ex_10-24.htm


     

    
      

      

    

    
 

    LICENSE
AND SUPPLY AGREEMENT

     

    dated
as of __November 17,
2008__between

     

    MEDA
AB

     

    and

     

    ULURU
Inc.

    


    
 


    
      
         


      

      
         


        
          

        

      

      
         


      

    


    THIS
LICENSE AND SUPPLY AGREEMENT (this “Agreement”) is made and entered into as of
this __November 17,
2008___ (the “Effective Date”), between MEDA AB, a corporation organized
and existing under the laws of Sweden, and having an address at Pipers väg 2,
Box 906 , 170 09 Solna, Sweden (“MEDA”) and ULURU Inc., a corporation organized
and existing under the laws of Delaware and having an address at 4452 Beltway
Drive, Addison, Texas, 75001, USA (“ULURU”).

    


    RECITALS

    WHEREAS,
ULURU is the owner of the rights to OraDiscTM A (amlexanox) and Aphthasol Paste
(5% amlexanox paste) for the prevention and treatment of aphthous
ulcers;

    


    WHEREAS,
On December 23, 1998, MEDA and ULURU entered into 5% Amlexanox Paste License
Agreement, whereas MEDA had been granted the rights to register, market,
promote, sell and distribute Aphthasol Paste (5% amlexanox paste) in several
European countries (hereinafter referred to as the “Old
Agreement”);

    


    WHEREAS,
the Parties intend to extent the territory of the Old Agreement and to add the
promotion and distribution rights for OraDiscTM A (amlexanox);

    


    WHEREAS,
ULURU desires to grant to MEDA, and MEDA desires to obtain from ULURU, an
exclusive license to register, promote, market, sell and distribute the Products
(as defined below) and an exclusive right to purchase from ULURU and distribute
the Products, all under the terms and subject to the conditions set forth
herein;

    


    WHEREAS,
MEDA and ULURU want to terminate the Old Agreement effective as of the Effective
Date and enter into this Agreement;

    


    NOW,
THEREFORE, in consideration of the mutual covenants and agreements set forth
herein, and for good and valuable consideration the receipt and sufficiency of
which are hereby acknowledged, the parties hereto hereby agree as
follows:

    


    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              1.  

            	
              DEFINITIONS

            


    

    


    
      	
              1.1.  

            	
              Definitions.

            


    

    


    As used
in this Agreement, the following capitalized terms have the meanings indicated
below:

    


    
      	
              1.1.1.  

            	
               “Affiliate”
      means, in the case of either Party, any corporation, joint venture, or
      other business entity which directly or indirectly controls, is controlled
      by, or is under common control with that Party. The term “control,” as
      used in this definition, means having the power to direct, or cause the
      direction of, the management and policies of an entity, whether through
      ownership of voting securities, by contract or otherwise. Notwithstanding
      the foregoing, for purposes of this Agreement, the term “Affiliate” does
      not include entities in which a Party or its Affiliates owns a majority of
      the ordinary voting power to elect a majority of the board of directors
      but is restricted from electing such majority by contract or otherwise,
      until such time as such restrictions are no longer in
    effect.

            


    

    


    
      	
              1.1.2.  

            	
              “Batch”
      means the volume of finished, packaged Products obtained from a validated
      Manufacturing run.

            


    

    


    
      	
              1.1.3.  

            	
              “Certificate
      of Analysis” means the document identifying the results of the Methods of
      Analysis for a specific Batch of Product in a form agreed to by the
      Parties in writing but which shall include, without limitation, the
      applicable Product Batch’s manufacturing date, expiration date, lot number
      and testing results and data.

            


    

    


    
      	
              1.1.4.  

            	
              “Confidential
      Information” means either MEDA Confidential Information, ULURU
      Confidential Information, or both, as the context
  requires.

            


    

    


    
      	
              1.1.5.  

            	
              “Contract
      Year” means each consecutive twelve (12) month period during the Term, the
      first of which shall commence on the first day of the calendar month
      following the date of Launch and end on the first anniversary
      thereof.

            


    

    


    
      	
              1.1.6.  

            	
              “Control”
      means, with respect to any item of information or intellectual property
      right, the possession, whether by ownership or exclusive license, of the
      right to grant a license or other right with respect
    thereto.

            


    

    


    
      	
              1.1.7.  

            	
              “Effective
      Date” has the meaning set forth in the
Preamble.

            


    

    


    
      	
              1.1.8.  

            	
              “EMEA”
      means (a) the European Medicines Evaluation Agency, London, United
      Kingdom, or (b) any local regulatory agency or governmental entity which
      fulfills a role similar to the EMEA, or any successor entities
      thereto.

            


    

    


    
      	
              1.1.9.  

            	
              “Facility”
      and / or “Facilities” means any and all facilities regarding the
      Manufacture of the Products and the supply of the Materials, which are
      listed in Exhibit B or
      any subsequent or replacement facilities approved by
  MEDA.

            


    

    


    
      	
              1.1.10.  

            	
              “Field”
      means the prevention and treatment of aphthous
  ulcers.

            


    

    


    
      	
              1.1.11.  

            	
              “Force
      Majeure Event” has the meaning set forth in Article
  11.

            


    

    


    
      	
              1.1.12.  

            	
              “Good
      Manufacturing Practice” or “GMP” means (a) the then current standards for
      the manufacture of pharmaceuticals, (b) such standards of good
      manufacturing practice as are required by the applicable laws and
      regulations of countries in which the Product is intended to be sold, to
      the extent such standards are not inconsistent with the then current
      standards for the manufacture of pharmaceuticals as set forth in the
      FD&C Act, and (c) any quality requirements set forth in this Agreement
      or the Quality Agreement attached hereto as Exhibit
      C.

            


    

    


    
      	
              1.1.13.  

            	
              “Indemnified
      Party” has the meaning set forth in Section
  8.1.3.

            


    

    


    
      	
              1.1.14.  

            	
              “Indemnifying
      Party” has the meaning set forth in Section
  8.1.3.

            


    

    


    
      	
              1.1.15.  

            	
              “Intellectual
      Property Rights” means Patents, designs, formulae, trade secrets,
      know-how, industrial models, and technical information Controlled by ULURU
      and whether now existing or coming into existence during the Term and
      which are necessary for and/or related to the use or distribution of the
      Products.

            


    

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              1.1.16.  

            	
              “Invention”
      means any new or useful method, process, manufacture, compound or
      composition of matter, whether or not patentable or copyrightable, or any
      improvement thereof arising during the Term with respect to the Products,
      its Manufacture and/or use.

            


    

    


    
      	
              1.1.17.  

            	
              “Launch”
      means the date on which the respective Product is sold by MEDA for the
      first time to a Third Party for commercial distribution in the
      Territory.

            


    

    


    
      	
              1.1.18.  

            	
              “Major
      Countries” shall mean (i) initially France, Germany, Italy, and United
      Kingdom and (ii) potentially later Spain, provided that ULURU had
      re-acquired the rights back from Esteve S.A., Spain, in accordance with
      Section 3.1.5.

            


    

    


    
      	
              1.1.19.  

            	
               “Manufacture,”
      “Manufactured” or “Manufacturing” means all activities involved in the
      production of the Products, including, without limitation, the
      preparation, formulation, finishing, testing, packaging, storage and
      labeling of the Products and the handling, storage and disposal of any
      residues or wastes generated
thereby.

            


    

    


    
      	
              1.1.20.  

            	
               “Materials”
      means all materials, including, without limitation, all raw materials,
      ingredients, packaging supplies and labels, required for the Manufacture
      of Products.

            


    

    


    
      	
              1.1.21.  

            	
              “MEDA”
      has the meaning set forth in the
Preamble.

            


    

    


    
      	
              1.1.22.  

            	
              “MEDA
      Confidential Information” means all information, specifications, know-how
      and data pertaining to MEDA’s business disclosed to ULURU, its Affiliates
      or its Third Party manufacturer hereunder, including, without limitation,
      marketing and sales plans, artwork, formats, equipment, logos, drawings,
      customer lists, regulatory filings, correspondence with the EMEA or any
      other Regulatory Authority, clinical study data, analytical data,
      operating procedures and all ordering and sales
    information.

            


    

    


    
      	
              1.1.23.  

            	
              “MEDA
      Trademarks” means any trademarks, trade name, trade dress, slogan, logo,
      or similar item selected by MEDA for use in connection with the Products,
      including but not limited to the trademark Apthasol®, as listed in Exhibit
      J.

            


    

    


    
      	
              1.1.24.  

            	
              “Methods
      of Analysis” means the methods of analysis for the Products which are
      mutually agreed upon in writing between the Parties and, on a date to be
      mutually agreed upon by the Parties, attached as an exhibit to this
      Agreement.

            


    

    


    
      	
              1.1.25.  

            	
              “Net
      Sales” means, with respect to the Product, the gross invoiced sales amount
      of the Products sold by MEDA or its Affiliates to non-affiliate Third
      Parties, after deduction of the following items, to the extent that such
      deductions are reasonable and actually allowed, taken or incurred, and
      (provided that such items do not exceed reasonable and customary amounts
      in the country in which the sale occurred): (a) trade and quantity
      discounts, net of any give-backs received by MEDA in return; (b) refunds,
      rebates, governmental rebates, retroactive price adjustments, service
      allowances and broker’s or agent’s commissions; (c) credits or allowances
      given for rejection or return of previously sold Products or for wastage
      replacement actually taken or allowed; and (d) any tax, duties or
      government charge levied on the sale of Product and borne by MEDA and/or
      its Affiliates (excluding national, state or local taxes based on income).
      Such amounts shall be determined from the books and records of MEDA and
      its Affiliates maintained in accordance with generally accepted accounting
      principles, consistently applied. Sales of the Products by and between a
      Party and its Affiliates for further distribution to a Third Party are not
      sales to Third Parties and shall be excluded from Net Sales calculations
      for all purposes.

            


    

    


    
      	
              1.1.26.  

            	
              “Old
      Agreement” shall have the meaning as set fort in the Preamble of this
      Agreement

            


    

    


    
      	
              1.1.27.  

            	
              “Party”
      or “Parties” means either MEDA, ULURU or both, as the context
      requires.

            


    

    


    
      	
              1.1.28.  

            	
              “Patents”
      shall mean (a) the patents listed in Exhibit D and
      (b) any and all patents, patent applications, patent disclosures awaiting
      filing determination, patent divisionals, continuations,
      continuations-in-part, reissues, re-examinations, renewals and extensions
      thereof Controlled by ULURU during the Term, within the Territory, which
      are necessary for the Manufacture, use or distribution of the
      Products.

            


    

    


    
      	
              1.1.29.  

            	
              “Person”
      means any natural person, corporation, general partnership, limited
      partnership, limited liability company, limited liability partnership
      proprietorship, other business organization, trust, union, association or
      governmental authority.

            


    

    


    
      	
              1.1.30.  

            	
               “Products”
      shall mean the Products listed in Exhibit
      A

            


    

    


    
      	
              1.1.31.  

            	
               “Recall”
      means any action by any Party to recover title to or possession of any
      Product sold or shipped to Third Parties or any action to prevent or
      interrupt the sale or shipment by a Party of the Products to Third Parties
      that would have been subject to recall if it had been sold or
      shipped.

            


    

    


    
      	
              1.1.32.  

            	
              “Regulatory
      Approval” means all consents, permits, approvals, licenses,
      authorizations, qualifications, notices or orders that are issued or
      granted by Regulatory Authorities which are required for the manufacture,
      marketing, promotion, pricing and sale of the Products in a country within
      the Territory.

            


    

    


    
      	
              1.1.33.  

            	
              “Regulatory
      Authority” means any domestic or foreign, federal, national, regional,
      state, county, city, municipal, local or other administrative, legislative
      regulatory or other governmental authority, agency, department, bureau,
      commission, or council involved in the granting of Regulatory Approval for
      the Products in the Territory.

            


    

    


    
      	
              1.1.34.  

            	
              “Rolling
      Forecast” has the meaning set forth in Section
  3.4.

            


    

    


    
      	
              1.1.35.  

            	
              “Seizure”
      means any action by the EMEA or any other Regulatory Authority to detain
      or destroy the Products or prevent the release of the
      Products.

            


    

    


    
      	
              1.1.36.  

            	
              “Specifications”
      means the specifications for the Products as set forth in the Exhibit E or in
      the Quality Agreement.

            


    

    


    
      	
              1.1.37.  

            	
              “Supply
      Failure” shall have the meaning as set forth in Section
    3.7.2.

            


    

    


    
      	
              1.1.38.  

            	
              “Term”
      means, with respect to each country in the Territory, the period
      commencing on the Effective Date and ending upon the expiration of the
      last-to-expire patent within the Patents in such country, except as and if
      sooner terminated in accordance with Article
9.

            


    

    


    
      	
              1.1.39.  

            	
              “Territory”
      means,

            


    

    (a)
initially:

    
      	
               
      

            	
              (aa)

            	
              Countries
      of the Old Agreement, which are: Denmark, Sweden, Norway, Finland,
      Estonia, Lithuania, Latvia and

            


    

    (bb)           New
countries, which are

    
      	
               
      

            	
              (i)

            	
              European
      Union countries: Austria, Belgium, Bulgaria, Cyprus, Czech Republic,
      France, Germany, Hungary, Ireland, Italy, Luxembourg, Malta, Netherlands,
      Poland, Romania, Slovakia, Slovenia, United Kingdom,
  and

            


    

    (ii)           Non-European
Union Countries: Switzerland, Turkey and

    
      	
               
      

            	
              (iii)

            	
              Russia
      and CIS Markets: Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan,
      Moldova, Russia, Tajikstan, Ukraine, Uzbekistan and
    Kyrgyzstan

            


    

    


    and (b)
potentially later Spain, Greece and Portugal provided that ULURU had re-acquired
the rights back from Esteve S.A., Spain, in accordance with Section 3.1.5, and
any other countries the Parties may agree on to add to this
Agreement.

    


    
      	
              1.1.40.  

            	
              “Third
      Party” means any Person other than MEDA, ULURU and their respective
      Affiliates.

            


    

    


    
      	
              1.1.41.  

            	
              “Trademarks”
      means all ULURU trademarks
OraDiscTM.

            


    

    


    
      	
              1.1.42.  

            	
              “ULURU”
      has the meaning set forth in the
Preamble.

            


    

    


    
      	
              1.1.43.  

            	
              “ULURU
      Confidential Information” means all information, specifications
      (including, without limitation, the Specifications), know-how and data
      pertaining to the Products and ULURU’s business or its Manufacturing
      operations disclosed to MEDA or its Affiliates, Third Party manufacturers
      or distributors hereunder, including, without limitation, all information,
      Specifications, know-how and data related to the design, implementation,
      performance and Manufacture of the Products, and any correspondence with
      the FDA, EMEA or any other Regulatory Authority, clinical study data,
      analytical data, or operating
procedures.

            


    

    


    
      	
              1.2.  

            	
              Construction of
      Certain Terms and Phrases.

            


    

    


    Unless
the context of this Agreement otherwise requires, (i) words of any gender
include each other gender; (ii) words using the singular or plural number also
include the plural or singular number, respectively; (iii) the terms “hereof,”
“herein,” “hereby” and derivative or similar words refer to this entire
Agreement; (iv) the terms “Article” or “Section” refer to the specified Article
or Section of this Agreement; and (v) Article and Section headings shall not
affect the meaning or construction of any provision of this
Agreement.

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    


    
      	
              2.  

            	
              TERMINATION
      OF THE OLD AGREEMENT

            


    

    


    
      	
              2.1.  

            	
              MEDA
      and ULURU hereby terminate by mutual agreement the Old Agreement effective
      as of the Effective Date.

            


    

    


    
      	
              2.2.  

            	
              The
      Parties hereby agree that neither Party shall have any rights and/or
      obligations towards the respective other Party resulting from the Old
      Agreement and/ or its termination.

            


    

    


    


    
      	
              3.  

            	
              SUPPLY

            


    

    


    
      	
              3.1.  

            	
              Grant of License /
      Expansion of the Territory.

            


    

    


    
      	
              3.1.1.  

            	
              Subject
      to the terms and conditions of this Agreement, ULURU hereby grants to MEDA
      (a) the exclusive right and sub licensable license in the Field under
      ULURU’s Intellectual Property Rights to market, offer for sale, sell,
      distribute and import products, including the Products, in the Territory,
      (b) the exclusive right and sub licensable license in the Field under
      ULURU’s Intellectual Property Rights to use the Products in the Territory,
      provided that such right and license is limited to such use as is
      necessary for MEDA to market, offer for sale, sell, distribute and import
      and, subject to the terms and conditions set forth in Section 3.8,
      Manufacture the Products in the Territory, and (c) a exclusive right and
      sub licensable license to use the Products and all information and
      Intellectual Property Rights with respect thereto (including, without
      limitation, data, studies and clinical trials) solely for the purpose of
      obtaining Regulatory Approvals for the Products. Except as expressly
      granted herein, ULURU retains all rights in the Intellectual Property
      Rights and the Products.

            


    

    


    
      	
              3.1.2.  

            	
              Except
      as specifically provided to the contrary in Section 3.1.1, the license
      granted in Section 3.1.1 shall not be construed (a) to effect any sale of
      ULURU ́s Intellectual Property Rights or any other proprietary ULURU
      technology; (b) subject to the terms and conditions set forth in Section
      3.8, to grant any license relating to ULURU’s methods of formulating,
      fabricating and Manufacturing the Products; (c) to grant MEDA any rights
      in or to the use of the Intellectual Property Rights by implication or
      otherwise. MEDA shall mark or have marked all containers or packages of
      the Products in accordance with the patent marking laws of the
      jurisdiction in which such units of Products are to be used or
      distributed.

            


    

    


    
      	
              3.1.3.  

            	
              Upon
      expiration of the Term in any country due to (i)the expiration of the
      last-to-expire patent within the Patents in such country or (ii) due to a
      termination of the Agreement for cause by MEDA in accordance with the
      provisions of Section 3.7.3, 9.4 and/or 9.5, MEDA shall have a
      non-exclusive, transferable, timely unrestricted license to those licenses
      set forth in Section 3.1.1, provided that MEDA will pay to ULURU the
      royalties in accordance with Articles 3.1.3 a)- d) of this
      Agreement:

            


    

    


    
      	
               
      

            	
              a)

            	
              In
      consideration for the license granted by ULURU to MEDA as set out above in
      Article 3.1.3, MEDA shall pay to ULURU a royalty of 5 % (five percent) on
      Net Sales of the Products.

            


    

    


    
      	
               
      

            	
              b)

            	
              MEDA
      will pay to ULURU the royalties quarterly (meaning any calendar quarter
      ending on 31st March, 30th June, 30th September or 31st December) within
      30 (thirty) days after the end of the relevant calendar quarter. The
      currency of the royalty payment shall be EURO. Each royalty payment shall
      be accompanied by a statement in a form as set forth in Article
      3.9.3 d) of this Agreement.

            


    

    


    
      	
               
      

            	
              c)

            	
              The
      rights and obligations of the Parties as to ULURU ́s right to inspect and
      examine MEDA ́s books - as laid down in Article 6.5.2 and 6.5.3 of this
      Agreement shall - apply
accordingly.

            


    

    


    
      	
               
      

            	
              d)

            	
              It
      is understood that MEDA ́s obligation to pay royalties to ULURU shall cease
      on a product by product basis upon the expiration of the last-to-expire
      patent within the Patents in such
country.

            


    

    


    
      	
              3.1.4.  

            	
              MEDA
      is free to decide whether (i) to use the Trademarks in the countries of
      the Territory or (ii) to register, at MEDA’s expense, and to use
      alternative MEDA Trademarks for the promotion, distribution and sale of
      the Products.

            


    

    


    
      	
               
      

            	
              a)

            	
              Trademarks

            


    

    In case
MEDA decides to use the Trademarks and not to register and use the MEDA
Trademarks the following shall apply:

    


    On
request of MEDA, ULURU agrees to register – at ULURU ́s own costs – in the
respective countries of the Territory the Trademark Ora Disc.

    


    Subject
to the terms and conditions of this Agreement, ULURU hereby grants to MEDA an
exclusive, non-transferable (except in accordance with a permitted assignment of
this Agreement under Section 14.3) license in the Field to use the Trademarks
solely in connection with the Manufacture, promotion, marketing, sale and
distribution  of the Products under this Agreement, within the
Territory. Based on the information provided by ULURU, MEDA acknowledges that
ULURU is the exclusive owner of the Trademarks and all associated goodwill and
registrations. MEDA agrees that it has no rights to use the Trademarks except
for the right to use the Trademarks as provided for in this Agreement and all
uses of the Trademark by MEDA, and the associated goodwill, shall inure solely
to the benefit of ULURU.

    


    MEDA
further agrees that upon the termination or expiration of this Agreement, all
right to use the Trademarks provided to MEDA hereby shall revert fully to
ULURU.

    


    Except as
consistently with this Agreement with respect to the Products, MEDA shall not
(a) use the Trademark as part of, or in conjunction with, any other names or
Trademarks without ULURU’s prior written approval; (b) use the Trademarks or any
confusingly similar marks, terms or designs, except as expressly authorized in
this Section 3.1.4; (c) attempt to register any such Trademarks, terms or
designs; (d) take any actions inconsistent with ULURU’s ownership of the
Trademark and any associated registrations, or attack the validity of the
Trademark, ULURU’s ownership thereof, or any of the terms of this Section 3.1.4;
(e) use the Trademark in any manner that would indicate MEDA is using such
Trademark other than as a licensee of ULURU; nor (f) assist any Affiliate or
Third Party to do any of the same.

    


    
      	
               
      

            	
              b)

            	
              MEDA
      Trademarks

            


    

    ULURU
agrees that MEDA is the exclusive owner of the MEDA Trademarks and all
associated goodwill and registrations. ULURU shall have no rights to use the
MEDA Trademarks except for the right to use the Trademark as provided for in
this Agreement.

    


    ULURU
further agrees that upon the termination or expiration of this Agreement, all
right to use the MEDA Trademarks hereby shall revert fully to MEDA.

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              3.1.5.  

            	
              ULURU
      will provide commercially reasonable efforts to re-acquire from Esteve SA,
      Spain the exclusive rights for the Manufacture, marketing, promotion, sale
      and distribution of the Products in Spain, Greece and Portugal. ULURU will
      promptly inform MEDA once the rights had been re-acquired from Esteve SA.
      In such a case, the parties agree to extend the Territory and to add
      Spain, Greece and Portugal to this Agreement. The Parties will stipulate
      the extension of the Territory in an amendment to this Agreement. To avoid
      any misunderstandings, the license payments applicable for Spain mentioned
      in Exhibit
      I are subject to ULURU ́s successful re-acquisition of the Product
      rights for Spain, Greece and
Portugal.

            


    

    


    
      	
              3.2.  

            	
              Registration of the
      Products / Regulatory
Approvals

            


    

    


    
      	
              3.2.1.  

            	
              At
      MEDA’s sole expense, MEDA agrees to make and maintain all Regulatory
      Approvals for the Products from the Regulatory Authorities in the
      countries of the Territory.

            


    

    


    
      	
              3.2.2.  

            	
              ULURU
      will provide MEDA with all documentation which is necessary for the
      registration process and the obtaining of the Regulatory Approvals,
      including but not limited to a certificate of pharmaceutical product
      (“CPP”) and the US dossiers of the Products. ULURU will use commercially
      reasonable efforts to assist MEDA in the obtainment of the Regulatory
      Approvals.

            


    

    


    
      	
              3.2.3.  

            	
              If
      MEDA decides not to register OraDiscTM A (amlexanox) in one of the Major
      Countries, the rights to the respective Product (and only to this Product)
      in the respective country granted by ULURU according to Section 3.1 shall
      revert to ULURU.

            


    

    


    To avoid
any misunderstandings, for any other countries other than the Major Countries,
MEDA is free to decide whether to make and /or maintain the Regulatory Approvals
or not.

    


    
      	
              3.2.4.  

            	
              Any
      Regulatory Approval shall become, if legally permitted in the respective
      country of the Territory, the sole property of MEDA. MEDA shall be (if
      legally permitted in the respective country of the Territory) the holder
      of the Regulatory Approvals.

            


    

    


    Upon
termination and/or expiration of this Agreement for whatever reason, ULURU shall
transfer the Regulatory Approvals (if due to legal regulations in a country of
the Territory ULURU must be holder of the Regulatory Approval) to MEDA or any
Third Party designated by MEDA.

    


    
      	
              3.3.  

            	
              Manufacture.

            


    

    


    
      	
              3.3.1.  

            	
              Subject
      to Section 3.4, ULURU shall Manufacture and deliver the Products to MEDA
      in such quantities and at such times as ordered by MEDA in accordance with
      this Agreement. During the Term, ULURU shall maintain the resources
      necessary to Manufacture the Products and shall provide, at its own
      expense, all Materials and labor necessary to do
  so.

            


    

    


    
      	
              3.3.2.  

            	
              ULURU
      may not transfer its Manufacturing and supply obligations under this
      Agreement to any Third Party without MEDA’s prior written consent. In any
      case, ULURU is solely responsible towards MEDA for the fulfillment of all
      of ULURU’s Manufacturing and supply obligations under this
      Agreement.

            


    

    


    
      	
              3.3.3.  

            	
              MEDA
      herewith approves the Third Party manufacturer of ULURU mentioned in Exhibit
      B.

            


    

    


    
      	
              3.3.4.  

            	
              If
      requested by MEDA, ULURU shall be responsible for (a), at MEDA’s cost and
      expense, supplying to MEDA, prior to the commencement of Manufacturing of
      the Product, a full scale validation Batch and the data reasonably
      requested by MEDA (including, without limitation, the final Product
      formulation, the processing requirements from start to finish for all
      production, the validated analytical methods, the Specifications and test
      method (both chemical and physical) for all elements of the disc component
      and the Product through the finished production of the Products and the
      validation protocols and schedules for processes, equipment, cleaning and
      packaging) and MEDA shall reimburse ULURU for ULURU’s actual, reasonable,
      out-of-pocket costs for the supply of such Batch and data, (b) at MEDA ’s
      cost and expense, scale-up, validation and stability of the Products for
      commercial production of the Products, including, without limitation, bulk
      production of the benzocaine gel, production of the mucoadhesive disc and
      development and validation of a mutually acceptable package configuration,
      (c) cooperating with MEDA with respect to the obtaining by MEDA of any
      Regulatory Approvals required to be obtained by MEDA with respect to the
      marketing, sale, offering to sell, importing and/or distribution of the
      Product, and (d) providing to MEDA complete Batch records for all
      validation Batches and, on an annual basis, providing one representative
      full Batch record.

            


    

    


    
      	
              3.4.  

            	
              Forecasts.

            


    

    


    At least
four (4) months prior to Launch, MEDA shall submit to ULURU a forecast of the
quantity of the Products that MEDA anticipates ordering from ULURU prior to
MEDA’s anticipated Launch of Products. MEDA shall submit to ULURU a forecast of
the quantity of the Products that MEDA anticipates ordering from ULURU during
the twelve (12) month period (broken down by month) following Launch and MEDA
shall update such forecast on a rolling twelve (12) months basis every month
thereafter (each, a “Rolling Forecast”). MEDA shall place purchase orders for at
least the quantity of the Products specified in the first three (3) months of
each such Rolling Forecast and the remaining nine (9) months shall be a
non-binding good faith estimate. Except as set forth in this Section 3.4, MEDA
shall not be required to order any fixed minimum quantity of the Products or any
quantity of the Products, notwithstanding any forecast or prior course of
dealing.

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              3.5.  

            	
              Orders and
      Delivery.

            


    

    


    MEDA
shall place its firm orders for the Product with ULURU by submitting a purchase
order, at least ninety (90) days prior to the delivery date requested therein,
which sets forth (a) the quantity of the Product ordered for delivery; and (b)
the delivery date for that order. Any such purchase order which is in accordance
with the terms and conditions of this Agreement shall be deemed to be accepted
by ULURU.

    


    For all
other purchase orders placed by MEDA, unless ULURU notifies MEDA in writing
within fifteen (15) days of receipt of a purchase order that it is unable to
deliver the Product in accordance with such purchase order, ULURU shall be
deemed to have accepted such purchase order as a binding order. If ULURU
notifies MEDA that it is unable to fill a purchase order that is not in
accordance with the terms and conditions of this Agreement, it shall indicate
the portion of such purchase order ULURU cannot supply by the requested delivery
date and specify alternate delivery dates; provided that in the event that MEDA
delivers a purchase order less than ninety (90) days prior to the requested
delivery date, ULURU shall use commercially reasonable efforts to meet such
requested delivery date despite the shortened lead time, and ULURU will not be
in breach of its obligations hereunder if, despite such commercially reasonable
efforts, ULURU is not able to meet such requested delivery date with respect to
such order. MEDA may cancel or modify any firm purchase order (in whole or in
part) at any time prior to the delivery for any quantity of Products for which
Manufacturing has not been completed pursuant to such purchase order at the time
that notice of cancellation or modification is received by ULURU; provided that
if Manufacturing has commenced but not completed pursuant to such firm purchase
order, MEDA shall reimburse ULURU for Material and labor costs in respect of any
works-in-progress pursuant to such cancelled or modified purchase order (or part
thereof) at the time notice of cancellation or modification is received by
ULURU; and provided, further, that MEDA shall reimburse ULURU for the actual,
reasonable out-of-pocket cost of any other Material purchased by ULURU to fill a
cancelled purchase order (or part thereof) that are unique to the Product and
cannot within a reasonable period of time otherwise be used in ULURU’s
operations.  All Products shall be delivered F.O.B. the Facility and
in accordance with MEDA’s instructions.  Title, possession and risk of
loss shall pass to MEDA upon delivery of Products to MEDA’s designated carrier
at the Facility’s loading dock.  The provisions of this Agreement
shall prevail over any inconsistent statement or provisions contained in any
document related to this Agreement passing between the parties hereto including,
but not limited to, any purchase order, acknowledgment, confirmation or
notice.

    


    
      	
              3.6.  

            	
              Shelf
      Life.

            


    

    


    ULURU
shall schedule Manufacturing operations so that all of the Products delivered
has the latest expiry date possible, and in no event shall any Products be
delivered to MEDA with an expiry date less than the maximum established expiry
date (as set forth in the Specifications) less three (3) months. If Product is
delivered to MEDA whose expiry date does not conform to the requirements set
forth in this Section 3.6, ULURU shall promptly, at its sole expense, replace
the non-conforming Product.

    


    
      	
              3.7.  

            	
              Supply
      Failures.

            


    

    


    
      	
              3.7.1.  

            	
              It
      is of essence to this Agreement that ULURU delivers the Products at the
      date stated in the purchase order. In the event that ULURU fails to
      deliver the Products on or before the delivery date specified in the
      applicable purchase order, ULURU or its Affiliates shall notify MEDA of
      such delay and the Parties shall consult in good faith to determine the
      period of such inability to supply such
Product.

            


    

    


    
      	
              3.7.2.  

            	
              If
      (i) MEDA reasonably determines that such or any other inability to so
      supply a Product will continue for more than 90 (ninety) days, or (ii) if
      ULURU fails to supply any of MEDA ́s purchase orders for Product and fails
      to cure such failure within 60 (sixty) days after the requested delivery
      date therefore (each of (i) and (ii) shall be referred to as a “Supply
      Failure”), then MEDA may, at its option either (x) agree to have ULURU
      supply the undelivered Product at a future date agreed upon the Parties or
      (ii) have up to 100 (hundred) % supplied by a secondary supplier of such
      Product as provided for in Article 3.8
below.

            


    

    


    In any
event ULURU shall use commercial reasonable efforts to resume the Manufacture as
promptly as possible. In the event of a Force Majeure, the Parties will work in
good faith to try and re-establish supply of Products as soon as
possible.

    


    
      	
              3.7.3.  

            	
              If
      ULURU continues to be delayed with the delivery of the Products for a
      period of six (6) consecutive months, MEDA has, without any time
      restriction, the right to terminate this
  Agreement.

            


    

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              3.8.  

            	
              Secondary
      Supplier:

            


    

    


    
      	
              3.8.1.  

            	
              MEDA
      shall have the right to establish and maintain secondary supplier (s) for
      all Products (in finished form). MEDA and UULURU shall jointly select and
      agree on a secondary supplier(s), provided however that if the Parties can
      not agree on a secondary supplier, then MEDA shall be entitled to appoint
      a secondary supplier at its sole
discretion.

            


    

    


    
      	
              3.8.2.  

            	
              ULURU
      shall cooperate with MEDA in the transfer of copies of the ULURU
      Confidential Information, technology and know- how necessary to
      Manufacture the Products to MEDA and/or its designated secondary supplier
      (s), (b) deliver to MEDA copies of such drawings, specifications, and
      other information in ULURU’s possession as may be necessary to Manufacture
      the Products or cause the Products to be Manufactured and (c) grant to
      MEDA a limited license in the Field under ULURU’s Intellectual Property
      Rights during the Term of this Agreement to Manufacture, make, or have
      made for MEDA’s distribution of the Product in the Territory, the
      Products; provided that to the extent that such technology and know-how
      constitutes ULURU Confidential Information (or any information constitutes
      Confidential Information of ULURU’s Third Party manufacturer) it shall be
      subject to the provisions of Article 10 and MEDA’s designated secondary
      supplier shall be required to enter into a confidentiality agreement with
      ULURU containing substantially the same terms as Article 10; and further
      provided that all items provided under clauses (a) and (b) above will be
      subject to the license granted pursuant to clause
  (c).

            


    

    


    
      	
              3.8.3.  

            	
              Subject
      to Section 3.8.1 following the establishment of any secondary supplier
      hereunder, MEDA may obtain from such secondary supplier such portion of
      its supplier requirements with the respect to the Product as is necessary
      to maintain such secondary supplier’s regulatory qualification, but in no
      event more than 10% of MEDA ́s total requirements for the Products. Product
      procured until this section 3.8.3 will be subject to a royalty of 5% of
      Net Sales in the Territory.

            


    

    


    
      	
              3.8.4.  

            	
              Notwithstanding
      the provisions of Section 3.8.3 above, but subject to Section 3.8.1 above,
      MEDA shall have the right to obtain from such secondary supplier(s) up to
      100% of its supply requirements with respect to any Products in the event
      (a) of expiration of the Term of this Agreement or (b) MEDA terminates the
      Agreement with respect to such Product pursuant to Article 3.7.4, 9.4 and
      9.5 of this Agreement, (c) in the event of a Supply Failure occurs with
      respect to such Product.

            


    

    


    
      	
              3.9.  

            	
              Marketing, Promotion
      and Distribution.

            


    

    


    
      	
              3.9.1.  

            	
              ULURU
      agrees that MEDA shall have only the obligation to market, promote, sell
      and distribute OraDiscTM A (amlexanox) in the countries of the Major
      Countries, Belgium, the Netherlands and in Turkey, provided that, nothing
      shall require MEDA to continue to market or sell the Products in any of
      these countries during a period of time that MEDA determines, in its sole
      judgment, that such Product is reasonably likely to be Subject to adverse
      regulatory or legal action, or infringe any intellectual property right of
      any Third Party in such country.

            


    

    


    
      	
              3.9.2.  

            	
              MEDA
      agrees to Launch in addition OraDiscTM A (amlexanox) in the countries of
      the Major Countries, Belgium, the Netherlands and in Turkey, within 6
      (six) months after Regulatory Approval has been granted, provided that
      ULURU has delivered MEDA with Products as laid down in the respective
      purchase order.

            


    

    


    If
OraDiscTM A (amlexanox) will not be launched in the countries of the Major
Countries, Belgium, the Netherlands and in Turkey within 6 (six) months after
Regulatory Approval has been granted, then ULURU will give MEDA the right to
remedy for another 4 (four) months. If Launch of the Products is not
effected in this additional 4 (four) months period, then the rights to the
respective Product (and only to this Product) in the respective country granted
by ULURU according to Section 3.1 shall revert to ULURU.

    


    To avoid
any misunderstandings, for any other countries than the countries of the Major
Countries, Belgium, the Netherlands and Turkey, MEDA is free to decide whether
to launch, market, promote, sell and distribute the OraDiscTM A (amlexanox) or
not. With regard to Aphthasol Paste (5% amlexanox paste) MEDA is to decide
whether to launch, market, promote, sell and distribute it or not

    


    
      	
              3.9.3.  

            	
              Subject
      to Section 3.9.1 – 3.9.2 above, MEDA
agrees

            


    

    


    a) to
market, sell and distribute the Products in accordance with the terms of this
Agreement.

    


    b) that
all promotion and selling activities are to be undertaken by MEDA at its own
cost and expense and without right of reimbursement therefore.

    


    c) to
provide to all customers in the Territory customer support relating to the
Products.

    


    d) to
remit on April 15th, July
15th,
October 15th and
January 15th of each
calendar quarter to ULURU a true, detailed and accurate report, in units and in
value, of all sales of Products and samples in the Territory in the preceding
calendar quarter.

    


    
      	
              3.9.4.  

            	
              ULURU
      agrees to support MEDA, as far as possible for and available within ULURU,
      in the promotion, marketing, sale and/or distribution of the Products in
      the Territory. Any costs related to such support will be borne by MEDA. If
      possible (i.e. where marketed by ULURU’s partners e.g. USA), ULURU will
      provide MEDA with examples of promotional material from its sub-licensees
      and distributors.

            


    

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              3.10.  

            	
              Supply of
      Samples

            


    

    


    As soon
as practicable after the Effective Date, the Parties will discuss in good faith
the terms and conditions (including but not limited the quantities and prices)
regarding ULURU ́s obligation to supply MEDA with samples of the
Products.

    


    
      	
              3.11.  

            	
              Clinical trials /
      Clinical Data

            


    

    


    
      	
              3.11.1.  

            	
              If
      (i) the Parties mutually agree to conduct further clinical trials and/or
      (ii) if a clinical trial is required for regulatory approval purposes,
      ULURU will contribute fifty (50%) per cent towards the cost of the
      respective clinical trial.

            


    

    


    
      	
              3.11.2.  

            	
              MEDA
      shall have the right to use and reference all clinical and other technical
      data generated by ULURU and ULURU’S licensees relating to the Products.
      ULURU and its licensees shall have the right to use and reference all
      clinical and other technical data generated by MEDA relating to
      Products.

            


    

    


    
      	
              3.12.  

            	
              Additional
      Responsibilities

            


    

    


    
      	
              3.12.1.  

            	
              MEDA
      shall be responsible, at MEDA’s cost and expense, for any consumer product
      testing and commercialization of the Products, including, without
      limitation, all sales and marketing activities related to the Products and
      the design of all Product packaging and related artwork, and the design of
      all labeling.

            


    

    


    
      	
              3.12.2.  

            	
              MEDA
      shall retain, at its own expense a selling and service organization with
      adequate experience, ability and training for purposes of marketing and
      selling the Products in the
Territory.

            


    

    


    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              4.  

            	
              COMPLIANCE,
      QUALITY AND ENVIRONMENTAL

            


    

    


    
      	
              4.1.  

            	
              Compliance with
      Law.

            


    

    


    ULURU
shall conduct all Manufacturing hereunder in a safe and prudent manner, in
compliance with all applicable laws and regulations (including, without
limitation, those dealing with occupational safety and health, those dealing
with public safety and health, those dealing with protecting the environment,
and those dealing with disposal of wastes), and in compliance with all
applicable provisions of this Agreement. ULURU shall obtain and maintain all
necessary Regulatory Approvals with respect to the Manufacture and supply of the
Products to MEDA. To the extent necessary for the Regulatory Approval of the
Products, ULURU shall permit the inspection of its premises and the Facilities
by Regulatory Authorities and shall supply all documentation and information
requested by MEDA or such Regulatory Authority to obtain or maintain Regulatory
Approval of the Products.

    


    
      	
              4.2.  

            	
              Manufacturing Quality;
      Storage.

            


    

    


    
      	
              4.2.1.  

            	
              All
      Products shall be Manufactured by ULURU at the Facilities using Materials
      and processing aids free of animal derived materials. ULURU shall sample
      and analyze all Materials upon receipt to ensure that such Materials are
      unadulterated, free of defects and meet the applicable Specifications
      therefore. ULURU shall take all necessary steps to prevent contamination
      and cross contamination of
Products.

            


    

    


    
      	
              4.2.2.  

            	
              The
      Products shall be unadulterated and free from contamination, dilutents and
      foreign matter in any amount and in accordance with the Product
      specifications and generally accepted pharmaceutical standards. ULURU
      shall perform the quality control tests (both when the Product is
      in-process and when it is finished) with respect to the Products in
      accordance with the Methods of Analysis, the cost of such to be included
      in the price hereinafter specified. ULURU shall promptly, upon completion
      of such tests, deliver to MEDA a copy of the record of such tests
      performed on, and a Certificate of Analysis for, each Batch of Product.
      ULURU shall deliver a representative sample from each Batch of Product to
      MEDA’s designated representative by the date reasonably specified by such
      representative.

            


    

    


    
      	
              4.2.3.  

            	
              Within
      sixty (60) days of the Effective Date, each of the Parties shall execute
      and deliver the Quality Agreement substantially in the form of Exhibit C and
      as mutually agreed to by the parties.  Each Party agrees to
      perform its respective obligations under the Quality Agreement in
      accordance with such agreement.  Prior to shipment, the Products
      shall be stored at all times in conditions at least as favorable as those
      set forth on the Product’s label, or in accordance with conditions
      reasonably specified by MEDA.

            


    

    


    
      	
              4.3.  

            	
              Testing by
      MEDA.

            


    

    


    MEDA may
test the Product samples in accordance with the applicable Methods of Analysis.
If the analysis of any Product performed by or for MEDA differs from ULURU ́s
analysis of the same Batch, MEDA shall advise ULURU and ULURU and MEDA agree to
consult with each other in order to explain and resolve the discrepancy between
each other’s determination. If, after good faith attempt by the Parties to do
so, such consultation does not resolve the discrepancy, an independent,
reputable laboratory as mutually agreed by the Parties shall repeat the
applicable Methods of Analysis on representative samples from such Batch
provided by both MEDA and ULURU. The costs of the independent laboratory
referred to above shall be borne by (a) MEDA if such laboratory determines that
the Product conforms to the Specifications or (b) ULURU if such laboratory
determines that the Product does not conform to the Specifications. If so
requested by MEDA in writing, ULURU shall promptly send a new Batch of the
Product (of similar quantity as to the amount of such Product being analyzed as
set forth above) to MEDA. MEDA shall not be obligated to pay for any of the
Product (and if MEDA has paid for such Product ULURU shall promptly reimburse
MEDA for the cost of replacing such Product, including, without limitation,
related costs such as testing and transportation costs) that such laboratory
determines does not conform to the Specifications, but shall be obligated to pay
for any new Batch of Product that is sent as specified above; provided that MEDA
must destroy (and certify destruction of) such non-conforming
Product.

    


    
      	
              4.4.  

            	
              Samples and Record
      Retention.

            


    

    


    ULURU
shall retain records and retention samples of each Batch of the Products as
required by the applicable laws, but for at least thirty-eight (38) months after
the expiration date of that Batch and shall make the same available to MEDA upon
request. Retention samples shall only be destroyed after the required holding
period; provided that in the event that MEDA provides written notice to ULURU
during such retention period (at least thirty-eight (38) month) that it desires
ULURU to retain such retention samples for a longer period of time, then ULURU
shall comply with such request until notified by MEDA that the sample need no
longer be retained. During and after the Term of this Agreement ULURU shall
reasonably assist MEDA with respect to any complaint, issue or investigation
relating to the Products.

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              4.5.  

            	
              Inspection.

            


    

    


    ULURU
shall give access to representatives of MEDA, at all reasonable times during
regular business hours, to the Facilities and any other facility in which
Products are Manufactured, tested, packaged and/or stored, and to all
Manufacturing records with respect to the Products, for the purpose of
inspection. MEDA shall have the right while at any such Facility to inspect and
copy (provided that to the extent that such copies constitute ULURU Confidential
Information (or Confidential Information of ULURU ́s Third Party Manufacturer)
they shall be subject to the provisions of Article 10) records and Regulatory
Approvals solely to evaluate work practices and compliance with all applicable
EMEA and other Regulatory Authority laws and regulations, occupational health
and safety, and environmental laws and regulations, GMP and warehousing
practices and procedures. The conduct of (or right to conduct) any inspection
under this Section 4.5 does not impose upon MEDA responsibility or liability for
the operation of the Facility. Such inspection shall be conducted after prior
written notice to ULURU, will be conducted in a manner that is not disruptive to
ULURU’s operations, and shall not be more frequent than is
reasonable.

    


    
      	
              4.6.  

            	
              Adverse Drug Events /
      Pharmacovigilance Agreement.

            


    

    


    
      	
              4.6.1.  

            	
              Each
      Party shall fully, accurately and promptly provide the other Party with
      all data known to it at any time during the Term of this Agreement or
      thereafter, which data indicate that any Product is or may be unsafe,
      lacks utility, or otherwise does not meet the
    Specifications.

            


    

    


    
      	
              4.6.2.  

            	
              Within
      sixty (60) days of the Effective Date, each of the Parties shall execute
      and deliver the Pharmacovigilance Agreement substantially in the form of
      Exhibit G
      and as mutually agreed to by the parties. Each Party agrees to perform its
      respective obligations under the Pharmacovigilance Agreement in accordance
      with such agreement.

            


    

    


    
      	
              4.7.  

            	
              Recalls and
      Seizure.

            


    

    


    
      	
              4.7.1.  

            	
              Each
      Party shall keep the other Party promptly and fully informed of any
      notification or other information whether received directly or indirectly
      which might result in the Recall or Seizure of the Products. If either
      Party determines that it is necessary to Recall any Product, it shall
      immediately notify the other Party and, prior to commencing any Recall,
      the Parties shall consult with one another to determine whether or not a
      Recall is necessary. If it is mutually agreed that a Recall is necessary
      (or if MEDA determines, in its sole discretion, that a Recall is
      necessary), then the Parties shall meet and determine the manner in which
      the Recall is to be carried out and review any instructions or suggestions
      of the applicable Regulatory Authorities. MEDA and ULURU shall effect the
      Recall in the manner agreed upon between the Parties in as expeditious a
      manner as possible and in such a way as to cause the least disruption to
      the sales of any Product and to preserve the goodwill and reputation
      associated with the Product. In any such situation, MEDA shall have the
      right to make all final decisions regarding such
  Recall.

            


    

    


    
      	
              4.7.2.  

            	
              In
      the event that a Recall results from any cause or event arising from
      ULURU’s breach of Sections 4.1, 4.2, 4.4, 4.6. 4.8 or the representations
      set forth in Sections 7.2.1, 7.2.4 or 7.2.5 and/or the defective
      Manufacture, storage or handling of the Products by ULURU (excluding
      defects relating to packaging or labeling supplied by or prepared at and
      in accordance with the direction of MEDA), ULURU shall be responsible for
      all expenses of the Recall incurred by MEDA and ULURU shall promptly
      replace such Product at no additional cost to MEDA consistent with
      directions received from the appropriate Regulatory Authority. In the
      event that a Recall results from any cause or event arising from defective
      Manufacture, storage, handling or distribution of the Products by MEDA or
      its Affiliates, distributors or contractors (including but not limited to
      defective Manufacture, storage, handling or distribution undertaken at the
      direction of MEDA and consistently with MEDA’s instructions), MEDA shall
      be responsible for the expenses of the Recall, including the cost of
      replacement Product. For the purposes of this Agreement, the expenses of a
      Recall shall include, without limitation, the expenses of notification and
      destruction or return of the recalled Product and all other costs incurred
      in connection with such Recall, including reasonable costs and attorneys’
      fees, but shall not include lost profits of either
  party.

            


    

    


    
      	
              4.8.  

            	
              Environmental,
      Occupational Health and
Safety.

            


    

    


    
      	
              4.8.1.  

            	
              ULURU
      shall promptly report to MEDA after any of the following incidents related
      to the Manufacturing operations hereunder occurs: (a) fatalities and/or
      significant injuries or occupational illness; (b) property damage in
      excess of € 50,000; (c) inspections by any environmental protection
      agency or occupational health and safety agency; or (d) requests for
      information, notices of violations or other significant governmental and
      safety agency communications relating to environmental, occupational
      health and safety compliance.

            


    

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              5.  

            	
              MANUFACTURING
      CHANGES

            


    

    


    
      	
              5.1.  

            	
              Voluntary
      Changes.

            


    

    


    ULURU
shall not make, nor shall any other Person make, any changes to the
Manufacturing process, the Manufacturing equipment, the Specifications, the
Materials, the sources of Materials or the Methods of Analysis without the prior
written consent of MEDA. If either Party requests in writing a change in the
Manufacturing process, the Manufacturing equipment, the Specifications, the
Materials, the source of Materials or Methods of Analysis with respect to the
Products that is not the result of a requirement of the EMEA or any other
Regulatory Authority, the other Party shall use commercially reasonable efforts
to make or accept such change, as the case may be. The requesting Party shall
provide the other Party with a detailed written report of all proposed changes
to the Manufacturing process, the Manufacturing equipment, the Specifications,
the Materials, the sources of Materials or the Methods of Analysis. The Party
initiating the change will bear the respective costs associated with such
voluntary change.

    


    
      	
              5.2.  

            	
              Required
      Changes.

            


    

    


    If the
EMEA or any other Regulatory Authority requests or requires, or takes any action
that requires, any change in the Manufacturing process, the Manufacturing
equipment, the Specifications, the Materials, the source of Materials or Methods
of Analysis with respect to the Products, the Parties shall meet and discuss an
implementation plan for such change and use commercially reasonable efforts to
accommodate as soon as practicable such change to meet the EMEA’s or such other
Regulatory Authority’s requirements. Each Party will bear its respective costs
associated with, or incurred as a result of, such change. Each Party agrees to
promptly forward to the other copies of any written communication received by
such Party from the EMEA or any other Regulatory Authority that may affect the
Manufacture, supply, or distribution of the Product as contemplated
herein.

    


    
      	
              6.  

            	
              PRICE
      AND PAYMENT

            


    

    


    
      	
              6.1.  

            	
              Prices for the
      Products.

            


    

    


    
      	
              6.1.1.  

            	
              The
      prices for the Products are set forth in Exhibit H. The
      prices include all Manufacturing and supply obligations of ULURU under
      this Agreement.

            


    

    


    
      	
              6.1.2.  

            	
              The
      prices shall be fixed for the Term of this Agreement, if not otherwise
      stipulated in Section 6.1.3 below.

            


    

    


    
      	
              6.1.3.  

            	
              ULURU
      shall be entitled to revise the prices of the Products in case that
      ULURU’s labor costs and/or Material costs will increase by more than 21⁄2%
      (two and one-half percent) compared to the costs/prices valid at the
      Effective Date, provided however that (i) ULURU will prove the increase in
      writing and (ii) MEDA ́s gross margin will not be below 70 (seventy) % and
      (iii) MEDA ́s prices for the products are not worse than the prices for the
      products to other licensees in
Europe.

            


    

    


    In case
of such justified increase, Exhibit H will be
amended accordingly. The change in the price shall become effective the first
day of the month following the written notification and documentation of the
price increase by ULURU to MEDA.

    


    
      	
              6.2.  

            	
              License
      payments.

            


    

    


    During
the Term of this Agreement, the license payments set forth in Exhibit I shall be
due and payable from MEDA to ULURU within sixty (60) days of the occurrence of
the applicable milestone set forth in Exhibit I, with the
exception that the license payment due on the Effective Date will be paid
immediately on signing the Agreement.

    


    
      	
              6.3.  

            	
              Payment.

            


    

    


    MEDA
shall pay invoices for Products delivered hereunder not later than sixty (60)
days after the later of receipt of Product covered by such invoice and receipt
of such invoice.

    


    
      	
              6.4.  

            	
              Taxes and Other
      Charges.

            


    

    


    All
prices are exclusive of taxes, shipping costs to the point of delivery, customs
duties and other charges, and MEDA agrees to bear and be responsible for the
payment of all such charges imposed, excluding taxes based upon ULURU’s net
income.

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              6.5.  

            	
              Audit
      Rights.

            


    

    


    
      	
              6.5.1.  

            	
              MEDA
      shall have the right, at its own expense, to access the books and records
      of ULURU and its Affiliates as may be reasonably necessary to verify the
      accuracy of the labor costs and Material costs referred to in Section
      6.1.3. Such access shall be conducted after thirty (30) days’ prior
      written notice to ULURU and during ordinary business hours, will be
      conducted in a manner that is not disruptive to ULURU’s operations, and
      shall not be more frequent than once per Contract Year or in respect of
      any Contract Year ending not more than twenty-four (24) months prior to
      the date of such notice. Subject to Section 6.5.3, if such independent
      certified public accountant’s report shows any overpayment by MEDA, ULURU
      shall remit to MEDA within thirty (30) days after MEDA’s receipt of such
      report, (a) the amount of such overpayment, and (b) if such overpayment
      exceeds three percent (3%) of the total amount owed for the period then
      being audited, the reasonable fees and expenses of any independent
      accountant performing the audit on behalf of MEDA. Subject to Section
      6.5.3., if such independent certified public accountant’s report shows any
      underpayment by MEDA, MEDA shall pay to ULURU within thirty (30) days
      after MEDA’s receipt of such report, the amount of such underpayment. Any
      audit or inspection conducted under this Agreement by MEDA or its agents
      or contractors will be subject to the confidentiality provisions of this
      Agreement, and MEDA will be responsible for compliance with such
      confidentiality provisions by such agents or
  contractors.

            


    

    


    
      	
              6.5.2.  

            	
              MEDA
      shall maintain books of account with respect to its sales of the Products
      in each country in the Territory. ULURU shall have the right, not more
      than once during each Calendar Year, to have an independent accountant
      selected and retained by ULURU to inspect and examine such books of MEDA
      during regular business hours for the purpose of verifying the statements
      of the aggregate Net Sales resulting from sales of Products and
      determining the correctness of the date of the license payments paid (or
      not yet paid). If such independent certified public accountant’s report
      shows any (i) underpayment by MEDA, or (ii) late payment by MEDA (due to
      the fact that the cumulated Net Sales set fort in the Exhibit I
      (license payment no. 4) had been achieved earlier), MEDA shall pay to
      ULURU within thirty (30) days after MEDA ́s receipt of such report, (a) the
      amount of such underpayment or late payment, and (b) if such (y)
      underpayment exceeds five percent (5%) of the total amount owed for the
      period then being audited or (z) late payment is more than three (3)
      months past due, the reasonable fees and expenses of any independent
      accountant performing the audit on behalf of ULURU. Otherwise, ULURU has
      to bear the costs of the independent accountant. Any audit or inspection
      conducted under this Agreement by ULURU or its agents or contractors will
      be subject to the confidentiality provisions of this Agreement, and ULURU
      will be responsible for compliance with such confidentiality provisions by
      such agents or contractors.

            


    

    


    
      	
              6.5.3.  

            	
              If
      any dispute arises under this Section 6.5 between the Parties relating to
      overpayments, underpayments or late payments, and the Parties cannot
      resolve such dispute within thirty (30) days of a written request by
      either Party to the other Party, the Parties shall hold a meeting,
      attended by the Chief Executive Officer or President of each Party (or
      their respective designees), to attempt in good faith to negotiate a
      resolution of the dispute. If, within sixty (60) days after such meeting
      request, the Parties have not succeeded in negotiating a resolution of the
      dispute, either Party may pursue any other available remedy, including,
      upon prior written notice to the other Party, instituting legal
      action.

            


    

    


    
      	
              6.6.  

            	
              Late
      Payments.

            


    

    


    If any
payment due to ULURU under this Agreement is not received by ULURU within ten
(10) days of the due date, then, commencing from the date on which such payment
was due the amount of such payment shall accrue interest calculated at an annual
rate equal to the prime rate plus two percent (2%) until such time as payment of
the overdue amount is made in full; provided that no interest shall accrue on
any amounts being disputed in good faith by MEDA with respect to which MEDA is
making diligent and good faith efforts to resolve.

    


    
      	
              6.7.  

            	
              Currency
      Exchange.

            


    

    


    All
payments to be made pursuant to this Agreement shall be made in EURO. Amounts
based on Net Sales in currencies other than EURO shall be converted on the last
business day of each calendar month to EURO at the MEDA financial statement
exchange rate applied by MEDA on a consistent basis in MEDA’s own financial
accounting.

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              7.  

            	
              REPRESENTATIONS
      AND WARRANTIES

            


    

    


    
      	
              7.1.  

            	
              Representation and
      Warranties of Each Party.

            


    

    


    Each of
MEDA and ULURU hereby represents warrants and covenants to the other Party
hereto as follows:

    


    
      	
              7.1.1.  

            	
              it
      is a corporation or entity duly organized and validly existing under the
      laws of the state or other jurisdiction of incorporation or
      formation;

            


    

    


    
      	
              7.1.2.  

            	
              the
      execution, delivery and performance of this Agreement by such Party has
      been duly authorized by all requisite corporate action and do not require
      any shareholder action or approval;

            


    

    


    
      	
              7.1.3.  

            	
              it
      has the power and authority to execute and deliver this Agreement and to
      perform its obligations hereunder;

            


    

    


    
      	
              7.1.4.  

            	
              the
      execution, delivery and performance by such Party of this Agreement and
      its compliance with the terms and provisions hereof does not and will not
      conflict with or result in a breach of any of the terms and provisions of
      or constitute a default under (a) a loan agreement, guaranty, financing
      agreement, agreement affecting a product or other agreement or instrument
      binding or affecting it or its property; (b) the provisions of its charter
      or operative documents or by laws; or (c) any order, writ, injunction or
      decree of any court or governmental authority entered against it or by
      which any of its property is bound;
and

            


    

    


    
      	
              7.1.5.  

            	
              it
      shall comply with all applicable laws and regulations relating to its
      activities under this Agreement.

            


    

    


    
      	
              7.2.  

            	
              Representations and
      Warranties of ULURU.

            


    

    


    ULURU
hereby further represents and warrants to MEDA that:

    


    
      	
              7.2.1.  

            	
              as
      of the date of each delivery of the Product by ULURU to a carrier, the
      Products (a) has been Manufactured, stored and shipped in strict
      accordance with GMPs, all applicable laws, rules, regulations or
      requirements and all applicable Regulatory Approvals in effect at the time
      of Manufacture; (b) conforms to the Specifications and the Quality
      Agreement, and is free from defects and are merchantable; (c) is not
      adulterated or misbranded; and (d) has been stored in accordance with
      procedures requested by MEDA;

            


    

    


    
      	
              7.2.2.  

            	
              as
      of the date of each supply of the Products by ULURU, ULURU has good and
      marketable title to the Products and the Products are free from all liens,
      charges, encumbrances and security
interests;

            


    

    


    
      	
              7.2.3.  

            	
              to
      ULURU’s actual knowledge as of the Effective Date, the Manufacture, use,
      importation, offer for sale and sale of the Products does not infringe any
      intellectual property rights of any Third Party within the
      Territory;

            


    

    


    
      	
              7.2.4.  

            	
              as
      of the date of each supply of the Products by ULURU, ULURU possesses all
      necessary Regulatory Approvals relating to ULURU’s Manufacture and supply
      to MEDA of the Products;

            


    

    


    
      	
              7.2.5.  

            	
              as
      of the Effective Date, the Patents are existing and have not been held to
      be invalid or unenforceable, in whole or in
  part;

            


    

    


    
      	
              7.2.6.  

            	
              as
      of the Effective Date, ULURU is the sole and exclusive owner of the
      Intellectual Property Rights existing as of the Effective Date, all of
      which are free and clear of any liens, charges and encumbrances (other
      than any licenses granted by ULURU to Third Parties, which grants do not
      conflict with the license grants to MEDA
  hereunder);

            


    

    


    
      	
              7.2.7.  

            	
              as
      of the Effective Date, and, except as disclosed to MEDA in writing, as of
      the date of each supply of the Products by ULURU, ULURU has received no
      notice that the practice of the Intellectual Property Rights or the
      Trademarks are subject to an infringement claim of any issued patent or
      Trademark owned or possessed by any Third Party within the
      Territory;

            


    

    


    
      	
              7.2.8.  

            	
              as
      of the Effective Date, the Intellectual Property Rights are not the
      subject to any funding agreement with any government or governmental
      agency; and

            


    

    


    
      	
              7.2.9.  

            	
              as
      of the Effective Date, or within ten (10) days thereof, ULURU has provided
      MEDA with any and all information relating to the Products, its
      Manufacture and formulation necessary for MEDA to conduct a freedom to
      operate opinion relating to the Territory, and all information has been
      provided so that MEDA may complete its due
  diligence.

            


    

    


    
      	
              7.3.  

            	
              No
      Presumption.

            


    

    


    Each
Party hereto represents that it has been represented by legal counsel in
connection with this Agreement and acknowledges that it has participated in the
drafting hereof. In interpreting and applying the terms and provisions of this
Agreement, the Parties agree that no presumption shall exist or be implied
against the Party which drafted such terms and provisions.

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              7.4.  

            	
              Remedy.

            


    

    


    As MEDA’s
sole and exclusive remedy for any breach of Section 7.2.1 discovered prior to
the distribution by MEDA or its Affiliates of the applicable Product, ULURU
shall promptly replace, at its sole cost and expense, any Product which fails to
comply with the representations set forth in Section 7.2.1; provided that such
nonconforming Product shall be returned to ULURU at ULURU ́s costs, only if after
ULURU’s inspection, such Product is determined to have been non-conforming
pursuant to the procedures set forth in Section 4.3. Except as otherwise
provided expressly in this Agreement, each Party is free to seek legal and
equitable recourse against the other in the event of any breach of this
Agreement (including, without limitation, any breach of such other Party’s
obligations, representations, or warranties under this Agreement), subject to
the limitations of liability set forth in Section 7.7 and, in such case, the
breaching party shall be liable for all damages, losses, liabilities, expenses
or penalties (excluding attorneys’ fees and expenses) incurred, assessed or
sustained by or against the non-breaching party, its Affiliates, directors,
officers, employees or agents arising out of such breach.

    


    
      	
              7.5.  

            	
              MEDA
      Responsibility.

            


    

    


    MEDA
shall not be responsible for any loss or cost incurred by ULURU during
Manufacture of the Products in compliance with the requirements set forth in
Section 7.2.1.

    


    
      	
              7.6.  

            	
              Disclaimer.

            


    

    


    
      	
              7.6.1.  

            	
              THE
      FOREGOING WARRANTIES ARE THE SOLE AND EXCLUSIVE WARRANTIES GIVEN BY ULURU
      WITH RESPECT TO THE PRODUCTS AND SERVICES PROVIDED HEREUNDER, AND ULURU
      GIVES AND MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR
      IMPLIED, OTHER THAN THE FOREGOING. WITHOUT LIMITING THE GENERALITY OF THE
      FOREGOING, EXCEPT FOR THE WARRANTIES EXPRESSLY PROVIDED IN SECTION 6, NO
      IMPLIED WARRANTY OF MERCHANTABILITY, VALIDITY, NON-INFRINGEMENT, TITLE,
      FITNESS FOR ANY PARTICULAR PURPOSE, AND NO IMPLIED WARRANTY ARISING BY
      USAGE OF TRADE, COURSE OF DEALING OR COURSE OF PERFORMANCE IS GIVEN OR
      MADE BY ULURU OR SHALL ARISE BY OR IN CONNECTION WITH ANY SALE OR
      PROVISION OF PRODUCTS OR SERVICES BY ULURU, OR MEDA’S USE OR SALE OF THE
      PRODUCT, OR ULURU’S AND/OR MEDA’S CONDUCT IN RELATION THERETO OR TO EACH
      OTHER. NO REPRESENTATIVE OF ULURU IS AUTHORIZED TO GIVE OR MAKE ANY OTHER
      REPRESENTATION OR WARRANTY OR TO MODIFY THE FOREGOING WARRANTY IN ANY
      WAY.

            


    

    


    
      	
              7.6.2.  

            	
              EXCEPT
      FOR THE WARRANTIES GIVEN BY MEDA AS EXPRESSLY PROVIDED IN ARTICLE 7, MEDA
      GIVES AND MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND OR NATURE,
      EXPRESS OR IMPLIED, WITH RESPECT TO THE MATTERS ADDRESSED IN THIS
      AGREEMENT.

            


    

    


    
      	
              7.6.3.  

            	
              The
      warranties set forth in this Article 7 do not apply to any nonconformity
      of the Product resulting from (a) repair, alteration, misuse, negligence,
      abuse, accident, mishandling or storage in an improper environment by any
      party other than ULURU (or its contract manufacturer), or (b) use,
      handling, storage or maintenance other than in accordance with Product
      Specifications or Product label.

            


    

    


    
      	
              7.7.  

            	
              Limitation of
      Liability.

            


    

    


    ULURU’S
LIABILITY, AND THE EXCLUSIVE REMEDY, IN CONNECTION WITH THE SALE OR USE OF THE
PRODUCTS (WHETHER BASED ON CONTRACT, NEGLIGENCE, BREACH OF WARRANTY, STRICT
LIABILITY OR ANY OTHER LEGAL THEORY), SHALL BE STRICTLY LIMITED TO ULURU’S
OBLIGATIONS AND MEDA’S RIGHTS AS SPECIFICALLY AND EXPRESSLY PROVIDED IN THIS
AGREEMENT.

    


    IN NO
EVENT WHATSOEVER SHALL EITHER PARTY HAVE ANY LIABILITY, OBLIGATION OR
RESPONSIBILITY TO THE OTHER PARTY OR SUCH OTHER PARTY’S AFFILIATES FOR ANY
INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES
ARISING IN ANY WAY IN CONNECTION WITH THE PRODUCTS OR ITS PURCHASE, SALE, USE OR
INABILITY TO USE.

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              8.  

            	
              INDEMNIFICATION
      AND INSURANCE

            


    

    


    
      	
              8.1.  

            	
              Indemnification.

            


    

    


    
      	
              8.1.1.  

            	
              ULURU
      shall defend, indemnify and hold harmless MEDA, its Affiliates, directors,
      officers, employees and agents from and against all damages, losses,
      liabilities, expenses, claims, demands, suits, penalties or judgments or
      administrative or judicial orders (including, without limitation,
      reasonable attorneys’ fees and expenses) incurred, assessed or sustained
      by or against MEDA, its Affiliates, directors, officers, employees or
      agents with respect to a claim by a Third Party arising out of (a) the
      negligent acts or omissions of ULURU; (b) any breach by ULURU of this
      Agreement or its representations, warranties or covenants hereunder; (c)
      any Recall or Seizure attributable to ULURU’s performance (including,
      without limitation, amounts MEDA pays or credits to its customers for
      Products so Recalled or Seized); (d) product liability, tort, nuisance or
      other claim arising out of the defective manufacture, storage or supply of
      the Products by ULURU; (e) any allegation that the Manufacture,
      importation, sale, offer for sale or use of the Products infringe any
      patent or other intellectual property, proprietary or protected right
      within the Territory; provided that ULURU will not be obligated to
      indemnify MEDA if and to the extent that the alleged infringement is
      caused by: (i) MEDA’s (including, without limitation, its Affiliates,
      agents, contractors, and sub-distributors) or its customers misuse or
      modification of the Products; or (ii) MEDA’s (including, without
      limitation, its Affiliates, agents, contractors, and sub- distributors) or
      its customers use of the Products in combination with any products or
      materials not provided by ULURU; and further provided that if the Product
      is held to constitute an infringement or misappropriation of any Third
      Party’s intellectual property rights or if in ULURU ́s opinion, the
      Products are, or is likely to be held to constitute, an infringement or
      misappropriation, ULURU may at its expense and option: (x) procure the
      right for MEDA to continue distributing the Products (y) upon prior
      approval by MEDA, which approval will not be unreasonably withheld or
      delayed, promptly replace the Product with a non-infringing and
      non-misappropriating equivalent product conforming to the applicable
      Product Specifications and Regulatory Approvals; provided that there shall
      not be any material delay in any such replacement; or (z) upon prior
      approval by MEDA, which approval will not be unreasonably withheld or
      delayed, modify the Product to make it non-infringing and
      non-misappropriating while conforming to the applicable Product
      Specifications and Regulatory Approvals; provided that there shall not be
      any material delay in any such modification; (f) any enforcement or other
      action by any Regulatory Authority relating to the Manufacture, the
      pricing of the Products by ULURU to MEDA or sale of the Products by ULURU
      to MEDA, or (f) ULURU’s failure to comply with any applicable law,
      regulation or order (including, without limitation, environmental laws,
      regulations and orders). The foregoing indemnification obligation shall
      not apply in the event and to the extent that such claim arose as a result
      of any indemnitee’s negligence, intentional misconduct or breach of this
      Agreement. The provisions of this Section shall survive the termination or
      expiration of this Agreement.

            


    

    


    
      	
              8.1.2.  

            	
              MEDA
      shall defend, indemnify and hold harmless ULURU, its directors, officers,
      employees and agents from and against all damages, losses, liabilities,
      expenses, claims, demands, suits, penalties or judgments or administrative
      or judicial orders (including, without limitation, reasonable attorneys’
      fees and expenses) incurred, assessed or sustained by or against ULURU,
      its directors, officers, employees or agents with respect to a claim by a
      Third Party arising out of (a) the negligent acts or omissions of MEDA;
      (b) any breach by MEDA of this Agreement or of its representations,
      warranties or covenants hereunder; (c) any allegation that the Trademarks
      or MEDA’s packaging or MEDA’s (or any Affiliate of MEDA’s) marketing
      materials infringes any patent or other proprietary or protected right of
      any Third Party; (d) any Recall or Seizure attributable to MEDA’s
      performance; (e) any enforcement or other action by any Regulatory
      Authority relating to the distribution or the pricing of the Products by
      MEDA or sale of the Products by MEDA to Third Parties; (f) MEDA’s failure
      to comply with any applicable law, regulation or order (including, without
      limitation, environmental laws, regulations and orders), or (g) the
      marketing and distributing of the Products by MEDA, its Affiliates or
      sub-distributors. The foregoing indemnification obligation shall not apply
      in the event and to the extent that such claim arose as a result of any
      indemnitee’s negligence, intentional misconduct or breach of this
      Agreement. The provisions of this Section shall survive the termination or
      expiration of this Agreement.

            


    

    


    
      	
              8.1.3.  

            	
              To
      receive the benefit of indemnification under this Section 8.1, the Party
      and its Affiliates, directors, officers, employees or agents seeking
      indemnification (an “Indemnified Party”) shall promptly notify the other
      Party (the “Indemnifying Party”), in writing, of any claim asserted or
      threatened against such Indemnified Party for which such Indemnified Party
      is entitled to indemnification hereunder from the Indemnifying Party. With
      respect to any such claim the Indemnified Party shall, at no out-of-pocket
      expense to it, reasonably cooperate with and provide such reasonable
      assistance to such Indemnifying Party as such Indemnifying Party may
      reasonably request. Such reasonable assistance may include, without
      limitation, providing copies of all relevant correspondence and other
      materials that the Indemnifying Party may reasonably request. The
      obligations of an Indemnifying Party under Sections 8.1.1 and 8.1.2 are
      conditioned upon the delivery of written notice to the Indemnifying Party
      of any asserted or threatened claim promptly after the Indemnified Party
      becomes aware of such claim; provided that the failure of the Indemnified
      Party to give such notice or any delay thereof shall not affect the
      Indemnified Party’s right to indemnification hereunder, except to the
      extent that such failure or delay impairs the Indemnifying Party’s ability
      to defend or contest any such claim. The Indemnifying Party shall have the
      right to assume the defense of any suit or claim for which indemnification
      is sought with counsel reasonably acceptable to the Indemnified Party. If
      the Indemnifying Party defends the suit or claim, the Indemnified Party
      may participate in the defense thereof at its sole cost and expense. An
      Indemnifying Party may not settle a suit or claim without the consent of
      the Indemnified Party if (a) such settlement would impose any monetary
      obligation on the Indemnified Party for which indemnification is not
      provided hereunder, (b) or require the Indemnified Party to submit to an
      injunction or otherwise limit the Indemnified Party’s rights under this
      Agreement, or (c) does not include a release of the Indemnified Party from
      all liability arising out of such suit or claim. Any payment made by an
      Indemnifying Party to settle any such suit or claim shall be at its own
      cost and expense.

            


    

    


    
      	
              8.1.4.  

            	
              The
      indemnification provided by this Article 8 shall be the Parties’ sole and
      exclusive remedy in connection with any third party
  claim.

            


    

     

    
      	
              8.2.  

            	
              Insurance.

            


      


      
        	
                8.2.1.  

              	
                At
      the time of Launch and continuing through the Term of this Agreement,
      ULURU shall have and maintain sufficient insurance coverage of any and all
      common insurances regarding the Manufacture and supply of the Products,
      including but not limited to Commercial General Liability including
      Contractual, Completed Operations and Product
  Liability.

              


      

      


      
        	
                8.2.2.  

              	
                Upon
      request of MEDA, ULURU shall prove the execution of the insurances and
      their maintenance by demonstrating a written approval of the
      insurer.

              


      

      
 

    

    
       

      
         

        
          

        

      

       

    

     

    
      	
              9.  

            	
              TERM
      AND TERMINATION

            


    

    


    
      	
              9.1.  

            	
              Term.

            


    

    


    This
Agreement shall commence on the Effective Date and continue, unless sooner
terminated as set forth below in this Article 9 or as otherwise specifically
stated in this Agreement, for the duration of the Term.

    


    
      	
              9.2.  

            	
              Termination Without
      Cause.

            


    

    


    MEDA may
terminate this Agreement at any time (a) after Launch by giving twelve (12)
months prior written notice to ULURU if MEDA, in its sole discretion, determines
to cease marketing the Products, or (b) prior to Launch by giving thirty (30)
days prior written notice to ULURU if MEDA, in its sole discretion, determines
not to Launch the Products. If MEDA terminates this Agreement pursuant to
subsection (a) above, MEDA is not obligated to transfer to ULURU any data
relating to the Products (including, without limitation, marketing studies or
otherwise) that MEDA generated prior to such termination. If MEDA terminates
this Agreement pursuant to subsection (b) above, then, MEDA shall transfer to
ULURU any data relating solely to the Products that MEDA generated, excluding
any NDAs.

    


    
      	
              9.3.  

            	
              Termination for
      Regulatory Action or Claim of
  Infringement.

            


    

    


    MEDA may
terminate this Agreement in its entirety immediately if the EMEA or any other
Regulatory Authority takes any action, the result of which is to prohibit or
permanently or otherwise restrict the Manufacture, storage, importation, sale,
offer for sale or use of the Products in any way that will have a material,
adverse effect on the sale price or sales volumes of the Products, or if any
claim is made that the Manufacture, storage, importation, sale, offer for sale
or use of the Products infringes any patent or other proprietary or protected
right of any Third Party.

    


    
      	
              9.4.  

            	
              Termination for
      Breach.

            


    

    


    If either
Party shall at any time fail to discharge any of its obligations hereunder and
shall fail to correct such default within thirty (30) days after the other Party
shall have given written notice to it thereof, the aggrieved Party shall be
entitled to notify the other Party that it intends to terminate this Agreement
unless such default is corrected and may so terminate ten (10) days after the
end of such thirty (30) day period if such default is continuing; provided that
if such default by the other Party shall be a recurring default and the other
Party does not reasonably satisfy the aggrieved party that such defaults shall
cease to occur, the aggrieved Party shall be entitled to terminate this
Agreement upon the occurrence of such default and the other Party shall not be
entitled to correct such default.

    


    
      	
              9.5.  

            	
              Termination for
      Bankruptcy.

            


    

    


    If either
Party by voluntary or involuntary action goes into liquidation, dissolves or
files a petition for bankruptcy or suspension of payments, is adjudicated
bankrupt, has a receiver or trustee appointed for its property or estate,
becomes insolvent or makes an assignment for the benefit of creditors, the other
Party shall be entitled by notice in writing to such Party to terminate this
Agreement forthwith.

    


    
      	
              9.6.  

            	
              Effect of
      Termination.

            


    

    


    Termination
or expiration of this Agreement, in whole or in part, shall be without prejudice
to the right of either Party to receive all payments accrued and unpaid at the
effective date of such termination or expiration, without prejudice to the
remedy of either Party in respect to any previous breach of any of the
representations, warranties or covenants herein contained and without prejudice
to any other provisions hereof which expressly or necessarily call for
performance after such termination or expiration.

    


    
      	
              9.7.  

            	
              MEDA’s Rights on
      Termination.

            


    

    


    In the
event of termination or expiration of this Agreement, MEDA may distribute the
remaining stocks of the Products in the Territory within a period of 9(nine)
months after the end of this Agreement.

    


    
      	
              9.8.  

            	
              Survival.

            


    

    


    The
following provisions shall survive the expiration or termination of this
Agreement: Sections 4.4, 4.6, 4.7, 6.3, 6.4, 6.5, 6.6, 6.7, 8.1, 9.6, 9.7 and
9.8 and Articles 7, 10, 12, 13 and 14.

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              10.  

            	
              CONFIDENTIALITY

            


    

    


    
      	
              10.1.  

            	
              Nondisclosure
      Obligation.

            


    

    


    Each of
MEDA and ULURU shall use only in accordance with this Agreement and shall not
disclose to any Third Party the Confidential Information received by it from the
other Party pursuant to this Agreement, without the prior written consent of the
other Party. The foregoing obligations shall survive for a period of five (5)
years after the termination or expiration of this Agreement. These obligations
shall not apply to Confidential Information that: (a) is known by the receiving
Party at the time of its receipt, and not through a prior disclosure by the
disclosing Party, as documented by business records; (b) is at the time of
disclosure or thereafter becomes published or otherwise part of the public
domain without breach of this Agreement by the receiving Party; (c) is
subsequently disclosed to the receiving Party by a Third Party who has the right
to make such disclosure; (d) is developed by the receiving Party independently
of the Confidential Information received from the disclosing Party and such
independent development can be documented by the receiving Party; or (e) is
required by law, regulation, rule, act or order of any governmental authority or
agency to be disclosed by a Party, provided that notice is promptly delivered to
the other Party in order to provide an opportunity to seek a protective order or
other similar order with respect to such Confidential Information and thereafter
the disclosing Party discloses to the requesting entity only the minimum
Confidential Information required to be disclosed in order to comply with the
request, whether or not a protective order or other similar order is obtained by
the other Party.

    


    
      	
              10.2.  

            	
              Permitted
      Disclosures.

            


    

    


    Each
Party may disclose the other Party’s Confidential Information to its employees
and Affiliates on a need-to-know basis and to its agents or consultants to the
extent required to accomplish the purposes of this Agreement; provided that the
recipient Party obtains prior agreement from such agents and consultants to whom
disclosure is to be made to hold in confidence and not make use of such
Confidential Information for any purpose other than those permitted by this
Agreement. Each Party will use at least the same standard of care as it uses to
protect proprietary or confidential information of its own to ensure that such
employees, agents, consultants, and Affiliates do not disclose or make any
unauthorized use of the other Party’s Confidential Information.

    


    
      	
              10.3.  

            	
              Disclosure of
      Agreement.

            


    

    


    Neither
MEDA nor ULURU shall release to any Third Party or publish in any way any
non-public information with respect to the terms of this Agreement without the
prior written consent of the other Party, which consent shall not be
unreasonably withheld or delayed, provided that either Party may disclose the
terms of this Agreement (a) to the extent required to comply with applicable
laws, including, without limitation, the rules and regulations promulgated by
the United States Securities and Exchange Commission; provided, further, that
prior to making any such disclosure, the Party intending to so disclose the
terms of this Agreement shall (i) provide the non-disclosing Party with written
notice of the proposed disclosure and an opportunity to review and comment on
the intended disclosure which is reasonable under the circumstances and (ii)
shall seek confidential treatment for as much of the disclosure as is reasonable
under the circumstances, including, without limitation, seeking confidential
treatment of any information as may be requested by the other Party; or (b) to
one or more Third Parties and/or their advisors in connection with a proposed
spin-off, joint venture, divestiture, merger or other similar transaction
involving all, or substantially all, of the Product, assets or business of the
disclosing Party to which this Agreement relates or to lenders, investment
bankers and other financial institutions of its choice solely for purposes of
financing the business operations of such Party; provided, further, that either
(i) the other Party has consented to such disclosure or (ii) such Third Parties
have signed confidentiality agreements with respect to such information on terms
no less restrictive than those contained in this Article 10; or (c) to its legal
counsel.

    


    
      	
              10.4.  

            	
              Publicity.

            


    

    


    All
publicity, press releases and other announcements relating to this Agreement or
the transactions contemplated hereby shall be reviewed in advance by, and shall
be subject to the approval of, both Parties.

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              11.  

            	
              FORCE
      MAJEURE

            


    

    


    If the
Manufacture, production, delivery, acceptance or use of Products specified for
delivery under this Agreement or if the performance of any other obligation
hereunder is prevented, restricted or interfered with by reason of fires,
accidents, explosions, earthquakes, floods, breakdown of plant, embargoes,
government ordinances or requirements, civil or military authorities, acts of
God or of the public enemy, or other similar causes beyond the reasonable
control of the Party whose performance is affected (any of the foregoing a
“Force Majeure Event”), then the Party affected, upon giving prompt written
notice to the other Party, shall be excused from such performance on a
day-for-day basis to the extent of such prevention, restriction, or interference
(and the other Party shall likewise be excused from performance of its
obligations on a day-for- day basis to the extent such Party’s obligations
relate to the performance so prevented, restricted or interfered with); provided
that the Party so affected shall use commercially reasonable efforts to avoid or
remove such causes of non-performance and both Parties shall proceed to perform
their obligations with dispatch whenever such causes are removed or cease. If
such Force Majeure Event continues for a period of ninety (90) consecutive days
or more and as a result either party has been unable to perform its obligations
under this Agreement for such ninety (90) day period, the other Party may
terminate this Agreement effective immediately, upon delivery of a notice of
termination in writing, provided that such event of Force Majeure Event is
continuing. If as a result of any Force Majeure Event above, ULURU is unable to
fully supply MEDA’s orders hereunder, ULURU shall allocate all available
quantities of Materials and Products to MEDA in the ratio that the quantities
ordered by MEDA in the twelve (12) month period immediately preceding such Force
Majeure Event bears to ULURU ́s requirements for its own use and for supply to
Third Parties for that same period; provided that if this Agreement has not been
in effect for a full twelve (12) month period, then such shorter period shall be
used in lieu of a twelve (12) month period.

    


    
      	
              12.  

            	
              INTELLECTUAL
      PROPERTY

            


    

    


    
      	
              12.1.  

            	
              MEDA Trademarks; MEDA
      Intellectual Property.

            


    

    


    
      	
              12.1.1.  

            	
              MEDA
      may advertise, promote, market and sell the Products either separately or
      as part of other products under any of the MEDA Trademarks and/or trade
      dress, whether registered or unregistered, in its sole discretion;
      provided that except as otherwise expressly permitted under Section 3.1.4
      with respect to the Trademark, MEDA may not use or adopt any Trademark or
      trade dress, or any such item confusingly similar thereto used or intended
      to be used prior to the first use of such Trademark. ULURU shall have no
      right, title or interest in or to any such MEDA Trademark or trade dress,
      and MEDA shall have no right, title or interest in or to any such
      Trademark (except for the license to the Trademark granted under Section
      3.1.4). So long as MEDA or any Affiliate of MEDA shall have any interest
      in any such MEDA Trademark or trade dress, whether registered or
      unregistered, whether as proprietor, owner, or licensee in any country of
      the world, ULURU shall not adopt, use, apply for registration, register or
      own such MEDA Trademark or trade dress, or any such item confusingly
      similar thereto in any country of the world, or take any action which
      weakens or undermines MEDA’s proprietary rights therein. So long as ULURU
      or any Affiliate of ULURU shall have any interest in any such Trademark or
      trade dress, whether registered or unregistered, whether as proprietor,
      owner, or licensee in any country of the world, except as otherwise
      expressly permitted under Section 3.1.4 with respect to the Trademark,
      MEDA shall not adopt, use, apply for registration, register or own such
      Trademark or trade dress, or any such item confusingly similar thereto in
      any country of the world, or take any action which weakens or undermines
      ULURU’s proprietary rights therein.

            


    

    


    
      	
              12.1.2.  

            	
              For
      the avoidance of doubt, MEDA shall at all times retain sole and exclusive
      ownership of its intellectual property, including, without limitation, all
      marketing and sales plans, artwork, formats, equipment, logos, drawings,
      customer lists, regulatory filings, correspondence with the EMEA or any
      other Regulatory Authority, clinical study data, analytical data,
      operating procedures, MEDA Trademarks and all ordering and sales
      information.

            


    

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              12.2.  

            	
              Inventions.

            


    

    


    
      	
              12.2.1.  

            	
              Except
      as otherwise provided for in this Section 12.2, each Party shall own all
      Inventions made solely by employees of such Party (or Third Parties acting
      on behalf of such Party) and shall jointly own with the other Party any
      Invention made jointly by employees of both Parties (or Third Parties on
      behalf of one or both Parties); provided that such Inventions were made
      without violation of any term or condition of this Agreement. All
      determinations of inventorship under this Agreement shall be made in
      accordance with the laws applicable in the respective country where the
      employee made the respective
invention..

            


    

    


    
      	
              12.2.2.  

            	
              If
      and to the extent applicable, Inventions Controlled by ULURU and know-how
      arising during the Term which relates to the Products and is Controlled by
      ULURU shall be automatically included in the Intellectual Property Rights
      under which MEDA is licensed pursuant to Section 3.1.1 hereof. With
      respect to any Inventions or know-how Controlled by MEDA specifically
      relating to the Products, MEDA hereby grants to ULURU an exclusive
      (subject to retained rights in MEDA), royalty-free license to use such
      Invention for the Manufacture of the Products for MEDA in the Territory
      during the Term. However, it is understood that in the event of Article
      3.8.3 and 3.8.4., a secondary supplier will also be entitled to use such
      Invention for the Manufacture of the Products for MEDA without any
      additional costs, provided that this Agreement has not been
      terminated.

            


    

    


    
      	
              12.2.3.  

            	
              During
      the Term of this Agreement both Parties shall require their employees and
      personnel involved in the performance of its duties under this Agreement
      to deliver such assignments, confirmations of assignments or other written
      instruments as are necessary to vest in the respective Party clear and
      marketable title to the Inventions.

            


    

    


    
      	
              12.2.4.  

            	
              All
      rights, title and interest in and to the ULURU Intellectual Property
      Rights shall remain exclusively owned by ULURU. The Inventions owned by
      ULURU under this Section shall be referred to herein as “ULURU
      Inventions”.

            


    

    


    
      	
              12.2.5.  

            	
              All
      rights, title, and interest in and to know-how, which is developed jointly
      by the Parties during the Term of this Agreement and related to the
      Products, its Manufacture and/or use shall be owned jointly by the
      Parties. All rights, title, and interest in and to any Regulatory Approval
      the primary responsibility for which is allocated to a particular Party
      hereunder that is developed or collected solely or jointly by the Parties
      in the Territory during the Term of this Agreement shall be owned
      exclusively by such Party.

            


    

    


    
      	
              12.3.  

            	
              Confidentiality of
      Information related to Intellectual
  Property.

            


    

    


    Any and
all information and material, including, without limitation, any and all
intellectual property rights therein and thereto, assigned to a Party pursuant
to the terms of this Agreement shall constitute Confidential Information of such
Party which shall be deemed the Disclosing Party with respect to such
Confidential Information.

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              12.4.  

            	
              Patent Rights to New
      inventions.

            


    

    


    
      	
              12.4.1.  

            	
              ULURU,
      at its own expense, shall use commercially reasonable efforts to prepare,
      file, prosecute and maintain its Intellectual Property Rights in the
      countries of the Territory.

            


    

    


    
      	
              12.4.2.  

            	
              With
      respect to any filings after the Effective Date, ULURU shall give MEDA a
      reasonable opportunity to review and comment upon the text of such
      applications in the Territory before filing, shall consult in good faith
      with MEDA with respect to such applications in the Territory, and shall
      supply MEDA with a copy of such applications in the Territory as filed,
      together with notice of its filing date and serial number. ULURU shall
      inform MEDA about the status of the prosecution of all patent applications
      included within the ULURU Intellectual Property Rights and its
      Intellectual Property Rights to Inventions and the maintenance of any
      patents included within the ULURU Intellectual Property Rights and its
      Intellectual Property Rights to Inventions in a country in the
      Territory.

            


    

    


    
      	
              12.4.3.  

            	
              ULURU
      shall consult with MEDA and provide MEDA with reasonable opportunity to
      comment on all correspondence received from and all submissions to be made
      to any Regulatory Authority in the Territory with respect to any such
      patent application or patent. ULURU shall consider in good faith, but will
      not be bound by, MEDA’s suggestions with respect to all submissions in the
      Territory made to any Regulatory Authority in the Territory with respect
      to any such patent application or
patent.

            


    

    


    
      	
              12.4.4.  

            	
              If
      ULURU elects not to file a patent application with respect to its new
      Inventions or to cease the prosecution and/or maintenance of any Patent
      under the ULURU Intellectual Property Rights in a country in the
      Territory, ULURU shall provide MEDA with written notice promptly after the
      decision to not file or continue the prosecution of such patent
      application or maintenance of such
patent.

            


    

    


    
      	
              12.4.5.  

            	
              In
      such event, ULURU shall permit MEDA, in MEDA’s sole discretion, to file a
      patent application with respect to such Invention or continue prosecution
      or maintenance of any such Patent under the ULURU Intellectual Property
      Right in such country at MEDA’s own expense. If MEDA elects to continue
      such prosecution or maintenance, ULURU shall execute such documents and
      perform such acts, at MEDA’s expense, as may be reasonably necessary to
      permit MEDA to file, prosecute or maintain such application or Patent in
      such country. In such event, MEDA shall own such patent application or
      Patent filed by MEDA hereunder.

            


    

    


    
      	
              12.4.6.  

            	
              The
      Parties shall mutually agree in good faith on a case-by- case-basis on
      which of the Parties shall have the first right to prepare, file,
      prosecute and maintain any jointly owned Invention and patent rights
      thereon (“Joint Patent Rights”) throughout the world as well as on the
      split of the applicable expenses and
costs.

            


    

    


    The
acting Party shall keep the other Party completely informed during the whole
application procedure as well as during the whole patent duration. The acting
Party shall provide the other Party advance copies of any official
correspondence related to the filing, prosecution and maintenance of such patent
filings, and shall provide the other Party a reasonable opportunity to comment
on all correspondence received from and all submission to be made to any
government patent office or authority with respect to any such patent
application or patent, and shall consider in good faith the other Party’s
suggestions with respect to all submission made to any government office or
authority.

    


    If either
Party (the “Declining Party”) at any time declines to share in the costs of
filing, prosecuting and maintaining any such Joint Patent Right, on a country by
country basis, the Declining Party shall provide the other Party (the
“Continuing Party”) with thirty (30) days prior written notice to such effect,
in which event, the Declining Party shall (i) have no responsibility for any
expenses incurred in connection with such Joint Patent Right and (ii) if the
Continuing Party elects to continue prosecution or maintenance, the Declining
Party, upon the Continuing Party’s request, shall execute such documents and
perform such acts, at the Continuing Party’s expense, as may be reasonably
necessary (x) to assign to the Continuing Party all of the Declining Party’s
right, title and interest in and to such Joint Patent Rights and (y) to permit
the Continuing Party to file, prosecute and/or maintain such Joint Patent
Right.

    


    If MEDA
is (i) the sole owner of a Joint Patent Right or (ii) the Continuing Party, such
Joint Patent Right shall no longer be considered to be part of the ULURU
Intellectual Property Rights for purposes of this Agreement and thereafter shall
be part of MEDA’ s intellectual property.

    


    If ULURU
is (i) the sole owner of a Joint Patent Right or (ii) is the Continuing Party,
such Joint Patent Rights shall no longer be considered to be part of MEDA’s
intellectual property for purposes of this Agreement and thereafter shall be
part of the ULURU Intellectual Property Rights.

    


    
      	
              12.4.7.  

            	
              Each
      Party shall, and shall cause its Affiliates, employees, attorneys and
      agents to, cooperate fully with the other Party and provide all
      information and data and execute any documents reasonably required or
      requested in order to allow the other Party to prosecute, file, and
      maintain patents and patent applications pursuant to this Section 12.4.
      Neither Party shall require the other Party to make any payment or
      reimburse for any expenses in connection with such cooperation, provision
      of information and data and execution of
  documents.

            


    

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              12.5.  

            	
              Enforcement of
      Intellectual Property
Rights.

            


    

    


    
      	
              12.5.1.  

            	
              If
      either Party becomes aware of any infringement of any of the Intellectual
      Property Rights, the Trademark, the MEDA Trademark or the validity of any
      of the Intellectual Property Rights, Trademark or the MEDA Trademark is
      challenged by a Third Party in the Territory, such Party will notify the
      other Party in writing to that effect. Any such notice shall include, as
      applicable, evidence to support an allegation of infringement by such
      Third Party.

            


    

    


    
      	
              12.5.2.  

            	
              ULURU
      shall have the first right, but not the obligation, to take action to
      obtain a discontinuance of infringement or bring suit against a Third
      Party infringer of Intellectual Property Rights and/or the Trademark in
      the Territory. Such right shall remain in effect until ninety (90) days
      after the date of notice given under Section 12.5.1. In the event that
      ULURU exercises such right, then: (a) ULURU shall not consent to the entry
      of any judgment or enter into any settlement with respect to such an
      action or suit without the prior written consent of MEDA (not to be
      unreasonably withheld), and (b) ULURU shall bear all the expenses of any
      such suit brought by ULURU claiming infringement of any Intellectual
      Property Rights and/or the Trademark. If, after the expiration of the
      ninety (90) day period, ULURU has not obtained, or is not diligently
      pursuing, a discontinuance of infringement of the Intellectual Property
      Rights and/or the Mark, filed suit against any such Third Party infringer
      of the Intellectual Property Rights and/or the Trademark, or provided MEDA
      with information and arguments demonstrating to MEDA’s reasonable
      satisfaction that there is insufficient basis for the allegation of such
      infringement of the Intellectual Property Rights and/or the Trademark,
      then MEDA shall have the right, but not the obligation, to bring suit
      against such Third Party infringer of the Intellectual Property Rights
      and/or the Trademark and to join ULURU as a party plaintiff, provided that
      MEDA shall bear all the expenses of such suit. In such event, MEDA shall
      not consent to the entry of any judgment or enter into any settlement with
      respect to such an action or suit without the prior written consent of
      ULURU (which consent shall not unreasonably be withheld) if such judgment
      or settlement includes a finding or agreement that such Intellectual
      Property Right and/or the Trademark is invalid or would enjoin or grant
      other equitable relief against
ULURU.

            


    

    


    With
regard to the MEDA Trademark, it is in the sole discretion of MEDA, whether to
take action to obtain a discontinuance of infringement or bring suit against a
Third Party infringer of the MEDA Trademark in the Territory or not to take any
action.

    


    
      	
              12.5.3.  

            	
              Each
      Party shall cooperate (including, without limitation, by executing any
      documents reasonably required to enable the other Party to initiate such
      litigation, testifying when requested or providing relevant documents)
      with the other Party in any suit for infringement of Intellectual Property
      Rights and/or the Trademark brought by the other Party against a Third
      Party in accordance with this Section and shall have the right to consult
      with the other Party and to participate in and be represented by
      independent counsel in such litigation at its own
  expense.

            


    

    


    
      	
              12.5.4.  

            	
              Neither
      Party shall be required pursuant to this Section 12.5 to undertake any
      activities, including, without limitation, legal discovery at the request
      of a Third Party except as may be required by lawful process of a court of
      competent jurisdiction.

            


    

    


    
      	
              12.5.5.  

            	
              Neither
      Party shall incur any liability to the other Party as a consequence of any
      such litigation or any unfavorable decision resulting therefrom,
      including, without limitation, any decision holding any of the patents
      within the Intellectual Property Rights invalid or
      unenforceable.

            


    

    


    
      	
              12.5.6.  

            	
              Any
      recovery obtained by either Party as a result of any such proceeding
      against a Third Party infringer shall be allocated as follows: (a) such
      recovery shall first be used to reimburse each Party for all litigation
      costs in connection with such litigation paid by that Party; and (b) the
      Party bringing the action shall receive the remaining portion of such
      recovery after payment of the amounts specified in clause
    (a).

            


    

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              12.6.  

            	
              MEDA
      Trademarks.

            


    

    


    Subject
to the restrictions in Sections 3.1.4 and 12.1, MEDA shall select and own all
MEDA Trademarks in connection with the marketing, promotion and sale of the
Products in the Territory. MEDA hereby grants to ULURU a limited, non-exclusive,
non-transferable, fully paid, royalty free, sublicensable license in and to all
MEDA Trademarks and copyrights to be contained in any such labeling for the sole
purpose of manufacturing and applying such labels to the Products in the conduct
of ULURU’s obligations hereunder; provided, however, that  ULURU
agrees to cooperate with and offer reasonable assistance to MEDA in facilitating
MEDA’s control of the quality of the Products branded with MEDA’s Trademarks
hereunder; but further provided that in no event is ULURU obligated to provide
such cooperation or assistance in any way that will (i) lower the quality of the
Products below that which ULURU deems acceptable for general commercial
distribution, (ii) be contrary to or in violation of any regulatory or statutory
obligations, or (iii) increase the cost of manufacturing and delivering the
Products hereunder beyond that contemplated by the Parties as of the Effective
Date.

    


    
      	
              12.7.  

            	
              Publications.

            


    

    


    
      	
              12.7.1.  

            	
              The
      Parties recognize that limited rights of review and/or comment exist for
      certain Third Party publications, such as medical, academic and scientific
      publications. Each Party agrees to provide the other Party with any such
      proposed publication or presentation promptly upon its receipt. Each Party
      may advise the other of any comments that it may have relating to such
      proposed publication or presentation and do so within the applicable time
      frame.

            


    

    


    
      	
              12.7.2.  

            	
              During
      the Term of this Agreement, unless otherwise prohibited by law, each Party
      shall submit to the other Party for review and approval any proposed
      publication or public presentation, especially including, without
      limitation, academic, scientific and medical information, which contains
      the non-disclosing Party’s Confidential Information or which disclose any
      non-public information contained within the Intellectual Property Rights
      or which makes any reference to the subject matter of this Agreement or
      the Products.

            


    

    


    
      	
              12.7.3.  

            	
              Written
      copies of each such proposed publication or presentation required to be
      submitted hereunder shall be submitted to the non-disclosing Party no
      later than fifteen (15) days before its intended submission for
      publication or presentation. The non-disclosing Party shall provide its
      comments with respect to such publications and presentations within ten
      (10) business days of its receipt of such written copy. The review period
      may be extended for an additional thirty (30) days in the event the non-
      disclosing Party can demonstrate reasonable need for such extension. By
      mutual agreement of the Parties in writing, this period may be further
      extended.

            


    

    


    
      	
              12.7.4.  

            	
              The
      Parties acknowledge that as publicly held corporations, the Parties may
      not lawfully disclose in advance certain information to any party,
      including, without limitation, the other Party. This may affect the
      Parties’ ability to submit for review certain proposed publications and
      public presentations.

            


    

    


    
      	
              12.7.5.  

            	
              Regarding
      their publications under this Section 12.7, MEDA and ULURU will each
      comply with standard academic practice regarding authorship of scientific
      publications and recognition of contribution of other parties in any
      publication.

            


    

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              13.  

            	
              NOTICES

            


    

    


    
      	
              13.1.  

            	
              Ordinary
      Notices.

            


    

    


    Correspondence,
reports, documentation, and any other communication in writing between the
Parties in the course of ordinary implementation of this Agreement shall be
delivered by hand, sent by facsimile or by overnight courier to the employee or
representative of the other Party who is designated by such other Party to
receive such written communication at the address or facsimile numbers specified
by such employee or representative.

    


    
      	
              13.2.  

            	
              Extraordinary
      Notices.

            


    

    


    
      	
              13.2.1.  

            	
              Extraordinary
      notices and communications (including, without limitation, notices of
      termination, Force Majeure Event, material breach, change of address,
      requests for disclosure of Confidential Information, claims or
      indemnification) shall be in writing and shall be delivered by hand, sent
      by facsimile or by overnight courier (and shall be deemed to have been
      properly served to the addressee upon receipt of such written
      communication) to the address set forth in Section 13.3 or such other
      address as notified in writing by such Party to the other
      Party.

            


    

    


    
      	
              13.3.  

            	
              Addresses.

            


    

    


    If to
ULURU

    


    ULURU Inc.

    4452
Beltway Drive

    Addison

    Texas
75001

    USA

    Attention:
Kerry P. Gray, President & CEO

    Telephone
No: (214) 905-5145

    Facsimile
No.: (214) 905-5130

    


    With a
copy to:

    


    Bingham
McCutchen LLP

    150
Federal Street

    Boston,
MA 02110-1726

    Attention:
General Counsel John J. Concannon III

    Facsimile
No.: (617) 951-8376

    


    If to
MEDA:

    


    MEDA
AB

    Pipers
väg 2

    Box
906

    170 09
Solna

    Sweden

    Attention:Anders
Lönner,CEO

    Telephone:
+46 8 630 19 00

    Facsimile:  +46
8 630 19 19

    


    With a
copy to:

    


    MEDA Pharma GmbH & Co.
KG

    Benzstrasse 1-3

    61352 Bad Homburg

    Germany

    Attention:
General Counsel Hans-Jürgen Kromp

    Telephone
No.: + 49 6172 888 - 2833

    Facsimile
No.:  + 49 6172 888 - 2927

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              14.  

            	
              GENERAL

            


    

    


    
      	
              14.1.  

            	
              Governing
      Law.

            


    

    


    This
Agreement shall be construed in accordance with and governed by the laws of
Switzerland, and to the exclusion of the provisions of the United Nations
Convention on Contracts for the International Sale of Goods.

    


    
      	
              14.2.  

            	
              Dispute Resolution /
      Arbitration Proceedings.

            


    

    


    
      	
              14.2.1.  

            	
              If
      one Party is of the opinion that the other Party has infringed any of its
      Confidential Information under this Agreement, then this Party may
      commence proceedings for infringement in any court of competent
      jurisdiction to enforce the said Confidential Information, including
      without limitation to apply injunctive
relief.

            


    

    


    
      	
              14.2.2.  

            	
              All
      disputes arising out of or in connection with this Agreement (other than
      those which a Party has elected to submit to national courts under Section
      14.2.1) shall first be attempted to be settled between the Parties on a
      good faith basis. If the Parties are unable to resolve the dispute within
      60 (sixty) days from the receipt by one Party of the other Party’s written
      notice asking for such amicable settlement discussions, then such dispute
      shall be finally settled by arbitration in accordance with the
      International Chamber of Commerce (ICC) Rules of Arbitration by three
      arbitrators, appointed in accordance with said rules. The place of
      arbitration shall be Zurich, Switzerland. The proceedings shall be
      conducted and all documentation shall be presented in
    English.

            


    

    


    
      	
              14.3.  

            	
              Assignment.

            


    

    


    This
Agreement shall not be assignable or transferable by either Party without the
prior written consent of the other Party (which consent shall not be
unreasonably withheld); provided that either Party may assign this Agreement and
its rights and obligations hereunder without the other Party’s consent in
connection with the transfer or sale of all or substantially all of the business
of such party to which this Agreement relates (or, if applicable, the business
unit or division of such Party primarily responsible for performance under this
Agreement) to another party, whether by merger, sale of stock, sale of assets or
otherwise; and provided further that in the event any NDA has been filed with
respect to the Products, MEDA shall have the right to assign or sublicense this
Agreement and its rights and obligations hereunder without ULURU’s consent. In
the event that MEDA sublicenses the Agreement or any rights or obligations
hereunder in accordance with the previous sentence, then MEDA shall guaranty the
performance of the sublicensee. In the event that either MEDA or ULURU assigns
this Agreement in accordance with this Section 13.3, then the assigning Party
shall be released from its obligations hereunder and shall have no further
obligations to the other Party pursuant to this Agreement. The rights and
obligations of the parties under this Agreement shall be binding upon and inure
to the benefit of the successors and permitted assigns of the parties. Any
attempted assignment in violation of this Section 13.3 shall be null and void,
without any force or effect.

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

    
      	
              14.4.  

            	
              Entire
      Agreement.

            


    

    


    This
Agreement and all Exhibits attached hereto (as the same may be amended from time
to time by the written agreement of the Parties) constitute the entire agreement
between the Parties with respect to the subject matter hereof and supersedes all
other documents, agreements, verbal consents, arrangements and understandings
between the Parties with respect to the subject matter hereof. This Agreement
shall not be amended orally, but only by an agreement in writing, signed by both
Parties that states that it is an amendment to this Agreement.

    


    
      	
              14.5.  

            	
              Severability.

            


    

    


    If any
term of this Agreement shall be found to be invalid, illegal or unenforceable,
it is the intention of the parties that the remainder of this Agreement shall
not be affected thereby; provided that neither Party’s rights under this
Agreement are materially adversely affected. It is further the intention of the
parties that in lieu of each such provision which is invalid, illegal or
unenforceable, there be substituted or added as part of this Agreement a
provision which shall be as similar as possible in the economic and business
objectives intended by the Parties to such invalid, illegal or unenforceable
provision, but which shall be valid, legal and enforceable. In the event that
either Party’s rights are materially adversely affected as a result of a change
in this Agreement as contemplated by this Section, such Party may terminate this
Agreement by notice in writing to the other Party given no later than sixty (60)
days after such change.

    


    
      	
              14.6.  

            	
              Independent
      Contractor.

            


    

    


    Each
Party shall act as an independent contractor and neither Party shall have any
authority to represent or bind the other Party in any way.

    


    
      	
              14.7.  

            	
              No
      Waiver.

            


    

    


    Any
waiver by one Party of any right of such Party or obligation of the other Party
must be in writing and shall not operate as a waiver of any subsequent right or
obligation.

    


    
      	
              14.8.  

            	
              Counterparts.

            


    

    


    This
Agreement may be executed in two or more counterparts (including, without
limitation, by facsimile transmission), each of which when so executed and
delivered shall be an original, but all of which together shall constitute one
and the same instrument.

    


    


    
      	
              14.9.  

            	
              Exhibits.

            


    

    


    Exhibit
A                      Products

    Exhibit
B                      Facilities
/ Third Party manufacturers

    Exhibit
C                      Quality
Agreement

    Exhibit
D                      Patents

    Exhibit
E                      Specifications

    Exhibit
F                      Intentionally
Omitted

    Exhibit
G                      Pharmacovigilance
Agreement

    Exhibit
H                      Prices

    Exhibit
I                      Licenses
Payments

    Exhibit
J                      MEDA
Trademarks


    
      
         


      

      
         


        
          

        

      

      
         


      

    


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

    


    MEDA AB:

    


    


    By:                  /s/ Anders
Lonner                                           

    Name:                                           Anders
Lönner

    Title:                                           CEO

    


    ULURU
Inc.:

    


    By:                 _/s/ Kerry P.
Gray_______

    Name:                                           Kerry
P. Gray

    Title:                                           President
& CEO


    
      
         


      

      
         


        
          

        

      

      
         


      

    


    EXHIBIT
A

    


    Products

    


    
      	
              Product

            	
              Substance

            	
              Presentation

            
	
              5%
      amlexanox paste

            	
              amlexanox

            	
              3 g
      tube

            
	
              OraDisc
      A (amlexanox)

            	
              amlexanox

            	
              2
      mg (per disc)

            


    

    


    



    
      
         


      

      
         


        
          

        

      

      
         


      

    


    EXHIBIT
B

    


    Facilities
and Third Party manufacturers

    


    APHTHASOLTM

    


    Manufacturing/Packaging

    Contract
Pharmaceuticals Limited

    7600
Danbro Crescent

    Mississauga,
Ontario Canada L5N 6L6

    


    Testing of Raw Materials,
Bulk, Final Product

    Innopharm
Inc.

    1
Valleywood Drive, Suite 100

    Markham,
Ontario L3R 5L9

    


    


    


    


    ORADISC
ATM

    


    Manufacturing

    BioMed
Sciences

    7584
Morris Court

    Allentown,
PA 18106

    


    Packaging

    Catalent
Pharma Solutions

    3001 Red
Lion Road

    Philadelphia,
PA 19114

    


    Raw Material
Testing

    API –
Innopharm

    Raw
Materials

    Celsis
Laboratory Group

    165
Fieldcrest Avenue

    Edison,
NJ 08837

    


    Final
Product

    ULURU
Inc. QC Lab

    4452
Beltway Drive

    Addison,
TX 75001


    
      
         


      

      
         


        
          

        

      

      
         


      

    


    EXHIBIT
C

    


    Quality
Agreement

    See
enclosure (22 pages)


    
      
         


      

      
         


        
          

        

      

      
         


      

    


    


    EXHIBIT
D

    


    Patents

    


    
      	
              TITLE

            	
              SERIALNO/

              PATENT
      NO

            	
              ISSUED

            	
              COUNTRY

            
	
              Use
      of Amlexanox for the Manufacture of a Medicament for Treating Aphthous
      Ulcers

            	
              97202524

              0836852

            	
              4/22/1998

            	
              Austria

            
	
              Use
      of Amlexanox for the Manufacture of a Medicament for Treating Aphthous
      Ulcers

            	
              97202524

              0836852

            	
              4/22/1998

            	
              Belgium

            
	
              Use
      of Amlexanox for the Manufacture of a Medicament for Treating Aphthous
      Ulcers

            	
              97202524

              0836852

            	
              4/22/1998

            	
              Switzerland

            
	
              Use
      of Amlexanox for the Manufacture of a Medicament for Treating Aphthous
      Ulcers

            	
              97202524

              0836852

            	
              4/22/1998

            	
              Germany

            
	
              Use
      of Amlexanox for the Manufacture of a Medicament for Treating Aphthous
      Ulcers

            	
              97202524

              0836852

            	
              4/22/1998

            	
              Denmark

            
	
              Use
      of Amlexanox for the Manufacture of a Medicament for Treating Aphthous
      Ulcers

            	
              97202524

              0836852

            	
              4/22/1998

            	
              Spain

            
	
              Use
      of Amlexanox for the Manufacture of a Medicament for Treating Aphthous
      Ulcers

            	
              97202524

              0836852

            	
              4/22/1998

            	
              France

            
	
              Use
      of Amlexanox for the Manufacture of a Medicament for Treating Aphthous
      Ulcers

            	
              97202524

              0836852

            	
              4/22/1998

            	
              Great
      Britain

            
	
              Use
      of Amlexanox for the Manufacture of a Medicament for Treating Aphthous
      Ulcers

            	
              97202524

              0836852

            	
              4/22/1998

            	
              Greece

            
	
              Use
      of Amlexanox for the Manufacture of a Medicament for Treating Aphthous
      Ulcers

            	
              97202524

              0836852

            	
              4/22/1998

            	
              Italy

            
	
              Use
      of Amlexanox for the Manufacture of a Medicament for Treating Aphthous
      Ulcers

            	
              97202524

              0836852

            	
              4/22/1998

            	
              Luxembourg

            
	
              Use
      of Amlexanox for the Manufacture of a Medicament for Treating Aphthous
      Ulcers

            	
              97202524

              0836852

            	
              4/22/1998

            	
              Monaco

            
	
              Use
      of Amlexanox for the Manufacture of a Medicament for Treating Aphthous
      Ulcers

            	
              97202524

              0836852

            	
              4/22/1998

            	
              Netherlands

            
	
              Use
      of Amlexanox for the Manufacture of a Medicament for Treating Aphthous
      Ulcers

            	
              97202524

              0836852

            	
              4/22/1998

            	
              Portugal

            
	
              Use
      of Amlexanox for the Manufacture of a Medicament for Treating Aphthous
      Ulcers

            	
              97202524

              0836852

            	
              4/22/1998

            	
              Sweden

            


    

    



    
      
         


      

      
         


        
          

        

      

      
         


      

    


    EXHIBIT
E

    


    Specifications

    


    PRODUCT – Amlexanox 5% Oral
Paste

    


    SPECIFICATIONS:

    


    
      	
              Parameter

            	
              Specification

            
	
              Appearance

            	
              Homogenous
      granular beige/tan colored paste free of lumps and foreign particles,
      packaged in tubes

            
	
              Amlexanox
      Identification

            	
              Positive

            
	
              Amlexanox
      Assay

            	
              4.75%
      - 5.25%

            
	
              Benzyl
      Alcohol Assay

            	
              2.25%
      - 2.75%

            
	
              AA-896
      Content

            	
              < 0.005%

            
	
              Viscosity

            	
              0.25
      x 106
      cps – 4.50 x 106
      cps

            
	
              Particle
      Size (<30 μm)

            	
              2 –
      25 μm

            
	
              Fill
      Weight

            	
              5.0
      – 5.8 g

            


    

    


    
      	
              Microbial
      Limits

               

            	 
      
	
              Aerobic
      Plate Count

            	
              < 500 CFU/g

            
	
              Yeast/Molds

            	
              < 100 CFU/g

            
	
              Pseudomonas
      species

            	
              Absent

            
	
              S.
      aureus

            	
              Absent

            
	
              E.
      coli

            	
              Absent

            
	
              Salmonella
      species

            	
              Absent

            


    


    
      
         


      

      
         


        
          

        

      

      
         


      

    


    PRODUCT – Amlexanox Mucoadhesive Patch,
2mg

    


    SPECIFICATIONS:

    


    
      	
              Parameter

            	
              Specification

            
	
              Appearance

            	
              Round,
      1⁄2” diameter patch, red on one side and white on the other
    side

            
	
              Amlexanox
      Content

            	
              2.00±
      0.10 mg

            
	
              Degradants:

              Total

              AA-896

              Unidentified

            	
               

               

              ≤
      0.1% Amlexanox Content

              ≤
      0.1% Amlexanox Content

              ≤
      0.1% Amlexanox Content

               

            
	
              Content
      Uniformity

              (d.u.
      = dosage unit)

            	
              1.70
      – 2.30 mg for at least 9 of 10 d.u. tested, no d.u. outside of 1.50 – 2.50
      mg; RSD ≤6.0%

              OR

              1.70
      – 2.30 mg for at least 27 of 30 d.u. tested, no d.u. outside of 1.50 –
      2.50 mg; RSD ≤7.8%

               

            
	
              Dissolution

            	
              Q = 75% for Amlexanox
      Released in 60 min.

              Acceptance
      per USP<711> Unit Sample

            
	
              Weight

            	
              35
      – 45 mg

            
	
              Microbial
      Limits:

              Aerobic
      Count

              Aerobic
      Spore Count

              Fungi

              E.
      coli

              P.
      aeruginosa

              Salmonella

              S.
      aureus

            	
               

              <10
      CFU/patch

              <10
      CFU/patch

              <10
      CFU/patch

              <10
      CFU/patch

              Negative

              Negative

              Negative

              Negative

            


    

    



    
      
         


      

      
         


        
          

        

      

      
         


      

    


    EXHIBIT
F

    


    Intentionally
Omitted


    
      
         


      

      
         


        
          

        

      

      
         


      

    


    EXHIBIT
G

    


    Pharmacovigilance
Agreement

    


    


    See
enclosure (13 pages)

    



    
      
         


      

      
         


        
          

        

      

      
         


      

    


    EXHIBIT
H

    


    Prices
(in EURO)

    


    5% amlexanox
paste:                                                                Three
(3) gram
tube                                                      €
2.20 (F.O.B.)

    


    OraDisc A
(amlexanox):                                                                           Blister
packs of 20
(2x10)                                                      €
2.20 (F.O.B.)

    


    


    



    
      
         


      

      
         


        
          

        

      

      
         


      

    


    EXHIBIT
I

    


    License
Payments

    


    


    In full
and final consideration of the licenses and the rights granted to MEDA by ULURU
under this Agreement, MEDA shall pay to ULURU the following license
payments:

    


    1.)           License Payments No. 1
(Effective Date)

    


    1.1           On
the Effective Date, MEDA will pay ULURU the following license
payments:

    


    
      	
              ·  

            	
              France                                                100,000
      Euros

            


    

    
      	
              ·  

            	
              Germany                                                100,000
      Euros

            


    

    
      	
              ·  

            	
              Italy                                      100,000
      Euros

            


    

    
      	
              ·  

            	
              United
      Kingdom                                                           100,000
      Euros

            


    

    
      	
              ·  

            	
              Belgium                                                  
      25,000 Euros

            


    

    
      	
              ·  

            	
              Netherlands                                                             50,000
      Euros

            


    

    
      	
              ·  

            	
              Turkey                                                  50,000
      Euros

            


    

    


    
      	
              ·  

            	
              Spain*                                                75,000
      Euros

            


    

    * provided that
Spain, Greece and Portugal will be added to the countries of the Territory
according to Section 3.1.5

    


    
      	
              1.2

            	
              In
      the event that the Regulatory Authorities does not grant the Regulatory
      Approval for OraDiscTM A, for whatever reason, in a country mentioned
      above, ULURU shall pay back to MEDA 50 (fifty) % of the license
      payment for the respective country.

            


    

    


    
      	
              1.3

            	
              For
      the remaining countries of the Territory there are no license payments
      applicable on the Effective Date.

            


    

    


    


    2.)           License Payments No.2
(Launch of Apthasol Paste)

    


    
      	
              2.1

            	
              Upon
      Launch of Apthasol Paste (amlexanox) in the countries mentioned below,
      MEDA will pay ULURU the following license
  payments:

            


    

    


    
      	
              ·  

            	
              Germany                                                200,000
      Euros

            


    

    
      	
              ·  

            	
              United
      Kingdom                                                           200,000
      Euros

            


    

    
      	
              ·  

            	
              Belgium                                                  
      25,000 Euros

            


    

    
      	
              ·  

            	
              Netherlands                                                              25,000
      Euros

            


    

    


    
      	
              2.2

            	
              For
      the remaining countries of the Territory there are no license payments
      applicable upon
      Apthasol Paste.

            


    

    


    


    3.)           License Payments No. 3
(Launch of OraDiscTM A)

    


    
      	
              3.1

            	
              Upon
      Launch of OraDiscTM A in the countries mentioned below, MEDA will pay ULURU
      the following license payments:

            


    

    


    
      	
              ·  

            	
              France                                                500,000
      Euros

            


    

    
      	
              ·  

            	
              Germany                                                300,000
      Euros

            


    

    
      	
              ·  

            	
              Italy                                      500,000
      Euros

            


    

    
      	
              ·  

            	
              United
      Kingdom                                                           300,000
      Euros

            


    

    
      	
              ·  

            	
              Belgium                                                   50,000
      Euros

            


    

    
      	
              ·  

            	
              Netherlands                                                            75,000
      Euros

            


    

    
      	
              ·  

            	
              Turkey                                                 100,000
      Euros

            


    

    


    
      	
              ·  

            	
              Spain*                                                325,000
      Euros

            


    

    * provided that
Spain, Greece and Portugal will be added to the countries of the Territory
according to Section 3.1.5

    


    
      	
              3.2

            	
              For
      the remaining countries of the Territory there are no license payments
      applicable upon launch of OraDiscTM.

            


    

    


    


    
      	
              4.)

            	
              License Payments No. 4
      (Upon achievement of cumulated Net Sales in a calendar
      year)

            


    

    


    
      	
              4.1

            	
              Upon
      the achievement of certain Net Sales of the Products within the countries
      of the Territory in a calendar year, MEDA will pay ULURU the following
      license payments, whereupon it is understood that these license payments
      are to be one time payments:

            


    

    


    
      	
              ·  

            	
              250,000
      Euros (two hundred fifty thousand) when cumulated Net Sales in a calendar
      year is equal to or greater than 5,000,000 Euros (five
      million)

            


    

    


    
      	
              ·  

            	
              500,000
      Euros (five hundred thousand) when cumulated Net Sales in a calendar year
      is equal to or greater than 15,000,000 Euros (fifteen
    million)

            


    

    


    
      	
              ·  

            	
              750,000
      Euros (seven hundred fifty thousand) when cumulated Net Sales in a
      calendar year is equal to or greater than 25,000,000 Euros (twenty five
      million)

            


    

    


    
      	
              ·  

            	
              1.000,000
      Euros (one million) when cumulated Net Sales in a calendar year is
      equal to or greater than 40,000,000 Euros (forty
  million)

            


    

    


    
      	
              4.2

            	
              Cumulative
      Net Sales in the countries of the Territory will be converted from local
      currency into Euros based on currency exchange rates published in the Wall
      Street Journal.

            


    


    
      
         


      

      
         


        
          

        

      

      
         


      

    


    EXHIBIT
J

    


    MEDA
Trademarks

    


    


    
      	
              Country

            	
              Trademark

            
	
              Denmark

            	
              AFTASOL

            
	
              Finland

            	
              AFTASOL

            
	
              Norway

            	
              AFTASOL

            
	
              Sweden

            	
              AFTASOL

            
	
              United
      Kingdom

            	
              Aphtheal

            
	
              United
      Kingdom

            	
              Aftasol

            
	
              Netherlands

            	
              Miraftil

            
	
              Luxembourg

            	
              Miraftil

            
	
              Austria

            	
              Aftasol

            
	
              Ireland

            	
              Aphtheal

            
	
              Germany

            	
              Miraphtil