Exhibit 10.5

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
BETWEEN
THE UAB RESEARCH FOUNDATION
AND
BRICKELL BIOTECH, INC.

DATED JUNE 26, 2012

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TABLE OF CONTENTS

 
 
 
Page
 
 
 
 
ARTICLE 1
 
DEFINITIONS
1
ARTICLE 2
 
GRANT OF LICENSE
4
ARTICLE 3
 
DEVELOPMENT AND COMMERCIALIZATION
6
ARTICLE 4
 
PROTECTION OF THE LICENSED PATENTS; PATENT PROSECUTION
7
ARTICLE 5
 
FINANCIAL TERMS
8
ARTICLE 6
 
RECORDKEEPING AND AUDIT RIGHTS
11
ARTICLE 7
 
INFRINGEMENT; ENFORCEMENT
12
ARTICLE 8
 
OTHER COVENANTS AND AGREEMENTS
14
ARTICLE 9
 
TERM AND TERMINATION
17
ARTICLE 10
 
COVENANTS; REPRESENTATIONS AND WARRANTIES; LIMITATIONS ON UABRF’S OBLIGATIONS
18
ARTICLE 11
 
LIABILITY AND INDEMNIFICATION
20
ARTICLE 12
 
MISCELLANEOUS
20
EXHIBIT A
 
LICENSED PATENTS
25
EXHIBIT B
 
DEVELOPMENT AND COMMERCIALIZATION PLAN AND [***]
26
EXHIBIT C
 
FORM OF [***] REPORT
31

        
    
        
        
        
        
        
        
        

 
i
 

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[***] LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this “Agreement”) is made and is effective as of the
26th day of June, 2012 (the “Effective Date”) between THE UAB RESEARCH
FOUNDATION, an Alabama not-for-profit corporation (“UABRF”) and BRICKELL
BIOTECH, INC., a Delaware corporation (the “Licensee”).
RECITALS:
WHEREAS, UABRF owns all right, title and interest in and to those patented and
patent pending advances developed by [***] (the “Inventors”) outlined in UABRF
Intellectual Property disclosures [***] and [***] referenced and made a part of
this Agreement as set forth in Exhibit A (“Exhibit A”);
WHEREAS, UABRF desires to have the intellectual property developed and
commercialized to benefit the public; and WHEREAS, the Licensee, a
pharmaceutical company specializing in the field of dermatology pharmaceuticals,
desires to obtain a license to the Licensed Patents upon the terms and
conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the premises described above and the mutual
promises and agreements set forth in this Agreement, the Parties agree as set
forth below.
ARTICLE I
DEFINITIONS
The Definitions used in this Agreement are set forth below.
1.1
“Affiliate” means any Person that directly or indirectly controls, is controlled
by, or is under common control with a Party. “Control” means (i) the beneficial
ownership of at least fifty percent (50%) of the voting securities of a Person
with voting equity, or (ii) the power to direct or cause the direction of the
management or policies of a Person.

1.2
“Agreement” means this agreement, as amended from time to time in accordance
with the terms and conditions set forth in this agreement.

1.3
“Applicable Law” means all laws, statutes and regulations promulgated by all
Regulatory Authorities and all Governmental Authorities.

1.4
“Development and Commercialization Plan” or “Plan” means a report of those
development, manufacturing, marketing and commercialization activities proposed
or undertaken by the Licensee with respect to the Licensed Patents as further
detailed in Section 3.1 and in a form similar to Exhibit B.

1.5
[***].

1.6
“First Commercial Sale” means the first sale of a Licensed Product to a Third
Party.

1

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1.7
“For Value” means any consideration, remuneration or benefit of any kind,
whether received directly or indirectly, including, but not limited to, cash,
equity, debt, preferential treatment, including waiver, rebate, discount, etc.

1.8
“Governmental Authorities” means, with respect to each country or jurisdiction,
all legislative and governmental authorities, bodies, commissions, agencies or
other instrumentalities of such country or jurisdiction.

1.9
“Infringement Notice” is defined in Section 7.1 of this Agreement.

1.10
“Inventors” are defined in the first recital of this Agreement.

1.11
“Licensed Field of Use” means the [***].

1.12
“Licensed Patents” means (a) the patents and/or patent applications set forth in
Exhibit A, (b) any foreign patent applications based thereon, (c) all patents
proceeding from such domestic and foreign patent applications, (d) all claims of
continuations-in-part that are entitled to the benefit of the priority date of
the parent Licensed Patent and are enabled by subject matter that is disclosed
in the parent Licensed Patent, (e) any patent or patent application jointly
developed by the Parties and or their Representatives arising from the Licensed
Patents (“New Patents”) as described in Section 4 below and (f) all divisionals,
continuations, reissues, reexaminations and extensions of any patent or patent
application described in (a) - (e) above. Licensed Patents specifically excludes
[***].

1.13
“Licensed Product” means 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 Patent Claim set forth in any Licensed Patent.

1.14
“Licensed Territory” means [***].

1.15
“Management Activities” means any and all Protection Activities and any other
steps deemed necessary and reasonable to commercialize the Licensed Patents.

1.16
“Net Sales” means the gross revenue and other consideration paid to Licensee or
its Affiliates or Sublicensees for [***], which are sold, leased or otherwise
commercialized by or for Licensee or any of its Affiliates or Sublicensees;
however, sales or other transfers of [***] between Licensee and its Affiliates
or Sublicensees shall be excluded from the computation of Net Sales, and no
payments will be payable to UABRF on such sales or transfers except where such
Affiliates or Sublicensees are end users or consumers; invoiced amounts shall be
reduced by the following deductions, directly attributable to the [***] and
specifically identified in writing, and borne by the seller to the extent they
are included in such gross revenue or other consideration:

[***]

2

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A Licensed Product shall be considered sold when it is shipped, delivered, or
invoiced, whichever is earlier. No deductions shall be made from Net Sales for
commission paid to individuals whether they are with independent sales agencies
or are regularly employed by Licensee or its Affiliates or Sublicensees and are
on its or their payroll, or for the cost of collections. In the event Licensee
transfers a Licensed Product to a Third Party in a bona fide arm’s length
transaction, for consideration, in whole or in part, other than cash, then the
Net Sales price for such Licensed Product shall be deemed to be the standard
invoice price then being invoiced by Licensee in an arm’s length transaction
with similar companies, and in the absence of such standard invoice price, then
the reasonable Fair Market Value of the Licensed Product, shall be determined in
the ordinary course of business using the accrual method of accounting in
accordance with generally accepted accounting principles.
1.17
“Non-Commercial Research Purposes” means any use and practice for academic
research and educational purposes, including research sponsored by commercial,
for-profit Third Parties, but excluding any disclosure of Proprietary
Information of Licensee to such commercial, for-profit Third Parties.

1.18
[***].

1.19
“Parties” means each of UABRF and the Licensee, and each of them individually is
a “Party.”

1.20
“Person” means an individual, corporation, partnership, trust, business trust,
association or any other entity with a separate legal identity, including the
Parties.

1.21
“Proprietary Information” is defined in Section 8.4.

1.22
“Protection Activities” means taking all actions deemed commercially necessary
and desirable to protect the Licensed Patents, including, but not limited to,
obtaining, filing for, securing, pursuing, prosecuting, continuing or
maintaining, the Patents and patent application(s).

1.23
“Protection Expenses” means all legal fees, costs and expenses reasonably
incurred by either Party in the performance of the Protection Activities, with
such fees, costs and expenses to be documented by written invoice.

1.24
“Regulatory Authority” means, with respect to any particular country or
jurisdiction, the Governmental Authority with the primary responsibility for the
evaluation or approval of pharmaceutical products before such products can be
tested, marketed, promoted, distributed or sold in such country, including
Governmental Authorities that have jurisdiction over the pricing of such
products. The term Regulatory Authority shall include the U.S. Food and Drug
Administration.

1.25
“Representative(s)” means, with respect to each Party and their Affiliates, all
trustees, directors, officers, employees, agents and professional advisors.

3

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1.26
“Sublicensee” means a Person to whom the Licensee has granted a sublicense
pursuant to Section 2.5 of this Agreement.

1.27
“Term” is defined in Section 10.1.

1.28
“Third Party” means any Person other than the Parties and their Affiliates.

1.29
“United States” means the United States of America.

1.30
“Valid Patent Claim” means (i) a pending patent claim included within the
Licensed Patents or (ii) an issued and unexpired patent claim included within
the Licensed Patents which has not been held permanently revoked, unenforceable
or invalid by a decision of a court or other governmental agency of competent
jurisdiction, to which an appeal has not or cannot be taken within the time
allowed for appeal, and which has not been disclaimed, denied or admitted to be
invalid or unenforceable through reissue, disclaimer or otherwise.

ARTICLE 2
GRANT OF LICENSE
2.1
Grant of License. Subject to the terms and upon the conditions set forth in this
Agreement, UABRF hereby grants to the Licensee [***] to (i) practice the [***]
and (ii) make, have made, develop, use, license, offer to sell, sell, import and
export [***], within the [***] in the [***] during the Term. The Licensee may
transfer its rights under this Agreement to an Affiliate, provided such
Affiliate assumes all of the obligations of the Licensee under this Agreement.

2.2
Rights of the United States Government. It is understood that a United States
Governmental Authority (NIH, Grant Nos. P01 CA034968 and P01 CA089019) has
funded research, during the course of or under which any of the Licensed Patents
were conceived or made, The United States Government is entitled, as a right,
under the provisions of 35 U.S.C. §§ 200-212 and applicable regulations of
Chapter 37 of the Code of Federal Regulations, to [***]. The Licensee
acknowledges that the rights and license granted to it pursuant to this
Agreement are subject to any and all rights of the United States Government.

2.3
Reservation of Rights by UABRF and its Affiliates. UABRF reserves the right, for
itself and for its Affiliates, to:

(a)
practice and use, and to permit its Representatives to practice and use, the
Licensed Patents within the Licensed Field of Use for Non-Commercial Research
Purposes;

(b)
grant to non-profit academic, educational or research institutions and
Governmental Authorities, [***];

(c)
permit their respective Representatives to disseminate and publish scientific
findings from research related to the Licensed Patents provided that in the
event of any prospective New Patent, Licensee shall be provided advance notice
and a reasonable time and opportunity for Protection Activities prior to any
disclosure; and

4

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(d)
practice, use and otherwise commercialize, including licensing, the Licensed
Patents to Third Parties for applications and uses outside of the Licensed Field
of Use.

2.4
Title Remains with UABRF. All right, title and interest in and to the [***]
remains with UABRF. Except as provided in this Agreement, no express or implied
licenses with respect to the Licensed Patents or any other rights are
transferred or granted to the Licensee by implication, estoppel or otherwise.

2.5
Right to Grant [***]. The Licensee has the right to grant [***] under this
Agreement on the following terms and conditions:

(a)
the execution of a [***] shall not in any way diminish, reduce or eliminate any
of the Licensee’s obligations under this Agreement, and the Licensee shall
remain primarily liable for such obligations and any breach of any provision of
this Agreement [***];

(b)
[***] who are not Affiliates of the Licensee, or who are not otherwise immediate
family members of, or controlled by the immediate family members of, Persons who
control the Licensee;

(c)
the Licensee shall obtain UABRF’s prior written consent of all [***], which
consent shall not be unreasonably withheld;

(d)
any [***] so granted shall be subject and subordinate to, and consistent with,
the terms of this Agreement;

(e)
the Licensee may not [***];

(f)
any [***] shall also provide that, in the event this Agreement is terminated or
upon the expiration of the Term, [***] on the terms stated therein;

(g)
[***] are to be [***] and the Licensee shall not receive f[***] under this
Agreement without the prior written consent of UABRF;

(h)
the Licensee shall provide UABRF with [***] under this Agreement within thirty
(30) days after the [***];

(i)
all such [***] confidential scientific information and other information
required by [***] to be kept confidential, provided that all relevant financial
terms and information shall be retained [***]; the disclosure of [***] to UABRF
shall be subject to the confidentiality obligations set forth in this Agreement;

(j)
UABRF is [***], and each agreement evidencing a [***] shall include a statement
and an acknowledgement [***] to this effect; and

(k)
[***].

5

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ARTICLE 3
DEVELOPMENT AND COMMERCIALIZATION
3.1
Development and Commercialization Plan. During the Term, the Licensee shall
[***] to develop, manufacture, commercialize and market the Licensed Patents
through a diligent program designed to accomplish the commercial exploitation of
the technology in the Licensed Patents in accordance with the usual and
customary practices for the pharmaceutical and cosmetics industry. The Parties
acknowledge that the Licensee has developed a written disclosure setting forth
its development and commercialization objectives (the “Plan”) as set forth in
Exhibit “B” (“Exhibit B”). The Parties further acknowledge and agree that the
Development and Commercialization Plan is intended to achieve [***] in Section
5.3 and to accomplish the commercialization of the Licensed Products.
Accordingly, such Plan is a dynamic arrangement that sets forth prospective
activities that may change over time in accordance with research results, market
opportunities and business conditions. The Licensee shall consult with UABRF in
the design and implementation of its Development and Commercialization Plan to
ensure a clear understanding of its proposed activities. However, the Licensee
shall have the sole responsibility and control over business objectives and
activities.

3.2
Amendment of the Plan. All material variations and deviations from and changes
to the Plan shall be promptly communicated in writing to UABRF.

3.3
Plan Report. The Licensee shall provide UABRF with written progress reports
detailing the activities of the Licensee relating to the Plan, each January and
July for a period of six (6) years from the Effective Date, or until the First
Commercial Sale. As a general guide, each such report shall provide information
regarding the accomplishments and progress made by the Licensee during the prior
reporting period and the objectives and goals to be reached during the
forthcoming reporting period. Subsequent to the foregoing development period and
for the balance of this Term of this Agreement, the Licensee shall provide UABRF
with annual reports outlining the status of the commercialization activities of
the Licensed Products.

3.4
Regulatory Approvals. With respect to each Licensed Product, and to the extent
regulatory approval is required, the Licensee shall [***] to obtain the approval
of each applicable Regulatory Authority prior to the First Commercial Sale in
each country/jurisdiction in which the Licensee intends to sell Licensed
Products.

3.5
Patent Markings. The Licensee shall ensure that each Licensed Product
manufactured and/or sold in the United States shall bear patent markings that
meet all applicable requirements of 35 U.S.C. §287, as amended from time to
time. All Licensed Products manufactured and/or sold outside of the United
States shall be marked in such a manner as to conform to the Applicable Law of
such country/jurisdiction.

3.6
Manufacturing in the United States. The Licensee shall use [***] any Licensed
Products sold in the United States that incorporate any invention or
intellectual property owned by

6

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UABRF and licensed to the Licensee under this Agreement that was developed using
funds provided by a United States Governmental Authority.
3.7
Information Sharing. Within fifteen (15) days of the Effective Date, UABRF shall
use reasonable effort to provide Licensee with all information in its immediate
possession related to or involving (i) the Licensed Patents and (ii) any and all
concepts or data arising from or related to potential further protectable
advances in the Licensed Field of Use only. Additionally, UABRF shall make
available to Licensee any and all publications that are within UABRF’s
possession as of the Effective Date.

ARTICLE 4
PROTECTION OF THE LICENSED PATENTS; PATENT PROSECUTION
4.1
Protection Activities.

(a)
Shared Responsibility. Subject to the terms and conditions set forth in this
Agreement, UABRF and Licensee shall work cooperatively to undertake Protection
Activities relating to the Licensed Patents. UABRF shall select legal counsel to
manage Protection Activities for patents and patent applications existing as of
the Effective Date of this Agreement. Licensee anticipates that it will initiate
the filing of [***]. Licensee shall be permitted to use its own legal counsel in
undertaking Protection Activities at its sole cost, provided all such activities
shall be coordinated with UABRF legal counsel to secure existing patent rights
without conflict. New Patents shall be assigned to UABRF and shall automatically
be included in Licensed Patents upon date of filing. Exhibit A shall be amended
accordingly to reflect the New Patents.

(b)
Consultation with the Licensee. UABRF, Licensee and their designated legal
counsel shall consult with the one another in connection with Protection
Activities and neither party will authorize or instruct counsel on prosecution
matters without first informing the other of such.

(c)
Foreign Protection Requested by the Licensee. The Licensee must identify those
jurisdictions, if any, where the Licensee seeks to undertake Protection
Activities with respect to any Licensed Patents. UABRF shall be responsible for
coordinating all Protection Activities at Licensee’s cost in connection with the
specific Licensed Patent in the relevant jurisdictions. Exhibit A shall be
amended accordingly to reflect these revised jurisdictions.

(d)
Disclaimed Licensed Patent Rights. The Licensee may, at any time during the
Term, provide written notice to UABRF that it no longer wishes to be responsible
for the Protection Expenses in connection with one or more Licensed Patents. In
such cases, (i) the Licensee shall continue to be responsible for all Protection
Expenses incurred in connection therewith until the expiration of sixty (60)
days and thereafter shall not be responsible for such expenses, and (ii) the
Licensed Patents so affected shall no longer be deemed to be licensed to the
Licensee in that specific jurisdiction and

7

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shall be deemed to have been disclaimed by the Licensee (each, a “Disclaimed
Licensed Patent Right”), (iii) the Licensee shall forfeit and shall no longer
have any rights or obligations with respect thereto and (iv) Exhibit A shall be
amended accordingly to delete the affected Licensed Patents.
ARTICLE 5
FINANCIAL TERMS
5.1
Protection Expenses. During the Term and with respect to each Licensed Patent,
other than Disclaimed Licensed Patent Rights, the Licensee will be financially
responsible for the payment of all Protection Expenses incurred after the
Effective Date. The Licensee shall pay such amounts to UABRF within thirty (30)
days of receipt of an invoice for the same from UABRF. UABRF shall be
responsible for all Protection Expenses incurred in connection with each
Disclaimed Licensed Patent Rights in jurisdictions specifically disclaimed by
the Licensee upon the expiration of the sixty (60) day notice period referred to
in Section 4.1.

5.2
License Fee. On or before the Effective Date, the Licensee shall pay to UABRF
[***].

5.3
Milestone Payments. During the Term, the Licensee shall pay to UABRF the [***]
in this Section 5.3. Each [***]. The Licensee shall provide written notice to
UABRF to accompany the payment [***].

[***]

[***]

5.4
[***] Payments. During the Term and with respect to each country or jurisdiction
within the Licensed Territory, the Licensee shall pay to UABRF [***]arising in
such country/jurisdiction until the expiration of the last Valid Patent Claim in
that country/jurisdiction. All amounts owing to UABRF under this section shall
be paid on a quarterly basis, on or before the thirtieth (30th) day following
the end of the calendar quarter in which such amounts were earned.

5.5
[***] Reports. Commencing with the first day of the calendar quarter following
the calendar quarter in which the obligation of the Licensee to pay [***] is
triggered, the Licensee shall provide to UABRF a written report setting forth
all applicable information specified in Exhibit “C” (“Exhibit C”), which such
report shall accompany the [***] to UABRF by the Licensee with respect to the
preceding calendar quarter. Reports furnished must include the [***] by Licensed
Product and by country/jurisdiction and must include the rate of currency
conversion and the date such conversion was calculated as described in Section
5.10 of this Agreement, in substantially the format set forth in Exhibit C.

5.6
[***] Income. The Licensee shall pay to UABRF the amounts, as laid out in the
chart below [***] during the Term with such payments being made to UABRF on or
before the thirtieth (30`”) day of receipt by the Licensee. All such payments
shall be accompanied by a written

8

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notification of the nature and origin of the payment, the identity of the
original maker of the payment and, if the original payment was made in a foreign
currency, must include the rate of currency conversion and the date such
conversion was calculated as described in Section 5.10 of this Agreement. In the
event that the Licensee [***].
[***]
5.7
[***] Payments from [***]. During the Term, [***] arising in the applicable
country/jurisdiction until the expiration of the last Valid Patent Claim in that
country/jurisdiction. Where sales or other transfers of Licensed Products shall
occur between Licensee and/or its Affiliates [***], such sales or other
transfers shall be [***]. For the avoidance of doubt, a [***] shall only be
payable to UABRF [***].

5.8
Address for Payments. Except as otherwise directed by UABRF, all amounts due to
be paid by the Licensee to UABRF pursuant to this Agreement shall be paid to
UABRF at the address set forth below its signature on the signature page of this
Agreement.

5.9
Late Payment Penalty. The balance of any amount which remains unpaid more than
thirty (30) days after it is due to UABRF shall accrue interest until paid at
the rate equal to the lesser of [***] or the maximum amount allowed under
Applicable Law. However, in no event shall this interest provision be construed
as a grant of permission for payment delays.

5.10
Currency Conversion. All amounts due to be paid to UABRF pursuant to this
Agreement shall be made [***]. Any and all amounts received by the Licensee or
generated in foreign currency shall be [***] at the rate quoted in the Wall
Street Journal (United States edition) for the last business day of the calendar
quarter in which [***] are due and payable to UABRF or on a business day no
earlier than five (5) business days before payment is made to UABRF.

5.11
Taxes. UABRF is exempt from [***]; therefore, all payments made by Licensee
under this Agreement shall be made without deduction for taxes, assessments or
other charges of any kind that are [***]. Any tax required to be withheld by the
Licensee under the laws of any foreign country or jurisdiction for the account
of UABRF shall be promptly paid by the Licensee for and on behalf of UABRF to
the appropriate Governmental Authority, and the Licensee shall use [***] to
furnish UABRF with proof of payment of such tax, together with official or other
appropriate evidence issued by the applicable Governmental Authority. Any such
amounts actually paid on UABRF’s behalf shall be deducted from any amounts due
to be paid to UABRF under this Agreement.

ARTICLE 6
RECORDKEEPING AND AUDIT RIGHTS
6.1
Books and Records. The Licensee shall keep complete and accurate books, accounts
and other records and documentation necessary to ascertain all transactions and
events pursuant to which payments due to UABRF pursuant to this Agreement arise
and are accrued and to verify the accuracy and completeness of such amounts. All
such books, accounts and other records and documentation shall be kept at the
Licensee’s principal place of business for a

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period of not less than six (6) years following the end of the calendar year to
which they pertain.
6.2
Right to Audit. UABRF shall have the right to have the Licensee’s books and
records audited by a qualified, independent accounting firm of its choosing,
under appropriate confidentiality provisions such as those set forth in Section
8.4 of this Agreement, to ascertain the accuracy of the reports and payments due
to UABRF under this Agreement and compliance by the Licensee, its Affiliates and
its Sublicensees with their obligations pursuant to this Agreement and any
sublicense. Such audit shall be conducted during normal business hours and in a
manner that does not interfere unreasonably with the Licensee’s business but not
more than once in any twelve (12) month period. If any such examination reveals
that the Licensee has underpaid or underreported any amount due under this
Agreement to UABRF for any calendar quarter examined, the Licensee shall
promptly pay to UABRF the amount so underpaid or underreported.

6.3
Reimbursement of Cost of Audit. If any such examination reveals that the
Licensee has underpaid or underreported any amount due under this Agreement to
UABRF by more than five percent (5%) for any calendar quarter examined, the
Licensee shall immediately reimburse UABRF the full costs and expenses incurred
by it with respect to the audit.

ARTICLE 7
INFRINGEMENT; ENFORCEMENT
7.1
Notification of Infringement. During the Term, each Party shall provide prompt
written notice to the other Party of any actual infringement or
suspected/potential infringement of the Licensed Patents of which such Party is
or becomes aware and shall provide, to the extent reasonable and practicable,
any available evidence of such infringement by a Third Party (an “Infringement
Notice”).

7.2
Licensee Right to Pursue/Prosecute. During the Term, the Licensee shall have the
right to resolve, in the Licensed Field of Use and in the Licensed Territory,
any suspected/potential infringement and prosecute any infringement of any
Licensed Patents, in its own name and at its own expense, provided:

(a)
the affected Licensed Patents [***] and are not a Disclaimed Licensed Patent
Right;

(b)
the claim relates to a Valid Patent Claim; and

(c)
the Licensee remains in compliance in all material respects with its obligations
under this Agreement.

The Licensee shall [***] to abate or terminate such infringement without
resorting to litigation, which may include negotiating and executing a
sublicense agreement that complies with the terms of Section 2.5 of this
Agreement. Before the Licensee commences an action with respect to any
infringement or potential infringement, it shall give careful consideration to
the views of UABRF and the potential effects on the public interest in making
its decision whether or not to sue. UABRF

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shall use reasonable efforts to cooperate with the Licensee in connection with
any remedial action undertaken by the Licensee and shall be responsible for the
costs and expenses incurred by it and for those costs and expenses incurred by
it at the reasonable request of the Licensee with respect to such cooperation.
7.3
Control of Suit; Joinder; Expenses.

(a)
Initiated by the Licensee. If the Licensee wishes to commence a lawsuit, it must
do so within ninety (90) days following the date of the relevant Infringement
Notice, and it shall bear all costs and expenses incurred by it in connection
with such lawsuit. UABRF shall co-operate fully with the Licensee in connection
with such lawsuit and shall be responsible for the costs and expenses incurred
by it and for those costs and expenses incurred by it at the reasonable request
of the Licensee with respect to such co-operation.

(b)
Initiated by UABRF. If the Licensee elects not to exercise its right to
commence, or fails to commence, an action within ninety (90) days of the date of
the relevant Infringement Notice, UABRF may do so at its own expense, and shall
retain sole control over the direction of such lawsuit. The Licensee shall
cooperate fully with UABRF in connection with such lawsuit and shall be
responsible for the costs and expenses incurred by it with respect to such
cooperation. If UABRF files an infringement lawsuit, the Licensee may not
thereafter commence a lawsuit against the same infringing party with respect to
the same acts of infringement which are the subject of UABRF’s lawsuit or with
respect to which settlement is reached by the infringing party and UABRF.

(c)
Joinder by UABRF. UABRF, to the extent permitted by Applicable Law, may elect to
join in as a party to any infringement lawsuit initiated by the Licensee, in
which case, both Parties shall jointly control the lawsuit and shall equally
share the responsibility of all legal fees, costs and expenses, unless otherwise
agreed to by the Parties. The Licensee may not join UABRF in as a party to any
lawsuit initiated by it without the prior written consent of UABRF, which such
consent shall not be unreasonably withheld, and without prior written agreement
between the Parties as to the responsibility between the Parties for all costs
and expenses incurred by the Parties. If UABRF is involuntarily joined as a
party to a lawsuit initiated by the Licensee, the Licensee shall pay all legal
fees, costs and expenses incurred by UABRF arising out of such joinder and
participation, including, but not limited to legal fees, costs and expenses
reasonably incurred by legal counsel selected and retained by UABRF to represent
it in such lawsuit. While UABRF remains a party to any infringement lawsuit
initiated by the Licensee, UABRF may not thereafter commence a lawsuit against
the same infringing party with respect to the same acts of infringement which
are the subject of the Licensee’s lawsuit or with respect to which settlement is
reached by the infringing party, the Licensee and UABRF.

7.4
Settlement. The Licensee may not settle, enter into a consent judgment or other
voluntary final disposition of any lawsuit initiated by it or to which it is a
party without the prior written

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consent of UABRF, which consent shall not be unreasonably withheld. Neither
Party may settle or otherwise dispose of any lawsuit to which it is a party,
which admits liability on the part of the other Party or which requires the
other Party to pay money damages or issue a formal statement without such other
Party’s prior written consent.
7.5
Recoveries.

(a)
Lawsuit initiated by the Licensee and in which only the Licensee is a party.
With respect to any lawsuit commenced by the Licensee pursuant to Section 7.3(a)
above and in which UABRF is not a party, any recovery of damages shall first be
applied in satisfaction of the costs and expenses incurred by the Licensee in
bringing such lawsuit, including attorneys’ fees, provided they are reasonably
incurred, and any balance shall be treated in accordance with Section 5.4.
[***].

(b)
Lawsuit initiated by the Licensee and in which UABRF joins.

(i)
With respect to any lawsuit commenced by the Licensee pursuant to Section 7.3(a)
above and in which UABRF is involuntarily joined as a party, any recovery of
damages (whether compensatory or punitive in nature) shall first be applied, pro
rata, in satisfaction of the costs and expenses incurred by the Licensee and
UABRF in bringing such lawsuit, including attorneys’ fees, provided they are
reasonably incurred (which such costs and expenses shall include all costs and
expenses incurred by UABRF arising out of such joinder and participation,
including, but not limited to legal fees and expenses reasonably incurred by
legal counsel selected and retained by UABRF to represent it in such lawsuit),
and any balance shall be treated in accordance with Section 5.4 of this
Agreement.

(ii)
With respect to any lawsuit commenced by the Licensee pursuant to Section 7.3(a)
above and in which UABRF voluntarily joins as a party, any recovery of damages
(whether compensatory or punitive in nature) shall first be applied, pro rata,
in satisfaction of the costs and expenses incurred by the Parties in bringing
such lawsuit, including attorneys’ fees, provided they are reasonably incurred,
and any balance shall be treated in accordance with Section 5.4 of this
Agreement.

(c)
Lawsuit initiated by UABRF and in which only UABRF is a party. With respect to
any lawsuit commenced by UABRF pursuant to Section 7.3(b) above, all recoveries
of damages [***]. Furthermore, the Licensee [***] under any existing or future
sublicense authorizing Licensed Products, [***].

(d)
Lawsuit initiated by UABRF and in which Licensee Joins. With respect to any
lawsuit commenced by the UABRF pursuant to Section 7.3(a) above and in which
Licensee voluntarily joins as a party, any recovery of damages (whether
compensatory or punitive in nature) shall first be applied, pro rata, in
satisfaction of the costs and expenses incurred by the Parties in bringing such
lawsuit, including attorneys’ fees,

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provided they are reasonably incurred, and any balance shall be treated in
accordance with Section 5.4 of this Agreement.
7.6
Inapplicablity of Licensee’s Rights. Notwithstanding Sections 7.1 - 7.5 above,
the rights and obligations of the Licensee under this article shall not apply to
(a) any Licensed Patents in which there are no Valid Patent Claims remaining or
(b) any Disclaimed Licensed Patent Rights.

ARTICLE 8
OTHER COVENANTS AND AGREEMENTS
8.1
Use of Names. No Party may, without the prior written consent of the other
Party: use (a) the name of the other Party or its Affiliates, if applicable, (b)
the name or image of any Representative of the other Party, or (c) any
trade-name, trademark, trade device, service mark, symbol, image, icon,
abbreviation, contraction or simulation thereof owned by the other Party in any
publication, advertising or sales promotional material, press release or in any
marketing or advertising documentation or material; or represent, either
directly or indirectly, that any product or service of the other Party is a
product or service of the representing Party or that it is made in accordance
with or utilizes the information or documents of the other Party.
Notwithstanding the foregoing, the Licensee may disclose that it has received a
license from UABRF in connection with any Licensed Product, and either Party may
use the name of the other Party to the extent such use is reasonably necessary
for complying with Applicable Law.

8.2
Publications. In furtherance of Section 2.3(c) of this Agreement, UABRF or its
Affiliates shall submit a copy of any proposed publication or disclosure
containing Proprietary Information to the Licensee at least sixty (60) days
prior to submission or disclosure. The Licensee shall have sixty (60) days from
its receipt to provide written notice to UABRF or its disclosing Affiliate as to
(i) specific edits to remove Licensee’s Proprietary Information prior to
publication or disclosure or (ii) the need to delay such publication or
disclosure for a reasonable period of time to undertake Protection Activities.
If the Licensee does not provide written notice of such request to UABRF or its
Affiliate within sixty (60) days, UABRF or its Affiliate shall be free to
publish or disclose to third parties the proposed publication or disclosure
without further obligation to the Licensee.

8.3
Insurance Coverage. Prior to commencing any clinical trial and during the Term,
the Licensee shall cause to be in effect through purchase from a reputable
insurance company or, upon the consent of UABRF, through a self-insurance
program, at its sole expense, shall maintain “occurrence based type” liability
insurance coverage or, if the Licensee is unable to obtain “occurrence based
type” liability insurance, a “claims made type” liability insurance coverage
([***]). Such insurance coverage shall include a contractual endorsement
providing coverage for all liability which may be incurred in connection with
this Agreement, including, but not limited to general liability and products
liability, and such other type of insurance coverage required by Applicable Law
or which it deems necessary to enable the Licensee to perform its obligations
under this Agreement. All such insurance coverage shall list UABRF and its
Affiliates as additional insureds. The Licensee shall provide evidence

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of such insurance coverage to UABRF within ten (10) business days of commencing
any clinical trial and at least annually thereafter. All such insurance coverage
shall require the insurance provider, or in the case of a self-insurance
program, the Licensee, to provide UABRF with at least thirty (30) days prior
written notice of any change in the terms or cancellation of coverage.
8.4
Confidentiality.

(a)
Exchange of Proprietary Information. The Parties acknowledge that during the
Term they are likely to share information with each other that they each
consider to be confidential and proprietary (“Proprietary Information”). For the
purposes of this Agreement, the Party that discloses Proprietary Information
shall be referred to as the “Disclosing Party” and the Party receiving the
Proprietary Information, the “Receiving Party.”

(b)
Nature of Proprietary Information. The Parties agree that all information that
is provided to the other Party shall be deemed to be Proprietary Information.
All information must be disclosed in writing or in another tangible medium and
must be clearly marked “Proprietary” or “Confidential”. Information disclosed
orally must be summarized and reduced to writing and identified as “Proprietary”
or “Confidential” in writing to the other Party within thirty (30) days of such
disclosure. Notwithstanding the above, the Parties specifically agree that any
reports provided by the Licensee pursuant to this Agreement shall be considered
Proprietary Information.

(c)
Restrictions. With respect to all Proprietary Information disclosed to it, the
Receiving Party (i) shall keep it confidential (other than as permitted by this
Agreement), (ii) shall store and maintain it with the same diligence and care as
its own proprietary information, but no less than reasonable diligence and care,
(iii) may only use it for the purpose for which it was disclosed by the
Disclosing Party, (iv) may not disclose it (other than as permitted by this
Agreement), (v) may not deconstruct, modify or copy it (other than as permitted
by this Agreement), and (vi) may not transfer or assign it to any Third Party
without the prior written consent of the Disclosing Party.

(d)
Access to the Proprietary Information. The Proprietary Information may be used
by, and disclosed to, on an “as-needed” basis, the Receiving Party’s
Representatives. The Licensee may disclose Proprietary Information relating to
the Licensed Patents to investors, prospective investors, consultants,
collaborators and other Third Parties in the chain of manufacturing and
distribution, if and only if, the Licensee obtains from such recipient a written
confidentiality agreement, the provisions of which are at least as protective of
UABRF’s Proprietary Information as these set forth in this section 8.4. Each
Party will promptly notify the other Party of any unauthorized use of or access
to the Proprietary Information of which it becomes aware.

(e)
Exceptions to Confidentiality Obligation. The restrictions of confidentiality
described above shall not apply to Proprietary Information (i) which as of the

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Effective Date or subsequent thereto is or becomes available to the public
without breach of this Agreement, (ii) if it is lawfully obtained from a Third
Party not bound by similar confidentiality and use restrictions and obligations,
(iii) if it is known by the Receiving Party prior to disclosure as evidenced by
contemporaneous records, or (iv) if it is at any time developed by the Receiving
Party independently of any disclosure made pursuant to this Agreement. In
addition, the confidentiality obligations shall not apply to the Receiving Party
if the Receiving Party is legally required by applicable law, court order or
Governmental Authority to disclose the Information, provided the Receiving Party
discloses only the minimum to comply and, if possible and in light of the
circumstances, provides reasonable prior notice to the Disclosing Party to
enable it to contest the requirement or to seek a protective order.
(f)
Termination or Expiration of this Agreement. Upon the expiration of the Term, or
the earlier termination of this Agreement, each Receiving Party shall, at the
Disclosing Party’s option and upon written notice thereof to the Receiving
Party, return all Proprietary Information, copies and other tangible expressions
thereof, to the Disclosing Party or provide the Disclosing Party with written
notice that the Proprietary Information in its possession, or in the possession
of its Representatives, has been destroyed within thirty (30) days after receipt
of the Disclosing Party’s written notice to the Receiving Party requiring the
Receiving Party to destroy the Proprietary Information in its possession. The
Receiving Party may retain one archival copy of the Information for purposes of
compliance of its obligations under this Agreement.

(g)
Continuing Obligations after Termination/Expiration. The restrictions and
obligations set forth in Section 8.4(c) above shall continue for seven (7) years
from the termination or expiration of this Agreement.

ARTICLE 9
TERM AND TERMINATION
9.1
Term. This Agreement shall commence on the Effective Date and shall continue,
unless terminated sooner in accordance with the terms of this Agreement, until
[***] (the “Term”).

9.2
Termination by the Licensee. The Licensee may terminate this Agreement at any
time, in its sole discretion, by giving not less than [***] prior written notice
to UABRF. Upon the reasonable request of UABRF, the Licensee shall provide
assistance, at its expense, to UABRF to enable UABRF to facilitate and effect
the transfer of applicable information and documents regarding the Licensed
Patents to a new licensee.

9.3
Termination by UABRF. UABRF shall have the right to immediately terminate this
Agreement upon the occurrence of any one or more of the following events:

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(a)
if the Licensee is in material default of any provision of this Agreement or its
obligations under this Agreement and such default has not been remedied within
sixty (60) days after receipt of a notice to cure from UABRF;

(b)
if the Licensee fails to make a payment due under this Agreement and fails to
cure such non-payment within forty-five (45) days of receipt of a non-payment
notice from;

(c)
if the Licensee fails to diligently undertake development and commercialization
activities as set forth in the Plan, provided however, Licensee shall be deemed
to have demonstrated sufficient diligence through the expenditure of time, money
or effort in planning, working, and undertaking objectives in accordance with
the Plan;

(d)
if an examination by UABRF pursuant to Section 6.2 shows an underreporting or
underpayment by the Licensee in excess of ten percent (10%) of any amounts due
to UABRF under this Agreement in any twelve (12) month period, provided however,
any disputed reporting or payment obligations by Licensee shall not be
considered a breach of this provision;

(e)
if the Licensee shall become insolvent, shall make an assignment for the benefit
of its creditors, or shall have a petition in bankruptcy filed for or against
it.

9.4
Effect of Termination or Expiration. Upon the termination of this Agreement or
the expiration of the Term, all payments then or thereafter [***] shall,
immediately and automatically, become owed directly to UABRF. Upon the natural
expiration of each Licensed Patent, Licensee shall receive [***].

ARTICLE 10
COVENANTS; REPRESENTATIONS AND WARRANTIES; LIMITATIONS ON UABRF’S OBLIGATIONS
10.1
The Licensee. The Licensee makes the following representations and warranties to
UABRF.

(a)
The Licensee is a corporation, duly incorporated, validly existing and in good
standing under the laws of the State of Delaware.

(b)
The Licensee has all necessary corporate power and authority to enter into this
Agreement and to consummate the transactions contemplated hereby.

(c)
The execution, delivery and performance of this Agreement by the Licensee will
not conflict with or result in a breach of, or entitle any party thereto to
terminate, an agreement or instrument to which the Licensee is a party, or by
which any of the Licensee’s assets or properties are bound.

(d)
This Agreement has been duly authorized, executed and delivered by the Licensee
and constitutes a legal, valid and binding agreement of the Licensee,
enforceable against the Licensee in accordance with its terms, except as such
enforceability may

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be limited by bankruptcy, insolvency, moratorium, reorganization or other
similar laws affecting creditors’ rights generally.
(e)
The Licensee possesses the necessary expertise and skill in the technical areas
pertaining to the Licensed Patents, to make Licensed Products, and to make its
own evaluation of the capabilities, safety, utility and commercial application
of the Licensed Patents.

(f)
Any activity undertaken with the Licensed Patents and the Licensed Products will
be conducted in compliance with all Applicable Laws.

10.2
UABRF. UABRF makes the following representations and warranties to the Licensee.

(a)
UABRF is a non-profit corporation, duly incorporated, validly existing and in
good standing under the laws of the State of Alabama.

(b)
UABRF has all necessary corporate power and authority to enter into this
Agreement and to consummate the transactions contemplated hereby.

(c)
The execution, delivery and performance of this Agreement by UABRF does not
conflict with or contravene its governing documentation, nor will the execution,
delivery and performance of this Agreement by UABRF conflict with or result in a
breach of, or entitle any party thereto to terminate, an agreement or instrument
to which UABRF is a party, or by which any of UABRF’s assets or properties are
bound.

(d)
This Agreement has been duly authorized, executed and delivered by UABRF and
constitutes a legal, valid and binding agreement of UABRF, enforceable against
UABRF in accordance with its terms, except as such enforceability may be limited
by bankruptcy, insolvency, moratorium, reorganization or other similar laws
affecting creditors’ rights generally.

(e)
UABRF has the right to grant the license under this Agreement.

(f)
To UABRF’s best knowledge and based upon information and representations and
warranties made to it by the Inventors, UABRF owns all right, title and interest
in the Licensed Patents and there have been no claims made against UABRF
asserting the invalidity or non-enforceability, and with respect to the Licensed
Patents, UABRF is not aware that any such claims exist.

(g)
The performance of Management Activities with respect to Disclaimed Licensed
Patent Rights will not conflict with or result in a breach of any of the terms,
conditions, or provisions of, or constitute a default under, this Agreement, and
no Third Party shall have any right of claim against the Licensee, with respect
to this Agreement or any rights remaining therein.

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10.3
Limitations on UABRF’s Representations and Warranties. Except as set forth in
this Agreement, UABRF makes no other representations or warranties of any kind.
In particular, UABRF makes no express or implied warranties regarding
merchantability, fitness for a particular purpose, non infringement of the
intellectual property rights of third parties, validity and scope of any
Licensed Patents, the capability, safety, efficacy, utility or commercial
application or usefulness for any purpose of any Licensed Patents, or that UABRF
will not grant licenses to one or more Third Parties to make, use or sell
products or perform processes that may be similar to and/or compete with any
Licensed Product.

10.4
No Obligation of UABRF. UABRF has no obligation to:

(a)
supervise, monitor, review or otherwise assume responsibility for the
production, manufacture, testing, marketing, sale or disposition of any Licensed
Product;

(b)
furnish any knowhow or other information relating to the Licensed Patents, other
than as specifically provided in this Agreement; or

(c)
bring or prosecute legal action against any Person for infringement of the
Licensed Patents.

ARTICLE 11
LIABILITY AND INDEMNIFICATION
11.1
No Liability of UABRF. Neither UABRF nor any of its Representatives have any
liability whatsoever to the Licensee or any Sublicensee or any Person for or on
account of any injury, loss or damage of any kind or nature, sustained by,
assessed or asserted against, or any other liability incurred by or imposed upon
the Licensee, or any Sublicensee or any Person, arising out of or in connection
with or resulting from:

(a)
the use of the Licensed Patents during the Term;

(b)
the production, use, practice, lease, or sale of any Licensed Product;

(c)
any advertising or other promotional activities with respect to (a) and/or (b)
above; or

(d)
the Licensee’s compliance with, and performance of the Licensee’s
representations and warranties given under, and the Licensee’s obligations
pursuant to, this Agreement.

11.2
Indemnification by the Licensee. The Licensee agrees to indemnify and hold UABRF
and its Representatives harmless from and against any and all claims, demands,
losses, costs, expenses, deficiencies, liabilities or causes of action of any
kind or nature (including, without limitation, reasonable attorneys’ fees and
other costs and expenses of defense) based upon, arising out of or otherwise
relating to:

(a)
the use of the Licensed Patents during the Term;

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(b)
the production, use, practice, lease, or sale of any Licensed Product;

(c)
any advertising or other promotional activities with respect to (a) and/or (b)
above; or

(d)
the Licensee’s compliance with, and performance of the Licensee’s
representations and warranties given under, and the Licensee’s obligations
pursuant to, this Agreement.

ARTICLE 12
MISCELLANEOUS
12.1
Entire Agreement. This Agreement is the sole and entire agreement by and between
the Parties regarding the subject matter set forth in this Agreement, and this
Agreement supersedes all prior agreements and understandings with respect
thereto. All previous negotiations, statements and preliminary instruments by
the Parties with respect to the subject matter hereof are merged in this
Agreement.

12.2
No Inducement. Each Party hereby acknowledges that in executing this Agreement,
such Party has not been induced, persuaded or motivated by any promise or
representation made by any other Party, unless expressly set forth in this
Agreement.

12.3
Independent Contractors. The relationship between the Parties is that of
independent contractors. No Party has the authority to bind or act on behalf of
the other Party without obtaining such other Party’s prior written consent. The
Parties do not intend to create an employer/employee relationship.

12.4
No Third Party Beneficiaries. This Agreement is entered into by and among the
Parties for the exclusive benefit of the Parties and their successors and
permitted assignees. This Agreement is expressly not intended for the benefit of
any creditor of a Party, or any other person. Except and only to the extent
provided by applicable statute, no such creditor or Third Party shall have any
rights under this Agreement or any other agreement between the Parties.

12.5
Assignment. Neither Party shall sell, assign, transfer or otherwise dispose of
this Agreement including by operation of law to a Third Party without the prior
written consent of the other, which consent shall not be unreasonably withheld
except that Licensee shall be permitted to assign this Agreement in the case of:
(i) an assignment to a wholly owned Affiliate of Licensee, (ii) the sale of
substantially all of the stock or assets of Licensee, or (iii) any merger or
acquisition or business combination resulting in a change of control of
Licensee, provided that any assignee (a) shall have the wherewithal to perform
this Agreement and (b) shall ratify this Agreement and abide by all of its terms
and conditions provisions. Any attempted assignment of this Agreement not in
compliance with the terms of this subsection will be null and void. No
assignment will relieve any Party of the performance of any accrued obligation
that such Party may then have pursuant to this Agreement.

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12.6
Amendments. Any and all modifications to this Agreement shall only be effective
and binding if in writing and signed by a duly authorized representative of each
Party.

12.7
Notices. Any notice, request, approval or consent required to be given under
this Agreement will be sufficiently given if in writing and delivered to a Party
in person, by recognized overnight courier or mailed in the United States Postal
Service, postage prepaid to the address appearing below such Party’s signature
on the last page of this Agreement, or at such other address as each Party so
designates in accordance with these criteria. Notice shall be deemed effective
upon receipt if delivered in person or by overnight courier or five (5) business
days after mailing with the United States Postal Service.

12.8
Disputes.

(a)
Equitable Relief. Either Party may seek equitable and injunctive relief in a
court of competent jurisdiction in the event of a breach or threatened breach by
the other Party of its obligations under this Agreement, without the requirement
to post a bond.

(b)
Internal Resolution. In the event of any dispute arising out of or relating to
this Agreement or to a breach thereof, including its interpretation, performance
or termination, the Parties shall try to settle such conflicts amicably between
themselves. In the event that the conflict is not resolved within sixty (60)
days after one Party notifies the other Party in writing concerning a dispute or
conflict, then the dispute or conflict shall be referred to executive officers
of each Party involved for resolving by negotiation in good faith as soon as
practicable but no later than sixty (60) days after its referral.

(c)
Mediation. In the event the Parties are still unable to resolve the dispute or
conflict by negotiation, the dispute or conflict may then be submitted by a
Party to a mediator, mutually agreed to by the Parties, for nonbinding
mediation. The Parties shall cooperate with the mediator in an effort to resolve
such dispute.

(d)
Arbitration. If the dispute is not resolved within sixty (60) days of its
submission to the mediator, either Party may submit the dispute for binding
arbitration. The arbitration shall be conducted by three (3) arbitrators, one to
be appointed by UABRF, one to be appointed by the Licensee and the third to be
appointed by the other two arbitrators. The arbitration shall be conducted in
accordance with the commercial rules of the American Arbitration Association,
which shall administer the arbitration. The arbitration, including the rendering
of the award, shall take place in [***] and shall be the exclusive forum for
resolving such dispute. The decision of the arbitrators shall be final and
binding upon the Parties and the expense of the arbitration, including, without
limitation, the award of attorneys’ fees to the prevailing Party, shall be paid
as the arbitrators determine.

12.9
Rights and Remedies. The rights and remedies provided by this Agreement are
cumulative, and the use of any one right or remedy by any Party shall not
preclude or waive the right to

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use any or all other remedies. Such rights and remedies are given in addition to
any other rights the Parties may have by law, statute, ordinance or otherwise.
12.10
Waiver. No waiver of a provision, breach or default shall apply to any other
provision or subsequent breach or default or be deemed continuous, nor will any
single or partial exercise of a right or power preclude any other further
exercise of any rights or remedies provided by law or equity.

12.11
Severability. In the event that any covenant, condition, or other provision
contained in this Agreement is determined to be invalid, void or illegal, such
covenant, condition or other provision shall be deemed deleted from the
Agreement and shall not affect the validity of the remaining provisions of this
Agreement.

12.12
Force Majeure. Neither Party shall be liable for any failure to perform as
required by this Agreement to the extent such failure to perform is due to
circumstances reasonably beyond such Party’s control, including, without
limitation, labor disturbances or labor disputes of any kind; accidents; acts,
omissions or delays in acting by any Governmental Authority; civil disorders;
insurrections; riots; war; acts of war (whether war be declared or not);
terrorism; acts of aggression; acts of God; fire; floods; earthquakes; natural
disasters; energy or other conservation measures imposed by law or regulation;
explosions; failure of utilities; mechanical breakdowns; material shortages;
disease or other such occurrences; provided that the affected Party uses
reasonable efforts to overcome or avoid the effects of such cause and continues
to perform its obligations to the extent possible.

12.13
Survivability. All rights and obligations of the Parties which by intent or
meaning have validity beyond or by their nature apply or are to be performed or
exercised after the termination or expiration of this Agreement shall survive
the termination or expiration of this Agreement for the period so specified, if
any, or for perpetuity.

12.14
Governing Law. This Agreement, and the application or interpretation hereof,
shall be governed exclusively by its terms and by [***].

12.15
Interpretation. Whenever used in this Agreement and when required by the
context, the singular number shall include the plural and the plural the
singular. Pronouns of one gender shall include all genders, masculine, feminine
and neuter.

12.16
Captions. The captions as to contents of particular sections or paragraphs
contained in this Agreement are inserted for convenience and are in no way to be
construed as part of this Agreement or as a limitation on the scope of the
particular sections or paragraphs to which they refer.

12.17
Counterparts. This Agreement may be executed in counterparts, each of which
shall be deemed an original but all of which shall constitute one and the same
instrument.

[The remainder of this page intentionally left blank]

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IN WITNESS WHEREOF, the Licensee and UABRF have each caused its duly authorized
representative to execute this Agreement, effective as of the Effective Date.
UABRF:
The UAB Research Foundation

By: /s/ David Winwood                                    
Name: David Winwood, Ph.D.
Title: CEO, UABRF

LICENSEE:
Brickell Biotech, Inc.

By: /s/ Andy Sklawer                                       
Name: Andy Sklawer
Title: Vice President, Operations, BBI.

Address For Notices:
Address For Notices:
Via Courier:
[***]
[***]

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EXHIBIT A
LICENSED PATENTS
[***]

23

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EXHIBIT B
DEVELOPMENT AND COMMERCIALIZATION PLAN
DEVELOPMENT AND COMMERCIALIZATION PLAN
[***]
Below is a summary of the planned development activities for [***]:
I.    Manufacturing of API:
Multiple manufacturing campaigns will be required during the development
program. [***]. The manufacturing of the initial batches to support pharmacology
activities will be initiated as soon as feasible upon the execution of the
license agreement. This activity includes the assessment and transfer of
analytical methods.
II.    API stability studies:
The stability program of the drug substance will be initiated upon manufacturing
of the first batch and will continue with representative samples from subsequent
manufacturing campaigns. The stability of GMP batches will conform to ICH
guidelines.
III.    Drug product Development and manufacturing:
Upon availability of drug substance, drug product development activities will be
initiated.
A suitable formulation for topical use will be developed along with all
analytical methods needed for characterization. Manufacturing campaigns to
support preclinical and clinical trials will be scheduled as needed and will
include manufacturing of product suitable to support GLP and GMP activities.
IV.    Drug product stability studies:
The stability program of the drug product will be initiated upon manufacturing
of the first batch and will continue with representative samples from subsequent
manufacturing campaigns. The stability of GMP batches will conform to ICH
guidelines.
V.    Pharmacology assessments:
To better define the pharmacological activities of [***], a series of studies
will be conducted. Information gained from initial studies may indicate the need
for subsequent assessments. At this point, the following [***] are planned:
[***]

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VI.    Toxicology assessments to enable up to 28 days of dosing:
Topical toxicology studies will be required to enable opening an IND for topical
use. The following studies are being considered:
[***]
VII. Clinical evaluation Phase 1/2a:
The clinical evaluation will start with an assessment of the tolerability and
bioavailability of [***] in healthy volunteers under maximum use conditions.
Assuming no relevant findings from topical toxicology studies and minimum
bioavailability after topical application, subsequent studies will be planned in
the intended to treat population:
[***]
Information from these clinical trials will be informative of the potential of
BBI-3000 to provide a clinically meaningful effect on the indication tested.
VIII.    Toxicology assessments to enable 12 weeks of dosing:
The indications intended require longer [***] for demonstration of maximum
efficacy. To enable [***] in clinical trials, the following toxicology studies
are being considered:
[***]
IX.    Clinical Evaluation Phase 2b studies:
To determine safety, tolerability, dose ranging and magnitude of treatment
effect that will be needed to demonstrate the [***] will be conducted. The final
design of these studies will be informed by the [***]. Phase 2b studies will be
[***].
X.    Comprehensive [***] and reproductive/development toxicology studies:
Considering the intended indication a more comprehensive toxicology assessment
of [***] as well as reproductive and development toxicity will be needed. The
design of these studies will be informed from previous toxicology studies.
XI.    Clinical Evaluation Phase 3 studies:
[***]. Final design of the studies will be informed from the Phase 2b study
results. Typically, [***]
XII.    Dermal safety studies:

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[***] are to be conducted with the to be marketed formulation. These studies are
typically conducted along with the Phase 3 clinical studies, however, depending
on findings from preliminary phases of development some of these studies, may
need to be conducted sooner.
XIII.    [***]:
For indications that will require recurrent treatment periods within a year,
[***]. This study typically includes [***] to ensure sufficient study population
at 1-year time point. Contingent upon the safety findings during the development
program, the data from this study may be provided after NDA submission.
XIV.    Carcinogenicity assessment:
Current data appears to indicate low risk for carcinogenicity. However, [***]
may be required, upon discussion with regulatory agencies.
XV.    NDA submission
[***]

[***]

26

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

EXHIBIT C
FORM OF [***]
Licensee:   
Inventor:   
Period Covered: From    / / 20
Prepared By:   
Approved By:   
Agreement No.:   
P# :   P   
Through:   / / 20
Date:    
Date:    

If license covers several major product lines, please prepare a separate report
for each line. Then combine all product lines into a summary report.
Report Type:     Single Product Line Report:    
Multiproduct Summary Report. Page l of _____ Pages
Product Line Detail. Line:________ Trade name:________ Page:_________
Report Currency: U. S. Dollars    Other    

Country
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
 
 
 
 
 
 
[***]
 
 
 
 
 
 
[***]
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[***]
 
 
 
 
 
 
Other:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TOTAL:
 
 
 
 
 
 

[***]

27

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

Exhibit 10.5

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 the [***] License Agreement (this “Amendment”) is made
as of October 29, 2015 (the “Amendment Effective Date”), by and between The UAB
Research Foundation, an Alabama not-for-profit corporation (“UABRF”) and
Brickell Biotech Inc., a Delaware corporation (“Licensee”), and amends the [***]
License Agreement between the parties, effective as of June 26, 2012 (the
“Agreement”).
The parties agree as follows:
1.
Effective as of June 26, 2012, Section 1.18 ([***]) is hereby amended and
replaced in its entirety with the following:

“[***]” means anything [***].
2.
All other provisions of the Agreement shall remain unchanged and effective. All
capitalized terms used but not defined in this Amendment will have the meaning
given to such terms in the Agreement. This Amendment may be executed in
identical counterparts, each of which will be deemed an original and all of
which together will constitute one instrument.

IN WITNESS WHEREOF, duly authorized representatives of each of the parties have
executed this Amendment as of the Amendment Effective Date.
UAB RESEARCH FOUNDATION

By: /s/ Kathy Nugent                                        
Name: Kathy Nugent, PhD                               
Title: Executive Director                                  
Date: 10/28/15                                                  

BRICKELL BIOTECH TNC.

By: /s/ Andy Sklawer                                       
Name: Andy Sklawer                                       
Title: COO                                                       
Date: 11/2/15                                                   

1