Portions
      herein identified by ** have

    been
      omitted pursuant to a request for

    confidential
      treatment and have been

    filed
      separately with the Commission

    pursuant
      to Rule 24b-2 of the Exchange

    Act
      of
      1934, as amended. 

     

    AMENDED
      & RESTATED LICENSE AND DEVELOPMENT AGREEMENT\

     

    By

     

    and

     

    Between

     

    **
      and

     

    FIDOPHARM,
      INC.

     

    
      
         

      

      
         

        
          

        

      

      
         

      

       

    

    TABLE
      OF CONTENTS

     

    
      	 	 	 	 	
              Page

            
	 	 	 	 	 
	
              INDEX

            	 	 
	 	 	 
	
              1.

            	
              DEFINITIONS

            	 	
              1

            
	 	 	 	 
	
              2.

            	
              LICENSE
                GRANT AND OTHER RIGHTS

            	 	
              3

            
	 	 	 	 
	 	
              2.1

            	
              Exclusive
                License

            	 	
              3

            
	 	
              2.2

            	
              Right
                of Reference

            	 	4
	 	
              2.3

            	
              Copyrighted
                Materials

            	 	
              4

            
	 	
              2.4

            	
              Exclusive
                Right of First Negotiation

            	 	
              4

            
	 	 	 	 	 
	
              3.

            	
              CONSIDERATION

            	 	
              4

            
	 	 	 	 
	 	
              3.1

            	
              Upfront
                Payment

            	 	
              4

            
	 	
              3.2

            	
              Supply
                Agreement

            	 	4
	 	
              3.3

            	
              No
                Additional Consideration

            	 	
              5

            
	 	 	 	 	 
	
              4.

            	
              DEVELOPMENT

            	 	5
	 	 	 	 	 
	 	
              4.1

            	
              Overview

            	 	
              5

            
	 	
              4.2

            	
              Development
                Plan

            	 	
              5

            
	 	
              4.3

            	
              Diligence

            	 	
              5

            
	 	
              4.4

            	
              Reporting
                and Data

            	 	
              5

            
	 	
              4.5

            	
              Compliance
                with Laws

            	 	
              5

            
	 	
              4.6

            	
              Access
                to Records and Facilities

            	 	
              6

            
	
            	
              4.7

            	
              Territory
                Specific Development

            	 	
              6

            
	 	 	 	 	 
	
              5.

            	
              PRODUCT
                REGISTRATION AND COMMERCIALIZATION

            	 	
              6

            
	 	 	 	 
	 	
              5.1

            	
              Product
                Registration

            	 	
              6

            
	 	
              5.2

            	
              Registration
                and Commercialization Plans

            	 	
              6

            
	 	
              5.3

            	
              Trademarks

            	 	
              6

            
	 	
              5.4

            	
              Cooperation

            	 	
              7

            
	 	
              5.5

            	
              Reporting

            	 	
              7

            
	 	 	 	 	 
	
              6.

            	
              SUPPLY
                OF PRODUCTS

            	 	
              7

            
	 	 	 	 
	 	
              6.1

            	
              Supply
                Agreement

            	 	
              7

            
	 	
              6.2

            	
              Technology
                Transfer

            	 	
              7

            
	 	 	 	 	 
	
              7.

            	
              PATENTS

            	 	7
	 	 	 	 
	 	
              7.1

            	
              Prosecution
                and Maintenance of Patents

            	 	
              7

            
	 	
              7.2

            	
              Notification
                of Infringement

            	 	
              7

            
	 	
              7.3

            	
              Enforcement
                Against Third Parties

            	 	
              8

            
	 	
              7.4

            	
              Alleged
                Infringement of Third Party’s Patents

            	 	
              8

            
	 	 	 	 	 
	
              8.

            	
              REPRESENTATIONS,
                WARRANTIES AND COVENANTS

            	 	
              8

            
	 	 	 	 
	 	
              8.1

            	
              **
                Representations, Warranties and Covenants

            	 	
              8

            
	 	
              8.2

            	
              Fidopharm
                Representations and Warranties

            	 	
              10

            


    

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    
      TABLE
        OF CONTENTS

      (continued)

    

    
       

      
        	 	 	 	 	
                Page

              
	 


      

    

    
      	 	
              8.3

            	
              Regulatory
                Cooperation

            	 	
              10

            
	 	
              8.4

            	
              Compliance
                with Laws

            	 	
              11

            
	 	 	 	 	 
	
              9.

            	
              CONFIDENTIALITY

            	 	
              11

            
	 	 	 	 
	 	
              9.1

            	
              Confidentiality;
                Nondisclosure; Nonuse

            	 	
              11

            
	 	
              9.2

            	
              Exception
                to Confidential Information

            	 	
              11

            
	 	
              9.3

            	
              Notification
                of Mandatory Disclosure

            	 	
              12

            
	 	
              9.4

            	
              Patent
                Application Filing

            	 	
              12

            
	 	
              9.5

            	
              Permitted
                Disclosure to Third Parties

            	 	
              12

            
	 	 	 	 	 
	
              10.

            	
              INDEMNIFICATION
                AND INSURANCE

            	 	
              12

            
	 	 	 	 
	 	
              10.1

            	
              **
                Indemnification Obligations

            	 	
              12

            
	 	
              10.2

            	
              Fidopharm’s
                Indemnification Obligations

            	 	
              12

            
	 	
              10.3

            	
              Indemnification
                Procedure

            	 	
              13

            
	 	
              10.4

            	
              Insurance

            	 	
              13

            
	 	 	 	 	 
	
              11.

            	
              TERM
                AND TERMINATION

            	 	
              13

            
	 	 	 	 
	 	
              11.1

            	
              Term

            	 	
              13

            
	 	
              11.2

            	
              Termination
                by Fidopharm

            	 	
              13

            
	 	
              11.3

            	
              Termination
                for Breach

            	 	
              14

            
	 	
              11.4

            	
              Termination
                for Bankruptcy, etc

            	 	
              14

            
	 	
              11.5

            	
              Termination
                for Failure

            	 	
              14

            
	 	
              11.6

            	
              Effect
                of Expiration or Termination.

            	 	
              15

            
	 	 	 	 	 
	
              12.

            	
              INJUNCTIVE
                RELIEF AND DISPUTE RESOLUTION

            	 	
              15

            
	 	 	 	 
	 	
              12.1

            	
              Equitable
                Relief

            	 	
              15

            
	 	
              12.2

            	
              Dispute
                Resolution

            	 	
              15

            
	 	 	 	 	 
	
              13.

            	
              MISCELLANEOUS

            	 	
              16

            
	 	 	 	 
	 	
              13.1

            	
              Force
                Majeure

            	 	
              16

            
	 	
              13.2

            	
              Further
                Assurances

            	 	
              16

            
	 	
              13.3

            	
              Assignment

            	 	
              16

            
	 	
              13.4

            	
              Choice
                of Law

            	 	
              16

            
	 	
              13.5

            	
              Notices

            	 	
              16

            
	 	
              13.6

            	
              Entire
                Agreement

            	 	
              17

            
	 	
              13.7

            	
              Amendments;
                Waivers

            	 	
              17

            
	 	
              13.8

            	
              Severability

            	 	
              17

            
	 	
              13.9

            	
              Independent
                Contractors

            	 	
              17

            
	 	
              13.10

            	
              Counterparts

            	 	
              17

            
	 	
              13.11

            	
              Headings

            	 	
              17

            


    

    
       

      
        
           

        

        
          ii

          
            

          

        

        
           

        

      

    

     

    AMENDED
      & RESTATED LICENSE AND DEVELOPMENT AGREEMENT

     

    THIS
      AMENDED & RESTATED LICENSE AND DEVELOPMENT AGREEMENT (“Agreement”)
      is
      made as of this 22nd day of April 2008 (“Effective
      Date”),
      by and
      between: **, a company having offices at **(“**”),
      and Fidopharm,
      Inc., a company having offices 777 Township Line Road, Suite 170, Yardley,
      Pennsylvania 19067 (“Fidopharm”).
      Fidopharm and **are together referred to as “Parties”
      and
      individually as a “Party”.

     

    RECITALS

     

    WHEREAS,
      **is
      developing ACI-based products for manufacture and commercialization for
      veterinary or animal application uses. 

     

    WHEREAS, the
      largest market in the world for ACI-based products for veterinary or animal
      application uses is the United States.

     

    WHEREAS, the
      Parties agree that Fidopharm has the requisite expertise and infrastructure
      to
      register and commercialize veterinary products in the United States.


     

    WHEREAS,
      **desires to grant Fidopharm an exclusive license to use its know-how and under
      its patent rights to, use, make, have made, market, offer for sale, import
      or
      export and sell ACI-based products for veterinary or animal application use
      in
      the United States, and Fidopharm desires to obtain such license.

     

    AND
      WHEREAS,
      **shall
      cause the JV to execute a supply agreement contemporaneously with the execution
      of this Agreement providing for the exclusive supply of Products to Fidopharm
      for sale and distribution in the Territory. 

     

    NOW,
      THEREFORE,
      in
      consideration of the mutual promises set forth herein, the Parties, intending
      to
      be legally bound, hereby agree as follows:

     

    1. DEFINITIONS

     

    As
      used
      herein, the following terms shall have the respective meanings set forth
      below:

     

    1.1 “ACI”
      means
      (a)
      Active A and/or (b) Active B. 

     

    1.2 “Active
      A”
      shall
      have the meaning on Schedule
      1. 

     

    1.3 “Active
      B”
      shall
      have the meaning on Schedule
      1. 

     

    1.4 “Affiliate”
      means
      any individual, corporation, company, partnership, trust, limited liability
      company, association or other business entity (“Person”)
      which
      directly or indirectly controls, is controlled by or is under common control
      with the Party in question. As used in this definition of “Affiliate,” the term
“control” shall mean, as to any Person, (a) direct or indirect ownership of
      fifty percent (50%) or more of the voting interests or other ownership interests
      in the Person in question (or such lesser percentage which is the maximum
      allowed to be owned by such Person in a particular jurisdiction); (b) direct
      or
      indirect ownership of fifty percent (50%) or more of the interest in the income
      of the Person in question; or (c) possession, directly or indirectly, of the
      power to direct or cause the direction of management or policies of the Person
      in question (whether through ownership of securities or other ownership
      interests, by contract or otherwise). Notwithstanding the foregoing, the owners
      of preferred stock (or common stock issued upon conversion thereof) of a Party
      such as financial institutions, venture capital funds and private equity
      investors will not be its “Affiliates” for purposes of this
      Agreement.

     

    
      
         

      

      
        1

        
          

        

      

      
         

      

    

     

    1.5 “Commercial
      Sale” means
      sale of Products by Fidopharm or its Affiliates to a Third Party in the
      Territory, other than distribution in connection with clinical trials of
      Products conducted by Fidopharm.

     

    1.6 “Confidential
      Information”
      means
      all secret or confidential proprietary information or data of a Party provided
      in written, oral, graphic, video, computer, electronic or other form to the
      other Party. 

     

    1.7 “Controlled”
means,
      with respect to any intellectual property right or other intangible property,
      the possession by license or ownership by a Party (or by an Affiliate) to grant
      to the other Party access or a license or sublicense as provided herein without
      violating the terms of any written contract with any Third Party. 

     

    1.8 “Development”
      means
      research and chemical development activities, including without limitation
      toxicology, test method development and stability testing, process development,
      formulation development, delivery system development, quality assurance and
      quality control development, statistical analysis, efficacy studies, product
      performance studies, environmental impact studies, manufacturing process
      development and scale-up, regulatory affairs, and product approval and
      regulatory activities other than filing for and seeking Product
      Registrations. 

     

    1.9 “Field”
      means
      any and all veterinary or animal application uses. 

     

    1.10 “JV”
means
      ** Limited, which shall be the entity responsible for supplying Products to
      Fidopharm. 

     

    1.11 “Know-How”
      means
      any proprietary technical or other information relating to Products and the
      make, use or sale of Products, including technology, experience, formulae,
      concepts, discoveries, trade secrets, inventions, modifications, improvements,
      data (including all chemical, clinical, toxicological, analytical, and quality
      control data), results, designs, ideas, analyses, methods, techniques, assays,
      research plans, procedures, tests, processes (including manufacturing processes,
      specifications and techniques), laboratory records, reports, summaries, and
      information contained in submissions to, and information received from,
      regulatory authorities, that are Controlled by **, its Affiliates, JV or
      Manufacturer as of the Effective Date or during the Term. 

     

    1.12 “Law”
      or
“Laws”
      means
      the laws, statutes, rules, codes, regulations, orders, judgments and/or
      ordinances of any governmental authority (including without limitation the
      Regulatory Authority).

     

    1.13 “Manufacturer”
      shall
      have the meaning set forth in Schedule
      1,
      which
      shall be amended upon the mutual agreement of the Parties.

     

    1.14 “Patents”
      means
      (a) the patents and patent applications listed in Schedule
      2,
      (b) all
      patents and patent applications related to Products that may be obtained,
      including the make, use or sale of Products and (c) all patents and patent
      applications which are divisions, continuations, continuations-in-part,
      reissues, renewals, re-examinations, foreign counterparts, substitutions or
      extensions of or to any patent applications or patents described in clauses
      (a)
      or (b) of this sentence, that are Controlled by **, its Affiliates, JV or
      Manufacturer as of the Effective Date or during the Term. The Parties hereby
      acknowledge that there are no Patents as of the Effective Date; provided, that
      upon the filing of a Patent application ** shall create a Schedule
      2
      which
      shall be updated as necessary.

     

    1.15 “Products”
      means
      any product containing ACI as its active chemical ingredient and which is
      covered by Patents and/or uses Know-How, including, but not limited to the
      following Products: 

     

    (a) “Product
      A”
      means a
      product Developed by **(including by any Affiliate of **or by any Third Party
      (on behalf of **or its Affiliates)) meeting the specifications set forth in
      Schedule
      1;
      and


     

    (b) “Product
      B”
      means a
      product Developed by **(including by any Affiliate of ** or by any Third Party
      (on behalf of **or its Affiliates)) meeting the specifications set forth in
      Schedule
      1.
      

     

    
      
         

      

      
        2

        
          

        

      

      
         

      

    

     

    1.16 “Product
      Registration”
      means,
      with respect to a Product in a particular country or territory, the registration
      or regulatory approval granted by the applicable governmental authority in
      such
      country or territory allowing for such Product to be marketed, distributed,
      sold
      or imported there.

     

    1.17 “Regulatory
      Authority”
      means
      the United State’s agency with jurisdiction over Products. 

     

    1.18 “Specifications”
      means,
      with respect to a Product, the specifications for such Product set forth in
      the
      Product Registration or as otherwise agreed to by the Parties.

     

    1.19 “Supply
      Agreement”
      means
      that Amended & Restated Manufacture and Supply Agreement entered into with
      the JV contemporaneously with this Agreement. 

     

    1.20 “Territory”
      means
      the United States and all of its states, territories and
      protectorates. 

     

    1.21 “Third
      Party” means
      any
      entity or person other than ** or Fidopharm or their respective
      Affiliates.

     

    1.22 “Unit”
      means
      a
      ** of Product. 

     

    1.23 Additional
      Definitions. Each
      of
      the following definitions is set forth in the Section of this Agreement
      indicated below: 

     

    
      	
              Definition

            	 	
              Section

            
	
              Agreement

            	 	
              Preamble

            
	
              Copyrighted
                Materials

            	 	
              2.3

            
	
              Costs

            	 	
              11.5

            
	
              Development
                Data

            	 	
              4.4(b)

            
	
              Development
                Plan

            	 	
              4.2(a)

            
	
              Effective
                Date

            	 	
              Preamble

            
	
              Fidopharm

            	 	
              Preamble

            
	
              Force
                Majeure

            	 	
              13.1

            
	
              Indemnifying
                Party

            	 	
              10.3

            
	
              Initial
                Products

            	 	
              4.1

            
	
              Initial
                Term

            	 	
              11.1

            
	
              **

            	 	
              Preamble

            
	
              Parties
                

            	 	
              Preamble

            
	
              Party

            	 	
              Preamble

            
	
              Person

            	 	
              1.1

            
	
              Registration
                and Commercialization Plan

            	 	
              5.2

            
	
              ROFN
                Notice

            	 	
              2.4

            
	
              Term

            	 	
              11.1

            
	
              Territory
                Development

            	 	
              4.7

            
	
              Territory
                Development Costs

            	 	
              4.7

            
	
              Third
                Party-Patent Infringement Notice

            	 	
              7.4

            
	
              Trademark

            	
                

            	
              5.3

            


    

     

    2. LICENSE
      GRANT AND OTHER RIGHTS

     

    2.1 Exclusive
      License. 

     

    (a) Subject
      to the terms and conditions of this Agreement, ** hereby grants Fidopharm an
      exclusive license, with a right to sublicense, to use the Know-How and under
      the
      Patents to, use, make, have made, market, offer for sale and import or export
      Products in the Field in the Territory. For clarity, Fidopharm’s right to export
      hereunder shall not include the right to export Product to end-users or
      commercial distributors outside of the Territory. 

     

    
      
         

      

      
        3

        
          

        

      

      
         

      

    

     

    (b) Notwithstanding
      the license grant above, Fidopharm shall not make or have Products made and
      supplied (other than through the JV) for Commercial Sale in the Territory unless
      there as been a Failure (as defined in the Supply Agreement). 

     

    2.2 Right
      of Reference. ** hereby
      grants Fidopharm the right to access, reference and use all data and regulatory
      filings (including all Product Registrations Controlled by **, its Affiliates,
      JV and Manufacturer) and regulatory communications associated with any
      submissions for the Products to the extent permitted under applicable Laws.
      Where required in order for Fidopharm to obtain such access, ** shall or shall
      cause the appropriate party to, as soon as reasonably possible (and in any
      event
      no later than thirty (30) days from the date of Fidopharm’s request), provide
      the applicable governmental authority with notice of its consent to such access
      by Fidopharm in the appropriate form. In the event that ** grants any Third
      Party any rights in Products, (i) ** shall use its best efforts to ensure that
      any such Third Party will grant ** a right to access, reference and use any
      and
      all data and regulatory filings related to Products and (ii) ** hereby grants
      Fidopharm a right to access, reference and use any and all data and regulatory
      filings related to Products which ** has such a right to access; provided,
      that
      in any event ** shall ensure that any such Third Party shall be subject to
      safety and adverse event reporting obligations no less stringent than the terms
      and conditions contained in Section 8.3
      and
      Fidopharm shall be made aware of any such safety or adverse events within
      twenty-four (24) hours of ** being informed of such an event. ** reserves the
      right to use such data worldwide in support of any registration held by it
      or a
      Third Party partner. 

     

    2.3 Copyrighted
      Materials. To
      the
      extent that ** develops or has developed any manuals, logos, and other
      copyrighted works for use with Products (individually and collectively, the
      “Copyrighted
      Materials”),
      **
      hereby grants Fidopharm a royalty-free, non-exclusive license to use and
      distribute such Copyrighted Materials in connection with marketing, promoting,
      selling or importing Products in the Field in the Territory. 

     

    2.4 Exclusive
      Right of First Negotiation. Prior
      to
      ** granting to a Third Party a license or similar right (including a
      co-promotion right or an option to acquire such license or right) to market,
      offer for sale, import or export one (1) or more products containing ACI (other
      than Products) in the Field in the Territory, it shall so advise Fidopharm
      in
      writing (an “ROFN
      Notice”).
      Upon
      request by Fidopharm within thirty (30) days after its receipt of the ROFN
      Notice, ** and Fidopharm shall discuss the terms and conditions under which
      **
      would grant to Fidopharm rights to market, offer for sale, import or export
      such
      products in the Field in the Territory. If the Parties agree to grant such
      rights to Fidopharm, including the terms and conditions of such grant, the
      Parties shall prepare and execute an amendment to this Agreement incorporating
      such additional rights and terms. If Fidopharm does not so request within the
      thirty (30) day period after its receipt of the ROFN Notice, or if the Parties
      do not agree in writing on the terms of such additional grant of rights to
      Fidopharm within ninety (90) days after the date of the ROFN Notice to
      Fidopharm, ** shall be free to grant to one or more Third Parties the right
      to
      market, offer for sale, import or export such products in the Field in the
      Territory, on such terms as ** considers appropriate. 

     

    3. CONSIDERATION

     

    3.1 Upfront
      Payment. In
      partial consideration of the grant of rights under this Agreement and **’s
      obligations to conduct the Development activities provided hereunder, Fidopharm
      shall pay ** an upfront payment of five hundred thousand dollars (US$500,000)
      within fourteen (14) days of the Effective Date. 

     

    3.2 Supply
      Agreement. As
      further consideration of the grant of rights under this Agreement and its
      obligations to conduct the Development activities provided hereunder, Fidopharm
      shall contemporaneously with this Agreement enter into the Supply
      Agreement. 

     

    
      
         

      

      
        4

        
          

        

      

      
         

      

    

     

    3.3 No
      Additional Consideration.
      ** shall
      be entitled to no additional consideration for the grant of rights to Fidopharm
      under this Agreement and **’s obligations to conduct the Development activities
      other than as provided under this Article 3
      and
      Section 4.7
      below. 

     

    4. DEVELOPMENT

     

    4.1 Overview.
      **
      shall be
      primarily responsible, at its sole cost except as otherwise specifically
      provided herein, for designing and conducting all Development activities
      necessary to receive Product Registrations for the Product A and Product B
      (together, the “Initial
      Products”)
      in
      accordance with the Development Plan.
      Fidopharm shall be responsible, at its sole cost, for submitting the Product
      Registrations to the Regulatory Authority.

     

    4.2 Development
      Plan.

     

    (a) The
      Development of the Initial Products shall be governed by a development plan
      (the
“Development
      Plan”).
      The
      initial Development Plan shall be attached hereto as Schedule
      4.2.
      The
      Development Plan shall include options for ‘essentially similar’ and complete
      clinical package registration data routes with costings, timelines, stage
      payments, ** and other elements to be set forth in the Development
      Plan.

     

    (b) The
      Development Plan, together with any updates thereto, shall be prepared and
      approved as follows from time to time during the Term, each Party shall have
      the
      right to propose amendments to and amend the existing Development Plan;
      provided, that in any event ** shall present Fidopharm an updated Development
      Plan at least once per calendar year for its review and approval, not to be
      unreasonably withheld or delayed. Fidopharm shall have a period of twenty-one
      (21) days from the date that the updated Development Plan is received to provide
      its approval. If approval or rejection is not provided to ** within such
      twenty-one (21)-day period, then the Development Plan shall be deemed approved.
      For purposes of clarity, no change to the Development Plan shall be made without
      the prior written approval of both Parties. 

     

    4.3 Diligence.
      ** shall
      carry out the Development activities, in strict accordance with the Development
      Plan and the timelines set forth therein, necessary for obtaining the Product
      Registrations as set forth in this Agreement, including generating any
      additional data necessary to obtain Product Registration specifically for the
      Territory at Fidopharm’s instruction. Fidopharm shall file the Product
      Registrations in accordance with the Registration and Commercialization Plan
      based on the data provided by **. 

     

    4.4 Reporting
      and Data.

     

    (a) Upon
      request, ** shall promptly, but in no event later than thirty (30) days after
      such request provide Fidopharm with (i) a summary in reasonable detail of all
      data generated or obtained from each discrete Development activity performed
      under the Development Plan, such as any toxicology study, pharmacokinetics
      study
      or stability study, (ii) a summary of the Development progress against the
      projected Development progress set forth in the current Development Plan and
      (iii) a final report of the results of each Development activity, together
      with
      all material supporting data. 

     

    (b) **
      shall
      provide Fidopharm copies of all substantive or material information with respect
      to the Development of Products, including clinical data compiled with respect
      to
      Products and all information and data filed with any governmental authority
      with
      respect to Products outside of the Territory, as soon as reasonably practicable
      after such information, data or results become available to or compiled by
      **,
      including any drafts and final versions of any study reports (the “Development
      Data”).
      Subject to the terms and conditions of this Agreement, Fidopharm shall have
      the
      right to use the Development Data or any portion thereof for the purpose of
      obtaining Product Registrations and commercializing Products in the
      Territory.
      

     

    4.5 Compliance
      with Laws. **
      or its
      agents shall perform its responsibilities under this Article 4, including those
      set forth in the Development Plan, in accordance with all applicable
      Laws. 

     

    
      
         

      

      
        5

        
          

        

      

      
         

      

    

     

    4.6 Access
      to Records and Facilities.
      ** shall
      maintain scientific records, in sufficient detail and in good scientific manner
      appropriate for obtaining Patents and regulatory purposes, which shall fully
      and
      properly reflect all work done and results achieved in the performance of
      Development under this Agreement. Fidopharm shall be entitled to have access
      during regular business hours and upon reasonable advance notice, to **’s
      records and facilities relating to the Development of Products for the purpose
      of monitoring compliance with all applicable Laws and other applicable
      regulatory requirements. In all Third Party agreements involving the Development
      of Products, ** shall require that the Third Parties thereto provide ** with
      access to such Third Party facilities and all such data
      generated by Third Parties.
      Fidopharm shall have the right to inspect such facilities on behalf of ** in
      the
      event that: 

     

    (a) a
      specific concern is raised regarding Product by any governmental authority
      (including the Regulatory Authority);

     

    (b) a
      routine
      inspection/audit for Regulatory Authority purposes;

     

    (c) a
      routine
      inspection to confirm compliance with the terms of this Agreement, including
      without limitation, the progress of Product Development; or

     

    (d) a
      routine
      inspection/audit for a Fidopharm customer.

     

    For
      clarity, inspection and audits pursuant to Section 4.6(d) shall be limited
      to
      two (2) separate visits in any twelve (12) month period for each specific Third
      Party; provided, that additional reasonable inspections/audits shall be
      permitted upon Fidopharm obtaining **’s prior consent, which shall not be
      unreasonably withheld, conditioned or delayed. All inspection/audit costs shall
      be borne by the Party incurring such costs.

     

    4.7 Territory
      Specific Development. To
      the
      extent that additional Development is necessary solely to obtain the Product
      Registration in the Territory (“Territory
      Development”),
      **
      shall supplement the current Development Plan with a budget setting forth the
      reasonable costs for conducting the Territory Development specific activities
      (“Territory
      Development Costs”)
      and
      shall submit such supplement to Fidopharm for its consent and upon approval
      of
      such Territory Development Costs by Fidopharm, Fidopharm shall reimburse such
      costs as they are incurred. 

     

    5. PRODUCT
      REGISTRATION AND COMMERCIALIZATION

     

    5.1 Product
      Registration. Fidopharm
      shall, at its sole expense, use commercially reasonable efforts to obtain and
      maintain Product Registrations in accordance with the Registration and
      Commercialization Plan. Fidopharm shall be the sole owner of all Product
      Registrations in the Territory. For clarity, Fidopharm shall have the sole
      right
      in determining whether or not to obtain and/or maintain any specific Product
      Registration in the Territory. 

     

    5.2 Registration
      and Commercialization Plans.
      No less
      than thirty (30) days prior to first Commercial Sale Fidopharm shall provide
      an
      annual development plan for its activities in order to obtain Product
      Registrations and after first Commercial Sale Fidopharm shall provide an annual
      commercialization plan for its efforts to commercialize Products (the
“Registration
      and Commercialization Plan”).
      Fidopharm shall update the Registration and Commercialization Plan annually
      and
      shall provide such updated plan to ** not later than thirty (30) days before
      start of each year. The Registration and Commercialization Plan description
      shall be agreed between the Parties.

     

    5.3 Trademarks.
      Fidopharm shall have the sole right to determine the trademark(s) or trade
      name(s) that Fidopharm shall adopt for use with Products (the “Trademark”).
      All
      goodwill generated through the use of Trademarks by Fidopharm shall inure to
      the
      benefit of Fidopharm. Fidopharm shall own all Trademarks and shall register
      and
      maintain such Trademarks at its sole cost and discretion. 

     

    
      
         

      

      
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    5.4 Cooperation.
      ** shall
      provide (a) reasonable cooperation and support to Fidopharm in connection with
      maintenance of the Product Registration and (b) all information (including
      Confidential Information) that is reasonably required for the Development and/or
      commercialization of Products. Subject to Article 9,
      Fidopharm may use such Confidential Information solely for the purpose of
      Developing and commercializing Products. 

     

    5.5 Reporting.
      Each
      Party shall keep the other Party informed of developments known by it that
      would
      reasonably be expected to have a material adverse effect on any Product or
      Product Registration, including, but not limited to, the general regulatory
      strategy for Products in the Territory.

     

    6. SUPPLY
      OF PRODUCTS.

     

    6.1 Supply
      Agreement. Contemporaneously
      with the execution of this Agreement Fidopharm shall enter into the Supply
      Agreement with the JV. Pursuant to the terms of the Supply Agreement, the JV
      shall supply Fidopharm’s requirements of Products. Notwithstanding the
      foregoing, as between Fidopharm and **, in the event of a conflict between
      the
      Supply Agreement and this Agreement, Fidopharm’s rights in regards to the
      licenses (and any other intellectual property related to the Products) and
      Product Registrations related to the Products shall be governed solely by the
      terms of this Agreement.

     

    6.2 Technology
      Transfer. In
      the
      event that there is a Failure (as defined in the Supply Agreement) or if this
      Agreement is terminated pursuant to Section 11.2(b), 11.3 or 11.4, (a) the
      restrictions set forth in Section 2.1(b)
      of this
      Agreement shall no longer be applicable (which for clarity, means that Fidopharm
      shall have the right to manufacture, or have manufactured, Product itself or
      by
      a Third Party) and (b) ** shall undertake, and/or, as necessary, cause the
      JV
      and Manufacturer to undertake, an immediate transfer to Fidopharm or its
      designee of all technology and Know-How necessary, useful or used to manufacture
      Products. ** shall also make available, or cause to be made available any
      individuals who may be useful implementing the manufacturing processes related
      to Products. 

     

    7. PATENTS

     

    7.1 Prosecution
      and Maintenance of Patents.
      ** will
      prosecute and maintain the Patents at its sole cost in the Territory, using
      counsel of its choice reasonably acceptable to Fidopharm and shall not abandon
      any Patent without the prior written consent of Fidopharm. During the Term,
      **
      pursuant to this Section 7.1 shall copy Fidopharm, or have Fidopharm copied,
      on
      all material or substantive documents regarding Patents, which are received
      from
      or to be filed in any patent office in the Territory, promptly following receipt
      from the patent office and within a reasonable time prior to filing with the
      patent office (but not less than thirty (30) days), as applicable, including
      copies of each patent application, office action, response to office action,
      declaration, information disclosure statement, request for terminal disclaimer,
      request for patent term extension and request for reexamination. Fidopharm
      shall
      have the right to comment on the prosecution of such Patents and provide such
      comments to **’s patent counsel, and ** shall consider all such comments in good
      faith. For the purposes of this Section 7.1, “prosecute
      and maintain”
means,
      with respect to a patent, the preparing, filing, prosecuting and maintenance
      of
      such patent, as well as re-examinations, reissues and requests for patent term
      extensions and the like with respect to such patent, together with the conduct
      of interferences, the defense of oppositions and other similar proceedings
      and
      appeals thereof with respect to a patent, but shall not include enforcement
      litigation or the defense of declaratory judgment actions. Also, as used in
      this
      Section 7.1, to “abandon” particular Patent shall include deciding not to defend
      against an opposition, not to defend an interference or similar proceeding,
      not
      to pursue an appeal of an adverse decision or not to pursue particular claims,
      in each case with respect to such Patent in the United States Patent &
Trademark Office.

     

    7.2 Notification
      of Infringement.
      The
      Parties shall promptly inform each other of any information that comes to their
      attention involving (a) actual or apparent infringements or misappropriations
      of
      the Patents, by any Third Party in the Territory, or (b) claims of alleged
      infringement made by any Third Party against either Party or its respective
      Affiliates or sub-licensees resulting from the Development, manufacture, import,
      offer for sale, sale or use of Products.

     

    
      
         

      

      
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    7.3 Enforcement
      Against Third Parties. 

     

    (a) Notice.
      If
      either Party reasonably believes that a Third Party is conducting any activities
      in the Territory that may constitute actual or potential infringement of the
      Patents, such Party shall promptly notify the other Party of such activities.
      

     

    (b) Fidopharm’s
      First Right to Enforce.
      Except
      as otherwise agreed, Fidopharm shall have the first right to bring and control
      any action or proceeding under such Patents in respect to an alleged
      infringement occurring in the Territory. If Fidopharm fails to bring an action
      or proceeding with respect to an alleged infringement occurring in the Territory
      within one-hundred-twenty (120) days following a request by ** to do so, **
      shall have the right to bring and control any such action or proceeding with
      respect to such Patents.

     

    (c) Cooperation.
      The
      Parties shall reasonably cooperate with each other in all actions or proceedings
      described in this Section 7.3,
      to the
      extent pertaining to an alleged infringement. The non-controlling Party agrees
      to be joined as a party plaintiff if necessary to prosecute the action or
      proceeding and shall provide all reasonable cooperation (including any necessary
      use of its name) required to prosecute such litigation; provided that the
      controlling Party shall reimburse the non-controlling Party for out-of-pocket
      expenses reasonably incurred in providing such cooperation at the controlling
      Party’s request. The non-controlling Party will be entitled to be represented by
      counsel of its own choice at its own expense.

     

    (d) Recoveries.
      Any
      recovery obtained by any Party as a result of any proceeding described in this
      Section 7.3,
      by
      settlement or otherwise, shall be applied in the following order of priority:
      (i) first, to reimburse each Party for all litigation costs in connection with
      such proceeding paid by that Party and not otherwise recovered (on a pro rata
      basis based on each Party’s respective litigation costs, to the extent the
      recovery was less than all such litigation costs); and (ii) second, the
      remainder shall be kept by the controlling Party. 

     

    7.4 Alleged
      Infringement of Third Party’s Patents.
      In the
      event that either Party is named as a defendant in any legal or other action
      or
      proceeding, including any settlement or negotiation, or learns of any threatened
      action or proceeding with respect to any alleged infringement of a Third Party
      patent or other proprietary right as a result of Developing, manufacturing,
      importing, offering for sale, selling or using Products such Party will promptly
      notify the other Party in writing (a “Third
      Party-Patent Infringement Notice”).
      The
      Parties will closely coordinate regarding any infringement, or alleged
      infringement, of Third Party rights related to Products; provided, that in
      the
      Territory, Fidopharm shall have the first right but not the obligation to defend
      any action brought by, or negotiate a settlement with, a Third Party claiming
      any infringement or potential infringement by Products of such Third Party’s
      rights. In the event that Fidopharm elects not to, or fails to, initiate any
      defense or settlement within one-hundred-twenty (120) days following its receipt
      of a Third Party-Patent Infringement Notice, ** shall have the right to take
      such steps as may be considered necessary or appropriate by ** to defend such
      infringement claim. Each Party shall render such reasonable assistance as may
      be
      requested by the defending Party in connection with such infringement actions.
      If one Party requests the other Party’s reasonable assistance in connection with
      such infringement claims or actions, the requesting Party shall reimburse the
      other Party for such direct, out-of-pocket expenses as are reasonably incurred
      during the course of its providing such requested assistance.

     

    8. REPRESENTATIONS,
      WARRANTIES AND COVENANTS. 

     

    8.1 **
      Representations, Warranties and Covenants.
      **
      hereby represents, warrants and covenants to Fidopharm as follows:

     

    
      
         

      

      
        8

        
          

        

      

      
         

      

    

     

    (a) The
      execution and delivery by ** of this Agreement and the performance by ** of
      its
      obligations hereunder have been duly authorized by all necessary corporate
      action on the part of **, and do not conflict with the terms of any other
      contract, agreement, arrangement or understanding to which ** is a
      party.

     

    (b) Except
      as
      set forth herein, no consent, approval, order or authorization of, or
      registration, qualification, designation, declaration or filing with, any
      federal, state or local governmental authority is required on the part of **
      in
      connection with the valid execution, delivery and performance of this
      Agreement.

     

    (c) **
      is and
      will be in compliance through the term of this Agreement in all material
      respects with all Laws applicable to its performance under this
      Agreement.

     

    (d) There
      is
      no action or proceeding pending or threatened against ** that questions the
      validity of this Agreement or any action taken by ** in connection with the
      execution of this Agreement. 

     

    (e) In
      regards to intellectual property:

     

    (i) **
      has
      not knowingly infringed any Third Party patent rights in developing Products.
      In
      the event that ** becomes aware of any Third Party patents rights being
      infringed, or potentially being infringed, by the development, manufacture
      or
      commercialization of a Product, ** shall notify Fidopharm of such infringement
      or potential infringement within twenty-four (24) hours of gaining such
      knowledge. 

     

    (ii) as
      of the
      Effective Date, there are no pending proceedings in any court or arbitration,
      administrative or other tribunal which are concerned with the validity or
      ownership of any of the Patents or Know-How. Without derogation from the
      foregoing, there are no oppositions, revocation, cancellation, invalidation
      or
      rectification proceedings pending in relation to any of the Patents or Know-How
      in any court. No Third Party has notified ** or any ** Affiliate of its
      intention to bring any such proceedings.

     

    (iii) **
      has
      not and no ** Affiliate has received any written complaints or threats and
      there
      are no pending proceedings or claims, alleging that the exploitation of the
      Patents or Know-How infringe or would infringe the intellectual property rights
      of any Person;

     

    (iv) Details
      of the Patents are set out in Schedule
      2
      and all
      the details are correct. Without derogation from the generality of the
      foregoing, the Patents are subsisting and all applications for Patents indicated
      in Schedule
      2
      as
      pending are pending. The legal and beneficial owner or applicant for
      registration of each of the Patents specified in Schedule
      2
      is
      correctly stated;

     

    (v) The
      Patents and Know-How are the only intellectual property rights owned by,
      licensed to or used by ** or its Affiliates in relation to Products and to
      the
      best of **’s knowledge no intellectual property rights other than the Patents or
      Know-How are required in order to Develop, manufacture, use, import and/or
      sell
      or commercialize Products in the Territory;

     

    (vi) All
      actions required to be taken before the Effective Date for the prosecution
      and
      maintenance of the Patents (including all applicable fees due and payable before
      such date) have been taken or paid; and

     

    (vii) The
      Patents are not and, during the Term, will not become subject to any encumbrance
      or lien in favor of any Third Party that is inconsistent with or otherwise
      restricts the rights and sublicenses granted to Fidopharm
      hereunder.

     

    (f) In
      regards to Development:

     

    (i) **
      **

     

    
      
         

      

      
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    (ii) All
      trials related to Products have been carried out and will be carried out in
      accordance with all relevant Laws;

     

    (iii) Neither
      ** nor any ** Affiliate is engaged in any litigation, opposition or arbitration
      proceedings affecting or relating to Products, the Patents, Know-How (including
      but not limited to claims relating to product liability) as plaintiff or
      defendant and there are no such proceedings pending or threatened by or against
      ** or any ** Affiliate and ** is not aware of facts or circumstances likely
      to
      give rise to any such proceedings; and

     

    (iv) No
      injunction has been granted against ** or its Affiliates in connection with
      Products, the Patents or Know-How.

     

    (g) Neither
      ** or any ** Affiliate has nor will provide (directly or indirectly) any Third
      Party access or rights to use its Know-How (including, without limitation,
      use
      of any data or under any Patents) for Development, regulatory approval or
      commercialization of any product containing Active A at a concentration range
      between **and **weight/volume. 

     

    (h) As
      of the
      Effective Date, neither it nor its Affiliates has been debarred or is subject
      to
      debarment and neither ** nor any of its Affiliates will use in any capacity,
      in
      connection with the Development or commercialization of Products, any Person
      who
      has been debarred pursuant to Section 306 of the United States Federal Food,
      Drug and Cosmetic Act, or who is subject of a conviction described in such
      section. Further, ** agrees to inform Fidopharm in writing immediately if it
      or
      any Person who is performing services hereunder is debarred or is the subject
      of
      a conviction described in Section 306, or if any action, suit, claim,
      investigation or legal administrative proceeding is pending or, to the best
      of
      **’s knowledge, is threatened, relating to the debarment of **, its Affiliates
      or any Person used in any capacity by ** or its Affiliates in connection with
      the Development or commercialization of Products. 

     

    8.2 Fidopharm
      Representations and Warranties.
      Fidopharm hereby represents and warrants to ** as follows:

     

    (a) The
      execution and delivery by Fidopharm of this Agreement and the performance by
      Fidopharm of its obligations hereunder have been duly authorized by all
      necessary corporate action on the part of Fidopharm, and do not conflict with
      the terms of any other contract, agreement, arrangement or understanding to
      which Fidopharm is a Party.

     

    (b) Except
      as
      set forth herein, no consent, approval, order or authorization of, or
      registration, qualification, designation, declaration or filing with, any
      federal, state or local governmental authority is required on the part of
      Fidopharm in connection with the valid execution, delivery and performance
      of
      this Agreement, where the failure to obtain any of the foregoing would not
      have
      a material adverse impact on the ability of Fidopharm to meet its obligations
      hereunder.

     

    (c) Fidopharm
      is and will be in material compliance throughout the Term with all of the
      applicable Laws relating to Products in the Territory.

     

    8.3 Regulatory
      Cooperation.

     

    (a) The
      Parties shall disclose to each other all reports or other knowledge they receive
      with respect to adverse experiences, and reports of mislabeling, stability
      failures or microbiological contamination.

     

    (b) In
      addition to and without limiting the requirements of Section 8.3(a)
      above,
      Fidopharm and ** agree, throughout the duration of this Agreement, to notify
      the
      other Party immediately of any information concerning any serious or unexpected
      side effect, injury, toxicity or sensitivity reaction, or any unexpected
      incidents, and the severity thereof, associated with the clinical uses, studies,
      investigations, tests and marketing of Products, whether or not determined
      to be
      attributable to Products. Each Party shall cooperate with the other to resolve
      any complaints received by either Party with respect to Products.

     

    
      
         

      

      
        10

        
          

        

      

      
         

      

    

     

    (c) Each
      of
      Fidopharm and ** shall promptly deliver to the other all material correspondence
      that such Party may receive, directly or indirectly, from regulatory authorities
      in jurisdictions where such Party (or its sublicensees, distributors, or
      sub-distributors) has rights to market Products, except for procedural,
      nonsubstantive communications which do not relate to the safety or efficacy
      of
      Products. Fidopharm and ** shall also immediately notify the other Party about
      any information such Party receives regarding any threatened or pending action
      by a governmental agency that may affect the safety and efficacy claims of
      Products or the continued marketing, promotion, distribution, sale or
      manufacture of Products. Upon receipt of any such information, the Parties
      shall
      consult in an effort to arrive at a mutually acceptable procedure for taking
      appropriate action, provided
      that
      nothing contained herein shall be construed as restricting either Party’s right
      to make a timely report of such matter to any governmental or regulatory agency
      or take other action that it deems to be appropriate or required by applicable
      law or regulation. It is Fidopharm’s responsibility to report adverse events in
      accordance with local Laws and requirements to governmental or regulatory
      agencies in the Territory.

     

    (d) Without
      limiting the foregoing, it is also understood that each Party may notify any
      of
      its Affiliates, licensees, distributors or sub-licensees of any incident or
      event reported by either Party under this Section 8.3.
      In
      addition, each Party shall, and shall require its respective Affiliates to:
      (i)
      to the extent permissible under time constraints and reporting requirements,
      provide to the other Party in advance of initial or periodic submission to
      the
      applicable regulatory authorities any and all adverse event reports from
      clinical trials and commercial experiences with Products; (ii) provide such
      adverse event reports to the other Party contemporaneously with the provision
      of
      such reports to the applicable regulatory authority; and (iii) adhere to all
      requirements of applicable Laws which relate to the reporting and investigation
      of adverse events and keep the other Party informed of such events. If a Party
      contracts with a Third Party for any research to be performed by such Third
      Party on Products, that Party shall require such Third Party to report to the
      contracting Party the information set forth above.

     

    8.4 Compliance
      with Laws.
      Both
      Parties shall comply in all material respects with all applicable Laws with
      respect to the supply, Development, testing, marketing, promotion, storage,
      import, distribution and sale of Products.

     

    9. CONFIDENTIALITY

     

    9.1 Confidentiality;
      Nondisclosure; Nonuse.
      During
      the Term, and for ten (10) years after the termination of this Agreement, each
      Party shall keep confidential the other Party’s Confidential Information and,
      except as expressly permitted herein, shall not disclose such Confidential
      Information to any Third Party in any manner whatsoever, in whole or in part,
      without first obtaining the other Party’s prior written consent to such
      disclosure. The standard of care required of each Party in protecting the
      confidentiality of the other Party’s Confidential Information shall be at least
      as strict as the same standard of care that the receiving Party uses in
      protecting its own Confidential Information, but in no event shall either Party
      use less than a reasonable standard of care. Neither Party shall use any
      Confidential Information of the other Party for any purpose other than to
      perform its obligations under this Agreement or as otherwise authorized under
      this Agreement. The receiving Party shall ensure that its employees,
      representatives, and agents comply with this provision, and shall be responsible
      for any breach by such employees, representatives, or agents.

     

    9.2 Exception
      to Confidential Information.
      The
      foregoing obligations of confidentiality, nondisclosure and nonuse shall not
      apply to any Confidential Information (a) which is now public knowledge or
      which
      hereafter becomes public knowledge through no breach of this Agreement by the
      receiving Party; (b) which the receiving Party received without restriction
      from
      an independent Third Party; (c) which the receiving Party can demonstrate was
      already in its possession at the time of receipt from the disclosing Party
      and
      not subject to another agreement between the Parties; or (d) which the receiving
      Party can demonstrate was independently developed by the receiving Party in
      the
      course of work by the officers, directors, employees, consultants or agents
      of
      itself or of its Affiliates, subsidiaries or related companies without the
      aid,
      use or application of Confidential Information of the disclosing
      Party.

     

    
      
         

      

      
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    9.3 Notification
      of Mandatory Disclosure.
      Each
      Party may use or disclose Confidential Information of the other Party to the
      extent such use or disclosure is reasonably necessary in complying with
      applicable Laws or required by governmental authorities or pursuant to a court
      order or otherwise submitting information to governmental authorities in
      connection with clinical trials or applying for Product Registrations,
      negotiating or making a permitted sublicense or otherwise exercising its rights
      hereunder; provided that if a Party is required under applicable Laws or court
      order to make any such disclosure of the other Party’s Confidential Information,
      it shall (i) give prompt written notice to the disclosing Party of the proposed
      disclosure, and allow the disclosing Party at least fourteen (14) business
      days
      to object to all or any portion of the disclosure before it is disclosed; (ii)
      provide written notice of disclosure immediately thereafter, if advance notice
      is not possible; (iii) minimize the extent of such disclosure, to the extent
      possible; and (iv) seek confidential treatment of such information prior to
      its
      disclosure, it being understood that any information so disclosed shall
      otherwise remain subject to the limitations on use and disclosure
      hereunder. 

     

    9.4 Patent
      Application Filing.
      Notwithstanding anything to the contrary, if a disclosing Party has not filed
      a
      necessary Patent application with respect to any applicable Confidential
      Information, it may require the receiving Party to delay the proposed authorized
      or required disclosure (to the extent the disclosing Party may legally do so),
      for up to ninety (90) days, to allow for the filing of such an
      application.

     

    9.5 Permitted
      Disclosure to Third Parties. Except
      as
      expressly permitted in this Agreement, neither Party shall disclose this
      Agreement or any terms of this Agreement to any Third Party without the prior
      written consent of the other Party; except that such consent shall not be
      required for disclosure to actual or prospective investors, collaboration
      partners or the other party in a proposed investment, merger, acquisition or
      a
      similar transaction, or to a Party’s accountants, attorneys and other
      professional advisors (provided that such disclosures shall be subject to
      continued confidentiality obligations at least as strict as is set forth
      herein). To the extent that either Party determines that it or the other Party
      is required to file or register this Agreement or a notification thereof to
      comply with the requirements of an applicable stock exchange or NASDAQ
      regulation or any governmental authority, including without limitation the
      U.S.
      Securities and Exchange Commission, such Party shall promptly inform the other
      Party thereof. Prior to making any such filing, registration or notification,
      the Parties shall agree on the provisions of this Agreement for which the
      Parties shall seek confidential treatment, it being understood that if one
      Party
      determines to seek confidential treatment for a provision for which the other
      Party does not, then the Parties will use reasonable efforts in connection
      with
      such filing to seek the confidential treatment of any such provision. The
      Parties shall cooperate, each at its own expense, in such filing, registration
      or notification, including without limitation such confidential treatment
      request, and shall execute all documents reasonably required in connection
      therewith. 

     

    10. INDEMNIFICATION
      AND INSURANCE

     

    10.1 **’s
      Indemnification Obligations.
      ** shall
      indemnify and hold Fidopharm harmless from and against any direct costs,
      expenses (including, without limitation, reasonable attorneys’ fees) or damages
      which arise from breach by ** of any of its representations, covenants,
      warranties or obligations set forth herein, including, without limitation,
      any
      claims in connection with (i) failure of Products supplied by ** to meet the
      Specifications, or (ii) any breach of its representations, warranties or
      covenants hereunder, except to the extent such damages are caused by or arise
      from (x) the gross negligence or willful misconduct of Fidopharm; or (y) any
      matter as to which Fidopharm has agreed to indemnify ** hereunder.

     

    10.2 Fidopharm’s
      Indemnification Obligations.
      Fidopharm shall indemnify and hold ** harmless from and against any direct
      costs, expenses (including, without limitation, reasonable attorneys’ fees) or
      damages which arise from the breach by Fidopharm of any of its representations,
      covenants, warranties or obligations set forth herein or from the marketing,
      sale or distribution of Products by Fidopharm and its Affiliates, distributors
      and permitted sublicensees, except to the extent such damages were caused by
      or
      arise from (i) the gross negligence or willful misconduct of **; or (ii) any
      matter as to which ** has agreed to indemnify Fidopharm hereunder.

     

    
      
         

      

      
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    10.3 Indemnification
      Procedure.

     

    (a) Promptly
      after the receipt by any Party hereto of notice of (a) any claim or (b) the
      commencement of any action or proceeding, such Party shall, if a claim with
      respect thereto is to be made against any Party obligated to provide
      indemnification pursuant to Section 10.1
      or
10.2
      hereof
      (the “Indemnifying
      Party”),
      give
      such Indemnifying Party written notice of such claim or the commencement of
      such
      action or proceeding. Such Indemnifying Party shall have the right, at its
      option, to compromise or defend, subject to Section 10.3(c)
      below,
      at its own expense and by its own counsel, any such matter involving the
      asserted liability of the Party seeking such indemnification. Such notice,
      and
      the opportunity to compromise or defend, shall be a condition precedent to
      any
      liability of the Indemnifying Party under the indemnification provisions of
      Section 10.1 or
      10.2.
      In the
      event that any Indemnifying Party shall undertake to compromise or defend any
      such asserted liability, it shall promptly notify the Party seeking
      indemnification of its intention to do so, and the Party seeking indemnification
      agrees to cooperate fully with the Indemnifying Party and its counsel in the
      compromise of, or defense against, any such asserted liability. In any event,
      the indemnified Party shall have the right, at its own expense, to participate
      in the defense of such asserted liability, provided,
      that
      the Indemnifying Party’s counsel shall make all final decisions concerning the
      defense or, subject to Section 10.3(c)
      below,
      compromise or settlement of such litigation.

     

    (b) Each
      of
      the Parties hereto shall be entitled to be represented at any proceedings
      brought against the other Party under this Article 10
      by its
      own counsel, at its own expense, and shall cooperate fully with the other Party
      in any such proceeding, provided
      it is
      adequately reimbursed for its out-of-pocket costs and expenses, excluding
      attorneys’ fees.

     

    (c) Neither
      Party may settle a claim described in this Article 10
      in a
      manner which would impose upon the other Party any monetary obligation or
      require such other Party to submit to an injunction or otherwise limit its
      rights, in each case, without the prior written consent of such other Party,
      which consent shall not be unreasonably withheld, conditioned, or
      delayed.

     

    10.4 Insurance. The
      Parties shall each maintain insurance in amounts commercially reasonable for
      the
      veterinary pharmaceutical industry commensurate with their rights and
      obligations hereunder. 

     

    11. TERM
      AND TERMINATION

     

    11.1 Term.
      The
      initial term of this Agreement shall begin on the Effective Date and shall
      continue for ten (10) years after the first Commercial Sale (the “Initial
      Term”)
      unless
      earlier terminated pursuant to this Article 11. At the expiration of the Initial
      Term, the term of this Agreement shall automatically renew for successive five
      (5) year periods (the Initial Term and all such renewal periods, the
“Term”)
      unless
      written notice of non-renewal is provided by Fidopharm to ** at least sixty
      (60)
      days prior to the applicable renewal date. 

     

    11.2 Termination
      by Fidopharm. 

     

    (a) Fidopharm
      shall have the right to terminate this Agreement without cause and without
      penalty upon ninety (90) days prior written notice to **, provided, that such
      period shall be extended for a reasonable period (not to exceed another sixty
      (60) days) in order to effect the transfer of Product Registrations pursuant
      to
      Section 11.6(e).
      For
      clarity, any early, without
      cause
      termination by Fidopharm ahead of Product registration deems all fees / costs
      paid to ** as not refundable. Should such a termination by Fidopharm occur
      during the implementation of the Development Plan, Fidopharm shall be liable
      for
      all reasonable non-cancelable ongoing costs, solely in regards to the Territory,
      necessary to complete the then current Development activities; provided, that
      **
      shall immediately terminate such ongoing commitments as soon as possible and
      shall not incur any non-necessary expenses in effectuating such termination.
      

     

    
      
         

      

      
        13

        
          

        

      

      
         

      

    

     

    (b) In
      the
      event that Fidopharm terminates the Supply Agreement pursuant to Section 12.2
      or
      12.3 therein, Fidopharm shall have the right to terminate this Agreement
      immediately and without penalty upon written notice to **.

     

    11.3 Termination
      for Breach.
      In the
      event of any material default by either Party in the performance of any of
      the
      terms and conditions of this Agreement, the other Party may terminate this
      Agreement upon ninety (90) days’ written notice; provided
      that (i)
      if during such ninety (90) day period the Party against whom the material
      default is claimed cures such default, (ii) if such breach cannot be cured
      within such ninety (90) day period, such Party takes reasonable steps to
      commence and proceeds diligently thereafter to cure such default and, in fact,
      cures such default within a reasonable period of time, or (iii) if such default
      is cured in any other manner satisfactory to the other Party as a substitute
      for
      full performance, then this Agreement will continue in full force and effect
      until it expires as provided herein.

     

    11.4 Termination
      for Bankruptcy, etc.
      Either
      Party shall be entitled to terminate this Agreement immediately:

     

    (a) if
      any
      creditor of the other Party or any other person levies or attempts to levy
      any
      distress, execution, sequestration or other process over the business assets
      of
      the other Party or an encumbrancer takes or attempts to take possession of
      the
      business or assets of the other Party;

     

    (b) if
      a
      petition shall be presented for the winding up of the other Party or if a
      meeting is convened for the purpose of passing a resolution for the winding
      up
      of the other Party;

     

    (c) if
      a
      receiver, administrative receiver, manager, trustee or administrator shall
      be
      appointed over all or any part of the business or assets of the other
      Party;

     

    (d) if
      the
      other Party or any director or creditor of such other Party shall present a
      petition to the court for an administrative order in respect of such other
      Party;

     

    (e) if
      the
      other Party shall convene a meeting of its creditors or shall make any proposal
      for or enter into any compromise, composition or scheme of arrangement with
      its
      creditors or make any assignment for the benefit of its creditors;

     

    (f) if
      the
      other Party shall be deemed to be unable to pay its debts within the meaning
      of
      any relevant insolvency law or any relevant insolvency decree or regulation
      (or
      any statutory amendment or reenactment thereof); or

     

    (g) if
      any
      event analogous to the foregoing shall occur under the laws of any relevant
      jurisdiction.

     

    11.5 Termination
      for Failure.
      In the
      event ** fails to provide (a) the necessary technical and regulatory batches
      needed for Product Registration in the Territory for the Initial Products within
      the agreed to timeline in the Development Plan; or (b) provide by December
      31,
      2008 (i) shelf life data under accelerated conditions demonstrating **-month
      and
      **-month accelerated stability for Product A and Product B and (ii) clinical
      efficacy of Product B, each from an independent lab reasonably acceptable to
      Fidopharm, and reasonable acceptability of **of Product A and Product B **
      by
      Fidopharm based on commercial viability of Products, Fidopharm shall have the
      right to terminate this Agreement immediately and upon such termination **
      shall
      reimburse any payments made to it under this Agreement and one hundred percent
      (100%) of the cost and expenses expended by Fidopharm to Develop, register
      and
      commercialize Products in the Territory up to five hundred thousand dollars
      ($500,000), including all costs and expenses for obtaining the Product
      Registrations (together with the upfront payment, the “Costs”);
      provided, that in the event ** has accomplished (x) subsection (i) of Section
      (b) above, the reimbursement shall be reduced by forty percent (40%) of the
      Costs, and/or (y) subsection (ii) of Section (b) above, the reimbursement shall
      be reduced by another forty percent (40%) of the Costs and/or (z) Section (a)
      above, the reimbursement shall be reduced by another twenty (20%) of the
      Costs.

     

    
      
         

      

      
        14

        
          

        

      

      
         

      

    

     

    11.6 Effect
      of Expiration or Termination.

     

    (a) No
      expiration or termination of this Agreement pursuant to this Article
11
      shall
      relieve either Party of obligations accrued to such date of expiration or
      termination or of obligations which continue by the terms hereof beyond such
      expiration or termination, including, but not limited to, any payment
      obligations hereunder. Articles 1, 9, 10 and 13 and Sections 2.4, 5.3, 6.2,
      8.1,
      8.2 and this Section 11.6 shall survive the termination or expiration of this
      Agreement

     

    (b) In
      the
      event that this Agreement expires or is terminated pursuant to Section 11.2(b),
      11.3 or 11.4 the licenses granted hereunder to Fidopharm shall become
      irrevocable, royalty-free, non-exclusive licenses, with the right to grant
      sublicenses, to market, promote and sell Products in the Field in the
      Territory.

     

    (c) Within
      thirty (30) days following the termination of this Agreement, each Party shall
      destroy, delete (as to Confidential Information stored in electronic format)
      or
      return to the other Party all Confidential Information of the other Party,
      and
      shall provide the other Party written certification of such destruction or
      return.

     

    (d) After
      termination of this Agreement, Fidopharm shall cease using or selling Products
      pursuant to the license grant herein (for clarity, the preceding shall not
      limit
      Fidopharm’s rights pursuant to the licenses granted under Section 11.6(b));
      provided, however, that Fidopharm may continue to sell in the ordinary course
      of
      business for a period of twelve (12) months reasonable quantities of Products
      which are manufactured and in Fidopharm’s normal inventory at the date of
      termination; provided that such Product had been ordered in-line with
      Fidopharm’s forecast. 

     

    (e) In
      the
      event of termination of this Agreement by Fidopharm pursuant to Section 11.2(a),
      Fidopharm shall (i) transfer to ** all rights, title and interests in and to
      the
      Product Registration and (ii) take such other steps requested by **, all of
      the
      foregoing at **’s sole cost and expense, to effect the transfer.
      Fidopharm will provide all reasonable support, at **’s reasonable cost, to
      facilitate the transfer of such Product Registrations in a timely
      manner.

     

    12. INJUNCTIVE
      RELIEF AND DISPUTE RESOLUTION

     

    12.1 Equitable
      Relief.
      Notwithstanding anything to the contrary in this Agreement, either Party will
      have the right to seek temporary injunctive relief or the ordering of specific
      performance in any court of competent jurisdiction as may be available to such
      Party under the laws and rules applicable in such jurisdiction with respect
      to
      any matters arising out of the other Party’s performance of or failure to
      perform its obligations under this Agreement.

     

    12.2 Dispute
      Resolution. In
      the
      event the Parties are unable to resolve any controversy or claim arising from
      this Agreement (“Dispute”),
      the
      Parties will submit such Dispute to arbitration under the rules of the American
      Arbitration Association, as the same may be amended by mutual agreement of
      the
      Parties. The Dispute shall be submitted to an expert panel in the pertinent
      field for binding arbitration. Such expert panel may be mutually agreed by
      the
      Parties, but if no such agreement is reached within ten (10) days after the
      written notice from one Party to the other, then each Party shall promptly
      select one expert, and those two (2) shall select a third expert, the three
      (3)
      of whom shall comprise the expert panel. The arbitrator(s) shall determine
      what
      discovery will be permitted, based on the principle of limiting the cost and
      time which the parties must expend on discovery; provided, the arbitrator(s)
      shall permit such discovery as they deem necessary to achieve an equitable
      resolution of the dispute. Both Parties will cooperate in providing fully to
      each other all requested information and documents relating to the arbitration
      proceedings, except for information and documents subject to any privilege.
      The
      place of any arbitration proceedings shall be New York, New York or such other
      location as the Parties may mutually agree. During the arbitration proceedings,
      except for the matter that is in dispute and under arbitration, this Agreement
      shall continue to be implemented by both Parties. Unless the expert panel for
      good cause determines otherwise, each Party shall bear one-half of the fees
      and
      expenses of the experts and shall bear its own costs and attorneys’ fees in
      connection with the arbitration proceeding; provided that the arbitrator(s)
      may
      in their discretion award to the prevailing party the costs and expenses
      incurred by the prevailing party in connection with the arbitration proceeding.
      The decision and/or award rendered by the arbitrator(s) shall be written, final
      and non-appealable and may be entered in any court of competent jurisdiction.
      The provisions of this subsection shall not prohibit either Party from seeking
      equitable relief to restrain any breach or threatened breach of this Agreement
      at any time in any court of competent jurisdiction as may be available to such
      Party under the laws and rules applicable in such jurisdiction. The arbitral
      proceedings and all pleadings and written evidence shall be in the English
      language. Any written evidence originally in a language other than English
      shall
      be submitted in English translation accompanied by the original or true copy
      thereof.

     

    
      
         

      

      
        15

        
          

        

      

      
         

      

    

     

    13. MISCELLANEOUS

     

    13.1 Force
      Majeure. Neither
      Party hereto shall be liable for damages, nor shall this Agreement be terminable
      or cancelable by reason of any delay or default in such Party’s performance
      hereunder (other than the payment of monies due and owing to a Party under
      this
      Agreement) if such default or delay is caused by acts of God, acts of public
      enemies, war or insurrection, civil commotion, destruction of production
      facilities or materials by earthquake, fire, flood or storm, epidemics, labor
      disputes or strikes, or failure of public utilities (“Force
      Majeure”).
      Each
      Party shall endeavor to resume its performance hereunder as soon as reasonably
      possible if such performance is delayed or interrupted by reason of Force
      Majeure.

     

    13.2 Further
      Assurances.
      Each of
      the Parties shall, from time to time during the term of this Agreement, upon
      request by the other, execute and deliver all such further documents or
      instruments as may be required in order to give effect to the purpose and intent
      of this Agreement. 

     

    13.3 Assignment.
      Neither
      Party shall assign this Agreement without the prior written consent of the
      other
      Party, provided, that either Party may assign this Agreement without the prior
      written consent of the other Party (a) to an Affiliate or (b) to a party in
      connection with the sale or transfer of substantially all of its assets with
      respect to the business to which this Agreement is related to such party. Any
      permitted assignee shall assume all obligations of its assignor under this
      Agreement. Any purported assignment in violation of this Section 13.3
      shall be
      void. No assignment shall relieve either Party of responsibility for the
      performance of any accrued obligation that such Party then has
      hereunder.

     

    13.4 Choice
      of Law.
      This
      Agreement shall be governed by, and construed in accordance with, the laws
      of
      the State of Delaware, USA, without giving effect to its principles of conflicts
      of laws. The Parties hereby submit to the exclusive jurisdiction of, and waive
      any venue objections against, federal and state courts of competent jurisdiction
      in the State of Delaware in any litigation or dispute arising out of this
      Agreement. The prevailing party in any dispute or legal action regarding the
      subject matter of this Agreement shall be entitled to recover attorney’s fees
      and costs.

     

    13.5 Notices.
      Any
      notice, request or other communication required or permitted by this Agreement
      to be given by any Party to another Party shall be in writing and either mailed
      by registered or certified mail, return receipt requested, by express delivery
      service or by facsimile transmission, addressed to such Party, Attention: the
      Managing Director, at its address indicated in the preamble or to such other
      address as such Party previously may have designated by like written notice.
      Notice shall be deemed to have been given upon receipt. Facsimile transmission
      numbers for the Parties are as follows:

     

    
      
         

      

      
        16

        
          

        

      

      
         

      

    

     

    
      	
              If
                to Fidopharm:

              Fidopharm,
                Inc. 

              777
                Township Line Road, Suite 170

              Yardley,
                PA 19067

              United
                States of America

              Attn:
                **

              Tel:
                

              Fax:
                

            	
              with
                a copy to:

              Morgan,
                Lewis & Bockius

              1701
                Market Street

              Philadelphia
                PA, 19103

              United
                States of America 

              Attn:
                Fahd M.T. Riaz, Esq.

              Tel:
                (215) 963-5372

              Fax:
                (215) 963-5001

            


    

    


    
      	
              If
                to **:

              **

              **

            	
              with
                a copy to:

              **

            


    

     

    13.6 Entire Agreement.
      This
      Agreement constitutes the entire agreement between the Parties with respect
      to
      the subject matter hereof and supersedes all prior written or oral agreements
      or
      understandings regarding the subject matter hereof or in conflict with its
      terms, including but not limited to, the License and Development Agreement
      entered into by the Parties on February 15, 2008. This Agreement will be
      construed as if it were drafted jointly by the Parties and shall not be strictly
      construed against either Party.

     

    13.7 Amendments;
      Waivers.
      No
      modification of any of the terms of this Agreement shall be deemed valid unless
      it is in writing and signed by the Party against whom such modification is
      sought to be enforced. The failure of either Party to insist upon the strict
      performance of any term of this Agreement or the waiver by either Party of
      any
      breach under this Agreement shall not prevent the subsequent strict enforcement
      of such term nor be deemed a waiver of any subsequent breach.

     

    13.8 Severability.
      In the
      event any court declares illegal or unenforceable, as written or applied, any
      provision of this Agreement, such provision shall be severed and the remaining
      provisions of this Agreement shall continue in full force and effect as if
      such
      provision had been deleted or made inapplicable to the situations to which
      such
      provision cannot be legally applied. The Parties shall use their best efforts
      to
      agree upon a valid and enforceable provision as a substitute for the severed
      provision, taking into account the intent of this Agreement.

     

    13.9 Independent
      Contractors.
      Each
      Party is an independent contractor under this Agreement. Nothing contained
      in
      this Agreement is intended nor is to be construed so as to constitute ** or
      Fidopharm as partners or joint venturers with respect to this Agreement. Neither
      Party shall have any express or implied right or authority to assume or create
      any obligations on behalf of or in the name of the other Party, or to bind
      the
      other Party to any other contract, agreement or undertaking with any Third
      Party
      or Affiliate.

     

    13.10 Counterparts.
      This
      Agreement may be executed by fax and in one or more counterparts, each of which
      shall be deemed to be an original but all of which together shall constitute
      one
      and the same instrument.

     

    13.11 Headings.
      The
      headings used in this Agreement have been inserted for convenience of reference
      only and do not define or limit the provisions hereof.

     

    ***
      Remainder of Page Intentionally Left Blank; Signature Page Follows
      ***

     

    
      
         

      

      
        17

        
          

        

      

      
         

      

       

    

    IN
      WITNESS WHEREOF,
      the
      Parties hereto have executed this Agreement as of the Effective
      Date.

    

      
        	
                FIDOPHARM,
                  INC.

              
	 
	
                /s/
                  **

              
	
                Name:
                  **

              
	
                Title:
                  President & CEO

              
	 
	 
	
                /s/
                  **

              
	
                Name:
                  **

              
	
                Title:
                  CEO

              


      

    

     

    
      
         

      

      
        18

        
          

        

      

      
         

      

       

    

    SCHEDULE
      1

    


    **

     

    
      
         

      

      
        19

        
          

        

      

      
         

      

       

    

    SCHEDULE
      2

    


    Patents

    


    No
      Patents exist as of the Effective Date. 

     

    
      
         

      

      
        20

        
          

        

      

      
         

      

    

     

    SCHEDULE
      4.2

     

    **

     

    
      
         

      

      
        21