Unassociated Document


    

      Exhibit
        10.7

      


      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
        LICENSE AGREEMENT
        (hereinafter referred to as this “Agreement”),
        effective as of this February 8, 2005 is entered into by and between The
        Cleveland Clinic Foundation, an Ohio non-profit corporation located at 9500
        Euclid Avenue, Cleveland, Ohio 44195 (the “Licensor”),
        and
        Greenwich Pharmaceuticals, Inc., a Delaware for-profit corporation located
        at
        787 Seventh Avenue, New York, New York 10019 (the “Company”).
        Licensor and Company shall individually be referred to as “Party”
        and
        collectively referred to as the “Parties.”

      


      WHEREAS,
        the
        Licensor owns rights to the research, development and commercialization of
        intellectual property relating to Sodium Stibogluconate, Pentamidine, analogues
        of Sodium Stibogluconate and Pentamidine, pentavalent antimony-based compounds
        and other compounds (collectively, the “Technology”)
        as
        claimed in Patent Rights or covered by Know-How (as defined below);
        and

      


      WHEREAS,
        the
        Company is interested in obtaining rights for the use, production, distribution,
        and marketing of products derived from the Technology, and Licensor is willing
        to grant such rights so that the Technology may be developed and the benefits
        enjoyed by the public.

      


      NOW,
        THEREFORE,
        it is
        agreed 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.

      


      1.2 “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 fifty percent (50%)
        of the
        directorships or similar positions with respect to such Entity.

      


      1.3 “Entity”
        shall
        mean any corporation, association, joint venture, partnership, trust,
        university, business, individual, government or political subdivision thereof,
        including an agency, or any other organization that can exercise independent
        legal standing.

      


      1.4 “Company”
        shall
        mean Greenwich Pharmaceuticals, Inc., a Delaware corporation.

      


      1.5 “Fair
        Market Value”
        shall
        mean a commercially reasonable price agreed to between a willing buyer and
        a
        willing seller in an arm’s length transaction.

      


      1.6 “Field
        of Use”
        shall
        mean all uses.

      


      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      1.7 “Improvements”
        shall
        mean (i) any modifications of a Licensed Process or Licensed Product developed
        by the Licensor after the date of this Agreement; (ii) any invention (whether
        patentable or not), information and data developed or discovered after the
        date
        of this Agreement that the manufacture, use or sale of which would be reasonably
        necessary in the manufacturing, use or sale of Licensed Products or Processes
        or
        would infringe an issued or pending claim within the Patent Rights.

      


      1.8 “Investigator(s)”
        shall
        mean Taolin Yi, Ph.D., members of his laboratory during their respective
        employment by Licensor, and any Licensor employee acting under Dr. Yi’s
        direction or control. 

      


      1.9 “Know-how”
        shall
        mean all tangible information (other than those contained in the Patent Rights)
        whether patentable or not (but which have not been patented), which are
        reasonably necessary to practice the Patent Rights or to sell Licensed Compound,
        Licensed Products or practice Licensed Processes, including formulations,
        processes and procedures, data, drawings and sketches, in vitro and in vivo
        data, animal data, laboratory data, observations, designs, testing and test
        results, regulatory information of a like nature, manufacturing processes
        developed by Investigators and owned by the Licensor, which Licensor have
        the
        right to disclose and license to the Company. 

      


      1.10 “Licensed
        Compound”
        shall
        mean, separately, (i) Sodium Stibogluconate; (ii) Pentamidine; (iii) each
        analogue of Sodium Stibogluconate; (iv) each analogue of Pentamidine, and
        (v)
        pentavalent antimony-based compounds; provided,
        however,
        such
        compounds in (i)-(v) are covered under the Patent Rights; and (v) any other
        compound described in the patent or patent application listed on Exhibit
        A.

      


      1.11 “Licensed
        Product(s)”
        shall
        mean:

      


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

      


      1.11.2 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;

      


      1.11.3 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.

      


      1.12 “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.

      


      1.13 “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 or any of its Affiliates
        or
        sublicensees, whether invoiced or not, less only the sum of the
        following:

      


      1.13.1 Usual
        trade discounts to customers;

      


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

      


      1.13.3 Amounts
        allowed or credited on returns or rejections;

      


      1.13.4 Licensed
        Product or Licensed Process revenues deemed uncollectible and actually written
        off during the accounting period; and

      


      
        
          
          

        

        
          2

          
            

          

        

        
          
          

        

      

      1.13.5 Outbound
        transportation prepaid or allowed and transportation insurance.

      


      1.14 “Patent
        Rights”
        shall
        mean all U.S. and foreign patents and patent applications set forth in
Exhibit
        A
        and:

      


      1.14.1 Any
        other
        United States and/or foreign patent applications and/or patents filed on
        behalf
        of the Investigators by CCF and owned by CCF that claim priority to any of
        the
        patents or applications listed in Exhibit
        A,
        together with any and all patents issuing thereon, including continuations,
        continuations in part, divisionals, reexaminations, extensions, and reissue
        applications and continuation-in-part applications and any United States
        or
        foreign patents granted upon such applications; 

      


      1.14.2 U.S.
        and
        foreign patents and patent applications claiming Improvements developed in
        the
        first year immediately following the Effective Date of this Agreement including
        any continuations, continuations-in-part, divisionals, reissues, reexaminations
        or extensions thereof;

      


      1.14.3 Any
        United States and/or foreign patents issuing from any application or other
        right
        listed in this Article 1.14.

      


      1.14.4 Any
        patent or patent application owned as of the Effective Date by Licensor claiming
        Licensed Compounds or their use or manufacture that that would be reasonably
        necessary for the Company to manufacture, use, or sell Licensed Products
        or
        Licensed Processes. 

      


      1.15 “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) sublicense to third parties, in accordance with Section
        2.2
        below, the rights granted under subsection (a) of this Section 2.1.
        Notwithstanding the foregoing, Licensor reserves the right to practice under
        the
        Patent Rights and utilize the Know-How for its own non-commercial research
        and
        educational purposes; provided,
        however,
        the
        Licensor shall not conduct any human clinical trials with a Licensed Product
        without first receiving written permission from Company.

      


      2.2 In
        accordance with Section 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 that such sublicenses shall be in writing.
        Within thirty- (30) days after execution or receipt thereof, as applicable,
        the
        Company shall provide Licensor with a copy of each sublicense issued hereunder.
        Upon termination of this Agreement, any sublicensee shall survive such
        termination provided that sublicensees agree in writing to fully comply with
        the
        terms and conditions this Agreement, provided, further, however, that such
        sublicensee is in good standing at the time of such termination and that
        if such
        sublicensee is not in good standing at the time of termination of this
        Agreement, the Company shall notify sublicensee of its default and such
        sublicensee shall have sixty- (60) days to cure any breach of its sublicense
        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.

      


      
        
          
          

        

        
          3

          
            

          

        

        
          
          

        

      

      2.3 The
        licenses granted in Sections 2.1 may be subject to the rights of the United
        States Government as set forth in 35 U.S.C. § 200 et seq. If there is any
        conflict between any Government rights and the rights granted herein, such
        Government rights shall prevail.

      


      2.4 The
        Licensor hereby grants to the Company, and the Company hereby accepts, the
        exclusive right to negotiate for a license, on a worldwide basis in all fields
        of use, and on commercially reasonable terms, any Improvements developed
        on or
        after the first anniversary of the Effective Date of this Agreement through
        the
        end of the Term (hereinafter “Follow-on
        Improvements”).
        In
        the event that Licensor files a U.S. patent application on any Follow-on
        Improvements, Licensor shall under confidentiality notify Company of such
        Follow-on Improvements prior to discussing a license with any third party.
        Company shall have no longer than thirty- (30) days immediately following
        the
        disclosure of such Follow-on Improvements to notify Licensor in writing of
        its
        desire to obtain a license to the Follow-on Improvements. Parties shall enter
        into good-faith negotiations for a license to the Follow-on Improvements
        for a
        period of ninety- (90) days. If within such time period, the Parties are
        not
        able to agree upon a license, Licensor shall have no further obligation to
        Company relating to such Follow-on Improvement.

      


      2.5 The
        Licensor covenants that it will not, during the term of this Agreement, (a)
        cause or assist in the assertion, instigation, maintenance or pursuit of
        any
        claim or litigation against the Company based on or alleging that the Company’s
        manufacture, use, or sale of Licensed Processes or License Products infringe
        on
        any rights under any patents or patent applications having the Investigator
        as
        an inventor and owned by the Licensor as of the Effective Date or (b) enter
        into
        a license with respect to or otherwise convey rights under, any of the patents
        and patent applications listed in Exhibit
        A
        to any
        third party. 

      


      2.6 Licensor
        shall, to the extent permitted by applicable law and regulations, provide
        the
        Company with, and/or give the Company access to the following information
        specifically pertaining to the research and development of the Technology
        to the
        extent that such information is reasonably available and accessible to Licensor:
        (i) copies of all regulatory submissions by the Licensor, its Affiliates,
        contractors or agents, (ii) copies of or access to all patient records and
        data
        (including those held by physicians, care facilities, or clinical trial
        organizations) to the extent the Licensor has copies thereof or can provide
        access thereto, (iii) copies of all computer data and reports pertaining
        to
        clinical trials, (iv) copies of all adverse event reports, (v) copies of
        all
        pre-clinical evaluations, (vi) any clinical trial material in the Licensor’s
        possession that has not expired, (vii) reasonable storage of and access to
        biological samples, (viii) physicians, CROs and health care administrators
        involved in trials, to the extent such persons are available, (ix) all drug
        manufacture files, if any, along with the right to use manufacturing processes,
        (x) remaining quantities of any active pharmaceutical ingredient intermediates
        pursuant to the terms of a supply agreement to be negotiated between the
        parties
        and (xi) all other information that the Company may reasonably request from
        the
        Licensor. All costs related to the duplication and transfer of such materials
        shall be borne by the Company. In addition, the Licensor shall assign or,
        if the
        Licensor is legally prohibited from assigning or the parties agree to
        cross-reference, cross-reference to the Company all regulatory filings relating
        to Licensed Products. To the extent that the Licensor has access to patient
        records, data, computer files, patient samples or other patient clinical
        trial
        information, the Licensor, to the extent permitted by law, on written request
        by
        the Company, shall arrange for the Company access to such documents,
        information, and materials. From time to time during the term of this Agreement,
        at the request and expense of the Company, the Licensor agrees to execute
        and
        deliver to the Company such documents and take such other actions as the
        Company
        may reasonably request in order to consummate more effectively the transactions
        contemplated hereby. The Licensor shall reasonably cooperate with the Company
        and provide the Company with such assistance as reasonably may be requested
        by
        the Company, including with respect to the transfer of clinical data and
        filings
        with the FDA. 

      


      
        
          
          

        

        
          4

          
            

          

        

        
          
          

        

      

      ARTICLE
        3 - COMMERCIALIZATION

      


      The
        Company shall use all commercially reasonable efforts to bring a Licensed
        Product to market through a thorough, vigorous and diligent program for
        exploitation of the Technology as timely and efficiently as possible. Such
        program shall include the preclinical and clinical development of Licensed
        Products, including research and development, manufacturing, laboratory and
        clinical testing and marketing. The Company shall continue active, diligent
        marketing efforts for a Licensed Product throughout the term of this Agreement.
        Company intends to fund and support ongoing research and clinical development
        at
        CCF, provided however, the Company funded research or clinical trials are
        conducted under the direction and control of the Company and such research
        and
        clinical development is in the best interest of commercially developing the
        compounds as determined by the Company in its sole discretion. Should the
        Company discontinue such research and clinical development with the Technology
        at the Cleveland Clinic, such action shall not be deemed a breach of this
        Agreement

      


      ARTICLE
        4 - ROYALTIES AND OTHER CONSIDERATION

      


      4.1 In
        partial consideration for the License Grant herein, Company will remit to
        the
        Licensor a non-creditable, non-refundable fee of Five Hundred Thousand Dollars
        ($500,000)
        within
        fifteen- (15) days of the Effective Date of this Agreement. Additionally,
        the
        Company will remit to Licensor [***] Dollars ($[***]) promptly upon execution
        of
        this Agreement to reimburse Licensor for accountable out of pocket expenses
        incurred directly from the filing, prosecuting, and maintaining of the Licensed
        Patents accrued prior to the execution of the License Agreement.

      


      4.2 Within
        thirty- (30) days immediately following the first anniversary of the License
        Agreement and every anniversary thereafter for the duration of the Term,
        Company
        would pay Licensor Thirty Five Thousand Dollars ($35,000)
        (the
“Maintenance
        Fee”).
        Maintenance Fees will be fully creditable against Earned Royalties payable
        pursuant to Section 4.1 and Milestone Payments due Licensor within the twelve-
        (12) months immediately following each payment.

      


      4.3 As
        further consideration for the license granted hereunder, the Company will
        make
        the following one-time milestone payments (each a “Milestone
        Payment”)
        to
        Licensor. The Company will not pay the same milestone twice on any Licensed
        Product containing a Licensed Compound already developed by the Company.
        For
        clarity, should the Company develop a Licensed Product containing Pentamidine,
        it would not have to pay the Milestone Payment listed below for the development
        of a subsequent Licensed Product containing Pentamidine, but would only be
        obligated to pay the Milestone Payment below if such subsequent Licensed
        Product
        contains an active ingredient other than Pentamidine and that is not present
        in
        a prior Licensed Product. Payments made pursuant to this Section 4.5 shall
        be
        credited against Earned Royalties payable pursuant to Section 4.1 and accrued
        for the same Licensed Product within the twelve (12) months immediately
        following the payment of such Milestone Payment. Accordingly, the Company
        shall
        remit to the Licensor:

      


      4.3.1 [***]
        Dollars ($[***]) upon the first dosing of a patient, with a Licensed Product,
        in
        the first Phase II clinical trial (or if in a country other than the United
        States, a regulatory equivalent of a Phase II Clinical Trial) under a
        Company-sponsored (or sublicensee-sponsored) Investigational New Drug
        Application (an “IND”)
        for
        such Licensed Product;

      


      4.3.2 [***]
        Dollars ($[***]) upon the first dosing of a patient, with a Licensed Product,
        in
        the first Phase III clinical trial (or if in a country other than the United
        States, a regulatory equivalent of a Phase III Clinical Trial) under a Company
        sponsored (or sublicensee sponsored) IND for such Licensed Product;

      


      
        
          
          

        

        
          5

          
            

          

        

        
          
          

        

      

      4.3.3 [***]
        Dollars ($[***]) upon the acceptance for review a Company sponsored (or
        sublicensee sponsored) New Drug Application (an “NDA”)
        by the
        United States Food and Drug Administration (the “FDA”)
        for
        such Licensed Product (or if in a country other than the United States, that
        countries regulatory equivalent on an NDA); and

      


      4.3.4 [***]
        Dollars ($[***]) upon the final approval by the FDA of a Company-sponsored
        (or
        sublicensee-sponsored) NDA for such Licensed Product filed by the Company
        or its
        sublicensee (or if in a country other than the United States, that countries
        regulatory equivalent of an NDA).

      


      For
        clarity, one time payments due to the Licensor in Sections 4.3.1-4.3.4 above
        shall be due on the first to occur of a United States and foreign clinical
        event
        (as applicable), but in no case both. The Company shall be responsible for
        notifying Licensor in writing of achievement of the milestones listed above
        within ten- (10) business days of their occurrence and Milestone Payments
        shall
        be due within thirty- (30) days following such written
        notification.

      


      4.4 During
        the Term, the Company shall pay to the Licensor royalties equal to [***]
        percent
        ([***]%) of annual Net Sales by the Company or its sublicensees resulting
        from
        the sale of any Licensed Product by the Company or its sublicensees to an
        end
        user (hereinafter “Earned
        Royalty”).
        

      


      4.5 No
        multiple Earned Royalties shall be payable because the use, lease or sale
        of any
        Licensed Product or Licensed Process is, or shall be, covered by more than
        one
        valid and unexpired claim contained in the Patent Rights.

      


      4.6 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 that 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.
        In no event shall Licensor’s Earned Royalty be calculated on a pro rata
        contribution to a combination product of less than [***] percent ([***]%)
        of the
        Net Sales.

      


      4.7 
        Royalty
        payments shall be paid in United States dollars 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. If Company is required
        by law, rule or regulation to withhold taxes from the types of payment due
        Licensor hereunder, the parties shall (a) deduct those taxes from the amount
        otherwise remittable to Licensor hereunder, (b) pay such taxes to the proper
        taxing authority, and (c) send evidence of the obligation together with proof
        of
        payment to Licensor within fifteen- (15) business days following that payment.
        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 Citibank, N.A. in New York, New York on the last business day
        of
        the calendar quarterly reporting period to which such royalty payments
        relate.

      


      
        
          
          

        

        
          6

          
            

          

        

        
          
          

        

      

      4.8 Royalties
        payable to Licensor shall be paid quarterly on or before March 30, June 30,
        September 30, and December 31 of each calendar year. Each such payment shall
        be
        for unpaid royalties that accrued within or prior to the Company’s most recently
        completed fiscal quarters.

      


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

      


      4.10 To
        the
        extent that the Company or any Affiliate of the Company is required (i) in
        its
        sole discretion 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 use or sell Licensed Products or Licensed Processes under the Patent
        Rights, the Earned Royalty payable under Section 4.1 shall be reduced by
        [***]
        the royalty payable to such third party; provided,
        however,
        in no
        event shall the Earned Royalty be reduced to less than [***] percent ([***]%)
        of
        Net Sales.

      


      4.11 Company
        will pay Licensor a fee of [***] percent ([***]%) of all revenue received
        from
        granting of sublicenses to sublicensees, excluding amounts paid by sublicensee
        to Company directly relating to (a) any issuance of debt or equity securities
        of
        the Company; (b) the research and development of the Technology or dedicated
        to
        establish a marketing and sales force for sales of the Technology; (c) Net
        Sales
        of Licensed Products; and/or (iv) in exchange for goods and/or services relating
        to a Licensed Product having a Fair Market Value equivalent to the amount
        received by the Company (the “Sublicense
        Fee”).
        For
        instance, the Company would not owe the Licensor a Sublicense Fee based on
        royalties it receives from a sublicensee for Net Sales of Licensed Products,
        other than those described in Section 4.4.

      


      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 up to once per year 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. If an inspection shows
        an
        under reporting or underpayment in excess of the greater of [***] percent
        ([***]%) and [***] Dollars ($[***]) for any twelve- (12) month period 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
        Section 5.4 of this Agreement. Notwithstanding the foregoing, 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, 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. These
        shall
        include at least the following:

      


      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;

      


      
        
          
          

        

        
          7

          
            

          

        

        
          
          

        

      

      5.2.3 Deductions
        applicable in computed Net Sales, if any; 

      


      5.2.4 Total
        Earned 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.

      


      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 so in writing.

      


      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
        ([***]%).

      


      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 Licensor
        may
        reasonably request, as may be pertinent to an accounting of
        royalties.

      


      5.6 On
        a
        semi-annual basis, the Company shall provide Licensor with a report detailing
        the clinical progress of Licensed Products that have been made since the
        previous such report and steps that are being taken to further develop and
        commercialize Licensed Products.

      


      5.7 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.

      


      ARTICLE
        6 - PATENT PROSECUTION AND MAINTENANCE

      


      6.1 Following
        the Effective Date, at the Company’s expense and providing Licensor has received
        the Patent Fee, the Company shall diligently prosecute and maintain the Patent
        Rights 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. Both parties
        agree to provide reasonable cooperation to each other to facilitate the
        application and prosecution of patents pursuant to this Agreement.

      


      6.2 The
        Company may, in its discretion, elect to abandon any patent applications
        or
        issued patent in the 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 or patent application.
        In
        such event, Licensor shall have the right, but not the obligation, to commence
        or continue such prosecution and to maintain any such patent or patent
        obligation under its own control and at its expense in which case the license
        to
        Company to such patent or patent application in such jurisdiction will
        terminate. 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 patents or patent
        applications.

      


      
        
          
          

        

        
          8

          
            

          

        

        
          
          

        

      

      6.3 Licensor
        hereby authorizes the Company (a) to include in any NDA for a Licensed Product,
        as the Company may deem appropriate under the Federal Food, Drug and Cosmetic
        Act (the “Act”),
        a
        list of patents included among the Licensed Patents that relate to such Licensed
        Product and such other information as the Company in its reasonable discretion
        believes is appropriate to be filed pursuant to the Act; (b) to commence
        suit
        for any infringement of the Licensed Patents under §271(e) of Title 35 of the
        United States Code occasioned by the submission by a third party of an IND,
        an
        Abbreviated New Drug Application (as that term is defined in the Act ) for
        a
        Licensed Product pursuant to §505(j) of the Act or an NDA for a Licensed Product
        pursuant to §505(b)(2) of the Act; and (c) to exercise any rights that may be
        exercisable by Licensor as patent owner under the Act to apply for an extension
        of the term of any patent included among the Licensed Patents. In the event
        that
        applicable law in any other country of the Territory hereafter provides for
        the
        extension of the term of any patent included among the Licensed Patents in
        such
        country, upon request by and at the expense of the Licensee, the Licensor
        shall
        use commercially reasonable efforts to obtain such extension or, in lieu
        thereof, shall authorize the Company or, if requested by the Company or its
        sublicensees to apply for such extension, in consultation with
        Licensor.

      


      6.4 Licensor,
        at the Company’s expense, agrees to reasonably cooperate with the Company or its
        sublicensees, as applicable, in the exercise of the authorization granted
        herein
        or which may be granted pursuant to this Article 6 and will execute such
        documents and take such additional actions as the Company may reasonably
        request
        in connection therewith, including, if necessary, permitting itself to be
        joined
        as a proper party in any suit for infringement brought by the Company under
        Section 6.2 and/or Section 6.3 above.

      


      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 Upon
        any
        material breach or default of this Agreement by the Company, other than as
        set
        forth in Section 7.1 above, Licensor shall have the right to terminate this
        Agreement and the rights, privileges and license granted hereunder by giving
        ninety- (90) days prior written notice to the Company. Subject to Article
        8,
        such termination shall become effective immediately upon notice from the
        Company
        following such ninety- (90) day period unless the Company shall have cured
        any
        such breach or default prior to the expiration of the ninety- (90) day period
        referred to above. If a dispute regarding termination is addressed according
        to
        Article 8, this Agreement shall remain in full force and effect until such
        dispute is settled in a manner that is not further appealable or not appealed
        provided however, that Company fulfills all rights and obligations to Licensor
        under this Agreement that are not in dispute.

      


      7.3 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
        thirty- (30) days notice thereof in writing to Licensor. 

      


      7.4 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.
        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.

      


      
        
          
          

        

        
          9

          
            

          

        

        
          
          

        

      

      7.5 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
        (the “Term”),
        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. 

      


      ARTICLE
        8 - DISPUTE RESOLUTION

      


      8.1 The
        Parties shall attempt in good faith to promptly resolve any dispute arising
        out
        of or relating to payments required under this Agreement between representatives
        who have authority to settle the controversy within thirty- (30) days of
        one
        party notifying the second party of such dispute in writing.

      


      8.2 If
        the
        matter pertaining to payments has not been resolved by negotiation within
        thirty- (30) days, the parties shall attempt in good faith to settle the
        dispute
        by mediation under the then-current rules of the American Arbitration
        Association (“AAA”).
        The
        neutral third party will be selected from the panel of neutrals of the AAA
        in
        accordance with the selection process of the AAA.

      


      8.3 If
        the
        matter has not been resolved by mediation within ninety- (90) days of the
        initiation of such procedure, or if either party does not participate in
        mediation in good faith, the dispute shall be settled by arbitration before
        a
        tribunal of three arbitrators in a location mutually agreeable to both parties
        in accordance with the rules of the AAA. Licensor shall select one- (1)
        arbitrator, the Company shall select one- (1) arbitrator, and the third
        arbitrator shall be selected by mutual agreement of the first two- (2)
        arbitrators.

      


      8.4 Any
        claim, dispute, or controversy that does not concern payments, including
        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.

      


      8.5 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 or any other issue not subject to arbitration,
        the
        arbitrators shall, to the extent possible, resolve all issues other than
        such
        issues including 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, and/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.

      


      8.6 The
        costs
        of such arbitration shall be borne proportionate to the finding of fault
        as
        determined by the Arbitrator. Any court of competent jurisdiction may enter
        judgment on the arbitration award.

      


      
        
          
          

        

        
          10

          
            

          

        

        
          
          

        

      

      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.

      


      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 pays all of Licensor’s reasonable out-of-pocket
        expenses. The Company shall indemnify and hold Licensor harmless against
        any
        costs, expenses or liability that may be found or assessed against Licensor
        in
        any such suit other than resulting from Licensor’s negligence or willful
        misconduct. Any recovery of damages pursuant to this Section 9.2 shall be
        retained entirely by the Company and allocated pursuant to Section 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 Section 9.2 above. 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 Section 4.1.1. 

      


      9.5 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 eobligation,
        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.

      


      9.6 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.
        

      


      
        
          
          

        

        
          11

          
            

          

        

        
          
          

        

      

      10.2 Nothing
        in this Agreement should be construed as:

      


      10.2.1 A
        warranty or representation by Licensor as to the validity or scope of any
        Patent
        Rights;

      


      10.2.2 A
        warranty or representation that anything made, used, sold or otherwise disposed
        of under any license granted in this Agreement is or will be free from
        infringement of patents of third parties; or

      


      10.2.3 A
        requirement that Licensor shall file any patent application, secure any patent,
        or maintain any patent, including without limitation any Licensed Patents,
        in
        force.

      


      10.3 The
        Company agrees to defend, indemnify and hold Licensor 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 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 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. The Licensor
        agrees
        to defend, indemnify and hold Company 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 out of a negligent or willful act of Licensor including pertaining
        to
        clinical evaluations of Licensed Compounds, Processes and Products.

      


      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.

      


      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
        or
        any of its units (including contraction, abbreviation or simulation of any
        of
        the foregoing) without the prior, written consent of Licensor; provided,
        however, that Licensor acknowledges and agrees that the Company may use the
        names of Licensor in various documents used by the Company for capital raising
        and financing without such prior written consent where the use of such names
        may
        be required by law. 

      


      
        
          
          

        

        
          12

          
            

          

        

        
          
          

        

      

      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 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.

      


      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:

      


      Notices
        or other Communications:

      


      CCF
        Innovations

      9500
        Euclid Avenue / Mailcode D20

      Cleveland,
        Ohio 44195

      Attn:
        Licensing Coordinator

      Tel:
        216-444-5757

      Fax:
        216-445-6515

      E-mail:
        arasr@ccf.org (Dr. Rahul Aras)

      


      For
        technical/scientific issues, with a copy to:

      


      Taolin
        Yi, Ph.D. / Mailcode NB40

      


      
        
          
          

        

        
          13

          
            

          

        

        
          
          

        

      

      For
        legal
        issues, with a copy to:

      


      Office
        of
        General Counsel / Mailcode H18

      


      


      For
        use
        of name and/or publicity issues, with a copy to:

      


      Chief
        Communications Officer / Mailcode H18

      


      Payments:

      


      The
        Cleveland Clinic Foundation

      Attention:
        CCF Innovations (Agreement No. 02190-001) 

      P.O.
        Lockbox 931532

      Cleveland,
        OH 44193

      


      Licensor’s
        Federal Tax Identification Number: 34-0714585.

      


      In
        the
        case of the Company:

      


      Greenwich
        Therapeutics, Inc.

      787
        Seventh Avenue

      48th
        Floor

      New
        York,
        NY 10019

      Attn:
        President and CEO

      Tel:
        (212) 554 4381

      Fax:
        (212) 554 4490

      


      ARTICLE
        15 - CONFIDENTIALITY

      


      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:

      


      (i) The
        Company receives at any time from a third-party lawfully in possession of
        same
        and having the right to disclose same;

      


      (ii) Is,
        as of
        the date of this Agreement, in the public domain, or subsequently enters
        the
        public domain through no fault of the Company;

      


      (iii) Is
        independently developed by the Company as demonstrated by written evidence
        without reference to information disclosed to the Company by
        Licensor;

      


      
        
          
          

        

        
          14

          
            

          

        

        
          
          

        

      

      (iv) Is
        disclosed pursuant to the prior written approval of Licensor; or

      


      (v) 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 - INSURANCE

      


      16.1 At
        such
        time as any product, process, service relating to, or developed pursuant
        to,
        this Agreement is being commercially distributed or sold (other than for
        the
        purpose of obtaining regulatory approvals) by Company or sublicensee, Company
        shall at its sole cost and expense, procure and maintain comprehensive general
        liability insurance in amounts not less than [***] Dollars ($[***]) per incident
        and naming the Licensor as additional insureds. Such comprehensive general
        liability insurance shall provide product liability coverage for Company’s
        indemnification under this Agreement. If Company elects to self-insure all
        or
        part of the limits described above (including deductibles or retentions which
        are in excess of [***] Dollars ($[***]) annual aggregate) such self-insurance
        program must be acceptable to Licensor. Such insurance will be considered
        primary as to any other valid and collectible insurance, but only as to acts
        of
        the named insured. The minimum amounts of insurance coverage required shall
        not
        be construed to create a limit of Company’s liability with respect to its
        indemnification under this Agreement.

      


      16.2 Company
        shall provide Licensor with written evidence of such insurance upon request
        of
        the Licensor. Company shall provide the Licensor with written notice at least
        sixty- (60) days prior to the cancellation or non-renewal of such insurance;
        if
        Company does not obtain replacement insurance providing commercially reasonable
        coverage within such sixty- (60) day period, the Licensor shall have the
        right
        to terminate this Agreement effective at the end of such sixty- (60) day
        period
        without notice or any additional waiting periods.

      


      16.3 Company
        shall maintain such comprehensive general liability insurance beyond the
        expiration or termination of this Agreement during (i) the period that any
        product, process, or service, relating to, or developed pursuant to, this
        Agreement is being commercially distributed or sold by Company or by a
        sublicensee, and (ii) a commercially reasonable period thereafter.

      


      ARTICLE
        17 - MISCELLANEOUS PROVISIONS

      


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

      


      17.2 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.

      


      17.3 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.

       

      17.4 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.

      


      
        
          
          

        

        
          15

          
            

          

        

        
          
          

        

      

      17.5 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.

      


      17.6 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.

      


      17.7 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.

      


      17.8 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.

      


      17.9 Each
        party hereto shall be excused from any breach of this Agreement that 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.

       

      ARTICLE
        18 - REPRESENTATIONS AND WARRANTIES OF LICENSOR

      


      As
        of the
        Effective Date of this Agreement, Licensor represents and warrants that to
        its
        knowledge and belief:

      


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

      


      (ii) Licensor
        has not issued any licenses, options, restrictions, liens, rights of third
        parties, disputes, royalty obligations, proceedings or claims limiting
        Licensor’s rights or the rights of the Company under this Agreement or which may
        reasonably lead to a claim of infringement or invalidity regarding, any part
        or
        all of the Patent Rights or Know How or their use;

      


      (iii) None
        of
        the Patent Rights, Licensed Products or Licensed Processes infringes or
        conflicts in any material respect with, and the Licensor has not received
        any
        notice of infringement of, or conflict with, any license, patent, or other
        intellectual property right of any third party and, to the knowledge of the
        Licensor. There is no claim pending, filed or threatened against Licensor,
        of
        infringement, interference or invalidity regarding any part or all of the
        Patent
        Rights or Know-how or their use;

      


      (iv) The
        US
        and foreign patent applications and patents itemized on Exhibit A set forth
        all
        of the patents and patent applications owned by or licensed by Licensor as
        of
        the Effective Date claiming the Technology in the Field of Use; and

      


      (v) 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.

      


      
        
          
          

        

        
          16

          
            

          

        

        
          
          

        

      

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

      


      THE
        CLEVELAND CLINIC FOUNDATION (LICENSOR):

      


      


      By: ______________________________   Date: __________,
        2005

      Name: Michael
        P. O’Boyle

      Title: Chief
        Financial Officer

      


      


      GREENWICH
        PHARMACEUITICALS, INC.

      


      


      By: ______________________________   Date: __________,
        2005

      


      Name: ______________________________

      


      Title: ______________________________

      


      


      Acknowledged
        (not signatories):

      


      


      By: ______________________________   Date: __________,
        2005

      Name: Derek
        Raghavan, M.D., Ph.D.

      Title: Chairman
        and Director, Cleveland Clinic Taussig Cancer Center

      


      


      By: ______________________________   Date: __________,
        2005

      Name: Paul
        DiCorleto, Ph.D.

      Title: Chairman,
        Lerner Research Institute

      


      


      By: ______________________________   Date: __________,
        2005

      Name: Taolin
        Yi, Ph.D.

      Title: Staff
        Scientist

      


      
        
          
          

        

        
          17

          
            

          

        

        
          
          

        

      

      EXHIBIT
        A

      


      
        	
                Serial
                  Number

              	
                Title

              	
                Pub.
                  Date

              
	
                [***]

              	
                [***]

              	
                [***]

              


      

       

       

      
        
          
          

        

        
          18

          
            

          

        

        
          
          

        

      

      EXHIBIT
        B

      


      Funding
        Sources:

      


      The
        following National Institute of Health grants to Taolin Yi, Ph.D. have funded
        the development of the Technology:

      


      1. R01
        CA79891 (Principal Investigator: Taolin Yi, Ph.D.);

      


      2. R01
        GM58893 (Principal Investigator: Taolin Yi, Ph.D.);

      


      3. R01
        CA096636 (Principal Investigator: Taolin Yi, Ph.D.); and

      


      4. R01
        CA102481 (Principal Investigator: Taolin Yi, Ph.D.)

       

       

      
        
          
          

        

        
          19