTD.

By: /s/ Tetsuo Onuma            
Name: Tetsuo Onuma
Title: President and Representative Director
 
 

2

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

Exhibit 10.2

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***],
HAS BEEN OMITTED BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED

AMENDMENT NO. 3
TO
LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
THIS AMENDMENT (this “Amendment”), dated March 14, 2018 (the “Amendment
Effective Date”), is entered into by and between Brickell Biotech, Inc., a
Delaware corporation (“Brickell”), and Kaken Pharmaceutical Co., Ltd., a company
legally organized and existing under the law of Japan (“Kaken”).
WHEREAS, Brickell and Kaken entered into a License, Development and
Commercialization Agreement on March 31, 2015 and thereafter amended it on April
7, 2015, February 24, 2016, and October 6, 2017 (as amended, the “Agreement”);
WHEREAS, the Agreement provides, among other things, that Kaken has the right to
[***] by [***];
WHEREAS, Brickell and Kaken entered into the ROFN Agreement on October 6, 2017
and Kaken [***]; and
WHEREAS, Brickell desires to [***] and Kaken is willing to assist Brickell in
[***] by [***] as set forth in this Amendment.
NOW THEREFORE, in consideration of the foregoing premises and the mutual
promises, covenants and conditions contained in this Amendment, the Parties
agree as follows:
1.    As used in this Amendment, capitalized terms shall have the same meanings
set forth in the Agreement, unless otherwise defined in this Amendment.
2.    Section 8.2 of the Agreement shall be amended as follows:
a.    [***]
b.    [***]
c.    The final paragraph of Section 8.2 shall be amended to read as follows:
[***]
[***]
3.    [***].
4.    Except as specifically set forth in this Amendment, all terms and
conditions of the Agreement shall remain in full force and effect.

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

5.    This Amendment may be executed in counterparts, each of which shall be
deemed an original, but all of which together shall constitute one and the same
instrument.
IN WITNESS WHEREOF, Brickell and Kaken have executed this Amendment by their
respective officers hereunto duly authorized, as of the Amendment Effective
Date.
BRICKELL BIOTECH, INC.

By: /s/ Andrew Sklawer          
Name: Andrew Sklawer
Title: COO

KAKEN PHARMACEUTICAL CO., LTD.

By: /s/ Tetsuo Onuma            
Name: Tetsuo Onuma
Title: President and Representative Director
 
 

2

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

Exhibit 10.2

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***],
HAS BEEN OMITTED BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED

AMENDMENT NO. 4
TO
LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
THIS AMENDMENT (this “Amendment”), dated May 22, 2018 (the “Amendment Effective
Date”), is entered into by and between Brickell Biotech, Inc., a Delaware
corporation (“Brickell”), and Kaken Pharmaceutical Co., Ltd., a company legally
organized and existing under the law of Japan (“Kaken’).
WHEREAS, Brickell and Kaken entered into a License, Development and
Commercialization Agreement on March 31, 2015 and thereafter amended it on April
7, 2015, February 24, 2016, October 6, 2017, and March 14, 2018 (as amended, the
“Agreement”); and
WHEREAS, Brickell desires [***] to [***] and Kaken desires to provide Brickell
with [***] to [***].
NOW THEREFORE, in consideration of the foregoing premises and the mutual
promises, covenants and conditions contained in this Amendment, the Parties
agree as follows:
1.    As used in this Amendment, capitalized terms shall have the same meanings
set forth in the Agreement, unless otherwise defined in this Amendment.
2.    The following new Section shall be added to the Agreement as Section 8.8:
8.8    [***].
8.8.1    [***]. Before Brickell commences any of the [***]. Brickell shall
obtain Kaken’s written consent on [***], such consent not to be unreasonably
withheld or delayed. Kaken shall have the right, during normal business hours,
upon reasonable advance notice, and on dates previously discussed in good faith
by the Parties, to reasonably monitor the activities of the [***] with respect
to such [***]; provided, that Brickell representative(s) may, at Brickell’s
election, be present with Kaken during any such monitoring activities. Subject
to circumstances that are outside the reasonable control of Brickell, Brickell
shall [***] and provide Kaken with a [***] reasonably acceptable to Kaken by no
later than [***]. For the avoidance of doubt, all [***] shall constitute [***]
and without limiting the Parties’ rights or obligations set forth in Section
4.6.2, Brickell shall promptly provide Kaken with copies of [***].
8.8.2    For purposes of this Agreement, “Phase III Criteria” shall mean (i) the
FDA’s positive review of [***] to be conducted by Brickell, which [***], (ii)
receipt by Kaken of [***] from Brickell reasonably acceptable to Kaken with
respect to [***] and (iii) Kaken and Brickell mutually agreeing that [***] and
that there will be [***] as a result of [***] in a manner necessary to satisfy
FDA requirements.

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

3.    Section 8.2 of the Agreement shall be amended as follows:
[***].
4.    [***]:
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]

5.    The Parties agree that if Kaken has [***] as set forth in Section 3 of
this Amendment [***], then Brickell may terminate this Amendment at any time
within thirty (30) days thereafter by written notice to Kaken, in which case
this Amendment shall be of no effect from and after the date of such
termination, and the terms set forth herein shall be void ab initio.
6.    Except as specifically set forth in this Amendment, all terms and
conditions of the Agreement shall remain in full force and effect.
7.    This Amendment may be executed in counterparts, each of which shall be
deemed an original, but all of which together shall constitute one and the same
instrument.

2

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

IN WITNESS WHEREOF, Brickell and Kaken have executed this Amendment by their
respective officers hereunto duly authorized, as of the Amendment Effective
Date.

BRICKELL BIOTECH, INC.

By: /s/ Andrew Sklawer         
Name: Andrew Sklawer
Title: Chief Operating Officer

KAKEN PHARMACEUTICAL CO., LTD.

By: /s/ Tetsuo Onuma            
Name: Tetsuo Onuma
Title: President and Representative Director
 
 

3