Document:

Exhibit

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 

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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.

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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.
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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.

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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 

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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.

	
		
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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”):

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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 

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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.

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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.

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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, 

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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 

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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 

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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-

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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

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

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

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

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

17

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

18

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

		
	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

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

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

	
		
	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

	[***]
	[***]

		
	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

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

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

4Exhibit

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

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
	 

[***] 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

		
	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

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

		
	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

		
	(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

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

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

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

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 

9

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 

10

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 

11

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, 

12

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 

13

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 

14

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:

15

		
	(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 

16

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.

17

		
	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;

18

		
	(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.

19

		
	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 

20

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]

21

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:
[***]
	[***]

22

EXHIBIT A 
LICENSED PATENTS
[***]

23

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:
[***]

24

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:

25

[***] 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

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