Document:

Unassociated Document

    

      Exhibit
        10.8

      

      Portions
        herein identified by [***] have been omitted pursuant to a request for
        confidential treatment under Rule 24b-2 of the Securities Exchange Act of
        1934.
        A complete copy of this document has been filed separately with the Securities
        and Exchange Commission. 

      

      

      LICENSE
        AGREEMENT

      (as
        amended)

      

      This
        Agreement (hereinafter referred to as this "Agreement"), effective as of
        this
        April 19, 2005, is entered into by and between the UNIVERSITY OF SOUTH FLORIDA
        RESEARCH FOUNDATION, INC., a corporation not for profit under Chapter 617
        Florida Statutes, and a direct support organization of the University of
        South
        Florida (“University”) pursuant to section 1004.28 Florida Statutes, having its
        principal office at 4202 East Fowler Avenue, Tampa, Florida 33620, U.S.A.
        (hereinafter referred to as “Licensor”), and GREENWICH THERAPEUTICS, INC. a
        corporation duly organized and existing under the laws of the State of Delaware
        with head quarters at 787 Seventh Avenue, 48th
        Floor,
        New York, NY 10019 (the "Company").

      

      WHEREAS,
        Licensor is the exclusive licensee under certain “Patent Rights” (as later
        defined herein) relating to Triciribine
        a/k/a Triciribine Monphosphate a/k/a Tricyclic Nucleoside a/k/a API-2 for
        inhibition of AKT
        with
        antitumor activity in cancer cells overexpressing AKT
        (the
“Technology”)
        and has
        the right to grant sublicenses under said Patent Rights; 

      

      WHEREAS,
        Licensor desires to have the Patent Rights utilized in the public interest
        and
        is willing to grant a license thereunder; and

      

      WHEREAS,
        Company intends to develop, produce, manufacture, market and/or sell products
        similar to the “Licensed Product(s)” (as later defined herein) and is willing to
        commit itself to a diligent program of exploiting the Patent Rights so that
        public utilization shall result therefrom; and

      

      WHEREAS,
        Company desires to obtain a license under the Patent Rights upon the terms
        and
        conditions hereinafter set forth.

      

      NOW,
        THEREFORE, in consideration of the premises and the mutual covenants contained
        herein, the parties hereto agree as follows:

      

      ARTICLE
        1 - DEFINITIONS

      

      For
        the
        purposes of this Agreement, the following words and phrases shall have the
        following meanings:

      

      1.1 "Affiliate"
        shall mean, with respect to any Entity (as hereinafter defined), any Entity
        that
        directly or indirectly controls, is controlled by, or is under common control
        with such Entity. 

      

      1.1.1 “Control”
        shall mean, for this purpose, direct or indirect control of more than fifty
        percent (50%) of the voting securities of an Entity or, if such Entity does
        not
        have outstanding voting securities, more than 50% of the directorships or
        similar positions with respect to such Entity. 

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      1.1.2 “Entity”
        shall mean any corporation, association, joint venture, partnership, trust,
        business, individual, or any other organization that can exercise independent
        legal standing.

       

      
        	 	
                1.2

              	
                "Company"
                  shall mean Greenwich Therapeutics, Inc.,
                  a
                  Delaware corporation.

              

      

      

      
        	 	
                1.3

              	
                “Field
                  of Use” shall mean all uses.

              

      

      

      1.4 "Improvements"
        shall mean any modification of a Licensed Process or Licensed
        Product or any inventions (whether patentable or not), information and data,
        in
        the Field of Use that, created or derived during the term of this Agreement,
        the
        manufacture use or sale of which would be commercially important or necessary
        in
        the practice of, or would infringe an issued or pending claim within the
        Patent
        Rights.

      

      1.5 "Know-how"
        shall mean all tangible information
        (other than those contained in the Patent Rights), existing prior to the
        Effective Date of this Agreement, whether patentable or not (but which have
        not
        been patented) and physical objects related to the Licensed Product, including
        but not limited to formulations, biological samples, tissues, animals,
        organisms, compounds, intermediates, laboratory notebooks, in vitro, preclinical
        or clinical design, information or results, other proprietary materials,
        processes, including but not limited to manufacturing processes, data, drawings
        and sketches, designs, testing and test results, regulatory information of
        a
        like nature, owned by any of Licensor, which Licensor has the right to disclose
        and license to the Company. 

      

      1.6 “Licensed
        Product(s)" shall mean:

      

      1.6.1 Any
        product which is covered in whole or in part by Patent Rights in the country
        in
        which the product is made, used, leased or sold;

      

      1.6.2 Any
        product which is manufactured using a process which is covered in whole or
        in
        part by Patent Rights in the country in which the process is used;

      

      1.6.3 Any
        product which is used according to a method or use which is covered in whole
        or
        in part by Patent Rights in the country in which the method is
        used.

      

      1.7 "Licensed
        Process(es)" shall mean any process, use or method, which is covered, in
        whole,
        or in part, by Patent Rights in the country in which the process or method
        is
        used.

      

      1.8 "Net
        Sales" shall mean the total gross receipts for sales of Licensed Products
        or
        practice of Licensed Processes by or on behalf of the Company, any of its
        Affiliates or sublicensees whether invoiced or not, less only the sum of
        the
        following:

      

      1.8.1
        Usual
        trade discounts allowed and provided to customers;

      

      1.8.2
        Sales,
        tariff duties and/or taxes directly imposed and with reference to particular
        sales;

       

      1.8.3
        Amounts
        allowed or credited on returns or rejections;

       

      1.8.4
        Bad debt
        deductions actually written off during the accounting period; and

      

      
        
          
          

        

        
          2

          
            

          

        

        
          
          

        

      

      1.8.5
        Outbound
        transportation prepaid or allowed and transportation insurance;

      

      1.8.6
        No
        deductions shall be made for commissions paid to individuals whether they
        be
        with independent sales agencies or regularly employed by Licensee and on
        its
        payroll, or for cost of collections. Notwithstanding anything to the contrary
        in
        this Article 1.8, Net Sales does not include sales of Licensed Products at
        or
        below the fully burdened cost of manufacturing solely for non-profit research
        or
        clinical testing or for indigent or similar public support or compassionate
        use
        programs. Net sales are calculated based on the final sale of the Licensed
        Product to an independent third party end user. If (i) the end user is a
        Sublicensee or Affiliate or (ii) if Licensed Product or Licensed Process
        is sold
        for consideration other than money, then Net Sales shall be calculated based
        on
        the final gross selling price of comparable Licensed Products sold in arm’s
        length transactions by Licensee to an end user.

      

      1.9 "Patent
        Rights" shall mean all U.S. and foreign patents and patent applications set
        forth in Exhibit A and:

      

      1.9.1 Any
        other
        United States or foreign patent applications or patents that claim priority
        to
        any of the patents or applications listed in Exhibit A, together with any
        and
        all patents issuing thereon, including continuations, divisionals,
        reexaminations, extensions, and reissue applications and any United States
        or
        foreign patents granted upon such applications, all of which shall be deemed
        added to Exhibit A;

      

      1.9.2 Any
        other
        intellectual property rights owned or controlled by the Licensor relating
        to the
        Technology that the Licensor has the right to license to the Company existing
        prior to the Effective Date of this Agreement.

      

      
        	 	
                1.10

              	
                “Territory”
                  shall mean the world.

              

      

      

      ARTICLE
        2 - GRANT

      

      2.1 Licensor
        hereby grants to the Company and the Company accepts, subject to the terms
        and
        conditions of this Agreement, an exclusive license in the Field of Use to
        practice under the Patent Rights and to utilize the Know-how in the Territory,
        and (a) to make, have made, use, lease and/or sell the Licensed Products
        and to
        practice and have practiced the Licensed Processes, to the full end of the
        term
        for which the Patent Rights are granted, unless sooner terminated as hereinafter
        provided and (b) to sublicense to third parties, in accordance with Section
        2.2
        below, the rights granted under subsection (a) of this Paragraph
        2.1.

      

      2.2 In
        accordance with 2.1 above, Licensor hereby grants to the Company the right
        to
        grant sublicenses to third parties under the license granted hereunder in
        its
        sole discretion, provided, however, that the Company provides Licensor with
        notice of its intent to enter into each such sublicense and the Company
        reasonably considers Licensor’s objections to such sublicense, if any, before
        the Company grants any such sublicense. Company agrees that any sublicenses
        granted by it shall contain such provisions as are necessary for the Company
        to
        meet its obligations under this Agreement. The Company will remain obligated
        to
        Licensor under the terms of this Agreement, unless this Agreement terminates
        in
        accordance with its terms, without regard to whether the Company has entered
        into a sublicense with a third party. 

      

      
        
          
          

        

        
          3

          
            

          

        

        
          
          

        

      

      2.2.1 Within
        thirty (30) days after execution or receipt thereof, as applicable, the Company
        shall provide Licensor with a copy of each sublicense issued
        hereunder.

      

      2.2.2 Upon
        termination of this Agreement other than by expiration in accordance with
        paragraph 7.6, any and all sublicenses shall survive such termination, provided,
        however, such sublicensee is not in default of such sublicense 90 days after
        receiving notification from Licensor that (i) Licensor has terminated this
        Agreement and (ii) Licensor believes that such sublicensee is in default
        of the
        sublicense agreement. Moreover, Licensor shall not be required to take on
        any
        additional obligations or restrictions in its agreement with sublicensee
        not
        already imposed on Licensor by this Agreement. Notwithstanding the foregoing,
        if
        Company believes that Licensor has terminated this Agreement for the primary
        purpose of doing business directly with the sublicensee, the termination
        may be
        disputed under the provisions of Article 8. 

      

      2.3 Licensor
        reserves to the University, Moffitt Research & Cancer Center, and the
        inventors the right to practice under the Patent Rights for noncommercial
        research and education purposes, including research for any sponsors (provided
        such research is for noncommercial purposes and funded by a not-for-profit
        sponsor). Licensor, the University, Moffitt Research & Cancer Center, and
        the inventors shall not have the right to conduct human clinical trials with
        any
        Licensed Product or Licensed Process except if (i) other non-licensees would
        have the right to conduct such clinical trials without the consent of the
        Company or (ii) Licensor is granted the right to conduct human clinical trials
        with a Licensed Product or Licensed Process by written agreement with the
        Company.

      

      2.4 Company
        shall initially have a right of first refusal to obtain the exclusive rights
        to
        Licensor (a) continuations in part relating to the patents or patent
        applications included in the Patent Rights and (b) United States and foreign
        patent applications based on research funded by Company that would be
        commercially important or necessary to practice the Patent Rights, including
        any
        continuations, continuations-in-part, divisionals, reissues, reexaminations,
        or
        extensions thereof (collectively (a) and (b) shall be the “Future Rights”).
        Accordingly, promptly after such filing, invention or creation and prior
        to
        disclosing to any third party the existence of any Future Rights, the Licensor
        shall disclose the applicable Future Rights to the Company. If the Company
        so
        determines, the Company and the Licensor shall negotiate, in good faith,
        a
        commercially reasonable exclusive license of the Future Rights to the Company.
        If the Company and Licensor do not enter into a definitive exclusive license
        with ninety (90) days from the date the Company received notice of such Future
        Right from the Licensor, then the Licensor shall have the right to solicit
        offers from third parties. If an offer relating
        to a Future Right(s) is
        extended to a third party under more
        favorable
        terms
        than those offered to the Company
        for such
        Future Right(s),
        such
        terms presented to the third party shall be presented to Company and Company
        shall have fifteen (15) days to accept such license on such offered terms
        (the
        Company’s “Right of First Refusal”). Both the Licensor and the Company shall be
        obligated to negotiate such terms in good faith. If
        an
        offer is extended to a third party for less favorable terms then the last
        offer
        to the Company than Licensor has no obligation to present such offer to the
        Company. The Right of First Refusal under this paragraph 2.4 shall extend
        for
        one year after the ninety (90) day negotiation period between the Company
        and
        the Licensor has expired under this paragraph 2.4 for the Future Rights being
        negotiated after which Licensor shall have the right to solicit offers from
        third parties relating to such Future Rights with no further obligation to
        Company.

      

      2.5 The
        Company shall have the exclusive first option to negotiate in good faith
        for a
        license agreement to obtain the exclusive rights to any Improvement relating
        to
        the Technology created by or under the direction or control of the Inventor(s),
        filed,
        created or invented after the date of this Agreement (“Option Rights”).
        Accordingly, promptly after such filing, invention or creation and prior
        to
        disclosing to any third party the existence of any Improvement, the Licensor
        shall disclose the applicable Option Rights to the Company. If the Company
        so
        determines, the Company and the Licensor shall negotiate, in good faith,
        a
        commercially reasonable exclusive license of the Option Rights to the Company.
        If the Company and Licensor do not enter into a definitive exclusive license
        with ninety (90) days from the date the Company received notice of such Option
        Rights from the Licensor, then the Licensor shall have the right to solicit
        offers from third parties relating to such Option Rights with no further
        obligation to Company.

      

      
        
          
          

        

        
          4

          
            

          

        

        
          
          

        

      

      2.6 The
        license granted hereunder shall not be construed to confer any rights upon
        Company by implication, estoppel or otherwise as to any technology except
        as
        specifically set forth herein.

       

      ARTICLE
        3 - COMMERCIALIZATION

      

      3.1 The
        Company shall use its commercially reasonable efforts to meet the Milestones
        under Article 4.5 and to bring a Licensed Product to market through a thorough,
        vigorous and diligent program for exploitation of the Licensed Products and
        Licensed Processes as timely and efficiently as possible. Such program shall
        include the preclinical and clinical development of Licensed Products and
        Licensed Processes, including research and development, manufacturing,
        laboratory and clinical testing and marketing. The Company shall continue
        active, diligent marketing efforts for Licensed Product(s) throughout the
        term
        of this Agreement. 

      

      3.2 A
        Development Committee (the “Committee”) shall be organized to monitor the
        clinical progress of the Licensed Products at the Company’s expense. The
        Committee will consist of independent scientific and technical thought leaders
        that are highly regarded by the scientific community in the field of each
        Licensed Product and at least one representative from each of Licensor and
        the
        Company. The Committee will be responsible for (i) making recommendations
        to the
        Company’s management relating to the pre-clinical and clinical development
        strategy; (ii) analysis and assessment of ongoing pre-clinical and clinical
        development of each Licensed Product; and (iii) assisting the Company to
        prepare
        pre-clinical and clinical development budgets. The actions and opinions of
        the
        Committee will be confidential, however, the Licensor representative may
        report
        clinical updates to a designated senior official at the Licensor who will
        agree
        to keep such information confidential. The Committee will meet at least two
        (2)
        times per year.

      

      3.3 The
        Company will conduct its first clinical study entitled "Targeted Inhibition
        of
        Akt Activation in patients with metastatic colorectal, pancreatic, breast
        and
        ovarian cancer: A phase I/II study and pharmacodynamic/pharmacokinetic
        evaluation of the Akt activation inhibitor, Triciribine (TCN-P)." at the
        facilities of the Licensor. The Company will reasonably consider using the
        facilities of the Licensor to conduct future clinical studies.

      

      ARTICLE
        4 - ROYALTIES AND OTHER CONSIDERATION

      

      4.1 The
        Company agrees to pay to Licensor the royalties set forth below, and in
        accordance with the provisions of Articles 4.5 and 4.6, to the end of the
        term
        of the Patent Rights or until this Agreement shall be terminated as hereinafter
        provided:

      

          4.1.1 During
        the term of the License Agreement, the Company shall pay to the Licensor
        “Running Royalties” equal to [***]
        percent ([***]%) of
        Net
        Sales of Licensed Products, by the Company or its sublicensees, of up to
        [***]
        Dollars ($[***]) in
        any
        calendar year; [***]
        percent ([***]%) of
        Net
        Sales of Licensed Products, by the Company or its sublicensees in excess
        of
        [***]
        Dollars ($[***]) but
        less
        than [***]
        Dollars ($[***]) in
        any
        calendar year; and [***]
        percent ([***]%) of
        Net
        Sales of Licensed Products, by the Company or its sublicensees equal to or
        in
        excess of [***]
        Dollars ($[***]) in
        any
        calendar year. 

      

      
        
          
          

        

        
          5

          
            

          

        

        
          
          

        

      

      4.2 In
        the
        event that a Licensed Product is sold in the form of a combination product
        containing one or more products or technologies which are themselves not
        a
        Licensed Product, the Net Sales for such combination product shall be calculated
        by multiplying the sales price of such combination product by the fraction
        A/(A+B) where A is the invoice price of the Licensed Product or the Fair
        Market
        Value of the Licensed Product if sold to an Affiliate and B is the total
        invoice
        price of the other products or technologies or the Fair Market Value of the
        other products or technologies if purchased from an Affiliate. In the case
        of a
        combination product which includes one or more Licensed Products, the Net
        Sales
        for such combination product upon which the royalty due to Licensor is based
        shall not be less than the normal aggregate Net Sales for such Licensed
        Product.

      

      4.3 
        Royalty
        payments shall be paid in United States dollars in Tampa, Florida or at such
        place as Licensor may reasonably designate consistent with the laws and
        regulations controlling in the United States and if applicable in any foreign
        country. Any taxes which the Company, its Affiliate or any sublicensee shall
        be
        required by law to withhold on remittance of the royalty payments shall be
        deducted from such royalty payment to Licensor. The Company shall furnish
        Licensor with the original copies of all official receipts for such taxes.
        If
        any currency conversion shall be required in connection with the payment
        of
        royalties hereunder, such conversion shall be made by using the exchange
        rate
        prevailing at Chase Manhattan Bank (N.A.) on the last business day of the
        calendar quarterly reporting period to which such royalty payments
        relate.

      

      4.4 Royalties
        payable to Licensor shall be paid semi-annually on or before June 30 and
        December 31 of each calendar year. Each such payment shall be for unpaid
        royalties which accrued within or prior to the Company's two most recently
        completed fiscal quarters.

      

      4.5 As
        further consideration for the license granted hereunder, the Company shall
        pay
        to Licensor the following one time “Milestone Payments” which shall not be
        deducted from royalties otherwise owed or which may in the future be owing
        payable to Licensor on account of sublicensing royalties and/or lump sum
        payments received by the Company or its Affiliate from sublicensees pursuant
        to
        paragraph 4.1.2:

      

      4.5.1 $40,000
        upon execution of this Agreement.

      

      4.5.2 Reimbursement
        for costs incurred by Licensor with respect to Patent Rights upon execution
        of
        this Agreement, which in no case shall exceed $[***].

      

          4.5.3  [***]
        Dollars ($[***]) upon
        the
        acceptance by the Food and Drug Administration (the “FDA”) of a Company
        sponsored Investigative New Drug Application (“an IND”) for a Licensed Product.
        For the purposes of this section 4.5.3, the IND shall be deemed “accepted” by
        the FDA sixty (60) days after submission of the IND to the FDA by the Company,
        provided, however, that the FDA has not notified the Company that it will
        not
        allow human clinical trials to commence under such IND;

      

      
        
          
          

        

        
          6

          
            

          

        

        
          
          

        

      

          4.5.4 [***]
        Dollars ($[***]) upon
        the
        first dosing of a patient, with a Licensed Product, in the first Phase II
        clinical trial sponsored by the Company or its sublicensee in any country
        under
        a Company sponsored IND or equivalent;

      

      4.5.5 [***]
        Dollars ($[***]) upon
        the
        first dosing of a patient, with a Licensed Product, in the first Phase III
        clinical trial sponsored by the Company or its sublicense in any country
        under a
        Company sponsored IND or equivalent;

      

      4.5.6 [***]
        Dollars ($[***]) upon
        the
        acceptance for review of the first Company sponsored (or sublicensee sponsored)
        New Drug Application (and “NDA”) by the FDA;

      

          4.5.7 [***]
        Dollars ($[***]) upon
        the
        final approval by the FDA of the first Company sponsored (or sublicensee
        sponsored) NDA for a Licensed Product filed by the Company or its
        sublicensee;

       

      4.6 No
        payment obligations shall be due with respect to any sale or sublicense covering
        any Licensed Product in a country if there are no issued Patent Rights
        underlying such Licensed Product in such country. 

      

      4.7 Should
        the Company or their sublicensees fail to file an IND for a Licensed Product
        with the FDA by the first anniversary of this Agreement (the “Penalty Date”),
        the Company shall remit a payment to the Licensor equal to [***]
        Dollars ($[***]) The
        Company shall remit an additional [***]
        Dollars ($[***]) (each
        a
“Penalty Payment”) for each thirty (30) day period following the Penalty Date
        that it does not file an IND for a Licensed Product with the FDA. Upon
        submission of an IND for a Licensed Product with the FDA, the Company shall
        no
        longer be required to make Penalty Payments.

      

      4.8 To
        the
        extent that the Company or any Affiliate of the Company is required (i) after
        appropriate legal analysis, or (ii) by order or judgment of any court in
        any
        jurisdiction, to obtain a license from a third party in order to practice
        the
        rights purported to be granted to the Company by Licensor hereunder under
        Patent
        Rights in such jurisdiction, then up to [***]
        percent ([***]%) of
        the
        royalties payable under such license in such jurisdiction may be deducted
        from
        royalties otherwise payable to Licensor hereunder, provided that in no event
        shall the aggregate royalties payable to Licensor in any semi-annual period
        in
        such jurisdiction be reduced by more than [***]
        percent ([***]%) as
        a
        result of any such deduction. 

      

      4.9  Upon
        each
        anniversary of this Agreement, the Company shall commit at least twenty-five
        thousand dollars ($25,000) specifically to be used in research and development
        related to potential products, research or development of Licensed Process
        or
        Licensed Product (the “Sponsored Research Funds”). 

      

      4.9.1 To
        the
        extent consistent with University’s rules and policy, and Florida Law, the
“Sponsored Research Funds” will be placed in a designated University of South
        Florida Research Foundation Research Fund(s) and disbursed to researchers
        by
        mutual agreement of Company and University’s Director of Sponsored Research, as
        further described in a Sponsored Research Agreement.

       

      4.10 Company
        agrees to provide Licensor [***]
        percent ([***]%) of
        any
        Fees received by Company prior to meeting the milestone contained hereunder
        Article 4.5.3 and [***]
        percent ([***]%) of
        any
        Fees received by the Company thereafter. As used herein, the term “Fees” means
        any fees, payments, or monies received by Company directly related to the
        sublicensing by the Company of rights to commercialize Licensed Products
        or
        Licensed Processes, excluding (a) payments received from the sale or issuance
        of
        debt or equity securities of the Company; (b) payments received by the Company
        that are specifically designated in any agreement with a third party to be
        dedicated to the research and development of the Technology or dedicated
        to
        establish a marketing and sales force for sales of the Technology; and (c)
        payments resulting from the sale of one or more Licensed Products, including
        royalties which shall be subject to Article 4.1.1.

      

      
        
          
          

        

        
          7

          
            

          

        

        
          
          

        

      

      

      ARTICLE
        5 - REPORTS AND RECORDS

      

      5.1 The
        Company shall keep full, true and accurate books of account containing all
        particulars that may be necessary for the purpose of showing the amounts
        payable
        to Licensor by way of royalty as aforesaid. Said books of account shall be
        kept
        at the Company's principal place of business and the supporting data shall
        be
        open upon reasonable notice to the Company, for three (3) years following
        the
        end of the calendar year to which they pertain, for inspection by Licensor’s
        internal audit division and/or by another designated auditor selected by
        Licensor, except one to whom the Company has reasonable objection, for the
        purpose of verifying the Company's royalty statement or compliance in other
        respects with this Agreement. Such obligation to maintain accurate books
        of
        account and the right to inspect them shall survive termination of this
        Agreement. If an inspection shows an under reporting or underpayment in excess
        of the greater of [***] Dollars ($[***]) or [***] percent ([***]%) of royalties
        payable for any quarter then the Company shall reimburse Licensor for the
        cost
        of the inspection at the time the Company pays the unreported royalties,
        including any late charges as required by paragraph 5.4 of this Agreement.
        All
        payments required under this Article 5 shall be due within thirty (30) days
        of
        the date Licensor provides the Company notice of the payment due.

      

      5.2 Within
        sixty (60) days from the end of each quarter of each calendar year, specifically
        sixty days from March 31, June 30, September 30, and December 31, the Company
        shall deliver to Licensor complete and accurate reports, giving such particulars
        of the business conducted by the Company during the preceding quarter under
        this
        Agreement as shall be pertinent to a royalty accounting hereunder, in a format
        similar to Exhibit D and shall include at least the following along with
        the
        information requested in Exhibit D:

      

      5.2.1 All
        Licensed Products and Licensed Processes used, leased or sold, by or for
        the
        Company or its Affiliates;

      

      5.2.2 Total
        amounts invoiced for Licensed Products and Licensed Processes used, leased
        or
        sold, by or for the Company or its Affiliates;

      

      5.2.3 Deductions
        applicable in computed Net Sales, if any; 

      

      5.2.4 Total
        royalties due based on Net Sales by or for the Company or its Affiliates
        or any
        sublicensee;

      

      5.2.5 Names
        and
        addresses of all sublicensees and Affiliates of the Company;

       

      5.2.6 On
        an
        annual basis, the Company's year-end financial statements.

      

      
        
          
          

        

        
          8

          
            

          

        

        
          
          

        

      

      5.3 With
        each
        such quarterly report submitted, the Company shall pay to Licensor the royalties
        due and payable under this Agreement. If no royalties shall be due, the Company
        shall indicate such in the report. 

      

      5.4 Amounts
        which are not paid when due and which are not the subject of a bona fide
        dispute
        shall accrue interest from the due date until paid, at a rate equal to the
        then
        prevailing prime rate of Citibank, N.A., plus [***] percent ([***]%), compounded
        annually.

      

      5.5 The
        Company agrees to forward to Licensor annually a copy of any report, which
        is in
        substance similar to the report required by this Article 5, received from
        any
        sublicensee and other documents received from any sublicensee as may be
        pertinent to an accounting of royalties.

      

      5.6 Licensor
        agrees to hold in confidence each report delivered by the Company pursuant
        to
        this Article 5 until the termination of this Agreement. Notwithstanding the
        foregoing, Licensor may disclose any such information required to be disclosed
        pursuant to any judicial, administrative or governmental request, subpoena,
        requirement or order, provided that Licensor take reasonable steps to provide
        the Company with the opportunity to contest such request, subpoena, requirement
        or order. However, it is understood and agreed that according to Florida
        Statute
        1004.22, Licensor shall make available upon request the title and description
        of
        a research project, the name of the researcher, and the amount and source
        of
        funding provided for such project. 

      

      5.7 Company
        may submit a new statement correcting for an unintentional and newly discovered
        overpayment for a period of one (1) year after the receipt of any such report
        and payment. Company’s sole remedy for such overpayment shall be credit against
        the following years payments due Licensor. 

      

      5.8 Company
        shall provide Development Reports, of which a sample is attached hereto as
        Exhibit C, semiannually, the first report being due six (6) months after
        the
        Effective Date of this Agreement. 

      

      ARTICLE
        6 - PATENT PROSECUTION AND MAINTENANCE

      

      6.1 The
        Company shall diligently prosecute and maintain the Patent Rights as set
        forth
        in Exhibit A hereto (as the same may be amended or supplemented from time
        to
        time after the date hereof), including, but not limited to, the filing of
        patent
        applications which may be required. The Company agrees to keep Licensor
        reasonably well informed with respect to the status and progress of any such
        applications, prosecutions and maintenance activities and to consult in good
        faith with Licensor and take into account Licensor’s comments and requests with
        respect thereto. The Company will provide Licensor, under confidentiality,
        with
        copies of all filings covering products
        incorporating the Technology.
        Company
        shall ensure that Licensor is simultaneously copied with Company on all
        communication from patent counsel, including attachments related to Patent
        Rights between Company and patent counsel. The Licensor shall be given the
        opportunity to review and comment upon the breadth and coverage of said patent
        applications, and patent counsel chosen by the Company and approved by Licensor,
        such approval not to be unreasonably withheld, shall use all due care to
        address
        and incorporate any comments offered by the Licensor. In addition, Licensor
        shall have the right to designate its own separate counsel, at Licensor’s
        expense, to review and comment upon the prosecution and drafting of any
        applications, prosecution or maintenance documents and said comments shall
        also
        be given due consideration. Both parties agree to provide reasonable cooperation
        to each other to facilitate the application and prosecution of patents pursuant
        to this Agreement.

      

      
        
          
          

        

        
          9

          
            

          

        

        
          
          

        

      

      6.2 The
        Company may, in its discretion, elect to abandon any patent applications
        or
        issued patent in the Patent Rights, in which case the Company shall have
        no
        further royalty obligation to Licensor in respect of any Licensed Products
        and
        Licensed Processes, the manufacture, use or sale of which is covered by an
        issued claim of such abandoned Patent Rights. Prior to any such abandonment,
        the
        Company shall give Licensor at least sixty (60) days notice and a reasonable
        opportunity to take over prosecution of such Patent Rights. In such event,
        Licensor shall have the right, but not the obligation, to commence or continue
        such prosecution and to maintain any such Patent Rights under its own control
        and at its expense and the Company shall then have no royalty or other
        obligation to Licensor in respect of any Licensed Products and Licensed
        Processes, the manufacture, use or sale of which is covered by an issued
        claim
        of such Patent Rights. The Company agrees to cooperate in such activities
        including execution of any assignments or other documents necessary to enable
        Licensor to obtain and retain sole ownership and control of such Patent
        Rights.

      

      ARTICLE
        7 - TERMINATION

      

      7.1 If
        the
        Company shall become bankrupt, or shall file a petition in bankruptcy, or
        if the
        business of the Company shall be placed in the hands of a receiver, assignee
        or
        trustee for the benefit of creditors, whether by the voluntary act of the
        Company or otherwise, this Agreement shall automatically terminate.

      

      7.2 Should
        the Company fail to make payment to Licensor of royalties due in accordance
        with
        the terms of this Agreement which are not the subject of a bona fide dispute
        between Licensor and the Company, Licensor shall have the right to terminate
        this License Agreement within seventy five (75) days after giving written
        notice
        of termination unless the Company shall pay to Licensor, within the seventy
        five
        (75) day period, all such royalties due and payable. In the event of a bona
        fide
        dispute over royalties, the parties shall resolve such dispute in accordance
        with Article 8. Subject to Article 8 and the immediately preceding sentence,
        upon the expiration of the seventy five (75) day period, if the Company shall
        not have paid all such royalties due and payable, the rights, privileges
        and
        license granted hereunder shall, at the option of Licensor,
        terminate.

      

      7.3 Upon
        any
        material breach or default of this Agreement by the Company, other than as
        set
        forth in Paragraph 7.1 and 7.2 above, which shall always take precedence
        in that
        order over any material breach or default referred to in this Section 7.3,
        Licensor shall have the right to terminate this Agreement and the rights,
        privileges and license granted hereunder by giving seventy five (75) days
        prior
        written notice to the Company. Such termination shall become effective
        immediately unless the Company shall have cured any such breach or default
        prior
        to the expiration of the seventy five (75) day period referred to above.
        If a
        dispute regarding termination is addressed according to Article 7, this license
        shall remain in full force and effect until such dispute is settled in a
        manner
        that is not further appealable or not appealed. 

      

      7.4 The
        Company shall have the right at any time to terminate this Agreement in whole
        or
        as to any portion of the Patent Rights, for any reason or no reason, by giving
        six (6) months notice thereof in writing to Licensor, and upon payment of
        all
        amounts due Licensor through the effective date of the termination.

      

      
        
          
          

        

        
          10

          
            

          

        

        
          
          

        

      

      7.5 Upon
        termination of this Agreement for any reason, nothing herein shall be construed
        to release either party from any obligation that matured prior to the effective
        date of such termination or obligations under Articles 4, 5, 8, 10, 13, and
        15,
        or as specifically specified in such Article. The Company and/or any sublicensee
        thereof may, however, after the effective date of such termination and
        continuing for a period not to exceed twelve (12) months thereafter, sell
        all
        completed Licensed Products, and any Licensed Products in the process of
        manufacture at the time of such termination, and sell the same, provided
        that
        the Company shall pay or cause to be paid to Licensor the royalties thereon
        as
        required by Article 4 of this Agreement and shall submit the reports required
        by
        Article 5 hereof on the sales of Licensed Products.

      

      7.6 In
        the
        event of termination under this Article 7, Licensor shall have the right
        to
        cross-reference and rely upon any such approvals and use all data submitted
        by
        Company to
        any
        regulatory agency in
        connection with Licensed Products, Licensed Processes or any products covered
        under the Patent Rights that Licensor or its other Licensee’s may seek approval
        on
        and,
        following termination of this Agreement, Licensor shall have the unrestricted
        right to provide such data to third parties.

      

      7.7 If
        not
        terminated sooner, this Agreement shall terminate, on a country by country
        basis, on the date of the last to expire claim contained in the Patent Rights,
        at which time the Company will have an irrevocable, paid up, royalty-free
        license under the Patent Rights to make, have made, use, have used, sell
        and
        have sold Licensed Products and Licensed Processes. 

      

      ARTICLE
        8 - DISPUTE RESOLUTION

      

      8.1 Any
        dispute arising from or relating to this Agreement, excluding any dispute
        relating to patent validity or infringement, which have not been resolved
        by
        good faith negotiations between the parties, shall be resolved by final and
        binding arbitration in Tampa, Florida, in accordance with the rules of the
        American Arbitration Association. One arbitrator shall be selected by Licensor,
        one arbitrator shall be selected by the Company and the third arbitrator
        shall
        be selected by mutual agreement of the first two arbitrators. The arbitrators
        shall have no power to add to, subtract from or modify any of the terms or
        conditions of this Agreement. Any award rendered in such arbitration may
        be
        enforced by either party in either the courts of the State of Florida or
        in the
        United States District Court for the Middle District of Florida, to whose
        jurisdiction for such purposes Licensor and Company each hereby irrevocably
        consents and submits.

      

      8.2 Any
        claim, dispute, or controversy concerning the validity, enforceability, or
        infringement of any patent contained in the Patent Rights licensed hereunder
        shall be resolved in any court having jurisdiction thereof.

      

      8.3 In
        the
        event that, in any arbitration proceeding, any issue shall arise concerning
        the
        validity, enforceability, or infringement of any patent contained in the
        Patent
        Rights licensed hereunder, the arbitrators shall, to the extent possible,
        resolve all issues other than validity, enforceability, and infringement;
        in any
        event, the arbitrators shall not delay the arbitration proceeding for the
        purpose of obtaining or permitting either party to obtain judicial resolution
        of
        such issues, unless an order staying the arbitration proceeding shall be
        entered
        by a court of competent jurisdiction. Neither party shall raise any issue
        concerning the validity, enforceability, or infringement of any patent contained
        in the Patent Rights licensed hereunder, in any proceeding to enforce any
        arbitration award hereunder, or in any proceeding otherwise arising out of
        any
        such arbitration award.

      

      
        
          
          

        

        
          11

          
            

          

        

        
          
          

        

      

      8.4 
        The
        costs of such arbitration shall be borne proportionate to the finding of
        fault
        as determined by the Arbitrator. Judgment on the arbitration award may be
        entered by any court of competent jurisdiction.

      

      8.5 Notwithstanding
        the foregoing, nothing in this Article shall be construed to waive any rights
        or
        timely performance of any obligations existing under this
        Agreement.

      

      ARTICLE
        9 - INFRINGEMENT AND OTHER ACTIONS

      

      9.1 The
        Company and Licensor shall promptly provide written notice, to the other
        party,
        of any alleged infringement by a third party of the Patent Rights and provide
        such other party with any available evidence of such infringement. Licensor
        and
        Company shall consult one another in a timely manner concerning any appropriate
        response to the infringement.

      

      

      9.2 During
        the term of this Agreement, the Company shall have the right, but not the
        obligation, to prosecute and/or defend, at its own expense and utilizing
        counsel
        of its choice, any infringement of, and/or challenge to, the Patent Rights.
        In
        furtherance of such right, Licensor hereby agrees that the Company may join
        Licensor as a party in any such suit (and will join at the Company’s request),
        provided that the Company pay all of Licensor’s reasonable out-of-pocket
        expenses. The Company shall indemnify and hold Licensor harmless against
        any
        costs, expenses, liability, claims or damages made against or sustained by
        Licensor in connection with such involvement, other than resulting from
        Licensor's negligence or willful misconduct. Company may not settle or
        compromise any such suit in a manner that imposes additional obligations
        or
        restrictions on Licensor not already imposed by this Agreement without
        Licensor’s written permission. Any recovery of damages pursuant to this
        Paragraph 9.2 shall be retained entirely by the Company and allocated pursuant
        to 9.4 below.

      

      9.3 In
        the
        event that a claim or suit is asserted or brought against the Company alleging
        that the manufacture or sale of any Licensed Product by the Company, an
        Affiliate of the Company, or any sublicensee, or the use of such Licensed
        Product by any customer of any of the foregoing, infringes proprietary rights
        of
        a third party, the Company shall give written notice thereof to Licensor.
        The
        Company may, in its sole discretion, modify such Licensed Product to avoid
        such
        infringement and/or may settle on terms that it deems advisable in its sole
        discretion, subject to paragraph 9.2. Otherwise,
        the Company shall have the right, but not the obligation, to defend any such
        claim or suit. In the event the Company elects not to defend such suit, Licensor
        shall have the right, but not the obligation to do so at its sole
        expense.

      

      9.4 Any
        recovery of damages by the Company, in any such suit, shall be applied first
        in
        satisfaction of any unreimbursed expenses and legal fees of the Company relating
        to the suit. The balance remaining from any such recovery shall be treated
        as
        royalties received by the Company from sublicensees and shared by Licensor
        and
        the Company in accordance with Paragraphs 4.1 and 4.2 hereof as applicable.
        

      

      9.5 The
        Company may credit the cost of any litigation costs incurred by the Company
        in
        any country pursuant to this Article 9 including all amounts paid in judgment
        or
        settlement of litigation within the scope of this Article 9 against royalties
        or
        other fees thereafter payable to the Licensors hereunder for such country.
        If
        the costs of such litigation in such country exceeds the royalties payable
        to
        the Licensors in any year in which such costs are incurred then the amount
        of
        such costs, expenses and amounts paid in judgment or settlement, in excess
        of
        the royalties payable shall be carried over and credited against royalty
        payments in future years for such country.

      

      
        
          
          

        

        
          12

          
            

          

        

        
          
          

        

      

      9.6 If
        within
        six (6) months after receiving notice of any alleged infringement, the Company
        shall have been unsuccessful in persuading the alleged infringer to desist,
        or
        shall not have brought and shall not be diligently prosecuting an infringement
        action, or if the Company shall notify Licensor, at any time prior thereto,
        of
        its intention not to bring suit against the alleged infringer, then, and
        in
        those events only, Licensor shall have the right, but not the obligation,
        to
        prosecute, at its own expense and utilizing counsel of its choice, any
        infringement of the Patent Rights, and the Company may, for such purposes,
        join
        the Licensor as a party plaintiff. The total cost of any such infringement
        action commenced solely by Licensor shall be borne by Licensor and Licensor
        shall keep any recovery or damages for infringement or otherwise derived
        therefrom and such shall not be applicable to any royalty obligation of the
        Company.

      

      9.7 In
        any
        suit to enforce and/or defend the Patent Rights pursuant to this Agreement,
        the
        party not in control of such suit shall, at the request and expense of the
        controlling party, cooperate in all respects and, to the extent possible,
        have
        its employees testify when requested and make available relevant records,
        papers, information, samples, specimens, and the like.

      

      ARTICLE
        10 - LIMITATION OF LIABILITY, INDEMNITY

       

      10.1 EXCEPT
        AS
        OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, LICENSOR MAKES NO
        REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR
        IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTY OF MERCHANTABILITY, FITNESS
        FOR
        A PARTICULAR PURPOSE, AND VALIDITY OF PATENTED RIGHTS CLAIMS, ISSUED OR PENDING.
        

      

      10.2 The
        Company agrees to defend, indemnify and hold Licensor, the University and
        their
        trustees, inventors, officers, employees and affiliates, harmless from and
        against all liability, demands, damages, including without limitation, expenses
        or losses including death, personal injury, illness or property damage arising
        directly or indirectly: (a) out of use by the Company, Company’s Affiliates,
        sublicensees, or its transferees of inventions licensed or information furnished
        under this Agreement or (b) out of any use, sale or other disposition by
        the
        Company, Company’s Affiliates, sublicensees, or its transferees of Patent
        Rights, Licensed Products or Licensed Processes, in each case which are not
        the
        result of Licensor's negligence or willful misconduct. The Company agrees
        that
        any sublicense agreement it enters relative to the Licensed Products and/or
        Licensed Processes shall contain a covenant by such sub-licensee providing
        for
        the indemnification of Licensor as provided in this Article.

      

      10.3  Licensor
        shall not be liable to Company or Company’s customers or sublicensees for any
        damages, including but not limited to, direct, special, incidental, indirect,
        economic, or consequential damages resulting from design defects, testing,
        labeling, manufacture, or other application of Licensed Products manufactured,
        tested, designed, sublicensed or sold pursuant to this Agreement.

      

      10.4  Company
        shall procure and maintain commercial general liability insurance, including
        without limitation, product liability insurance, in amounts customary in
        the
        relevant industry in which Company commercially exploits Licensed Products
        or
        Licensed Process. Such insurance coverage shall extend to indemnities of
        Company
        and Licensor shall be named as an insured. Insurance coverage shall be obtained
        through insurance carriers reasonably acceptable to Licensor. Product liability
        insurance shall be maintained prior to the first commercial sale of a Licensed
        Product and shall be continued for a commercially reasonable amount of time
        after the expiration of this Agreement.

      

      
        
          
          

        

        
          13

          
            

          

        

        
          
          

        

      

      10.5 LICENSEE
        shall promptly notify RESEARCH FOUNDATION of all claims involving the
        Indemnities.

      

      10.6 Nothing
        in this Agreement shall be construed as a warranty or representation by RESEARCH
        FOUNDATION or University that it will not grant licenses to others to make,
        use
        or sell products or processes not covered by the claims of the Patent Rights
        which may be similar to or compete with products made or sold by LICENSEE
        or its
        sublicensee.

      

      ARTICLE
        11 - ASSIGNMENT

      

      This
        Agreement and the rights and duties appertaining hereto may not be assigned
        by
        either party without first obtaining the written consent of the other which
        consent shall not be unreasonably withheld. Any such purported assignment,
        without the written consent of the other party, shall be null and of no effect.
        Notwithstanding the foregoing, the Company may assign this Agreement without
        the
        consent of Licensor (i) to a purchaser, merging or consolidating corporation,
        or
        acquiror of substantially all of the Company's assets or business and/or
        pursuant to any reorganization qualifying under section 368 of the Internal
        Revenue Code of 1986 as amended, as may be in effect at such time, or (ii)
        to an
        Affiliate of the Company. In either such case, Company shall notify Licensor
        in
        writing within thirty (30) days of such assignment. Notwithstanding the
        foregoing, Licensor may assign this Agreement or any individual sections
        or
        paragraphs under this Agreement, without the consent of Company, to Moffitt
        Research & Cancer Center.

      

      ARTICLE
        12 - PAYMENT OF FEES AND EXPENSES

      

      Each
        of
        the Company and Licensor shall be responsible for their own expenses relating
        to
        the preparation and consummation of this Agreement and the agreements and
        transactions contemplated hereby. 

      

      ARTICLE
        13 - USE OF NAMES AND PUBLICATION

      

      13.1 Nothing
        contained in this Agreement shall be construed as granting any right to the
        Company or its Affiliates to use in advertising, publicity, or other promotional
        activities any name, trade name, trademark, or other designation of Licensor,
        the inventors, the University nor any of its employees, any of its units
        (including contraction, abbreviation or simulation of any of the foregoing),
        nor
        any adaptation thereof, without the prior, written consent of Licensor;
        provided, however,
        Company
        may state that such has been licensed by Licensor under one or more of the
        patents and/or applications comprising the Patent Rights. 

      

      13.2 Nothing
        herein shall be deemed to establish a relationship of principal and agent
        between Licensor and the Company, nor any of their agents or employees for
        any
        purpose whatsoever.

      

      13.3 In
        the
        event that Licensor desires to publish or disclose, by written, oral or other
        presentation, Patent Rights, Know-how, or any material information related
        thereto then Licensor shall notify the Company and in writing by facsimile
        where
        confirmed by the receiving party, and/or by certified or registered mail
        (return
        receipt requested) of their intention at least sixty (60) days prior to any
        speech, lecture or other oral presentation and at least ninety (90) days
        before
        any written or other publication or disclosure. The Licensor shall include
        with
        such notice a description of any proposed oral presentation or, in any proposed
        written or other disclosure, a current draft of such proposed disclosure
        or
        abstract. The Company may request that the Licensor, no later than thirty
        (30)
        days following the receipt of such notice, delay such presentation, publication
        or disclosure for up to an additional sixty (60) days in order to enable
        the
        Company to file, or have filed on their behalf, a patent application, copyright
        or other appropriate form of intellectual property protection related to
        the
        information to be disclosed or request that Licensor do so. Upon receipt
        of such
        request to delay such presentation, publication or disclosure, Licensor shall
        arrange for a delay of such presentation, publication or disclosure until
        such
        time as the Company or Licensor have filed, or had filed on its behalf, such
        patent application, copyright or other appropriate form of intellectual property
        protection in form and in substance reasonably satisfactory to the Company
        and
        Licensor. If the Licensor does not receive any request from the Company to
        delay
        such presentation, publication or disclosure, Licensor may submit such material
        for presentation, publication or other form of disclosure.

      

      
        
          
          

        

        
          14

          
            

          

        

        
          
          

        

      

      ARTICLE
        14 - PAYMENTS, NOTICES AND OTHER COMMUNICATIONS

      

      Any
        payment, notice or other communication required or permitted to be given
        pursuant to this Agreement shall be in writing and sent by certified first
        class
        mail, postage prepaid, by hand delivery or by facsimile if confirmed in writing,
        in each case effective upon receipt, at the addresses below or as otherwise
        designated by written notice given to the other party:

       

      In
        the
        case of Licensor:

      

      USF
        Research Foundation, Inc.   

      USF
        Box
        30445    

      Tampa,
        Florida 33620-3044 

      Attention:
        Assistant Director   

      Tel:
        813-974-4903 

      Fax:
        813-974-3348

      

      In
        the
        case of the Company:

       

      Greenwich
        Therapeutics, Inc.

      787
        Seventh Avenue, 48th Floor

      New
        York,
        NY 10019

      Attn:
        President

      Tel:
        212-554-4300

      Fax:
        212-554-4355

      

      15.
        CONFIDENTIALITY

      

      15.1 Any
        proprietary or confidential information relating to the Patent Rights (including
        but not limited to Know-how and patent prosecution documents relating to
        Patent
        Rights) collectively constitute the “Confidential Information." The Company and
        Licensor agree that they will not use the Confidential Information for any
        purpose unrelated to this Agreement, and will hold it in confidence during
        the
        term of this Agreement and for a period of five (5) years after the termination
        or expiration date of this Agreement. The Company shall exercise with respect
        to
        such the Confidential Information the same degree of care as the Company
        exercises with respect to its own confidential or proprietary information
        of a
        similar nature, and shall not disclose it or permit its disclosure to any
        third
        party (except to those of its employees, consultants, or agents who are bound
        by
        the same obligation of confidentiality as the Company is bound by pursuant
        to
        this Agreement). However, such undertaking of confidentiality by the Company
        shall not apply to any information or data which:

      

      
        
          
          

        

        
          15

          
            

          

        

        
          
          

        

      

      15.1.1 The
        Company receives at any time from a third-party lawfully in possession of
        same
        and having the right to disclose same.

      

      15.1.2 Is,
        as of
        the date of this Agreement, in the public domain, or subsequently enters
        the
        public domain through no fault of the Company.

      

      15.1.3 Is
        independently developed by the Company as demonstrated by written evidence
        without reference to information disclosed to the Company by
        Licensor.

      

      15.1.4 Is
        disclosed pursuant to the prior written approval of Licensor.

      

      15.1.5 Is
        required to be disclosed pursuant to law or legal process (including, without
        limitation, to a governmental authority) provided, in the case of disclosure
        pursuant to legal process, reasonable notice of the impending disclosure
        is
        provided to Licensor and Licensor has agreed to such disclosure in writing
        or
        has exhausted its right to contest such disclosure.

      

      ARTICLE
        16 - MISCELLANEOUS PROVISIONS

      

      16.1 This
        Agreement shall be construed, governed, interpreted and applied in accordance
        with the laws of the State of Florida, without regard to principles of conflicts
        of laws.

      

      16.2 If
        this
        Agreement or any associated transaction is required by the law of any nation
        to
        be either approved or registered with any governmental agency, the Company
        shall
        assume all legal obligations to do so and the costs in connection therewith.
         

      

      16.3  The
        parties hereto acknowledge that this Agreement, including the Appendices
        and
        documents incorporated by reference, sets forth the entire agreement and
        understanding of the parties hereto as to the subject matter hereof, and
        shall
        not be subject to any change of modification except by the execution of a
        written instrument subscribed to by the parties hereto.

      

      16.4  The
        provisions of this Agreement are severable, and in the event that any provision
        of this Agreement shall be determined to be invalid or unenforceable under
        any
        controlling body of law, such invalidity or unenforceability shall not in
        any
        way affect the validity or enforceability of the remaining provisions
        hereof.

      

      16.5  The
        failure of either party to assert a right hereunder or to insist upon compliance
        with any term or condition of this Agreement shall not constitute a waiver
        of
        that right or excuse a similar subsequent failure to perform any such term
        or
        condition by the other party.

      

      16.6 The
        headings of the several articles are inserted for convenience of reference
        only
        and are not intended to be a part of or to affect the meaning or interpretation
        of this Agreement.

      

      16.7 This
        Agreement will not be binding upon the parties until it has been signed below
        on
        behalf of each party, in which event, it shall be effective as of the date
        recited on page one. The provision of this Agreement shall be binding upon
        and
        shall inure to the benefit of the parties hereto, their heirs, administrators,
        successors and assigns. 

      

      
        
          
          

        

        
          16

          
            

          

        

        
          
          

        

      

      16.8 This
        Agreement embodies the entire understanding of the parties and shall supersede
        all previous communications, representations or understandings, either oral
        or
        written, between the parties relating to the subject matter hereof.

      

      16.9 Each
        party hereto shall be excused from any breach of this Agreement which is
        proximately caused by governmental regulation, act of war, strike, act of
        God or
        other similar circumstance normally deemed outside the control of the
        parties.

      

      16.10 Company
        agrees to mark the Licensed Products sold in the United States with all
        applicable United States patent numbers. All Licensed Products shipped to
        or
        sold in other countries shall be marked in such a manner as to conform with
        the
        patent laws and practice of the country of manufacture or sale.

       

      16.11 It
        is
        understood that Licensor is subject to United States laws and regulations
        controlling the export or transfer of defense articles, technical data, computer
        software, laboratory prototypes, and other commodities (collectively “technical
        information”). Said laws include but are not limited to: the Export Control Act,
        International Traffic in Arms Regulations and the Export Administration Act
        of
        1979. Licensor’s obligations hereunder are contingent on compliance with said
        laws and regulations. It is understood that compliance with said laws and
        regulations may require of both Licensor and Company: (1) export license(s);
        (2)
        written compliance plan(s) with said laws and regulations; or (3)
        modification(s) to existing facilities. Licensor does not represent that
        a
        license(s), compliance plan(s) or modification(s) will or will not be required.
        In the event that an export license(s) is required, Licensor does not represent
        that it shall be issued by the cognizant governmental agencies. In the event
        that a compliance plan(s) or modification(s) is required, Licensor does not
        represent that said plan(s) or modification(s) will be approved by the cognizant
        governmental agencies. In all cases the cost of any (1) export licenses for
        Company or Company’s employees; (2) compliance plans required of Company; and
        (3) modifications to Company’s facilities shall be the sole responsibility of
        Company. Company hereby agrees to comply with any export controls or federal
        regulations which may apply to the Licensed Products or Licensed
        Processes.

       

      ARTICLE
        17-REPRESENTATIONS AND WARRANTIES

      

      17.1 Licensor,
        to the best of its knowledge, represents and warrants that:

      

      17.1.1  Licensor
        has all right, title, and interest in and to the Patent Rights and Know-how,
        including the exclusive, absolute, irrevocable right, title and interest
        thereto, free and clear of all liens, charges, encumbrances or other
        restrictions or limitations of any kind whatsoever.

      

      17.1.2  There
        are
        no licenses, options, restrictions, liens, rights of third parties, disputes,
        royalty obligations, proceedings or claims relating to, affecting, or limiting
        Licensor’s rights or the rights of the Company under this Agreement, or which
        may lead to a claim of infringement or invalidity regarding, any part or
        all of
        the Patent Rights or Know How or their use. 

      

      17.1.3  There
        is
        no claim, pending or threatened, of infringement, interference or invalidity
        regarding any part or all of the Patent Rights or Know-how or their use.
        

      

      17.1.4  The
        US
        and foreign patent applications and patents itemized on Exhibit A set forth
        all
        of the patents and patent applications for the Technology in the Field of
        Use
        owned by or licensed by Licensor on the Effective Date.

      

      
        
          
          

        

        
          17

          
            

          

        

        
          
          

        

      

      17.1.5  There
        are
        no inventors of Patent Rights other than those listed as inventors on the
        patent
        filings.

      

      17.1.6  Licensor
        has provided Company with copies of all documents reflecting support or funding
        for all or part of the research leading to Patent Rights and Know How, and
        has
        listed all funding agencies on Exhibit B. 

      

      17.2 It
        is
        understood that the United States Government (through its agencies or otherwise)
        or the Government of the State of Florida may have funded research during
        the
        course of or under which some of the inventions of the Patent Rights may
        have
        been conceived or made. The United States Government and the Government of
        the
        State of Florida are entitled, as a right, under the provisions of 35 U.S.C.
        §202-212 and applicable regulations of Title 37 of the Code of Federal
        Regulations and other federal and state regulations, to a nonexclusive,
        nontransferable, irrevocable, paid-up license to practice or have practiced
        the
        inventions of such Patent Rights for governmental purposes. Any license granted
        to LICENSEE in this Agreement shall be subject to such right, if
        any.

      

      17.3 Each
        of
        Company and Licensor warrants and represents that the persons signing this
        Agreement on its behalf have authority to execute this Agreement and that
        execution of this Agreement does not violate any law, rule, or regulation
        applicable to it or any contract or other agreement by which it is
        bound.

      

      (signatures
        on next page)

      

      

      

      

      
        
          
          

        

        
          18

          
            

          

        

        
          
          

        

      

       

      IN
        WITNESS WHEREOF,
        the
        parties hereto have executed this Agreement, in triplicate by proper persons
        thereunto duly authorized.

      

      
        	GREENWICH
                THERAPEUTICS, INC.	 	 	UNIVERSITY
                OF SOUTH FLORIDA 
RESEARCH FOUNDATION, Inc.
	 	 	 	 
	By: ________________________   	 	 	By: ________________________   
	
                Name:
                  ________________________   

              	 	 	Name: Rod Casto, Ph.D. 
	
                Title:
                  _______________________   

              	 	 	Title: Executive Director
&
                Secretary 
	
                Date:
                  ________________________ 

              	 	 	Date:
                ________________________    

      

      
 

      
        
          	
                  UNIVERSITY
                    OF SOUTH FLORIDA

                  BOARD
                    OF TRUSTEES, a public body

                  corporate

                	 	 	
                
	 	 	 	 
	By: ________________________   	 	 	
                
	
                  Name:
                    ________________________   

                	 	 	
                
	
                  Title:
                    _______________________   

                	 	 	
                
	
                  Date:
                    ________________________ 

                	 	 	
                
	 	 	 	 
	 	 	 	 
	By:
                  ___________________________	 	 	 
	Name:
                  ___________________________	 	 	 
	Title: ___________________________  	 	 	 
	Date: ________________________	 	 	 
	 	 	 	 

        

      

      

      

       

      (signature
        page to the License Agreement by and among 

      the
        parties above date April 19, 2005)

       

      
        
          
          

        

        
          19

          
            

          

        

        
          
          

        

      

      EXHIBIT
        A

       

      [***]

       

      
        
          
          

        

        
          20

          
            

          

        

        
          
          

        

      

      EXHIBIT
        B

      

      Support
        & funding leading to Patent Rights and Know How:

      

      National
        Cancer Institute

      CA89242
        & CA77935

       

      
        
          
          

        

        
          21

          
            

          

        

        
          
          

        

      

      EXHIBIT
        C

      

      Form
        of
        Development Report

      

      THIS
        REPORT IS CONFIDENTIAL AND MAY CONTAIN MATERIAL NON PUBLIC
        INFORMATION

      

      When
        appropriate, indicate estimated start date and finish date for
        activities.

      

      A. Date
        Development Plan Initiated and Time Period Covered by this Report.

       

      B. Development
        Report 

       

      1. Activities
        completed since last report including the object and parameters of the
        development, when initiated, when
        completed and the results.

       

      2. Activities
        currently under investigation, i.e., ongoing activities including object
        and
        parameters of such activities,
        when initiated, and projected date of completion.

       

      C. Future
        Development Activities 

       

      1. Activities
        to be undertaken before next report including, but not limited to, the type
        and
        object of any studies conducted
        and their projected starting and completion dates.

       

      2. Estimated
        total development time remaining before a product will be
        commercialized.

       

      D. Changes
        to Initial Development Plan  

      1. Reasons
        for change.

       

      2. Variables
        that may cause additional changes.

       

      E.
        Items
        to be Provided if Applicable:

      

      1. Information
        relating to Licensed Products that has become publicly available, e.g.,
        published articles, competing products,
        patents, etc.

      

      2. Development
        work being performed by third parties, other than Licensee, to include name
        of
        third party, reasons
        for use of third party, planned future uses of third parties including
reasons
        why and type of work.

      

      3. Update
        of
        competitive information trends in industry, government compliance (if
        applicable) and market plan.

      

      
        
          4.
            Information
            and copies of relevant materials evidencing the status of any patent
            applications or other protection relating to Licensed Products or the
            Licensed
            Patents.

        

      

      

      PLEASE
        SEND DEVELOPMENT REPORTS TO:

      

      
        
          	University
                  of South Florida Research Foundation, Inc.
4202 E. Fowler Avenue,
                  FAO126
Tampa, FL 33620
ATTN: Assistant Director 
Phone No.:
                  813-974-4903 
Fax No.: 813-974-3348	
                  University of South Florida
Division of Patents &
                    Licensing
4202 E. Fowler Avenue, FAO126
Tampa, FL 33620

                  ATTN:
                    Director

                  Phone No.: 813-974-0994
Fax No.:
                    813-974-8490

                

        

      

       

        

      
        
          
          

        

        
          22

          
            

          

        

        
          
          

        

      

      Exhibit
        D

      USF
        Royalty Report

      

      

      

      Licensee:__________________________ Agreement
        No:_______________________

      

      Inventor(s):_______________________
        USF Ref: No:_______________________

      

      Period
        Covered: From:____/_____/_____ Through:_______/_______/_____________

      

      Prepared
        By:_______________________ Approved
        by:________________________

      

      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 __ of ___ Pages

      

      Report
        Currency: ___US Dollars ___Other_________________________ 

       

      
        	
                Country

              	
                Gross
                  Sales

              	
                *Less

                Allowances

              	
                Net
                  Sales

              	
                Royalty
                  Rate

              	
                Royalty

                 

              	
                Due

              
	 	 	 	 	 	
                This
                  Year

              	
                Last
                  Year

              
	
                U.S.A.

              	 	 	 	 	 	 
	
                Canada

              	 	 	 	 	 	 
	
                Europe

              	 	 	 	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 	 
	
                Japan

              	 	 	 	 	 	 
	
                Others:

              	 	 	 	 	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 	 
	
                TOTAL:

              	 	 	 	 	 	 

      

      

      

      Total
        Royalty:________Conversion Rate(s):___________Royalty in U.S.
        Dollars:________________

      

      
        
          

        

      Milestone
        Payment 1:_________;Milestone Payment 2:_________Milestone Payment
        3:__________

      

      The
        following Royalty forecast is non-binding and for USF’s internal planning
        purposes only:

       

      Royalty
        Forecast Under this Agreement: Next
        Quarter:________Q2:______Q3:______Q4:______

       

      On
        a
        separate page, please indicate the reason for returns or other adjustments
        if
        significant. Also, note any unusual occurrences that affect royalty amounts
        during this period. To assist USF’s forecasting, please comment on any
        significant expected trends in sales volume. 

      

      

      
        
          
          

        

        
          23Exhibit 10.44

    Exhibit
      10.44

    
 

    AMENDMENT NO.
      1
      dated as of August 25, 2005, to the Amended and Restated Credit Agreement dated
      as of November 3, 2004 (the “Credit
      Agreement”),
      among
      ADVANCE AUTO PARTS, INC. (“Holdings”),
      ADVANCE STORES COMPANY, INCORPORATED (the “Borrower”),
      the
      financial and other institutions party thereto as lenders (the “Lenders”),
      and
      JPMORGAN CHASE BANK, N.A., as administrative agent (in such capacity, the
“Administrative
      Agent”)
      for
      the Lenders.

     

    A.  Pursuant
      to the Credit Agreement, the Lenders have extended credit to the Borrower,
      and
      have agreed to extend credit to the Borrower, pursuant to the terms and subject
      to the conditions set forth therein.

     

    B.  The
      Borrower has requested that the Lenders agree to amend certain provisions of
      the
      Credit Agreement, as set forth herein.

     

    C.  The
      undersigned Lenders are willing to agree to such amendment pursuant
      to the terms and subject to the conditions set forth herein.

     

    In
      consideration of the premises and the agreements, provisions and covenants
      herein contained, the parties hereto hereby agree, on the terms and subject
      to
      the conditions set forth herein, as follows:

     

    SECTION
      1.   Definitions;
      References.
      Unless
      otherwise specifically defined herein, each term used herein that is defined
      in
      the Credit Agreement shall have the meaning assigned to such term in the Credit
      Agreement. Each reference to “hereof”, “hereunder”, “herein” and “hereby” and
      each other similar reference and each reference to “this Agreement” and each
      other similar reference contained in the Credit Agreement shall from and after
      the date hereof refer to the Credit Agreement with such amendments effected
      hereby.

     

    SECTION
      2.   Amendment
      to Section 5.01.
      Clauses
      (a) and (b) of Section 5.01 of the Credit Agreement are hereby amended by
      deleting the words “and consolidating” wherever such words appear. 

     

    SECTION
      3.   Amendment
      to Section 6.04.
      Section
      6.04 of the Credit Agreement is hereby amended by (i) deleting the text “and” at
      the end of clause (l), (ii) replacing the “.” at the end of clause (m) with “;
      and”, and (iii) inserting immediately after clause (m) of such
      Section:

     

    (n)
      Guarantees by any Loan Party of any obligation (other than Indebtedness) of
      any
      other Loan Party.

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    2 

     

    SECTION
      4.   Amendment
      to Section 6.08.
      Section 6.08 of the Credit Agreement is hereby amended by (i) deleting
      the text “and” at the end of clause (f), (ii) replacing the “.” at the
      end of clause (g) with “and”, and (iii) inserting immediately after
      clause (g) of such Section:

     

    (h)
      Guarantees of obligations of Subsidiaries that are not Loan Parties permitted
      by
      Section 6.04.

     

    SECTION
      5.   Amendment
      to Section 6.12.
      Section
      6.12 of the Credit Agreement is hereby amended by replacing the portion of
      the
      table set forth therein applicable to periods ending on or after December
      31, 2005, with the following:

     

     

    
      	
               Fiscal
                Year

              Ending

            	
              Amount

            
	
              
              

            	
               

            
	
              December
                31, 2005

            	
              $325,000,000 

            
	 	 
	
              December
                30, 2006

            	
              $375,000,000 

            
	 	 
	
              Each
                fiscal year thereafter 

            	
              $400,000,000 

            

    

     

    SECTION
      6.   Representations
      and Warranties.
      Each of
      Holdings and the Borrower represents and warrants to each of the Lenders
      that:

     

    (a)
        After
      giving effect to this Amendment, the representations and warranties of each
      Loan
      Party set forth in the Loan Documents are true and correct on the date hereof
      with the same effect as if made on the date hereof, except for representations
      and warranties expressly made as of an earlier date, which were true and correct
      as of such earlier date.

     

    (b)
        After
      giving effect to this Amendment, no Default shall have occurred and be
      continuing.

     

    SECTION
      7.   Conditions
      to Effectiveness.
      This
      Amendment shall become effective as of the date (the “Amendment
      Effective Date”)
      on
      which the following conditions precedent have been satisfied:

     

    (i)
        the
      Administrative Agent shall have received counterparts of this Amendment that,
      when taken together, bear the signatures of Holdings, the Borrower and the
      Required Lenders; and

     

    (ii)
        the
      Administrative Agent shall have received all amounts due and payable by the
      Borrower hereunder or under the Credit Agreement on or prior to the Amendment
      Effective Date, including, to the extent invoiced, reimbursement or payment
      of
      all out-of-pocket expenses (including expenses due pursuant to Section 10 of
      this Amendment) required to be reimbursed or paid by the Borrower hereunder
      or
      thereunder.

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    3

     

    SECTION
      8.   Applicable
      Law.
      THIS
      AMENDMENT SHALL BE GOVERNED BY, AND CONSTRUED IN ACCORDANCE WITH, THE LAWS
      OF
      THE STATE OF NEW YORK.

     

    SECTION
      9.   Counterparts.
      This
      Amendment may be executed in two or more counterparts, each of which shall
      constitute an original but all of which when taken together shall constitute
      but
      one contract. Delivery of an executed signature page of this Amendment by
      facsimile transmission shall be effective as delivery of a manually executed
      counterpart hereof.

     

    SECTION
      10.   Expenses.
      The
      Borrower agrees to reimburse the Administrative Agent for its out-of-pocket
      expenses in connection with this Amendment, including the reasonable fees,
      charges and disbursements of Cravath, Swaine & Moore LLP, counsel
      for the Administrative Agent.

     

    SECTION
      11.   Headings.
      The
      Section headings used herein are for convenience of reference only, are not
      part
      of this Amendment and are not to affect the construction of, or to be taken
      into
      consideration in interpreting, this Amendment.

     

    SECTION
      12.   Effect
      of Amendment.
      Except
      as expressly set forth herein, this Amendment shall not by implication or
      otherwise limit, impair, constitute a waiver of, amend, or otherwise affect
      the
      rights and remedies of the Lenders or the Administrative Agent under the Credit
      Agreement or any other Loan Document, and shall not alter, modify, amend or
      in
      any way affect any of the terms, conditions, obligations, covenants or
      agreements contained in the Credit Agreement or any other Loan Document, all
      of
      which are ratified and affirmed in all respects and shall continue in full
      force
      and effect. Nothing herein shall be deemed to entitle any Loan Party to a
      consent to, or a waiver, amendment, modification or other change of, any of
      the
      terms, conditions, obligations, covenants or agreements contained in the Credit
      Agreement or any other Loan Document in similar or different circumstances.
      This
      Amendment shall apply and be effective with respect to the matters expressly
      referred to herein. After the Amendment Effective Date, any reference to the
      Credit Agreement shall mean the Credit Agreement as amended or modified hereby.
      This Amendment shall constitute a “Loan Document” for all purposes of the Credit
      Agreement and the other Loan Documents.

     

    IN
      WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly
      executed by their respective authorized officers as of the day and year first
      written above.

     

    [The
      remainder of this page intentionally left blank]

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

      4

       

       

      

      
        	ADVANCE AUTO PARTS, INC.
	 	 	 
	 	by: 	 
	 	 	
                
                  
 
Name:

                 
                  Title:

              

      

       

    

     

    
      
        	
                ADVANCE STORES COMPANY,

                INCORPORATED,

              
	 	 	 
	 	by: 	 
	 	 	
                
                  

                

                  Name:

                  Title: 

              

      

       

      

      
        	
                JPMORGAN CHASE BANK, N.A.,

                individually and as Administrative Agent,

              
	 	 	 
	 	by: 	 
	 	 	
                
                  

                

                  Name:

                  Title: 

              

      

       

     

    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    5

    
      

      
        	
                SIGNATURE PAGE TO AMENDMENT NO. 1 DATED AS OF AUGUST 25, 2005,
                  TO THE
                  AMENDED AND RESTATED CREDIT AGREEMENT DATED AS OF NOVEMBER 3, 2004,
                  among ADVANCE AUTO PARTS, INC., ADVANCE STORES COMPANY, INCORPORATED,
                  THE
                  LENDERS and JPMORGAN CHASE BANK, N.A., as Administrative
                  Agent,

              
	 	 	 
	Name of Institution ___________________, 
	 	 	 
	 	by: 	 
	 	 	
                
                  

                

                  Name:

                  Title:

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