EXCLUSIVE LICENSE AGREEMENT

Exhibit 10.36

PORTIONS OF THIS EXHIBIT MARKED “[* * *]” HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, AND THE OMITTED PORTIONS HAVE BEEN FILED SEPARATELY IN PAPER FORM WITH THE SECURITIES AND EXCHANGE COMMISSION.

EXCLUSIVE LICENSE AGREEMENT

     This EXCLUSIVE LICENSE AGREEMENT (hereinafter called this “ Agreement ” is made and effective as of the 15 ^th day of June, 2006 by and between:

Laboratorios Sophia, S.A. de C.V. a legal entity duly organized and existing under the laws of Mexico, having its principal office of business at Av. Hidalgo 737, Colonia Centro, Guadalajara, Jalisco, C.P.44 100, Mexico (“ SOPHIA ”);

And

SIRION Therapeutics, Inc., a legal entity duly organized and existing under the laws of the State of Florida, U.S.A., having its principal office of business at 3110 Cherry Palm Drive, Suite 340, Tampa, Florida 33619, U.S.A. (hereinafter called “ SIRION ”);

WITNESSETH:

     WHEREAS, SOPHIA is the owner of patent rights in certain areas of the world, including the United States, to topical ophthalmic formulations containing “Cyclosporin A” (hereinafter defined in detail); and

     WHEREAS, SOPHIA has exclusive licensing rights, throughout the world, including the United States, for said ophthalmic formulations containing Cyclosporin A; and

     WHEREAS, SOPHIA desires to grant SIRION an exclusive license (the “ License ”) to develop, use, obtain governmental approval for, manufacture, sell, distribute, and promote an ophthalmic solution containing Cyclosporin A in the Territory (hereinafter defined), according to the, terms and conditions set forth herein, and SIRION wishes to receive such license and the obligations therein; and

     WHEREAS, SOPHIA and SIRION understand and acknowledge that the exercise of this Agreement by either Party may result in the creation of new inventions or discoveries.

     NOW THEREFORE, in consideration of the foregoing, the mutual covenants contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, SOPHIA and SIRION (SOPHIA and SIRION collectively called “ Parties ” and/or individually called “ Party ”, and all other entities not hereto named will be referred to as “ Third Parties ” hereby agree as follows:

Article 1
Definitions

     1.01 The following terms used in this Agreement shall have the meanings set forth in this Article 1, unless the context clearly requires otherwise, and the singular shall include the plural and vice versa. All other terms shall be afforded their generally accepted legal definitions.

     “ Compound ” shall mean a certain chemical substance having the chemical structure of Cyclo[[(E)-(2S,3R,4R)-3- hydroxy-4-methy-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl]. This Compound is also referred to as “Cyclosporin A.”

     “ Product ” shall mean a the topical ophthalmic solution containing the Compound as an active ingredient at [* * *], for the treatment of ophthalmic diseases and a ophthalmic carrier solution referenced in US Patent # 6,071,958 known as “Sophisen”. The Product is already commercialized in Mexico under the trademark of “Modusik-A”.

     “ Effective Date ” shall mean the date first above written on which this Agreement was signed by the Parties and shall become effective.

     “ First Commercialization ” shall mean the date of the first commercial offer for sale by SIRION of the Product in commercial quantities to a Third Party in the Territory according to the terms of this Agreement.

     “ Governmental Approval ” shall mean any kind of approvals by the United States Food and Drug Administration (“U.S. FDA”) or equivalent future governmental authority in the Territory, necessary to commercialize the Product in the Territory, including, without limitation, any approvals necessary for the development, manufacture, distribution, and sale of the Product in the Territory.

     “ Territory ” shall mean the United States of America as well as Puerto Rico, Guam, the U.S. Virgin Islands, and any other U.S. territories and possessions.

     “ Cumulative Net Sales ” shall mean the total Net Sales made according to this Agreement that start to accumulate from the First Commercialization and may be calculated at any given time during the term of this Agreement.

     “ Net Sales ” shall mean the gross invoiced amount charged by SIRION to sell the Product to Third Parties in the Territory, less (a) all normal and customary deductions of any type or nature (such as, e.g., returns, credits, refunds, discounts, allowances, rebates, chargebacks and adjustments); and (b) freight, shipping, insurance costs, customs, duties, taxes and other governmental charges and surcharges imposed upon the sale or distribution of the Product. However, the deductions under this definition may not exceed [* * *] of the gross’ invoiced amount. For the purpose of clarification, the gross invoiced amount and deductions thereof apply to aggregate, rather than individual, sales of the Product, and do not apply to sales of anything other than the Product, even if sold simultaneously with the Product.

     “ Patent Rights ” shall mean granted under U.S. Patents No.6,071,958 issued June 6, 2000 for “Sophisen” as well as any and all reissues, re-examinations, and patent term extensions thereof.

     “ Quarterly Period ” shall mean each calendar quarter commencing January 1 ^st , April 1 ^st . July 1 ^st and October 1 ^st and running through, respectively, the following March 31 ^st , June 30 ^th , September 30 ^th , and December 31 ^st .

     “ Technical Information & Know-How ” shall mean any and all scientific and clinical data and knowledge which relate to the Product or the Compound, which are necessary or useful for the practice of the Patent Rights and the grant of this Agreement, including without limitation, the development of the Product, obtaining Government Approval, and the manufacture and sale of the Product in the Territory.

     “ Development Activity ” shall mean any and all tests, studies and other activities for SIRION to research and develop the Product, including but not limited to activities to obtain and maintain the Governmental Approval in the Territory.

     “ Financial Year ” shall mean the annual twelve-month period that begins on January 1 ^st in a given year and runs through December 31 ^st of that year.

     “ FDA ” shall mean the United States Food and Drug Administration.

Article 2
Grant License

     2.01 SOPHIA hereby grants by way of a license to SIRION, and SIRION hereby accepts, a sole and exclusive, running royalty-bearing license under the Patent Rights and using the Technical Information & Know-How to make or have the Product made, develop, manufacture, use, market, offer to sell, and sell the Product, in the Territory. This license shall not include the right for SIRION to sell the Product from the Territory to any party outside of the Territory. The license granted to SIRION herein shall not include the right to grant further licenses or sub-licenses to any third party without the prior written consent of SOPHIA, such con not to be unreasonably withheld. Nothing in this Agreement shall’ affect, and SOPHIA

shall retain the right to grant, other sub-licenses to the Product outside of the Territory.

     2.02 SOPHIA hereby represents that it has the full right and authority to enter into this Agreement, to grant the licenses provided herein and to perform its obligations hereunder. SOPHIA further represents and warrants that neither it, nor any of its affiliates or subsidiaries, shall assert the rights granted to SIRION under this Article 2 in the Territory for the term of this Agreement. SOPHIA’ additionally represents and warrants that as of the Effective Date it has not licensed the right’ to import the Product into the Territory from outside the Territory to a Third Party, nor will it do so itself or by way of a license to a Third Party for the term of this Agreement.

     2.03 SIRION represents and warrants that SIRION will comply, with all applicable governmental laws and regulations relating to the development, marketing, sale, distribution, and promotion to sell of the Product in the Territory.

     2.04 Notwithstanding Section 2.01 above, SIRION shall have a right to contract for manufacture of the Product in whole or in part with any Third Party in the Territory and subject to obtaining prior written approval of SOPHIA, such approval not to be unreasonably withheld, until such time as SOPHIA can make or have the Product made in an FDA-approved manufacturing facility suitable for production of the Product.

     2.05 Further to Section 2.04 above, if SOPHIA at any point in the future does manufacture the Product for SIRION pursuant to this Section 2.04, it shall do so on a “most-favored customer” status as to price and all other material terms, i.e. SOPHIA shall manufacture the Product for SIRION at least at the lowest price and, most favorable terms it offers to any other of its customers. If the price offered to SIRION is higher than the current price paid to the FDA approved manufacturer in use at the time of the FDA approval of the SOPHIA manufacturing facility, SIRION will have the right to continue to purchase the product from said manufacturer.

Article 3
Term of Agreement

     3.01 This Agreement and the license granted therein shall become effective as of the Effective Date and shall continue in effect until the later of (i) ten (10) years from the First Commercialization, or (ii) the expiration or invalidation of all of the Patent Rights. At the expiration of the term of this Agreement as stated in this article, but not its termination according to Article 17, SIRION shall have a fully paid-up, perpetual right to the Technical Information & Know-How.

Article 4
Technical Information and Know-How

     4.01 Within a reasonable period after the Effective hate, SOPHIA shall provide SIRION with

documentation of all Technical Information and Know-How, known to and reasonably available to SOPHIA at the Effective Date, already translated into the English language. SIRION will be required to conduct any translations of the Technical Information and Know-How of this section into a language other than English at its own expense and risk. Specific items to be transferred include, but are not limited to, manufacturing processes, non-clinical study data, and clinical study data.

     4.02 SOPHIA represents and warrants that the Technical Information and Know-How provided to SIRION according to this article shall be reasonably sufficient for SIRION to effectively exercise the rights granted to it by this Agreement.

     4.03 SIRION shall not use any Technical Information and Know-How provided under this Agreement for any purpose other than the development, manufacture and commercialization of the Product during the term of this Agreement or anytime thereafter.

     4.04 SIRION agrees and acknowledges that clinical data and information of the Technical Information and Know-How may not comply with applicable regulatory requirements, codes and regulations including Good Laboratory Practice and Good Clinical Practice, and that any failure to apply and utilize for the Development Activities for obtaining Governmental Approval shall not be deemed a breach by SOPHIA of this Agreement. Accordingly, if SIRION were to be requested or required to conduct an additional clinical study, re-clinical study, or re-non-clinical study for the clinical data, non-clinical data, and information involved in Technical Information and Know-How, SIRION shall conduct them at its sole cost and risk.

Article 5
P roduct Development and Governmental Approval

     5.01 SIRION represents and promises that it will make a commercially diligent and reasonable effort to, at its own expense and risk, develop, market, and promote the sale of the Product in the Territory, including, but not limited to, performing all activities and preparation, filing, and support of the application documents necessary to obtain Governmental Approvals in the Territory. Specifically, SIRION shall be responsible for any and all clinical trials required to obtain Governmental Approval, including those done on humans, at its sole cost and risk.

     5.02 SOPHIA shall provide SIRION with access to any and all documents in its possession that might be required by SIRION to obtain Governmental Approval and not otherwise provided by this Agreement, upon SIRION’s request, and in the English language if possible. hi the event that SIRION requires the presence of personnel of SOPHIA in the Territory or at any location outside Guadalajara, Mexico, S1RION shall provide SOPHIA, with reasonable anticipation, a proposed agenda for the travel. In this case all travel, accommodation and food expenses of SOPHIA’s personnel shall be borne by SIRION.

     5.03 Occasionally, but at least [* * *], SIRION shall provide SOPHIA with the written report concerning the progress of all Development Activities and of obtaining Governmental Approval. Further, SIRION shall

promptly notify SOPHIA upon obtaining any Governmental Approval in the Territory.

     5.04 Within [* * *] days after the Effective Date, SIRION shall provide SOPHIA with a development plan and schedule of the Product in the Territory (the “ Development Plan and Schedule ”) for SOPHIA’s review and comment. SOPHIA shall provide SIRION with SOPHIA’s comments and advice, and SIRION shall take SOPHIA’s comments and advice into consideration for the Development Plan and Schedule. In the event that SIRION renews or updates the Development Plan and Schedule, above procedure shall again be applied.

     5.05 Notwithstanding anything else to the contrary stated herein, in the event that the schedule of the Development Plan and Schedule is delayed due to SIRION’s complete omission and gross negligence, SOPHIA shall have a right to notify SIRION :thereof and if SIRION fails to remedy the situation in all material respects within [* * *] days after receiving SOPHIA’s notice then SOPHIA shall have the option, upon notice to SIRION, to terminate this Agreement.

     5.06 Upon the request of SOPHIA, SIRION shall provide SOPHIA with any data, information and result (the “ Results ”) generated from the Development Activities. SIRION agrees and acknowledges that SOPHIA and its affiliates, subsidiaries, or sub-licensees shall have the right to use the Results for the sole purposes of development, manufacture, obtaining the governmental approval and sale of the Product outside of the Territory without any compensation to SIRION. SIRION shall provide SOPHIA with the reliability assurance certificates that the Results would be generated by SIRION in compliance with applicable GLP (Good Laboratory Practice), GCP (Good Clinical Practice).

     5.07 Upon the request of SOPHIA, SIRION shall provide SOPHIA with any and all copies of the New Drug Application Dossier (“ NDA ”) submitted to the FDA for obtaining the Governmental Approval and copy of certificate of Governmental Approval. SIRION agrees and acknowledges that SOPHIA and its affiliates, subsidiaries, or sub-licensees shall have the right to use, free of charge, such copies of the NDA and copy of certificate of Governmental Approval for the sole purposes of development, manufacture, obtaining the Governmental Approval and sale of the Product outside of the Territory without any compensation to SIRION.

     5.08 If SIRION, in its reasonable but sole business judgment, no longer wishes to develop, obtain Governmental Approval for, or commercialize the Product according to this Agreement, it shall notify SOPHIA of this fact and the Parties shall discuss a resolution thereof. In such a case, with the express written permission of SOPHIA, such permission not to be unreasonably withheld, the terms of this Agreement may be altered or the entire Agreement terminated according to the terms of Section 17.04. In the event of a termination of the Agreement under this section, SIRION shall have [* * *] to pay SOPHIA any outstanding debts remaining under this Agreement.

     5.09 In the event that SIRION have not obtain the Governmental Approval as of the [***], then SOPHIA shall have the option, upon notice to SIRION, to terminate this Agreement.

Article 6
Marketing

     6.01 Within [* * *] of obtaining Governmental Approval, SIRION shall launch, promote, and sell the Product in the Territory.

     6.02 SIRION shall, in advance of any sales or distribution, furnish SOPHIA with a copy of the package inserts included with the Product, and thereafter, any revised version thereof. In all cases the inserts shall include the notice that the Product is sold under License of SOPHIA.

     6.03 SIRION shall prepare, at its own costs and expenses, appropriate marketing, advertising and promotional material for the Product.

     6.04 At least [* * *] months before the occurrence of First Commercialization, SIRION shall submit to SOPHIA a sales forecast of the Product covering the [* * *] Financial Years after the Financial Year of the First Commercialization, addressing each subsequent Financial Year separately, including a forecast of a sales peak of the Product and its timing, for SOPHIA’s review.

Article 7
Governance

     7.01 In an effort to facilitate this Agreement, the Parties together shall form a development and commercialization committee (hereinafter referred to as the ‘Joint Committee’ or “JC”) comprised of members from each Party, the purpose of which is to oversee and achieve the individual Party requirements, including those of Articles 4, 5, and 6, as well as the ultimate success of the Agreement. With respect to the clinical and regulatory development of the Product, the JC shall be advisory in nature, but shall not interfere with the judgment of SIRION as to the best course of action to achieve a regulatory approval and maximize commercial potential.

     7.02 Within ninety (90) days of the Effective Date, the Parties shall form the JC comprised of at least one (1) and up to three (3) members from each Party, provided that the number from each Party be equal at all times. The JC committee members shall work in mutual cooperation to achie