Exhibit 10.4

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 AGREEMENT
THIS LICENSE AGREEMENT (“Agreement”) is made effective as of December 15, 2012
(the “Effective Date”) by and among BODOR LABORATORIES, INC., a Florida
corporation, having an office located at 4400 Biscayne Boulevard, Suite 980,
Miami, FL 33137 (“BLI”) and NICHOLAS S. BODOR, a Florida resident residing at
10225 Collins Ave., Apt 1002, Bal Harbour, FL, USA 33154 (“Bodor”) (collectively
BLI and Bodor are referred to herein as “Licensor”), and BRICKELL BIOTECH, INC.,
a Delaware corporation having an office located at 2600 Southwest Third Avenue,
Suite 950, Miami, Florida 33129, and any Affiliates (collectively, “Licensee”).
Licensor and Licensee are each individually referred to herein as a “Party” and
collectively referred to as the “Parties.”
BACKGROUND:
WHEREAS, Licensor holds all right, title and interest in and to the intellectual
property related to the Licensed Patents and Licensed Know-How; and
WHEREAS, Licensee wishes to obtain a license from Licensor to the Licensed
Patents and Licensed Know-How, all on the terms and conditions set forth below.
NOW, THEREFORE, in consideration of the recitals, mutual covenants and promises
contained herein, the Parties hereto agree as follows:
ARTICLE I

DEFINITIONS
As used in this Agreement, the following terms shall have the meanings
indicated:
1.1    “Affiliate,” with respect to a Party, shall mean any corporation or
non-corporate business entity, firm, partnership or other entity, which
controls, is controlled by, or is under common control with such Party. For
purposes of this definition, “control” shall mean the ownership of at least
fifty percent (50%) of the voting stock of such entity or any other comparable
equity or ownership interest, or (a) in the absence of the ownership of at least
fifty percent (50%) of the voting stock of a corporation, or (b) in the case of
a non-corporate business entity, possession, directly or indirectly, the power
to direct, or cause the direction of, the management and policies of such entity
whether through the ownership or control of voting securities, by contract or
otherwise.
1.2    “Commercially Reasonable Efforts” shall mean those efforts normally
extended by a pharmaceutical company similarly situated to Licensee to develop
and commercialize pharmaceutical products and considering all aspects of the
development cycle, including preclinical

1

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and clinical results, or lack thereof, regulatory factors, financial factors,
marketing factors and standard product planning with respect to comparable or
potentially competing products.
1.3    “Field” shall mean the prescription use of the Licensed Product to [***].
1.4    “Gross Sales” shall mean the prices actually charged by Licensee in the
sale of a Licensed Product.
1.5    “Inventions” shall mean any patentable discovery, invention, improvement,
idea, concept, technique, method, process, formula or technology within the
Field.
1.6    “Licensed Know-How” shall mean any and all rights in any information,
data, process, method that is necessary or desirable to practice in best mode
any invention claimed in the Licensed Patents that has been developed by the
Licensor on or prior to the Effective Date.
1.7    “Licensed Patent” shall mean the patent application(s) listed on Exhibit
“A” (“Exhibit A”), any patents issuing thereon, and any continuations,
continuations-in-part, reissues, re-examinations, extensions and foreign
counterparts thereof.
1.8    “Licensed Product” shall mean any product or part thereof, process or
service, the development, manufacture, use, import, export, offer for sale or
sale of which is covered by, or which cannot be undertaken or completed without
infringing, a Valid Claim set forth in any Licensed Patent, and/or which
incorporates any Licensed Know-How.
1.9    “Net Sales” [***]
1.10    “Sublicensee” shall mean any non-Affiliate third party to whom Licensee
has granted the right to manufacture, distribute, or otherwise market a Licensed
Product in accordance with the terms of this Agreement.
1.11    “Territory” shall mean [***].
1.12    “Valid Claim” shall mean a claim of an issued and unexpired patent,
including any regulatory or judicial extensions of the patent term, or a claim
of a pending patent application, contained in the Licensed Patents, which has
not been held un-patentable, invalid or unenforceable by a court or other
government agency of competent jurisdiction and has not been admitted to be
invalid or unenforceable through reissue, re-examination, disclaimer or
otherwise.
ARTICLE 2

LICENSE
2.1    Grant.
2.1.1    Exclusive. Licensor hereby grants to Licensee an [***], license under
the Licensed Patents and Licensed Know-How in the Field within the Territory to
[***] Licensed Product.

2

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2.1.2    Right of Sublicense. Any sublicense granted by Licensee to any
Sublicensee shall be subject to a written sublicense agreement that contains
terms and conditions that (a) impose obligations that are comparable to the
obligations applicable to Licensee under this Agreement including, but not
limited to, the audit rights set forth in Section 3.8, (b) are at least as
protective of the Licensed Patents, Licensed Know-How and Licensor Confidential
Information (as defined in Section 5.1) as the terms contained in this Agreement
and (c) include no provisions that would be a violation of any terms and
conditions set forth in this Agreement. Without limiting the foregoing, each
such sublicense agreement shall provide that Licensor is a third party
beneficiary of such sublicense agreement, with the right to enforce the terms
thereof in the event that Licensee does not enforce its rights. Licensee shall
notify Licensor in writing of the grant of any such sublicense within ten (10)
days thereof, which notice shall identify the Sublicensee and shall be
accompanied by a copy of the applicable sublicense agreement. The terms of such
sublicense agreements, and the identity of all Sublicensees shall be
Confidential Information (as defined below) of Licensee. Licensee shall use
Commercially Reasonable Efforts to monitor the performance of any Sublicensee
under any sublicense granted pursuant to this Section 2.1.2.
2.1.3    No Rights. Licensor shall not be permitted, and shall cause its
Affiliates to refrain from the practice of any rights granted to Licensee under
this Article 2 in the Field in the Territory during the Term of this Agreement.
2.1.4    Additional Rights. During the Term of this Agreement, Licensor shall
not grant to any third party any right or license whatsoever under the Licensed
Patents or Licensed Know-How in the Field. Licensor retains the right to grant
other licenses outside the Field.
2.1.5    New Inventions. Any new Invention or discovery, whether patentable or
not, made solely by Licensee or in combination with any third party, as a result
of the exercise of this Agreement, shall be Licensee’s property. The Parties
shall reasonably cooperate in any patent application procedures for inventions
or discoveries made under this section at Licensee’s expense.
2.1.6    [***].
2.1.7    Limitations. Except as expressly set forth herein, this Agreement does
not grant to Licensee any right, title, interest, ownership or license by
implication, estoppel or otherwise, to any intellectual property rights of
Licensor.
2.2    Obligations of Licensee.
2.2.1    Diligence Events. Licensee shall use [***] at its own cost and expense
to develop a Licensed Product, to conduct all development necessary to obtain
regulatory approval to market such Licensed Product, and to commercialize such
Licensed Product, according to the applicable completion date listed in the
table below for the Licensed Product.

3

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[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]

2.2.2    Development Plan. Licensee will deliver to Licensor an annual updated
development plan for the Licensed Product (the “Development Plan”) no later than
January 31 of each year during the Term. The purpose of the Development Plan is
[***]. The Development Plan will include, at a minimum, the information listed
in Exhibit “B” (“Exhibit B”).
2.2.3    Licensee Diligence Default. Where the Licensee fails to [***] the
Licensed Product in accordance with the Development Plan and Diligence Events,
and fails to diligently undertake actions to remedy any such deficiency, and
where mediation has failed to accomplish a satisfactory resolution, the Licensor
may consider such failure to be a material breach under this Agreement and shall
have the right to terminate this Agreement pursuant to Section 4.2.2.
2.3    Obligations of Licensor.
2.3.1    Information. On or before the Effective Date of this Agreement,
Licensor shall provide Licensee with a copy of all tangible materials and
information in its possession related to or involving the Licensed Patents. Such
information and materials shall generally include but not be limited to all
patent correspondence, patent searches, patent files, patent landscaping,
inventor disclosures, and patent applications and schedules. Licensor shall
provide and make available to Licensee all manufacturing information and data,
all formulation information and data, and all clinical and pre-clinical data,
including toxicity data, whether submitted or not, as part of any Investigative
New Drug Application or New Drug Application filing of Licensor or its
sublicensees or Affiliates with respect to a Licensed Product subject to
provisions of confidentiality. Such rights shall include the right to reference
any of Licensor’s regulatory filings with the FDA or any other governmental
agency. Licensor agrees to use its reasonable efforts to identify and make
available inventors and any key scientific personnel to discuss research,
development and commercialization activities as reasonably required.
2.4    Mutual Party Obligations.
2.4.1    Right of Access to Data. Each Party will make available, at no cost,
data and any reports, including but not limited to full study reports, of any
non-clinical and/or clinical study in animals or humans, related to the Licensed
Patents and Licensed Know-How, on a confidential basis within sixty (60) days of
the generation of same, such that: (i) Licensor may share such data with any
other party, on a confidential basis, as background information in respect of
any other non-competing application outside of the Field and have the right to
reference any or all such data, (ii) Licensee may share such data, on a
confidential basis, as background information to its Affiliates, financing
sources, and potential investors and have the right to reference any or all such
data for

4

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development of Licensed Product in the Field only, and (iii) Licensee shall
utilize such data to ensure full compliance with the regulatory authorities and
to inform future development of the Licensed Product, provided neither party
shall be required to disclose internally developed information to any competitor
without the permission of the developing party.
ARTICLE 3

PAYMENTS AND REPORTS
3.1    Milestone Payments and Clinical Obligations. As consideration for the
rights and licenses granted by Licensor to Licensee hereunder, Licensee agrees
to pay Licensor the following amounts at the following times:
3.1.1    Milestone Payments. Licensee shall pay to Licensor milestone payments
(each, a “Milestone Payment”) as set forth in the following table [***] if and
when each Milestone Event is achieved. Licensee shall notify Licensor promptly
in writing (but in each case within thirty (30) days) of its achievement of each
Milestone Event. Each Milestone Payment (other than Upfront payments) shall be
due within sixty (60) days following the achievement of the applicable Milestone
Event.

[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]

3.1.2    Clinical Obligations. Licensee shall [***]. The activities undertaken
and the results achieved from all clinical development efforts shall be made
available to Licensor on a confidential basis and in a timely manner, subject to
Section 2.4.1, including but not limited to the right to reference such
information.
3.2    Royalties.
3.2.1    Patent Royalty. Licensee will pay a royalty to Licensor [***] (“Patent
Royalty” or collectively, “Patent Royalties”). Except for sales pursuant to
[***]. The payment of a Patent Royalty shall commence [***].
3.2.2    Sublicense Royalty. During the term of this Agreement, should Licensee
enter into any sublicense with an unaffiliated third party (“Sublicensee”) for
the sale of Licensed Products (“Sublicensing Agreement”), the rate for Patent
Royalties payable to Licensor shall be in accordance with the following schedule
based on the patent royalty rate set forth in the Sublicensing Agreement (the
“Sublicensee Patent Royalty Rate”):

5

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[***]
[***]
[***]
[***]
[***]
[***]

3.2.2.1    Sublicense Royalty Examples. For the avoidance of doubt: [***].
3.2.3    No Duplication of Royalties. The Royalty on Net Sales of Licensed
Products shall be [***] upon a [***] to any [***].
3.3    Sublicense Fee. In addition and not in lieu of the fees set forth in
Section 3.1, Licensee shall pay Licensor the sum of [***].
3.4    Timing of Royalty Payments. The Patent Royalty will be payable commencing
[***].
3.5    Royalty Reports and Payments. After [***] by Licensee or Sublicensees of
a Licensed Product for which a Patent Royalty is payable under this Article 3,
Licensee shall make quarterly written reports to Licensor within forty-five (45)
days after the end of each calendar quarter, stating in each such report the
number, description, Gross Sales, and itemized Net Sales of such Licensed
Product sold during the calendar quarter. Simultaneously with the delivery of
each such report, Licensee shall pay to Licensor the Patent Royalty, if any, due
to Licensor for the period of such report. If no Patent Royalty is due, Licensee
shall so report. Such reports shall be Confidential Information of Licensee
subject to Article 5, herein. [***] payable with respect to the amount of [***].
3.6    Currency Conversion. Where any currency conversion is to be made in
connection with the calculation of any amounts hereunder, such conversion shall
be made using the selling exchange rate for conversion of the foreign currency
into U.S. dollars, quoted for current transactions reported in The Wall Street
Journal for the last business day of the period to which such calculation
pertains.
3.7    Interest. In addition to any other rights and remedies of Licensor under
this Agreement, any amounts owed to Licensor under this Agreement shall, if not
paid when due, accrue interest at a rate that is the lesser of [***].
3.8    Audits. Licensee shall maintain, and shall cause its Sublicensees to
maintain, complete and accurate books and records relating solely to Net Sales
of the Licensed Product and any amounts payable to Licensor under this
Agreement, which records shall contain sufficient information to permit Licensor
to confirm the accuracy of any reports delivered to Licensor hereunder. The
relevant party shall retain such records for at least eighteen (18) months
following the end of the calendar year to which they pertain, during which time
Licensor, or Licensor’s appointed agents, shall have the right, at Licensor’s
expense, through an independent certified public accountant selected by Licensor
(“Licensor’s CPA”), to inspect, copy, and audit such records during normal
business hours to verify any reports and payments made. Licensor shall have the
right to inspect Licensee’s books and records as needed in Licensor’s reasonable
discretion. In the event that any audit performed under this Section 3.8 reveals
[***], Licensee shall bear the full cost of

6

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such audit and shall remit any amounts due to Licensor within sixty (60) days of
receiving notice thereof from Licensor. In the event that any audit performed
under this Section 3.8 reveals an [***], Licensor shall return the [***] to
Licensee within sixty (60) days of receiving the audit report or credit Licensee
in an amount of [***]. If Licensee disputes the findings of the Licensor’s CPA,
then within thirty (30) days after receipt by Licensee of Licensor’s CPA’s
report, Licensee shall designate an independent certified public accountant
(“Licensee’s CPA”) to work with the Licensor’s CPA in a commercially reasonable
manner in an attempt to resolve the disputed findings. If the Licensor’s CPA and
the Licensee’s CPA are unable to resolve the differences, the Licensor’s CPA and
the Licensee’s CPA will agree upon an independent third-party CPA (The
“Independent Third-Party CPA”) and the Independent Third-Party CPA shall review
and inspect the identical books, records, and other documents reviewed by the
Licensor’s CPA and the Licensee’s CPA and issue an independent report pertaining
thereto (the “Independent Third-Party Report”). The Independent Third-Party
Report shall be binding upon both parties. If the Independent Third-Party Report
reflects an [***] then being reviewed, the reasonable and necessary fees and
expenses of the Licensor’s CPA and the Independent Third-Party’s CPA shall be
paid by the Licensee. Otherwise, the fees and expenses of the Licensee’s CPA and
the Independent Third-Party CPA shall be paid by the Licensor.
ARTICLE 4

TERM AND TERMINATION
4.1    Term. The term of this Agreement shall commence on the Effective Date,
and shall continue in full force and effect until either (i) termination by
either Party in accordance with Section 4.2 or (ii) upon the last to occur of
[***].
4.2    Termination for Cause.
4.2.1    By Licensee. Licensee may terminate this Agreement for Cause. For
purposes of this paragraph, “Cause” shall mean any material breach of any
material provision of this Agreement by Licensor that is not cured within sixty
(60) days after receipt by Licensor of written notice thereof from Licensee or,
in the event that cure is not possible within such sixty (60) day period,
Licensor shall have taken reasonable steps to ensure that the breach is cured as
soon as reasonably possible.
4.2.2    By Licensor. Licensor may terminate this Agreement (i) for Cause or
(ii) immediately upon written notice to Licensee if Licensee or any Sublicensee
brings a patent challenge against Licensor, or assists others in bringing a
patent challenge against Licensor (except as required under a court order or
subpoena). For purposes of this paragraph, “Cause” shall mean any material
breach of any material provision of this Agreement by Licensee that is not cured
within sixty (60) days after receipt by Licensee of written notice thereof from
Licensor or, in the event that cure is not possible within such sixty (60) day
period, Licensee shall have taken reasonable steps to ensure that the breach is
cured as soon as reasonably possible; provided, however, that if the material
breach is non-payment to Licensor of amounts due, then Licensee shall have sixty
(60) days to cure, except in circumstances where there is a good faith dispute
between the Parties as to sums due and owing and the Parties are engaged in a
dispute resolution process to determine the legitimacy of any demand for sums
due and any undisputed amounts are paid in full.

7

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4.2.3    Termination for Insolvency of Bankruptcy. Either Party may, by written
notice, terminate this Agreement with immediate effect if the other Party: (i)
makes a general assignment for the benefit of creditors; (ii) files an
insolvency petition in bankruptcy; (iii) petitions for or acquiesces in the
appointment of any receiver, trustee or similar officer to liquidate or conserve
its business or any substantial part of its assets; (iv) commences proceeding
involving its insolvency, bankruptcy, reorganization, adjustment of debt,
dissolution, liquidation or any other similar proceeding for the release of
financially distressed debtors under the laws of any jurisdiction; or (v)
becomes a party to any proceeding or action of the type described above in (iii)
or (iv), and such proceeding or actions remains =dismissed or =stayed for a
period of more than ninety (90) days.
4.2.4    Termination Without Cause. Licensee may terminate this Agreement
without cause, upon providing sixty (60) days written notice to Licensor by
certified mail.
4.3    Effect of Termination.
4.3.1    Expiration. Upon any expiration of this Agreement pursuant to Section
4.1(i) or (ii) hereof, the license granted to Licensee under Article 2 shall
survive such termination but shall convert to non-exclusive, fully paid up,
irrevocable and perpetual license.
4.3.2    Termination by Licensee pursuant to Section 4.2.1. Upon termination of
this Agreement by Licensee pursuant to Section 4.2.1, Licensee’s license rights
in Article 2 shall survive such termination and remain in full force and effect;
provided that Licensee fulfills its payment obligations and other obligations
under Article 3. The foregoing shall be in addition to any other rights of
Licensee against Licensor pursuant to this Agreement or applicable law.
4.3.3    Termination by Licensor pursuant to Section 4.2.2. Upon termination of
this Agreement by Licensor pursuant to Section 4.2.2, (i) Licensee’s license
rights under the Licensed Patents and Licensed Know-How and all other rights of
Licensee hereunder shall terminate. The foregoing shall be in addition to any
other rights of Licensor against Licensee pursuant to this Agreement or
applicable law and (ii) Licensee shall promptly return to Licensor all Licensor
Confidential Information, and all other documentation in the possession of
Licensee relating to the Licensed Products, including, without limitation, all
studies, data, protocols, materials, results and regulatory filings.
4.3.4    Termination by Licensee pursuant to Section 4.2.4. Upon termination of
this Agreement by Licensee pursuant to Section 4.2.4, Licensee’s license rights
under the Licensed Patents and Licensed Know-How and all other rights of
Licensee hereunder shall terminate. Licensee shall promptly return to Licensor
all Licensor Confidential Information, and all other documentation in the
possession of Licensee relating to the Licensed Products, including, without
limitation, all studies, results and regulatory filings.
4.3.5    Remedies. Termination of this Agreement for any reason shall not
release any Party hereto from any liability which, at the time of such
termination, has already accrued to the other Party or which is attributable to
a period prior to such termination, nor preclude either Party from pursuing any
rights and remedies it may have hereunder or at law or in equity which accrued
or are based upon any event occurring prior to such termination.

8

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4.4    Survival. Article 1, Section 3.5 and Articles 4, 5 and 7 through 10,
shall survive expiration or termination of this Agreement for any reason.
ARTICLE 5

CONFIDENTIALITY
5.1    Confidential Information. Except as expressly provided in this Agreement,
neither Party shall use, other than a Permitted Use, as defined below, or
disclose to any third party, any confidential, proprietary or trade secret
information (the “Confidential Information”) received from the other Party
hereto, during the term of this Agreement and for five (5) years thereafter.
5.2    Limitations. Notwithstanding Section 5.1 above, Confidential Information
shall not include any of the following information which the receiving Party can
demonstrate by competent evidence: (i) was already known to the receiving Party,
other than under an obligation of confidentiality, at the time of disclosure, as
evidenced by the receiving Party’s written records; (ii) was generally available
to the public or otherwise part of the public domain at the time of disclosure
to the receiving Party; (iii) became generally available to the public or
otherwise part of the public domain after its disclosure and other than through
any act or omission of the receiving Party in breach of this Agreement; (iv) was
independently developed by the receiving Party without reference to any
information or materials disclosed by the disclosing Party, as evidenced by the
receiving Party’s written records; or (v) was subsequently disclosed to the
receiving Party by a person without breach of any legal obligation to the
disclosing Party.
5.2.1    Permitted Disclosures. In addition, either Party may disclose
Confidential Information of the other (i) to their legal representatives,
employees and Affiliates, and legal representatives and employees of Affiliates,
consultants and Sublicensees, to the extent such disclosure is reasonably
necessary to achieve the purposes of this Agreement, and provided such
representatives, employees, consultants and Sublicensees have agreed in writing
to obligations of confidentiality with respect to such information no less
stringent than those set forth herein; (ii) in connection with the filing and
prosecution of the Licensed Patents; (iii) to a potential Sublicensee or as
reasonably required in the course of a contemplated public offering or private
financing provided that the receiving person shall have agreed in writing to
obligations of confidentiality with respect to such information no less
stringent than those set forth herein; or (iv) if disclosure is compelled to be
disclosed by a court order or applicable law or regulation, provided that the
Party compelled to make such disclosure requests confidential treatment of such
information, provides the other Party with sufficient advance notice of the
compelled disclosure to provide adequate time to seek a protective order and
discloses only the minimum necessary to comply with the requirement to disclose.
5.2.2    Permitted Use. The Confidential Information may only be used to
develop, market, and sell Licensed Products (each, a “Permitted Use” and,
collectively, the “Permitted Uses”).
5.3    Non-Disclosure. The terms of this Agreement shall not be publicly
disclosed by Licensee or Licensor to any third party unless both Parties
expressly agree in writing. However,

9

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this restriction shall not apply to communications required by law or
regulation, except that in such event the Parties shall coordinate to the extent
possible with respect to the details of any such announcement. This restriction
shall not apply to disclosures of the terms of this Agreement made to officers,
directors, shareholders, employees, investment bankers, attorneys and other
professional advisors, consultants, prospective investors and/or strategic
partners of either Party, all of whom shall take such information subject to
provisions of confidentiality consistent herewith. Once a particular public
disclosure has been approved with respect to a particular third party, further
disclosures to such third party which do not differ materially therefrom may be
made without obtaining any further consent of the other Party.
ARTICLE 6

PATENT RIGHTS AND RESPONSIBILITIES
6.1    Patent Prosecution and Maintenance. Licensor shall have the initial right
and obligation [***]. Licensor shall consider, to the extent possible, any
comments made by Licensee and its counsel in connection therewith, and shall
[***] unless such comments would adversely affect the reasonable interests of
Licensor. If Licensor intends to [***].
6.2    Patenting Costs. Subsequent to the Effective Date of the License
Agreement, Licensee shall be responsible for payment of [***] which shall
include but not be limited to issuance fees, grant fees, maintenance fees and
[***].
6.3    Ongoing External Patenting Costs. For any Patenting Costs [***] (either
orally or in writing, including via email) of all material actions necessary for
the filing, prosecution, issuance and maintenance of such Licensed Patents,
together with an estimate of Patenting Costs for same. [***]. Payments directly
to [***] are made with the understanding that such payments [***]. Time is of
the essence with respect to such payments.
6.4    Infringement.
6.4.1    Disclosure. In the event that either Licensor or Licensee becomes aware
of the infringement of any Licensed Patents, each shall promptly inform the
other in writing of all details available.
6.4.2    Licensee Rights. In the event of infringement by a third party of any
Licensed Patents, Licensee may enforce the Licensed Patents against the
infringers by appropriate legal proceedings or otherwise. Licensor agrees to
join in any enforcement proceedings at the request of Licensee, and at
Licensee’s expense. Licensee shall be responsible for all costs and expenses of
any enforcement activities, including legal proceedings, against infringers in
which Licensee participates. Licensor may at their own expense be represented by
their counsel in any such legal proceedings acting in an advisory but not
controlling capacity.
6.4.3    Allocation. After deduction of the costs and expenses of enforcement
for which Licensee is responsible under Section 6.4.2, all recoveries by way of
royalties and damages with respect to infringement actions instituted during the
terms of this Agreement, excluding any

10

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prosecuted by Licensor under Section 6.4.4, shall belong to Licensee and shall
be considered Net Sales under this Agreement, giving rise to royalty obligations
under Article 3.
6.4.4    Licensor Rights. In the event of infringement by a third party of any
Licensed Patents which Licensor wishes to prosecute, Licensor shall first make a
written request or demand that Licensee proceed with such prosecution. In the
event that Licensee fails or declines to proceed within thirty days after
receipt of a written request or demand by Licensor to do so, then Licensor in
their own discretion, may prosecute the infringer in the name of Licensor and
Licensee. Any actions by Licensor pursuant to this clause shall be at their own
expense. Licensor may collect and retain for their use any and all recoveries in
any proceeding pursuant to their rights under this clause. Recoveries collected
and retained by Licensor under this Section 6.4.4 shall not be considered Net
Sales or give rise to royalty obligations under Article 3. Licensee will execute
any documents necessary for Licensor to exercise their rights under this clause.
6.5    Default Rights. Licensee shall have the right but not the obligation to
intercede in the event Licensor defaults in its obligations or materially fails
to take timely steps to manage and protect the Licensed Patents in a
commercially reasonable manner to ensure the preservation and uninterrupted use
of the entirety of the license rights granted hereunder.
ARTICLE 7

INDEMNIFICATION
7.1    By Licensee. Licensee agrees to indemnify, hold harmless, and defend
Licensor and its Affiliates, officers, directors, partners, employees, and
agents (each, “Licensor Indemnitee”), from and against any and all losses,
damages, costs, fees, expenses (including attorneys’ fees), fines, penalties and
other liabilities resulting from, arising out of, or related to, (i) any
product, process, or service that is made, used, sold, imported or performed by
Licensee (or its Sublicensees, agents, contractors, distributors, consultants or
employees) in the exercise of the license rights granted herein or otherwise in
connection with the Licensed Patents or Licensed Know-How and (ii) any material
breach of any of its representations, warranties, covenants or agreements under
this Agreement; provided, however, that Licensee shall not be liable for any
negligence or intentional wrongdoing on the part of any Licensor Indemnitee.
7.2    By Licensor. The Licensor agrees to indemnify, hold harmless, and defend
Licensee and its Affiliates, officers, directors, partners, employees, and
agents (each, “Licensee Indemnitee”), from and against any and all losses, and
other liabilities resulting from, arising out of, or related to, any product,
process, or service that was made, used, sold, imported or performed by Licensor
(or its Sublicensees, agents, contractors, distributors, consultants, or
employees) in connection with the Licensed Patents or Licensed Know-How
occurring prior to the Effective Date of this Agreement.
7.3    Procedure. All indemnification obligations in this Agreement are
conditioned upon the party seeking indemnification: (i) promptly notifying the
indemnifying party of any claim or liability of which the party seeking
indemnification becomes aware (including a copy of any related complaint,
summons, notice or other instrument); provided, however, that failure to provide
such notice within a reasonable period of time shall not relieve the
indemnifying party of any of its

11

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obligations hereunder except to the extent that the indemnifying party is
prejudiced by such failure; (ii) cooperating with the indemnifying party in the
defense of any such claim or liability (at the indemnifying party’s expense);
and (iii) not compromising or settling any claim or liability without prior
written consent of the indemnifying party. Except with the written consent of
each indemnitee, no indemnitor shall enter into any settlement that does not
include the unconditional release of each indemnitee from all liability with
respect to indemnified claims.
7.4    Insurance. Prior to the first commercial sale of any Licensed Product,
Licensee will procure and maintain at its expense comprehensive general
liability insurance with a reputable insurer in the amount of not less than
[***]. Such comprehensive general liability insurance shall [***]. Licensee will
maintain such insurance during the period that any Licensed Product is being
distributed, sold or provided by Licensee. Licensee will provide Licensor with
written evidence of such insurance upon request of Licensor, and will provide
Licensor with written notice at least thirty (30) days prior to any
cancellation, non-renewal, reduction or other material change in such insurance.
ARTICLE 8

REPRESENTATIONS AND WARRANTIES
8.1    Licensor. Licensor represents and warrants that: (i) it is a corporation
duly organized validly existing and in good standing under the laws of the State
of Florida; (ii) the execution, delivery and performance of this Agreement have
been duly authorized by all necessary corporate actions on the part of Licensor;
(iii) Licensor is the sole and exclusive owner of all right, title and interest
in and to the Licensed Patents; (iv) none of the Licensed Patents has been
legally declared invalid or is the subject of a pending or threatened action or
proceeding for opposition or cancellation, or any reexamination, opposition or
interference proceeding, or any form of proceeding for a declaration of
invalidity, or other proceeding or action to invalidate, render unenforceable,
limit in scope, or otherwise limit any Licensor’s rights in the Licensed
Patents; (v) Licensor has the right to grant the rights and licenses granted
herein; (vi) it has not previously granted, and will not grant during the Term
of this Agreement, any right, license or interest in or to the Licensed Know-How
or Licensed Patents or any portion thereof in the Field, inconsistent with the
license granted to Licensee herein; and (vii) the list of patents and patent
applications in Exhibit A is a complete and accurate list of all patents and
patent applications owned or controlled by Licensor as of the Effective Date
that relate to the Field.
8.2    Licensee. Licensee represents and warrants that: (i) it is a corporation
duly organized validly existing and in good standing under the laws of the State
of Delaware and (ii) the execution, delivery and performance of this Agreement
have been duly authorized by all necessary corporate action on the part of
Licensee.
8.3    Warranty Exclusions. EXCEPT AS EXPRESSLY SET FORTH IN THIS ARTICLE 8, NO
PARTY MAKES ANY OTHER EXPRESS OR IMPLIED WARRANTY AS TO THE LICENSED KNOW-HOW,
LICENSED PATENTS OR THE LICENSED PRODUCTS, INCLUDING, WITHOUT LIMITATION, ANY
IMPLIED WARRANTY OF TITLE, NON-

12

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INFRINGEMENT, OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND HEREBY
DISCLAIMS THE SAME.
ARTICLE 9

DISPUTE RESOLUTION
9.1    Mediation. Excluding emergency actions for injunctive relief contemplated
by Section 9.4, in the event of any dispute, a complaining party shall promptly
communicate the circumstances of any disagreement in writing with sufficient
facts to enable the responding party to understand and react to the complaint.
The respondent shall then promptly act in good faith to engage in direct written
and oral communications with the complainant including, as required, one or more
executive officers of each Party to negotiate a formal resolution to any
dispute. Should such dispute not be remedied to the satisfaction of the
complainant within thirty (30) days of such communication, the Parties hereby
agree to undertake mediation at a shared cost for a period of no less than
thirty (30) days in an effort to resolve such issue without formal legal action
as set forth in Section 9.2.
9.2    Disputes. Subject to Sections 9.1 and 9.4, should mediation be
unsuccessful, the Parties agree that all disputes, controversies or differences
which may arise between them or for the breach of any of the terms hereof shall
be referred to and settled by arbitration in accordance with the Rules of the
American Arbitration Association (“Rules”) as currently in force by one or more
arbitrators appointed under such Rules. Such arbitration hereunder shall be
conducted in the English language and shall be held in Miami-Dade County,
Florida. The determination of the arbitration shall be final, binding and
conclusive upon the Parties hereto. Notwithstanding anything herein to the
contrary, the relevant cure periods for breach under this Agreement shall be
suspended while either Party pursues resolution to a dispute through
arbitration.
9.3    Prevailing Party. The substantially prevailing Party shall be entitled to
reimbursement of reasonable fees and costs, including attorneys’ fees.
9.4    Injunctive Relief. Notwithstanding anything to the contrary contained in
this Article 9, either Party may seek a preliminary injunction or other
provisional equitable relief in a court of competent jurisdiction if, in its
reasonable judgment, such action is necessary to avoid irreparable harm to
itself or to preserve its rights under this Agreement.
ARTICLE 10

GENERAL
10.1    Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of Florida, without reference to
principles of conflicts of laws.
10.2    Independent Contractors. The relationship of the Parties hereto is that
of independent contractors. The Parties hereto are not deemed to be agents,
partners or joint ventures of the other for any purpose as a result of this
Agreement or the transactions contemplated thereby.

13

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10.3    Assignment. This Agreement shall not be assignable or transferable, by
operation of law or otherwise, by either Party without the other Party’s written
consent, which shall not be unreasonably withheld, except that either Party or
its permitted assignees may assign this Agreement (i) in whole or in part to an
Affiliate of the assigning Party provided that the assigning Party agrees in
writing to remain liable for the Affiliate’s performance of its obligations
under this Agreement; or (ii) in whole to an independent third party who
acquires all or substantially all of the assets of the assigning Party or the
assets of the business of the assigning Party to which this Agreement relates;
provided that in each case the assignee agrees in writing to assume the
assigning Party’s obligations under this Agreement. Any attempt to assign or
transfer this Agreement or any portion thereof in violation of this Section 10.3
shall be void. For the avoidance of doubt, in addition to the above, Licensor
shall be permitted to transfer ownership of one or more of the Licensed Patents
provided that the new owner becomes a party to this Agreement and added to the
definition of Licensor. Upon such transfer, the transferring party shall no
longer be a party to this Agreement and shall be automatically released from any
and all obligations under this Agreement with no further action required.
10.4    Right to Independently Develop. Nothing in this Agreement will impair
Licensee’s right to independently acquire, license, develop for itself, or have
others develop for it, intellectual property and technology performing similar
functions as the Licensed Know-How or Licensed Patents or to market and
distribute products based on such other intellectual property and technology,
provided that the Licensee is in compliance with the obligations set forth in
Article 5.
10.5    Notices. Any required notices hereunder shall be given in writing by
certified mail or overnight express delivery service at the address of each
Party set forth in the recitals, or to such other address as either Party may
indicate on its behalf by written notice. Notice shall be deemed served when
delivered or, if delivery is not accomplished by reason or some fault of the
addressee, when tendered.
10.6    Force Majeure. Neither Party shall lose any rights hereunder or be
liable to the other Party for damages or losses (except for payment obligations)
on account of failure of performance by the defaulting Party if the failure is
occasioned by war, strike, fire, Act of God, earthquake, flood, lockout,
embargo, failure of suppliers, or any other reason where failure to perform is
beyond the reasonable control and not caused by the negligence, intentional
conduct or misconduct of the non-performing Party and the non-performing Party
has exerted all reasonable efforts to avoid or remedy such force majeure;
provided, however, that in no event shall a Party be required to settle any
labor dispute or disturbance.
10.7    Compliance with Laws. Each Party shall furnish to the other Party any
information reasonably related to the subject matter of this Agreement requested
or required by that Party during the term of this Agreement or any extensions
hereof to enable that Party to comply with the requirements of any U.S. or
foreign federal, state and/or government agency.
10.8    Limitation Of Liability. EXCEPT AS PROVIDED UNDER ARTICLE 7, OR IN THE
EVENT OF A BREACH UNDER ARTICLE 5, NEITHER PARTY SHALL BE LIABLE TO THE OTHER
FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL OR INDIRECT

14

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DAMAGES ARISING OUT OF THE PERFORMANCE OF THIS AGREEMENT, HOWEVER CAUSED, UNDER
ANY THEORY OF LIABILITY.
10.9    Further Assurances. At any time or from time to time on and after the
date of this Agreement, Licensor shall at the reasonable written request of
Licensee (i) deliver to Licensee such records, data or other documents
consistent with the provisions of this Agreement, (ii) execute and deliver or
cause to be delivered, all such consents, documents or further instruments of
transfer or license, and (iii) take or cause to be taken all such actions, as
Licensee may reasonably deem necessary or desirable in order for Licensee to
obtain the full benefits of this Agreement and the transactions contemplated
hereby.
10.10    Severability. In the event that any provisions of this Agreement are
determined to be invalid or unenforceable by a court of competent jurisdiction,
the remainder of the Agreement shall remain in full force and effect without
said provision. The Parties shall in good faith negotiate a substitute clause
for any provision declared invalid or unenforceable, which shall most nearly
approximate the intent of the Parties in entering this Agreement.
10.11    Waiver. The failure of a Party to enforce any provision of the
Agreement shall not be construed to be a waiver of the right of such Party to
thereafter enforce that provision or any other provision.
10.12    Entire Agreement and Amendments. This Agreement sets forth the entire
agreement and understanding of the Parties with respect to the subject matter
hereof, and supersedes all prior discussions, agreements and writings in
relating thereto. This Agreement may not be altered, amended or modified in any
way except by a writing signed by both Parties. Future amendments shall be made
in substantially the same form as indicated in Exhibit 2 of this Agreement.
10.13    Counterparts. This Agreement may be executed in two counterparts which
may be delivered by fax or email, each of which shall be deemed an original and
which together shall constitute one instrument. Upon request, each party shall
provide an original signature to the other party.
Signature page follows

15

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IN WITNESS WHEREOF, Licensor and Licensee have executed this License Agreement
by their respective duly authorized representatives.

BODOR LABORATORIES, INC.

By: /s/ Erik T. Bodor                

Date: December 17th, 2012            

By: /s/ Nicholas Bodor            
Nicholas Bodor, Individually

BRICKELL BIOTECH, INC.

By: /s/ Andrew Sklawer            
Andrew Sklawer, Vice President

Date: December 15, 2012

16

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

17

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

18

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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. 1 TO
LICENSE AGREEMENT
THIS AMENDMENT NO. 1 TO LICENSE AGREEMENT (“Amendment No. 1”) is made effective
October 21, 2013 (the “Effective Date”) by and among BODOR LABORATORIES, INC., a
Florida corporation, having an office located at 4400 Biscayne Boulevard, Suite
980, Miami, FL 33137 (“BLI”) and NICHOLAS S. BODOR, a Florida resident residing
at 10225 Collins Ave., Apt 1002, Bal Harbour, FL, USA 33154 (“Bodor”)
(collectively BLI and Bodor are referred to herein as “Licensor”), and BRICKELL
BIOTECH, INC., a Delaware corporation having an office located at 2600 Southwest
Third Avenue, Suite 350, Miami, Florida 33129, and any Affiliates (collectively,
“Licensee”).
WITNESSETH:
WHEREAS, Licensor and Licensee entered into an exclusive license agreement dated
December 15, 2012 (the “License Agreement”); and
WHEREAS, Licensee and Licensor desire to amend Exhibit A of the License
Agreement to [***].
NOW, THEREFORE, Licensee and Licensor, in consideration of the mutual covenants
and agreements and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, do hereby agree as follows:
1.
Amendments. The License Agreement is hereby amended as follows:

a.
Exhibit A of the License Agreement. Exhibit A is hereby amended and restated in
its entirety as set forth in the revised “Exhibit A” attached hereto and made
part of this Amendment No. 1 as Attachment A.

2.
Capitalized Terms. Capitalized terms herein shall, unless otherwise provided for
in this Amendment No. 1 have the same meaning as set forth in the License
Agreement.

3.
Term and Termination. This Amendment No. 1 shall be effective and shall run
concurrently with the License Agreement. In the event that the License Agreement
shall be terminated for any reason, this Amendment No. 1 shall also be
terminated.

4.
Counterparts. This Amendment No. 1 may be executed in any number of
counterparts, with the same effect as if all had signed the same document. All
counterparts shall be construed together and shall constitute one agreement.

1

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5.
Full Force and Effect. Except as specifically set forth herein, all other terms
and provisions of the License Agreement shall remain in full force and effect.
In the event of a conflict between this Amendment No. 1 and the License
Agreement, this Amendment No. 1 shall govern.

2

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IN WITNESS WHEREOF, the Parties hereto executed this Amendment No. 1 to the
License Agreement as of the Effective Date.

BODOR LABORATORIES, INC.

By: /s/ Erik T. Bodor                    

Its: VP Research and CFO                

Date: October 29, 2013                

By: /s/ Nicholas Bodor                
Nicholas Bodor, Individually

Date: October 29, 2013                

BRICKELL BIOTECH, INC.

By: /s/ Andrew Sklawer                
Andrew Sklawer, Vice President

Date: October 29, 2013

3

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

4

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

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. 2 TO
LICENSE AGREEMENT
THIS AMENDMENT NO. 2 TO LICENSE AGREEMENT (“Amendment No. 2”) is made effective
[March 31], 2015 (the “Effective Date”) by and among BODOR LABORATORIES, INC., a
Florida corporation, having an office located at 4400 Biscayne Boulevard, Suite
980, Miami, FL 33137 (“BLI”) and NICHOLAS S. BODOR, a Florida resident residing
at 10225 Collins Ave., Apt 1002, Bal Harbour, FL, USA 33154 (“Bodor”)
(collectively BLI and Bodor are referred to herein as “Licensor”). and BRICKELL
BIOTECH, INC., a Delaware corporation having an office located at 2600 Southwest
Third Avenue, Suite 350, Miami, Florida 33129, and any Affiliates (collectively,
“Licensee”).
WITNESSETH:
WHEREAS, Licensor and Licensee entered into an exclusive license agreement dated
December 15, 2012 as amended by Amendment No. 1 to License Agreement, effective
as of October 21, 2013 (the “License Agreement”); and
WHEREAS, Licensee and Licensor desire to make certain amendments to the License
Agreement.
NOW, THEREFORE, Licensee and Licensor, in consideration of the mutual covenants
and agreements and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, do hereby agree as follows:
1.
Addition of Defined Term. The following shall be added immediately after Section
1.1 of the License Agreement as a new Section 1.2 (and the remaining defined
terms shall be renumbered accordingly):

1.2 “Asia” shall mean Japan, China (including Hong Kong), South Korea, Taiwan,
Malaysia, Cambodia, Singapore, Thailand, Indonesia and Vietnam.
2.    Amendment to Section [***] of the License Agreement. [***]:

2.2.1 Diligence Events. Licensee shall use [***] at its own cost and expense to
[***].
.

1

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[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]

3.
Amendment to Section 3.2.2 of the License Agreement. Section 3.2.2 of the
License Agreement is hereby amended and restated as follows:

3.2.2 [***]:

3.2.2.1 [***]:

[***]
[***]
[***]
[***]
[***]
[***]

[***].

3.2.2.2 [***].

4.
Amendment to Exhibit A of the License Agreement. Exhibit A of the License
Agreement is hereby amended and restated as set forth on Attachment A.

5.
Capitalized Terms. Capitalized terms herein shall, unless otherwise provided for
in this Amendment No. 2 have the same meaning as set forth in the License
Agreement.

6.
Term and Termination. This Amendment No. 2 shall be effective and shall run
concurrently with the License Agreement. In the event that the License Agreement
shall be terminated for any reason, this Amendment No. 2 shall also be
terminated.

7.
Counterparts. This Amendment No. 2 may be executed in any number of
counterparts, with the same effect as if all had signed the same document. All
counterparts shall be construed together and shall constitute one agreement.

8.
Full Force and Effect. Except as specifically set forth herein, all other terms
and provisions of the License Agreement shall remain in full force and effect.
In the event of a conflict between this Amendment No. 2 and the License
Agreement, this Amendment No. 2 shall govern.

2

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IN WITNESS WHEREOF, the Parties hereto executed this Amendment No. 2 to the
License Agreement as of the Effective Date.

BODOR LABORATORIES, INC.
By: /s/ Erik T. Bodor                    

Its: CFO                        

By: /s/ Nicholas Bodor                
Nicholas Bodor, Individually

BRICKELL BIOTECH, INC.

By: /s/ Andrew Sklawer                
Andrew Sklawer, Vice President

3

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

4